18-691-1 Me. Code R. § 1

Current through 2022-24, June 15, 2022
Section 691-1-1 - [Effective7/1/2022]Adult Use Marijuana Program
1.1- Statutory Authority

The Department of Administrative and Financial Services (referred heretofore as the Department), acting through its Office of Marijuana Policy, has developed the following rule in accordance with the statutory authority provided in Title 28-B, § 104 for the purpose of implementing, administering and enforcing the provisions of 28-B MRS, chapter 1.

1.2- Department Authority

The Department may enforce this rule 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, times of apparent activity or other reasonable time, any marijuana establishment, vehicles used to transport marijuana or marijuana products or business records.

1.3- Communication with Department
1.3.1Written 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:
A. Mail;
B. In-person delivery;
C. Facsimile; or
D. E-mail.
1.3.2Submission 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.
1.4- Definitions
1.Action level: "Action level" means the threshold value for determining whether a sample passes or fails an analytical test.
2.Active license: "Active license" means a license issued by the Department that authorizes cultivation, sample collection, testing, manufacture or sale of marijuana or marijuana products in accordance with 28-B MRS and this rule, including a provisional active license to operate a marijuana testing facility.
3.Adult use marijuana: "Adult use marijuana" means marijuana cultivated, manufactured, tested, distributed or sold by a marijuana establishment.
4.Adult use marijuana product: "Adult use marijuana product" means a marijuana product that is manufactured, distributed or sold by a marijuana establishment.
5.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.
6.Analyte: "Analyte" means a chemical, compound, element, bacteria, yeast, fungus or toxin that is identified or measured.
7.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.
8.Apparent activity: "Apparent activity" is any sights, sounds, smells or other indications that persons are present at a marijuana establishment.
9.Applicant: "Applicant" means a person who submits an application for a license under this rule to the Department for review that the Department has not yet approved or denied.
10.Batch: "Batch" means:
a. A harvest batch; or
b. A production batch.
11.Batch number: "Batch number" means a distinct group of numbers, letters or symbols, or any combination thereof, assigned to a specific batch of adult use marijuana by a cultivation facility, sample collector, testing facility, or a marijuana store or to a specific batch of adult use marijuana or adult use marijuana products by a products manufacturing facility, sample collector, testing facility or a marijuana store.
12.Best Practices Guide: "Best Practices Guide" means the Best Practices for the Sampling of Adult Use Marijuana, Version 3.1, dated September 11, 2020, published by the Department available at: https://www.maine.gov/dafs/omp/adult-use/applications-forms; which is incorporated herein by reference. All licensees and any employee of a licensee collecting samples of marijuana, marijuana concentrate, or marijuana products for mandatory testing must collect samples in accordance with the best practices described in the guide.
13.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.
14.Business hours: "Business hours" means 9 A.M. to 5 P.M. Monday through Friday.
15.Cannabinoid: "Cannabinoid" means a chemical compound that is unique to, and derived from, marijuana.
16.Caregiver: "Caregiver" has the same meaning as in 22 MRS §2422(8-A).
17.Certificate of analysis: "Certificate of analysis" means the report prepared for the party requesting testing and the Department about the analytical testing performed and results obtained by the marijuana testing facility.
18.Certification: "Certification" means the process by which an agency or organization evaluates and recognizes a marijuana testing facility as meeting certain predetermined qualifications or standards, thereby certifying the marijuana testing facility. The Department of Health and Human Services (DHHS), Center for Disease Control and Prevention (CDC), is responsible for certification of all marijuana testing facilities.
19.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 marijuana testing facility, in accordance with chain of custody protocol prescribed by the marijuana testing facility. This record, at a minimum, must include the sample location, the number and types of containers, the mode of collection, the authorized individual who collected the sample, the date and time of collection, preservation and requested analyses.
20.Chain of custody protocols: "Chain of custody protocols" means the procedures developed and employed by the marijuana 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 marijuana testing facility. In addition, these protocols document all handling of the samples within the marijuana testing facility and, if applicable, by the sample collector or self sampler.
21.CBD: "CBD" means cannabidiol.
22.Child-resistant: "Child-resistant" means, with respect to packaging or a container:
a. Specially designed or constructed to be significantly difficult for a typical child under 5 years of age to open and not to be significantly difficult for a typical adult to open and reseal; and
b. With respect to any product intended for more than a single use or that contains multiple servings, resealable.
23.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. Co-located licensees must share identical ownership with the co-located entity. A licensee that is also a registered caregiver or a registered dispensary may co-locate its operations with that same registered caregiver or registered dispensary.
24.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 marijuana store. The conditional license does not authorize possession, transfer, cultivation, testing, manufacture or sale of marijuana or marijuana products.
25.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.
26.Container: "Container" means a sealed package in which adult use marijuana or an adult use marijuana product is placed that meets all applicable packaging, labeling and health and safety requirements of this rule.
27.Controlled entry area: "Controlled entry area" means an indoor entry area directly inside the licensed premises of a marijuana 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 marijuana 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 is verified.
28.Criminal justice agency: "Criminal justice agency" has the same meaning as in 16 MRS §803(4).
29.Cultivation: "Cultivation" or "cultivate" means the planting, propagation, growing, harvesting, drying, curing, grading, trimming or other processing of marijuana for use or sale. "Cultivation" or "cultivate" does not include manufacturing, testing or marijuana extraction.
30.Cultivation facility: "Cultivation facility" means a facility licensed under this rule to purchase marijuana plants and seeds from other cultivation facilities; to cultivate, prepare and package adult use marijuana; to collect and transport samples of marijuana cultivated by that facility for mandatory testing; to sell adult use marijuana to products manufacturing facilities, to marijuana stores and to other cultivation facilities; and to sell marijuana plants and seeds to other cultivation facilities and immature marijuana plants and seedlings to marijuana stores. A cultivation facility includes a nursery cultivation facility. Licensees that cultivate marijuana in a nursery cultivation facility may sell an unlimited number of marijuana seeds and a sum total of 12 seedlings and immature plants to a consumer 21 years of age or older.
31.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.
32.Department: "Department" means the Department of Administrative and Financial Services.
33.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 Marijuana Certification Program, the technology and testing methods used by marijuana testing facilities under this rule.
34.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 marijuana establishment license, including without limitation:
a.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.
b.Other Equity Ownership. Any employee, independent contractor, professional, or other person who/which has an agreement with the licensee that provides for their attaining any form of equity ownership. Except that employee equity ownership vested pursuant to an employee stock ownership program is governed by paragraph i.
c.Royalty License Partners. All person(s) who/which expect to receive financial payment, including without limitation, royalty payments, profit share or revenue share, in return for the licensing of an intellectual property asset or proprietary property, whether or not such assets or property be trademarked or patented, including without limitation, standard operating procedures, brand names, products, packaging, marketing materials, business plans or financial projections.
d.Contractor and Other Profit Sharing Arrangements. Any independent contractor, professional, or other person, except a natural person who is an employee of the licensee, who/which has an agreement with the licensee that provides for their attaining or receiving any form of profit sharing, commissions or the like.
e.Capital Investors and Lenders. All persons that invest in or lend money to a licensee with the expectation of receiving repayment, with or without additional interest and/or other financial payments or benefits as a condition of investing or lending. Lenders include persons that are holders of any negotiable instruments the licensee is indebted to. Except that state- or federally-chartered banks, credit unions or savings/loan institutions whose only financial interest constitutes a loan, need only provide a copy of the financial instrument recording the terms of the loan.
f.Management Contractors and Consultants. Persons that exert significant influence or decision making authority over the licensee's business plan, marketing strategy, operations or that otherwise control the business; and including any third-party contracted persons or other entities which provide ongoing management and/or consulting services to a licensee for a period longer than 6 months.
g.Officers, Directors, Managers, and General Partners. Any persons in these positions.
h.Business Entities. If any of the persons above are business entities, they shall list all persons which have the interests listed in (a), (b) and (g) in the business entity, until only individuals remain, excepting only individuals who own less than 5% of the total shares in a publicly traded company.
i.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.
35.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:
a. An offense for which the sentence, including any term of probation, incarceration or supervised release, was completed 10 or more years prior to the submission of an application for a license under this rule; or
b. An offense that consisted of conduct that is authorized under 28-B MRS, chapter 3.
36.Edible marijuana product: "Edible marijuana product" means a marijuana product intended to be consumed orally, including, but not limited to, any type of food, drink or pill containing marijuana or marijuana concentrate.
37.Exit packaging: "Exit packaging" means an opaque bag, pouch or other container that marijuana and/or marijuana products are placed in by a licensee after a retail sale to a consumer and before the purchased items leave the licensed premise.
38.Facility director: "Facility director" means the individual who is legally authorized to direct the activities of a marijuana testing facility and who commits the appropriate resources to comply with this rule.
39.Facility plan: "Facility plan" means the comprehensive plan submitted by an applicant for an active marijuana establishment, and amendments thereto submitted after licensure, that includes all information regarding the physical location where the marijuana establishment is located, the operation of the marijuana establishment, the security measures utilized by the marijuana establishment, and as applicable, the cultivation activities of the marijuana establishment. A facility plan includes, as applicable, the operating, cultivation, and security plans of a licensee.
40.Flowering: "Flowering" means, with respect to a marijuana plant, the gametophytic or reproductive state of a female marijuana plant during which the plant is in a light cycle intended to produce flowers, trichomes and cannabinoids characteristic of marijuana.
41.Full active license: "Full active license" means a license issued by the Department to a marijuana testing facility that has received full certification from the CDC and ISO/IEC 17025:2017 accreditation for at least one technology and analyte, that authorizes testing of marijuana or marijuana products in accordance with 28-B MRS, Chapter 1, subchapters 2 and 6 and this rule.
42.Full certification: "Full certification" means certification granted by the CDC pursuant to Rules for the Certification of Marijuana Testing Facilities, 18-691 CMR, ch. 5, to a marijuana testing facility that has received ISO/IEC 17025:2017 accreditation for at least one technology and analyte and meets all other requirements of this rule. Full certification is a prerequisite for the issuance of a full active license by the Department pursuant to this rule.
43.Harvest batch: "Harvest batch" means a specific quantity of adult use marijuana harvested from adult use marijuana 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.
44.Homogeneity: "Homogeneity" means the amount of marijuana or marijuana concentrate and cannabinoids within the product being consistent and reasonably equally dispersed throughout the product or each portion of the product or concentrate, or a representative sample.
45.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.
46.Immature marijuana plant: "Immature marijuana plant" means a marijuana plant that is not a mature marijuana plant or a seedling.
47.Infused marijuana product: "Infused marijuana product" means a product or compound that includes one or more marijuana concentrate along with other materials or ingredients, including without limitation, edible marijuana products and topical marijuana products.
48.Inhaled marijuana product: "Inhaled marijuana product" means marijuana, marijuana concentrate or marijuana products that are intended to be consumed by inhalation, including, without limitation: marijuana flower or trim, pre-rolled marijuana cigarettes, vaporizer cartridges and vaporizer pens.
49.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.
50.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.
51.Intoxication: "Intoxication" means a substantial impairment of an individual's mental or physical faculties as a result of drug or alcohol use.
52.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.
53.Kief: "Kief" means the dried or drying resinous trichomes of marijuana plant that have separated from marijuana flower or have been separated from marijuana flower by processes other than extraction. Kief is marijuana flower.
54.Law enforcement officer: "Law enforcement officer" has the same meaning as in 17-A MRS §2(17).
55.Licensed premises: "Licensed premises" means the premises specified in a license to operate a marijuana establishment within which the licensee is authorized under this rule to cultivate, manufacture, distribute, sample, test or sell adult use marijuana or adult use marijuana products.
56.Licensee: "Licensee" means a natural person or business entity licensed pursuant to 28-B MRS to operate a marijuana establishment.
57.Limited access area: "Limited access area" means a building, room or other area within the licensed premises of a marijuana establishment where a licensee is authorized to cultivate, store, weigh, manufacture, sample, package or otherwise prepare for testing, transfer or retail sale, marijuana and marijuana 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.
58.Liquid: "Liquid" means a substance that flows freely but is of constant volume, having a consistency like that of water or oil.
59.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.
60.Manufacture: "Manufacture" or "manufacturing" means the production, blending, infusing, compounding or other preparation of marijuana and marijuana products, including but not limited to marijuana extraction or preparation by means of chemical synthesis. "Manufacture" or "manufacturing" does not include cultivation or testing.
61.Marijuana: "Marijuana" means the leaves, stems, flowers and seeds of a marijuana plant, whether growing or not. "Marijuana" includes marijuana concentrate, except where context indicates otherwise, but does not include hemp as defined in 7 MRS §2231, or a marijuana product.
62.Marijuana concentrate: "Marijuana concentrate" means the resin extracted from any part of a marijuana plant and every compound, manufacture, salt, derivative, mixture or preparation from such resin, including, but not limited to, hashish. In determining the weight of marijuana concentrate in a marijuana product, the weight of any other ingredient combined with marijuana or marijuana concentrate to prepare the marijuana product may not be included.
63.Marijuana drink: "Marijuana drink" means a liquid edible marijuana product with a concentration of less than 1 mg of THC per ounce of liquid.
64.Marijuana establishment: "Marijuana establishment" means a cultivation facility, a products manufacturing facility, a testing facility, a sample collector or a marijuana store licensed under 28-B MRS and this rule.
65.Marijuana extraction: "Marijuana extraction" means the process of extracting marijuana concentrate from marijuana using water, lipids, gases, solvents or other chemicals or chemical processes.
66.Marijuana flower: "Marijuana flower" means the pistillate reproductive organs of a mature marijuana plant, whether processed or unprocessed, including the flowers and buds of the plant. "Marijuana flower" does not include marijuana trim or whole mature marijuana plants, but does include kief.
67.Marijuana plant: "Marijuana plant" means all species of the plant genus cannabis, including, but not limited to, a mother plant, a mature marijuana plant, an immature marijuana plant or a seedling but it does not include a marijuana product or "hemp" as defined in 7 MRS §2231.
68.Marijuana product: "Marijuana product" means a product composed of marijuana or marijuana concentrate and other ingredients that is intended for use or consumption. "Marijuana product" includes, but is not limited to, an edible marijuana product, a marijuana ointment and a marijuana tincture. "Marijuana product" does not include marijuana concentrate.
69.Marijuana store: "Marijuana store" means a facility licensed under this rule to purchase adult use marijuana, immature marijuana plants and seedlings from a cultivation facility, to purchase adult use marijuana and adult use marijuana products from a products manufacturing facility, to collect and transport samples of marijuana, marijuana concentrate and marijuana products in that marijuana store's possession for mandatory testing, and to sell adult use marijuana, adult use marijuana products, immature marijuana plants and seedlings to consumers.
70.Marijuana Testing Facility or Testing Facility: "Marijuana testing facility" or "testing facility" means an entity licensed according to 28-B MRS §503, including those also registered as marijuana testing facilities in accordance with 22 MRS §2423-A, to test marijuana, marijuana 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 marijuana testing facility is authorized to collect samples of marijuana, marijuana concentrate and marijuana products without a separate sample collector license in accordance with Rules for the Certification of Marijuana Testing Facilities, 18-691 CMR, ch. 5.
71.Marijuana trim: "Marijuana trim" means any part of a marijuana plant, whether processed or unprocessed, that is not marijuana flower or a marijuana seed, except that "marijuana trim" does not include the stalks or roots of the marijuana plant.
72.Marijuana waste "Marijuana waste" means marijuana, marijuana plants or marijuana products that are unfit for retail sale for reasons including, without limitation, failed mandatory testing, expired products or crop failure.
73.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 marijuana, marijuana plants, marijuana concentrate, or marijuana products are within. If the container consists of only a single layer, then the outer surface of the container is the marketing layer.
74.Matrix or matrices: "Matrix" or "matrices" means the component or substrate that contains the analyte of interest (e.g. marijuana flower, trim, marijuana cigarettes, types of marijuana concentrate, types of marijuana products, etc.).
75.Mature marijuana plant: "Mature marijuana plant" means a marijuana plant that is flowering.
76.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.
77.Moisture content: "Moisture content" means the percentage of water in a dry sample, by weight.
78.Mother plant: "Mother plant" means a marijuana plant that is used solely for the taking of seedling cuttings.
79.Municipality: "Municipality" means a city, town or plantation in this State that is not located within the unorganized and deorganized areas.
80.Mycotoxin: "Mycotoxin" means any toxic substance produced by a fungus and especially a mold.
81.Opaque: "Opaque" means, with respect to packaging or a container, that any product inside of the packaging or container cannot be seen from outside the packaging or container.
82.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 marijuana establishment.
83.Person: "Person" means a natural person or a business entity.
84.Plan of record: "Plan of record" means, as applicable, a licensee's current facility plan and 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.
85.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 marijuana plants. The surface area of the plant canopy must be calculated in square feet and measured using the outside boundaries of the area and must include all of the area within the 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 marijuana plants and seedlings and that are not used by the licensee at any time to cultivate mature marijuana plants.
86.Plant regulator: "Plant regulator" means any substance or mixture of substances intended through physiological action for accelerating or retarding the rate of growth or rate of 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.
87.Premises: "Premises" means the designated area within a structure or structures and land specified 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 adult use marijuana and marijuana products occurs. The premises must be a contiguous area and may be occupied only by one establishment, unless otherwise permitted by statute or this rule, except that nothing in this definition may be construed to prohibit the siting of multiple marijuana establishments in the same building or property so long as each establishment operates in a physically distinct space from any other establishment.
88.Production batch: "Production batch" means a specific quantity of marijuana concentrate or a marijuana 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 marijuana trim or kief.
89.Products manufacturing facility: "Products manufacturing facility" means a facility licensed under this rule to purchase adult use marijuana from a cultivation facility or another products manufacturing facility; to manufacture, label and package adult use marijuana and adult use marijuana products; to collect and transport samples of marijuana, marijuana concentrate and marijuana products manufactured by that facility for mandatory testing; and to sell adult use marijuana and adult use marijuana products to marijuana stores and to other products manufacturing facilities
90.Propagation: "Propagation" means the process of reproducing marijuana plants through the use of marijuana seeds, cuttings or grafting.
91.Provisional active license: "Provisional active license" means a license issued by the Department to a marijuana testing facility that has received provisional certification from the CDC and has applied for, but not yet received, ISO/IEC 17025:2017 accreditation for at least one technology and analyte, that authorizes testing of marijuana or marijuana products in accordance with 28-B MRS, Chapter 1, subchapter 2 and 6 and this rule.
92.Provisional certification: "Provisional certification" means certification granted by the CDC pursuant to Rules for the Certification of Marijuana Testing Facilities, 18-691 CMR, ch. 5, to a marijuana testing facility that has not yet received ISO/IEC 17025 accreditation for at least one technology and analyte, but for which an application is pending, and that meets all other requirements of this rule. Provisional certification is a prerequisite for the issuance of a provisional active license by the Department pursuant to this rule.
93.Qualifying patient: "Qualifying patient" means a person who possesses a valid certification for the medical use of marijuana pursuant to 22 MRS §2423-B.
94.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.
95.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; operational techniques and activities that are used to fulfill requirements for quality; also the system of activities and checks used to ensure that measurement systems are maintained within prescribed limits, providing protection against "out of control" conditions and ensuring that the results are of acceptable quality.
96.Quality assurance manual: "Quality assurance manual" means a document stating the management policies, objectives, principles, organizational structure and authority, responsibilities, accountability and implementation of an agency, organization or a marijuana testing facility, to ensure the quality of its product and the utility of its product to its users.
97.Quality system: "Quality system" means a structured and documented management system describing the policies, objectives, principles, organizational authority, responsibilities, accountability and implementation plan of an organization for ensuring quality in its work processes, products (items) and services. The quality system provides the framework for planning, implementing and assessing work performed by the organization and for carrying out required QA and QC activities. A marijuana testing facility's quality system must account for anomalies arising 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.
98.Registered caregiver: "Registered caregiver" means a caregiver who is registered by the department pursuant to 22 MRS §2425-A.
99.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 marijuana or related supplies and educational materials to qualifying patients and the caregivers of those patients.
100.Requester: "Requester" means a person who submits a request to a licensed marijuana testing facility for State-mandated testing of marijuana or marijuana products.
101.Resident: "Resident" means a natural person who:
a. Has filed a resident individual income tax return in this State pursuant to Title 36, Part 8 in each of the 4 years prior to the year in which the person files an application for licensure under this rule; this requirement does not apply after May 31, 2021;
b. Is domiciled in this State; and
c. Maintains a permanent place of abode in this State and spends in the aggregate more than 183 days of the taxable year in this State.
102.Retail sale hours: "Retail sale hours" means the hours during which a marijuana store licensee is open to the public to conduct sales to consumers.
103.Sale: "Sale" or "sell" means a transfer of marijuana or marijuana products for consideration.
104.Sample: "Sample" means, as applicable, an amount of:
a. Marijuana, marijuana concentrate or marijuana product collected from an adult use marijuana establishment for mandatory testing:
i. By an employee of a testing facility in accordance with 28-B MRS §604 and this rule;
ii. By a sample collector, in accordance with 28-B MRS §604 and this rule; or
iii. By a self-sampler in accordance with 28-B MRS §604-A and this rule;
b. Marijuana, marijuana concentrate or marijuana product provided to a testing facility by a marijuana establishment or other person for mandatory testing or testing for research and development purposes in accordance with 28-B MRS, chapter 1;
c. Adult use marijuana or adult use marijuana product collected from a licensee by the Department for the purposes of testing the marijuana or marijuana product for quality control purposes pursuant to 28-B MRS §512(2);
d. Adult use marijuana provided by a cultivation facility to another licensee for business or marketing purposes pursuant to 28-B MRS §501(8) (trade samples); or e. Adult use marijuana or adult use marijuana product provided to another licensee by a products manufacturing facility for business or marketing purposes pursuant to 28-B MRS §502(6) (trade samples).
105.Sample collection SOP: "Sample collection SOP" means a standard operating procedure for the collection of samples of marijuana, marijuana concentrate and marijuana 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 this rule.
106.Sample collector: "Sample collector" means a person licensed pursuant to this rule and 28-B MRS, ch. 1 to collect samples of marijuana and marijuana 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").
107.Seedling: "Seedling" means a marijuana plant that is:
a. Not flowering;
b. Less than 24 inches in height; and
c. Less than 24 inches in width.
108.Self-sampler or Self-sampling licensee: "Self-sampler" or "self-sampling licensee" means a cultivation facility, products manufacturing facility or marijuana store licensee that collects samples of marijuana, marijuana concentrate and marijuana products for mandatory testing or an employee of a cultivation facility, products manufacturing facility or marijuana store licensee who collects samples of marijuana, marijuana concentrate and marijuana products for that licensee for mandatory testing. Any individual collecting samples for mandatory testing must hold a valid individual identification card ("IIC").
109.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.
110.Synthetic cannabinoid: "Synthetic cannabinoid" means a designed compound with structural features that allow binding to the known cannabinoid receptors present in human cells and that produce psychoactive effects like those of marijuana.
111.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.
112.Target organism: "Target organism" means an organism that is being tested for in an analytical procedure or test method.
113.Testing: "Testing" or "test" means the research and analysis of marijuana, marijuana products or other substances for contaminants, safety or potency. "Testing" or "test" includes the collection of samples of marijuana and marijuana products for testing purposes but does not include cultivation or manufacturing. Nothing in this definition shall be construed to permit any licensee except a marijuana testing facility to perform analyses of marijuana, marijuana concentrate or marijuana products for mandatory testing without a separate marijuana testing facility license issued by the Department.
114.Testing facility: "Testing facility" means a facility licensed under this rule to develop, research and test marijuana, marijuana products and other substances.
115.Testing facility director: "Testing facility director" means the marijuana testing facility director who is legally authorized to direct the activities of a marijuana testing facility and who commits the appropriate resources to comply with this rule.
116.THC: "THC" means tetrahydrocannabinol.
117.Tincture: "Tincture" means a liquid edible marijuana product with a concentration of greater than 1 mg of THC per ounce of liquid.
118.Topical marijuana product: "Topical marijuana product" means non-edible marijuana or marijuana products that are intended to be applied topically and absorbed transdermal, including without limitation salves, creams, lotions, transdermal patches or balms.
119.Total CBD: "Total CBD" means the sum of CBD and CBDA. Total CBD is calculated by a marijuana testing facility using the following equation: Total CBD = CBD + (CBDA*0.877).
120.Total THC: "Total THC" means the sum of THC and THCA. Total THC is calculated by a marijuana testing facility using the following equation: Total THC = delta-9 THC + (THCA*0.877).
121.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 marijuana or marijuana product on the premises, tracking all inventory, acquisition, and sales as well as the transfer of any marijuana or marijuana product to another facility, including for the purposes of testing or provision of trade samples to another licensee.
122.Universal symbol: "Universal symbol" means an image developed by the department, and made available to licensees, that indicates that a container, package or product contains marijuana or contains or is a marijuana product.1
123.Unorganized and deorganized areas: "Unorganized and deorganized areas" has the same meaning as in 12 MRS §682(1).
124.Unusable: "Unusable" means that the Marijuana can no longer be smoked, eaten, ingested, topically applied or otherwise ingested. Nor can the marijuana be further manipulated in a manner to extract more than a trace amount of cannabinoid.
125.Visibly intoxicated: "Visibly intoxicated" means in 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.
126.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.
127.Wholesale container: "Wholesale container" means a sealed package in which adult use marijuana, marijuana concentrate and marijuana products are conveyed during an authorized transfer.

1 Office of Marijuana Policy, Universal Symbol, OMP Website: Resources, https://www.maine.gov/dafs/omp/resources/universal-symbol (accessed August 18, 2021).

18-691 C.M.R. ch. 1, § 1