1 Colo. Code Regs. § 212-3-1-115

Current through Register Vol. 47, No. 24, December 25, 2024

Section 1 CCR 212-3-1-115 - Definitions

Basis and Purpose - 1-115

The statutory authority for this rule includes, but is not limited to, sections 44-10-202(1)(c), 44-10-202(1)(j), and 44-10-103, C.R.S., and all of the Marijuana 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 is not intended to be a defined term, it is not capitalized. This Rule 1-115 was previously Rules M and R 103, 1 CCR 212-1 and 1 CCR 212-2.

Definitions. The following definitions of terms, in addition to those set forth in section 44-10-103, C.R.S., apply to all rules promulgated pursuant to the Marijuana Code, unless the context requires otherwise:

"Acceptability Criteria" means the specified limits placed on the characteristics of an item or method that are used to determine data quality.

"Audited Product" means a Regulated Marijuana Product with an intended use of:

(1) metered dose nasal spray,

(2) vaginal administration, or

(3) rectal administration. Audited Product types may raise public health concerns requiring additional safeguards and oversight. These product types may only be manufactured and Transferred by a Medical Marijuana Products Manufacturer in strict compliance with Rule 5-325 or Retail Marijuana Products Manufacturer in strict compliance with Rule 6-325. Prior to the first Transfer of an Audited Product to a Medical Marijuana Store, Medical Marijuana Cultivation Facility that has obtained a Centralized Distribution Permit, Retail Marijuana Store or Retail Marijuana Cultivation Facility that has obtained a Centralized Distribution Permit, the Medical Marijuana Products Manufacturer or Retail Marijuana Products Manufacturer shall submit to the Division and, if applicable, to the Local Licensing Authority or Local Jurisdiction an independent third-party audit verifying compliance with Rule 5-325 or Rule 6-325. All rules regarding Regulated Marijuana Product apply to Audited Product except where Rules 5-325, 6-325, 4-215, 3-1010, and 3-1015 apply different requirements.

"Cannabinoid" means a class of lipophilic molecules that are naturally occurring in Cannabis sativa L.

"CBD" means cannabidiol.

"CBDA" means cannabidiolic acid.

"Certificate of Analysis" means an official document issued by a Regulated Marijuana Testing Facility that shows results of scientific tests performed on a product.

"Chain of Custody" or "COC" means the chronological documentation that records the sequence of custody, control, transfer, analysis, and disposal of a Test Batch.

"Commercially Reasonable Royalty" means a right to compensation in the form of a royalty payment for the use of intellectual property with a direct nexus to the cultivation, manufacture, Transfer or testing of Regulated Marijuana. A Commercially Reasonable Royalty must be limited to specific intellectual property the Commercially Reasonable Royalty interest owns or is otherwise authorized to license or to a product or line of products. A Commercially Reasonable Royalty must not cause reasonable consumer confusion or violate any federal copyright, trademark or patent law or regulation will not be approved. To determine whether the Commercially Reasonable Royalty 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 product may be sold.

d. The licensor's established policy and marketing program to maintain an 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 their 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.

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.

"Controlling Beneficial Owner" or "CBO" means a Person that satisfies one or more of the following criteria:

a. A natural person, an Entity that is organized under the laws of and for which its principal place of business is located in one of the states or territories of the United States or District of Columbia, a trust, the trustee of a trust, a Publicly Traded Corporation, or a Qualified Private Fund that is not a Qualified Institutional Investor:

i. Acting alone or Acting in Concert, that owns or Acquires Beneficial Ownership of ten percent or more of the Owner's Interest of a Regulated Marijuana Business;

ii. That is an Affiliate that Controls a Regulated Marijuana Business and includes, without limitation, any Manager; or

iii. That is otherwise in a position to Control the Regulated Marijuana Business except as authorized in section 44-10-506 or 44-10-606, C.R.S.; or

b. A Qualified Institutional Investor acting alone or Acting in Concert that owns or Acquires Beneficial Ownership of more than thirty percent of the Owner's Interest of a Regulated Marijuana Business.

c. Unless the context otherwise requires, the defined term Controlling Beneficial Owner includes Direct Beneficial Interest Owner.

"Decontamination" means the process of neutralization or removal of dangerous substances or other contaminants from Regulated Marijuana without changing the product type of the Regulated Marijuana following a failed test.

"Designated Test Batch Collector" means an Owner Licensee or an Employee Licensee who has been designated by a Regulated Marijuana Business and completed training required by Rule 4-225 to engage in Sample Increment Collection for the purpose of creating Test Batches.

"Disproportionate Impacted Area" means a census tract in the top 15th percentile for that state in at least two of the following categories as measured by the United States Census Bureau:

a. the percent of residents in the census tract receiving public assistance;

b. the percent of residents in the census tract falling below the federal poverty level;

c. the percent of residents in the census tract failing to graduate from high school; and

d. the percent of residents in the census tract who are unemployed.

"Edible Regulated Marijuana Product" means any Regulated Marijuana Product for which the intended use is oral consumption, including but not limited to, any type of food, drink, or pill. "Medical Marijuana" or "Retail Marijuana" may be substituted for "Regulated Marijuana" when referring exclusively to either Edible Medical Marijuana Product or Edible Retail Marijuana Product.

"Food-Based Regulated Marijuana Concentrate" means a Regulated Marijuana Concentrate that was produced by extracting Cannabinoids from Regulated Marijuana through the use of propylene glycol, glycerin, butter, olive oil or other typical cooking fats. "Medical Marijuana" or "Retail Marijuana" may be substituted for "Regulated Marijuana" when referring exclusively to either Food-Based Medical Marijuana Concentrate or Food-Based Retail Marijuana Concentrate.

"Genetic Material" means cannabis material used to propagate cannabis plants and includes:

a. Immature Plants containing a delta-9 tetrahydrocannabinol concentration of no more than three-tenths of one percent on a dry-weight basis;

b. Cannabis seeds;

c. Tissue culture; and

d. Small amounts of fragments of the cannabis plant containing a delta-9 tetrahydrocannabinol concentration of no more than three-tenths of one percent on a dry weight basis.

"Heat/Pressure-Based Regulated Marijuana Concentrate" means a Regulated Marijuana Concentrate that was produced by extracting Cannabinoids from Regulated Marijuana through the use of heat and/or pressure. The method of extraction may be used by only a Regulated Marijuana Products Manufacturer and can be used alone or on a Production Batch that also includes Physical Separation-Based Medical Marijuana Concentrate, Physical Separation-Based Retail Marijuana Concentrate, or Solvent-Based Regulated Marijuana Concentrate. "Medical Marijuana" or "Retail Marijuana" may be substituted for "Regulated Marijuana" when referring exclusively to either Heat/Pressure-Based Medical Marijuana Concentrate or Heat/Pressure-Based Retail Marijuana Concentrate.

"Hemp" means the plant Cannabis sativa L. and any part of the plant, including the seeds of the plant and all derivatives, extracts, Cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of no more than three-tenths of one percent on a dry weight basis.

"Hemp Product" means a finished product that contains Hemp and that:

a. Is a cosmetic, a dietary supplement, a food, a food additive, or an herb;

b. Is intended for human use or consumption;

c. Contains any part of the Hemp plant, including naturally occurring Cannabinoids, compounds, concentrates, extracts isolates, or resins;

d. Is produced from Hemp;

e. Contains no more than 1.75 milligrams of tetrahydrocannabinol (THC) per serving; and

f. Contains a ratio of cannabidiol (CBD) to THC of greater than or equal to 15 to one (15:1).

"Identification Badge" means a physical badge issued by the Division to a natural person possessing an Owner License or Employee License, used to verify the identity and license status of the natural persons on the Licensed Premises of a Regulated Marijuana Business.

"Immature Plant" means a nonflowering marijuana plant that is no taller than fifteen inches and no wider than fifteen inches produced from a cutting, clipping or seedling.

"Intoxicating Cannabinoid" means a Cannabinoid that is classified as an Intoxicating Cannabinoid in section 44-10-209, C.R.S., or by the State Licensing Authority by rule, in coordination with the Department of Public Health and Environment.

"Inventory Tracking System" means the required seed-to-sale tracking system that tracks Regulated Marijuana from either the seed or Immature Plant stage until the Regulated Marijuana is sold to a patient at a Medical Marijuana Store or to a consumer at a Retail Marijuana Store, Transferred to a Medical Marijuana Testing Facility or Retail Marijuana Testing Facility, Transferred to a Sampling Manager, Transferred to an Industrial Fiber Products Producer, Transferred to a Pesticide Manufacturer, or destroyed by a Regulated Marijuana Business, or used in a Research Project by a Marijuana Research and Development Facility.

"Inventory Tracking System Trained Administrator" means an Owner Licensee of a Regulated Marijuana Business or an Employee Licensee employed by a Regulated Marijuana Business, each of whom has attended and successfully completed Inventory Tracking System training and has completed any additional training required by the Division.

"Kief" means a subset of Physical Separation-Based Marijuana Concentrate that consists of the resinous crystal-like trichomes that have been physically separated from Regulated Marijuana flower, shake, or trim that results in a higher concentration of Cannabinoids.

"License" means a License, permit, or registration pursuant to the Marijuana Code.

"Marijuana Hospitality Business" means a facility, which may be mobile, licensed to permit the consumption of marijuana pursuant to article 10; rules promulgated pursuant to article 10; and the provisions of an enacted, initiated, or referred ordinance or resolution of the local jurisdiction in which the Licensee operates.

"Material Change" means a change that the Licensee makes to their product's design, cultivation process, or manufacturing process that a Licensee knows, or should reasonably know, could affect the product's quality or ability to comply with the requirements set forth in these Rules including, but not limited to, intended use, testing, and product safety. This includes any change that would require a substantive revision to a Regulated Marijuana Business's Standard Operating Procedures. See Rule 4-230(K) for additional examples of Material Change.

"Medical Marijuana" means marijuana that is grown, processed, and sold pursuant to the provisions of article 10 and for a purpose authorized by section 14 of article XVIII of the state constitution but shall not be considered a nonprescription drug for purposes of section 12-42.5-102(21), C.R.S. or 39-26-717, C.R.S., or an over-the-counter medication for purposes of section 25.5-5-322, C.R.S. If the context requires, Medical Marijuana includes Medical Marijuana Concentrate and Medical Marijuana Products.

"Medical Marijuana Business Operator" means an Entity or Person that is not an owner and that is licensed to provide professional operational services to a Medical Marijuana Business for direct remuneration from the Medical Marijuana Business(es). A Medical Marijuana Business Operator is not, by virtue of its status as a Medical Marijuana Business Operator, a Controlling Beneficial Owner or a Passive Beneficial Owner of any Medical Marijuana Business it operates.

"Medical Marijuana Concentrate" means a subset of Medical Marijuana that is separated from the Medical Marijuana plant and results in matter with a higher concentration of Cannabinoids than naturally occur in the plant. Medical Marijuana Concentrate contains Cannabinoids and may contain terpenes and other chemicals that are naturally occurring in Medical Marijuana plants that have been separated from Medical Marijuana. Medical Marijuana Concentrate may also include residual amounts of the types of solvents, as permitted by the Marijuana Rules. The State Licensing Authority may further define by rule subcategories of Medical Marijuana Concentrate and authorize limited Ingredients based on the method of production of Medical Marijuana Concentrate. Unless the context otherwise requires, Medical Marijuana Concentrate is included when article 10 of the Colorado Revised Statutes refers to Medical Marijuana Product.

"Medical Marijuana Transporter" means an Entity or Person licensed to transport Medical Marijuana and Medical Marijuana Products from one Medical Marijuana Business to another Medical Marijuana Business and to temporarily store the transported Medical Marijuana and Medical Marijuana Products at its Licensed Premises, but is not authorized to sell Medical Marijuana or Medical Marijuana Products under any circumstances.

"Microbial Control Step" means a post-harvest process that is intended to reduce the presence of microbial contaminant(s) in a Harvest Batch or Production Batch that is performed prior to testing consistently on all Harvest Batches or Production Batches of a particular type, strain, or intended use, as documented in the Regulated Marijuana Business's Standard Operating Procedures.

"Penny Stock" means any equity security other than a Security:

a. That is a National Market System stock, provided that:

i. The Security is registered, or approved for registration upon notice of issuance, on a national securities exchange that has been continuously registered as a national securities exchange since April 20, 1992; and the national securities exchange has maintained quantitative listing standards that are substantially similar to or stricter than those listing standards that were in place on that exchange on January 8, 2004; or

ii. The Security is registered, or approved for registration upon notice of issuance, on a national securities exchange, or is listed, or approved for listing upon notice of issuance on, an automated quotation system sponsored by a registered national securities association, that:

A. Has established initial listing standards that meet or exceed the following criteria:

1. The issuer shall have:

(a) stockholders' equity of $5,000,000;

(b) market value of listed Securities of $50 million for 90 consecutive days prior to applying for a listing (market value means the closing bid price multiplied by the number of Securities listed); or

(c) net income of $750,000 (excluding non-recurring items) in the most recently completed fiscal year or in two of the last three most recently completed fiscal years;

2. The issuer shall have an operating history of at least one year or a market value of listed Securities of $50 million (market value means the closing bid price multiplied by the number of Securities listed);

3. The issuer's stock, common or preferred, shall have a minimum bid price of $4 per share;

4. In the case of common stock, there shall be at least 300 round lot holders of the Security (a round lot holder means a holder of a normal unit of trading);

5. In the case of common stock, there shall be at least 1,000,000 publicly held shares and such shares shall have a market value of at least $5 million (market value means the closing bid price multiplied by the number of publicly held shares, and shares held directly or indirectly by an officer or director of the issuer and by any Person who is the Beneficial Owner of more than 10 percent of the total shares outstanding are not considered to be publicly held);

6. In the case of a convertible debt security, there shall be a principal amount outstanding of at least $10 million;

7. In the case of rights and warrants, there shall be at least 100,000 issued and the underlying security shall be registered on a national securities exchange or listed on an automated quotation system sponsored by a registered national securities association and shall satisfy the requirements of paragraphs (a) or (e) of this definition;

8. In the case of put warrants (that is, instruments that grant the holder the right to sell to the issuing company a specified number of shares of the company's common stock, at a specified price until a specified period of time), there shall be at least 100,000 issued and the underlying Security shall be registered on a national securities exchange or listed on an automated quotation system sponsored by a registered national securities association and shall satisfy the requirements of paragraphs (a) or (e) of this definition;

9. In the case of units (that is, two or more Securities traded together), all component parts shall be registered on a national securities exchange or listed on an automated quotation system sponsored by a registered national securities association and shall satisfy the requirements of paragraphs (a) or (e) of this definition; and

10. In the case of equity Securities (other than common and preferred stock, convertible debt securities, rights and warrants, put warrants, or units), including hybrid products and derivative products, the national securities exchange or registered national securities association shall establish quantitative listing standards that are substantially similar to those found in paragraph (a)(ii) of this definition; and

B. Has established quantitative continued listing standards that are reasonably related to the initial listing standards set forth in paragraph (a)(ii) of this definition, and that are consistent with the maintenance of fair and orderly markets;

b. That is issued by an investment company registered under the Federal Investment Company Act of 1940;

c. That is a put or call option issued by the Options Clearing Corporation;

d. That has a price of five dollars ($5.00) or more;

i. For purposes of this paragraph (d):

A. A Security has a price of five dollars or more for a particular transaction if the Security is purchased or sold in that transaction at a price of five dollars or more, excluding any broker or dealer commission, commission equivalent, mark-up, or mark-down; and

B. Other than in connection with a particular transaction, a Security has a price of five dollars or more at a given time if the inside bid quotation is five dollars or more; provided, however, that if there is no such inside bid quotation, a Security has a price of five dollars or more at a given time if the average of three or more interdealer bid quotations at specified prices displayed at that time in an interdealer quotation system, by three or more market makers in the Security, is five dollars or more.

C. The term "inside bid quotation" shall mean the highest bid quotation for the Security displayed by a market maker in the Security on an automated interdealer quotation system that has the characteristics set forth in section 17B(b)(2) of the Federal Securities Exchange Act of 1934, or such other automated interdealer quotation system designated by the Federal Securities Exchange Commission for purposes of this definition, at any time in which at least two market makers are contemporaneously displaying on such system bid and offer quotation for the Security at specified prices.

ii. If a Security is a unit composed of one or more Securities, the unit price divided by the number of shares of the unit that are not warrants, options, rights, or similar Securities must be five dollars or more as determined in accordance with paragraph (d)(i), and any share of the unit that is a warrant, option, right, or similar security, or a convertible security, must have an exercise price or conversion price of five dollars or more;

e. That is registered, or approved for registration upon notice of issuance, on a national securities exchange that makes transaction reports available provided that:

i. Price and volume of information with respect to transactions in that security is required to be reported on a current and continuing basis and is made available to vendors of market information pursuant to the rules of the national securities exchange;

ii. The Security is purchased or sold in a transaction that is effected on or through the facilities of the national securities exchange, or that is part of the distribution of the Security; and

iii. The Security satisfies the requirements of paragraphs (a)(i) or (a) (ii);

f. That is a security futures product listed on a national securities exchange or an automated quotation system sponsored by a registered national securities association; or

g. Whose issuer has:

i. Net tangible assets in excess of $2,000,000, if the issuer has been in continuous operation for at least three years, or $5,000,000 if the issuer has been in continuous operation for less than three years; or

ii. Average revenue of at least $6,000,000 for the last three years.

"Production Batch" means

(a) any amount of Regulated 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 Medical Marijuana or Retail Marijuana; or

(b) any amount of Regulated Marijuana Product of the same exact type, produced using the same Ingredients, Standard Operating Procedures, and the same Harvest Batch(es) of Harvested Marijuana (single strain or multiple strain) and/or Production Batch(es) of Regulated Marijuana Concentrate; or

(c) any amount of Pre-Rolled Marijuana or Infused Pre-Rolled Marijuana of the same exact type, produced using the same ingredients, Standard Operating Procedures, and the same Harvest Batch(es) of Regulated Marijuana Concentrate.

"Professional Engineer" means a natural person who is licensed by the State of Colorado as a professional engineer pursuant to article 120 of title 12 of the Colorado Revised Statutes.

"Proficiency Testing" means an assessment of the performance of a Medical Marijuana Testing Facility's or Retail Marijuana Testing Facility's methodology and processes. Proficiency Testing is also known as inter-laboratory comparison. The goal of Proficiency Testing is to ensure results are accurate, reproducible, and consistent.

"Propagation" means the reproduction of Regulated Marijuana plants.

"Publicly Traded Corporation" means any Person other than an individual that is organized under the laws of and for which its principal place of business is located in one of the states or territories of the United States or District of Columbia or another country that authorizes the sale of marijuana that:

a. Has a class of Securities registered pursuant to 15 U.S.C. sec. 77a et seq., that:

i. Constitutes Covered Securities; or

ii. Is qualified and quoted on the OTCQX or OTCQB tier of the OTC markets if:

A. The Person is then required to file reports and is filing reports on a current basis with the Federal Securities Exchange Commission pursuant to 15 U.S.C. sec. 78a et seq., as if the Securities constituted Covered Securities; and

B. The Person has established and is in compliance with corporate governance measures pursuant to corporate governance obligations imposed on Securities qualified and quoted on the OTCQX tier of the OTC markets.

b. Is an Entity that has a class of Securities listed on the Canadian Securities Exchange, Toronto Stock Exchange, TSX Venture Exchange, or NEO Exchange, if:

i. The Entity constitutes a Foreign Private Issuer whose Securities are exempt from registration pursuant to 15 U.S.C. sec. 78a et seq., pursuant to 17 CFR 240.12g3-2 ; and

ii. The Entity has been, for the preceding three hundred sixty-five days or since the formation of the Entity, in compliance with all governance and reporting obligations imposed by the relevant exchange on such Entity; or

c. Publicly Traded Corporation does not include:

i. An Ineligible Issuer, unless such Publicly Traded Corporation satisfies the definition of Ineligible Issuer solely because it is one or more of the following, and the Person is filing reports on a current basis with the Federal Securities and Exchange Commission pursuant to 15 U.S.C. sec. 78a et seq., as if the Securities constituted Covered Securities, and prior to becoming a Publicly Traded Corporation, the Person for at least two years was licensed by the State Licensing Authority as a Regulated Marijuana Business with a demonstrated history of operations in the state of Colorado, and during such time was not subject to suspension or revocation of the business license:

A. a Blank Check Company;

B. an issuer in an offering of Penny Stock; or

C. a Shell Company.

ii. A Person disqualified as a Bad Actor.

"Qualified Institutional Investor" means:

a. A bank as defined in 15 U.S.C. sec. 78c (a)(6), if the bank is current in all applicable reporting and record-keeping requirements under such act and rules promulgated thereunder;

b. A bank holding company as defined in 12 U.S.C. sec. 1841 (a)(1), if the bank holding company is registered and current in all applicable reporting and record-keeping requirements under such act and rules promulgated thereunder;

c. An insurance company as defined in 15 U.S.C. sec. 80a-2 (a)(17), if the insurance company is current in all applicable reporting and record-keeping requirements under such act and rules promulgated thereunder;

d. An investment company registered and subject to 15 U.S.C. sec. 80a-1, et seq., if the investment company is current in all applicable reporting and record-keeping requirements under such act and rules promulgated thereunder;

e. An employee benefit plan or pension fund subject to 29 U.S.C. sec. 1001 et seq., excluding an employee benefit plan or pension fund sponsored by a Licensee or an intermediary or holding company Licensee which directly or indirectly owns ten percent or more of a Licensee;

f. A state or federal government pension plan; or

g. A group comprised entirely of persons specified in (a) through (g) of this definition; or

h. Any other entity identified by rule by the state licensing authority.

"Reduced Testing Allowance" means the allowance for a Regulated Marijuana Business to conduct less testing than otherwise required by Rules 4-215 and 4-230 upon demonstrating that Standard Operating Procedures and production practices result in consistent passing test results over a time frame established in Rules 4-215 and 4-230.

"Remediation" means the process of neutralization or removal of dangerous substances or other contaminants from Regulated Marijuana while changing the product type of the regulated marijuana following a failed test.

"Retail Food Establishment" means a retail operation that stores, prepares, or packages food for human consumption or serves or otherwise provides food for human consumption to consumers directly or indirectly through a delivery service, whether such food is consumed on or off the premises or whether there is a charge for such food.

"Retail food establishment" does not mean:

a. Any private home;

b. Private boarding house;

c. Hospital and health facility patient feeding operations licensed by the department of public health and environment;

d. Child care centers and other child care facilities licensed by the department of human services;

e. Hunting camps and other outdoor recreation locations where food is prepared in the field rather than at a fixed based of operation;

f. Food or beverage wholesale manufacturing, processing, or packaging plants, or portions thereof, that are subject to regulatory controls under state or federal laws or regulations;

g. Motor vehicles used only for the transport of food;

h. Establishments preparing and serving only hot coffee, hot tea, instant hot beverages, and non-potentially hazardous doughnuts or pastries obtained from sources complying with all laws related to food and food labeling;

i. Establishments that handle only non-potentially hazardous prepackaged food and operations serving only commercially prepared, prepackaged foods requiring no preparation other than the heating of the food within its original container or package;

j. Farmers markets and roadside markets that offer only uncut fresh fruit and vegetables for sale;

k. Automated food merchandising enterprises that supply only prepackaged non-potentially hazardous food or drink in bottles, cans, or cartons only, and operations that dispense only chewing gum or salted nuts in their natural protective covering;

l. The donation, preparation, sale, or service of food by a nonprofit or charitable organization in conjunction with an event or celebration if such donation, preparation, sale, or service of food:

i. Does not exceed the duration of the event or celebration or a maximum of fifty-two days within a calendar year; and

ii. Takes place in the county in which such nonprofit or charitable organization resides or is principally located.

m. A home, commercial, private, or public kitchen in which a person produces food products sold directly to consumers pursuant to the "Colorado Cottage Foods Act," section 25-4-1614, C.R.S.

"Retail Marijuana Business Operator" means an Entity or Person that is not an owner and that is licensed to provide professional operational services to a Retail Marijuana Businesses for direct remuneration from the Retail Marijuana Business.

"Retail Marijuana Concentrate" means a subset of Retail Marijuana that is separated from the Retail Marijuana plant and results in matter with a higher concentration of Cannabinoids than naturally occur in the plant. Retail Marijuana Concentrate contains Cannabinoids and may contain terpenes and other chemicals that are naturally occurring in Retail Marijuana plants that have been separated from Retail Marijuana. Retail Marijuana Concentrate may also include residual amounts of the types of solvents, as permitted by the marijuana rules. The State Licensing Authority may further define by rule subcategories of Retail Marijuana Concentrate and authorize limited Ingredients based on the method of production of Retail Marijuana Concentrate. Unless the context otherwise requires, Retail Marijuana Concentrate is included when article 10 of the Colorado Revised Statutes refers to Retail Marijuana Product.

"Retail Marijuana Cultivation Facility" means an Entity licensed to cultivate, prepare, and package Retail Marijuana and sell Retail Marijuana to Retail Marijuana Stores, to Retail Marijuana Products Manufacturers, and to other Retail Marijuana Cultivation Facilities, but not to consumers.

"Retail Marijuana Hospitality and Sales Business" means a facility, which cannot be mobile, licensed to permit the consumption of only the Retail Marijuana or Retail Marijuana Products it has sold pursuant to the provisions of an enacted, initiated, or referred ordinance or resolution of the local jurisdiction in which the Licensee operates.

"Safe Harbor Hemp Product" means a hemp-derived compound or Cannabinoid, whether a finished product or in the process of being produced, that is permitted to be manufactured for distribution, produced for distribution, packaged for distribution, processed for distribution, prepared for distribution, treated for distribution, transported for distribution, or held for distribution in Colorado for export from Colorado but that is not permitted to be sold or distributed in Colorado.

"Semi-synthetic Cannabinoid" means a substance that is created by a chemical reaction that converts one Cannabinoid extracted from a cannabis plant directly into a different Cannabinoid.

a. Semi-synthetic Cannabinoid includes Cannabinoids, such as cannabinol (CBN) that was produced by the conversion of cannabidiol (CBD).

b. Semi-synthetic Cannabinoid does not include Cannabinoids produced via decarboxylation of naturally occurring acidic forms of Cannabinoids, such as tetrahydrocannabinolic acid, into the corresponding neutral Cannabinoid, such as THC, through the use of heat or light, without the use of chemical reagents or catalysts, and that results in no other chemical change.

"Social Equity Licensee" means a natural person who:

a. On or before February 1, 2025, submits an application for a finding of suitability and meets the criteria established pursuant to section 44-10-308(4), C.R.S.; and

b. On and after February 1, 2025, submits an application for a finding of suitability and meets the criteria established pursuant to section 44-10-308(6), C.R.S.

A person qualified as a Social Equity Licensee may participate in the accelerator program established pursuant to the Marijuana Code or may hold a Regulated Marijuana Business License or permit issued pursuant to the Marijuana Code.

"Solvent-Based Regulated Marijuana Concentrate" means a Regulated Marijuana Concentrate that was produced by extracting Cannabinoids from Regulated Marijuana through the use of a solvent approved by the Division pursuant to Rule 5-315 and Rule 6-315. "Medical Marijuana" or "Retail Marijuana" may be substituted for "Regulated Marijuana" when referring exclusively to either Solvent-Based Medical Marijuana Concentrate or Solvent-Based Retail Marijuana Concentrate.

"Standard Operating Procedure" (SOP) means a written document detailing instructions for the methods required to be followed for the routine performance of operations, analysis, or tasks. An SOP must include a clear and unique title, a purpose explaining the reason for the SOP and its scope. It must list all materials and equipment required to complete the procedure and provide definitions for any ambiguous, unclear or abbreviated terms. It must also delegate responsibilities by specifying individuals or job titles responsible for overseeing and completing the procedure. The procedure section must be a detailed step-by-step instruction dictating how and when an operation is routinely performed. Health and safety guidelines or protocols must be outlined. Any additional documents, forms, or references needed to complete the task or used to create the task must be included in an appendix or reference section. The SOP must also document all revisions and updates.

"Synthetic Cannabinoid" means a Cannabinoid-like compound that was produced by using chemical synthesis, chemical modification, or chemical conversion, including by using in-vitro biosynthesis or other bioconversion of such a method.

a. Synthetic Cannabinoid does not include:

i. A compound produced through the decarboxylation of naturally occurring Cannabinoids from their acidic forms; or

ii. A semi-synthetic Cannabinoid.

"Target Potency" means the potency that a Medical Marijuana Products Manufacturer intends for an individual Medical Marijuana Product, or a Retail Marijuana Products Manufacturer intends for an individual Retail Marijuana Product, prior to testing, which is also outlined in the Licensee's Standard Operating Procedures.

"Total CBD" means the sum of the percentage by weight of CBDA multiplied by 0.877 plus the percentage by weight of CBD i.e., Total CBD= (%CBDA x 0.877) + %CBD.

"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 Regulated Marijuana from one Licensee to another Licensee, to a patient, to a consumer, or to any other permitted Persons. A Transfer includes the movement of Regulated Marijuana 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 in the Inventory Tracking System, even if no physical movement of the Regulated Marijuana occurs.

"Vegetative" means the state of the cannabis plant after it is an Immature Plant but before it is Flowering. During this phase, the plant is typically developing roots, stems, stalks, and leaves, and is not producing flowers or seeds.

1 CCR 212-3-1-115

42 CR 23, December 10, 2019, effective 1/1/2020

43 CR 21, November 10, 2020, effective 1/1/2021

44 CR 07, April 10, 2021, effective 5/1/2021

44 CR 13, July 10, 2021, effective 8/1/2021

44 CR 23, December 10, 2021, effective 1/1/2022

45 CR 21, November 10, 2022, effective 12/1/2022

46 CR 23, December 10, 2023, effective 1/8/2024

47 CR 17, September 10, 2024, effective 8/7/2024, exp. 12/4/2024 (Emergency)

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