18-691-10 Me. Code R. § 1

Current through 2024-51, December 18, 2024

Section 691-10-1 - Administrative

The rules governing the adult use cannabis program establish the requirements for becoming a licensed cannabis establishment, including fees, application and licensing processes, and procedures for cultivation, manufacture, sample collection, testing, and retail sale of adult use cannabis and adult use cannabis products. The activities described in the rules governing the adult use cannabis program may be considered a violation of federal law. Persons cultivating, manufacturing, collecting samples of, testing, selling, purchasing, or otherwise receiving adult use cannabis or adult use cannabis products may be subject to federal sanctions for what may otherwise be considered authorized conduct in the State of Maine, and compliance with the rules governing the adult use cannabis program does not exempt licensees, their employees, or customers from possible federal prosecution. The Department is not responsible or liable for the actions of licensed cannabis establishments under the rule.

(1)Statutory Authority. The Department of Administrative and Financial Services (referred heretofore as the Department), acting through its Office of Cannabis Policy, has developed the rules governing the adult use cannabis program in accordance with the statutory authority provided in Title 28-B, §104-C for the purpose of implementing, administering and enforcing the provisions of 28-B MRS, ch. 1.

(2)Department Authority. The Department may enforce this rule and all other rules governing the adult use program and any relevant provisions of 4 MRS,5 MRS, 28-B MRS, and other general statutes, laws, executive orders, or subsequently passed legislation. The Department shall set licensing fees in accordance with 28-B MRS §207. As applicable, the Department may delegate authority to appropriate state and local agencies. The Department, or an agent thereof, shall have the authority to inspect, during business hours any cannabis establishment, vehicles used to transport cannabis, cannabis products, or inventory tracking system records.

(3)Communication with Department.

(A)Written Communications. If an applicant or licensee is required to or elects to submit anything in writing to the Department, unless otherwise prescribed by the Department, the applicant or licensee may submit the writing to the Department via:

(1) Mail;

(2) In-person delivery;

(3) Facsimile; or

(4) E-mail.

(B)Submission Deadline. If a written notification must be submitted by a deadline it must be received by the Department, regardless of the method used to submit the writing, by 5:00 p.m. Eastern Time (ET)

(4)Definitions.

Action level: "Action level" means the threshold value for determining whether a sample passes or fails an analytical test.

Active license: "Active license" means a license issued by the Department that authorizes cultivation, sample collection, testing, manufacture or sale of cannabis, or cannabis products in accordance with 28-B MRS and the rules governing the adult use cannabis program, including a provisional active license to operate a cannabis testing facility.

Adult use cannabis: "Adult use cannabis" means cannabis cultivated, manufactured, tested, distributed, or sold by a cannabis establishment. Unless otherwise specified, all references throughout this rule and the rules governing the adult use cannabis program to "cannabis" are referring to "adult use cannabis".

Adult use cannabis product: "Adult use cannabis product" means a cannabis product that is manufactured, distributed, or sold by a cannabis establishment.

Advertising: "Advertising" means publicizing the trade name of a licensee together with words or symbols referring to cannabis or publicizing the brand or logo of cannabis or cannabis products.

Analyst: "Analyst" means the designated individual who tests the samples by performing the "hands-on" analytical methods and associated techniques. The analyst is responsible for applying required testing facility practices and other pertinent quality controls to meet the required level of quality.

Analyte: "Analyte" means a chemical, compound, element, bacteria, yeast, fungus, or toxin that is identified or measured.

Another jurisdiction: "Another jurisdiction" means the Federal Government, the United States military, the District of Columbia, the Commonwealth of Puerto Rico, the Commonwealth of the Northern Mariana Islands, the United States Virgin Islands, Guam, American Samoa, and each of the several states of the United States except Maine.

Applicant: "Applicant" means a person who submits an application for a license, or as applicable, an individual identification card, under the rules governing the adult use cannabis program to the Department for review that the Department has not yet approved or denied.

Batch: "Batch" means:

(1) A harvest batch; or

(2) A production batch.

Batch number: "Batch number" means a distinct group of numbers, letters or symbols, or any combination thereof, assigned to a specific batch of cannabis by a cultivation facility, sample collector, testing facility, or a cannabis store or to a specific batch of cannabis or cannabis products by a products manufacturing facility, sample collector, testing facility, or a cannabis store.

Best Practices Guide: "Best Practices Guide" means the Best Practices for the Sampling of Adult Use Cannabis, Version 3.1, dated September 11, 2020, published by the Department available at: https://www.maine.gov/dafs/ocp/sites/maine.gov.dafs.ocp/files/inline-files/AUMP_Mandatory_Testing-Best_Practice_Guide_Sample_Collection.pdf which is incorporated herein by reference. All licensees and any employee of a licensee collecting samples of cannabis, cannabis concentrate, or cannabis products for mandatory testing must collect samples in accordance with the best practices described in the guide.

Brand: "Brand" means a name, term, design, or symbol that identifies a licensee's or licensed goods or services as distinct from those of other licensees or brands.

Business entity: "Business entity" means a partnership, association, company, corporation, limited liability company, or other entity incorporated or otherwise formed or organized by law. "Business entity" does not include a federal, state, or municipal government organization.

Business hours: "Business hours" means 9 A.M. to 5 P.M. Monday through Friday.

Cannabinoid: "Cannabinoid" means a chemical compound that is unique to, and derived from, cannabis.

Cannabis: "Cannabis" means the leaves, stems, flowers and seeds of a cannabis plant, whether growing or not. "Cannabis" includes cannabis concentrate, except where context indicates otherwise, but does not include hemp as defined in 7 MRS §2231, or a cannabis product.

Cannabis concentrate: "Cannabis concentrate" means the resin extracted from any part of a cannabis plant and every compound, manufacture, salt, derivative, mixture or preparation from such resin, including, but not limited to, hashish. In determining the weight of cannabis concentrate in a cannabis product, the weight of any other ingredient combined with cannabis or cannabis concentrate to prepare the cannabis product may not be included.

Cannabis drink: "Cannabis drink" means a liquid edible cannabis product with a concentration of less than 1 mg of THC per ounce of liquid.

Cannabis establishment: "Cannabis establishment" means a cultivation facility, a products manufacturing facility, a testing facility, a sample collector, or a cannabis store licensed under 28-B MRS and the rules governing the adult use cannabis program.

Cannabis extraction: "Cannabis extraction" means the process of extracting cannabis concentrate from cannabis using water, lipids, gases, solvents, or other chemicals or chemical processes.

Cannabis flower: "Cannabis flower" means the pistillate reproductive organs of a mature cannabis plant, whether processed or unprocessed, including the flowers and buds of the plant. "Cannabis flower" does not include cannabis trim or whole mature cannabis plants, but does include kief.

Cannabis plant: "Cannabis plant" means all species of the plant genus cannabis, including, but not limited to, a mother plant, a mature cannabis plant, an immature cannabis plant, or a seedling but it does not include a cannabis product or "hemp" as defined in 7 MRS §2231.

Cannabis product: "Cannabis product" means a product composed of cannabis or cannabis concentrate and other ingredients that is intended for use or consumption. "Cannabis product" includes, but is not limited to, an edible cannabis product, a cannabis ointment, and a cannabis tincture. "Cannabis product" does not include cannabis concentrate.

Cannabis store: "Cannabis store" means a facility licensed under the rules governing the adult use cannabis program to purchase cannabis, immature cannabis plants and seedlings from a cultivation facility, to purchase cannabis and cannabis products from a products manufacturing facility, to collect and transport samples of cannabis, cannabis concentrate, and cannabis products in that cannabis store's possession for mandatory testing, and to sell cannabis, cannabis products, immature cannabis plants, and seedlings to consumers.

Cannabis Testing Facility or Testing Facility: "Cannabis testing facility" or "testing facility" means an entity licensed according to 28-B MRS §503, including those also registered as cannabis testing facilities in accordance with 22 MRS §2423-A, to test cannabis, cannabis products, and other substances for research and development and to analyze contaminants in and the potency and cannabinoid profile of samples in an approved location. A cannabis testing facility is authorized to collect samples of cannabis, cannabis concentrate, and cannabis products without a separate sample collector license in accordance with Rules for the Certification of Cannabis Testing Facilities, 18-691 CMR, ch. 5.

Cannabis trim: "Cannabis trim" means any part of a cannabis plant, whether processed or unprocessed, that is not cannabis flower or a cannabis seed, except that "cannabis trim" does not include the stalks or roots of the cannabis plant.

Cannabis waste: "Cannabis waste" means cannabis, cannabis plants, or cannabis products that are unfit for retail sale for reasons including, without limitation, failed mandatory testing, expired products, or crop failure.

Caregiver: "Caregiver" has the same meaning as in 22 MRS §2421-A(11).

Certificate of analysis: "Certificate of analysis" means the report prepared for requests for testing by a party, for the Department about the analytical testing performed, and for results obtained by the cannabis testing facility.

Certification: "Certification" means the process by which an agency or organization evaluates and recognizes a cannabis testing facility as meeting certain predetermined qualifications or standards, thereby certifying the cannabis testing facility. The Department of Health and Human Services (DHHS) and Center for Disease Control and Prevention (CDC) are responsible for certification of all cannabis testing facilities.

Chain of custody form: "Chain of custody form" means a record, either paper-based or electronic, that documents the possession of the samples at the time of receipt by the cannabis testing facility, in accordance with chain of custody protocol prescribed by the cannabis testing facility. This record, at a minimum, must include: the sample location; the number and types of containers; the mode of collection; the name of the authorized individual who collected the sample; and the date and time of collection, preservation, and requested analyses.

Chain of custody protocols: "Chain of custody protocols" means the procedures developed and employed by the cannabis testing facility to record the possession of samples from the time of sampling through the retention time specified by the client or program. These procedures are performed at the special request of the client and include the use of a chain of custody form that documents the collection, transport, and receipt of compliance samples by the cannabis testing facility. In addition, these protocols document all handling of the samples within the cannabis testing facility and, if applicable, by the sample collector or self-sampler.

CBD: "CBD" means cannabidiol.

Child-resistant: "Child-resistant" means, with respect to packaging or a container:

(1) Specially designed or constructed to be significantly difficult for a typical child under five years of age to open and not to be significantly difficult for a typical adult to open and reseal; and

(2) With respect to any product intended for more than a single use or that contains multiple servings, resealable.

Co-location: "Co-location" means the siting of multiple adult use licensees or an adult use licensee with a registered caregiver or registered dispensary within a licensed premises.

Conditional license: "Conditional license" is a license issued by the Department that authorizes the licensee to seek local authorization to operate a cultivation facility, testing facility, products manufacturing facility, or cannabis store. The conditional license does not authorize possession, transfer, cultivation, testing, manufacture or sale of cannabis or cannabis products.

Consumer sample: "Consumer sample" means a sample of adult use cannabis flower, an edible cannabis product or a cannabis vape cartridge that is provided by a cannabis store to a consumer who is at least 21 years of age for no remuneration at the request of, or with affirmative consent from, the adult use consumer. Each of the following is one consumer sample:

(1) 0.5 grams of cannabis flower, whether as unprocessed flower or as an uninfused, raw pre-rolled cannabis cigarette that contains only cannabis flower and trim;

(2) One serving of an edible cannabis product that does not contain more than 10 milligrams of THC;

(3) One cannabis vape cartridge that contains 0.5 grams or less of cannabis concentrate.

Contaminant: "Contaminant" means an unacceptable level of an unwanted or objectionable substance, toxin, pollution, or foreign material that causes impurity in a product. Contaminants include, but are not limited to, pesticides, microbiology, filth, heavy metals, and residual chemical solvents.

Container: "Container" means a sealable package in which cannabis or a cannabis product is placed in that meets all applicable packaging, labeling, and health and safety requirements of the rules governing the adult use cannabis program.

Controlled entry area: "Controlled entry area" means an indoor entry area directly inside the licensed premises of a cannabis store, containing the door leading to a public right of way that is used for the purpose of verifying the identification and age of an adult use consumer prior to the consumer's entry to the sales area of the cannabis store. The controlled entry area shall be conspicuous and make it apparent to consumers that entry to the retail sales area is not permitted until identification and appropriate age is verified.

Criminal justice agency: "Criminal justice agency" has the same meaning as in 16 MRS §803(4).

Cultivation: "Cultivation" or "cultivate" means the planting, propagation, growing, harvesting, drying, curing, grading, trimming, or other processing of cannabis for use or sale. "Cultivation" or "cultivate" does not include manufacturing, testing, or cannabis extraction.

Cultivation facility: "Cultivation facility" means a facility licensed under the rules governing the adult use cannabis program to purchase cannabis plants and seeds from other cultivation facilities; to cultivate, prepare, and package cannabis; to collect and transport samples of cannabis cultivated by that facility for mandatory testing; to sell cannabis to products manufacturing facilities, to cannabis stores, and to other cultivation facilities; to sell cannabis plants and seeds to other cultivation facilities; to sell immature cannabis plants and seedlings to cannabis stores; and as applicable, to conduct sales to consumers by delivery. A cultivation facility includes a nursery cultivation facility. Licensees that cultivate cannabis in a nursery cultivation facility may sell an unlimited number of cannabis seeds and a sum total of twelve seedlings and immature plants to a consumer 21 years of age or older.

Cultivation plan: "Cultivation plan" means the information regarding an applicant's cultivation activities listed in a conditional application for a license to operate a cultivation facility and facility plan required for an active license to operate a cultivation facility; including a nursery cultivation facility.

Curbside pickup: "Curbside pickup" means retrieval of a sales order containing cannabis and/or cannabis products at an outdoor area, included within the licensed premises of a cannabis store or immediately adjacent to the primary public ingress and egress of the cannabis store, designated for curbside pickup by a consumer 21 years of age or older.

Custodian: "Custodian" means the person who has legal custody and power over the person of a child who is under 18 years of age.¹

Delivery: "Delivery" means the transportation by a tier 1, tier 2, and nursery cultivation facility, products manufacturing facility, and cannabis store licensee, from the licensed premises of the cannabis store to a private residence or business, as applicable in accordance with the rules governing the adult use cannabis program, of sales orders of cannabis and cannabis products to consumers 21 years of age or older who request such sales orders through a telephonic or internet-based platform.

Department: "Department" means the Department of Administrative and Financial Services.

Department of Agriculture, Conservation and Forestry (DACF): "Department of Agriculture, Conservation and Forestry" or "DACF" means the Maine Department of Agriculture, Conservation and Forestry that includes the Board of Pesticides Control ("BPC") and the Division of Quality Assurance and Regulations that issues food establishment licenses and oversees the certification of scales used for commercial purposes.

Department of Health and Human Services (DHHS): "Department of Health and Human Services (DHHS)" means the Maine Department of Health and Human Services. DHHS includes the Maine Center for Disease Control and Prevention (CDC), which certifies, through its Maine Cannabis Testing Facility Certification Program, the technology and testing methods used by cannabis testing facilities under the rules governing the adult use cannabis program.

Direct or Indirect Financial Interest: "Direct or Indirect Financial Interest" means any interest in a sole proprietorship or business entity that is applying for or holds a cannabis establishment license, including without limitation:

(1)Equity Owners. Proprietors, partners, shareholders, persons with membership interests, and persons with any other equity ownership interests, such as purchase warrants or options, whether whole or partial. If the equity owner is a business entity, all business entities and natural persons who have an aggregate ownership interest in that equity owner business entity of 5% or more are deemed to be indirect financial interests of the applicant or cannabis establishment licensee.

(2)Other Equity Ownership. Any employee, independent contractor, professional, or other person who has an agreement with the applicant or licensee that provides for the person's attaining any form of equity ownership. Except that employee equity ownership vested pursuant to an employee stock ownership program is governed by paragraph 4. If the other equity owner is a business entity, all business entities and natural persons who have an aggregate ownership interest in that other equity owner business entity of 5% or more are deemed to be indirect financial interests of the applicant or cannabis establishment licensee.

(3)Non-Owner Interests. All persons who expect to receive financial payment in the form of royalty payments, profit sharing, revenue sharing, or similar payment, such as, but not limited to royalty license partners, parties to a profit sharing agreement, capital investors, and management contractors or consultants. If the non-owner interest is a business entity, all business entities and natural persons who have an aggregate ownership interest in that non-owner interest business entity of 5% or more are deemed to be indirect financial interest holders of the applicant or cannabis establishment licensee.

(4)Employee Stock Ownership Program (ESOP). Any shares designated solely for inclusion in a portion of shares reserved for employees of the licensee for the purpose of vesting an equity ownership interest in an employee or employees of the licensee. A licensee offering an ESOP must designate a percentage of equity ownership interests for the ESOP and must report annually the identity of any person holding an equity interest in the licensee through the ESOP.

Disqualifying drug offense: "Disqualifying drug offense" means a conviction for a violation of a state or federal controlled substance law that is a crime punishable by imprisonment for one year or more; except that "disqualifying drug offense" does not include:

(1) An offense for which the sentence, including any term of probation, incarceration or supervised release, was completed five or more years prior to the submission of an application for a license under the rules governing the adult use cannabis program; or

(2) An offense that consisted of conduct that would be authorized under Title 28- B, or that, if the person convicted of the offense had been acting under the authority of a license pursuant to Title 28-B, would have been authorized under Title 28-B.

Edible cannabis product: "Edible cannabis product" means a cannabis product intended to be consumed orally, including, but not limited to, any type of food, drink, or pill containing cannabis or cannabis concentrate.

Exit packaging: "Exit packaging" means a bag, pouch or other container that cannabis and/or cannabis products are placed in by a licensee after a retail sale to a consumer or sales order to a consumer via delivery or curbside pickup and before the purchased items leave the licensed premise.

Facility director: "Facility director" means the individual who is legally authorized to direct the activities of a cannabis testing facility and who commits the appropriate resources to comply with the rules governing the adult use cannabis program.

Facility plan: "Facility plan" means the comprehensive plan submitted by an applicant for an active cannabis establishment, and amendments thereto submitted after licensure, that includes all information regarding the physical location where the cannabis establishment is located, the operation of the cannabis establishment, the security measures utilized by the cannabis establishment, and as applicable, the cultivation activities of the cannabis establishment. A facility plan includes, as applicable, the operating, cultivation, and security plans of a licensee.

Final form: "Final form" means for the purpose of mandatory testing, cannabis, or a cannabis product that is in the form that will be sold to an adult use cannabis consumer; except, that the cannabis or cannabis product need not be prepackaged into individual retail units to be considered in its final form.

Flowering: "Flowering" means, with respect to a cannabis plant, the gametophytic or reproductive state of a female cannabis plant during which the plant is in a light cycle intended to produce flowers, trichomes, and cannabinoids characteristic of cannabis.

Full active license: "Full active license" means a license issued by the Department to a cannabis testing facility that has received full certification from the CDC and ISO/IEC 17025:2017 accreditation for all required technologies and analytes, that authorizes testing of cannabis or cannabis products in accordance with 28-B MRS, ch. 1, subchapters 2 and 6 and the rules governing the adult use cannabis program.

Full certification: "Full certification" means certification granted by the CDC pursuant to Rules for the Certification of Cannabis Testing Facilities, 18-691 CMR, ch. 5, to a cannabis testing facility that has received ISO/IEC 17025:2017 accreditation for all required technologies and analytes and meets all other requirements of the rules governing the adult use cannabis program. Full certification is a prerequisite for the issuance of a full active license by the Department pursuant to the rules governing the adult use cannabis program.

Group of cannabis plants: "Group of cannabis plants" means cannabis plants at the same stage of growth, that are intended to be harvested at the same time, and that are the same varietal or cultivar of the plant genus Cannabis that:

(1) Are planted in the same specific area at the same time;

(2) Are transplanted to the same specific area at the same time; or

(3) Include cannabis plants that were planted in a specific area and cannabis plants that were transplanted to the same specific area.

Guardian: "Guardian" means a person who has qualified as a guardian of a minor or incapacitated person pursuant to appointment by a parent or spouse or the court. "Guardian" includes a limited, an emergency and a temporary substitute guardian, but not a guardian ad litem.²

Handbill: "Handbill" is a flyer, leaflet, or sheet that advertises cannabis, cannabis products, or a cannabis establishment.

Harvest batch: "Harvest batch" means a specific quantity of cannabis harvested from cannabis plants of the same strain, grown under the same conditions, and harvested during a specified period of time from a specified cultivation area within a cultivation facility.

Homogeneity: "Homogeneity" means the amount of cannabis, cannabis concentrate, and/or cannabinoids within the product being consistent and reasonably equally dispersed throughout the cannabis product, cannabis concentrate, a representative sample, or each portion thereof.

Identity statement: "Identity statement" means the name of a business entity as it is commonly known and used in any advertising or marketing by the business entity.

Immature cannabis plant: "Immature cannabis plant" means a cannabis plant that is not a mature cannabis plant or a seedling.

Indoor: "Indoor" means, for the purpose of cultivating cannabis, cultivation of mature cannabis plants using artificial light or light deprivation in an enclosed structure.

Infused cannabis product: "Infused cannabis product" means a product or compound that includes one or more cannabis concentrates along with other materials or ingredients, including without limitation to, edible cannabis products and topical cannabis products.

Inhaled cannabis product: "Inhaled cannabis product" means cannabis, cannabis concentrate, or cannabis products that are intended to be consumed by inhalation, including, without limitation to: cannabis flower or trim, pre-rolled cannabis cigarettes, vaporizer cartridges, and vaporizer pens.

Inherently hazardous substance: "Inherently hazardous substance" means a liquid chemical, compressed gas, or commercial product that has a flash point at, or lower than, 38 degrees Celsius or 100 degrees Fahrenheit, including, but not limited to, butane, propane, and diethyl ether. "Inherently hazardous substance" does not include any form of alcohol or ethanol.

Intermediate packaging: "Intermediate packaging" means packaging materials that are not part of the marketing layer or container, but are included inside an outer container layer, such as a marketing layer.

Intoxication: "Intoxication" means a substantial impairment of an individual's mental or physical faculties as a result of drug or alcohol use.

ISO/IEC 17025:2017: "ISO/IEC 17025:2017" means the general requirements for the competence of testing and calibration laboratories issued in 2017 joint technical committee of the International Organization for Standardization and the International Electrotechnical Commission, and any subsequent revision or version thereof.

Kief: "Kief" means the dried or drying resinous trichomes of cannabis plant that have separated from cannabis flower or have been separated from cannabis flower by processes other than extraction. Kief is cannabis flower.

Law enforcement officer: "Law enforcement officer" has the same meaning as in 17-A MRS §2(17).

Licensed premises: "Licensed premises" means the premises specified in a license to operate a cannabis establishment within which the licensee is authorized under the rules governing the adult use cannabis program to cultivate, manufacture, distribute, sample, test, or sell cannabis or cannabis products.

Licensee: "Licensee" means a natural person or business entity licensed pursuant to 28-B MRS to operate a cannabis establishment.

Limited access area: "Limited access area" means a building, room or other area within the licensed premises of a cannabis establishment, or as applicable for cannabis stores conducting sales at a specified event, the permitted premises for a specified event, where a licensee is authorized to cultivate, store, weigh, manufacture, sample, package, or otherwise prepare for testing, transfer, or retail sale, cannabis and cannabis products. A limited access area can only be accessed by authorized persons displaying individual identification cards or authorized contractors of the licensee aged 21 and older displaying a visitor identification badge.

Liquid: "Liquid" means a substance that flows freely but is of constant volume; having a consistency like that of water or oil.

Local authorization: "Local authorization" means authorization from a municipality in accordance with 28-B MRS §402 or authorization from the Maine Land Use Planning Commission and either a town, plantation, or county commission in accordance with 28- B MRS §403. Local authorization is not required for sample collector licenses.

Logo: "Logo" means a graphic mark, emblem, or symbol used by a licensee to promote consumer association and recognition of the licensee.

Manufacture: "Manufacture" or "manufacturing" means the production, blending, infusing, compounding, or other preparation of cannabis and cannabis products, including but not limited to cannabis extraction or preparation by means of chemical synthesis. "Manufacture" or "manufacturing" does not include cultivation or testing.

Marketing layer: "Marketing layer" means the outermost layer of a retail sale container, which is most predominantly apparent and visible, such as a box or bag that another container containing cannabis, cannabis plants, cannabis concentrate, or cannabis products are within. If the container consists of only a single layer, then the outer surface of the container is the marketing layer.

Matrix or matrices: "Matrix" or "matrices" means the component or substrate that contains the analyte of interest (e.g., cannabis flower, trim, cannabis cigarettes, types of cannabis concentrate, types of cannabis products, etc.).

Mature cannabis plant: "Mature cannabis plant" means a cannabis plant that is flowering.

Method: "Method" means a body of procedures and techniques for performing an activity (e.g., sampling, chemical analysis, or quantification), systematically presented in the order in which they are to be executed.

Minor: "Minor" means a natural person who has not attained 21 years of age.

Mother plant: "Mother plant" means a cannabis plant that is used solely for the taking of seedling cuttings.

Municipality: "Municipality" means a city, town, or plantation in this State that is not located within the unorganized and deorganized areas.

Mycotoxin: "Mycotoxin" means any toxic substance produced by a fungus, especially a mold.

Office of Cannabis Policy: "Office of Cannabis Policy" or "the Office" means the division of the Department of Administrative and Financial Services responsible for administration and enforcement of the Cannabis Legalization Act and the Maine Medical Use of Cannabis Act.

Operating plan: "Operating plan" means information regarding the operating requirements listed in an application for a conditional license and included in the facility plan submitted for an active license to operate a cannabis establishment.

Outdoor: "Outdoor" or an "outdoor cultivation area" means, for the purpose of cultivating cannabis, a cultivation area that is neither enclosed in a building or structure that is permanently fixed to the ground, nor a foundation that is used to create cultivation conditions that are not materially impacted by ambient atmospheric conditions of the area where the licensed premises is located. An outdoor cultivation area is one where mature cannabis plants cannot be cultivated between the months of November and March without being materially impacted by atmospheric conditions.

Parent: "Parent" means a natural or adoptive parent or a parent established under Title 19-A, ch. 61, unless parental rights have been terminated.³

Permitted premises for a specified event: "Permitted premises for a specified event" means the premises at a specified event location described in a specified event permit issued to a cannabis store pursuant to 28-B MRS §504-A, where a cannabis store is authorized to sell cannabis and cannabis products.

Person: "Person" means a natural person or a business entity.

Plan of correction: "Plan of correction" means a written plan to address violations of 28-B MRS or the rules governing the adult use cannabis program that includes:

(1) Action steps to address any violation of the requirements of the adult use cannabis program identified by the Department in its Notice of Violation;

(2) The date by which each action step will be complete; and

(3) The steps to be taken by the licensee, or interventions implemented by the licensee, to ensure that the violation does not happen again.

Plan of record: "Plan of record" means, as applicable, a licensee's current facility plans as well as the operating, cultivation, and security information listed in the licensee's applications for a conditional or active license on file with and approved by the Department.

Plant canopy: "Plant canopy" means the total surface area within the licensed premises of a cultivation facility that is authorized by the Department for use at any time by the cultivation facility licensee to cultivate mature cannabis plants. The surface area of the plant canopy must be calculated in square feet (sq. ft.), measured using the outside boundaries of the area, and must include all of the area within such boundaries. If the surface area of the plant canopy consists of noncontiguous areas, each component area must be separated by identifiable boundaries. If a tiered or shelving system is used by the cultivation facility licensee, the surface area of each tier or shelf must be included in calculating the area of the plant canopy. Calculation of the area of the plant canopy may not include the areas within the licensed premises of cultivation facility that are used by the licensee to cultivate immature cannabis plants and seedlings and that are not used by the licensee at any time to cultivate mature cannabis plants.

Plant regulator: "Plant regulator" means any substance or mixture of substances intended through physiological action for accelerating or decelerating the rate of growth or maturation, or for otherwise altering the behavior of plants or the produce thereof. "Plant regulator" does not include substances to the extent that they are intended as plant nutrients, trace elements, nutritional chemicals, plant inoculants, or soil amendments.

Principal: "Principal" means:

(1) A natural person operating as a sole proprietor;

(2) The officers of a corporation organized pursuant to Title 13-C who have authority to manage, direct or oversee the applicant's or licensee's operations, if the applicant or licensee is a corporation;

(3) The directors of a corporation organized pursuant to Title 13-C, if the applicant or licensee is a corporation;

(4) The shareholders of a corporation organized pursuant to Title 13-C, if no officers or directors are appointed and the applicant or licensee is a corporation;

(5) The general or limited partners of a partnership organized under Title 31, chapter 19, if the applicant or licensee is a partnership;

(6) The nonmember managers or managing members of a limited liability company organized under Title 31, chapter 21, if the applicant or licensee is organized as a limited liability company; and

(7) Any other natural person to whom the applicant or licensee has given authority to manage, direct or oversee the applicant's or licensee's operations.

If an officer, director, shareholder, partner, manager or member under paragraph 2, 3, 4, 5 or 6 is a business entity, "principal" means any natural person to whom the business entity has given authority to manage, direct or oversee the applicant's or licensee's operations.

"Principal" does not include those persons whose managerial responsibilities are limited to staff supervision and who are not authorized to act on behalf of the applicant or licensee. For purposes of this subsection, "operations" does not include human resources, information technology, marketing or accounting and finance.

Premises: "Premises" means the designated area within a structure or structures and land specified in the facility plan included in a license application that is owned, leased, or otherwise held under the control of the applicant or licensee where conduct related to the cultivation, manufacture, sampling, testing, or sale of cannabis and cannabis products occurs. The premises must be a contiguous area and may only be occupied by one establishment, unless otherwise permitted by statute or the rules governing the adult use cannabis program; except that nothing in this definition may be construed to prohibit the siting of multiple cannabis establishments in the same building or property so long as each establishment operates in a physically distinct space from any other establishment. "Premises" may also mean "permitted premises for a specified event," for appropriately permitted cannabis stores conducting sales of cannabis and cannabis products at specified event off of the licensed premises of the cannabis store.

Pre-packaged retail unit: "Pre-packaged retail unit" means cannabis or a cannabis product that has passed all mandatory testing and is packaged into an individual container for retail sale to a consumer 21 years of age or older.

Private residence: "Private residence" means the part of a building or structure with a fixed location used as a dwelling; including without limitation: a private home, townhouse, condominium, apartment, mobile home, vacation home, cabin, or cottage.

Production batch: "Production batch" means a specific quantity of cannabis concentrate or a cannabis product that is produced during a specified period of time using the same extraction and/or manufacturing method, formulation and/or recipe, and standard operating procedure. Production batch also includes the combination of two or more harvest batches of cannabis trim or kief.

Products manufacturing facility: "Products manufacturing facility" means a facility licensed under the rules governing the adult use cannabis program to purchase cannabis from a cultivation facility or another products manufacturing facility; to manufacture, label, and package cannabis and cannabis products; to collect and transport samples of cannabis, cannabis concentrate, and cannabis products manufactured by that facility for mandatory testing; to sell cannabis and cannabis products to cannabis stores and to other products manufacturing facilities; and as applicable, to conduct sales to consumers by delivery.

Propagation: "Propagation" means the process of reproducing cannabis plants through the use of cannabis seeds, cuttings, or grafting.

Provisional active license: "Provisional active license" means a license issued by the Department to a cannabis testing facility that has received provisional certification from the CDC and has applied for, but not yet received, ISO/IEC 17025:2017 accreditation for all required technologies and analytes, that authorizes testing of cannabis or cannabis products in accordance with 28-B MRS, ch. 1, subchapter 2 and 6, and the rules governing the adult use cannabis program.

Provisional certification: "Provisional certification" means certification granted by the CDC pursuant to Rules for the Certification of Cannabis Testing Facilities, 18-691 CMR, ch. 5, to a cannabis testing facility that has not yet received ISO/IEC 17025 accreditation for all required technologies and analytes, but for which an application is pending, and that meets all other requirements of the rules governing the adult use cannabis program. Provisional certification is a prerequisite for the issuance of a provisional active license by the Department pursuant to the rules governing the adult use cannabis program.

Qualifying patient: "Qualifying patient" means a person who possesses a valid certification for the medical use of cannabis pursuant to 22 MRS §2423-B.

Quality assurance (QA): "Quality assurance (QA)" means a set of operating principles that enable testing facilities to produce defensible data of known accuracy and precision. Quality assurance includes without limitation employee training, equipment preventative maintenance procedures, calibration procedures, and quality control testing.

Quality control (QC): "Quality control (QC)" means the overall system of technical activities that measures the attributes and performance of a process, item, or service against defined standards to verify that they meet the stated requirements established by the client; the operational techniques and activities that are used to fulfill requirements for quality; the system of activities and checks used to ensure that measurement systems are maintained within prescribed limits, to protect against "out of control" conditions ensure that the quality of results is acceptable.

Quality assurance manual: "Quality assurance manual" means a document containing policies and records used to ensure the quality and utility of cannabis and cannabis products to its users in accordance with the quality system.

Quality system: "Quality system" means a structured and documented management system that describes the policies, objectives, principles, organizational structure, management authority responsibilities, fiduciary duties liability, and implementation plan of an organization for ensuring quality in its work processes, products (items), and services. The quality system provides the framework to plan, implement, and assess work performed by the organization and to carryout required QA and QC activities. The quality system of a cannabis testing facility must account for anomalies that arise from the collection and transport of samples for mandatory testing conducted by a self-sampler or a sample collector licensee--including provisions regarding the use of blanks.

Radio: "Radio" means a system for transmitting sound without visual images, and includes broadcast, cable, on-demand, satellite, or internet programming. Radio includes any audio programming downloaded or streamed via the internet.

Registered caregiver: "Registered caregiver" means a caregiver who is registered by the department pursuant to 22 MRS §2425-A.

Registered dispensary: "Registered dispensary" or "dispensary" means an entity registered under 22 MRS §2425-A that acquires, possesses, cultivates, manufactures, delivers, transfers, transports, sells, supplies, or dispenses cannabis or related supplies and educational materials to qualifying patients and the caregivers of those patients.

Remediation: "Remediation" means a process by which a licensee mitigates or otherwise removes a contaminant from a batch of cannabis or cannabis products that has failed mandatory testing due to the presence of the contaminant. Remediation also means the process by which a products manufacturing facility licensee reformulates or repackages a batch of edible cannabis products that has failed mandatory testing due to THC potency in excess of the per serving or per package potency limits. Remediation may include without limitation the application of heat, radiation, or ozone; or solvent extraction; or further drying and curing. Dilution of contaminants through the addition of uncontaminated material to batches of cannabis or cannabis products that are contaminated is not an approved remediation method.

Requester: "Requester" means a person who submits a request to a licensed cannabis testing facility for State-mandated testing of cannabis or cannabis products.

Retail sale hours: "Retail sale hours" means the hours during which a cannabis store licensee is open to the public to conduct sales to consumers.

Sale: "Sale" or "sell" means a transfer of cannabis or cannabis products for consideration.

Sales delivery manifest: "Sales delivery manifest" means a record required by the Department for a licensed cannabis store to document the possession, transportation, and delivery of sales orders of cannabis and/or cannabis products by tier 1, tier 2, and nursery cultivation facilities, products manufacturing facilities, and cannabis stores to adult use consumers age 21 or older at a private residence or business, as applicable in accordance with the rules governing the adult use cannabis program.

Sales Order: "Sales Order" means cannabis or cannabis product, or a combination of cannabis and/or cannabis products, requested by an adult use consumer, through a telephonic or internet-based platform, to be conveyed to the consumer via curbside pickup at a cannabis store or via delivery to a private residence or business, as applicable in accordance with the rules governing the adult use cannabis program, by an employee of the cannabis store.

Sample: "Sample" means, as applicable, an amount of:

(1) Cannabis, cannabis concentrate, or cannabis product collected from an adult use cannabis establishment for mandatory testing:

(a) By an employee of a testing facility in accordance with 28-B MRS §604 and the rules governing the adult use cannabis program;

(b) By a sample collector, in accordance with 28-B MRS §604 and the rules governing the adult use cannabis program; or

(c) By a self-sampler in accordance with 28-B MRS §604-A and the rules governing the adult use cannabis program;

(2) Cannabis, cannabis concentrate, or cannabis product provided to a testing facility by a cannabis establishment or other person for mandatory testing, or testing for research and development purposes, in accordance with 28-B MRS, ch. 1;

(3) Cannabis or cannabis product collected from a licensee by the Department for the purposes of testing the cannabis or cannabis product for quality control purposes pursuant to 28-B MRS §512(2);

(4) Cannabis provided by a cultivation facility to another licensee for business or marketing purposes pursuant to 28-B MRS §501(8) (trade samples); or

(5) Cannabis or cannabis product provided to another licensee by a products manufacturing facility for business or marketing purposes pursuant to 28-B MRS §502(6) (trade samples).

Sample collection SOP: "Sample collection SOP" means a standard operating procedure for the collection of samples of cannabis, cannabis concentrate, and cannabis products for mandatory testing published by the Department that must be used by all licensees collecting, transporting, and transferring samples for mandatory testing. The current sample collection SOP is Appendix A of 18-691 CMR, ch. 40.

Sample collector: "Sample collector" means a person licensed pursuant to the rules governing the adult use cannabis program and 28-B MRS, ch. 1, to collect samples of cannabis and cannabis products for testing and to transport and deliver those samples to a testing facility. A sample collector must hold a valid individual identification card ("IIC").

Seedling: "Seedling" means a cannabis plant that is:

(1) Not flowering;

(2) Less than 24 inches (in) in height; and

(3) Less than 24 inches (in) in width.

"Seedling" includes clones and tissue cultures.

Self-sampler or Self-sampling licensee: "Self-sampler" or "self-sampling licensee" means a cultivation facility, products manufacturing facility, or cannabis store licensee that collects samples of cannabis, cannabis concentrate, and cannabis products, for mandatory testing; or an employee of a cultivation facility, products manufacturing facility or cannabis store licensee who collects samples of cannabis, cannabis concentrate and cannabis products for that licensee for mandatory testing. Any individual collecting samples for mandatory testing must hold a valid individual identification card ("IIC").

Specified event: "Specified event" means an event that occurs outside the licensed premises of a cannabis store that is not conducted primarily for the benefit or enjoyment of minors and that is not more than ten consecutive days in duration or ten occurrences in duration. For purposes of this definition, "occurrence" means an event that is less than 24-hours in duration and that occurs during the same calendar year as another occurrence.

Specified event permit: "Specified event permit" means a temporary authorization for a cannabis store to conduct sales of cannabis and cannabis products on the permitted premises for a specified event in accordance with 28-B MRS §504-A.

Standard operating procedure (SOP): "Standard operating procedure (SOP)" means a written document that details the method for an operation, analysis, or action, with thoroughly prescribed techniques and steps.

Tamper-evident: "Tamper-evident" means, with respect to a device or process, bearing a seal, a label, or a marking that makes unauthorized access to or tampering with a package, product, or container easily detectable.

Target organism: "Target organism" means an organism that is being tested for in an analytical procedure or test method.

Technical assistance: "Technical assistance" means assistance provided by the Office when a licensee is found to be in violation of the laws or rules governing the adult use cannabis program. Technical assistance:

(1) May be offered in person and will be documented in writing;

(2) Includes an explanation of any applicable laws or rules;

(3) Includes an explanation of how the program participant is in violation; and

(4) May include a timeline for corrective action to be taken and advice or guidance regarding how the program participant can comply with program requirements.

Television: "Television" means a system for transmitting visual images and sound that are reproduced on screens, and includes broadcast, cable, on-demand, satellite, or internet programming. Television includes any video programming downloaded or streamed via the internet.

Testing or Test: "Testing" or "test" means the research and analysis of cannabis, cannabis products, or other substances for contaminants, safety, or potency. "Testing" or "test" includes the collection of samples of cannabis and cannabis products for testing purposes but does not include cultivation or manufacturing. Nothing in this definition shall be construed to permit any licensee except a cannabis testing facility to perform analyses of cannabis, cannabis concentrate, or cannabis products for mandatory testing without a separate cannabis testing facility license issued by the Department.

Testing facility: "Testing facility" means a facility licensed under the rules governing the adult use cannabis program to develop, research, and test cannabis, cannabis products, and other substances.

Testing facility director: "Testing facility director" means the cannabis testing facility director who is legally authorized to direct the activities of a cannabis testing facility and who commits the appropriate resources to comply with the rules governing the adult use cannabis program.

THC: "THC" means tetrahydrocannabinol.

Tincture: "Tincture" means a liquid edible cannabis product with a concentration of greater than 1 mg of THC per ounce of liquid.

Topical cannabis product: "Topical cannabis product" means non-edible cannabis or cannabis products that are intended to be applied topically and absorbed transdermal; including without limitation to, salves, creams, lotions, transdermal patches, or balms.

Total CBD: "Total CBD" means the sum of CBD and CBDA. Total CBD is calculated by a cannabis testing facility using the following equation: Total CBD = CBD + (CBDA*0.877).

Total THC: "Total THC" means the sum of THC and THCA. Total THC is calculated by a cannabis testing facility using the following equation: Total THC = delta-9 THC + (THCA*0.877).

Transport manifest: "Transport manifest" means a record, either paper or electronic, required by the Department for a licensed facility to document the possession of the cannabis or cannabis product on the premises, tracking all inventory, acquisition, and sales as well as the transfer of any cannabis or cannabis product to another facility, including for the purposes of testing or provision of trade samples to another licensee.

Universal symbol: "Universal symbol" means an image developed and made available to licensees by the Department indicates that a container, package, or product contains cannabis, cannabis concentrates, or is itself a cannabis product.⁴

Unorganized and deorganized areas: "Unorganized and deorganized areas" has the same meaning as in 12 MRS §682(1).

Unpackaged cannabis or cannabis products: "Unpackaged cannabis or cannabis products" means cannabis or a cannabis product that has not been packaged into an individual child-resistant, tamper-evident container for retail sale to a consumer 21 years of age or older.

Unusable: "Unusable" means that the cannabis or cannabis product can no longer be smoked, eaten,, topically applied, or otherwise ingested. Nor can the cannabis or cannabis product be further manipulated in a manner to extract more than a trace amount of cannabinoid.

Visibly intoxicated: "Visibly intoxicated" means a state of intoxication accompanied by a perceptible act, a series of acts, or the appearance of an individual that clearly demonstrates the state of intoxication (I.e. Incoherence, lack of physical coordination and balance, etc.).

Water activity: "Water activity" means a measure of the quantity of water in a product that is available, and therefore capable of, supporting bacteria, yeasts, and fungi. Water activity is reported in the unit Aw.

Wholesale container: "Wholesale container" means a sealed package in which cannabis, cannabis concentrate, and cannabis products are conveyed during an authorized transfer.

¹22 MRS §4002(5).

²18-C MRS §1-201(22).

³22 MRS §4002(7).

⁴ Office of Cannabis Policy, Universal Symbol, OCP Website: Resources, https://www.maine.gov/dafs/ocp/resources/universal-symbol (accessed June 20, 2024).

18-691 C.M.R. ch. 10, § 1