Section 501.105 - General Operational Requirements for Medical Marijuana Treatment Centers(1) Written Operating Procedures. Every MTC shall have and follow a set of detailed written operating procedures. If the MTC has an additional location, it shall develop and follow a set of such operating procedures for that facility. A CMO shall have written operating procedures that comply with both 935 CMR 501.105(1) and 500.105(1): Written Operating Procedures and may do so by having two sets of written operating procedures applicable to each medical-use and adult-use operations or having one set of written operating procedures, provided it complies with both medical-use and adult-use requirements. Operating procedures shall include, but need not be limited to, the following: (a) Security measures in compliance with 935 CMR 501.110.(b) Employee security policies, including personal safety and crime prevention techniques.(c) A description of the MTC's hours of operation and after hours contact information, which shall be provided to the Commission, made available to Law Enforcement Authorities on request, and updated pursuant to 935 CMR 501.101(1)(c)11.(d) Storage and waste disposal of Marijuana in compliance with 935 CMR 501.105(11) and 501.105(12).(e) Description of the various strains of Marijuana to be cultivated and dispensed, and the form(s) in which Marijuana will be dispensed.(f) Price list for Marijuana, MIPs, and any other available products, and alternate price lists for Patients with documented Verified Financial Hardship as required by 935 CMR 501.050(1)(h).(g) Procedures to ensure accurate recordkeeping, including inventory protocols for Transfer and inventory and procedures for integrating a secondary electronic system with the Seed-to-sale SOR.(h) Plans for quality control, including product testing for contaminants in compliance with 935 CMR 501.160.(i) A staffing plan and staffing records in compliance with 935 CMR 501.105(9)(d).(j) Emergency procedures, including a disaster plan with procedures to be followed in case of fire or other emergencies.(k) Alcohol, smoke, and drug free workplace policies.(l) A plan describing how Confidential Information and other records required to be maintained confidentially will be maintained.(m) A policy for the immediate dismissal of any MTC Agent who has: 1. Diverted Marijuana, which shall be reported to Law Enforcement Authorities and to the Commission;2. Engaged in unsafe practices with regard to operation of the MTC, which shall be reported to the Commission; or3. Been convicted or entered a guilty plea, plea of nolo contendere, or admission to sufficient facts of a felony drug offense involving distribution to a minor in the Commonwealth, or a like violation of the laws of any Other Jurisdiction.(n) A list of all board of directors, members and Executives of an MTC, and Members, if any, of the Licensee, shall be made available on request by any individual. This requirement may be fulfilled by placing this information on the MTC's website.(o) Policies and procedure for the handling of cash on MTC Premises including, but not limited to, storage, collection frequency, and transport to financial institution(s), to be available on inspection.(p) The standards and procedures by which the MTC determines the price it charges for Marijuana, and a record of the prices charged, including the MTC's policies and procedures for the provision of Marijuana to Registered Qualifying Patients with Verified Financial Hardship without charge or at less than the market price, as required by 935 CMR 501.050(1)(h).(q) Policies and procedures for energy efficiency and conservation that shall include: 1. Identification of potential energy use reduction opportunities (including, but not limited to, natural lighting, heat recovery ventilation and energy efficiency measures), and a plan for implementation of such opportunities;2. Consideration of opportunities for renewable energy generation including, where applicable, submission of building plans showing where energy generators could be placed on the site, and an explanation of why the identified opportunities were not pursued, if applicable;3. Strategies to reduce electric demand (such as lighting schedules, active load management and energy storage); and4. Engagement with energy efficiency programs offered pursuant to M.G.L. c. 25, § 21, or through municipal lighting plants.(r) Policies and procedures to promote workplace safety consistent with the standards set forth under the Occupational Safety and Health Act of 1970, 29 U.S.C. § 651, et seq., including the general duty clause whereby each employer: 1. shall furnish to each of its employees employment and a place of employment which are free from recognized hazards that are causing or are likely to cause death or serious physical harm to its employees;2. shall comply with occupational safety and health standards promulgated under 29 U. S.C. § 651, et seq. Each employee shall comply with occupational safety and health standards and all rules, regulations, and orders issued pursuant to 29 U.S.C. § 651, et seq., which are applicable to the employee's own actions and conduct. All current and updated regulations and references at 29 CFR Parts 1903, 1904, 1910, 1915,1917,1918,1926,1928, and 1977 are incorporated by reference, and applicable to all places of employment covered by 935 CMR 501.000.
(s) A description of the MTC's patient education activities in accordance with 935 CMR 501.140(6).(2)MTC Agent Training. (a) MTCs and Independent Testing Laboratories shall ensure that all MTC Agents and Laboratory Agents complete minimum training requirements prior to performing job functions. 1. At a minimum, MTC Agents shall receive a total of eight hours of training annually. The eight-hour total training requirement shall be tailored to the roles and responsibilities of the job function of each MTC Agent.2. A minimum of four hours of training shall be from Responsible Vendor Training Program courses established under 935 CMR 501.105(2)(b). Any additional RVT hours over the four-hour RVT requirement may count toward the eight-hour total training requirement.3. Non-RVT training may be conducted in-house by the MTC or by a third-party vendor engaged by the MTC. Basic on-the-job training MTCs provide in the ordinary course of business may be counted toward the eight-hour total training requirement.4. Agents responsible for tracking and entering product into the Seed-to-sale SOR shall receive training in a form and manner determined by the Commission. At a minimum, staff shall receive eight hours of on-going training annually.5. MTCs shall maintain records of compliance with all training requirements noted above. Such records shall be maintained for four years and MTCs shall make such records available for inspection on request.6. An individual who is both a Marijuana Establishment Agent and MTC Agent at a CMO location shall receive the training required for each license under which the agent is registered including, without limitation, with respect to patient privacy and confidentiality requirements, which may result in instances that would require such an agent to participate in more than eight hours of training.(b)Responsible Vendor Training.1. All current MTC Agents, including Laboratory Agents, involved in the handling or sale of Marijuana for medical use at the time of licensure or renewal of licensure, as applicable, shall have attended and successfully completed a Responsible Vendor Training Program to be designated a "Responsible Vendor". a. MTC Agents shall first take the Basic Core Curriculum.b. On completing the Basic Core Curriculum, an MTC Agent is eligible to take the Advanced Core Curriculum.c.Exception for Administrative Employees. MTC Agents who serve as administrative employees and do not handle or sell Marijuana are exempt from the four-hour RVT requirement but may take a Responsible Vendor Training Program course on a voluntary basis as part of fulfilling the eight-hour total training requirement.2. Once an MTC is designated a Responsible Vendor, all MTC Agents employed by the MTC that are involved in the handling or sale of Marijuana for medical use shall successfully complete the Basic Core Curriculum within 90 days of hire.3. After successful completion of the Basic Core Curriculum, each MTC Agent involved in the handling or sale of Marijuana for medical use shall fulfill the four-hour RVT requirement every year thereafter for the MTC to maintain designation as a Responsible Vendor. Failure to maintain Responsible Vendor status is grounds for action by the Commission.4.Responsible Vendor Trainer Certification. a. No owner, manager or employee of a Responsible Vendor Trainer may be a Person or Entity Having Direct or Indirect Ownership or Control of an MTC.b. Responsible Vendor Trainers shall submit their program materials to the Commission prior to offering courses, every two years following for Commission certification of the Responsible Vendor Trainer and Responsible Vendor Training Program curriculum, and on request. The process for certification will be in a form and manner determined by the Commission.c. Responsible Vendor Training Program courses shall consist of at least two hours of instruction time.d. Except as provided in 935 CMR 501.105(2)(b)4.e., Responsible Vendor Training Program courses shall be taught in a real-time, interactive, virtual or in-person classroom setting in which the instructor is able to verify the identification of each individual attending the program and certify completion of the program by the individual.e. Responsible Vendor Training Program courses may be presented in a virtual format that is not taught in a real-time, provided that the Responsible Vendor Trainer, as part of its application for certification, can demonstrate means: i. To verify the identification of each trainee participating in the program course and certify completion by the individual.ii. To track trainees' time needed to complete the course training;iii. To allow for the trainees to ask questions of the Responsible Vendor Trainer, for example, by email, virtual discussion board, or group/class discussion; andiv. To evaluate each trainee's proficiency with course material.f. Responsible Vendor Trainers shall seek certification for each Basic Core Curriculum and Advanced Core Curriculum. Applications for Advanced Core Curriculum certification will be open on or before July 1, 2022.g. Responsible Vendor Trainers shall maintain its training records at its principal place of business for four years.h. Responsible Vendor Trainers shall make the records available for inspection by the Commission and any other applicable licensing authority on request during normal business hours.i. Responsible Vendor Trainers shall provide to the appropriate MTC and MTC Agent written documentation of attendance and successful evaluation of proficiency, such as passage of a test on the knowledge of the required curriculum for each attendee.j. Trainees who can speak and write English fluently shall successfully demonstrate proficiency, such as passing a written test with a score of 70% or better.k. MTC Agents who cannot speak or write English may be offered a verbal evaluation or test, provided that the same questions are given as are on the written test and the results of the verbal test are documented with a passing score of 70% or better.l. Responsible Vendor Trainers shall solicit effectiveness evaluations from MTC Agents who have completed their program(s). 5.Basic Core Curriculum. The Basic Core Curriculum shall cover the following subject matter: a. Marijuana's effect on the human body, including:i. Scientifically based evidence on the physical and mental health effects based on the type of Marijuana Product;ii. The amount of time to feel impairment;iii. Visible signs of impairment; andiv. Recognizing the signs of impairment.b. Diversion prevention and prevention of sales to minors, including best practices.c. Compliance with all tracking requirements.d. Acceptable forms of identification. Training shall include: i. How to check identification;ii. Spotting and confiscating fraudulent identification;iii. Patient registration cards currently and validly issued by the Commission;iv. Common mistakes made in identification verification; andv. Prohibited purchases and practices, including purchases by persons younger than 21 years old in violation of M.G.L. c. 94G, § 13.e. How to engage and work with persons with disabilities.f. Other key state laws and rules affecting MTC Agents, which shall include: i. Conduct of MTC Agents;ii. Permitting inspections by state and local licensing and enforcement authorities;iii. Local and state licensing and enforcement, including registration and license sanctions;iv. Incident and notification requirements;v. Administrative, civil, and criminal liability;vi. Health and safety standards, including waste disposal;vii. Patrons prohibited from bringing marijuana and Marijuana Products onto licensed premises;viii. Permitted hours of sale;ix. Licensee responsibilities for activities occurring within licensed premises;x. Maintenance of records, including confidentiality and privacy; andg. Such other areas of training determined by the Commission to be included in a Responsible Vendor Training Program. 6.Advanced Core Curriculum. a. Each Advanced Core Curriculum class shall be approved by the Commission prior to being offered. The curriculum shall build on the knowledge, skills, and practices covered in the Basic Core Curriculum.b. An Advanced Core Curriculum class shall include standard and best practices in one or more of the following areas ii. Product Manufacturing;vii. Energy and Environmental Best Practices;viii. Social Justice and Economically Reparative Practices;ix. Implicit Bias and Diversity Training;xi. Food Safety and Sanitation;xii. Confidentiality and Privacy;xiii. In depth coverage of any topic(s) taught in the Basic Core Curriculum; orxiv. Such other topic as the Commission may approve in its sole discretion.7.Delivery Core Curriculum. In addition to the Basic Core Curriculum, all MTC Agents acting as delivery employees of an MTC shall have attended and successfully completed the Delivery Core Curriculum prior to making a delivery, which shall, to the extent not covered in Basic Core Training include, without limitation, training on:a. Safely conducting deliveries;b. Safe cash handling practices;c. Strategies for de-escalating potentially dangerous situations;d. Securing product following any instance of diversion, theft or loss of Finished Marijuana Products pursuant to 935 CMR 501.110(1)(m);e. Collecting and communicating information to assist in investigations;f. Procedures for checking identification;g. Indications of impairment; andh. Such other areas of training determined by the Commission to be included in a Responsible Vendor Training Program.(3)Handling of Marijuana. (a) An MTC shall Process Marijuana in a safe and sanitary manner. An MTC shall Process the leaves and flowers of the female Marijuana plant only, which shall be: 1. Well cured and free of seeds and stems;2. Free of dirt, sand, debris, and other foreign matter;3. Free of contamination by mold, rot, other fungus, pests and bacterial diseases and satisfying the sanitation requirements in 105 CMR 500.000: Good Manufacturing Practices for Food, and if applicable, 105 CMR 590.000: State Sanitary Code Chapter X: Minimum Sanitation Standards for Food Establishments;4. Prepared and handled on food-grade stainless steel tables with no contact with MTC Agents' bare hands; and5. Packaged in a secure area.(b) All MTCs, including those that develop, Repackage, or Process non-Edible MIPs, shall comply with the following sanitary requirements: 1. Any MTC Agent whose job includes contact with Marijuana or non-Edible MIPs, including cultivation, production, or packaging, is subject to the requirements for food handlers specified in 105 CMR 300.000: Reportable Diseases, Surveillance, and Isolation and Quarantine Requirements;2. Any MTC Agent working in direct contact with preparation of Marijuana or nonEdible MIPs shall conform to sanitary practices while on duty, including: a. Maintaining adequate personal cleanliness; andb. Washing hands thoroughly in an adequate hand washing area before starting work, and at any other time when hands may have become soiled or contaminated.c. Hand washing facilities shall be adequate and convenient and shall be furnished with running water at a suitable temperature.3. Hand washing facilities shall be located in the MTC in Production Areas and where good sanitary practices require employees to wash and/or sanitize their hands, and shall provide effective hand-cleaning and sanitizing preparations and sanitary towel service or suitable drying devices;4. There shall be sufficient space for placement of equipment and storage of materials as is necessary for the maintenance of sanitary operations;5. Litter and waste shall be properly removed, disposed of so as to minimize the development of odor, and minimize the potential for the waste attracting and harboring pests. The operating systems for waste disposal shall be maintained in an adequate manner pursuant to 935 CMR 501.105(12);6. Floors, walls, and ceilings shall be constructed in such a manner that they may be adequately kept clean and in good repair;7. There shall be adequate safety lighting in all Processing and storage areas, as well as areas where equipment or utensils are cleaned;8. Buildings, fixtures, and other physical facilities shall be maintained in a sanitary condition;9. All contact surfaces, including utensils and equipment, shall be maintained in a clean and sanitary condition. Such surfaces shall be cleaned and sanitized as frequently as necessary to protect against contamination, using a sanitizing agent registered by the US Environmental Protection Agency (EPA), in accordance with labeled instructions. Equipment and utensils shall be so designed and of such material and workmanship as to be adequately cleanable;10. All toxic items shall be identified, held, and stored in a manner that protects against contamination of Marijuana and MIPs. Toxic items may not be stored in an area containing products used in the cultivation of Marijuana. The Commission may require an MTC to demonstrate the intended and actual use of any toxic items found on the Premises;11. An MTC's water supply shall be sufficient for necessary operations. Any private water source shall be capable of providing a safe, potable, and adequate supply of water to meet the MTC's needs;12. Plumbing shall be of adequate size and design, and adequately installed and maintained to carry sufficient quantities of water to required locations throughout the MTC. Plumbing shall properly convey sewage and liquid disposable waste from the MTC. There shall be no cross-connections between the potable and wastewater lines;13. An MTC shall provide its employees with adequate, readily accessible toilet facilities that are maintained in a sanitary condition and in good repair;14. Products that can support the rapid growth of undesirable microorganisms shall be held in a manner that prevents the growth of these microorganisms;15. Storage and transportation of finished products shall be under conditions that will protect them against physical, chemical, and microbial contamination as well as against deterioration of them or their container; and16. All vehicles and transportation equipment used in the transportation of Marijuana Products or Edibles requiring temperature control for safety shall be designed, maintained, and equipped as necessary to provide adequate temperature control to prevent the Marijuana Products or Edibles from becoming unsafe during transportation, consistent with applicable requirements pursuant to 21 CFR 1.908(c).(c) All MTCs shall comply with sanitary requirements during the development or Processing of Edibles. All Edibles shall be prepared, handled, and stored in compliance with the sanitation requirements in 105 CMR 590.000: State Sanitary Cpde Chapter X - Minimum Sanitation Standards for Food Establishments.(d) All Marijuana in the process of cultivation, production, preparation, transport, or analysis shall be housed and stored in such a manner as to prevent diversion, theft, or loss. 1. Such items shall be accessible only to the minimum number of specifically authorized MTC Agents essential for efficient operation;2. Such items shall be returned to a secure location immediately after completion of the process or at the end of the scheduled business day; and3. If a manufacturing process cannot be completed at the end of a working day, the Processing area or tanks, vessels, bins, or bulk containers containing Marijuana shall be securely locked inside an area or building that affords adequate security.4. Unless otherwise authorized by the Commission, a CMO shall comply with 935 CMR 500.105(3): Requirements for the Handling of Marijuana and 935 CMR 501.105(3).(4) Advertising Requirements. (a)Permitted Practices. 1. A Marijuana Establishment may develop a Brand Name to be used in labeling, signage, and other materials; provided however, that use of medical symbols, images of Marijuana or Marijuana Products, or related Paraphernalia, images that are appealing to persons younger than 21 years old, and colloquial references to Marijuana and Cannabis are prohibited from use in the Brand Name2. Brand Name Sponsorship of a charitable, sporting or similar event, so long as the following conditions are met: a. Sponsorship of the event is limited to the Brand Name.b. Any advertising at or in connection with such an event is prohibited, unless such advertising is targeted to entrants or participants reasonably expected to be 21 years of age or older, as determined by reliable, current audience composition data, and reasonable safeguards have been employed to prohibit advertising from targeting or otherwise reaching entrants or participants reasonably expected to be younger than 21 years old, as determined by reliable, current audience composition data; unless such advertising is targeted to entrants or participants reasonably expected to be 21 years of age or older, as determined by reliable, current audience composition data, and reasonable safeguards have been employed to prohibit advertising from targeting or otherwise reaching entrants or participants reasonably expected to be younger than 21 years old, as determined by reliable, current audience composition data;3. An MTC engaging in Brand Name Sponsorship under 935 CMR 501.105(4)(a)2. shall retain documentation of reliable, reasonable audience composition data that is the basis for allowing any such advertising or branding for a period of one year, or longer if otherwise required by the Commission, or a court or agency with jurisdiction.4. An MTC may display, in secure, locked cases, samples of each product offered for sale and subject to the requirements of 935 CMR 501.110 for Marijuana Treatment Centers. These display cases may be transparent. An authorized MTC Agent may remove a sample of Marijuana from the case and provide it to the Registered Qualifying Patient for inspection, provided the Registered Qualifying Patient may not consume or otherwise use the sample, unless otherwise authorized in 935 CMR 501.000.5. The MTC may post prices in the store and may respond to questions about pricing. The MTC shall provide a catalogue or a printed list of the prices and strains of Marijuana available at the MTC to Registered Qualifying Patients and may post the same catalogue or printed list on its website and in the retail store.6. An MTC may engage in reasonable advertising practices that are not otherwise prohibited in 935 CMR 501.105(4)(b) that do not jeopardize the public health, welfare or safety of the general public or promote the diversion of Marijuana or Marijuana use in individuals younger than 21 years old or otherwise promote practices inconsistent with the purposes of M.G.L. c. 94G or 94I. Any such advertising created for viewing by the public shall include the statement "Please Consume Responsibly", in a conspicuous manner on the face of the advertisement and shall include a minimum of two of the following warnings in their entirety in a conspicuous manner on the face of the advertisement: a. "This product may cause impairment and may be habit forming";b. "Marijuana can impair concentration, coordination and judgment. Do not operate a vehicle or machinery under the influence of this drug";c. "There may be health risks associated with consumption of this product"; ord. "Marijuana should not be used by women who are pregnant or breastfeeding".(b)Prohibited Practices. The following advertising activities are prohibited: 1. Advertising in such a manner that is deemed to be is deceptive, misleading, false or fraudulent, or that tends to deceive or create a misleading impression, whether directly or by omission or ambiguity;2. Advertising by means of television, radio, internet, mobile applications, social media, or other electronic communication, billboard or other outdoor advertising, or print publication, unless at least 85% of the audience is reasonably expected to be 21 years of age or older or comprised of individuals with debilitating conditions, as determined by reliable and current audience composition data;3. Advertising, including statements by a Licensee, that makes any false or statements concerning other Licensees and the conduct and products of such other Licensees that is deceptive, misleading, false or fraudulent, or that tends to deceive or create a misleading impression, whether directly or by omission or ambiguity;4. Advertising on any billboards or any other public signage which fails to comply with all state laws and local ordinances;5. Installation of any illuminated signage or external signage beyond the period of 30 minutes before sundown until closing; provided however, that the Commission may further specify minimum signage requirements;6. The use of vehicles equipped with radio or loudspeakers for the advertising of Marijuana or Marijuana Products;7. The use of radio or loudspeaker equipment in any MTC for the purpose of attracting attention to the sale of Marijuana or Marijuana Products;8. Operation of any website of an MTC that fails to verify that the entrant is a Qualifying Patient or Caregiver or the entrant is 21 years of age or older;9. Use of unsolicited pop-up advertisements on the internet or text message; unless the advertisement is a mobile device application installed on the device by the owner of the device who is a Qualifying Patient or Caregiver or 21 years of age or older and includes a permanent and easy opt-out feature;10. Any advertising, including the use of Brand Names, of an improper or objectionable nature including, but not limited to, the use or language or images offensive or disparaging to certain groups;11. Any advertising solely for the promotion of Marijuana or Marijuana Products on MTC Branded Goods including, but not limited to, clothing, cups, drink holders, apparel accessories, electronic equipment or accessories, sporting equipment, novelty items and similar portable promotional items;12. Advertising on or in public or private vehicles and at bus stops, taxi stands, transportation waiting areas, train stations, airports, or other similar transportation venues including, but not limited to, vinyl-wrapped vehicles or signs or logos on transportation vehicles not owned by the MTC;13. The display of signs or other printed material advertising any brand or kind of Marijuana or Marijuana Products that are displayed on the exterior of any licensed Premises;14. Advertising of the price of Marijuana or Marijuana Products, except as permitted above pursuant to 935 CMR 501.105(4)(a)5.;15. Display of Marijuana or Marijuana Products so as to be clearly visible to a person from the exterior of an MTC;16. Advertising, marketing or branding including any statement, design, representation, picture, or illustration that encourages or represents the use of Marijuana for any purpose other than to treat a Debilitating Medical Condition or related symptoms;(c) The Commission shall maintain and make available a list of all MTCs, their dispensing location, and their contact information.(d) Nothing in 935 CMR 501.105(4) prohibits an MTC from using a mark provided by the Commission which uses images of Marijuana.(e) CMOs shall comply with the requirements of each 935 CMR 500.105(4): Advertising Requirements and 935 CMR 501.105(4) with respect to the applicable license. A CMO may develop a single marketing campaign; provided, however, it shall apply the most restrictive requirements applicable under either license.(5)Labeling of Marijuana and Marijuana Products. (a)Labeling of Marijuana Not Sold as a Marijuana Product . Prior to Marijuana being sold or Transferred, an MTC shall ensure the placement of a legible, firmly Affixed label on which the wording is no less than 1/16 of an inch in size on each package of Marijuana that it makes available for retail sale. The Affixed label shall contain at a minimum the following information, but may not include a Qualifying Patient's name:1. The name and registration number, telephone number, email address of the MTC that produced the Marijuana, together with the retail Licensee's business telephone number, electronic mail address, and website information, if any;2. The date that the MTC packaged the contents and a statement of which Licensee performed the packaging;3. A batch number, sequential serial number, and bar code when used, to identify the batch associated with manufacturing and Processing;4. Net weight or volume in U.S. customary or metric units, listed in that order;5. The full Cannabinoid Profile of the Marijuana contained within the package, including THC and other Cannabinoid levels;6. A statement and a seal certifying that the product has been tested for contaminants, that there were no adverse findings, and the date of testing in accordance with M.G.L c. 94G, § 15;7. This statement, including capitalization: "This product has not been analyzed or approved by the FDA. There is limited information on the side effects of using this product, and there may be associated health risks. Marijuana use during pregnancy and breast-feeding may pose potential harms. It is against the law to drive or operate machinery when under the influence of this product. KEEP THIS PRODUCT AWAY FROM CHILDREN.";8. The following symbol or easily recognizable mark issued by the Commission that indicates the package contains Marijuana: Click to view image
9. The following symbol or other easily recognizable mark issued by the Commission that indicates that the product is harmful to children: Click to view image
10.935 CMR 501.105(5)(a) may not apply to Marijuana packaged for transport of wholesale cultivated Marijuana in compliance with 935 CMR 501.105(13); provided however, that the MTC is responsible for compliance with 935 CMR 501.105(5) for all Marijuana Products sold or displayed to Patients.(b)Labeling of Edibles. Prior to Edibles being sold or Transferred, the MTC shall place a legible, firmly Affixed label on which the wording is no less than 1/16 of an inch in size on each Edible that it prepares for retail sale or wholesale. The Affixed label shall contain at a minimum the following information, but may not include a Qualifying Patient's name:1. The name and registration number of the Marijuana Product Manufacturer that produced the Marijuana Product, together with the Marijuana Product Manufacturer's business telephone number, e-mail address and website information, if any;2. The name of the Marijuana Product;3. Refrigeration of the product is required, as applicable;4. Total net weight or volume in U.S. customary and metric units, listed in that order, of the Marijuana Product;5. The number of servings in the Marijuana Product and the specific weight in milligrams of a serving size;6. The type of Marijuana used to produce the product, including what, if any, Processing technique or solvents were used;7. A list of ingredients, including the full Cannabinoid Profile of the Marijuana contained within the Marijuana Product, including the amount of delta-nine-tetrahydrocannabinol ([DELTA]9-THC) and other Cannabinoids in the package and in each serving of a Marijuana Product as expressed in absolute terms and as a percentage of volume;8. The amount, in grams, of sodium, sugar, carbohydrates and total fat per serving;9. The date of creation and the recommended "use by" or expiration date which may not be altered or changed;10. A batch number, sequential serial number and bar codes when used, to identify the batch associated with manufacturing and Processing;11. Directions for use of the Marijuana Product;12. A statement and a seal that the product has been tested for contaminants, that there were no adverse findings, and the date of testing in accordance with M.G.L. c. 94G, § 15;13. A warning if nuts or other Known Allergens are contained in the product;14. This statement, including capitalization: "The impairment effects of edible products may be delayed by two hours or more. This product has not been analyzed or approved by the FDA. There is limited information on the side effects of using this product, and there may be associated health risks. Marijuana use during pregnancy and breast-feeding may pose potential harms. It is against the law to drive or operate machinery when under the influence of this product. KEEP THIS PRODUCT AWAY FROM CHILDREN.";15. The following symbol or easily recognizable mark issued by the Commission that indicates the package contains Marijuana: Click to view image
16. The following symbol or other easily recognizable mark issued by the Commission that indicates that the product is harmful to children: Click to view image
17.935 CMR 501.105(5)(b) shall apply to Edibles produced by an MTC for transport to another Licensee in compliance with 935 CMR 501.105(8) and shall be in addition to any regulation regarding the appearance of Edibles under 935 CMR 501.150.(c)Labeling of Marijuana Concentrates and Extracts. Prior to Marijuana concentrates or extracts being sold or Transferred, the MTC shall place a legible, firmly Affixed label on which the wording is no less than 1/16 of an inch in size on each Marijuana concentrate container that it prepares for retail sale or wholesale. The Affixed label shall contain at a minimum the following information, but may not include a Qualifying Patient's name: 1. The name and registration number of the Marijuana Product Manufacturer that produced the Marijuana Product, together with the Marijuana Product Manufacturer's business telephone number and e-mail address;2. The name of the Marijuana Product;3. Product identity, including the word "concentrate" or "extract", as applicable;4. Total net weight or volume expressed in U.S. customary units and metric units, listed in that order, of a Marijuana Product;5. If applicable, the number of servings in the Marijuana Product and the specific weight in milligrams of a serving size;6. The type of Marijuana used to produce the product, including what, if any, Processing technique or solvents were used;7. A list of ingredients including, but not limited to, the full Cannabinoid Profile of the Marijuana contained within the Marijuana Product, including the amount of delta-nine-tetrahydrocannabinol ([DELTA]9-THC) and other Cannabinoids in the package and in each serving of a Marijuana Product as expressed in absolute terms and as a percentage of volume, and the amount of specific additives infused or incorporated during the manufacturing process, whether active or inactive including, but not limited to, thickening agents, thinning agents, and specific terpenes, expressed in absolute terms and as a percentage of volume; a. For Marijuana Vaporizer Devices, identification of specific additives shall include, but not be limited to, any additives identified on the FDA's Inactive Ingredient Database for "Respiratory (inhalation)" or "Oral" routes of administration and based on dosage form as an aerosol product or inhalant. The FDA Inactive Ingredient Database is available at https://www.fda.gov/media/72482/download . If the FDA database or its equivalent is no longer available, licensees shall use the database identified by the Commission.b. For Marijuana Vaporizer Devices produced using only cannabis-derived terpenes, the following statement: "This product was produced using only cannabis-derived terpenes."c. For Marijuana Vaporizer Devices produced using terpenes other than cannabis-derived terpenes, the following statement: "This product was produced using terpenes derived from sources other than cannabis."8. The date of creation and the recommended "use by" or expiration date;9. A batch number, sequential serial number, and bar code when used, to identify the batch associated with manufacturing and Processing;10. Directions for use of the Marijuana Product;11. A statement and a seal that the product has been tested for contaminants, that there were no adverse findings, and the date(s) of testing in accordance with M.G.L. c. 94G, § 15. Marijuana Products that are required to undergo more than one screening shall list all applicable dates of testing;12. A warning if nuts or other Known Allergens are contained in the product;13. This statement, including capitalization: "This product has not been analyzed or approved by the FDA. There is limited information on the side effects of using this product, and there may be associated health risks. Marijuana use during pregnancy and breast-feeding may pose potential harms. It is against the law to drive or operate machinery when under the influence of this product. KEEP THIS PRODUCT AWAY FROM CHILDREN.";14. The following symbol or easily recognizable mark issued by the Commission that indicates the package contains Marijuana: Click to view image
15. The following symbol or other easily recognizable mark issued by the Commission that indicates that the product is harmful to children: Click to view image
16.935 CMR 501.105(5)(c) shall apply to Marijuana concentrates and extracts produced by an MTC for transport to another Licensee in compliance with 935 CMR 501.105(13).(d)Labeling of Marijuana Infused Tinctures, Topicals or Other Non-edible Marijuana-infused Products. Prior to Marijuana-infused Tinctures, topicals or other non-edible Marijuana-infused Products being sold or Transferred the MTC shall place a legible, firmly Affixed label on which the wording is no less than 1/16 of an inch in size on each container of Marijuana-infused Product that it prepares for retail sale or wholesale. The Affixed label shall contain at a minimum the following information, but may not include a Qualifying Patient's name: 1. The name and registration number of the MTC that produced the Marijuana Product, together with the MTC's business telephone number, e-mail address and website information, if any;2. The Marijuana Product's identity;3. The type of Marijuana used to produce the product, including what, if any, Processing technique or solvents were used;4. A list of ingredients, including the full Cannabinoid Profile of the Marijuana contained within the Marijuana Product, including the amount of delta-nine-tetrahy drocannabinol ([DELTA]9-THC) and other Cannabinoids in the package and in each serving of a Marijuana Product as expressed in absolute terms and as a percentage of volume;5. Total net weight or volume as expressed in U.S. customary units and metric units, listed in that order, of the Marijuana Product;6. If applicable, the number of servings in the Marijuana Product and the specific weight in milligrams of a serving size;7. The date of product creation;8. A batch number, sequential serial number, and bar code when used, to identify the batch associated with manufacturing and Processing;9. Directions for use of the Marijuana Product;10. A statement and a seal that the product has been tested for contaminants, that there were no adverse findings, and the date of testing in accordance with M.G.L. c. 94G, § 15;11. A warning if nuts or other Known Allergens are contained in the product;12. This statement, including capitalization: "This product has not been analyzed or approved by the FDA. There is limited information on the side effects of using this product, and there may be associated health risks. Marijuana use during pregnancy and breast-feeding may pose potential harms. It is against the law to drive or operate machinery when under the influence of this product. KEEP THIS PRODUCT AWAY FROM CHILDREN.";13. The following symbol or easily recognizable mark issued by the Commission that indicates the package contains Marijuana: Click to view image
14. The following symbol or other easily recognizable mark issued by the Commission that indicates that the product is harmful to children: Click to view image
15.935 CMR 501.105(5)(d) shall apply to Marijuana-infused Tinctures and topicals produced by an MTC for transport to another Licensee in compliance with 935 CMR 501.105(8).(e)Labeling of Repackaged Marijuana. Prior to Repackaged Marijuana being sold, the Retailer shall place a legible, firmly Affixed label on which the wording is no less than 1/16 inch in size on each container of Marijuana that it prepares for retail sale. 1. The Affixed label shall contain at a minimum the following information, but may not include a Qualifying Patient's name:a. The name and registration number of the Cultivator that produced the Marijuana;b. Business or trade name of licensee that packaged the product, if different from the Cultivator;d. Type of Marijuana or name of strain;e. The full Cannabinoid Profile of the Marijuana contained within the Repackaged Product, including the amount of delta-nine-tetrahydrocannabinol ([DELTA]9-THC) and other Cannabinoids in the package;f. Weight in grams of usable marijuana used in product;g. A batch number, sequential serial number, and bar code when used, to identify the batch associated with manufacturing and Processing;h. A statement and a seal that the product has been tested for contaminants, that there were no adverse findings, and the date of testing in accordance with M.G.L. c. 94G, § 15;i. This statement, including capitalization: "This product has not been analyzed or approved by the FDA. There is limited information on the side effects of using this product, and there may be associated health risks. Marijuana use during pregnancy and breast-feeding may pose potential harms. It is against the law to drive or operate machinery when under the influence of this product. KEEP THIS PRODUCT AWAY FROM CHILDREN.";j. The following symbol or easily recognizable mark issued by the Commission that indicates the package contains Marijuana: Click to view image
k. The following symbol or other easily recognizable mark issued by the Commission that indicates that the product is harmful to children: Click to view image
2. In circumstances where the labeling of the Marijuana Product is unreasonable or impractical, the MTC may include the labeling information on a peel-back label or may place the product in a sealed bag with an insert or additional, easily readable label firmly Affixed to that bag.(f) In circumstances where the labeling of the Marijuana Product is unreasonable or impractical, the MTC may include the labeling information on a peel-back label or may place the product in a take-away bag with an insert or additional, easily readable placed within that bag.(g) CMOs shall comply with the labeling requirements in 935 CMR 500.105(5) for all adult-use sales and 935 CMR 501.105(5) for all medical-use sales.(6)Packaging of Marijuana and Marijuana Products. (a)Child-resistant Packaging. MTCs engaged in product manufacturing operations shall ensure that all Marijuana and Marijuana Products that are provided for sale to Registered Qualifying Patients shall be sold in child-resistant packaging. To comply with 935 CMR 501.105(6), Licensees shall ensure: 1. That to the extent it is not Unreasonably Impracticable for the specific type of product, Marijuana Products are packaged in containers that are:a. Opaque and plain in design;b. Do not use bright colors, cartoon characters and other features designed to appeal to minors;c. Resealable for any Marijuana Product intended for more than a single use or containing multiple servings; andd. Certified by a qualified child-resistant packaging testing firm that the packaging complies with the most recent poison prevention packaging regulations of the U.S. Consumer Product Safety Commission as included at 16 CFR 1700.2. That where compliance with the requirements of child-resistant packaging is deemed to be Unreasonably Impracticable or too challenging for Patients to maneuver, Marijuana Products shall be placed in an packaging that is:a. Capable of being resealed after it has been opened; andb. Includes the following statement, including capitalization, in at least ten-point Times New Roman, Helvetica or Arial font: "KEEP OUT OF REACH OF CHILDREN".(b)Limits on Packaging Design. Packaging for Marijuana or Marijuana Products sold or displayed to Patients, including any label or imprint Affixed to any packaging containing Marijuana or Marijuana Products or any exit packages, may not be attractive to minors. Packaging is explicitly prohibited from: 1. Imitating or having a semblance to any existing branded consumer products, including foods and beverages, that do not contain Marijuana;3. Featuring a design, brand or name that resembles a non-Cannabis consumer product of the type that is typically marketed to minors;4. Featuring symbols or celebrities that are commonly used to market products to minors;5. Featuring images of minors; and6. Featuring words that refer to products that are commonly associated with minors or marketed to minors.(c) Packaging of Multiple Servings. 1. Packaging for Marijuana Products sold or displayed for Registered Qualifying Patients in multiple servings shall include the following statement on the exterior of the package in a printed font that is no smaller than ten-point Times New Roman, Helvetica or Arial, including capitalization: "INCLUDES MULTIPLE SERVINGS."2. Packaging for Marijuana Products in solid form sold or displayed for Registered Qualifying Patients in multiple servings shall allow a Registered Qualifying Patient to easily perform the division into single servings.a. Edibles in a solid form shall be easily and permanently scored to identify individual servings.b. Notwithstanding 935 CMR 501.105(6)(c)2.a., where a product is unable, because of its form, to be easily and permanently scored to identify individual servings, the product shall be packaged in a single serving size. The determination of whether a product can be easily and permanently scored shall be decided by the Commission consistent with sub-regulatory guidelines established by the Commission and provided to Licensees.(d) Each single serving of an Edible contained in a multiple-serving package may be marked, stamped or otherwise imprinted with the symbol issued by the Commission under 935 CMR 501.105(5) that indicates that the single serving is a Marijuana Product.(e) Serving size shall be determined by the MTC.(f) CMOs shall comply with the packaging requirements in 935 CMR 500.105(6): Packaging of Marijuana and Marijuana Products for adult use sales or 935 CMR 501.105(6) for medical use sales.(7) Packaging and Labeling Pre-approval. Prior to Marijuana or Marijuana Product being sold at an MTC, a CMO, a Licensee or License Applicant may submit an application for packaging and label approval to the Commission. An application for preapproval may be submitted at any time prior to Marijuana or Marijuana Product being sold or at any time a substantive change is made to the packaging or labeling of Marijuana or Marijuana Product. The Commission shall charge a fee for packaging and labeling preapproval pursuant to 935 CMR 501.005. (a) Packaging and labeling preapproval review shall be limited to the physical attributes of, and statutorily required warnings on, the packaging and label, including but not limited to legibility, but may not include a review of specific Independent Testing Laboratory test results required pursuant to 935 CMR 501.105(5). The packaging and labeling preapproval process shall be in addition to the requirements of 935 CMR 501.105(5) and (6).(b) In addition to an application for packaging and labeling preapproval in a form and manner determined by the Commission, an applicant for preapproval shall submit electronic files of the following to the Commission: 1. For packaging preapproval, two images of the packaging, one depicting the front of the packaging and one depicting the back of the packaging. Photographs shall be electronic files in a JPEG format with a minimum photo resolution of 640 x 480 and print resolution of 300 DPI. Photographs shall be against a white background.2. For labeling preapproval, one image of each label requested for review. Photographs shall be electronic files in a JPEG format with a minimum photo resolution of 640 x 480 and print resolution of 300 DPI. Photographs shall be against a white background.(c) The Commission shall make every effort to make a preapproval determination based on information submitted. In the event that a preapproval determination is unable to be made conclusively based on submitted photographs, the Commission may request to view the packaging or label in person or through a video conference. Any such request by the Commission shall be made to the applicant electronically or in writing.(8)Inventory. (a) Subject to Marijuana or Marijuana Products being entered into the Seed-to-sale SOR, a Marijuana Establishment may Transfer product to an MTC, and an MTC may Transfer product to a Marijuana Establishment as long as there is no violation of the dosing limitations set forth in 935 CMR 500.150(4): Dosing Limitations or the limitations on total MTC inventory as set forth in 935 CMR 501.105(8)(m). Such Transfers cannot violate provisions protecting patient supply under 935 CMR 501.140(12). An MTC shall limit its Transfer of inventory of seeds, plants, and Usable Marijuana to reflect the projected needs of Registered Qualifying Patients.(b) Real-time inventory shall be maintained as specified by the Commission and in 935 CMR 501.105(8)(c) and (d) including, at a minimum, an inventory of Marijuana plants, Marijuana plant seeds and Clones in any phase of development such as Propagation, Vegetation, and Flowering, Marijuana ready for dispensing, all MIPs, and all damaged, defective, expired, or contaminated Marijuana and MIPs awaiting disposal.(c) An MTC shall: 1. Establish inventory controls and procedures for the conduct of inventory reviews, and comprehensive inventories of Marijuana and MIPs in the process of cultivation, and finished, stored Marijuana;2. Conduct a monthly inventory of Marijuana in the process of cultivation and finished, stored Marijuana;3. Conduct a comprehensive annual inventory at least once every year after the date of the previous comprehensive inventory; and4. Promptly transcribe inventories if taken by use of an oral recording device.(d) The record of each inventory shall include, at a minimum, the date of the inventory, a summary of the inventory findings, and the names, signatures, and titles of the individuals who conducted the inventory.(e) An MTC shall attach plant tags to all Marijuana, Clones, and plants and attach package tags to all Finished Marijuana and Marijuana Products, and track all Marijuana seeds, Clones, plants, and Marijuana Products, using a Seed-to-sale methodology in a form and manner to be approved by the Commission.(f) The failure to enter inventory into the Seed-to-sale SOR may result in the suspension or revocation of an MTC License.(g) The use of the Seed-to-sale SOR does not preclude an MTC from using a secondary electronic tracking system so long as it complies with 935 CMR 501.105(8). The MTC shall seek approval from the Commission, in a form and manner determined by the Commission, to integrate its secondary system with the Seed-to-sale SOR.(h) Prior to the point of sale, an MTC shall specify the suggested retail price for any Marijuana or Marijuana Product intended for patient sale.(i) An MTC shall limit its inventory of seeds, plants, and Usable Marijuana to reflect the projected needs of Registered Qualifying Patients.(j) An MTC may acquire Marijuana and Marijuana Product from or distribute Marijuana or Marijuana Product to another MTC or Marijuana Establishment in accordance with 935 CMR 501.140(8) and subject to the following: 1. The distribution and acquisition of Marijuana and Marijuana Product, including MIPs, to and from all other MTCs does not exceed, cumulatively, 45% of the MTC's total annual inventory of Marijuana as measured by weight, or for Marijuana Product, including MIPs, as measured by its combined dry weight equivalent in Marijuana concentrate; except that such requirement shall not apply to CMOs; and2. A documented emergency occurs such as loss of crop, vandalism, or theft, or other circumstance as approved by the Commission.(k) Any distribution and acquisition of Marijuana and MIPs shall be tracked in the Seed-to-sale SOR in a form and manner determined by the Commission. Any distribution of Marijuana and MIPs that is not tracked in the Seed-to-sale SOR may result in the suspension or revocation of an MTC License or other administrative action.(l) An MTC may not engage in a transfer of inventory that would violate the provisions protecting patient supply under 935 CMR 501.140(12).(m) A CMO shall implement procedures for electronic separation of medical-and adult-use Marijuana, MIPs, and Marijuana Products in the Seed-to-sale SOR.(n) A CMO shall designate whether Marijuana or MIPs, or Marijuana Products are intended for sale for adult use or medical use through the SOR. Products shall be transferred to the appropriate license within the Seed-to-sale SOR prior to sale. After the point of sale, there shall be a reconciliation of that inventory in the SOR.(9)Recordkeeping. Records of an MTC shall be available for inspection by the Commission, on request. The financial records of an MTC shall be maintained in accordance with generally accepted accounting principles. Written records that are required and are subject to inspection include, but are not limited to, all records required in any section of 935 CMR 501.000 in addition to the following: (a) Operating procedures as required by 935 CMR 501.105(1);(b) Inventory records as required by 935 CMR 501.105(8)(d);(c) Seed-to-sale Electronic Tracking System records for all Marijuana and MIPs as required by 935 CMR 501.105(8)(e);(d) The following personnel records: 1. Job descriptions for each employee and volunteer position, as well as organizational charts consistent with the job descriptions;2. A personnel record for each MTC and Laboratory Agent. Such records shall be maintained for at least 12 months after termination of the individual's affiliation with the MTC and shall include, at a minimum, the following: a. All materials submitted to the Commission pursuant to 935 CMR 501.029 and 501.030;b. Documentation of verification of references;c. The job description or employment contract that includes duties, authority, responsibilities, qualifications, and supervision;d. Documentation of all required training, including training regarding privacy and confidentiality requirements, and the signed statement of the individual indicating the date, time, and place he or she received said training and the topics discussed, including the name and title of presenters;e. A copy of the application that the MTC submitted to the Commission on behalf of any prospective MTC agent;f. Documentation of periodic performance evaluations;g. Notice of completed Responsible Vendor Training Program and in-house training for MTC Agents required under 935 CMR 501.105(2); andh. A record of any disciplinary action taken.3. A staffing plan that will demonstrate accessible business hours and safe cultivation conditions;4. Personnel policies and procedures, including, at a minimum, the following: b. Whistle-blower policy; and5. All background check reports obtained in accordance with M.G.L. c. 6, § 172, 935 CMR 501.029, 935 CMR 501.030, and 803 CMR 2.00: Criminal Offender Record Information (CORI);(e) Business records, which shall include manual or computerized records of: 1. Assets and liabilities;2. Monetary transactions;3. Books of accounts, which shall include journals, ledgers, and supporting documents, agreements, checks, invoices, and vouchers;4. Sales records that indicate the name of the Registered Qualifying Patient or Personal Caregiver to whom Marijuana has been dispensed, including the quantity, form, and cost;5. Salary and wages paid to each employee, stipend paid to each board of directors member, and any executive compensation, bonus, benefit, or item of value paid to any individual affiliated with an MTC, including Persons or Entities Having Direct or Indirect Control over the MTC.(f) Waste disposal records as required under 935 CMR 501.105(12); and(g) Following closure of an MTC, all records shall be kept for at least two years at the expense of the MTC and in a form and location acceptable to the Commission.(10)Liability Insurance Coverage or Maintenance of Escrow. (a) An MTC shall obtain and maintain general liability insurance coverage for no less than $1,000,000 per occurrence and $2,000,000 in aggregate, annually, and product liability insurance coverage for no less than $1,000,000 per occurrence and $2,000,000 in aggregate, annually, except as provided in 935 CMR 501.105(10)(b) or otherwise approved by the Commission. The deductible for each policy shall be no higher than $5,000 per occurrence.(b) An MTC that documents an inability to obtain minimum liability insurance coverage as required by 935 CMR 501.105(10)(a) may place in escrow a sum of no less than $250,000 or such other amount approved by the Commission, to be expended for coverage of liabilities.(c) The escrow account required pursuant to 935 CMR 501.105(10)(b) shall be replenished within ten business days of any expenditure.(d) Reports documenting compliance with 935 CMR 501.105(10) shall be made in a manner and form determined by the Commission pursuant to 935 CMR 501.000.(e) A CMO shall maintain the insurance coverage or escrow account required under 935 CMR 500.105(10): Liability Insurance Coverage or Maintenance of Escrow or 501.105(10) per location.(11)Storage Requirements. (a) An MTC shall provide adequate lighting, ventilation, temperature, humidity, space, and equipment, in accordance with applicable provisions of 935 CMR 501.105 and 501.110.(b) An MTC shall have separate areas for storage of Marijuana that is outdated, damaged, deteriorated, mislabeled, or contaminated, or whose containers or packaging have been opened or breached, until such products are destroyed.(c) MTC storage areas shall be maintained in a clean and orderly condition.(d) MTC storage areas shall be free from infestation by insects, rodents, birds, and pests of any kind.(e) MTC storage areas shall be maintained in accordance with the security requirements of 935 CMR 501.110.(12)Waste Disposal.(a) All recyclables and waste, including organic waste composed of or containing Finished Marijuana and MIPs, shall be stored, secured, and managed in accordance with applicable state and local statutes, ordinances, and regulations. All exterior waste receptacles located on the MTC's Premises shall be locked and secured to prevent unauthorized access.(b) Liquid waste containing Marijuana or by-products of Marijuana Processing shall be disposed of in compliance with all applicable state and federal requirements including, but not limited to, for discharge of pollutants into surface water or groundwater (Massachusetts Clean Waters Act, M.G.L. c. 21, §§ 26 through 53; 314 CMR 3.00: Surface Water Discharge Permit Program; 314 CMR 5.00: Groundwater Discharge Permit Program; 314 CMR 12.00: Operation, Maintenance and Pretreatment Standards for Wastewater Treatment Works and Indirect Dischargers; the Federal Clean Water Act, 33 U.S.C. 1251et seq., the National Pollutant Discharge Elimination System Permit Regulations at 40 CFR Part 122, 314 CMR 7.00: Sewer System Extension and Connection Permit Program), or stored pending disposal in an industrial wastewater holding tank in accordance with 314 CMR 18.00: Industrial Wastewater Holding Tank and Container Construction, Operation, and Record Keeping Requirements.(c) Organic material, recyclable material and solid waste generated at an MTC shall be redirected or disposed of as follows:1. Organic and recyclable material shall be redirected from disposal in accordance with the waste disposal bans described at 310 CMR 19.017: Waste Bans.2. To the greatest extent feasible:a. Any recyclable material as defined in 310 CMR 16.02: Definitions shall be recycled in a manner approved by the Commission; andb. Any Marijuana containing organic material as defined in 310 CMR 16.02: Definitions shall be ground up and mixed with other organic material as defined in 310 CMR 16.02 at the MTC such that the resulting mixture renders any Marijuana unusable for its original purpose. Once such Marijuana has been rendered unusable, the organic material may be composted or digested at an aerobic or anaerobic digester at an operation that complies with the requirements of 310 CMR 16.00: Site Assignment Regulations for Solid Waste Facilities.3. Solid waste containing Marijuana generated at an MTC shall be ground up and mixed with other solid waste at the MTC such that the resulting mixture renders any Marijuana unusable for its original purpose. Once such Marijuana has been rendered unusable, the resulting solid waste may be brought to a solid waste transfer facility or a solid waste disposal facility (e.g., landfill or incinerator) that holds a valid permit issued by the Department of Environmental Protection or by the appropriate agency in the jurisdiction in which the facility is located.(d) No fewer than two MTC Agents shall witness and document how the solid waste or organic material containing Marijuana is handled on-site including, but not limited to, the grinding up, mixing, storage and removal from the MTC in accordance with 935 CMR 501.105(12). When Marijuana Products or waste is disposed or handled, the MTC shall create and maintain an electronic record of the date, the type and quantity disposed or handled, the manner of disposal or other handling, the location of disposal or other handling, and the names of the two MTC Agents present during the disposal or other handling, with their signatures. An MTC shall keep these records for at least three years. This period shall automatically be extended for the duration of any disciplinary action and may be extended by an order of the Commission.(13)Transportation Between MTCs. (a)General Requirements.1. A licensed MTC shall be licensed to transport its Marijuana and Marijuana Products to other licensed establishments, including Marijuana Establishments, except as otherwise provided in 935 CMR 501.105(13).2. Marijuana Products may only be transported between licensed MTCs by registered MTC Agents.3. A Marijuana Transporter licensed pursuant to 935 CMR 500.050(9) may Transfer Marijuana and Marijuana Products to or from an MTC.4. The originating and receiving licensed MTCs shall ensure that all transported Marijuana Products are linked to the Seed-to-sale SOR. For the purposes of tracking, seeds and Clones will be properly tracked and labeled in a form and manner determined by the Commission.5. Any Marijuana Product that is undeliverable or is refused by the destination MTC shall be transported back to the originating establishment.6. All vehicles transporting Marijuana Products shall be staffed with a minimum of two MTC Agents. At least one agent shall always remain with the vehicle when the vehicle contains Marijuana or Marijuana Products. a. Notwithstanding 935 CMR 501.105(13)(a)6., an Independent Testing Laboratory shall ensure that all vehicles operated by the Independent Testing Laboratory or a Marijuana Transporter used solely for transporting Marijuana or Marijuana Products for testing purposes in accordance with 935 CMR 501.160 that contain Marijuana and Marijuana Products with a total Wholesale value in excess of $5,000 in the vehicle are staffed with a minimum of two Agents.b. Notwithstanding 935 CMR 501.105(13)(a)6., for all vehicles transporting Marijuana or Marijuana Products solely for testing purposes in accordance with 935 CMR 501.160 that contain Marijuana and Marijuana Products with a total Wholesale value of $5,000 or less in the vehicle, an Independent Testing Laboratory or Marijuana Transporter may staff the vehicle with one Agent.7. Prior to leaving an MTC for the purpose of transporting Marijuana Products, the originating MTC shall weigh or count inventory, and account for, on video, all Marijuana Products to be transported.8. Within eight hours after arrival at the destination MTC, the destination MTC shall re-weigh or re-count inventory, and account for, on video, all Marijuana Products transported.9. When videotaping the weighing, counting, inventorying, and accounting of Marijuana Products before transportation or after receipt, the video shall show each product being weighed, the weight, and the manifest.10. Marijuana Products shall be packaged in sealed, labeled, and tamper or child-resistant packaging prior to and during transportation.11. In the case of an emergency stop during the transportation of Marijuana Products, a log shall be maintained describing the reason for the stop, the duration, the location, and any activities of personnel exiting the vehicle. Licensees shall comply with applicable requirements of 935 CMR 501.110(9).12. An MTC transporting Marijuana Products shall ensure that all transportation times and routes are randomized.13. An MTC transporting Marijuana Products shall ensure that all transport routes remain within the Commonwealth.14. All vehicles and transportation equipment used in the transportation of Cannabis Products or Edibles requiring temperature control for safety shall be designed, maintained, and equipped as necessary to provide adequate temperature control to prevent the Cannabis products or Edibles from becoming unsafe during transportation, consistent with applicable requirements pursuant to 21 CFR 1.908(c).15. All vehicles shall be equipped with a video system that includes one or more video cameras in the storage area of the vehicle and one or more video cameras in the driver area of the vehicle and which shall remain operational at all times during the entire transportation process and which shall have:a. The ability to produce a clear color still photo whether live or recorded; andb. A date and time stamp embedded in all recordings which shall always be synchronized and set correctly and may not significantly obscure the picture.(b)Reporting Requirements.1. MTC agents shall document and report any unusual discrepancy in weight, count, or inventory to the Commission and Law Enforcement Authorities not more than 24 hours of the discovery of such a discrepancy.2. MTC agents shall report to the Commission and Law Enforcement Authorities any vehicle accidents, diversions, losses, or other reportable incidents that occur during transport, not more than 24 hours of such accidents, diversions, losses, or other reportable incidents.(c)Vehicles. 1. A vehicle used for transporting Marijuana Products shall be:a. Exclusively owned or leased by the MTC or otherwise licensed by the Commission as a Third-party Transporter;b. Properly registered, inspected, and insured in the Commonwealth (documentation of such status shall be maintained as records of the MTC, and shall be made available to the Commission on request);c. Equipped with an alarm system approved by the Commission; andd. Equipped with functioning heating and air conditioning systems appropriate for maintaining correct temperatures for storage of Marijuana Products.2. Marijuana Products may not be visible from outside the vehicle.3. Any vehicle used to transport or deliver Marijuana or Marijuana Products must comply with applicable Massachusetts Registry of Motor Vehicles (RMV) requirements, but may not include any additional external marking that indicate the vehicle is being used to transport or deliver Marijuana or Marijuana Products.4. When transporting Marijuana Products, no other products may be transported or stored in the same vehicle.5. No firearms may be located within the vehicle or on an MTC Agent.(d)Storage Requirements.1. Marijuana Products shall be transported in a secure, locked storage compartment that is a part of the vehicle transporting the Marijuana Products.2. The storage compartment shall be sufficiently secure that it cannot be easily removed.3. If an MTC is transporting Marijuana Products for more than one licensed MTC at a time, the Marijuana Products for each Licensee shall be kept in a separate locked storage compartment during transportation and separate manifests shall be maintained for each MTC.4. If an MTC is transporting Marijuana Products to multiple other establishments, it may seek the Commission's permission to adopt reasonable alternative safeguards.(e)Communications.1. Any vehicle used to transport Marijuana Products shall contain a global positioning system (GPS) monitoring device that is: a. Not a mobile device that is easily removable;b. Attached to the vehicle at all times that the vehicle contains Marijuana Products;c. Monitored by the MTC during transport of Marijuana Products; andd. Inspected by the Commission prior to initial transportation of Marijuana Products, and after any alteration to the locked storage compartment.2. Each MTC Agent transporting Marijuana Products shall always have access to a secure form of communication with personnel at the originating location when the vehicle contains Marijuana and Marijuana Products.3. Secure types of communication include, but are not limited to: a. Two-way digital or analog radio (UHF or VHF);4. When choosing a type of secure communications, the following shall be taken into consideration: a. Cellular signal coverage;e. Frequency of transportation.5. Prior to, and immediately after leaving the originating location, the MTC Agents shall use the secure form of communication to contact the originating location to test communications and GPS operability.6. If communications or the GPS system fail while on route, the MTC Agents transporting Marijuana Products shall return to the originating location until the communication system or GPS system is operational.7. The MTC Agent or Agents transporting Marijuana Products shall contact the originating location when leaving any scheduled location or making any unscheduled stops.8. The originating location shall have an MTC Agent assigned to monitoring the GPS unit and secure form of communication, who shall log all official communications with MTC Agents transporting Marijuana Products.(f)Manifests. 1. An MTC shall complete a manifest prior to transporting Marijuana or Marijuana Products between Marijuana Establishments or an MTC. An MTC may utilize a physical or electronic manifest during the transportation of Marijuana or Marijuana Products.2. Prior to transport, the manifest shall be securely transmitted to the destination MTC by facsimile or email.3. On arrival at the destination MTC, an MTC Agent at the destination MTC shall compare the manifest produced by the agents who transported the Marijuana Products to the copy transmitted by facsimile or email. This manifest shall, at a minimum, include: a. The originating MTC name, address, and registration number;b. The names and registration numbers of the agents who transported the Marijuana Products;c. The name and registration number of the MTC Agent who prepared the manifest;d. The destination MTC name, address, and registration number;e. A description of the Marijuana Products being transported, including the weight and form or type of product;f. The mileage of the transporting vehicle at departure from originating MTC and mileage on arrival at destination MTC, as well as mileage on return to originating MTC;g. The date and time of departure from originating MTC and arrival at destination MTC for each transportation;h. A signature line for the MTC Agent who receives the Marijuana Products;i. The inventory weight or count before departure and on receipt;j. The date and time that the transported products were reweighed and re-inventoried;k. The name of the MTC Agent at the destination MTC who reweighed and re-inventoried products; and l. The vehicle make, model and license plate number.4. The manifest shall be maintained within the vehicle during the entire transportation process, until the delivery is completed. a. If utilizing a physical copy of the manifest, the licensed MTC Agent must be able to access the physical copy at any time during transportation.b. If utilizing an electronic manifest, the licensed MTC Agent must be able to access the electronic manifest at any time during transportation.5. An MTC shall retain all transportation manifests for no less than one year and make them available to the Commission on request.(g)Requirements for Agents. 1. Each employee or agent transporting or otherwise handling Marijuana Products for an MTC shall be registered as an MTC Agent and have a driver's license in good standing issued by the Massachusetts Registry of Motor Vehicles for all classes of vehicle the MTC agent will operate for the MTC prior to transporting or otherwise handling Marijuana Products.2. An MTC Agent shall carry his or her Agent Registration Card at all times when transporting Marijuana Products and shall produce his or her Agent Registration Card to the Commission or Law Enforcement Authorities on request.(h) MTCs engaged in transportation operations shall use best management practices to reduce energy and water usage, engage in energy conservation and mitigate other environmental impacts.(i) A CMO can transport adult use and medical use Marijuana and Marijuana Products if it is appropriately licensed to do so. Where a CMO is transporting both adult use and medical use Marijuana, MIPs and Marijuana Products, the CMO shall comply with the more restrictive security provisions.(14)Access to the Commission, Emergency Responders, and Law Enforcement. (a) The following individuals shall have access to an MTC or MTC transportation vehicle: 1. Representatives of the Commission as authorized by St. 2016, c. 334, as amended by St. 2017, c. 55, M.G.L. c. 94G, M.G.L. c. 94I, and 935 CMR 501.000.2. Representatives of other state agencies of the Commonwealth; and3. Emergency responders while responding to an emergency.(b) 935 CMR 501.000 may not be construed to prohibit access to authorized law enforcement personnel or local public health, inspectional services, or other permit-granting agents acting within their lawful jurisdiction(15)Energy Efficiency and Conservation. An MTC shall demonstrate consideration of the following factors as part of its operating plan and application for licensure:(a) Identification of potential energy use reduction opportunities (such as natural lighting and energy efficiency measures), and a plan for implementation of such opportunities;(b) Consideration of opportunities for renewable energy generation including, where applicable, submission of building plans showing where energy generators could be placed on the site, and an explanation of why the identified opportunities were not pursued, if applicable;(c) Strategies to reduce electric demand (such as lighting schedules, active load management, and energy storage); and(d) Engagement with energy efficiency programs offered pursuant to M.G.L. c. 25, § 21, or through municipal lighting plants.(16)Bond.(a) Prior to commencing operations, an MTC shall provide proof of having obtained a surety bond in an amount equal to its licensure fee payable to the Marijuana Regulation Fund to ensure payment of the cost incurred for: 1. the destruction of Cannabis goods necessitated by a violation of M.G.L. c. 94G, 94I, or 935 CMR 501.000;2. The costs and compensation of a Court Appointee;3. The cessation of operation of the MTC; or4. Such other uses that the Commission may authorize to ensure public health, safety and welfare(b) All bonds required under 935 CMR 501.000 shall be issued by a corporate surety licensed to transact surety business in the Commonwealth.(c) If the MTC is unable to secure a surety bond, as required by 935 CMR 501.105(16)(a) it may place in escrow a sum of no less than $5,000 or such other amount approved by the Commission, to be expended for coverage of liabilities.(d) The escrow account required pursuant to 935 CMR 501.105(16)(c) shall be replenished within ten business days of any expenditure required under 935 CMR 501.105, except if the MTC has ceased operations. Documentation of the replenishment shall be promptly sent to the Commission.(17)Reports to the Commission. The Commission may require ongoing reporting on operational, quality, and financial information in a form and manner determined by the Commission.(18)Requirements on the Expiration, Revocation, or Voiding of Certificate of Licensure of MTC.(a) If a License to operate expires without being renewed, is revoked, or becomes void, the MTC shall: 1. Immediately discontinue cultivation and production of Marijuana;2. Weigh or count inventory of all unused Marijuana in all stages of cultivation and all MIPs in any stage of production, and create and maintain a written record of all such items;3. Dispose of the unused Marijuana in accordance with 935 CMR 501.105(12) after approval by the Commission. Such disposal shall be in the public interest; and4. Maintain all records as required by 935 CMR 501.105(9)(g).(b) If the MTC does not comply with the requirements of 935 CMR 501.105(15)(a), the Commission shall have the authority to, at the MTC's expense, secure the MTC, and after a period of 30 calendar days, seize, and destroy the inventory and equipment and contract for the storage of MTC records.(19)Prohibitions. (a) Unless otherwise authorized by the Commission, an MTC may not dispense, deliver, or otherwise transfer Marijuana to a person other than a Registered Qualifying Patient or to his or her Personal Caregiver, to another MTC or to a laboratory as provided for in 935 CMR 501.105(13).(b) Unless otherwise authorized by the Commission, an MTC may not acquire Marijuana or Marijuana plants, except through the cultivation of Marijuana by that MTC or another MTC as specified in 935 CMR 501.105(13); provided, however that an MTC may acquire Marijuana seeds, cuttings or genetic plant material. Cuttings or genetic plant material may only be acquired within 90 days of receiving a final Certificate of Licensure, or such other time period approved by the Commission and otherwise as authorized under 935 CMR 501.105(13).(c) Unless authorized by the Commission, an MTC is prohibited from acquiring, possessing, cultivating, delivering, Transferring, transporting, supplying, or dispensing Marijuana for any purpose except to assist Registered Qualifying Patients.(d) An MTC may not give away any Marijuana except as required pursuant to 935 CMR 501.050(1)(g). An MTC may not provide any samples of Marijuana.(e) An MTC may not receive orders for Marijuana in any manner other than from a Registered Qualifying Patient or Personal Caregiver in person at the MTC, except in the cases of delivery, in which an order may be received by telephone or through a password-protected, internet-based platform.(f) An MTC may not fill orders for Marijuana in any manner other than to a Registered Qualifying Patient or Personal Caregiver in person at the MTC, except in the case of delivery, in which an order may be delivered only to the Residence of a Registered Qualifying Patient or Personal Caregiver or the Caregiving Institution of a Registered Qualifying Patient. The Qualifying Patient or caregiver receiving the delivery shall possess a temporary or an annual Registration Card and valid photo identification as required pursuant to 935 CMR 501.140(2). An MTC is prohibited from delivering adult use Marijuana.(g) Unless authorized by the Commission, an MTC may not sell any products other than Marijuana, including MIPs and Marijuana seeds, and other Marijuana Accessories and products such as vaporizers that facilitate the use of Marijuana for medical purposes.(h) Consumption of Marijuana on the Premises or grounds of any MTC is prohibited; provided, however, that an MTC may administer medical use Marijuana for the purposes of teaching use of vaporizers, or demonstration of use of other products as necessary. An MTC is prohibited from administering adult use Marijuana.(i) An MTC may not adulterate Marijuana, including with psychoactive additives or other illegal substances.(j) An MTC may not sell Marijuana to a Registered Qualifying Patient with a Hardship Cultivation Registration or to his or her Personal Caregiver(s); provided however, that the MTC may sell seeds to such individuals or gift seeds pursuant to 935 CMR 501.105(19)(1)(g).Adopted by Mass Register Issue 1380, eff. 12/23/2018.Amended by Mass Register Issue 1403, eff. 11/1/2019.Amended by Mass Register Issue 1406, eff. 11/1/2019.Amended by Mass Register Issue 1434, eff. 1/8/2021.Amended by Mass Register Issue 1436, eff. 1/8/2021.Amended by Mass Register Issue 1441, eff. 1/8/2021.Amended by Mass Register Issue 1535, eff. 11/22/2024.