18- 691 C.M.R. ch. 4, § 3

Current through 2024-16, April 17, 2024

Section 691-4-3 - Authorized Manufacturing Conduct for Tier 1 and Tier 2 Manufacturing Facilities and IHS Registrants

The marijuana facility applicant must fulfill the following general requirements to apply for and annually renew a registration with the Department for manufacturing marijuana for medical use. Unless otherwise specified, all requirements of this section apply to tier 1 and tier 2 marijuana manufacturing facilities; patients, caregivers, dispensaries, and free-standing entities using inherently hazardous substances; and caregivers and dispensaries that manufacture marijuana or marijuana products on behalf of other authorized entities. Only facilities located and operating within the State of Maine may apply for registration. A marijuana manufacturing registration issued by the Department does not authorize the facility to cultivate marijuana or engage in retail sales of marijuana, nor does it exempt the facility from electrical permitting and inspection or food establishment licensing requirements.

3.1 General Provisions

3.1.1.General Requirements for Manufacturing Facility and Inherently Hazardous Substance Use Registration

A. Applications for registration must be in the name of the proprietors, partners, or corporation that directly owns the business. Applicants must be truthful on all application forms, attachments, and additional information required by the Department.

B. A marijuana manufacturing registration or inherently hazardous substances registration may not be issued unless the applicant has:

(1) Provided a valid form of identification, verifying the applicant(s) is age 21 or older;

(2) Completed all application forms prescribed by the Department;

(3) Paid all required fees;

(4) Submitted to a criminal history check conducted within the most recent 12 months for the applicant, and all principal owners, board members and assistants;

(5) Demonstrated that the applicant has received local authorization to conduct manufacturing activities and/or use inherently hazardous substances if required by 22 MRS, chapter 558-C and these rules; and

(6) Provided all additional documentation and information required by the application or Department.

C. A registration is valid only after the person or entity completes any enrollment process required by the Department, including payment of required fees and costs associated with use of the track and trace system.

D. A person required to register as a manufacturing facility or obtain an inherently hazardous substances registration must obtain a Department-issued registry identification card. If an entity, all facility directors, principal officers, board members, principal owners, employees and assistants must obtain a registry identification card.

3.1.2.Local Authorization for Manufacturing Facilities and the Use of Inherently Hazardous Substances

All applicants seeking to register a marijuana manufacturing facility and/or use inherently hazardous substances in a municipality pursuant to 22 MRS, chapter 558-C, must provide to the Department proof of local authorization to operate such a facility and/or use inherently hazardous substances. Local authorization must be indicated on forms provided by the Department and must include as an attachment a copy of any local ordinance or warrant article authorizing the applied-for conduct. In order to obtain from the Department a Local Authorization Form, the applicant must provide to the Department, in writing, the following information:

A. The name and date of birth of the applicant;

B. The type of manufacturing facility (tier 1 or 2) and/or a list of all inherently hazardous substances and potentially hazardous extraction methods to be used in the manufacture and extraction of marijuana, marijuana concentrate, and marijuana products;

C. A description of the manufacturing activities that will occur on the premises;

D. A diagram of the premises illustrating in which areas of the premises each manufacturing activity will occur;

E. If the property is also used as a residence, the location of that residence within the property and plans for complete separation of that residence from the facility including:

(1) An entirely separate entrance from a public right of way; and

(2) Acknowledgement that no solvent extraction will occur in the same building or structure where the residence is located;

F. A diagram illustrating the areas of the premises where any solvent, chemical and other inherently and/or potentially hazardous substances will be stored;

G. If required, the name, education and relevant experience of the person overseeing food safety procedures and requirements;

H. Equipment to be used, including UL or other safety listing;

I. Standard operating procedures for each process to be used to manufacture a marijuana product;

J. Plans for ventilation and filtration systems that prevent marijuana odors from significantly altering the environmental odor outside, while reducing the risk of fire or respiratory harm within the facility;

K. Any extraction methods and solvents to be used for extraction;

L. Background screening process for employees;

M. Plans for compliance with a relevant food safety, refrigeration, storage and sanitary standards;

N. Plans for compliance with packaging, labeling and other requirements;

O. Plans for disposal of marijuana and marijuana product waste;

P. A list of all safety and personal protective equipment to be used on the premises; and

Q. Plans for compliance with all applicable building and electrical codes and federal and state environmental requirements.

3.2 - Tier 1 and Tier 2 Manufacturing Facilities

3.2.1.Registration Requirements.Any person or entity manufacturing marijuana or marijuana products for medical use must register as a tier 1 or tier 2 manufacturing facility unless that person or entity is a patient, caregiver, or dispensary acting in compliance with 22 MRS, chapter 558-C and all Department rules and engages in conduct explicitly exempted from registration in Sections 2.2, 2.3 or 2.4 of this Rule.

3.2.2.Tier 1 and Tier 2 Manufacturing Facility Authorized Manufacturing.

A. A registered tier 1 or tier 2 manufacturing facility may possess harvested marijuana for manufacturing marijuana and marijuana products for medical use:

(1) Pursuant to 22 MRS §2324-F(1) a tier 1 manufacturing facility may possess up to 40 pounds of harvested marijuana.

(2) Pursuant to 22 MRS §2423-F(2) tier 2 manufacturing facility may possess up to 200 pounds of harvested marijuana.

B. A tier 1 or tier 2 manufacturing facility must track all inventory, including all transactions and transfers, in accordance with Department rules.

C. The facility is required to monitor possession limits using scales validated by weights and measure standards.

D. The facility must keep physically separate and account separately for marijuana and marijuana products regulated under this Section and any other marijuana the facility may be authorized to possess, including without limitation marijuana or marijuana products intended for adult use if the facility is also licensed for this purpose.

E. A registered tier 1 or tier 2 manufacturing facility may only engage in marijuana extraction using inherently hazardous substances if it obtains an IHS registration issued by the Department.

F. A registered manufacturing facility is required to track and trace inventory, transactions and transfers using the electronic system designated by the Department.

(1) A registered manufacturing facility must maintain scales to reliably measure, manage and report inventory.

(2) Any marijuana waste or abandoned marijuana product must be accounted for in the manufacturer's electronic record.

G. The registered manufacturing facility must ensure that all proprietors, partners, board members, officers and assistants have valid registry identification cards.

H. A registered manufacturing facility may manufacture marijuana products or marijuana products using methods that are considered generally safe and potentially hazardous extraction methods using ethanol, including solutions of ethanol and potable water (see Section 4.1 ). Any other extraction methods or solvents are prohibited unless a registration to use inherently hazardous extraction methods is obtained in accordance with this rule.

I. Manufacture must be performed in a manner that results in the amount of marijuana or concentrate, and cannabinoid content within the product being homogeneous throughout the product and consistent with product labels.

J. A registered manufacturing facility may manufacture edible marijuana products or tinctures only if it acquires a food establishment license pursuant to 22 MRS §2167.

K. A registered manufacturing facility may accept harvested marijuana from a qualifying patient, registered caregiver, dispensary, or another registered marijuana manufacturing facility to manufacture a marijuana product or concentrate for that person or entity. The facility must transfer to that person or entity, in return, all the marijuana products and marijuana concentrate produced using the marijuana provided to the facility. The facility may not cultivate marijuana, engage in retail sale or participate in any way to transfer marijuana except as provided in 22 MRS §2423-F(4).

L. A registered manufacturing facility may conduct testing of marijuana products or marijuana concentrate manufactured by the facility for research and development purposes. Only testing performed by a licensed marijuana testing facility will be accepted when the test is required by the Department.

M. A registered manufacturing facility may receive reasonable compensation for producing marijuana products and marijuana concentrate.

3.3 - Manufacturing Facility Application Requirements An application for initial registration or annual renewal for a tier 1 or tier 2 manufacturing facility must be filed with the Department. Any incomplete applications will not be processed and may be returned. A complete application for registration includes the completed application form prescribed by the Department along with all information required in the application forms approved by the Department.

A. Without limitation, required information includes:

(1) A valid email address that the Department may use to send notice to the facility;

(2) The physical address of the premises where an applicant will engage in the activities authorized under this section;

(3) The name, address and date of birth of each proprietor, principal officer, director, board member and assistant of the facility or entity;

(4) A notice indicating whether the applicant plans to engage in extraction involving inherently hazardous substances and whether it meets the requirements of Section 4.1 of these rules;

(5) A premises diagram of the manufacturing facility that includes a brief statement of the principal activity to be conducted in each room or partitioned area, including where inherently hazardous substances may be used;

(6) The name of each facility director or principal officer in charge of the manufacturing facility and each facility director or principal officers' qualifications or job descriptions;

(7 ) Resumes that document appropriate experience and education for personnel specified in Section 7;

(8) The type of manufacturing registration for which the applicant is applying;

(9) A copy of standard operating procedures specified on the application forms;

(10) Payment of the non-refundable application fee; and

(11) If required by these rules, proof that the entity seeking registration has received local authorization from the municipality where manufacturing and/or extraction activities will be conducted.

B. The facility is responsible for complying with the program-related information sent electronically to the email on record.

C. When the facility or entity changes its physical location, and when a person registered under this subsection changes the location at which the person engages in activities authorized under this section, the facility, entity or person must notify the Department prior to the relocation

3.4 - Inherently Hazardous Substance Registrants

3.4.1.Registration Requirements. Any person or entity manufacturing marijuana concentrate using inherently hazardous substances or potentially hazardous substances other than ethanol must obtain an IHS registration certificate from the Department. Any person or entity that has notified the Department of its intent to engage in extraction using inherently hazardous substances in accordance with 22 MRS §2423-F(3)(A)(4) and is otherwise in compliance with 22 MRS §2423-F(3)(A) may continue to operate pending issuance of an IHS registration from the Department.

3.4.2.Authorized Manufacture Using Inherently Hazardous Substances

A. IHS registrants may possess harvested marijuana for IHS extraction for medical use:

(1) A freestanding IHS registrant who applies and is registered may possess up to 40 pounds of harvested marijuana.

(2) A registrant that is also a qualifying patient, exempt caregiver, registered caregiver ortier 1 or tier 2 registered manufacturing facility may possess up to 40 pounds of harvested marijuana in addition to any other marijuana the registrant is authorized to possess.

B. A registered manufacturing facility is required to track and trace inventory, transactions and transfers using the electronic system chosen by the Department.

(1) A marijuana facility registrant must electronically enroll in the track and trace system by the Department and pay required costs. Costs to use the monitoring system may include the vendor's monthly license fee(s) and individual charges for identification tags that may be required to properly identify marijuana plants and marijuana products or concentrates.

(2) A registered manufacturing facility must maintain scales to reliably measure, manage and report inventory.

(3) Any marijuana waste or abandoned marijuana product must be accounted for the manufacturer's electronic record.

(4) The facility is required to monitor possession limits using scales validated by weights and measure standards.

C. The facility must keep physically separate and account separately for marijuana and marijuana products regulated under this section and any other marijuana the facility may be authorized to possess, including without limitation, marijuana and marijuana products intended for adult use if the facility is also licensed for that purpose.

D. The IHS registrant may manufacture marijuana concentrate using inherently hazardous substances for extracting marijuana as provided in this rule.

E. The IHS registrant must ensure that all assistants have a valid registry identification card.

F. The IHS registrant may accept harvested marijuana from a qualifying patient, a registered caregiver or a registered caregiver, or dispensary, to manufacture marijuana concentrate for that person or entity. The facility must transfer to that person or entity, in return, all marijuana concentrate produced using the marijuana provided to the facility. The facility may not cultivate marijuana, engage in retail sale or participate in any way to transfer marijuana except as separately authorized in 22 MRS, chapter 558-C.

G. The IHS registrant may conduct testing of marijuana concentrate manufactured by the facility for research and development purposes. Only testing performed by a licensed marijuana testing facility will be accepted when the test is required by the Department.

H. The IHS registrant may receive reasonable compensation for producing marijuana concentrate.

I. The IHS registrant is prohibited from modifying equipment after a professional engineer certifies the equipment as approved in writing by the engineer.

J. Use of unauthorized solvents by the registrant may result in an immediate revocation of registration.

3.5 - Inherently Hazardous Substance Registration-Additional Application Requirements Any qualifying patient, caregiver, dispensary, or other manufacturing facility intending to use inherently hazardous substances in manufacturing must first obtain an inherently hazardous substance registration from the Department. A complete application for registration includes the completed application form prescribed by the Department along with all information required in the application form. Without limitation, required information includes:

A. Notice to the Department regarding their intent to extract using inherently hazardous substances as required pursuant to 22 MRS §2423-F(3)(A);

B. A list of any inherently hazardous substances to be used;

C. The process to be used;

D. A premises diagram of the manufacturing facility that includes a brief statement of the principal activity to be conducted in each room or partitioned area, including where inherently hazardous substances may be used;

E. Indication of whether the manufacturing facility is located in the same building as a residence or an area open to the public, along with a description of safety measures to protect the health and safety of other occupants of the building;

F. Certification by a professional engineer licensed in the State of Maine pursuant to 32 MRS, chapter 19 of the safety and location of the professional grade closed loop equipment used for marijuana extraction and the professional engineer's approval of the standard operating procedures for the marijuana extraction;

G. Certification by a professional engineer licensed in the State of Maine pursuant to 32 MRS, chapter 19, or a State or authorized local official, that the equipment used for marijuana extraction and the location of the equipment comply with state law and all applicable local and state building codes, electrical codes and fire codes, including the chapters of the most recent National Fire Protection Association Fire Code relating to marijuana extraction facilities; and

H. Documentation from the manufacturer of the marijuana extraction system, or certification by a professional engineer licensed in the State of Maine, showing that a professional grade, closed-loop extraction system that is capable of recovering the solvents used to produce marijuana concentrate is used by the person or entity.

3.6 - Department Action on Registration Application In reviewing an application for registration, the Department may take one or more of the following actions:

A. Reject, deny or refuse to accept an application that is missing information or attachments required by the application;

B. Investigate applicants to verify all State and local requirements have been satisfied;

C. Verify all information and attachments to the application;

D. Investigate any and all applicants, assistants, and board members named in the application to ensure no person or individual has a disqualifying drug offense;

E. Request additional information in order to fully verify all requirements for registration;

F. Permit the applicant to voluntarily withdraw the application; or

G. Extend the period of time for applicants to correct or cure applications that fail to meet requirements for registration by the Department.

3.7 - Denial of Application

3.7.1.Grounds for Denial of Application.The following acts or conditions may provide grounds for the Department to deny a registration application:

A. The applicant(s) or any principal officer, board member or assistant of the applicant:

(1) Makes false statements or material omissions in connection with the application or during the verification of information in the application or its attachments;

(2) Fails to cooperate with Department during the application process, which may include an inspection of the premises used for manufacturing activities;

(3) Fails to submit information requested as part of a complete application; or

(4) Fails to meet any of the requirements for registration;

B. The applicant(s) or any principal officer, board member or assistant of the applicant or person or entity authorized to engage in marijuana extraction has a disqualifying drug offense, or would be denied an approval, credential, certification, authorization or renewal under Title 20-A, section 6103 or 13011 based on that criminal history record check;

C. The applicant makes any changes affecting the accuracy and completeness of the application, including without limitation:

(1) Changes to ownership, board members and required personnel;

(2) Changes of location; or

(3) Changes to corporate structure; or

D. The applicant engaged in marijuana extraction using inherently hazardous substances without first notifying and registering with the Department to conduct such activities. Except that any person or entity that has notified the Department of its intent to engage in extraction using inherently hazardous substances in accordance with 22 MRS §2324-F(3)(A) may continue to operate pending issuance of an IHS registration from the Department and such operation prior to registration shall not be considered grounds for denial of the registration application.

3.7.2 Process for Denial; Appeal.The Department will establish an objective process pursuant to the Maine Administrative Procedure Act, 5 MRS, chapter 375.

A. If the Department denies an application for a registration, it will notify the applicant in writing and provide reason for denial.

B. A denial of an application for registration is a final agency action, subject to judicial review. The Department may provide the opportunity for an administrative hearing.

3.8 - Annual Renewal of Registration

A. Registration is valid for up to one year from the date of issuance. A registrant for a marijuana manufacturing facility must apply for renewal of the registration no later than 60 days prior to the expiration of the current registration term to avoid lapse of authorization.

B. The Department may accept a renewal application within 60 days of the current registration's expiration date.

C. The Department may administratively extend the expiration date of a registration, provided the registrant has submitted a complete renewal application.

D. A registrant may not operate or exercise the privileges of the registration at any time if the registration is expired, unless expressly agreed to in writing by the Department.

3.9 - Annual Criminal History Record Check

A. A marijuana manufacturing facility registrant or an applicant, and any principal officer, board member or assistant of a manufacturing facility is subject to annual criminal history checks beyond initial registration.

B. A registrant or an applicant and any principal officer, board member or assistant of a manufacturing facility must disclose all convictions of a disqualifying drug offense for the 10 years prior to the date of the application.

C. A registrant or an applicant, and any principal officer, board member or assistant of a manufacturing facility must provide court dispositions and other information requested by the Department for each conviction that is a disqualifying drug offense.

D. Any person subject to a criminal history record check who is administering marijuana on school grounds may be required to submit to fingerprinting and pay any associated fee. Fingerprints may be forwarded to the State Bureau of Identification (SBI) for State and national criminal history record checks. The person or entity who has an expired or revoked registration and is not subject to this rule may submit a written request to remove a fingerprint from the SBI files.

3.10 - Application Fees An applicant is required to pay the following fees for initial manufacturing facility and/or IHS registration and annual renewal:

A. Tier 1. The annual fee for registering and renewing a tier 1 manufacturing facility registration is $150.

B. Tier 2. The annual fee for registering and renewing a tier 2 manufacturing facility registration is $250.

C. IHS registration. To use inherently hazardous substances for marijuana extractions, a qualifying patient, caregiver, dispensary, tier 1 manufacturing facility, or tier 2 manufacturing facility is required to complete an IHS registration application, including payment of the IHS registration fee of $350.

D. The cost of a criminal history check required for the applicant is $31 for each background check conducted through the State Bureau of Identification, and $60 if a federal or national background check is conducted.

E. All application fees are non-refundable.

18- 691 C.M.R. ch. 4, § 3