18-691-1 Me. Code R. § 3

Current through 2023-3, January 18, 2023
Section 691-1-3 - General Compliance
3.1 - Reporting of Ownership, Financial, Management and Other Interests

Licensees shall not attempt to conceal or disguise ownership or other control over their operations. The Department retains discretion to determine when a transfer of ownership interests has occurred. Licensees must comply with all reporting requirements regarding ownership, financial, management and other interests as required by this rule. Natural persons with indirect financial interests as defined in Section 1.4(50)(h) shall be included in the same category as those with a like direct financial interest. It is the exclusive responsibility of the applicant to clearly indicate on any forms, attachments, and supplemental information supplied to the Department any content the applicant deems to be trade secrets or other information that would be within the scope of a privilege against discovery or use as evidence recognized by the courts of this State in civil or criminal trials if the records or inspection thereof were sought in the course of a court proceeding, which may otherwise be included as a "public record" pursuant to 1 MRS §402(3) in a response to a request for records and information under the Maine Freedom of Access Act.

3.1.1Notice and Department Approval Required. Any change in ownership interests, including those in Section 1.4(50)(a), (b), and (g), requires Departmental approval under Section 2.11 prior to anyone with a new ownership interest associating with the licensee.
3.1.2Notice and Individual Identification Cardholders. Before any new officer, director, manager or general partner or new contractor or consultant as defined in Section 1.4(50)(f) may associate with a licensee, the licensee shall comply with 28-B MRS §213 and this rule in regards to that person.
3.1.3Notice and Assessment. For any financial interest that does not require prior approval or notice as above, such as Section 1.4(50)(c) and (e) the licensee shall notify the Department prior to the beginning of that association and the Department will consider whether the interest has been appropriately characterized and whether 28-B MRS §205(2) is implicated.
3.1.4Notice of Termination and Changes. The licensee shall notify the Department within 5 business days of the termination of any direct or indirect financial interest, and of any significant change to the nature or extent of that interest.
3.1.5No Prior Notice Required. Without prior notice to and approval by the Department, licensees may employ and contract with any persons who clearly do not fall within the definition of those with direct or indirect financial interests in the licensee, for the operation of a cannabis establishment, so long as each such person has a valid individual identification card. Employment of an employee having a direct or indirect financial interest in the license solely through an ESOP as defined in Section 1.4(50)(i) does not require prior notice or approval by the Department provided that the licensee appropriately reports the ESOP, by reporting annually, on forms provided by the Department, the name of any person holding an equity interest in the licensee through an ESOP. Compensation for such persons must not be structured as a means of evading the provisions of this rule. As employers, licensees are required to follow all applicable local, state and federal employment laws. including, without limitation, laws pertaining to workplace safety, hours and wages, and all other laws pertaining to the employment of persons in the State of Maine. Nothing in this rule shall be construed to exempt a cannabis establishment from the rights and responsibilities associated with being an employer.
3.2 - Premises

Only activities authorized by this rule and 28-B MRS may be conducted on the licensed premises. No other activities besides those authorized by this rule and 28-B MRS may be conducted at any time on the licensed premises, including without limitation: sampling events, catered events or parties.

3.2.1Controlling Entry to Cannabis Establishments.
A. Cannabis establishments must design entry points so that no person under 21 years of age is allowed entry to the premises.
(1) All establishment types must designate specific places at which an employee or licensee will:
(a) Verify the age and identity of all persons entering the premises;
(b) Require authorized contractors to sign the visitor entry log before entering limited access areas; and
(c) Receive mail and other deliveries.
(2) Nursery cultivation facilities and cannabis stores must designate specific places at which an employee or licensee will check for a valid government-issued form of identification and controlling access to areas of the premises designated for retail sales, in compliance with section 3.9.4 of this rule.
B. Entry points must be designed so as not to enable a person under 21 years of age to handle cannabis or cannabis products.
3.2.2Access to Adults Aged 21 or Older.
A. Cannabis stores and nursery cultivation may allow access to adults aged 21 or older, after verifying their age on a valid government-issued form of identification, for the following purposes:
(1) Consultations between employees and adult customers;
(2) Distribution of printed materials about cannabis;
(3) Sales or returns of products that may be legally sold by the licensee; and
(4) Customer restrooms, if provided.
B. A cannabis establishment may not allow the purchaser of cannabis or cannabis products to consume them on the premises.
C. A cannabis testing facility may designate on its facility plan a portion of the premises where it will receive samples for non-mandatory testing from licensees, persons 21 years of age or older, and/or qualifying patients, caregivers, registered caregivers or registered dispensaries in accordance with 28-B MRS §§503 and 503-A and this rule.
3.2.3Limited Access Areas.
A. Limited access areas include, but are not limited to:
(1) Areas in cultivation facilities in which mature cannabis plants, mother plants, immature plants or seedlings are grown; or cannabis is cut, stored, trimmed, cured or otherwise cultivated; cannabis is packaged for transfer; or cannabis waste is stored or processed.
(2) Areas in testing facilities in which cannabis or cannabis products are received, stored, handled, tested, transferred or discarded.
(3) Areas in cannabis product manufacturing facilities in which cannabis or cannabis concentrate is received, stored, combined with other ingredients or otherwise manufactured; cannabis products are stored, cooled, cut, packaged or labeled; cannabis or cannabis products are refrigerated; or cannabis waste is discarded or destroyed.
(4) Areas in cannabis stores in which a person would be able to touch or handle cannabis or cannabis products, including point of sale areas intended for employees only.
B. Any other area that is used to cultivate, store, weigh, manufacture, package or otherwise prepare for sale adult use cannabis and adult use cannabis products is also considered a limited access area.
C. It is the sole responsibility of the licensee to control access to limited access areas and limit access only to the following persons:
(1) The establishment's owners, managers or employees who are displaying a valid individual identification card issued to that person;
(2) Sample collectors who are displaying a valid individual identification card issued to that person;
(3) Employees of a testing facility who are displaying a valid individual identification card issued to that person;
(4) Contractors aged 21 or older (including, but not limited to, electricians, plumbers, engineers or alarm technicians) who will not handle cannabis plants, cannabis or cannabis products, in compliance with this subsection;
(5) Staff or agents of the Department;
(6) Law enforcement officers; and
(7) Employees or agents of other local or state agencies with regulatory authority, including but not limited to fire marshals, electrical inspectors, pesticide control staff, and environmental inspectors.
D. Staff or agents of the Department, and employees or agents of local or state agencies with regulatory authority shall provide proof of identification but shall not be considered visitors and shall not be denied entry to any area of the premises.
E. Security.
(1) Nurseries and cannabis stores that admit persons 21 years of age or older for the purpose of purchasing cannabis plants, cannabis, or cannabis products shall use identification checks, locked doors, video surveillance, counters, and locked displays, in accordance with their Department-approved security plan, to prevent unauthorized entry to limited access areas
(2) Other licensees shall use identification checks, locked doors, and video surveillance, in accordance with their Department-approved security plan, to prevent unauthorized entry to limited access areas.
(3) Any security breaches must be reported within 24 hours, in writing, to the Department.
F. Required Signage.
(1) All areas of ingress and egress to limited access areas on the premises shall be clearly identified by posting a sign which shall be no smaller than 8.5 inches high and 11 inches wide, composed of letters not less than a half inch in height, which shall state: "Pursuant to State Law: Do Not Enter - Authorized Persons Only."
(2) If a person must pass through a limited access area to reach other limited access areas, and there is no other route through which a person can gain access to the subsequent limited access areas, then signage must only be posted on the first limited access area through which a person must pass.
G. Contractors and other authorized visitors.
(1) Contractors and other authorized visitors who will not handle cannabis plants, cannabis or cannabis products, including but not limited to electricians, plumbers, engineers and alarm technicians, do not require an individual identification card.
(2) A contractor may enter a limited access area only if wearing a visitor identification badge, signed in and recorded on a visitor entry log.
(3) At all times while in a limited access area, the contractor shall display in a conspicuous place on their person a visitor identification badge.
(a) The visitor identification badge must display an identifying mark, which may be a clearly identifiable letter, number or symbol or combination thereof.
(b) The visitor identification badge may be displayed on a sticker, a card on a lanyard, a card pinned to the clothing of the visitor, or by other effective means.
(4) A visitor entry log must include, at a minimum:
(a) The date and time of the visitor's entry;
(b) The date and time of the visitor's departure;
(c) The full name of the visitor;
(d) The identifying number of the visitor's state- or federally-issued identification;
(e) The identifying mark on the visitor identification badge; and
(f) The purpose for which the contractor is accessing the limited access area[s].
3.3 - Security

Cultivation facilities, testing facilities, products manufacturing facilities, and cannabis stores must provide adequate security at the licensed premises. This section does not apply to sample collectors.

3.3. 1Mandatory Requirements for Cultivation Facilities, Testing Facilities, Products Manufacturing Facilities and Cannabis Stores. As applicable, cannabis establishments must enact security measures to prevent the diversion of cannabis or cannabis products that are being cultivated, manufactured, tested, packaged, stored, displayed or transported.
A. Lighting
(1) Any gate or perimeter entry point of a cannabis establishment must have lighting sufficient for observers to see, and cameras to record, any activity within 10 feet of the gate or entry.
(2) A motion detection lighting system may be employed to light required areas in low-light conditions.
B. Doors and windows
(1) Commercial grade locks, appropriate for facilities requiring high levels of physical security, are required on all perimeter entry doors and on all doors separating limited access areas from areas open to visitors and customers.
(2) All external entrances to indoor facilities on the licensed premises must be able to be locked.
(3) All perimeter windows must be in good condition and lockable.
C. Alarm system
(1) Monitored sensors are required on all perimeter entry points and perimeter windows, except that perimeter windows may be protected by appropriately located motion sensors
(2) Alarm systems must be monitored by a licensed security company capable of contacting the licensee and, if necessary, law enforcement.
(3) The system must include an audible alarm, which must be capable of being disabled remotely by the security company.
D. Video surveillance
(1) Placement and coverage of cameras shall be sufficient:
(a) Cameras must be permanently fixed inside each entry/exit point (perimeter and limited access area) to allow identification of persons entering the premises and limited access areas.
(b) Cameras must be permanently fixed outside each entry/exit point (perimeter and limited access area) to allow identification of persons exiting the premises and limited access areas.
(c) A sufficient number of cameras must be permanently fixed to allow the viewing, in its entirety, of any area where cannabis, cannabis plants, immature cannabis plants, seedlings, seeds, cannabis concentrate or cannabis products are cultivated, manufactured, stored or prepared for transfer or sale or where samples for mandatory testing are collected, and prepared and sealed for transport to a cannabis testing facility;
(i) Except that outdoor cultivation areas must have only a sufficient number of cameras permanently fixed to allow the viewing of the entirety of the perimeter of the cultivation area inside of the exterior fence; and
(ii) Indoor cultivation areas, including each grow room and each drying room, must have only a sufficient number of cameras permanently fixed to allow the viewing of all points of ingress and egress to and from the cultivation area.
(d) A sufficient number of cameras must be permanently fixed to allow the viewing, in its entirety, of any area where cannabis waste is stored before being made unusable, or where cannabis waste is made unusable.
(e) A camera must be permanently fixed at each point of sale to ensure identity of the purchaser.
(f) A sufficient number of cameras shall be permanently fixed to allow recording of all transactions conducted in areas designated by a cannabis store for curbside pickup by customers, including any areas not included in the licensed premises of the cannabis store but immediately adjacent to the primary public ingress and egress of the cannabis store where the cannabis store intends to conduct curbside pickup by consumers.
(i) Any curbside pickup location outside the licensed premises must be in a place designated for parking or standing and capable of being entirely within the view of cameras permanently fixed to the exterior of the licensed premises where such cameras can clearly capture the entirety of the transaction conducted via curbside pickup.
(g) A sufficient number of cameras shall be permanently fixed to allow recording of all areas outside of the premises within 10 feet of the exterior fence and gates of a cultivation facility with outdoor growing.
(h) Cameras, either mobile or fixed, must be maintained to allow recording of all transactions conducted via delivery. Cameras recording sales via delivery must be sufficient to record the entirety of the transaction and to ensure identity of the purchaser.
(2) Video surveillance shall meet the following minimum requirements:
(a) Minimum camera resolution is 720p.
(b) System storage and cameras are internet protocol (IP) compatible.
(c) All cameras must record continuously twenty-four hours per day or be motion activated and at a minimum of 15 frames per second.
(i) Motion activated video storage must capture and store footage for no less than 120 seconds prior to motion activation and 120 second following the cessation of motion.
(d) All recorded images must clearly and accurately display the time and date. Time is to be measured in accordance with the U.S. National Institute Standards and Technology standards.
(e) The surveillance system storage device must be secured on the premises in a lockbox, cabinet or closet, or must be on a third-party server or secured in another manner to protect from employee tampering or criminal theft.
(f) Surveillance equipment used to record deliveries shall be secured when not in use and recordings shall be uploaded to the surveillance system server, including if applicable, a third-party cloud-based server, within 24 hours of the transaction.
(g) Video surveillance is not intended to include the use of any computer software or application that performs facial surveillance as defined by 25 MRS §6001(1) (D) and (E).
(3) All surveillance recordings, including recordings made of deliveries, must be kept for a minimum of 45 days on the licensee's recording device.
(4) All videos are subject to inspection by any Department employee and must be copied and provided to the Department upon request.
(5) Licensees shall maintain a list of all persons with access to video surveillance recording and procedures for controlling access to recordings.
3.3.2Fencing and Lighting Requirements for Cultivation Facilities. A cultivation facility that cultivates seedlings, immature plants, mother plants or mature plants in outdoor areas or in greenhouses or other structures that do not meet all security requirements for buildings must secure such cultivation areas with fencing and lighting.
A. Any cultivation facility with cultivation areas that do not meet the requirements for building security shall erect secure fencing around such areas. Fencing and all gates must be secure, at least 6 feet high and obscure, or have a cover that obscures, the Limited Access Area from being readily viewed from outside of the fenced in area. Such fencing must be commercial or security grade, not agricultural or residential grade, and designed to prevent access to the cultivation area by unauthorized persons.
B. Lighting shall be designed to sufficiently illuminate a perimeter of at least 10 feet around any point of entry, whether it is a gate or access from a building. A licensee may use motion sensor lighting in cultivation areas.
3.3.3Additional Security Measures. The licensee may choose to enact additional security measures to enhance the safety of the cannabis establishment. Any additional security measures implemented by a licensee are subject to the following requirements:
A. Measures to prevent employee or contractor theft:
(1) Licensees may designate areas for employee and contractor storage of bags, overcoats and other belongings.
(2) Licensees may place limits on the size of bags to be brought to the cannabis establishment.
(3) Licensees may institute other reasonable procedures for checking for stolen cannabis or cannabis products when an employee or contractor leaves the premises.
B. Security guards:
(1) Security guards are permitted but not required at cannabis establishments.
(2) Security guards employed or contracted by a licensee must:
(a) Meet all qualifications of 32 MRS, chapter 93;
(b) Be at least 21 years of age;
(c) Comply with all requirements of 32 MRS, chapter 93; and
(d) Obtain and display individual identification cards if they will be in limited access areas or in a vehicle that is transporting cannabis plants, cannabis or cannabis products.
(3) Security guards must not consume cannabis or cannabis products or be intoxicated while performing any duties for a licensee.
(4) Licensees, employees and security guards must comply with all laws and regulations related to firearms and other weapons.
3.3.4Written Security Plan. Before cultivating, manufacturing, testing, selling, storing or transporting cannabis or cannabis products, each licensee shall receive Department approval of a written security plan, included in the licensee's facility plan of record, demonstrating compliance with all requirements of this rule.
A. At a minimum, the security plan shall provide sufficient detail so that the Department may determine whether the following requirements are met:
(1) Lighting adequately illuminates entry and exit points;
(2) All doors and windows are lockable;
(3) Fences (if present) meet height and other requirements;
(4) Alarm sensors are present on all entry points and windows and are remotely monitored;
(5) Video cameras are present in all required locations;
(6) Video cameras and storage meet all required specifications; and
(7) In areas of the premises (if any) designated for retail sales, lockable and secure display cases or counters of sufficient height to prevent the public from handling cannabis plants, cannabis or cannabis products without direct supervision of a licensee or employee.
B. Each licensee shall adhere to the security plan and notify the Department in writing through the submission of a revised security plan 14 days prior to making any material change to security measures. The Department may determine at any time that the revised security plan does not meet minimum requirements. Except in exigent circumstances, which must be communicated to the Department in 24 hours, a licensee may not make any material changes to security measures without prior notice to the Department in writing.
C. Material changes include, but are not limited to: the addition or removal of sensors or cameras; or changes to the location of sensors, cameras, points of entry or exit or points of sale or authorized transfers; changing security monitoring companies; and changes to lighting.
3.4 - General Conduct
3.4.1.General Requirements.
A. Cannabis licensees are responsible for the operation of their licensed business in compliance with Maine Revised Statutes, Titles 28-B, 17-A, 36; this rule; and any other applicable state laws and rules.
B. Licensees and their employees must conduct business and maintain the licensed premises, surrounding area, and vehicles transporting product, in compliance with the following laws, as they now exist or may later be amended:
(1) Falsification in Official Matters, 17-A MRS, chapter 19;
(2) Offenses against Public Order, 17-A MRS, chapter 21;
(3) Drugs, 17-A MRS, chapter 45; and
(4) Motor Vehicles and Traffic, 29-A MRS.
C. Licensees have the responsibility to control their conduct and the conduct of employees, customers, contractors and visitors on the licensed premises at all times. Licensees shall ensure that at all times during business hours, as applicable, and hours of apparent activity that there is, on-site, an individual identification cardholder authorized to cooperate with Department inspection of the premises and business records. Except as otherwise provided by law, licensees or employees may not:
(1) Be disorderly or visibly intoxicated by liquor, cannabis or controlled substances on the licensed premises;
(2) Permit any disorderly or visibly intoxicated person to remain on the licensed premises;
(3) Engage in or allow behavior on the licensed premises that provokes conduct which presents a threat to public safety;
(4) Engage in, or permit any employee or other person to engage in, conduct on the licensed premises that is prohibited by any portion of 28-B MRS,17-A MRS or 36 MRS; any part of this rule; or any other applicable state laws and rules; or
(5) Engage in or permit any employee or other person to engage in the consumption of any type of cannabis, cannabis concentrate or cannabis product on the premises, except:
(a) A licensee may allow an employee who is a qualifying patient to consume legally obtained medical cannabis or cannabis products on the licensed premises. Pursuant to 22 MRS §2426(2)(B), no employer is required to accommodate the ingestion of medical cannabis in any workplace or any employee working while under the influence of cannabis.
(b) An employee of a licensee may ingest, consume or apply products for quality control, research or development, or employee educational purposes, so long as the licensee does not allow any products to be smoked on the premises and the licensee ensures that the person conducting the testing does not operate any equipment or machinery or a motor vehicle while under the influence of the cannabis product.
D. Licensees are prohibited by this rule from manufacturing, selling or offering for sale any cannabis product intended for intravenous delivery or that involves any type of injection involving piercing of the skin of a human or animal.
3.4.2.General Sanitary Requirements. In addition to the requirements found in Maine Food Code Chapter 33, this rule and all other applicable rules and laws, a cannabis establishment licensee must:
A. Prohibit an individual from working at a licensed premise who has or appears to have:
(1) An open or draining skin lesion unless the individual wears an absorbent dressing and protective gloves; or
(2) Any illness accompanied by diarrhea or vomiting if the individual has a reasonable possibility of contact with cannabis or cannabis products on the licensed premises;
B. Require all persons who work in direct contact with cannabis or cannabis products conform to hygienic practices while on duty, including but not limited to:
(1) Maintaining adequate personal cleanliness; and
(2) Washing hands thoroughly in an adequate hand-washing area before starting work, prior to having contact with cannabis or cannabis products and at any other time when the hands may have become soiled or contaminated;
C. Provide adequate and convenient hand-washing facilities, furnished with potable running water at a suitable temperature, effective hand-cleaning and sanitizing preparations and sanitary towel service or suitable drying device;
D. Properly remove all litter and waste from the licensed premises and maintain the operating systems for waste disposal in an adequate manner so that they do not constitute a source of contamination in areas where cannabis or cannabis products are exposed;
E. Provide employees with adequate and readily accessible toilet facilities that are maintained in a sanitary condition and good repair; and
F. Hold cannabis or cannabis products in a manner that prevents pathogenic microorganism growth or toxin formation.
3.5 - Adherence to Written Plans Approved by the Department

Cannabis establishment licensees are required to conduct operations in accordance with all written plans and applications and supplemental materials submitted by the licensee as an applicant, conditional licensee or active licensee and approved by the Department as indicated by the issuance of a cannabis establishment license.

3.5.1Covered Plans. As applicable, a licensee is responsible for developing, obtaining approval for and adhering to any plans that the Department may require to promote public health, public safety and orderly operation of the adult use cannabis program in accordance with the 28-B MRS and this rule. At minimum:
A. All cannabis establishments must develop, receive approval for and operate in accordance with its facility plan.
B. All cannabis establishments must operate in accordance with:
(1) Any applicable written plans of record included in the facility plan of record;
(2) Any other written assurances regarding operations to the Department for the purposes of ensuring health and safety;
(3) Local ordinances, land use standards and/or warrant articles;
(4) Any permits issued, or conditions imposed by a municipality, town, plantation, county commission or the Maine Land Use Planning Commission in connection with local authorization; and
(5) Any plans required by any other federal, state or local regulations.
C. Licensees collecting their own samples for mandatory testing must comply with all Department-required forms, SOPs and guidance.
3.5.2Plans of Record. The Department shall keep on file a copy of all facility plans as well as copies of certifications of testing facilities. The most recent plan, whether submitted with the issuance of the cannabis establishment license, or by the subsequent approval of an application to change, shall be the plan of record with which the licensee must comply.
3.5.3Licensee Responsibility. A cannabis establishment licensee is solely responsible for the operation of the cannabis establishment in accordance with the cannabis establishment facility plan of record on file with the Department.
3.5.4Changes to Facility Plan, including changes to operations, cultivation or security information included therein. Any material changes to the facility plan of record of any cannabis establishment must be approved by the Department. A material change includes without limitation: changes to the licensed premises including changes to the floor plan, security equipment, manufacturing equipment, display cases or any other area of the licensed premises where cannabis is cultivated, manufactured, stored or sold, the addition or removal of curbside pickup locations - including those curbside pickup locations outside the licensed premises but immediately adjacent to the primary public ingress and egress of the cannabis store, the commencement or cessation of delivery activities and seasonal or temporary cessation of authorized activities at a licensed cannabis establishment in excess of 30 days.
A. An application to materially change the facility plan of a cannabis establishment must be:
(1) Submitted on forms made available by the Department;
(2) Accompanied by all required fees associated with a change of facility plan; and
(3) Consistent with 28-B MRS, this rule and any other applicable laws and rules.
B. No licensee shall make material changes to operations, including cultivation or security practices, until the application for changes to the facility plan have been approved by the Department.
C. Within 30 days of receiving an application for changes to the facility plan, the Department shall:
(1) Approve the application for changes to the facility plan and update the facility plan of record on file with the Department; or
(2) Deny the application for changes to the facility plan only if the changes requested are in violation of 28-B MRS, this rule, conditions required for local approval or other applicable laws or rules.
D. The Department may place an application for changes to a facility plan on hold if the cannabis establishment applying for the change of facility plan is currently under investigation for a violation of 28B MRS, this rule or other related laws or rules.
E. For purposes of this section, a licensee proposing to co-locate a medical cannabis operation not currently operating on the premises shall constitute a material change in the facility plan.
3.6 - Requirements Applicable to Cultivation Facilities
3.6.1General Compliance. In addition to the general compliance requirements pursuant to this rule, including without limitation Section 3, and all requirements pursuant to 28-B MRS,36 MRS and all other applicable laws and rules, a cannabis cultivation licensee must comply with the requirements of this subsection.
3.6.2Privileges Granted. A cannabis cultivation licensee shall only exercise those privileges granted to it by the Department. In accordance with 28-B MRS, this rule and all other applicable laws and rules, a cannabis cultivation licensee may within limited access areas of the premises as described in the cannabis establishment facility plan of record:
A. Propagate and cultivate cannabis plants;
B. If appropriately licensed as a pesticide applicator with the Department of Agriculture, Conservation and Forestry, Board of Pesticides Control, apply pesticides, fungicides and growth regulators permitted for use on cannabis to cannabis plants;
C. Trim, dry, cure and store cannabis;
D. Prepare cannabis plants and cannabis for authorized transfer and participate in authorized transfers of cannabis plants and cannabis;
E. Package cannabis for retail sale:
(1) A cannabis cultivation establishment may package cannabis flower and trim for retail sale; and
(2) A cannabis cultivation establishment may produce pre-rolled cannabis cigarettes, so long as the pre-rolled cannabis cigarettes contain only cannabis flower or trim.
F. Prepare cannabis waste for disposal and dispose of cannabis waste;
G. Transfer cannabis samples to products manufacturing and cannabis store licensees pursuant to 28-B MRS and this rule;
H. Collect samples for mandatory testing in compliance with this rule;
I. Transfer cannabis testing samples to a licensed cannabis testing facility; and
J. Performed authorized transfer of cannabis plants and cannabis.
3.6.3Authorized Sources of Cannabis Plants and Seeds. A cultivation facility licensee may acquire cannabis plants and seeds by the following processes:
A. By lawful purchase from another cultivation facility licensee, including a nursery cultivation facility.
B. By gift from an individual person, who must be a resident of the State of Maine:
(1) A cultivation facility licensee may receive, by gift from an individual, only seedlings pursuant to this rule;
(2) A cultivation facility licensee may not accept, during a 90 day period, more than one transfer of seedlings from each individual gifting seedlings to that licensee;
(3) A cultivation facility licensee may not accept more than 6 seedlings from an individual gifting seedlings to the licensee;
(4) Before accepting a gift of seedlings, the cultivation facility must receive approval from the Department, in writing, to accept the gift of seedlings. A cultivation facility licensee that receives seedlings as a gift from an individual, shall record on forms made available by the Department, the full name, contact telephone number and the identification number of a valid state identification belonging to the individual;
(5) The individual gifting the seedlings to the licensee may not receive remuneration of any kind in return; and
(6) The gift of the seedlings must not be conditional or contingent upon any other terms or requirements of the licensee.
C. By way of limited authorization for the sale of cannabis plants (including seedlings, immature plants, mother plants and mature plants) and cannabis seeds by registered caregiver or registered dispensary to cannabis cultivation licensee, pursuant to 28-B MRS §501(6):
(1) A cultivation facility licensee may not make such purchases unless the cultivation facility licensee is:
(a) A natural person who is also a registered caregiver or registered dispensary; or
(b) A business entity that is also a registered caregiver or registered dispensary.
(2) A cultivation facility may not make such purchases more than 1 year after it is first issued a cultivation facility license.
(3) A cultivation facility may not make such purchases after September 8, 20222.
(4) A cultivation facility must enter all cannabis seedlings, immature plants, mother plants and mature cannabis plants acquired through such purchases into the tracking system.
(5) A cultivation facility must report such purchases on a form supplied by the Department.
(6) A cultivation facility must pay any excise tax that would have been owed if the same amount of cannabis plants or seeds had been sold by a cultivation facility.
(7) Any cannabis seeds and cannabis must be transported in accordance with all requirements relevant to transfers between licensees.
(8) A cultivation facility may not make such a purchase from a registered caregiver or registered dispensary that previously has made a sale of cannabis or cannabis seeds under this provision.
(9) Any cannabis or cannabis seeds obtained in violation of this paragraph, and any cannabis derived therefrom, are subject to seizure and destruction by the Department, in addition to any administrative penalties that the Department may impose.
3.6.4Cannabis Cultivation Establishment Premises.
A. The premises of a cannabis cultivation establishment must comply with all security requirements described in Section 3.3.
B. All electrical equipment, including but not limited to growing lights, cultivation equipment and packaging equipment, must be agency approved including UL, ETL, and CSA.
C. Any cultivation of seedlings, immature plants, mother plants or mature plants must take place in:
(1) A fully enclosed secure indoor facility or secure greenhouse with walls, a roof, lockable doors, and secure windows as described in Section 3.3 that prevent entry by unauthorized persons; or
(2) Within a secured fenced area, as described in Section 3.3, structures, or an expanse of open or cleared ground.
D. The entire area within the fence surrounding non-secure greenhouses, other structures or expanse of open or cleared ground shall be considered a limited access area.
(1) An outdoor or greenhouse cannabis cultivation facility must provide sufficient security measures to demonstrate that outdoor areas are not readily accessible by unauthorized individuals.
(2) It shall be the responsibility of the licensee to maintain physical security in a manner similar to a cultivation facility located in an indoor licensed premise so it can be fully secured and alarmed.
E. A nursery cultivation facility or a cultivation facility that also holds a cannabis store license on the same premises must use a fence or other adequate security measures to separate areas of the premises designated for retail sales from limited access areas, including any area where samples for mandatory testing are collected, packaged, and sealed for transport to a cannabis testing facility.
3.6.5Authorized Mature Plant Canopy. At no time may a cannabis cultivation licensee cultivate mature cannabis plants in an area not clearly illustrated on the facility plan of record previously filed and approved by the Department. At no time may the total area in square feet in which mature cannabis plants are cultivated exceed the total area for which the cannabis cultivation licensee has been approved as indicated on the license issued to the licensee by the Department.
3.6.6Cultivation of Medical and Adult Use Cannabis on the Same Premises. A cultivation facility may cultivate both medical cannabis and adult use cannabis only if:
(1) it has received the Department's approval of a facility plan to cultivate both, and
(2) it is a validly registered caregiver or dispensary. The cultivation facility must:
A. Cultivate medical cannabis in an area physically and visually separated from the area used to cultivate adult use cannabis;
B. Track all medical cannabis separately from adult use cannabis;
C. Store all medical cannabis separately from adult use cannabis;
D. Ensure that medical cannabis is never cultivated simultaneously or contemporaneously with adult use cannabis on the same piece of equipment;
E. Keep a log of the following information for all equipment used to cultivate both medical cannabis and adult use cannabis:
(1) The name of the licensee or employee who operated the equipment;
(2) The tracking information for the cannabis or cannabis concentrate that was processed using the equipment;
(3) The exact date, time and duration the equipment was used; and
(4) The tracking information for the resulting cannabis concentrate or cannabis product; and
F. Make the log for any piece of equipment available to the Department.
3.7 - Requirements Applicable to Testing Facilities
3.7.1General Requirements. Before accepting any cannabis or cannabis products for mandatory testing pursuant to 28-B MRS §602, a cannabis testing facility must:
A. Obtain certification from the Department of Health and Human Services, Maine Center for Disease Control and Prevention, in accordance with 18-691 CMR, Ch. 5, at any point during the licensure process, but prior to the issuance of a full or provisional active license by the Department. Approval by the CDC of plans, standard operating procedures, financial and business arrangements, or other documents and information provided for certification by the CDC pursuant to the Rules for the Certification of Cannabis Testing Facilities, 18-691 CMR, ch. 5 does not constitute approval by DAFS for the purposes of licensure pursuant to this rule; and
B. Obtain a conditional license from the Department, in accordance with Section 2.4; obtain local authorization to operate a cannabis testing facility, in accordance with Section 2.7.2; and an active license from the Department, in accordance with Section 2.7.
3.7.2Prohibited Conduct. In addition to any other restrictions or prohibitions contained in this rule, 28-B MRS,18 - 691 CMR, Ch. 5, any other applicable Federal, State or Local rules or laws or any accreditation requirements, cannabis testing facilities are subject to the following prohibitions.
(1) No testing facility or owner, officer, director, manager, general partner, or employee of a cannabis testing facility may have a direct or indirect financial interest in a cultivation facility, products manufacturing facility, manufacturing facility, cannabis store, registered caregiver or registered dispensary.
(2) No owner, officer, director manager or general partner of a cannabis testing facility may be a registered caregiver.
(3) No testing facility may conduct testing on behalf of a registered caregiver who is an employee of that testing facility.
(4) Cannabis or cannabis products may not be collected, accepted, transported, purchased, transferred or destroyed without entering the cannabis or cannabis products into the tracking system required by the Department by 11:59 P.M. that same day.
(5) A cannabis testing facility may not transfer any cannabis or cannabis products or samples to any person or entity other than the person or entity who provided the sample, a law enforcement officer authorized to collect the cannabis or cannabis product, another licensed cannabis testing facility with a valid license to perform the testing requested, or the Department.
(6) No owner, officer, director, manager, general partner, contractor or employee of a cannabis testing facility may accept any gifts of goods, services, or money from a cultivation facility, products manufacturing facility, cannabis store, registered caregiver or registered dispensary or a person or an organization representing such entities.
(7) A cannabis testing facility shall maintain the confidentiality of test results and may not report test results with any identifying information to anyone other than the person or entity who submitted the sample, law enforcement officers authorized to collect the information, the CDC, or the Department.
(8) No employee of a cannabis testing facility may alter the results of any test. In cases in which a sample was retested in accordance with Section 7 of this rule, both test results shall be maintained.
(9) No employee of a cannabis testing facility may conceal from the Department the results of any mandatory test for cannabinoid content or contamination.
(10) No testing facility may fail to operate within the requirements of this rule, any term of certification or any order, or any request or other directive made under authority of or under the statutory authority vested in the Department.
(11) No testing facility may engage in, aid, abet, cause or permit any action prohibited under this rule.
(12) No testing facility may fail to provide timely and accurate data reporting.
(13) No testing facility may engage in false or deceptive advertising.
(14) A cannabis testing facility must maintain its certification at all times for at least one analyte and technology required as part of mandatory testing to remain licensed by the Department.
(15) No testing facility may continue to operate after a municipality or the Maine Land Use Planning Commission informs the Department that it has revoked, suspended or not renewed local authorization.
3.7.3Personnel Qualifications. A cannabis testing facility must employ at all times qualified staff who meet the requirements of certification by the CDC.
A. A cannabis testing facility must ensure that a cannabis testing facility director meeting CDC certification requirement is onsite and available during on average, at least 60% of the business hours indicated on the facility plan.
B. A cannabis testing facility must keep a current record of all individual identification cards, the individual identification card number and date of issuance and expiration for every officer, director, manager, general partner, employee, or any other individual identification card holder of the cannabis testing facility.
3.7.4Written SOPs are Requirements of Licensing and Must be Followed.
A. Actual practice must conform to the written procedures required under 18-691 CMR ch.5.
(1) The cannabis testing facility must maintain copies of the methods from which the procedures are developed and must ensure that the applicable requirements are incorporated into each procedure.
(2) A copy of each procedure must be available to all personnel that engage in that activity.
(3) An analyst must use the cannabis testing facility's SOP beginning on its effective date.
B. It is the exclusive responsibility of the cannabis testing facility to clearly indicate on any SOPs supplied to the Department any content the cannabis testing facility deems to be trade secrets or other information that would be within the scope of a privilege against discovery or use as evidence recognized by the courts of this State in civil or criminal trials if the records or inspection thereof were sought in the course of a court proceeding, which may otherwise be included as a "public record" pursuant to 1 MRS §402(3) in a response to a request for records and information under the Maine Freedom of Access Act.
C. The cannabis testing facility must make the SOPs available to the Department and the CDC upon request.
3.7.5A Cannabis Testing Facility Must Comply with all Recordkeeping Requirements of 18-691 CMR, Ch. 5 and this Rule.
A. The cannabis testing facility must maintain analytical records to demonstrate to the Department and the CDC the following: the analyst's name; date of analysis; approver of the certificate of analysis and relevant data package; the test method; and the materials used.
(1) Cannabis testing facility records may be on paper or on electronic, magnetic or optical media and must be stored in such a way that the records are readily retrieved when requested by the Department or the CDC.
(2) If the cannabis testing facility records are not on paper, the cannabis testing facility must be able to produce the records in hard copy for the Department or the CDC, upon request.
(3) All cannabis testing facility records must be kept for a minimum of five years.
(4) The Department and the CDC must be allowed access to all electronic data, including standards records, calibration records, extraction logs, cannabis testing facility notebooks and all other cannabis testing facility-related documents as required by this rule and 18-691 CMR, Ch. 5.
B. The cannabis testing facility must maintain all analytical records and documents, forms, records and standard operating procedures associated with the cannabis testing facility's methods as required by this rule and 18-691 CMR, Ch. 5.
C. If records are missing or incomplete, or if the cannabis testing facility does not produce records for the Department or the CDC upon request, the Department may take disciplinary or enforcement action against the cannabis testing facility. A cannabis testing facility shall have 7 calendar days from the request to respond.
3.7.6Electronic Data Storage and Security.
A. A cannabis testing facility must store all raw unprocessed instrument output data files and processed quantitation output files on some form of electronic, magnetic or optical media. The cannabis testing facility must allow access to these records for inspection and audit by the Department or the CDC.
B. A cannabis testing facility must install, manage and maintain password-protection for electronically stored data, including any certificate of analysis.
3.7.7Test Waste Disposal.
A. A cannabis testing facility must dispose of all unused test samples and waste generated by the testing of samples of cannabis, cannabis concentrate and cannabis products in accordance with the facility's SOPs and this rule.
B. The cannabis testing facility must discard hazardous waste in accordance with Section 8.1 of this rule.
C. The cannabis testing facility must discard cannabis waste in accordance with Section 8.2 of this rule.
3.7.8Security
A. All cannabis on the premises must be tracked using the chain-of-custody forms and the inventory tracking system in accordance with this rule and 18-691 CMR, Ch. 5.
B. The cannabis testing facility must install key-card doors, alarms or other means of detecting entrance and exit to limited access areas and during times that are outside of the business hours of the facility.
C. The cannabis testing facility must develop and implement security protocols that can prevent diversion, theft and loss of samples.
D. The security protocol must be documented in writing and available to all testing facility personnel during normal business hours and must be included in training materials. The cannabis testing facility must ensure that personnel have a thorough understanding of the security protocol.
E. The cannabis testing facility must deter the unauthorized entrance into areas within the cannabis testing facility where samples are present by controlling access to those areas through the following means:
(1) Limiting access to specific personnel, in order for them to execute their specific job function and duties;
(2) Implementing an access-control-card system capable of preventing unauthorized access through access control points and recording the transaction history of all entrants;
(3) Using a monitored security alarm system;
(4) Maintaining a visitor arrival and departure log, which must contain, at a minimum, the name of the visitor, date and time of arrival and departure, and the purpose of the visit; and
(5) Installing security cameras at all access points to the premises, in storage areas for samples and where cannabis waste will be destroyed.
F. The cannabis testing facility must store and secure cannabis with a commercial-grade lock in a room or cabinet capable of preventing diversion, theft, and loss. Secured areas must be locked at all times, except when managing or retrieving a secured item or items. The cannabis testing facility must store cannabis and cannabis product samples apart and away from non-cannabis samples and items. The cannabis testing facility must designate secured areas for storage of the following:
(1) Test samples of cannabis and cannabis products;
(2) Waste containing cannabis;
(3) Reference standards for analysis of cannabinoids; and
(4) Any controlled substances related to cannabinoids.
G. Testing facilities must notify the Department within one business day of discovering any of the following:
(1) An unexplained loss of 5% or more of the inventory of unpackaged and unused production batch samples held at the cannabis testing facility;
(2) An unexplained loss of one or more units of packaged batch samples held at the cannabis testing facility; or
(3) Diversion or theft of cannabis, unauthorized or prohibited conduct, or any other criminal activity pertaining to the operation of the cannabis testing facility.
H. The cannabis testing facility must also comply with security requirements of Section 3.3 of this rule.
I. In addition to any samples collected for mandatory testing by the cannabis testing facility, a cannabis testing facility may only accept samples for mandatory testing from:
(1) Licensed sample collectors; or
(2) A self-sampler in compliance with this rule.
3.8 - Requirements Applicable to Products Manufacturing Facilities
3.8.1General Product Safety. In addition to other provisions in this rule, 28-B MRS and all other applicable rules and laws, a cannabis products manufacturing facility must:
A. Ensure that all equipment and surfaces that come into contact with any cannabis or other ingredients are food grade and made of materials that do not react adversely with cannabis, any ingredient, chemical or solvent being used;
B. Construct, install and maintain all counters and surface areas in a manner that reduces the potential for development of microbials, molds, mildew, fungi and other contaminants, and that can be easily cleaned;
C. Maintain the premises in a manner that is:
(1) Free from conditions that may result in contamination; and
(2) Suitable to facilitate safe and sanitary operations;
D. Provide adequate refrigeration for perishable cannabis products that will be consumed and utilize adequate storage facilities and transport methods;
E. Ensure that all electrical equipment used for extraction is agency approved including UL, ETL, and CSA;
F. Maintain a log of all maintenance, service and repairs to any equipment used for extraction using inherently hazardous substances;
G. Ensure that all chemicals and substances used in the manufacturing process are stored in a safe location on the premises and in a manner to prevent contamination of any cannabis or cannabis products; and
H. Collect and submit samples of cannabis concentrate and cannabis products for mandatory testing in accordance with all requirements of this rule.
3.8.2Prohibited Conduct. In addition to any other restrictions or prohibitions contained in this rule, 28-B MRS and any other applicable rules or laws, a cannabis products manufacturing establishment may not:
A. Manufacture a cannabis product that by its shape or design is likely to appeal to persons under 21 years of age, including without limitation:
(1) Products that are modeled after non-cannabis products commonly consumed by and marketed to persons under 21 years of age; or
(2) Products in the distinct shape of a human, animal or fruit.
B. Manufacture a cannabis product by adding or infusing cannabis into a commercially available non-cannabis end product;
C. Manufacture any product that does not contain cannabis;
D. Manufacture any edible cannabis product that has more than 10 milligrams of THC per serving;
E. Package together for sale an edible cannabis product that has more than 100 milligrams of total THC; or
F. Engage in the sale of cannabis, if required testing is not verified/verifiable with certificate of analysis, or if testing reports unsafe levels of potentially harmful substances.
3.8.3Tracking. A cannabis products manufacturing facility must enter into the tracking system all required information each time a batch is created.
3.8.4Extraction.
A.Generally safe extraction methods. The Department permits the following generally safe extraction methods, so long as they are listed in the facility plan of record:
(1) Mechanical extraction using:
(a) Potable water and ice made from potable water;
(b) Dry screening or sieving;
(c) Cryogenic or subzero processing not involving a solvent; or
(d) Pressure and temperature.
(2) Infusion of cannabis in food grade fats or synthetic food additives:
(a) Propylene glycol;
(b) Glycerin;
(c) Butter;
(d) Olive Oil; or
(e) Other typical cooking fats.
B.Potentially hazardous extraction methods. The Department will permit potentially hazardous solvent extraction using a 99 percent or greater purity of the following solvents, using storage, preparation, electrical, gas monitoring, fire suppression and exhaust systems methods approved in the facility plan of record, so long as the solvents are listed in the facility plan of record and the end result does not exceed allowable limits specified by the Department:
(a) CO2;
(b) Ethanol, including solutions of ethanol and potable water; or
(c) A liquid chemical, compressed gas or commercial product that has a flashpoint above 38 degrees Celsius or 100 degrees Fahrenheit.
C.Inherently hazardous extraction methods. Upon certification by a professional engineer licensed in Maine that the manufacturing facility's storage, preparation, electrical, gas monitoring, fire suppression and exhaust systems are adequate, the Department will permit inherently hazardous solvent extraction using a 99 percent or greater purity of the following solvents, so long as the solvents are listed in the facility plan of record and the end result does not exceed allowable limits specified by the Department:
(a) Butane;
(b) Propane;
(c) Acetone;
(d) Heptane;
(e) Pentane; or
(f) Any other chemicals approved by the Department in writing.
D. Pressurized canned flammable fuel, including without limitation butane or propane in containers intended for camp stoves, handheld torch devices, refillable cigarette lighters and similar consumer products are prohibited for use in extraction.
E. As applicable, all licensees and employees must:
(1) Operate all inherently hazardous substance extraction equipment in accordance with the equipment manufacturer's instructions;
(2) Work in an environment with proper ventilation, controlling all sources of ignition where a flammable atmosphere is or may be present;
(3) Use proper eye protection, respiratory protection and gloves;
(4) Use only potable water and ice made from potable water in processing; and
(5) Undergo safety training on fire prevention and safe operation of equipment used for manufacturing.
F. A cannabis products manufacturing facility performing extraction may be subject to inspection by the state fire marshal, local fire department, building inspector or code enforcement officer to confirm that no health or safety concerns are present, and that the facility is in compliance with all applicable standards contained in the NFPA model fire code.
3.8.5Edible Cannabis Products Manufacturing. In addition to all other provisions of this rule, 28-B MRS and all other applicable rules or laws, a cannabis products manufacturing facility that has declared edible cannabis products as part of their facility plan of record may manufacturer edible cannabis products in accordance with the following:
A. Must obtain a food establishment license from the State of Maine pursuant to 22 MRS §2167.
B. May not:
(1) Manufacture edible cannabis products intended for non-human consumption;
(2) Manufacture edible cannabis products within the same licensed food establishment that operates as a restaurant or that prepares non-cannabis food to be served to order;
(3) Share a food establishment with a person or entity not licensed as a cannabis products manufacturing establishment; or
(4) Process or prepare food intended for commercial sale that does not contain cannabis;
C. Shall be subject to inspection by state or local regulatory authorities including but not limited to the local fire department, building inspector or code enforcement officer to confirm that no health, safety or threats to the public welfare are present; and
D. Shall comply with all applicable standards of the relevant local jurisdiction and the Maine Food Code.
(1) The addition of cannabis to food is not considered adulteration as provided in 22 MRS §2158-B.
(2) In the event of a conflict between this rule and the Maine Food Code, this rule shall control.
3.8.6.Edible Cannabis Product Safety.
A. Cannabis and cannabinoid content must be homogeneous throughout:
(1) The product, or that portion of the product that contains THC; and
(2) Each serving.
B. Serving sizes must be standardized.
(1) The size of a standardized serving of cannabis shall be no more than 10mg of total THC.
(2) A cannabis products manufacturing facility that manufactures edible cannabis product shall determine the total number of standardized servings per package of cannabis for each product that it manufactures.
(3) No individual edible cannabis product unit for sale shall contain more than 100 milligrams of total THC, which must be readily divisible into individual servings containing no more than 10 milligrams of THC per serving.
(4) Determinations of cannabinoid content must comply with the testing requirements of this rule.
(5) When determining whether a serving of edible cannabis products exceeds the potency limits, a licensee may account for the following variance in the potency in excess of 10 milligrams per serving:
(a) Testing facility uncertainty, as indicated on the testing facility's certificate of analysis for the mandatory potency test results. A variance for testing facility uncertainty cannot exceed 5% or 0.5 milligrams per serving; and
(b) An additional 10% allowable variance for edible cannabis products, which cannot exceed 1 milligram per serving;
(c) For a total maximum allowable potency of 11 milligrams of total THC per serving plus testing facility uncertainty which cannot exceed 5% or 0.5 milligrams per serving.
(6) When determining whether a multi-serving package of edible cannabis products exceeds the potency limits, a licensee may account for the following variance in the potency in excess of 100 milligrams per package:
(a) Testing facility uncertainty, as indicated on the testing facility's certificate of analysis for the mandatory potency test results. A variance for testing facility uncertainty cannot exceed 5% or 5 milligrams per package; and
(b) An additional allowable variance of up to 5 milligrams per package;
(c) For a total maximum potency per multi-serving package of edible cannabis products of 105 milligrams of total THC plus testing facility uncertainty which cannot exceed 5% or 5 milligrams per multi-serving package.
(7) Unless impracticable, each single standardized serving of cannabis shall be marked, stamped or otherwise imprinted with the Department-approved universal symbol directly on at least one side of the edible cannabis product in a manner to cause the universal symbol to be distinguishable and easily recognizable. The universal symbol marking shall:
(8) Be centered either horizontally or vertically on each standardized serving of cannabis; and
(9) If centered horizontally on a serving, the height and width of the universal symbol shall be of a size that is at least 25% of the serving's width, but not less than ¼ inch by ¼ inch; or
(10) If centered vertically on a serving, the height and width of the universal symbol shall be of a size that is at least 25% of the serving's height, but not less than ¼ inch by ¼ inch.
C. The following categories of edible cannabis products are considered to be per se practicable to mark with the universal symbol:
(1) Chocolate;
(2) Soft confections;
(3) Hard confections or lozenges;
(4) Consolidated baked goods (including without limitation cookies, brownies, cupcakes, and granola bars); and
(5) Pressed pills and capsules.
3.8.7Manufacturing of Medical Cannabis Products and Adult Use Cannabis Products on Same Premises.
A. A products manufacturing facility may possess medical cannabis or medical cannabis concentrate only if it has received the Department's approval of a facility plan to extract concentrate from medical cannabis and/or produce medical cannabis products and it is a validly registered caregiver or registered dispensary. The products manufacturing facility must:
(1) Track all medical cannabis, medical cannabis concentrate and medical cannabis products separately from adult use cannabis, adult use cannabis concentrate and adult use cannabis products in the tracking system.
(2) Store all medical cannabis, medical cannabis concentrate and medical cannabis products separately from adult use cannabis, cannabis concentrate and cannabis products.
(3) Ensure that medical cannabis or medical cannabis concentrate is never manufactured simultaneously or contemporaneously with adult use cannabis or cannabis concentrate on the same piece of equipment.
(4) Keep a log of the following information for all equipment used to extract from both medical cannabis and adult use cannabis or to manufacture both medical cannabis products and adult use cannabis products:
(a) The name of the licensee or employee who operated the equipment;
(b) The tracking information for the cannabis or cannabis concentrate that was manufactured using the equipment;
(c) The exact date, time and duration the equipment was used; and
(d) The tracking information for the resulting cannabis concentrate or cannabis product.
B. A log for any piece of equipment used to manufacture cannabis must be made available to the Department or the Maine Revenue Service for inspection.
3.9 - Requirements Applicable to Cannabis Stores and Nursery Cultivation Facilities
3.9.1Authorized Conduct. In accordance with the requirements and restrictions of 28-B MRS, this rule and any other applicable laws or rules, a cannabis store licensee or nursery cultivation facility may:
A. Between the hours of 7:00 A.M. and 10:00 P.M. local time or the retail sales hours permitted by local regulation:
(1) Sell or transfer permitted items on the licensed premises, and as applicable to cannabis stores, via curbside pickup or delivery, to consumers age 21 or older, within the limits described in this Section:
(a) Cannabis stores may sell cannabis seeds, cannabis seedlings, immature cannabis plants, cannabis or cannabis products, along with cannabis paraphernalia, noncannabis food and non-alcoholic beverages, clothing and other generally permissible retail items.
(b) Nursery cultivation facilities may sell cannabis seeds, cannabis seedlings, immature cannabis plants and agricultural or gardening supplies relating to the cultivation of cannabis.
(2) Accept returns of products sold by the licensee at the same premises to the person making the return and offer a refund or exchange of equal or lesser value;
(3) Refuse to sell any item to any person; or
(4) Provide consultations between employees and adult consumers.
B. At any time, except during those business hours the licensee indicated on its operating plan that it does not intend to conduct authorized activities:
(1) Prepare and transport permitted items to another licensee;
(2) Accept deliveries of permitted items and manage its inventory;
(3) Enter transfers or deliveries into the tracking system;
(4) Dispose of cannabis waste, including returned cannabis and cannabis products;
(5) Conduct employee training; or
(6) Perform administrative work, cleaning or maintenance.
3.9.2Sales Limits.
A. A cannabis store conducting sales on the licensed premises of the cannabis store, or by curbside pickup, or delivery, may not knowingly sell more than the following amounts to an individual at any one time or within one day:
(1) Two and one-half ounces of cannabis; or
(2) Two and one-half ounces of cannabis and cannabis concentrate that includes no more than five grams of cannabis concentrate, whether sold alone, contained in an inhalant delivery system, or contained in edible cannabis products.
B. A nursery cultivation facility may not sell more than a sum total of 12 seedlings or immature plants to an individual at any one time or within one day.
C. A nursery cultivation facility may not sell cannabis, cannabis products, cannabis plants or seeds via curbside pickup or delivery.
D. A cannabis store or nursery cultivation facility is required to report to law enforcement the identity of any individual who explicitly communicates the intent to divert adult use cannabis to individuals under the age of 21, across state lines or to be engaging in the unlicensed sale of cannabis.
E. A licensee shall report any criminal activity of which it is aware related to the unlicensed sale or diversion of cannabis, cannabis products or cannabis plants. Failure to report such activity to appropriate law enforcement entities may result in penalties up to and including license revocation and monetary fines.
F. A licensee shall report all transactions into the tracking system.
3.9.3Prohibited Conduct. In addition to any other prohibitions and restrictions of 28-B MRS, this rule or any other applicable laws or rules, a cannabis store or nursery cultivation facility must not:
A. Conduct any transaction without face-to-face verification of the purchaser's identity and age of 21 or older on an approved form of government-issued identification;
B. Sell cannabis or a cannabis product that has not passed mandatory testing;
C. Sell a cannabis or cannabis product that is not properly packaged or labeled in accordance with Section 9 of this rule;
D. Give away adult use cannabis, adult use cannabis products, immature cannabis plants or cannabis seedlings;
E. Sell or give away:
(1) Mature cannabis plants; or
(2) Consumable products containing tobacco or alcohol that do not contain cannabis.
F. Except for nonedible adult use cannabis products that do not contain THC, sell to any person in any individual sales transaction an amount of adult use cannabis, adult use cannabis products or immature cannabis plants or seedlings that exceeds the personal adult use limitations of 28-B MRS §1501(1);
G. Sell adult use cannabis, adult use cannabis products, immature cannabis plants or cannabis seedlings using:
(1) An automated dispensing or vending machine;
(2) A drive-through sales window;
(3) An Internet-based sales platform; or
(4) A third-party delivery service.
H. Accept payment for a retail sale prior to verifying that the purchaser is at least 21 years of age;
I. For retail sales occurring via curbside pickup or delivery, transfer a sales order to an individual prior to verifying that the identity of the individual receiving the sales order is the same as the individual who requested the sales order;
J. Sell adult use cannabis or adult use cannabis products to a person who is visibly intoxicated;
K. Sell or offer for sale to consumers adult use cannabis and adult use cannabis products within the same facility or building in which the licensee also sells or offers for sale to qualifying patients cannabis and cannabis products for medical use pursuant to 22 MRS, chapter 558-C.
L. Sell or give away pressurized containers of butane or other materials that could be used in the home production of cannabis concentrate, except that a cannabis store or nursery cultivation facility may sell or give away disposable butane lighters;
M. Sell or give away any items that are attractive to persons under 21 years of age as defined in Section 3.8.2 of this rule;
N. Sell an edible cannabis product that according to its label, exceeds 10 milligrams of THC per serving and 100 milligrams of THC in the total product;
O. Discount cannabis or a cannabis product if the retail sale is made in conjunction with the retail sale of any other items, including other cannabis or cannabis products;
P. Sell cannabis or cannabis products at a nominal price for promotional purposes;
Q. Permit consumers to be present on the licensed premises or conduct sales, including sales via curbside pickup or delivery, between the hours of 10:00 p.m. and 7:00 a.m. local time the following day or any hours not permitted by local regulation;
R. Conduct curbside pickup of cannabis or cannabis products at a location not approved by OCP on the licensee's facility plan of record;
S. Conduct any activities during hours or on days not authorized in the licensee's facility plan, except as communicated to and approved by the Department in writing in accordance with Section 3.5.5;
T. Deliver adult use cannabis or adult use cannabis products to a location that is not a private residence, including without limitation:
(1) Dormitories of educational institutions or licensed summer camps;
(2) Inns, hotels, motels, lodging houses, campgrounds; and
(3) Private and public property including but not limited to schools, parks, parking lots, sidewalks, streets, nonresidential buildings or nonresidential portions of buildings maintained by private or public entities.
U. Deliver adult use cannabis or adult use cannabis products to a private residence located inside a drug-free safe zone designated by a municipality;
V. Deliver tobacco products as defined in 22 MRS §1551(3);
W. Sell or transfer returned cannabis or cannabis products to another consumer;
X. Permit a consumer to open or alter a package containing cannabis or a cannabis product or otherwise remove cannabis or a cannabis product from packaging required by this rule within the premises or in an area that the licensee controls;
Y. Knowingly permit a consumer to bring cannabis or cannabis products onto the premises except for cannabis or cannabis products being returned for refund or exchange as allowed by this rule;
Z. Sell any item not allowed under this rule or any of the following items:
(1) Pet or animal food, treats or other pet or animal products containing cannabis;
(2) Injectable cannabis; or
(3) Any other cannabis products not meant for human consumption or use;
AA. Sell mother plants, mature cannabis plants or tissue cultures;
BB. Use any electrical equipment, including but not limited to display lighting, not listed as approved by a nationally recognized testing laboratory or not approved by the authority having jurisdiction; or
CC. Engage in the sale of cannabis seeds, cannabis plants, cannabis or cannabis products if mandatory testing is not verified or verifiable with certificate of analysis, or if testing reports unsafe levels of potentially harmful substances.
3.9.4Controlling Access to Retail Sales Areas. The cannabis store or nursery cultivation facility shall maintain control of areas of the premises designated for retail sales, using one of the following arrangements:
A. Permitting consumers to enter the controlled entry area for the purpose of verification of their photo identification prior to entry to the retail sales area; or
B. Keeping entry doors locked. The establishment shall use a door buzzer or other means to alert employees that a person wants to enter the premises. A licensee or employee shall check for valid identification before allowing entry.
3.9.5Curbside Pickup of Seeds, Seedlings, Immature Cannabis Plants, Cannabis and Cannabis Products.

A cannabis store may permit curbside pickup by adult use consumers of adult use cannabis and/or cannabis products if:

A. The licensee has indicated that it will be conducting curbside pickup on its facility plan of record;
B. The licensee conducts curbside pickup only in those areas designated for curbside pickup on the licensee's facility plan of record;
C. The licensee has implemented all required security measures for curbside pickup;
D. The licensee verifies the age and identity of the purchaser, to confirm that the individual is at least 21 years of age and is the person who initiated the order, prior to conveying to the purchaser any package containing a sales order;
E. The adult use cannabis and/or cannabis products are appropriately packaged and labeled in accordance with Section 9 of this Rule; and
F. All sales of cannabis and cannabis products conducted via curbside pickup are appropriately tracked in accordance with Section 4 of this Rule.
3.9.6Delivery of Seeds, Seedlings, Immature Cannabis Plants, Cannabis and Cannabis Products.

A cannabis store may deliver adult use cannabis and/or cannabis products to consumers at a private residence if the licensee:

A. Has indicated that it will be conducting delivery of adult use cannabis and/or cannabis products on its facility plan of record;
B. Has implemented all required security measures for delivery;
C. Ensures that any employees delivering adult use cannabis and/or cannabis products have been trained to properly verify the age and identity of the adult use consumer purchasing and receiving adult use cannabis or cannabis products. Such training shall include, at a minimum:
(1) Instruction on how to verify the authenticity of the government-issued, unexpired photo identification produced by a consumer.
(2) Instruction on a policy maintained by the licensee requiring all employees to verify that any adult use consumer receiving a sales order via delivery is:
i. At least 21 years of age; and
ii. The individual who initiated the purchase of the cannabis or cannabis products included in the delivery order; and
(3) Instruction requiring the termination of a sale via delivery if the employee conducting the delivery is unable to verify the age or identity of the consumer receiving the cannabis or cannabis products, or if the consumer is visibly intoxicated;
D. Conducts all deliveries of sales orders by motor vehicle only;
E. Provides adequate refrigeration for perishable cannabis products in transit;
F. Ensures that any employee delivering adult use cannabis and/or adult use cannabis products does not convey a sales order to a purchaser if:
(1) The purchaser is not at least 21 years of age;
(2) The purchaser's identity cannot be verified; or
(3) The purchaser is visibly intoxicated;
G. Ensures that deliveries are made only to private residences, except that a cannabis store licensee shall not deliver to any private residence located in any drug free safe zone designated by a municipality;
H. Ensures that the order is appropriately packaged and labeled in accordance with Section 9 of this Rule and placed in exit packaging before the licensee or its employees removes the order from inside of the cannabis store;
I. Ensures that the sales order does not include tobacco products as defined in 22 MRS §1551(3); and
J. Ensures that all retail sales of cannabis and cannabis products conducted via delivery are accompanied by a sales delivery manifest and appropriately tracked in accordance with Section 4 of this Rule.

Nothing in this section shall be construed to require an employee delivering a sales order to a private residence to enter the private residence in order to complete the retail sale.

3.9.7Display of Seeds, Seedlings, Immature Cannabis Plants, Cannabis and Cannabis Products. Cannabis seeds, seedlings, immature cannabis plants, cannabis and cannabis products may only be displayed in such a way that prevents access to persons who are not licensees or employees.
A. As permitted under the type of license, cannabis seeds, cannabis seedlings, immature cannabis plants, cannabis and cannabis products may be displayed in such ways that prevents access to persons who are not licensees or employees.
B. As permitted under the type of license, displays accessible by persons other than licensees and employees may include packaging and marketing materials for cannabis seeds, cannabis seedlings, immature cannabis plants, cannabis or cannabis products and mock examples, provided that no actual cannabis seedlings, immature cannabis plants, cannabis or cannabis products are present.
3.9.8Point of Sale Areas. A cannabis store or nursery cultivation facility must keep all permitted cannabis seeds, cannabis seedlings, immature cannabis plants, cannabis and cannabis products in limited access areas where access is restricted to licensees and employees.
A. No person 21 years of age or older who is not a licensee or employee may handle cannabis seeds, cannabis seedlings, immature cannabis plants, cannabis and cannabis products in the point of sale area unless a licensee or its employee supervises the person at all times.
B. A person 21 years of age or older who is not a licensee or employee may only handle cannabis seeds, cannabis seedlings, immature cannabis plants, cannabis or cannabis products without the supervision of a licensee or employee following the completion of a sale and the purchased items are placed into exit packaging; except that a licensee is not required to place cannabis seedlings or immature cannabis plants in exit packaging.
3.9.9Exit Packaging. A cannabis store or nursery cultivation facility, after a retail sale, must place all items purchased fully within appropriate exit packaging prior to a customer leaving the premises. For sales to consumers conducted by curbside pickup or delivery, all sales orders to be picked up curbside or delivered to a private residence must be placed in exit packaging in accordance with this section before transporting or transferring the order to the consumer.
A. All exit packaging must be opaque and fully enclose the purchased items.
B. All cannabis and cannabis products other than seedlings or immature plants must leave the premises in child-resistant, tamper-evident packaging.
(1) Cannabis or cannabis products that are not prepackaged in child-resistant containers must be placed into child-resistant exit packaging.
(2) Cannabis or cannabis products that are not prepackaged in tamper-evident containers must be placed into tamper-evident exit packaging.
C. A licensee may charge a fee to consumers for exit packaging.
D. A licensee may sell reusable exit packaging that is child-resistant and opaque but not tamper-evident.
E. A customer may supply reusable exit packaging, so long as:
(1) The reusable packaging is of a type sold by the licensee, and the licensee or employee verifies that it is legal exit packaging;
(2) The licensee or employee verifies that the reusable exit packaging is in sound condition; and
(3) The reusable packaging is used only for cannabis or cannabis products that are prepackaged in tamper-evident packaging and that such sale otherwise meets applicable packaging requirements of 28-B MRS §701(2).
F. A licensee shall maintain a copy of the certificate showing that all types of exit packaging required to be child-resistant meet the requirements of 16 C.F.R. 1700.15 (1995) and 16 C.F.R. 1700.20 (1995).
3.9.10Sales Tax. A cannabis store or cannabis nursery cultivation facility must track sales and remit sales taxes according to 36 MRS and the rules of the Maine Revenue Service.
3.10 - Requirements Applicable to Sample Collectors
3.10.1General Requirements. Before collecting samples of cannabis, cannabis concentrate and cannabis products for mandatory testing, a sample collector must:
A. Obtain an active sample collector license from the Department;
B. Ensure that all individuals employed by the sample collector who will be collecting samples of cannabis, cannabis concentrate or cannabis products are in possession of a valid IIC issued by the Department;
C. Ensure that each individual employed by the sample collector who will be collecting samples of cannabis, cannabis concentrate or cannabis products:
a. Is physically able to perform the duties of a sample collector, with or without reasonable accommodations;
b. Is trained and able to pass initial and ongoing demonstrations of sample collection in compliance with the Sample Collection SOP;
c. Completes, when available, 8 hours of initial training on various sampling techniques; and
d. Completes, when available, 8 hours of periodic refresher training annually; and
D. Prior to every sample collection for mandatory testing, and in accordance with the sample collection recordkeeping requirements and sample collection SOP published by the Department, contact the cannabis testing facility(ies) conducting the mandatory analyses for instructions regarding the sample collection event, including without limitation:
a. Sample collection tools to be used by the sample collector based upon the matrices to be sampled;
b. Sample collection containers necessary to store the samples collected based on the analyses to be conducted;
c. Sample storage and transportation requirements based upon the matrices sampled and analyses to be conducted; and
d. Any additional considerations regarding sample collection, transportation, storage or receipt of the samples by the cannabis testing facility(ies) conducting the mandatory analyses.
3.10.2Prohibited Conduct. In addition to any other restrictions or prohibitions contained in this rule, 28-B MRS and any other applicable Federal, State or Local rules or laws, sample collectors are subject to the following prohibitions:
A. No sample collector or owner, officer, director, manager, general partner or employee of a sample collector may have a direct or indirect financial interest in a cultivation facility, products manufacturing facility, manufacturing facility, cannabis store, registered caregiver or registered dispensary.
B. No owner, officer, director, manager or general partner of a sample collector may be a registered caregiver.
C. No sample collector may collect samples for a registered caregiver that is an employee of that sample collector.
D. Samples of cannabis, cannabis concentrate and cannabis products may not be collected, transported, transferred or destroyed without entering the samples of cannabis, cannabis concentrate or cannabis products into the tracking system required by the Department by 11:59 that same day.
E. Samples of cannabis, cannabis concentrate and cannabis products may not be stored by the sample collector except during transport from the site where the samples were collected to the cannabis testing facility(ies) conducting mandatory analyses.
F. Samples of cannabis, cannabis concentrate and cannabis products may not be stored overnight by a sample collector except in exigent circumstances as described in Section 4.2.5 of this rule.
3.10.3Use of Sample Collection SOP and Best Practices Guide Published by the Department Required. A sample collector must collect samples of cannabis, cannabis concentrate and cannabis products using the Sample Collection SOP and Best Practices Guide published by the Department when collecting samples of cannabis, cannabis concentrate or cannabis products for mandatory testing. A sample collector must document the sample collection event in accordance with the requirements of Section 3.11 of this rule
A. The sample collector must keep complete records for each sample collection event conducted.
B. The sample collector must collect samples in accordance with the Sample Collection SOP published by the Department. The Department may require a sample collector to demonstrate to the Department proper sample collection technique in accordance with the Sample Collection SOP at the request of the Department.
C. The sample collector must collect samples in accordance with the Best Practices Guide published by the Department.
D. The sample collector must ensure that at all times the sample collector and its employees are using the correct version of the Sample Collection SOP (Appendix A of this rule) and Best Practices Guide available on the Department's website at: https://www.maine.gov/dafs/ocp/adult-use/applications-forms.
3.10.4Record Keeping. A sample collector must maintain records in accordance with this rule.
A. A sample collector must track all samples collected in the inventory tracking system required by the Department.
B. A sample collector must keep for five years from the date of a sample collection event a copy all records generated by sample collection event conducted by the sample collector and its employees in accordance with Section 3.11 of this rule.
C. A sample collector must keep personnel records that include information on any training on sample collection received by its employees and a copy of the Department's Sample Collection Standard Operating Procedure for Mandatory Testing (Appendix A) signed by each IIC holder who will be collecting samples.
D. A sample collector must keep an up-to-date list of all personnel and vehicles used to conduct sample collection or the transport of samples from the site where the samples are collected to cannabis testing facilities for analyses.
E. A sample collector must make all required records available to the Department at its request. A sample collector must allow access to the Department to any premises where records are kept, including without limitation all vehicles used to transport samples of cannabis, cannabis concentrate and cannabis products and any physical or electronic location used to store all documents required by this rule.
3.10.5Waste Disposal. A sample collector may not dispose of waste generated by the collection, storage or transport of samples.
A. Waste generated by the collection, storage or transport of samples must be disposed of by the licensee from which the samples were collected.
B. If samples of cannabis, cannabis concentrate or cannabis products collected and transported by a sample collector are rejected by a cannabis testing facility, the sample collector will return the samples of cannabis, cannabis concentrate or cannabis products to the licensee from which the samples were collected.
3.10.6Security. A sample collector will employ security measures adequate to ensure that samples of cannabis, cannabis concentrate and cannabis products are not stolen or otherwise diverted during the course of sample collection, transport and as necessary due to exigent circumstances, storage.
3.11 - Recordkeeping Requirements for Sample Collection, Transport and Receipt
3.11.1Sample Collection Records. Licensees collecting samples for mandatory testing, including self-sampling licensees, sample collectors, and cannabis testing facility staff collecting samples for mandatory testing must retain records of every sample collection event in accordance with this section. Licensees may use their own sample collection form, a form provided by the cannabis testing facility conducting the mandatory analyses or a sample collection log or any other format that the licensee can make available to the Department upon request, so long as such records include all information required by this rule. A licensee who is not a self-sampling licensee shall provide the licensee for whom the licensee is collecting samples for mandatory testing with a copy of all sample collection records generated by the sample collection event.

All sample collection records shall be retained for a minimum of 5 years and shall include, for every sample collection event, all information required by this rule and the Sample Collection SOP in Appendix A herein, including without limitation:

A. The name and individual identification card number of the individual identification cardholder collecting samples for mandatory testing;
B. Instructions, if any, provided to the self-sampling licensee or sample collector licensee by the cannabis testing facility conducting the mandatory analyses regarding the following:
a. Sample collection tools to be used to collect samples of cannabis, cannabis concentrate or cannabis products, based upon matrix type sampled and mandatory analyses required;
b. Sample storage containers to be used to collect and store the samples of cannabis, concentrate or cannabis products, based upon matrix type sample and mandatory analyses required;
c. Special instructions regarding sample storage and transport, including without limitation:
i. The temperature at which the samples should be stored and transported;
ii. The environmental humidity at which the samples should be stored and transported;
iii. Any instructions regarding sample storage and transport required to maintain the integrity of the samples during storage and transport; and
iv. Any other instructions regarding sample receipt by the cannabis testing facility;
C. Any anomalies noted by the sample collector in the batch sampled at the time of the sample collection event;
D. The type, number and weight of each sample storage container used to store sample increments collected;
E. The total weight of the composite sample and the weight of any additional sample increments collected for homogeneity testing;
F. The seal numbers for every tamper evident seal affixed to a sample container used in the sample collection event;
G. An attestation signed by the individual identification cardholder who collected the samples for mandatory testing and affixed tamper evident seals to every sample container in accordance with the Department's Sample Collection SOP, that is also signed by an individual identification cardholder who witnessed the tamper evident seals being affixed to the sample containers. All signatures must be either wet or digital. The attestation must include, without limitation, the following:
a. A statement attesting that the self-sampler or sample collector:
i. Collected all samples in accordance with the Department's Sample Collection SOP, Best Practices Guide and any instructions provided by the cannabis testing facility conducting the mandatory analyses;
ii. Collected all sample increments randomly and that the self-sampler or sample collector did not intentionally enrich, alter, tamper with, degrade or otherwise alter the sample increments collected;
iii. Was not asked by, nor allowed, another individual identification cardholder to enrich, alter, tamper with, degrade or otherwise alter the sample increments collected;
iv. Sealed the sample collection containers with tamper evident seals in the presence of the witness countersigning the attestation; and
v. Acknowledges that any intentional misrepresentation in the sample collection records or any attempt at tampering with the samples collected is grounds for revocation of the individual's individual identification card and/or revocation, suspension or limitation of the sampling licensee's license; and
b. A statement attesting that the witness:
i. Was present for the sealing of the sample containers with the tamper evident seal;
ii. Did not witness the sample collector enrich, alter, tamper with, degrade or otherwise alter the sample increments when affixing the tamper evident seals to the sample containers;
iii. Did not enrich, alter, tamper with, degrade or otherwise alter the sample increments when the tamper evident seals were affixed to the sample containers; and
iv. Acknowledges that any intentional misrepresentation by the witness is grounds for revocation of the witness' individual identification card and/or revocation, suspension or limitation of the sampling licensee's license.
3.11.2Sample Transportation Records. Except as permitted by this rule, the licensee that collected samples of cannabis, cannabis concentrate and cannabis products for mandatory testing must transport those samples to the cannabis testing facility conducting the mandatory analyses. A cannabis testing facility that did not collect the samples for mandatory testing, but that offers a service to transport samples collected by self-sampling licensees to its testing facility for mandatory testing, may offer to transport samples from self-sampling licensees to the cannabis testing facility for mandatory analyses. A cannabis testing facility may not transport samples to any other licensee unless otherwise authorized by this rule or 18-691 CMR, ch. 5. All samples of cannabis, cannabis concentrate and cannabis products must be appropriately tracked in the Department's inventory tracking system and accompanied by a transport manifest in accordance with this rule.
3.11.3Sample Receipt Records. A cannabis testing facility must maintain sample receipt records in accordance with the cannabis testing facility's quality system and must at all times maintain chain-of-custody records for all samples of cannabis, cannabis concentrate and cannabis products received by the cannabis testing facility from the time of receipt through storage, analysis and destruction. A cannabis testing facility may require any licensee delivering samples to the cannabis testing facility to record sample information on a form created by or in a database maintained by the cannabis testing facility, in addition to any sample collection records maintained by the licensee. The cannabis testing facility conducting mandatory analyses is responsible for maintaining all sample receipt records and must make those records available to the Department upon request.

2 Pursuant to 28-B MRS §501(6) this limited authorization expires two years after the Department issued the first active cultivation facility license. The first active cultivation facility license was issued September 8, 2020.

18-691 C.M.R. ch. 1, § 3