Section 691-4-1 - Administration1.1 - Purpose and Scope This rule is promulgated to establish standards and procedures related to manufacturing marijuana, marijuana concentrate, and marijuana products. This rule implements requirements of 22 MRS, chapter 558-C, including a marijuana track and trace system, and establishes minimum standards for manufacturing marijuana and marijuana products for medical use, including requirements for facility registration, requirements for engaging in marijuana extraction using inherently hazardous substances, staff qualifications, and security and testing. This rule protects public health and assures safe practices related to marijuana manufacturing, requiring a level of competency of facility personnel and appropriate equipment to process and extract marijuana. This rule establishes the form and content of initial and renewal applications for certification. This rule is in addition to the requirements of 10-144 Code of Maine Rules ("CMR"), chapter 122, Maine Medical Use of Marijuana Program Rule. In case of any inconsistencies between this rule and Chapter 122, this rule controls.(APA Office Note: 10-144 chapter 122 has been relocated to 18-691 chapter 2.)1.2 - Authority 22 558-C.1.3 - Definitions For the purposes of this rule, the definitions included in this rule are in addition to the MRS, chapter definitions contained in 22 MRS, chapter 558-C; unless the context otherwise indicates, the following terms have the following meanings: 1.Audit means a systematic and independent examination of facilities, equipment, personnel, training, procedures, record-keeping, data validation, data management and reporting aspects of a system to determine whether quality assurance, quality control and technical activities are being conducted as planned. An audit is conducted to determine whether these activities will effectively achieve quality objectives. 2.Act means the Maine Medical Use of Marijuana Act. 3.Assistant means a person paid to perform a service for a caregiver, dispensary, manufacturing facility or marijuana testing facility, whether as an employee or independent contractor, whose services include direct or indirect contact with marijuana or marijuana products. 4.Cannabidiol (CBD) is Chemical Abstracts Service number 13956-29-1.5.Certificate of analysis means the document prepared by a testing facility that documents the analytical testing performed and results produced by the testing laboratory for a specific marijuana sample or product. 6.Department means the Department of Administrative and Financial Services.7.Exempt caregiver means a natural person who is a caregiver for no more than two family members or members of the caregiver's household, is exempt from registration pursuant to 22 MRS §2423-A(3)(C) and may not possess more than 8 pounds of marijuana. 8.Extraction means a process of extracting marijuana concentrate from marijuana using water, lipids, gases, solvents or other chemicals or chemical processes. The use of inherently hazardous substances in marijuana extraction is restricted by this rule. 9.Harvested marijuana means plant material harvested from a mature marijuana plant, except the stalk, leaves and roots of the plant that are not used for a qualifying patient's medical use. Harvested marijuana includes marijuana concentrate and marijuana products. 10.Homogeneous means manufactured in a manner that results in the amount of marijuana or marijuana concentrate and cannabinoids within the product being consistent and reasonably equally dispersed throughout the product or throughout each portion of the product or concentrate; or a sample representative of the whole. 11.Inherently hazardous substance("IHS") means a liquid chemical; a compressed gas; carbon dioxide (CO2); or a commercial product that has a flash point at or lower than 38 degrees Celsius or 100 degrees Fahrenheit, including, but not limited to, butane, propane and diethyl ether. For the purposes of this Rule, inherently hazardous substances include the potentially hazardous extraction methods listed at Section 4.1.2(B) and excludes any form of alcohol or ethanol. A person or entity extracting marijuana is authorized to use only inherently hazardous substances approved by this rule. 12Inherently hazardous substance registration means a valid registration issued by the Department authorizing a tier 1 or tier 2 manufacturing facility, patient, caregiver, dispensary, or freestanding entity to engage in extraction using the inherently hazardous substances approved by the Department only and that do not exceed thresholds established for required testing.13.Local authorization means authorization from a municipality in accordance with 22 MRS §2429-D.14.Manifest form means a record, either paper or electronic, required by the Department for a registered caregiver, dispensary, or licensed facility to document the possession and transfer of the marijuana or marijuana product on the premises, tracking all inventory, acquisition, sales and waste disposal.15. Manufacturing facility means a registered tier 1 or tier 2 manufacturing facility or a person or entity authorized to engage in marijuana extraction using IHS under 22 MRS §2423-F. 16.Manufacture or manufacturing means the production, blending, infusing, compounding or other preparation of marijuana concentrate and marijuana products by a registered manufacturing facility, or by a patient, caregiver or dispensary as authorized under 22 MRS, chapter 558-C. Manufacturing includes, but is not limited to, marijuana extraction or preparation by means of chemical synthesis. "Manufacturing or manufacture" does not include cultivation.17.Marijuana concentrate means the resin extracted from any part of a marijuana plant and every compound, manufacture, salt, derivative, mixture or preparation from such resin, including, but not limited to hashish. 18.Marijuana means the leaves, stems, flowers and seeds of all species of the plant genus Cannabis, whether growing or not, used for medical purposes and conduct authorized under 22 MRS, chapter 558-C. 19.Marijuana product means a product composed of marijuana, or marijuana concentrate and other ingredients that is intended for medical use. "Marijuana product" includes, but is not limited to, an edible marijuana product, a marijuana inhalant, a marijuana ointment and a marijuana tincture. "Marijuana product" does not include marijuana concentrate. 20.Marijuana testing facility means an entity licensed by the Department and certified to test medical use marijuana, including concentrates and products containing marijuana, for research and development purposes and to analyze contaminants in, and the potency and cannabinoid profile of, marijuana samples and products containing marijuana cultivated in accordance with 22 MRS, chapter 558-C.21.Patient means a qualifying patient, or a visiting qualifying patient, who is 18 years of age or older, and possesses a valid written certification for the medical use of marijuana obtained pursuant to 22 MRS §2423-B or a valid out-of-state credential for the medical use of marijuana pursuant to 22 MRS §2423-D.22. Person means any individual, firm, partnership, joint venture, association, corporation, limited liability company, estate, trust, business trust, receiver, syndicate, or any other group or combination acting as a unit, and the plural as well as the singular.23.Premises means the structure or structures and land specified in the application for registration that is owned, leased, or otherwise held under the control of the applicant or registrant where conduct related to marijuana manufacturing takes place. The premises must be a contiguous area and may only be occupied by one registrant, unless otherwise permitted by statute and this rule.24. Registration certificate means a document containing a unique registry identification number that permits the manufacturing of marijuana and marijuana products for medical use.25.Registry identification card means a photographic identification card issued by the Department to an individual who is authorized to manufacture marijuana or marijuana products for medical use, in the capacity of or in the employ of a patient, caregiver, dispensary or manufacturing facility. For the purposes of these rules, the Department may issue a registry identification card to any person who holds an active and valid Individual Identification Card issued under Maine's Adult Use Marijuana Program authorized by 28-B MRS, chapter 1.26.Sample means a portion of marijuana or marijuana product containing marijuana regulated under this rule that may be analyzed for testing or for research and development purposes.27.Sampler means a person authorized to collect samples of marijuana and marijuana products. 28.Sampling date means the date that a sample was collected from the manufacturer, in order to be reported as such, when reporting the sample results to marijuana testing facility clients.29.Tetrahydrocannabinol (THC and delta-9 THC) is substance defined in Chemical Abstracts Service number 1972-08-3. 30.Track and trace system means the record-keeping required and approved by the Department for registered caregivers, dispensaries, and manufacturing facilities to monitor inventory and transfers of marijuana for medical use for compliance purposes. Visitor means any person, other than officer, assistant, or employee of the manufacturing facility, who enters into any areas of the manufacturing facility where marijuana is manufactured or stored.18- 691 C.M.R. ch. 4, § 1