230-RICR-80-05-1. Rules and Regulations Related to the Medical Marijuana Program Administered by the Office of Cannabis Regulation at the Department of Business Regulation (version Amendment, 03/25/2020 to 01/04/2022)

1.1 Definitions and Authority 1.1.1 Definitions A. The following definitions are for terms used in this Part, including but not limited to many of the relevant definitions from R.I. Gen. Laws §§ 21-28.6-3 and 21-28-1.02. 1. “Act” means R.I. Gen. Laws Chapter 21-28.6 entitled, “The Edward O. Hawkins and Thomas C. Slater Medical Marijuana Act,” as amended. 2. "Advertising" means the act or practice of calling public attention to one’s product or service. 3. “Agent” means an agent of a marijuana establishment licensee including but not limited to “testing agents.” 4. "Authorized purchaser" means a natural person who is at least twenty-one (21) years old and who is registered with DOH for the purposes of assisting a qualifying patient in purchasing marijuana from a compassion center. An authorized purchaser may assist no more than one patient and is prohibited from consuming marijuana obtained for the use of the qualifying patient. An authorized purchaser shall be registered with DOH and shall possesses a valid registry identification card. 5. "Cannabis" means all parts of the plant of the genus marijuana, also known as marijuana sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of the plant; and every compound, manufacture, salt, derivative, mixture, or preparation of the plant, its seeds, or resin regardless of cannabinoid content or cannabinoid potency including "marijuana," and "industrial hemp" or "industrial hemp products" which satisfy the requirements of R.I. Gen. Laws Chapter 2-26. 6. "Cannabis testing laboratory" means a third-party analytical testing laboratory licensed by DOH, in coordination with the DBR regulations, to collect and test samples of cannabis. 7. “Cardholder" means a person who has been registered or licensed with DOH or DBR pursuant to the Act and possesses a valid registry identification card or license. As used in this regulation, “cardholder” includes: a. A registered primary caregiver, or b. A person registered with DBR as a principal officer, board member, employee, volunteer, or agent of a compassion center, licensed medical marijuana cultivator, cannabis testing lab or any other DBR medical marijuana licensee. 8. “CBD” means cannabidiol, which is a cannabinoid found in the cannabis plant. 9. “Child-Resistant” shall mean packaging in accordance with the Poison Prevention Packaging Act of 1970, 16 C.F.R. Part 1700, incorporated below at § 1.1.7(A) of this Part. 10. "Commercial unit" means a building or other space within a commercial or industrial building, for use by one business or person and that is rented or owned by that business or person. 11. "Compassion center" means a not-for-profit corporation, subject to the provisions of R.I. Gen. Laws Chapter 7-6, and is licensed under R.I. Gen. Laws § 21-28.6-12, that acquires, possesses, cultivates, manufactures, delivers, transfers, transports, supplies, or dispenses medical marijuana, and or related supplies and education materials, to patient cardholders and/or their registered caregiver, cardholder or authorized purchaser. 12. "Compassion center cardholder" means a principal officer, board member, employee, volunteer, or agent of a compassion center who has registered with DBR and has been issued and possesses a valid registry identification card. 13. “DBR,” “Department” or “Office” shall refer to the Office of Cannabis Regulation within the Rhode Island Department of Business Regulation or its successor agency. 14. “DBR regulations” means these Regulations, the Rules and Regulations Related to the Medical Marijuana Program Administered by the Office of Cannabis Regulation at the Department of Business Regulation. 15. "Debilitating medical condition" means: a. Cancer, glaucoma, positive status for human immunodeficiency virus, acquired immune deficiency syndrome, Hepatitis C, post-traumatic stress disorder, or the treatment of these conditions; b. A chronic or debilitating disease or medical condition, or its treatment, that produces one or more of the following: cachexia or wasting syndrome; severe, debilitating, chronic pain; severe nausea; seizures, including but not limited to, those characteristic of epilepsy; or severe and persistent muscle spasms, including but not limited to, those characteristic of multiple sclerosis or Crohn's disease; or agitation of Alzheimer's Disease; or c. Any other medical condition or its treatment approved by DOH, as provided for in R.I. Gen. Laws § 21-28.6-5. 16. “DEM” means the Rhode Island Department of Environmental Management or its successor agency. 17. “Department of Public Safety” or “RISP” means the Rhode Island Department of Public Safety, Division of State Police, or its successor agency. 18. “DOH” means the Rhode Island Department of Health or its successor agency. 19. “DOH regulations” means the Rules and Regulations related to the Medical Marijuana Program Administered by the Department of Health, 216-RICR-20-10-3 , as the same may be amended from time to time, and the DOH Testing Regulations. 20. “DOH testing regulations” means the testing requirements, standards, and procedures for conduct of testing through “approved third party testing providers” to be promulgated by DOH, including but not limited to 216-RICR-60-05-6 . 21. "Dwelling unit" means the room, or group of rooms, within a residential dwelling used or intended for use by one family or household, or by no more than (3) unrelated individuals, with facilities for living, sleeping, sanitation, cooking, and eating. 22. "Handbill" means a flyer, leaflet or sheet that advertises marijuana. 23. “Interest holders” or "Key persons" means with respect to an applicant or licensed entity, the following persons or entities: a. All persons and/or entities with any ownership interest with respect to the applicant/licensee, including parent companies if the applicant licensee is a subsidiary of another entity, and b. All officers, directors, members, managers or agents of the applicant/licensee, and any other entities described in § 1.1(A)(23)(a) of this Part, and c. All persons or entities with managing or operational control with respect to the applicant/licensee, its operation, any other entities described in §§ 1.1(A)(23)(a) and (b) of this Part, the license and/or licensed facilities whether they have an ownership interest or not, and d. All investors or other persons or entities with any financial interest with respect to the applicant/licensee, any other entities described in §§ 1.1(A)(23)(a), (b) and (c) of this Part, its operations, the license, and/or licensed facilities, whether they have ownership interest or not, and e. All persons or entities that hold interest(s) arising under shared management companies, management agreements, or other agreements that afford third-party management or operational control with respect to the applicant/licensee, its operations, the license and/or the licensed facilities, and f. To the extent that any Interest Holder is an entity (corporation, partnership, LLC, etc.), all Interest Holders in that entity and all Interest Holders therein down to the individual person level. 24. “Licensed cooperative cultivation” means a cooperative cultivation that is required to obtain a license from DBR pursuant to R.I. Gen. Laws § 21-28.6-14. 25. "Licensed medical marijuana cultivator" means a person or entity, as identified in R.I. Gen. Laws § 43-3-6, who has been licensed by DBR to cultivate medical marijuana pursuant to R.I. Gen. Laws § 21-28.6-16. 26. "Marijuana" means all parts of the plant cannabis sativa L., whether growing or not; the seeds of the plant; the resin extracted from any part of the plant; and every compound, manufacture, salt, derivative, mixture, or preparation of the plant, its seeds or resin, but shall not include the mature stalks of the plant, fiber produced from the stalks, oil or cake made from the seeds of the plant, any other compound, manufacture, salt, derivative, mixture, or preparation of mature stalks, (except the resin extracted from it), fiber, oil or cake, or the sterilized seed from the plant which is incapable of germination. Marijuana shall not include hemp as defined in R.I. Gen. Laws § 2-26-3. Marijuana sub-categories include but are not limited to: a. “Mature marijuana plant” means a marijuana plant that has flowers or buds that are readily observable by an unaided visual examination. b. “Immature marijuana plant” means a marijuana plant, rooted or unrooted with no observable flowers or buds. c. “Plant” means collectively or independently “mature marijuana plants” and/or “immature marijuana plants” as the context requires. d. “Unusable marijuana” means marijuana seeds, stalks, unusable roots and shall not count towards any weight-based possession limits established in the Act. e. “Usable marijuana” means the leaves and flowers of the marijuana plant, and any mixture or preparation thereof, but does not include the sterilized seeds, stalks, and roots of the plant. f. “Dried marijuana” means the leaves and flowers of the marijuana plant after the wet harvested leaves and flowers of the marijuana plant have undergone the drying process and may be capable of combustion. (1) A batch of dried marijuana means marijuana that is cultivated utilizing the same growing practices, harvested within a 72-hour period at the same location and cured under uniform conditions. (2) A batch of dried marijuana shall not exceed 10 pounds for the purpose of sampling for required testing and shall not consist of more than one strain, cultivars, or genetic composition. g. “Wet marijuana” means the harvested leaves and flowers of the marijuana plant before they have reached a dry state. Pursuant to § 1.14 of this Part, marijuana that has been dried and shall be assumed to have yielded twenty percent (20%) of the weight of the wet marijuana. h. “Marijuana infused products” means product infused with medical marijuana or an extract of medical marijuana that is intended for use or consumption other than by smoking or vaping, including but not limited to ingestible and edible products. (1) “Medical edibles” or “Edible” means any product consumed orally that is not otherwise considered an ingestible and is approved for sale by DBR. (2) “Medical ingestible” or “Ingestible” means any topical, transdermal patch, tincture, capsule or other non-edible product approved for sale by DBR. i. “Concentrate,” synonymous with “extract,” is any type of medical marijuana product that is refined from usable marijuana into a more homogenized form of usable marijuana including but not limited to hash, supercritical CO2 oil, hash oil, shatter, budder, wax, infused butter, and rosin. 27. "Medical marijuana" means marijuana and marijuana products which satisfy the requirements of R.I. Gen. Laws Chapter 21-28.6 and have been given the designation of "medical marijuana" by DBR due to dose, potency, form or other characteristic. Medical marijuana products are only available for use by patient cardholders and may only be sold to or possessed by patient cardholders, or their registered caregiver, or authorized purchaser in accordance with the Act. Medical marijuana may not be sold to, possessed by, manufactured by, or used except as permitted under R.I. Gen. Laws Chapter 21-28.6 and any regulations promulgated thereunder. 28. "Medical marijuana emporium" means any establishment, facility or club, whether operated for-profit or nonprofit, or any commercial unit, at which the sale, distribution, transfer or use of medical marijuana or medical marijuana products is proposed and/or occurs to, by or among registered patients, registered caregivers, authorized purchaser cardholders or any other person. This shall not include a compassion center regulated and licensed by DBR pursuant to the terms of R.I. Gen. Laws Chapter 21-28.6. 29. “Marijuana establishment licensee” means any person or entity licensed by DBR or DOH under the Act whose license permits it to engage in or conduct activities in connection with the medical marijuana program. “Marijuana establishment licensees” shall include compassion centers, medical marijuana cultivators, and cannabis testing laboratories. 30. “Material financial interest or control” means: a. Any ownership interest, regardless of the size of the holding, and including any ownership interest through a subsidiary or affiliate; b. Trusteeship, mortgage, guarantor, endorser or surety relationship, or loan relationship, except that loan relationship for the purposes of this definition shall exclude accounts payable and accounts receivable on account of a medical marijuana purchase order; c. Any other beneficial financial interest as determined by DBR such that the holder bears the risk of loss (other than as an insurer) or has an opportunity to gain profit from the operation or sale of the regulated medical marijuana business; and/or d. Managerial or operational control, including but not limited to interlocking directors or officers or through a management agreement. 31. “Medical marijuana plant tag set” or “plant tag” or “plant tag certificate” means any tag, identifier or registration certificate or inventory tracking system authorized or issued by DBR or which DBR requires be used for the lawful possession and cultivation of medical marijuana plants in accordance with R.I. Gen. Laws Chapter 21-28.6. a. A “plant set” or “set” is defined as one (1) mature plant and one (1) immature plant. 32. “Medical marijuana program tracking system” means any system(s) designated by DBR and/or DOH designed and used to record and track all “seed to sale” activities and transactions which may include the use of unique identifiers. The Medical Marijuana Program Tracking System may also be used for registration, licensing, and tagging applications, renewals, change of information, and communications, as well as to record and/or report any other additional information directed by DBR and/or DOH. 33. "Medical use" means the acquisition, possession, cultivation, manufacture, use, delivery, transfer, or transportation of medical marijuana or paraphernalia relating to the consumption of marijuana to alleviate a patient cardholder's debilitating medical condition or symptoms associated with the medical condition in accordance with the provisions of R.I. Gen. Laws Chapter 21-28.6. 34. “Print media” means any publication made physically available. 35. “Process validation” means the collection and evaluation of data from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products. 36. "Qualifying patient" means a person who has been certified by a practitioner as having a debilitating medical condition and is a resident of Rhode Island. 37. “Quarantine” means the storage and/or identification of marijuana, marijuana product, medical marijuana or medical marijuana product, to prevent distribution or transfer of the product, in a physically separate area clearly identified for such use or through other procedures as defined by DBR. 38. "Radio" means a system for transmitting sound without visual images, and includes broadcast, cable, on-demand, satellite or internet programming. Radio includes any audio programming downloaded or streamed via the internet such as podcasts. 39. “Related party transactions” means and includes, but is not limited to, transactions between and/or among: a. An entity/applicant/licensee and its principal owners, management, key persons/interest holders and/or parent, affiliates, or members of “any person within his or her family,” as defined in 520-RICR-00-00-1.3 ; b. Parties with which the entity/applicant/licensee may deal if one party controls or can materially influence the management or operating policies of the other to an extent that one of the transacting parties might be prevented from fully pursuing its own separate interests; or c. Other parties that can materially influence the management or operating policies of the transacting parties or that have an ownership interest in one of the transacting parties and can materially influence the other to an extent that one or more of the transacting parties might be prevented from fully pursuing its own separate interests. 40. “Registry identification card” means a document issued by DOH or DBR, as applicable, that identifies a person as a registered qualifying patient, a registered primary caregiver, or authorized purchaser, or a document issued by DBR or DOH that identifies a person as a registered principal officer, board member, employee, volunteer, or agent of a compassion center, licensed medical marijuana cultivator, cannabis testing lab or any other marijuana establishment licensee. 41. “Seed to sale” means all medical marijuana program regulated activities and transactions from point of origin to the point of sale. Seed to sale activities and transactions include but are not limited to: all cultivation, harvest, processing, manufacturing, and packaging and labeling; all purchases, acquisitions or third party supply of marijuana; all sales and dispensing transactions; any other transfers of marijuana as permitted by the Act and any regulations promulgated thereunder; any instances of destruction of marijuana; and testing compliance tracking. 42. "Television" means a system for transmitting visual images and sound that are reproduced on screens, and includes broadcast, cable, on-demand, satellite, or internet programming. Television includes any video programming downloaded or streamed via the internet. 43. “Testing agent” means an employee of an approved cannabis testing laboratory or other entity who performs independent testing of medical marijuana and/or marijuana products in accordance with the DOH Testing Regulations. 44. "THCA” means tetrahydrocannabinolic acid, which is a cannabinoid found in the cannabis plant. 45. “THC” means delta-9-tetrahydrocannabinol, which is a psychoactive cannabinoid found in the cannabis plant. 46. “Total potential THC” means the potential amount of total THC found in a cannabis plant or product by using the equation Total Potential THC = (.877 x THCA%) + THC% or another equation or methodology approved by DBR and/or DOH. 47. “Volunteer” is a registration that only applies to compassion centers and shall be limited to compassion center persons whose volunteer activities and use of compassion center resources is strictly limited to participation in educational programming conducted for compassion center cardholders and registered qualifying patients, primary caregivers, and authorized purchasers. Volunteers shall not be permitted to be otherwise involved in the growth, cultivation, weighing, packaging or labeling, manufacturing, processing, dispensing or sale of medical marijuana. B. All other terms used herein shall have the same meanings as set forth in the Act, including particularly the definitions under R.I. Gen. Laws § 21-28.6-3, and as may be further defined within the Act, any DBR regulations under this Chapter and the DOH Regulations. 1.1.2 Limitations on Scope of the Rhode Island Medical Marijuana Program A. These DBR Regulations apply to all activities requiring authorization, registration and/or licensure under the Act to ensure the safe and regulated use of medical marijuana. See R.I. Gen. Laws § 21-28.6-3(22) (defining “medical use”) and R.I. Gen. Laws § 21-28.6-2(5) (legislative findings making distinction between medical and non-medical use). B. The protections and immunities for participation in the Rhode Island Medical Marijuana Program set forth in R.I. Gen. Laws §§ 21-28.6-4 (patient and caregivers), 21-28.6-12(h) (compassion centers), and 21-28.6-16(m) (cultivators) do not apply to any activities beyond the borders of the state of Rhode Island. 1.1.3 DBR’s Role in Administration of the Rhode Island Medical Marijuana Program DBR is responsible for the administrative functions required to implement the provisions of the Act and the DBR Regulations related to compassion centers, licensed cultivators, cooperative cultivations, registered caregivers and patients who grow their own medical marijuana plants including but not limited to licensing, operational requirements, and enforcement to ensure the state’s interest in public health and public safety. See R.I. Gen. Laws §§ 21-28.6-2 and 42-14-2. 1.1.4 DBR General Rulemaking Authority R.I. Gen. Laws § 42-14-17 provides that DBR may promulgate such rules and regulations as are necessary and proper to carry out the duties assigned to it by any provision of law. 1.1.5 Procedural Rules All hearings and enforcement actions shall be conducted in accordance with DBR’s Rules of Procedure for Administrative Hearings, Part 10-00-2 of this Title, and the Rhode Island Administrative Procedures Act, R.I. Gen. Laws Chapter 42-35. 1.1.6 Acceptance of Electronic Records and Signatures In accordance with the Uniform Electronic Transactions Act (UETA), R.I. Gen. Laws Chapter 42-127.1, DBR may determine whether, and the extent to which, it will accept electronic records, documents, notifications, and signatures from other persons or entities where the Act or DBR administered regulations refer to written records, documents, notifications, and signatures. 1.1.7 Incorporated Materials A. These regulations hereby adopt and incorporate 16 C.F.R. Part 1700 (2019) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations. B. These regulations hereby adopt and incorporate 21 C.F.R. Part 101 (2019) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations. C. These regulations hereby adopt and incorporate under 40 C.F.R. § 152.25(f) (2015) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations. D. These regulations hereby adopt and incorporate the EPA’s Active Ingredients Eligible for Minimum Risk Pesticide Products (December 2015) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations. E. These regulations hereby adopt and incorporate EPA’s Inert Ingredients Eligible for FIFRA 25(b) Pesticide Products (November 2016) by reference, not including any further editions or amendments thereof and only to the extent that the provisions therein are not inconsistent with these regulations. 1.2 Compassion Center Application, Licensing and Renewals A. R.I. Gen. Laws § 21-28.6-12(c) authorizes DBR to promulgate regulations regarding compassion center applications and licensure. B. Compassion Center Application Period and License Application Timeline 1. Applications for compassion centers may only be submitted to DBR for consideration during an open application period announced by DBR. Open application periods will only be announced upon the availability of a compassion center license such as may be due to an expansion in the limit of available licenses, the failure of a qualified applicant to be selected through the application process as described in § 1.2(E)(6) of this Part, or the failure of a selected applicant to satisfy licensing requirement(s) of the Act or the DBR Regulations, or the event of the revocation, relinquishment, or expiration without renewal of an existing compassion center license, as provided in R.I. Gen. Laws §§ 21-28.6-12(b)(7)(ii), 21-28.6-12(b)(8), and 21-28.6-12(d)(3). C. Application for Compassion Center License 1. Pursuant to R.I. Gen. Laws § 21-28.6-12(c)(3) and as reflected in the application materials, DBR shall evaluate the overall health needs of qualifying patients and safety of the public including analysis of patient enrollment and location data, patient caregiver data, the location of existing compassion centers, municipalities where compassion centers are permitted or prohibited under local zoning, comments submitted by the public, and input solicited from registered qualifying patients, registered primary caregivers, and municipalities to determine license areas or “application zones” where new compassion centers shall be licensed. The number of zones, the geographic boundaries of each zone, and the number of compassion centers permitted in each zone are set forth in § 1.15 of this Part and were determined by DBR after conducting this analysis and taking into consideration all public comments and input. 2. An applicant who applies for a compassion center license may only submit one application per zone. A person or entity cannot be an interest holder with respect to more than one applicant/application for a compassion center license per zone. An applicant may apply for a license in more than one zone provided, however, that if an applicant is selected for a license in more than one zone, the applicant must select a single zone in which the applicant will proceed with licensing in accordance with § 1.2(E) of this Part. Another applicant will then be selected for the zone or zones which were not selected. Applicants who apply in more than one zone must submit a separate application and separate application fee for each zone they apply to and indicate in each application all applications it has submitted and in which zones. 3. DBR will evaluate applications based upon the information provided by applicants on the application forms/submissions and otherwise obtained during the application process. 4. Each application for a compassion center shall be on such forms and through such submission mechanisms as designated by DBR and shall include, but not be limited to the following: a. A non-refundable application fee of $10,000. R.I. Gen. Laws § 21-28.6-12(c)(1)(i). b. The applicant’s legal and any d/b/a name(s), certificate of incorporation under R.I. Gen. Laws § 7-6-36 or certificate of authority under R.I. Gen. Laws § 7-6-70, copies of articles of incorporation and bylaws, and, if applicable, documentation of recognition as a tax-exempt organization by the US Internal Revenue Service. c. A business plan, including: (1) Applicant’s experience running a non-profit organization or other business, and applicant’s experience running a medical marijuana business, as applicable; (2) Detailed description of amount and source of equity, debt and operating capital for the proposed compassion center, including financial statements or other documentation establishing the source of any funds; (3) Start-up funding and long-term financial feasibility plan; (4) Detailed timeline for initiating operations; (5) Funds for capital improvements and operating needs; (6) Financial capability; (7) Financial oversight and compliance plan; (8) Services for hardship patients and charity care; (9) Three (3) year projected income statement; (10) Number and category description of FTEs (full time equivalents) and associated payroll expenses (with benefits) required for staffing; (11) Description of products and services; (12) Marketing, promotional and sales plan including pricing strategy; (13) Industry and market assessment and analysis; and (14) Segment and customer profile. d. A Security and Safety Plan, in accordance with R.I. Gen. Laws § 21-28.6-12(c)(1)(vi), which specifies how the applicant will ensure security and safety at the licensed premises, including but not limited to: (1) Description of security equipment, including hardware, software applications and compliance with industry standards and specifications; (2) Third-party vendors; (3) Standard operating procedures; (4) Cash management and/or electronic payment processing, as applicable; and (5) Confirmation of secured deposit banking account, or proposed plan to obtain such account prior to the beginning of licensed activities. e. An Operations Manual for the compassion center including policies, procedures and documents for the following: (1) Record keeping and records retention; (2) Education and training of employees and volunteers; (3) Job descriptions, employment contracts and volunteer agreements, if applicable; (4) Patient and personal data privacy; (5) Patient confidentiality, education, counseling and outreach; (6) Alcohol and drug free workplace; (7) Assuring steady supply for patients; (8) Labeling and packaging; (9) Advertising; (10) Voluntary and mandatory recalls of medical marijuana products, including recalls due to any action initiated at the request or order of DBR, and any voluntary action by a licensed cultivator or compassion center to remove defective or potentially defective medical marijuana from the market, as well as any action undertaken to promote public health and safety; (11) Ensuring any outdated, damaged, deteriorated, mislabeled, or contaminated medical marijuana is quarantined from other medical marijuana and destroyed; (12) Environmental impact overview and plan for operations; and (13) Process validation for all smokable and vapable products, as applicable. f. The proposed physical location of the compassion center by plat and lot number, street address and zoning district. This may also include one additional location proposed to be used for the secure cultivation of medical marijuana subject to § 1.6.4(A) of this Part. Regarding the proposed physical location(s), the applicant shall submit: (1) Evidence of compliance for the location(s) with the local zoning laws in the form of a certificate or letter from an authorized zoning official. (2) Evidence that the physical location is not located within one thousand feet (1,000’) of the property line of a preexisting public or private school in compliance with R.I. Gen. Laws § 21-28.6-12(f)(2). For the purposes of this paragraph, “private school” shall be deemed to refer to any nonpublic institution of elementary or secondary (K-12th Grade) education, accredited or recognized as a private school by the department of elementary and secondary education or the school committee of the city or town having jurisdiction over private schools. For purposes of this paragraph, the 1000-foot distance shall be measured from the secured compassion center premises, which shall include allotted outdoor areas (such as parking and loading areas), to the property line of the school, which shall include the school building, land, and appurtenances. (3) A draft diagram of the proposed facilities, including where within the facility the medical marijuana will be stored, processed, packaged, manufactured and dispensed, and where security alarms and cameras and surveillance recording storage will be located, patient access areas, limited access areas, patient parking capacity and access for persons with disabilities in accordance with applicable law, and showing the location of the facility relative to streets and other public areas. (4) A description of objective parameters (such as distances from streets and public areas) and/or proposed measures (such as black-out window shades) that ensure that marijuana at the premises shall not be visible from the street or other public areas. (5) Documents evidencing either ownership of property or lease agreement with owner of property to allow the operation of a compassion center on the property, if property has already been purchased or leased at the time of the application or a signed letter of intent for such a sale or lease. g. A certification regarding nonprofit compliance as required in DBR’s application form which includes the following certifications and information as to status and any existing and/or proposed: (1) Nonprofit status and operation; (2) Management companies, vendors and contracts; (3) Related party transactions; (4) Real estate and equipment transactions; (5) Compensation of officers, directors and employees; and (6) Revenue and profit-sharing arrangements. h. A disclosure and certification as to owners and other key persons/interest holders as required in DBR’s application form and including certifications, disclosures and information regarding: (1) All persons and entities with ownership interests; (2) All officers, directors, members, managers and agents; (3) All persons or entities with managing or operational control; (4) All investors or other persons or entities with any financial interest; (5) All persons or entities with interests arising under management companies or agreements or other agreements that afford third-party managerial or operational control; (6) If the compassion center premises and/or other operational assets will be owned or leased by a person or entity other than the applicant, the legal name and current address of such person or entity and a list of all persons or entities (legal names and current addresses) having any ownership or financial interest in such entity, whether direct or indirect; and (7) The legal names and current addresses of all creditors that will loan money to, finance and/or hold a security interest in the premises and/or other assets to be used in the compassion center operations, if any. i. If any key person/interest holder identified in § 1.2(C)(4)(h) of this Part has a material financial interest or control in another compassion center, cultivator, cooperative cultivation or other marijuana establishment licensee as determined by DBR, that key person/interest holder must disclose that interest in the application form and include a plan of divesture in accordance with § 1.2(F)(7) of this Part; provided that if it is a licensed cultivator that is pursuing licensure in accordance R.I. Gen. Laws § 21-28.6-12(b)(10), then disclosures must be made in accordance with that section of the Act. j. If a compassion center will have a management agreement in place, it shall also include a copy of the management agreement or management agreement proposal and a list of persons who have any ownership or financial interest in or operational or managerial control over the management company. k. An organization chart and schedule of compensation/remuneration as required by DBR’s application form. l. Evidence of appointment of a compliance officer for the compassion center and the compassion center’s legal and operational compliance plan. m. Licenses, disciplinary actions, denials of applications, including: (1) Disclosure and description of any applications, licenses or registrations made or held by the applicant and/or interest holders/key persons thereof in any state, municipality, county, province, district, country or territory’s cannabis or medical marijuana program. (2) A disclosure, description and copies of any withdrawals, denials, suspensions, revocations, consent orders/agreements and/or other enforcement or regulatory actions as to the applicant and/or interest holders/key persons thereof by any state, municipality, county, province, district, country or territory’s in connection with the matters disclosed in § 1.2(C)(4)(m)((1)) of this Part or any other licensed or unlicensed cannabis related activity. n. Tax Affidavit in accordance with R.I. Gen. Laws § 5-76-1 et seq . o. Other written materials which will allow DBR to determine the compassion center’s ability to comply with the review criteria contained in R.I. Gen. Laws § 21-28.6-12(c)(3). p. All other information required by DBR as described in the application form. 5. Only applications which DBR has determined to be complete (i.e., which satisfy all applicable application requirements including but not limited to those above) shall be eligible and accepted for further evaluation and review. Incomplete applications will be deficient and will not be considered further and the application fee will not be refunded. D. Compassion Center Application Review Criteria 1. The Department shall review complete applications and information otherwise obtained during the application process utilizing the criteria specified in R.I. Gen. Laws § 21-28.6-12(c)(3) of the Act and § 1.2 of this Part in order to determine whether an application is qualified. 2. If an applicant seeking a license to operate a compassion center is notified that its application has been deemed “qualified” by DBR, it shall be eligible for selection in accordance with § 1.2(E) of this Part. 3. In determining whether an applicant is “qualified,” DBR shall determine whether such information adequately demonstrates an ability of the applicant to satisfy licensing requirements and compliance with the Act and program regulations. E. Application Selection Process 1. Once DBR completes its review of all applications, DBR will notify all qualified applicants and publicly announce the date, time, and manner of randomly selecting qualified applicants for approval in each available zone. 2. DBR will publicly post the names of the qualified applicants for each zone. A random drawing to select the licensee(s) in each zone will be held in a manner that can be observed by the public. A duly authorized representative of all qualified applicants shall attend the random selection in person. The authorized representative of any qualified applicant which has applied for a license in multiple zones must be present and prepared at the time of the drawing to select and commit to a single zone if the applicant is selected for more than one zone. 3. DBR will select a qualified applicant for each available zone. After the qualified applicant(s) have been selected for each available zone, any applicant selected for multiple zones must accept a single zone and reject the other zones. After each applicant, if any, which has been selected for multiple zones accepts a single zone and rejects all others, another applicant will be drawn and selected for any rejected zone(s). This process shall continue until there is a separate and distinct qualified applicant selected for each available zone. Once a zone selection has been made, the decision is final and cannot thereafter be amended or altered. Any applicant selected for multiple zones who chooses which single zone they would like to be licensed in, may not thereafter alter that decision or change zones at any time. 4. The selected applicants shall not change or alter their proposed location to another location within the same zone without prior DBR approval. A selected applicant may not relocate or change the proposed location outside of the zone for which they were selected. 5. The selected applicants shall be deemed approved conditionally, subject to satisfaction of all requirements for final licensure. 6. If at the conclusion of the selection process there are any available zones which have not been awarded to, or selected by, a qualified applicant, and if there are no more qualified applicants for those zones to select from, DBR may reopen the application period and accept applications for any unawarded or unchosen zones and repeat the application, review, and selection processes in accordance with § 1.2 of this Part, and may do so without repeating or revising the analysis which was previously conducted under § 1.2(C)(1) of this Part. F. Prerequisites to Issuance of Compassion Center License and Commencement of Operations 1. Upon notification by DBR, the approved applicant must take reasonable and documented efforts to complete the prerequisites for issuance of the license. If satisfaction of all requirements for licensure takes longer than nine (9) months, the approved applicant must show good cause to DBR why additional time should be granted and the application approval should not be rescinded. 2. Once the license has been issued by DBR, the compassion center must take reasonable and documented efforts to launch compassion center activities, which for purposes of this paragraph shall mean actual acquisition and dispensing of medical marijuana pursuant to the Act. If commencement of such activities takes longer than three (3) months, the compassion center must show good cause to DBR why the license should not be revoked for non-use. 3. Any compassion center applicant selected for licensure in accordance with § 1.2(E) of this Part must satisfy the below requirements before a license authorizing operation of a compassion center will be issued: a. Annual Compassion Center Registration Fee: The annual license fee set by R.I. Gen. Laws § 21-28.6-12(c)(5)(ii) of five hundred thousand dollars ($500,000) must be paid. b. Final Information and Documentation to be Supplied - The applicant must provide any updates to previously submitted application information and the following additional items to DBR: (1) Unless already provided with the application, documents confirming ownership or executed lease agreement as to the compassion center premises. (2) Evidence of full compliance of the facility with the local zoning laws in the form of a certificate or letter from an authorized zoning official of the municipality and certification by an authorized officer of the applicant as to compliance with any other applicable local ordinances. (3) A current Certificate of Occupancy (or equivalent document) to demonstrate compliance with the relevant provisions of R.I. Gen. Laws Chapters 23-28.1 and 23-27.3 [Fire Safety Code and State Building Code, respectively] for each physical address to be utilized as a compassion center or for the secure cultivation of medical marijuana, if applicable. (4) Updated interest holder/key person disclosure and updated certification of nonprofit status and compliance pursuant § 1.2(C)(4) of this Part. (5) Evidence of completion of divestiture plan pursuant to § 1.2(F)(7) of this Part. (6) If there are any material deviations from the approved application, the applicant must submit a request for and obtain a variance from DBR. DBR may deny the variance in its sole and absolute discretion. (7) In the event the applicant holds a cultivation license that will merge into the compassion center license pursuant to R.I. Gen. Laws § 21-28.6-12(b)(10), the applicant shall provide to DBR a certificate from the Rhode Island Secretary of State as to articles of merger of the cultivator license holder entity into the applicant entity or certified articles of dissolution of the cultivator entity, and such other documents evidencing the merger and/or transfer of assets and operations as required by DBR. (8) Evidence that the applicant has acquired a seed to sale Medical Marijuana Program Tracking System and all necessary equipment and software to implement tracking. 4. Submission of proposed activities or functions in an application by an applicant who is selected for a license does not guarantee or authorize approval for that applicant to conduct all proposed activities or activities in the manner or method proposed. 5. In accordance with R.I. Gen. Laws § 21-28.6-12(f)(5): a. The applicant must schedule an on-site inspection of the compassion center with the RISP to inspect the facility’s security. b. The compassion center may be required to make any RISP or DBR recommended changes regarding the security or operations of the facility and its personnel prior to commencing licensed activities. c. Nothing herein shall limit DBR’s authority to require a licensee to implement additional security and safety recommendations from RISP or DBR in the future. 6. DBR Pre-License Inspection a. Before a compassion center license will be issued, a DBR inspection is required. Approved applicants should contact DBR to coordinate said inspection. Nothing in this paragraph should be construed as limiting inspections at an earlier time in addition to the final pre-license inspection. 7. Divestiture of Prohibited Material Financial Interest and Control a. A compassion center and interest holders/key persons thereof may not have any “material financial interest or control” in another Rhode Island compassion center, a cultivator, or a licensed cooperative cultivation or vice versa. R.I. Gen. Laws §§ 21-28.6-12(b)(1)(ii) and 21-28.6-12(d)(5)(v). b. R.I. Gen. Laws § 21-28.6-12(f)(10) authorizes regulations regarding testing of medical marijuana and marijuana product cultivated and/or manufactured by compassion centers, which will include ensuring the independence of cannabis testing laboratory. A compassion center may not have any material financial interest or control in a Rhode Island DOH-approved cannabis testing laboratory and vice versa. c. If a compassion center application is approved, and any prohibited material financial interest or control has been identified by DBR or is otherwise known to the compassion center applicant, such interest or control must be divested prior to issuance of the compassion center license and in any event no later than thirty (30) days following DBR’s notification of the requirement to divest. The plan of divestiture and documents evidencing completion of plan shall be filed with DBR. In the event an applicant or licensee failed to disclose a prohibited material financial interest, the applicant must demonstrate to DBR why the application should not be denied, or the license revoked for failure to disclose this prohibited interest. d. In addition to required disclosure in the application, the duty to disclose and divest prohibited material financial interests and control is a continuing obligation of the applicant and of licensure. 8. Registry Identification Card Requirements a. Before commencement of operations, all owners, members, officers, directors, managers, agents, employees, and volunteers of the compassion center must apply for a registry identification card. All persons required to apply for a compassion center registry identification card, except employees and volunteers, shall submit to a national criminal background check as provided in § 1.4 of this Part. Such individuals may be hired, appointed, or retained prior to receiving a registry identification card, but may not begin operations or work in medical marijuana cultivation, storage, processing, packaging, manufacturing, transport, dispensing or other medical marijuana activities requiring licensure pursuant to the Act until receipt of the card. G. DBR Post-License Inspection of Operations and Inventory 1. After the compassion center license is issued, the compassion center shall apply to DBR to source inventory in accordance with § 1.6.4(B) of this Part. 2. After the compassion center obtains inventory but prior to conducting retail sales, the compassion center shall schedule and pass an inspection with DBR. 3. DBR may conduct a post-licensure inspection upon commencement of operations, including but not limited to inspection for compliance of medical marijuana and marijuana product inventory with the tagging and tracking requirements set forth in §§ 1.6.1 and 1.6.2 of this Part. Nothing in this paragraph shall be construed to limit DBR’s general inspection powers as delineated in § 1.13(A) of this Part. 4. DBR shall have the right but not the obligation to notify a compassion center’s banking institution of any non-compliant activity, violations and/or enforcement action(s) taken by DBR. H. Prohibited Business Relationships with Medical Practitioners 1. R.I. Gen. Laws § 21-28.6-12(d)(5)(iv) prohibits compassion center license holders or any cardholders under the license from entering into a business relationship with any medical practitioner who provides written certifications of qualifying patients’ medical conditions in connection with Rhode Island’s Medical Marijuana Program. 2. Prohibited business relationships include but are not limited to: a. Employment; b. Fee splitting; c. Referral or similar fees; d. Cost sharing; e. Subsidies or reimbursement; and f. Any other similar business or financial relationships with a practitioner or any affiliated persons or entities who provide or otherwise facilitate patient certifications to Rhode Island residents, whether directly or indirectly, including through another medical marijuana program license. 3. Pursuant to § 1.13 of this Part, DBR may review and audit the books and records of licensees to ascertain compliance with the Act and Regulations. Any compassion center licensee which has or whose cardholders have prohibited business relationships in violation of the Act may be subject to enforcement proceedings including revocation of licensure by DBR. I. Variance Requests - Changes in Licensed Premises, Activities, Ownership and Control 1. A license authorizing operation of a compassion center shall not be assigned or otherwise transferred to other persons or locations. 2. The compassion center has a continuing obligation to update, amend and/or correct any information requested and/or submitted to DBR during the application process or following licensure. 3. The compassion center must seek pre-approval from DBR by means of requesting a variance for all material changes to the submitted and/or approved compassion center application or any materials, operations or plans approved thereafter by DBR. DBR may deny the variance if it determines that such variance will cause harm to public health and safety or cause the applicant to be in violation of the Act or any regulations promulgated thereunder, or otherwise would have caused the licensee to not have qualified for licensure originally. 4. A compassion center shall submit to DBR a written request for a variance for any proposed change described below at least sixty (60) calendar days prior to the proposed effective date of the change: a. Proposed change in ownership of the compassion center; b. Proposed change in the membership of a board of directors or board of trustees; c. Proposed change in corporate officer; d. Proposed merger, dissolution, entity conversion or amendment of corporate organization; e. Proposed entering into a management agreement, changing management companies, and/or material changes to an existing management agreement; f. Proposed changes to the approved premises or location; g. Proposed changes in the interest holder/key person disclosure and certification or certification of nonprofit compliance, including but not limited to investors and financiers, and anyone else required to be disclosed in those forms; h. Proposed changes to approved premises floor plan: (1) The compassion center must include in its variance request a renovation plan that specifically addresses quality control procedures for the protection of medical marijuana and medical marijuana products from any contamination during the construction process and further address any other criteria DBR requires; i. Proposed expansion/modification of the premises, including expanding or modifying the scope or scale of approved and/or licensed activity: (1) Any request to expand or modify the premises, scope or scale of approved and/or licensed activity further requires that the request to expand be justified by the projected needs of qualifying patients as determined by DBR. See R.I. Gen. Laws § 21-28.6-12(i)(1). j. Proposed changes to security and safety plans, operations manual and business plans; k. Change of status of applications, licensure or disciplinary or enforcement activity in other jurisdictions; and l. Any other changes requiring a variance as determined by DBR. 5. All variances must be approved by DBR, provided however that no variance which affects a majority change in ownership, control, financial interest and/or compensation/remuneration will be approved in the first year of licensed activities, except upon DBR’s determination that public health, safety or welfare requires such variance. 6. As to any proposed change of ownership or to a management agreement that will effect a change of majority control and/or decision-making authority with respect to the operation of the compassion center or as to any proposed change in an approved premises location for the cultivation and/or sale of medical marijuana, DBR may require the compassion center to submit a new application, which may include a new application fee and/or hearing. 7. Unless the compassion center provides timely notice of the above changes and receives a variance issued by DBR or a DBR waiver of the requirement of prior notice and issued variance, the license shall be void and returned to DBR. 8. Change in contact information: a. The compassion center shall notify DBR in writing within ten (10) days of any changes in the licensee’s mailing addresses, email addresses, phone numbers, or any other changes in contact information reported on the most recent initial/renewal application. Note that a change in business address/location is subject to the pre-approval variance requirements in § 1.2(I)(4) of this Part. J. Discontinuance of Business Operations 1. The license shall be void and returned to DBR if the compassion center discontinues its operation, unless the discontinuance is on a temporary basis and approved by DBR. K. Annual Renewal 1. Compassion center licenses shall be issued for one-year terms. 2. Annual renewals shall be submitted on such forms and include such information as required by DBR. 3. Pursuant to R.I. Gen. Laws § 21-28.6-12(d)(2), DBR’s review of compassion center renewal applications shall include consideration of whether the compassion center is adequately providing patients with access to medical marijuana at reasonable rates. 4. An annual inspection shall be part of the annual renewal process. 5. Renewal applications shall include an updated certification of nonprofit compliance and an interest holder/key person disclosure and certification as required by §§ 1.2(C)(4)(g) and (h) of this Part. 6. The renewal period is one year from the date of first issuance and will occur annually on that date unless and until the license is revoked or surrendered. The issuance of temporary licenses by DBR, pursuant to R.I. Gen. Laws § 21-28.6-12(d)(4), does not alter this renewal period or license term with respect to payment of the annual license fee. 1.3 Licensed Cultivator Application, Licensing and Renewals A. R.I. Gen. Laws § 21-28.6-16(b)(1) authorizes DBR to promulgate regulations regarding the form and content of licensing and renewal applications for licensed cultivators. B. Licensed Cultivator Application and License Timeline 1. R.I. Gen Laws § 21-28.6-16(o) prohibits DBR from reopening the application period to new applicants for a medical marijuana cultivator license. Should DBR be hereafter authorized to reopen the application period to new applicants, these regulations, including the application provisions, shall apply. DBR reserves the right to modify the application periods based on patient and program need and to limit the number and/or classes of new licenses available to new applicants based on the projected needs of the Rhode Island Medical Marijuana Program population. See R.I. Gen. Laws § 21-28.6-16 (location and possession restrictions, regulation of licensing and oversight requirements). C. Post-Approval Process and Timeline 1. Upon notification of approval of an application from DBR, the approved applicant must take reasonable and documented efforts to complete the prerequisites for issuance of the license pursuant to the steps detailed in § 1.3(F) of this Part. If such efforts take longer than nine (9) months, the approved applicant must show good cause to DBR why additional time should be granted and the application approval should not be rescinded. 2. Once the license has been issued, the licensed cultivator must take reasonable and documented efforts to launch licensed cultivator activities, which for purposes of this paragraph shall mean actual medical marijuana cultivation, processing, packaging, manufacturing, and/or other medical marijuana activities requiring a cultivator license pursuant to the Act. If such efforts take longer than six (6) months, the licensed cultivator must show good cause to DBR why the license should not be revoked for non-use. D. Classes of Cultivator Licenses 1. Cultivator licenses shall be divided into the following categories: License Class Size of Facility* Micro-license 0 – 2,500 sq. ft. Class A 0 – 5000 sq. ft. Class B 5,001 – 10,000 sq. ft. Class C 10,001 – 15,000 sq. ft. Class D 15,001 – 20,000 sq. ft. 2. For facilities over 20,000 sq. ft., please contact DBR prior to submitting the application. 3. Unless DBR issues notice otherwise permitting new license applications, only Micro-license, Class A, and Class B applications will be accepted. An applicant who is considering eventually applying to operate a larger facility may detail any such plan on the application. 4. Facility size shall be determined as a total of any area where marijuana will be cultivated, stored, processed, packaged, and/or manufactured. 5. An authorized officer of the applicant shall certify the square footage calculation. E. Application for Cultivator License 1. DBR will evaluate applicants based upon the information provided by applicants on the application forms/submissions and otherwise obtained during the application process. 2. Each application for a licensed cultivator shall be on such forms and through such submission mechanisms as designated by DBR. 3. All categories of cultivator applications shall be accompanied by a non-refundable application fee of five-thousand dollars ($5000). 4. Pursuant to R.I. Gen. Laws § 21-28.6-16(i), cultivators shall only be licensed at a single location registered with DBR and RISP, must abide by all local ordinances, including zoning ordinances, and may be subject to any additional location restrictions promulgated by DBR. With respect to local zoning, medical marijuana cultivation may fall within various zoning use categories including without limitation the following zoning use categories: agricultural uses (such as greenhouse and nursery), industrial uses (light and general), manufacturing and processing (such as factory) or specific medical marijuana related use categories. Whether medical marijuana cultivation is a permitted use, prohibited use or allowed by special use permit within these or any other use categories is determined by local zoning authorities. 5. The application shall contain the following minimum information: a. The applicant’s legal and any d/b/a name(s), certificate of incorporation or organization in Rhode Island or certificate of authority to transact business in Rhode Island, articles of incorporation or organization, bylaws or operating agreement and corporation organization chart. b. Regarding the proposed physical location, the application shall include: (1) The proposed physical location of the licensed cultivator (by plat and lot number, mailing address, etc.), if a precise location has been determined. If a precise physical location has not been determined, a description of the general location(s) where it may be sited, if approved, and the expected schedule for purchasing or leasing said location(s). (2) Approximate calculation of the square footage of the proposed facility. (3) Evidence of compliance for the location with local zoning laws in the form of a certificate or letter from an authorized zoning official. (4) Evidence that the physical location is not located within one thousand feet (1,000’) of the property line of a preexisting public or private school. For the purposes of this paragraph, “private school” shall be deemed to refer to any nonpublic institution of elementary or secondary (K-12th Grade) education, accredited or recognized as a private school by the department of elementary and secondary education or the school committee of the city or town having jurisdiction over private schools. For purposes of this paragraph, the 1000-foot distance shall be measured from the secured cultivator premises, which shall include allotted outdoor areas (such as parking and loading areas), to the property line of the school, which shall include the school building, land, and appurtenances. (5) A draft diagram of the proposed facility, including where within the facility the medical marijuana will be cultivated, stored, processed, packaged, and/or manufactured, and where security alarms and cameras and surveillance recording storage will be located, and showing the location of the facility relative to streets and other public areas. (6) A description of objective parameters (such as distances from streets and public areas) and/or proposed measures (such as black-out window shades) that ensure that marijuana at the premises shall not be visible from the street or other public areas. (7) Evidence of either ownership of property or agreement by owner of property to allow the operation of a licensed cultivator on the property, if property has already been purchased or leased at the time of the application. c. A business plan, including scope of activities, budget and resource narratives, and timeline for initiating operations. d. The legal name, current address, and date of birth of each officer and director or member/manager of the applicant. e. A list of all persons or business entities (legal names and current addresses) that currently have or are expected to have direct or indirect authority over the management or policies of the applicant. f. If the applicant proposes to have a management agreement in place, it shall also include a copy of the management agreement or management agreement proposal and a list of persons who have any ownership interest or operational control over the management company. g. A list of all persons or business entities (legal names and current addresses) having any ownership interest in the applicant entity, whether direct or indirect. h. If the cultivator premises and/or other operational assets will be owned or leased by a person or entity other than the applicant, the legal name and current address of any such person or entity and a list of all persons or entities (legal names and current addresses) having any ownership in such entity, whether direct or indirect. i. The legal names and current addresses of all creditors providing loans or financial and/or holding a security interest in the premises and/or other assets to be used in the cultivator operations, if any. j. Tax Affidavit in accordance with R.I. Gen. Laws § 5-76-1 et seq . k. Policies and procedures for handling voluntary and mandatory recalls of medical marijuana products including recalls due to any action initiated at the request or order of DBR, and any voluntary action by a licensed cultivator or compassion center to remove defective or potentially defective medical marijuana from the market, as well as any action undertaken to promote public health and safety. l. Policies and procedures for ensuring that any outdated, damaged, deteriorated, mislabeled, or contaminated medical marijuana is segregated from other medical marijuana and destroyed. m. Process validation for smokable and vapable products. n. Evidence of appointment of a compliance officer. o. All other information required by DBR as described in the application form, including for example experience and regulatory history of the applicant and its key personnel. 6. Only applications which DBR has determined to be complete (i.e., adequately addresses all application requirements above and contains complete responses to all mandatory questions) shall be eligible for review. F. Prerequisites to Issuance of Cultivator License and Commencement of Operations 1. If an applicant seeking to operate as a licensed cultivator is notified that its application has been approved by DBR, it shall complete the below steps before a cultivator license will be issued. 2. Annual Cultivator License Fees License Class Size of Facility* Annual License Fee Micro-license 0 – 2,500 sq. ft. $5,000 Class A 0 – 5000 sq. ft. $20,000 Class B 5,001 – 10,000 sq. ft. $35,000 Class C 10,001 – 15,000 sq. ft. $50,000 Class D 15,001 – 20,000 sq. ft. $80,000 3. Final Information and Documentation to be Supplied. The applicant must provide any updates to previously submitted application information and the following additional items to DBR: a. A sufficient description of the final physical location of the cultivator premises (by plat and lot number, mailing address, etc.). b. Evidence of complete compliance of the facility with the local zoning laws in the form of certificate or letter from an authorized zoning official of the municipality and certification by an authorized officer of the applicant as to compliance with any other applicable local ordinances. c. Unless already provided at time of initial application, evidence that the physical location for the cultivator premises is not located within one thousand feet (1,000’) of the property line of a preexisting public or private school. d. A current Certificate of Occupancy (or equivalent document) to demonstrate compliance of the cultivator facility with the relevant provisions of R.I. Gen. Laws Chapters 23-28.1 and 23-27.3 [Fire Safety Code and State Building Code, respectively]. e. Evidence of either ownership of property or agreement by owner of property to allow the operation of a licensed cultivator on the property. f. A final diagram of the facility, including where marijuana will be cultivated, stored, processed, packaged, and manufactured, and where security alarms and cameras and surveillance recording storage will be located. g. The legal name, current address, and date of birth of any person who will be an employee or agent of the cultivator at its inception. h. Evidence of completion of divestiture plan and other individual relinquishment requirements pursuant to § 1.3(F)(5) of this Part. 4. DBR Pre-License Inspection. Before a cultivator license will be issued, a DBR inspection is required. Approved applicants should contact DBR to coordinate said inspection. Nothing in this paragraph should be construed as limiting inspections at an earlier time in addition to the final pre-license inspection. The cultivator may be required to make any changes required by DBR regarding the security of the facility and its personnel prior to commencing licensed activities. 5. Divestiture of Prohibited Material Financial Interest and Control a. A licensed cultivator and key persons/interest holders thereof may not have any “material financial interest or control” in another Rhode Island licensed cultivator, a compassion center, or a licensed cooperative cultivation or vice versa. See R.I. Gen. Laws §§ 21-28.6-16(i) and 21-28.6-16(b)(2). b. R.I. Gen. Laws § 21-28.6-16(f) authorizes regulations regarding testing of medical marijuana and marijuana product cultivated and/or manufactured by licensed cultivators, which will include ensuring the independence of cannabis testing laboratory. Accordingly, a licensed cultivator may not have any material financial interest or control in a Rhode Island DOH-approved cannabis testing laboratory and vice versa. c. If a licensed cultivator application is approved and any prohibited material financial interest or control has been identified by DBR or is otherwise known to the licensed cultivator applicant, such interest or control must be divested prior to issuance of the cultivator license and in any event no later than thirty (30) days following DBR’s notification of the requirement to divest. The plan of divestiture and documents evidencing completion of plan shall be filed with DBR. In addition, the applicant must demonstrate to DBR why the application should not be denied, or the license revoked for failure to disclose this prohibited interest. d. If applicable, before issuance of the cultivator license, the cultivator applicant entity and its officers, directors or managers/members, and any other person with an ownership or controlling interest must relinquish any caregiver registrations or cooperative cultivation licenses held in order to comply with R.I. Gen. Laws § 21-28.6-16(a). e. The duty to divest prohibited material financial interests and control is a continuing obligation of the applicant and of licensure. G. DBR Post-Licensure Inspection of Operations, Inventory and Requirements 1. After the cultivator license is issued, the licensed cultivator shall notify DBR when it obtains inventory and commences operations. DBR may conduct a post-licensure inspection upon this commencement of operations, including but not limited to inspection for compliance of medical marijuana and marijuana product inventory with the tagging and tracking requirements set forth in §§ 1.6.1 and 1.6.2 of this Part. Nothing in this paragraph shall be construed to limit DBR’s general inspection powers as delineated in § 1.13 of this Part. 2. Any key person/interest holder of a licensed medical marijuana cultivator shall not be a registered primary caregiver cardholder for any qualifying patient(s) other than himself/herself and shall not hold a cooperative cultivation license. R.I. Gen. Laws § 21-28.6-16(a). H. Variance Requests - Changes in Licensed Premises, Activities, Ownership and Control 1. A cultivator license shall not be assigned or otherwise transferred to other persons or locations, unless pre-approved in accordance with the below paragraphs. 2. A licensed cultivator has a continuing obligation to update, amend and/or correct any information requested and/or submitted in the application process to DBR. 3. The licensed cultivator must seek pre-approval from DBR by means of requesting a variance for all material changes to the approved cultivator application or any materials or plans approved thereafter by DBR. DBR may deny the variance if it determines that such variance will cause harm to public health and safety or cause the applicant to be in violation of the Act or any regulations promulgated thereunder, or otherwise would have caused the licensee to not have qualified for licensure originally. 4. A licensed cultivator shall submit to DBR a written request for a variance for any proposed change described below at least sixty (60) calendar days prior to the proposed effective date of the change: a. A proposed change in ownership of the licensed cultivator; b. Proposed change in the membership of a board of directors, board of trustees, or managers/members; c. Proposed change in corporate officer; d. Proposed merger, dissolution, entity conversion or amendment of corporate organization; e. Proposed entering into a management agreement, changing management companies, and/or material changes to an existing management agreement; f. Proposed changes in the approved licensed cultivator premises; g. Proposed change to approved premises floor plan (1) The licensed cultivator must include in its variance request a renovation plan that specifically addresses quality control procedures for the protection of medical marijuana and medical marijuana products from any contamination during the construction process and further address any other criteria DBR requires. h. Proposed expansion/modification of the premises, including expanding or modifying the scope or scale of approved and/or licensed activity: (1) Any request to expand or modify the premises, scope or scale of approved and/or licensed activity further requires explanation by the cultivator that the request to expand is justified by the projected needs of qualifying patients as determined by DBR. See R.I. Gen. Laws § 21-28.6-16(d). (2) Additionally, any approved increase in the size of the facility that causes the facility to be reclassified based on the license fee structure set forth in § 1.3(F)(2) of this Part shall require payment of the difference between the paid fee and the fee applicable to the new classification of the facility. DBR, in its sole discretion, may prorate the fee increase or may offer a rebate for a size decrease. i. Or any other changes requiring a variance as determined by DBR. 5. All variances must be pre-approved by DBR. Unless the licensed cultivator provides timely notification of the above changes and receives a variance issued by DBR or a waiver of the requirement of prior notice and issued variance, the license shall be void and returned to DBR. 6. As to any proposed change of ownership or to a management agreement that will effect a change of majority control and/or decision-making authority with respect to the operation of the licensed cultivator or as to any proposed change in an approved licensed cultivator premises location, DBR may require the licensed cultivator to follow the process for a new application, which may include a new application fee. 7. Change in contact information: a. The licensed cultivator shall notify DBR in writing within ten (10) days of any changes in the licensee’s mailing addresses, email addresses, phone numbers, or any other changes in contact information reported on the most recent initial/renewal application. Note that a change in business address/location is subject to the pre-approval variance requirements in § 1.3(H) of this Part. I. Discontinuance of Business Operations 1. The license shall be void and returned to DBR if the cultivator discontinues its operation, unless the discontinuance is on a temporary basis and approved by DBR. J. Annual Renewal 1. Cultivator licenses shall be issued for one-year terms. 2. Annual renewals shall be submitted on such forms and include such information as prescribed by DBR. 3. An annual inspection shall be part of the annual renewal process. 4. A licensed cultivator must submit to DBR an annual license fee. The annual license fee shall be determined by the below table and must be paid in full before a license will be issued or renewed. License Class Size of Facility* Annual License Fee Micro-license 0 – 2,500 sq. ft. $5,000 Class A 0 – 5000 sq. ft. $20,000 Class B 5,001 – 10,000 sq. ft. $35,000 Class C 10,001 – 15,000 sq. ft. $50,000 Class D 15,001 – 20,000 sq. ft. $80,000 5. A licensed cultivator may renew an existing Medical Marijuana Cultivator license at a lower class for the ensuing license year. a. The licensed cultivator must seek pre-approval from DBR by means of requesting a variance. The written request shall include a certified floor plan and a submission of any other required information to DBR in a form designated by DBR along with a completed renewal application. Upon approval, the license shall become fixed at the lower class and not be subject to change without DBR approval. b. Renewal at a lower license class will include payment of the annual license fee applicable to such lower class. 1.4 Registry Identification Cards A. Eligibility 1. Pursuant to R.I. Gen. Laws §§ 21-28.6-12(c)(6), 21-28.6-16(b) and 21-28.6-6(g), all principal officers, board members, employees, agents, and volunteers of a compassion center or licensed cultivator, and all primary caregivers shall apply for registry identification cards. 2. Cardholders shall be at least twenty-one (21) years old. B. Application Requirements 1. Every applicant for a registry identification card shall submit: a. A complete application on such forms and through such submission mechanisms as directed by DBR; and b. The non-returnable, non-refundable annual fee of one hundred dollars ($100.00) for each initial application and subsequent annual renewal. R.I. Gen. Laws §§ 21-28.6-5(c), 21-28.6-12(c)(6) and 21-28.6-16(b) and (l). c. Fees may be waived in certain circumstances for primary caregiver applicants in accordance with § 1.4(B)(5) of this Part. 2. DBR shall verify the information contained in the application or renewal and shall approve or deny an application or renewal within thirty-five (35) days of receiving a complete application. 3. If DBR fails to respond by issuing a valid registry identification card in response to a valid and complete application submitted pursuant to the Act or these Regulations within thirty-five (35) days of its submission, provided that the application was not denied, the registry identification card shall be deemed granted and a copy of the registry identification application shall be deemed a valid registry identification card. R.I. Gen. Laws § 21-28.6-9(b). 4. DBR may deny an application or renewal if: a. The applicant did not provide the information required pursuant to the Act; b. DBR determines that the information provided was falsified; c. The applicant or designating patient has violated the Act or the DBR Regulations under his or her previous registration; d. The applicant or designating patient has otherwise failed to satisfy the application or renewal requirements; e. The designating patient has elected to grow medical marijuana for themselves and/or has obtained medical marijuana grow tags under their patient registration, or is otherwise growing their own marijuana; or f. The designating patient, caregiver applicant, or caregiver cardholder previously failed to satisfy program requirements set forth in R.I. Gen. Laws § 21-28.6-15(a)(5). 5. Primary Caregiver Applicants Only a. The application fee may be waived if the primary caregiver submits satisfactory evidence with the application that they or their qualifying patient(s) are a recipient of Medicaid, Supplemental Security Income (SSI), Social Security Disability Insurance (SSDI), Veteran Disability, or Railroad Disability. b. Applications from eligible primary caregivers appointed by patients who are currently receiving chemotherapy or have been admitted to hospice will be expedited and their applications, if deemed complete, will be issued within seventy-two (72) hours of receipt and the application fee will be waived. c. Patients and caregivers that qualify for any free or reduced registry fees are still subject to required processing fees for the issuance of registry identification cards. C. Criminal Background Checks 1. All compassion center and licensed cultivator owners, members, officers, directors, managers, agents, and primary caregiver applicants will be subject to a national criminal background check as part of their application for a registry identification card. R.I. Gen. Laws §§ 21-28.6-6(g)(1), 21-28.6-12(c)(7) and 21-28.6-16(k). 2. DBR shall deny an application for a registry identification card if the background check reveals the applicant has been convicted of a felony drug offense or has entered a plea of nolo contendere for a felony drug offense and received a sentence of probation, unless the applicant successfully petitions for an exception pursuant to § 1.4(C)(8) of this Part. R.I. Gen. Laws §§ 21-28.6-12(c)(7), 21-28.6-9(c) and 21-28.6-16(k)(2). 3. Applicants shall apply to RISP, the Attorney General's Office or Local Law Enforcement for a national criminal identification records check that shall include fingerprints submitted to the Federal Bureau of Investigation. R.I. Gen. Laws §§ 21-28.6-6(g)(1), 21-28.6-12(c)(7)(i) and 21-28.6-16(k). 4. Upon the discovery of a felony drug offense conviction or a plea of nolo contendere for a felony drug offense with a sentence of probation, RISP, the Attorney General's Office or Local Law Enforcement shall inform the applicant, in writing, of the nature of the felony. R.I. Gen. Laws §§ 21-28.6-6(g)(1), 21-28.6-12(c)(7)(i) and 21-28.6-16(k) and (k)(2). 5. Upon discovery of disqualifying information, RISP, the Attorney General's Office or Local Law Enforcement shall notify DBR, in writing, without disclosing the nature of the felony, that a felony drug offense conviction or a plea of nolo contendere for a felony drug offense with probation has been found. R.I. Gen. Laws §§ 21-28.6-6(g)(1), 21-28.6-12(c)(7)(i) and 21-28.6-16(k) and (k)(2). 6. In those situations in which no felony drug offense conviction or plea of nolo contendere for a felony drug offense with probation has been found, RISP, the Attorney General's Office or Local Law Enforcement shall inform the applicant and DBR, in writing, of this fact. R.I. Gen. Laws §§ 21-28.6-6(g)(2), 21-28.6-12(c)(7)(ii) and 21-28.6-16(k)(1). 7. Applicants shall be responsible for any expense associated with the national criminal background check with fingerprints. R.I. Gen. Laws §§ 21-28.6-12(c)(7)(iii), 21-28.6-6(g)(6) and 21-28.6-16(k)(3). 8. DBR, in its discretion, may grant a registry identification card if the disqualifying offense was for conduct that occurred prior to the enactment of the Act or that was prosecuted by an authority other than the state of Rhode Island and for which the Act would otherwise have prevented a conviction, or in accordance with R.I. Gen. Laws § 21-28.6-6(g)(5). a. To seek relief from a criminal background disqualification pursuant to R.I. Gen. Laws § 21-28.6-6(g)(5), the applicant must make the request for relief to the DBR in writing on any applicable forms. b. To seek relief from criminal background disqualification pursuant to R.I. Gen. Laws § 21-28.6-12(c)(7), the applicant must make the request for relief to the DBR in writing, setting forth in detail why the Act would have prevented a conviction, including all applicable court records and legal documents. c. DBR may conduct a hearing on the issue and, if so, the applicant shall bear the burden of proof to show why the relief should be granted. 9. The compassion center, licensed cultivator or primary caregiver will be notified in writing of the purpose for denying a cardholder application. R.I. Gen. Laws §§ 21-28.6-6(g), 21-28.6-12(c)(7) and 21-28.6-16(k). a. In the case of key person/interest holder applicants, DBR shall limit its disclosure of the purpose to a statement of the fact that disqualifying information was found, without revealing to the compassion center or licensed cultivator any further detail of the offense. 10. DBR will not require a person subject to a national criminal background check under this subsection to undergo such a check more than once every two (2) years, unless a more frequent time frame is mandated and/or agreed to as part of an enforcement action, or unless DBR has been notified of disqualifying conviction/plea. D. Issuance of the Registry Identification Card 1. Once the application is approved by DBR, the owners, members, officers, directors, managers, agents, employees, and volunteers of the compassion center or cultivator, or primary caregiver is responsible for getting a registry identification card from DBR. 2. The registry identification card shall contain: a. For compassion center and licensed cultivator cardholders (R.I. Gen. Laws § 21-28.6-12(c)(6)): (1) The name, address and date of birth of the person; (2) The legal name of the compassion center or cultivator that the individual is affiliated with; (3) The category of the person’s affiliation: principal officer, board member, employee, agent, or volunteer; (4) The date of issuance and expiration date of the registry identification card; (5) A random registry identification number; and (6) A photograph. b. For registered primary caregivers (R.I. Gen. Laws § 21-28.6-6(h)): (1) The name of the person applying as a primary caregiver; (2) The date of issuance and expiration date of the registry identification card; (3) A random registry identification number; (4) A photograph; and (5) Any additional information as required by DBR. 3. Registry identification cards shall not be transferable to another cardholder. E. Expiration and Renewal of the Registry Identification Cards 1. Registry identification cards shall expire one year after issuance. 2. Renewal applications shall be on such forms and through such submission mechanisms as directed by DBR. R.I. Gen. Laws §§ 21-28.5(c), 21-28.6-12(c)(8), and 21-28.6-16(b). 3. Renewal applications must be received by DBR prior to the expiration of the registry identification card. 4. Any renewal of a registry identification card shall be subject to the same provisions and requirements covering issuance and denial of any card as originally issued. F. Required Updates to DBR 1. Name and Address: A cardholder shall notify DBR of any change in his or her name, email or mailing address within ten (10) business days of such change. R.I. Gen. Laws §§ 21-28.6-6(i)(3) and (4), 21-28.6-12(c)(9) and (10), and 21-28.6-16(l)(1) and (2). a. Changes in name and/or address require the cardholder to remit a ten-dollar ($10.00) fee to DBR. b. Upon receipt of the notice and fee, DBR will issue an updated registry identification card. c. A cardholder who fails to notify DBR of any of these changes may be subject to a fine up to one hundred fifty dollars ($150). 2. Lost/Stolen Cards: If a cardholder loses his or her registry identification card (most importantly if a card is suspected to be stolen), the cardholder shall notify DBR and submit a ten-dollar ($10.00) fee within ten (10) business days of losing the registry identification card. a. Upon receipt of the notice and fee, DBR will issue a replacement registry identification card within five (5) days with a new random identification number. R.I. Gen. Laws §§ 21-28.6-6(h)(6), 21-28.6-12(c)(11) and 21-28.6-16(l)(3). 3. Primary Caregiver Cardholders only: a. A primary caregiver cardholder must notify DBR of any change in the cardholder's status of appointing patient, or if their appointing patient ceases to have his or her debilitating medical condition, within ten (10) days of such change. b. Upon receipt of notice from a primary caregiver cardholder of any changes related to the appointing patient and a ten-dollar ($10.00) fee, DBR will issue a new registry identification card. c. If a patient cardholder has ceased to suffer from a debilitating medical condition, their appointed caregiver’s card and registration shall be deemed null and void and the former caregiver shall be subject to any penalties that may apply to the person's non-medical production, manufacture, distribution, or use of marijuana. 4. In all circumstances requiring issuance of a new registry identification card, the cardholder shall be responsible for getting the updated registry identification card from DBR. G. Duty to Notify DBR of Disqualifying Criminal Information 1. A cardholder shall notify DBR of any disqualifying criminal convictions as defined in R.I. Gen. Laws §§ 21-28.6-6(g), 21-28.6-12(c)(7) and 21-28.6-16(k)(2). Such notification must be made in writing within ten (10) business days. H. Termination of a Registry Identification Card 1. Pursuant to R.I. Gen. Laws § 21-28.6-12(i), a person found to have dispensed marijuana to a non-cardholder or in excess of the statutory limits is not eligible to be a compassion center cardholder, and such person's registry identification card shall be immediately revoked. 2. If a cardholder violates any other provisions of the Act, DBR Regulations, or DOH Regulations, his or her registry identification card may be suspended/revoked as determined by DBR pursuant to § 1.13 of this Part and R.I. Gen. Laws §§ 21-28.6-6(g) and (i)(8), 21-28.6-12(c)(14) and 21-28.6-16(l)(5). 3. Compassion Center and Cultivator Cardholders a. When a cardholder ceases work with a compassion center or licensed cultivator, whether voluntarily, involuntarily or upon the compassion center or licensed cultivator closing, his or her registry identification card shall be null and void. In that situation, the compassion center or licensed cultivator and/or the cardholder shall notify DBR and the registry identification card shall be returned to DBR within ten (10) days. No hearing shall be necessary to render the card null and void in this situation. In addition to being null and void, a penalty of up to one hundred and fifty dollars ($150) may be assessed for failure to return the card within the ten (10) day period. R.I. Gen. Laws §§ 21-28.6-6(i)(3) (caregivers), 21-28.6-12(c)(9) and (f)(3) (compassion centers) and 21-28.6-16(l) (cultivators). 4. Primary Caregiver Cardholders a. When a qualifying patient cardholder changes his or her primary caregiver or authorized purchaser, DBR shall notify the primary caregiver cardholder within ten (10) days. The primary caregiver cardholder's protections as provided in the Act as to that patient shall expire ten (10) days after notification by DBR. If the primary caregiver cardholder is connected to no other qualifying patient cardholders in the program, he or she must return his or her registry identification card to the DBR. R.I. Gen. Laws § 21-28.6-6(i)(5). 1.5 Product Packaging and Labeling Requirements for Retail- Ready Medical Marijuana Products 1.5.1 Authority and Applicability A. These retail-ready medical marijuana product packaging and labeling requirements for compassion centers and licensed cultivators are promulgated pursuant to R.I. Gen. Laws §§ 21-28.6-12(f)(11) and 21-28.6-16(g). B. Compassion centers and licensed cultivators shall have ninety (90) calendar days from the effective date of these regulations to comply with these requirements. C. The compassion center is responsible for ensuring all medical marijuana products are retail-ready prior to sale to a qualifying patient, registered primary caregiver or authorized purchaser. 1.5.2 General Packaging Requirements A. All retail-ready medical marijuana products must be in compliant packaging upon entering the compassion center retail sale space. B. In addition to any other requirements pursuant to § 1.5 of this Part, any package containing retail-ready medical marijuana product must: 1. Be opaque, of a neutral color, and light resistant; a. Neutral colors include but are not limited to: black, white, gray, beige, brown, and tan. Neutral colors do not include primary and secondary colors (such as red, orange, yellow, green, blue, or purple) or any variant of primary or secondary colors. 2. Fully enclose the product; 3. Protect the product from contamination; 4. Not impart any toxic or deleterious substance to the medical marijuana product; 5. Be Child Resistant as defined in § 1.1 of this Part; and 6. Be able to be resealed in a Child Resistant manner unless the package contains a single-serving medical marijuana edible or ingestible pursuant to § 1.5.2(D) and (E) of this Part respectively. C. Exit Package 1. Except for medical marijuana edibles and ingestibles, upon DBR approval, any other retail-ready medical marijuana product placed into a container that is not child-resistant shall be placed into a child-resistant Exit Package at the point of sale. 2. The Exit Package is not required to be labeled pursuant to § 1.5 of this Part if the package(s) within the Exit Package containing the retail-ready medical marijuana product comply with all labeling requirements pursuant to § 1.5 of this Part. D. Additional Packaging Requirements for Retail-Ready Medical Marijuana Edibles 1. A single serving unit shall not exceed ten (10) milligrams (“mgs”) of active THC. 2. A single serving unit, if sold individually, shall be placed into a child-resistant container that may or may not be resealable. 3. Multiple single serving units may be placed together into a single child resistant and resealable package, so long as the active THC per package does not exceed one hundred (100) mgs. 4. Multiple packages may be bundled and sold together so long as the: a. Total amount of THC per serving unit does not exceed ten (10) mgs; b. Total amount of THC per package does not exceed one hundred (100) mgs; and c. Total amount of THC per bundled package does not exceed the maximum amount a patient can possess pursuant to the Act and the equivalency table in § 1.14 of this Part. 5. For Medical Marijuana Edibles in liquid form packaged as a single serving unit, the container may be sealed using a metal crown cork style bottle cap. 6. For Medical Marijuana Edibles in liquid form containing multiple serving units, the container must have a resealing cap or closure which maintains child resistance compliance. 7. Medical Marijuana Edibles in liquid form containing multiple serving units must include a measuring device such as a measuring cap, cup or dropper with the package containing the medical marijuana product. Hash marks on the package do not qualify as a measuring device. E. Additional Packaging Requirements for Medical Marijuana Ingestibles 1. A single serving unit, if sold individually, of a Medical Marijuana Ingestible must be placed into a child-resistant container that may or may not be resealable. 2. Multiple single serving units may be placed together into a single child resistant and resealable package. 3. Multiple packages may be bundled and sold together so long as the total amount of THC per bundled package does not exceed the maximum amount a patient can possess pursuant to the Act and the equivalency table in § 1.14 of this Part. 4. For Medical Marijuana Ingestibles in liquid form packaged as a single serving unit, the container may be sealed using a metal crown cork style bottle cap. 5. For Medical Marijuana Ingestibles in liquid form with multiple serving units, the container must have a resealing cap or closure. 6. Medical Marijuana Ingestibles in liquid form with multiple serving units must include within the package: a. A measuring device such as a measuring cap, cup or dropper that is capable of dispensing a ten (10) mg serving unit; b. Hash marks on the package do not qualify as a measuring device. F. Additional Packaging Requirements for Retail-Ready Medical Concentrates 1 Cartridges and any other devices, as determined by DBR, shall receive a consumer testing certificate which is subject to DBR review. 2. Electronic vaporization devices must have internal or external temperature controls to prevent combustion and have a heating element made of inert material. 3. The total THC per package shall not exceed 500 mgs. 1.5.3 General Labeling Requirements A. Each package containing retail-ready medical marijuana products must be labeled with all required information pursuant to § 1.5 of this Part before being sold to a registered patient, registered primary caregiver or authorized purchaser. B. Labeling text must be: 1. No smaller than size 6 font, unless otherwise specified. 2. In Times New Roman, Calibri, Arial, Helvetica or any other font determined by DBR to be easily read. 3. In black or white, unless otherwise specified. 4. Clearly written or printed in the English language. a. In addition to the required English label, licensees may include an additional, accurate foreign language translation on the label that otherwise complies with these rules. C. All required information must be unobstructed and conspicuous. Multiple labels may be affixed to the package, provided that none of the information required is obstructed. D. Required information may be stated in a peel-back accordion, expandable, or extendable style so long as the label can be easily identified by a consumer as containing important information. E. All packages containing retail-ready medical marijuana products must be clearly labeled with the following information: 1. The business(es) or tradename(s) and license number(s) of the licensee(s) who produced the product; 2. The business or tradename and license number of the compassion center selling the product; 3. The unique identifier generated by the Medical Marijuana Program Tracking System; 4. Total THC and Total CBD as provided by a licensed cannabis testing laboratory; a. Upon request, a compassion center must disclose the name of the licensed cannabis testing lab that conducted the tests and provide the results of all required tests for any medical marijuana or medical marijuana product. 5. A DBR-selected universal warning symbol must appear on the front or most predominantly displayed area of the package, no smaller than one (1) inch by one (1) inch; a. Vape cartridges sold containing medical marijuana product must include the DBR-approved symbol in a manner that is clear and conspicuous; 6. If applicable, the recommended expiration date, or “use by” date; 7. Poison Control Contact Information “American Association of Poison Control Center (800) 222-1222”; and 8. For smokable and vapable products, the net weight of the medical marijuana product prior to its placement in the package, using a standard of measure compatible with the tracking system. F. Additional Labeling Requirements for Retail-Ready Medical Marijuana Infused Products: 1. Total contents of THC and CBD must be stated per serving unit in milligrams (mgs), and in font larger than size 6, bolded, underlined and in red, so as to stand from surrounding text to the consumer; 2. Total contents of THC and CBD must be stated per package, in milligrams (mgs), in font larger than size 6, bolded, underlined and in red, so as to stand out from surrounding text to the consumer; 3. The serving size; and 4. The number of servings per package. G. The following information may be placed on an insert but must accompany each retail-ready medical marijuana product sold: 1. A complete list of all nonorganic pesticides, herbicides, and fertilizers that were used in the cultivation and production of the medical marijuana product; 2. For medical marijuana infused products, the net weight of the medical marijuana or medical marijuana product prior to its placement in a package, using a standard of measure compatible with the tracking system; 3. For medical marijuana products consisting in whole or in part of marijuana flower or marijuana trim, the date of the harvest batch; 4. For marijuana products including concentrates and marijuana infused products that were manufactured, the date on which the manufacturing batch was created; 5. For processed medical marijuana products, the processing technique or solvent(s) used to produce the product; 6. For processed medical marijuana products, a list of all chemicals, diluents, additives, ingredients and/or excipients used to produce the medical marijuana product or that were added to the medical marijuana product; 7. For medical marijuana infused products, a list of all ingredients used to manufacture the marijuana infused product, including identification of any major allergens contained in the product in accordance with the Food Allergen Labeling and Consumer Protection Act of 2004, 21 U.S.C. § 343 (2010), specifically milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat and soybeans; 8. For medical marijuana edibles and ingestibles, a nutritional fact panel in accordance with 21 C.F.R. Part 101, incorporated above at § 1.1.7(B) of this Part; 9. For medical marijuana topicals, a list of all ingredients in descending order of predominance by weight or volume as applicable; and 10. For medical marijuana topicals, the amount recommended for use at any one time. 1.5.4 Imprinting of the Universal Symbol A. As directed by DBR, unless deemed impracticable by DBR, each single standardized serving unit of a medical marijuana infused product shall be marked, stamped or otherwise imprinted with a DBR-selected universal symbol directly on at least one side of the medical marijuana infused product in a manner to cause the universal symbol to be distinguishable and easily recognizable. The universal symbol marking shall: 1. Be centered either horizontally or vertically on each standardized serving of marijuana; and 2. If only imprinted on one-side, the imprinted side must be the front or most predominantly displayed area of medical marijuana infused product; and 3. If centered horizontally on a serving, the height and width of the universal symbol shall be of a size that is at least 25% of the serving’s width, but not less than ¼ inch by ¼ inch; or 4. If centered vertically on a serving, the height and width of the universal symbol shall be of a size that is at least twenty-five percent (25%) of the serving’s height, but not less than ¼ inch by ¼ inch. B. Unless determined by DBR to be impractical, the following categories of marijuana infused product are considered to be per se practicable to mark with the universal symbol: 1. Chocolate; 2. Soft confections; 3. Hard confections or lozenges; 4. Consolidated baked goods (e.g. cookie, brownie, cupcake, granola bar); and 5. Pressed pills and capsules. 1.5.5 Prohibitions A. Medical marijuana products shall not: 1. Be in the shape of a human, animal, fruit, cartoon character, or any other shape that is especially attractive to children as determined by DBR; 2. Imitate or have a resemblance to any existing branded consumer products, including foods and beverages that do not contain marijuana; 3. Be in the shape of a marijuana plant or leaf; and 4. Cause a reasonable consumer confusion as to whether the medical marijuana product is a trademarked product. B. All logos or graphics are prohibited unless prior to use are approved by DBR. 1. The logo or graphic submitted to DBR for approval: a. Must not be larger than the required universal symbol; b. Can be colored; and c. Must only be used for the purpose of identifying the compassion center selling and/or the cultivator(s) producing the product. 2. The logo or graphic submitted to DBR for approval must not: a. Reasonably appear to target individuals under the age of twenty-one (21), including but not limited to, the use of animal characters, toys, cartoon characters or similar images. b. Imitate or have a resemblance to any existing branded consumer products, including foods and beverages that do not contain marijuana. c. Include images of children or minors. d. Include images of a marijuana plant, marijuana leaf or marijuana product or any person using or consuming the product. e. Include words, a design or brand that resembles a product that is commonly associated with children or minors or marketed to children or minors. f. Include symbols or celebrities that are commonly used to market products to minors. g. Include the word or make any reference to “candy” or “candies”. h. Include any false or misleading statements, including any statements regarding health or physical benefits to the consumer. i. Include any seal, flag, crest, coat of arms, or other insignia that could reasonably mislead any reasonably prudent person to believe that the product has been endorsed or manufactured by the State of Rhode Island or any agency or municipality thereof. j. Cause a reasonable consumer confusion as to whether the medical marijuana or medical marijuana product is a trademarked product. k. Violate any state or federal trademark law or regulation. 1.5.6 Warnings A. Warnings on all retail-ready medical marijuana products must: 1. Be in the English language; 2. Be in Times New Roman, Calibri, Arial, Helvetica or any other font that can be easily read; 3. Be in text no smaller than size 8 font and bolded; 4. Not be covered or obscured; and 5. Be displayed in a bright yellow box as to stand out from other labeling requirements, unless otherwise stated. B. The following warnings must be displayed on all medical marijuana products, when applicable; 1. “Warning: For Medical use ONLY. This product contains marijuana. Store in a securely locked cabinet away from children.” 2. “Warning: It is unlawful to transport this product outside of Rhode Island.” 3. “Warning: For medical use by a registered patient only. Not for resale.” 4. For medical marijuana products intended to be smoked or vaporized: a. “Warning: Smoking and Vaping is hazardous to your health.” b. “Warning; Vaping can expose you to toxic chemicals that may lead to death”. 5. For all medical marijuana infused products, it must state in slightly larger or bolded font as to stand out from surrounding text, with priority placement, a. “Effects of this product may be delayed by 3 or more hours.” 6. For all topical products, it must state: a. “For Topical Application – Do Not Eat or Smoke.” C. In addition to the warnings above, rotating warnings must accompany all retail-ready medical marijuana products at the point of sale. D. Rotating warnings shall: 1. Be in the English language; 2. Be in Times New Roman, Calibri, Arial, Helvetica or any other font that can be easily read; 3. Be in text no smaller than size 10 font and bolded; and 4. Not cover or obscure any required information pursuant to § 1.5 of this Part. 5. Accompany all retail-ready medical marijuana products at the point of sale based on a rotating schedule as determined by DBR. E. The rotating warnings are: 1. “Warning: Marijuana has intoxicating effects and may be habit forming and addictive.” 2. “Warning: Do not operate a vehicle or machinery under the influence of marijuana.” 3. “Warning: Marijuana should not be used by women that are pregnant or breastfeeding.” 4. “Warning: Early and frequent cannabis use has been associated with the onset of psychosis.” F. Compassion Centers shall post any additional warnings at the point of sale as determined by DBR. 1.6 Operational Requirements for Marijuana Establishment Licensees R.I. Gen. Laws §§ 21-28.6-12(b)(1)(ii)-(iv) and 21-28.6-16(b)(2)-(4) authorize DBR to promulgate regulations regarding minimum oversight requirements, minimum record-keeping requirements and minimum security requirements for compassion centers and licensed cultivators. The operational requirements set forth in this section are promulgated in accordance with that statutory duty of general regulatory supervision over licensed compassion centers and licensed cultivators and in accordance with other provisions of the Act. R.I. Gen. Laws §§ 21-28.6-12 and 21-28.6-16. 1.6.1 Medical Marijuana Program Tracking System A. Upon direction by the DBR and in accordance with R.I. Gen. Laws §§ 21-28.6-12(g)(3), and 21-28.6-16(d) each compassion center and licensed cultivator shall be required to utilize the state approved Medical Marijuana Program Tracking System to document and monitor compliance with the Act and all regulations promulgated thereunder. Applicable licensees may be required to pay costs associated with use of the Medical Marijuana Program Tracking System which may be assessed on an annual, monthly, per use, or per volume basis and payable to the state or to its approved vendor. B. All information related to the acquisition, propagation, cultivation, transfer, manufacturing, processing, testing, storage, destruction, wholesale and/or retail sale of all marijuana and medical marijuana products possessed by licensees and/or distributed to registered cardholders in accordance with the Act must be kept completely up-to-date in the Medical Marijuana Program Tracking System, including but not limited to: 1. Planting and propagation of plants; 2. Transition of immature to mature plants; 3. Harvest dates with yield documentation; 4. Destructions of immature plants, mature plants and medical marijuana products; 5. Transportation of immature plants, mature plants, and medical marijuana products; 6. Theft of immature plants, mature plants, and medical marijuana products; 7. Adjustment of product quantities and/or weights; 8. Conversion of product types including waste documentation; 9. Required test results as reported by a cannabis testing laboratory; 10. Retail and wholesale transaction data; 11. Product compliance data; 12. A complete inventory including, but not limited to: a. Batches or lots of useable marijuana; b. Batches or lots of concentrates; c. Batches or lots of extracts; d. Batches or lots of marijuana infused products; e. Immature plants, f. Mature plants; g. Marijuana waste; and 13. Any other information or technical functions DBR deems appropriate. 1.6.2 Tagging of Plants and Medical Marijuana Products A. Unique identifier tags shall be placed in a manner to clearly display their association with a particular plant, plant material, or product as approved by DBR. For example: 1. Affixed to the plant itself or the plant receptacle; 2. By labeling drying racks and other receptacles that wet marijuana dries on; 3. On a label affixed to a storage/transport package and/or retail-ready package; and/or 4. Any other means DBR deems appropriate. B. All immature plants, usable marijuana, medical marijuana products and waste must be tagged with the following information unless otherwise approved by DBR: 1. The licensee’s license number and tradename/business name; 2. The unique identifier generated by the Medical Marijuana Program Tracking System; 3. Strain name or product name (waste excluded); 4. The quantity of the product; and 5. Any other information or technical functions DBR deems appropriate. C. Each mature marijuana plant must be physically tagged and tracked individually with the following information unless otherwise approved by DBR: 1. The licensee’s license number and tradename or business name; 2. The unique identifier generated by the Medical Marijuana Program Tracking System; 3. Strain name; 4. Date of creation; and 5. Any other information or technical functions DBR deems appropriate. D. The unique identifier tags may not be transferred or assigned except when affixed to marijuana plants, usable marijuana, or medical marijuana products which are being sold/transferred/transported in accordance with §§ 1.6.3 and 1.6.8 of this Part. E. Return of unique identifier tags upon revocation or abandonment of the license shall be specifically governed by DBR order or agreement which may include coordinated efforts with law enforcement. Disposal of unique identifier tags by the compassion center or licensed cultivator as may be required by DBR, such as in the regular course of tagging if different stages will require different tag forms or such as recall of tags due to new technology, shall be handled in accordance with further instructions provided by DBR. 1.6.3 Permitted and Prohibited Sources of Marijuana; Contract Requirements; Sales and Transfers A. Licensed cultivators shall only sell to and receive medical marijuana and marijuana products from Rhode Island licensed compassion centers and Rhode Island licensed cultivators, as authorized by R.I. Gen. Laws § 21-28.6-16(a). 1. As part of such sales transactions, the licensed cultivator may transfer and transport medical marijuana and medical marijuana products to a registered compassion center or licensed cultivator in accordance with § 1.6.8 of this Part. 2. A licensed cultivator may only receive medical marijuana and marijuana products from a Rhode Island registered compassion center if the receipt is pursuant to a written contract or purchase order for the licensed cultivator to process the medical marijuana into a product to be furnished back to the compassion center. R.I. Gen. Laws § 21-28.6-16(e). B. Pursuant to R.I. Gen. Laws § 21-28.6-16(e), a compassion center shall only purchase or otherwise receive marijuana from a Rhode Island licensed cultivator, with which it has a “formal agreement.” 1. Compassion centers shall not transfer medical marijuana or medical marijuana products to another compassion center. R.I. Gen. Laws § 21-28.6-12(d)(5)(v). C. The requirements for a “formal agreement” shall be as follows: 1. A written executed contract or purchase order shall be required for all sales or services from a licensed cultivator to a compassion center and from a licensed cultivator to licensed cultivator and shall contain the following minimum terms: a. Date of execution/placement of the contract/purchase order; b. Description and amount of product to be sold and/or services to be provided; c. The total price and per unit price of the product to be sold and/or services to be provided; d. The specific date or date range not spanning more than thirty (30) calendar days for fulfillment of the order, performance of the services, and delivery or pickup; e. The payment due date, as specifically agreed between the parties, but if no date is specifically agreed to, payment shall be made within thirty (30) calendar days of delivery or pickup; and f. Contracts/purchase orders pursuant to this paragraph may not be modified but may be cancelled or voided by the creation of a new replacement contract/purchase order. D. In accordance with R.I. Gen. Laws §§ 21-28.6-4(c) and (j), a marijuana establishment licensee shall not purchase or otherwise receive marijuana from any qualifying patient cardholder or primary caregiver after December 31, 2016. This prohibition extends to purchases and transfers from cooperative cultivations. E. Permitted and Prohibited Sales and Transfers 1. Compassion center sales to qualifying patients, directly or through their caregivers or authorized purchasers, are only permitted if those qualifying patients, caregivers, or authorized purchasers are registered and compliant with the Act and all regulations promulgated thereunder. Only marijuana products that have been designated as medical marijuana in accordance with § 1.7 of this Part may be sold or distributed. For such sales, a compassion center shall be strictly bound by the dispensing limits of R.I. Gen. Laws § 21-28.6-12(g). 2. Sales to out-of-state patients a. Compassion centers may conduct sales to out-of-state patient cardholders in accordance with R.I. Gen. Laws § 21-28.6-4(o), provided the receiving or purchasing patient has a valid medical marijuana card, or its equivalent, which has been issued by the applicable regulating authority for the medical marijuana program of the issuing U.S. state/jurisdiction/territory. The patient must also possess and present valid government issued identification matching the name on their medical marijuana card. b. Each patient verified pursuant to § 1.6.3(E)(2)(a) of this Part, shall complete an intake form (upon a form acceptable to DBR) which includes at minimum the home state card registration number (or if the home state registration number is not available, a unique identifier assigned by the compassion center). c. The compassion center shall log and track all transactions with each out-of-state patient cardholder in the Medical Marijuana Program Tracking System according to the issuing state’s patient card registration number or the unique identifier assigned to that person by the compassion center. d. Out-of-state patient information shall be maintained confidentially in accordance with § 1.6.6(D)(2) of this Part. e. The compassion center shall provide each out-of-state patient cardholder with a notice regarding the requirements and prohibitions under the Act and any regulations promulgated thereunder that apply to dispensing and use of medical marijuana within the State of Rhode Island, including without limitation notice of medical marijuana dispensing and possession limits, prohibition of taking medical marijuana and medical marijuana products across state lines and prohibition of smoking in public places. 3. Sales for delivery to a qualifying patient cardholder’s residence are deemed permitted provided that such sales comply with § 1.6.9 of this Part. 4. Any transfer to or from a third-party testing provider shall be in accordance with § 1.11 of this Part, the Act and any regulations promulgated thereunder. 5. Unless specifically permitted by § 1.6 of this Part, no other compassion center or licensed cultivator sales or transfers of marijuana or marijuana products or services are permitted. 1.6.4 Inventory Limit, Sources and Control A. Inventory Limit 1. Pursuant to R.I. Gen. Laws § 21-28.6-12(i)(1), a compassion center must limit its inventory of marijuana, including but not limited to immature plants, mature plants, and medical marijuana products, to reflect the projected needs of qualifying patients. a. Compassion centers shall not expand or increase the size, scope, scale or capacity of their previously approved and licensed medical marijuana cultivation facility, or cultivation, manufacturing or processing activities without prior approval from DBR in accordance with the variance procedures set forth in § 1.2(I) of this Part. b. A compassion center may apply to relocate their existing licensed medical marijuana cultivation facility, or cultivation activities to a new premises provided that the size, scope, scale and capacity of the cultivation or cultivation activities are not increased or expanded unless approved by DBR pursuant to § 1.6.4(A)(1)(e) of this Part. c. Compassion centers licensed after July 1, 2019, shall not engage in the cultivation of medical marijuana unless approved by DBR pursuant to § 1.6.4(A)(1)(e) of this Part. d. A compassion center applicant may propose to cultivate medical marijuana. Any compassion center applicant that is approved to cultivate marijuana in accordance with the Act and the DBR regulations may only cultivate medical marijuana at one address or location. If approved, the cultivation of medical marijuana may occur at: (1) The same licensed address or location where the compassion center is authorized to or proposes to conduct retail sales of medical marijuana; or (2) If the address or location where an applicant or licensee is authorized to or proposes to conduct retail sales of medical marijuana does not permit or is not suitable for medical marijuana cultivation, then the applicant may propose to use a second location for cultivation in accordance with § 1.2(I) of this Part. e. DBR shall only consider requests, in its discretion, to establish, expand or increase the size, scope, scale or capacity of a compassion center’s new or previously approved and licensed medical marijuana cultivation facility, or cultivation activities after DBR has completed a recent market demand assessment to project the needs of qualifying patients and DBR has determined that the proposed establishment expansion, or increase in size, scope, scale or capacity is in the best interest of and for the mutual benefit of program participants and required to meet the projected needs of qualifying patients. f. Any licensed compassion center in violation of the Act, the DBR Regulations, and the cultivation limits established therefrom shall be ineligible to apply to establish, expand, or relocate a medical marijuana cultivation facility, or medical marijuana cultivation activities, in addition to having their compassion center license suspended and subject to revocation pursuant to R.I. Gen. Laws § 21-28.6-12(d)(5). g. A licensed cultivator which has applied for and been approved or selected to hold a compassion center license after July 1, 2019, shall be able to continue their previously licensed operations under a newly issued compassion center license, provided that the cultivator license shall be surrendered to DBR, in accordance with R.I. Gen. Laws § 21-28.6-12(b)(10). h. Licensed cultivators shall be subject to the limitations of the class of their issued license. Licensed cultivators may cultivate, manufacture, process and possess medical marijuana and medical marijuana products within the confines of the class size of their licensed facility, provided that all medical marijuana and medical marijuana products are tracked in the Medical Marijuana Program Tracking System and in accordance with § 1.6.1 of this Part. B. Inventory Sources 1. Legal Pre-Existing Inventory: a. A licensed cultivator or compassion center, whose officers, directors, members/managers, or employees possessed medical marijuana plants in compliance with the provisions of the Act before the license was granted, may transfer such marijuana plants to the licensee’s inventory through a one-time transaction upon licensure provided such marijuana plants are properly tagged in compliance with § 1.12 of this Part and tracked in compliance with §§ 1.6.1 and 1.6.2 of this Part. b. Except as provided in § 1.6.4(B)(1)(a) of this Part or through the regulated sale of medical marijuana to a qualifying patient, their registered caregiver or authorized purchaser, transfers of marijuana and marijuana product between the licensed marijuana establishment and its officers, directors, members/managers, and/or employees is strictly prohibited. C. Inventory Control 1. Upon direction by DBR, each compassion center and licensed cultivator shall utilize the state approved Medical Marijuana Program Tracking System for all inventory tracking from seed to sale as defined in § 1.6.1 of this Part. 2. If the compassion center or licensed cultivator is notified by DBR that the Medical Marijuana Program Tracking System is not available, the compassion center or licensed cultivator will be provided with direction as to alternative inventory control measures, which may include but are not necessarily limited to the compassion center or licensed cultivator being directed to: a. Conduct an initial comprehensive inventory of all medical marijuana, including usable marijuana available for dispensing and/or sale, marijuana plants and seedlings, unusable marijuana, and wet marijuana, at each authorized location on the date the compassion center first dispenses, or the licensed cultivator first cultivates medical marijuana or as of another date certain set by DBR. b. Conduct daily subsequent comprehensive inventories. c. Conduct a monthly inventory review of stored, usable marijuana, seedlings, plants, and wet marijuana. 3. Upon request, DBR may require a compassion center or licensed cultivator to conduct and provide the results of alternative inventory control measures outlined above, regardless of the availability and use of the Medical Marijuana Program Tracking System. 1.6.5 Minimum Security Requirements A. R.I. Gen. Laws §§ 21-28.6-12(b)(1)(iv) and 21-28.6-16(b)(4) authorize DBR to promulgate regulations regarding the minimum-security requirements for compassion centers and licensed cultivators. B. General Security Requirements shall include: 1. Each compassion center or licensed cultivator shall implement appropriate security and safety measures to deter and prevent the unauthorized entrance into areas containing medical marijuana and the theft of marijuana. 2. Use or carry of firearms on the premises and/or perimeter of the compassion center or licensed cultivator is a prohibited form of security, except by security guards licensed by the Office of the Rhode Island Attorney General pursuant to R.I. Gen. Laws Chapter 5-5.1 and who are under written contract to provide security services to the compassion center or licensed cultivator and by law enforcement personnel during duty. 3. The outside perimeter shall be lighted as follows: a. The compassion center retail premises shall be well-lit at all times. For any alternative cultivation only site, the outside perimeter shall have adequate lighting to deter theft which may include motion activated lighting acceptable to DBR. b. The outside perimeter of the licensed cultivator shall have adequate lighting to deter theft which may include motion activated lighting acceptable to DBR. 4. Except for persons whose visit falls within § 1.6.5(B)(6) of this Part, any person who does not have a valid registry identification card who enters any area where marijuana and marijuana products are grown, cultivated, stored, weighed, packaged, processed, manufactured or sold shall be considered a “visitor” and must be escorted at all times by a registry identification card holder. However, visitors are only permitted for a legitimate business-related purpose such as building maintenance, repairs or installation of equipment, or provision of goods or services. Any visitor that regularly gains access to the facility may be required by DBR to obtain a registry identification card. The compassion center or licensed cultivator must maintain a visitor log for any such activity as detailed in § 1.6.5(H)(1)(d) of this Part. 5. Each compassion center or licensed cultivator shall ensure that the storage of marijuana and any marijuana products is in a locked area. At all points of ingress and egress, the compassion center or licensed cultivator shall ensure the use of a working commercial-grade, non-residential door lock. 6. Registered qualifying patients, primary caregivers, and authorized purchasers who do not hold compassion center registration cards are only permitted within point of sale areas of a compassion center. In such areas, the compassion center shall ensure that all marijuana and marijuana products are kept behind the sales counter or other partition and make reasonable efforts to limit the number of registered qualifying patients, primary caregivers, and authorized purchasers present in relation to the number of compassion center cardholders to assure adequate monitoring and control of point of sale area activities. C. Security Alarm Requirements 1. Each compassion center or licensed cultivator shall have a fully operational security alarm system of an appropriate commercial standard as deem acceptable by DBR at each authorized physical address that will provide suitable protection against theft and diversion, including alarms at all outside perimeter entry points and outside perimeter windows. 2. A fully operational security alarm system may include a combination of hard-wired systems and systems interconnected with a radio frequency method such as cellular or private radio signals that emit or transmit a remote or local audible, visual, or electronic signal; motion detectors, pressure switches, duress alarms (a silent system signal generated by the entry of a designated code into the arming station to indicate that the user is disarming under duress); panic alarms (an audible system signal to indicate an emergency situation); and hold-up alarms (a silent system signal to indicate that a robbery is in progress). 3. A fully operational security alarm system shall at a minimum provide for immediate automatic or electronic notification to alert municipal and/or state law enforcement agencies or public safety personnel to an unauthorized breach or attempted unauthorized breach of security at the compassion center or licensed cultivator or any other authorized physical address and to any loss-of-electrical support backup system to the security alarm system. 4. Each compassion center or licensed cultivator shall establish a protocol for the testing and maintenance of the security alarm system, which shall at a minimum provide for a maintenance inspection/test of the alarm system for each authorized location at intervals not to exceed thirty (30) calendar days from the previous inspection/test and prompt completion of all necessary repairs to ensure the proper operation of the alarm system. 5. If the compassion center or licensed cultivator suffers a failure of the security alarm system, due to loss of electrical support, mechanical function, or otherwise, that is expected to exceed an eight (8) hour period, in addition to the notice requirements provided in §§ 1.6.5(C)(3) and 1.6.5(I) of this Part, the compassion center or licensed cultivator must also close the authorized physical address(es) impacted by the failure/malfunction until the security alarm system has been restored to full operation, or, if approved by DBR, provide alternative security. D. Video Surveillance Requirements 1. Each compassion center or licensed cultivator must have a fully operational video surveillance and camera recording system with appropriate protocols, which shall, at a minimum, comply with all of the below requirements: a. Video surveillance equipment shall, at a minimum, consist of digital or network video recorders, video monitors, and digital archiving devices capable of playback quality sufficient to identify and monitor all individuals (including sufficient clarity of facial features) and activities in the monitored areas. b. The recording system must record in digital format. c. The date and time must be embedded on the recording without significantly obscuring the picture. Time is to be measured in Eastern Standard Time. d. All video surveillance systems must be equipped with a failure notification system that provides prompt notification of any surveillance interruption and/or the complete failure of the surveillance system. Said notification must be routed to compassion center or licensed cultivator personnel specifically designated by management and to DBR. e. All video surveillance equipment shall have sufficient battery backup to support a minimum of four (4) hours of recording in the event of a power outage. f. Video recordings must be archived in a format and maintained in a manner that ensures authentication of the recording as legitimately-captured video and guarantees that no alteration of the recorded image has taken place. g. Remote access to a continuous live feed video on a real time basis must be available at all times to compassion center or licensed cultivator personnel specifically designated by management and to DBR. Additionally, all video surveillance records and recordings must be made available upon request to DBR. DBR employees and representatives will hold video surveillance records and recordings of point-of-sale areas confidential except for authorized release in accordance with applicable law. h. The system must include a color printer or similar equipment capable of printing still photos of a quality sufficient to identify individuals and activities in the monitored areas. i. The licensee must ensure that DBR has continuous access to live feed video. Failure to maintain ongoing access by DBR may result in enforcement proceedings pursuant to § 1.13 of this Part. E. Placement of Cameras and Required Camera Coverage 1. Camera coverage is required for all areas where marijuana and marijuana products are grown, cultivated, stored, weighed, packaged, processed, manufactured or sold, including all areas of ingress and egress thereto, point-of-sale areas, security rooms (as defined below), all points of ingress and egress to the exterior of the compassion center or licensed cultivator, and any computer or other digital access points. 2. Camera views of required coverage areas shall be continuously recorded twenty (24) hours a day, (7) seven days per week. 3. Camera placement shall be capable of identifying activity occurring within twenty (20) feet of all points of ingress or egress and shall allow for the clear and certain identification of any individual and activities on the licensed premise. 4. All entrances and exits to the facility shall be recorded from both indoor and outdoor vantage points. 5. The system shall be capable of recording all pre-determined surveillance areas in any lighting conditions. F. Location and Maintenance of Surveillance Equipment 1. Surveillance recording equipment and all video surveillance records and recordings must be housed in a designated, locked and secured room or other enclosure with access limited to compassion center or licensed cultivator personnel specifically authorized by management (the “security room”). The compassion center or licensed cultivator must keep on site a current list of all authorized employees and service personnel who have access to the security room and a video surveillance equipment maintenance activity log. 2. If the compassion center or licensed cultivator suffers a failure of the video surveillance system, due to loss of electrical support, mechanical function, or otherwise, that is expected to exceed an eight (8) hour period, in addition to the notice requirements provided in § 1.6.5(I) of this Part, the compassion center or licensed cultivator must also close the authorized physical address(es) impacted by the failure/malfunction until the video surveillance system has been restored to full operation, or, if approved by DBR, provide alternative premises monitoring. G. Emergency Plan 1. The compassion center or licensed cultivator shall develop and maintain an emergency plan with procedures to be followed to prevent and, if not prevented, to adequately address and mitigate consequences of theft or burglary or attempts thereof, fire, natural disasters, and other emergencies, including cybersecurity and data breach procedures to prevent a compromise of the integrity of the Medical Marijuana Program Tracking System. 2. The plan shall include training for employees on crime prevention and personal safety techniques. H. Security-Related Record-Keeping 1. The compassion center or licensed cultivator shall maintain the following documentation on-site and with digital back-up for a period of at least twenty-four (24) months after the event: a. Inventory records including, at a minimum, the date the inventory was conducted, a summary of the inventory findings and the name, signature and title of the individual who conducted the inventory. b. All records of maintenance, inspections, and tests of the security alarm and video surveillance systems and of servicing, modifications, or upgrades performed on said systems. These records shall include, at a minimum, the date of the action, a summary of the action(s) performed and the purpose therefor, and the name, signature and title of the individual who performed the action(s). c. Emergency notification reports as required by § 1.6.5(I) of this Part. d. Visitor logs which shall include the name of each visitor, a photocopy of the visitor’s government issued ID upon first visit, the date and time of the beginning and end of the visit, the reason for the visit (i.e. maintenance, authorized pickup, etc.), and the name of the escorting registry identification cardholder. e. All surveillance recordings must be kept for a minimum of sixty (60) calendar days. Video recordings shall not be destroyed if the compassion center or licensed cultivator knows or should have known of a pending criminal, civil or administrative investigation or any other proceeding for which the recording may contain relevant information. f. All records applicable to the surveillance system shall be maintained on the compassion center or licensed cultivator premises. However, a backup record may be stored and maintained offsite. At a minimum, licensees shall maintain a map of the camera locations, direction of coverage, camera numbers, surveillance equipment maintenance activity log, user authorization list and operating instructions for the surveillance equipment. This information shall be limited to key personnel only. I. Emergency Notifications and Reports 1. Compassion centers or licensed cultivators shall provide notification of emergency events to DBR and municipal and/or state law enforcement as outlined below. 2. Immediately upon discovery of the event, the compassion center or licensed cultivator shall provide telephone notification to the appropriate municipal and/or state law enforcement authorities and first responders regarding any of the following “emergency events”: a. Theft or burglary or an attempt thereof; b. Any fire; c. A natural disaster that results in the destruction of or damage to medical marijuana or marijuana products; d. A failure of the security alarm system or video surveillance system, due to loss of electrical support, mechanical function, or otherwise, that is expected to exceed an eight (8) hour period; e. A security alarm activation; or f. Any other event which requires response by law enforcement or public safety personnel. 3. The compassion center or licensed cultivator shall provide e-mail notification to DBR immediately upon discovery of any data breach or cybersecurity threat to the Medical Marijuana Program Tracking System and immediately after notification to law enforcement/first responders of any other emergency event as defined above in § 1.6.5(I)(2) of this Part. A follow-up telephone notification to DBR shall be provided no later than the next business day. 4. The compassion center or licensed cultivator shall submit a follow-up written report to DBR within twenty-four (24) hours for each emergency event. The written report shall include, at a minimum, a description of the event(s), identification of known or suspected cause(s) for the event(s), any corrective action(s) taken to prevent a recurrence, and the name, title, and signature of the individual preparing the report. 5. Any notification and report of an emergency event required to be made to DBR pursuant to these DBR Regulations shall be made using the mailing address, telephone number, and/or e-mail address provided by DBR to approved licensees, as applicable. 6. Upon written direction to the compassion center or licensed cultivator, DBR may require that the written and telephone notifications and reporting must be replaced or supplemented by notifications and reporting through the Medical Marijuana Program Tracking System or any other electronic system or means DBR mandates the compassion center or licensed cultivator to utilize. 1.6.6 Record-Keeping and Reporting A. R.I. Gen. Laws §§ 21-28.6-12(b)(1)(iii) and 21-28.6-16(b)(3) authorizes DBR to promulgate regulations regarding the minimum record-keeping requirements for compassion centers and licensed cultivators. B. Operations Manual. Each compassion center or licensed cultivator shall develop, implement, and maintain on the premises an operations manual which addresses, at a minimum, all of the following subject areas and requirements. 1. Procedures for the organization, administration, command, and control of the compassion center or licensed cultivator (including but not limited to organizational chart, chain of command protocols, etc.). 2. Procedures to ensure accurate record-keeping, including but not limited to protocols to ensure that: a. All acquisitions, dispensing, and sales of marijuana are logged into the Medical Marijuana Program Tracking System on a real time basis. b. All dispensing and sales transactions: (1) Are to registered qualifying patients, primary caregivers, authorized purchasers and verified out-of-state patient cardholders; and (2) Adhere to the limits for usable marijuana prescribed by statute and the marijuana product equivalency limits set by § 1.14 of this Part. c. Procedures on proper training and use of the Medical Marijuana Program Tracking System and any other tracking system used by the compassion center or licensed cultivator. 3. Policies and procedures for handling voluntary and mandatory recalls of marijuana. a. Such procedures shall be adequate to deal with recalls due to any action initiated at the request or order of DBR, and any voluntary action by a compassion center or licensed cultivator to remove defective or potentially defective medical marijuana or medical marijuana delivery devices from the market, as well as any action undertaken to promote public health and safety. 4. Policies and procedures for ensuring that any outdated, damaged, deteriorated, mislabeled, or contaminated marijuana is quarantined from other marijuana and destroyed. 5. Records retention policies. 6. Ethics and compliance policies. 7. Alcohol and drug free workplace policy. 8. If applicable, medical marijuana manufacturing protocols, safety measures, process validation for smokable and vapable products, and training information. 9. Odor control and mitigation plan. 10. Policies and procedures for pesticide use (see § 1.6.15(E) of this Part). 11. Applicable for compassion centers only: a. A description of the compassion center’s outreach activities to registered qualifying patients, registered primary caregivers, and authorized purchasers. b. Customer service protocols, including the handling of complaints. c. Procedures for safely dispensing medical marijuana only to registered qualifying patients, registered primary caregivers, and authorized purchasers, including procedures for verifying authenticity of registry identification cards and other forms of identification. C. Personnel Records 1. Each compassion center or licensed cultivator shall maintain a personnel record for each employee, agent or volunteer for a period of at least one (1) year after termination of the individual’s affiliation with the compassion center or licensed cultivator. Said personnel record shall contain the following minimum documentation and information: a. An application for employment or to volunteer or offers to provide services as an agent. b. An employment or engagement description detailing duties, responsibilities, authority, qualifications and supervision. c. If applicable, a copy of any employment or engagement contract, including salary or compensation terms, or for volunteers, volunteer agreement. d. A record of any disciplinary action taken. e. Documentation of all required training, which shall include a signed statement from the individual indicating the date, time and place he or she received said training, topics discussed, and the name and title of presenters. 2. Each compassion center or licensed cultivator shall maintain a current list of all cardholders associated with that compassion center or licensed cultivator. D. Additional Records to be Maintained 1. In addition to all other specific record-keeping requirements of the Act, the DBR Regulations, and the DOH Regulations, the compassion center or licensed cultivator shall maintain the following records for a minimum of five (5) years: a. All contracts and purchase orders, including documentation of any cancelled contracts or purchased orders and any contracts and purchase orders voided by replacement contracts. b. Invoices and any supporting documentation of all marijuana purchases, acquisitions, transfers, and payments. c. Contracts pertaining to the security alarm and security camera systems. d. Contracts with vendors, including any approved third-party testing providers. e. All records normally retained for tax purposes. f. Complaints. g. Management contracts. h. Compensation records and financial statements. i. Compassion Centers Only – Nonprofit corporate records including, but not limited to articles of organization, bylaws, meeting agendas, minutes and corporate resolutions. 2. All records maintained by a compassion center which pertain to one or more registered qualifying patients, registered primary caregivers or authorized purchasers shall be: a. Considered confidential health care information under applicable Rhode Island law; and b. Protected as health care information in accordance with the Federal Health Insurance Portability and Accountability Act of 1996, as amended. E. Records Storage and Responsibility for Loss of Records and Data 1. Records pertaining to transactions occurring within the last six (6) months shall be stored on the licensed premises. Records dating further back may be stored off the premises with DBR’s approval. 2. The compassion center or licensed cultivator shall exercise due diligence and reasonable care in preserving and maintaining all required records to guard against loss of records and data, including cybersecurity of electronically-maintained records. 1.6.7 Use on Premises Prohibited Compassion centers or licensed cultivators shall not permit the use of marijuana or marijuana products on the premises of the compassion center or licensed cultivator, including any parking areas that are designated for compassion center clients or otherwise within the control of the compassion center or licensed cultivator. 1.6.8 Transportation of Medical Marijuana Products A. Authorized Transport Vehicle Requirements 1. Authorized transports shall be conducted in such a manner as to ensure that marijuana and marijuana products are secured and safe at all times during transport. 2. In order to qualify as an “authorized transport vehicle” the marijuana establishment licensee shall use a vehicle meeting all the following criteria: a. The vehicle bears no markings that indicate that the vehicle is being used to transport marijuana nor indicates the name of the marijuana establishment licensee; b. The vehicle is equipped with a global positioning system monitoring device that is monitored by the originating marijuana establishment licensee during an authorized transport; c. The vehicle is equipped with an alarm system; d. The vehicle is equipped with functioning heating and air conditioning systems appropriate for maintaining correct temperatures for storage of marijuana products; e. Marijuana products must not be visible from outside the vehicle; and g. Marijuana products must be stored and transported in a secure, locked storage compartment that is a part of the vehicle transporting the marijuana products. However, the trunk of a vehicle does not qualify as a “locked storage compartment.” 3. When transporting marijuana products, no other products may be transported or stored in the same vehicle. 4. No firearms may be located within the vehicle or on the person of the authorized transport cardholder. 5. Any other security and safety requirements as determined by DBR. B. Detailed Transport Manifests 1. All marijuana establishment licensees shall create and maintain detailed transport manifests for all authorized transports, which DBR may require be generated through and/or maintained in the Medical Marijuana Program Tracking System. 2. The detailed transport manifest shall be prepared by the originating marijuana establishment licensee and transmitted in advance to the receiving license. Both licensees shall retain copies of detailed transport manifests as part of their record retention responsibilities. 3. The detailed transport manifest shall include the following minimum information: a. Departure date and approximate time of departure. b. Names, location addresses, and registration/license numbers of the originating and receiving marijuana establishment facilities. c. Unique identifier generated by the Medical Marijuana Program Tracking System. d. If for transport to a registered qualifying patient pursuant to an approved patient home delivery plan, as set forth in § 1.6.9 of this Part, the patient registry identification card number and any such other information pursuant to approved delivery plan. e. Product names or descriptions. f. Quantities (by weight or unit) of each product to be delivered. g. Product name or descriptions and quantities (by weight or unit) of each product which was received by the marijuana establishment licensee. h. Arrival date and approximate time of arrival. i. Delivery vehicle make, model and license plate number. j. Names, registry identification card numbers, and signatures of the authorized transport cardholders. C. Authorized Transportation Requirements 1. The originating marijuana establishment licensee shall ensure that all delivery times and routes are randomized. 2. The originating marijuana establishment licensee shall ensure that all transport routes remain within the state of Rhode Island. 3. Authorized transports may only be made by authorized transport cardholders affiliated with the particular marijuana establishment licensee that is the source or recipient party to an authorized transaction. 4. If using one authorized transport vehicle, the vehicle shall be operated/occupied by a minimum of two authorized transport cardholders and at least one such cardholder shall remain in the authorized transport vehicle at all times until the vehicle returns to the originating marijuana establishment licensee. 5. If using two authorized transport vehicles, the authorized transport vehicles shall travel together at all times during the authorized transport and each vehicle shall be operated/occupied by at least one authorized transport cardholder. These vehicles shall not be left unattended for any period of time during any authorized transportation. 6. During all authorized transports: a. The authorized transport cardholders must have on their persons their compassion center or licensed cultivator registry identification cards and the detailed transport manifest; and b. A copy of the detailed transport manifest shall also accompany the marijuana and marijuana products in the locked storage compartment of the authorized transport vehicle. 7. Any authorized transport vehicle carrying marijuana and marijuana products shall travel directly from the originating marijuana establishment licensee to the receiving marijuana establishment licensee. 8. In case of an emergency stop, a detailed written account must be maintained describing the reason for the event, the duration, the location, any activities occurring during the stop, and any personnel exiting the vehicle during the stop. 9. Prior to leaving the originating marijuana establishment licensee for an authorized transport to another marijuana establishment licensee, the originating marijuana establishment licensee must weigh, inventory, and account for on video all marijuana and marijuana product to be transported. 10. For authorized transports to and from a marijuana establishment licensee, the transport manifest shall be accompanied by a copy of any contract/purchase order for which the transport is being made and documentation of the actual payment date, if prepaid. 11. Upon arrival at the destination marijuana establishment licensee, the receiving party shall confirm receipt of each item in the presence of the delivering authorized transport cardholder and then initial each received line item on both the originating licensee’s manifest and the receiving licensee’s manifest. The receiving party shall then immediately re-weigh, re-inventory, and account on video for all marijuana and marijuana product transported. 12. Both the originating and recipient marijuana establishment licensees shall timely adjust their records to reflect in its records the completed authorized transport of marijuana, including logging such information in the Medical Marijuana Program Tracking System. All records and entries in the Medical Marijuana Program Tracking System shall be easily reconciled by unique identifier, product name and quantity, with the applicable detailed transport manifest. 13. Any unusual discrepancies in the quantity described in the detailed transport manifest and the quantities received shall be reported to DBR and municipal and/or state law enforcement within twenty-four (24) hours. 14. Any vehicle accidents, diversions, or losses during authorized transports of marijuana shall be reported to DBR and law enforcement as an “emergency event” pursuant to § 1.6.5(I) of this Part. 15. Transportation to or from a third-party testing provider shall be in accordance with the DOH Testing Regulations. 1.6.9 Home Delivery – Compassion Centers Only A. Home delivery of medical marijuana by licensed compassion centers shall be deemed “permitted sales” and “permitted compassion center activity” provided medical marijuana is sold and delivered in compliance with the Act and the DBR Regulations, including but not limited to the following: 1. The compassion center’s proposed home delivery plan has been approved by DBR. 2. Medical marijuana shall only be delivered to a valid qualifying patient cardholder who has been issued a valid patient card by DOH. 3. The Rhode Island patient cardholder must register in advance with the compassion center’s delivery program through a process clearly identified in the proposed delivery plan which has been approved by DBR. 4. Medical marijuana deliveries shall only be made to the Rhode Island patient cardholder’s home address or to the hospice, treatment, or other medical care facility where the patient cardholder is admitted, provided the facility permits the patient’s possession and/or use of medical marijuana on the premises. 5. Medical marijuana deliveries shall only be made to or accepted by the Rhode Island patient cardholder registered with the compassion center’s delivery program. This must be verified and documented by the compassion center through a process clearly identified in the proposed delivery plan which has been approved by DBR. B. Until otherwise approved by DBR, home delivery of medical marijuana shall be limited to Rhode Island patient cardholders who: 1. Do not have a caregiver or authorized purchaser registered with the compassion center to make purchases on their behalf; 2. Are eligible for hospice care, or who are currently undergoing chemotherapy or radiation treatment; or 3. Are homebound and unable to travel or have a valid disability parking license, placard or permit. 4. In addition, patients who qualify for home delivery under § 1.6.9(B)(2) or (3) of this Part must submit a letter to the compassion center to that effect signed by a practitioner licensed to practice medicine in Rhode Island when registering for home delivery. C. Transportation requirements for home delivery of medical marijuana include but are not limited to the following: 1. Compassion centers may only conduct home delivery between the hours of 8:00 a.m. and 8:00 p.m. 2. All home delivery vehicles must be qualified as an “authorized transport vehicle” pursuant to § 1.6.8(A) of this Part and shall be operated by transport cardholders authorized by the compassion center. 3. All home delivery vehicles shall comply with the detailed transport manifest requirements in § 1.6.8(B) of this Part. 4. A home delivery vehicle may not possess more than seven thousand five hundred dollars ($7,500) worth of medical marijuana products at a time. 5. A home delivery vehicle shall comply with the personnel requirements in §§ 1.6.8(C)(4) and (5) of this Part. 6. In order to obtain and maintain DBR approval of the home delivery plan, compassion centers must make delivery available to eligible Rhode Island patient cardholders statewide and may not refuse delivery to a patient based on the location of their home unless it is for a reason approved by DBR. 7. Compassion centers must make delivery available to each of their eligible Rhode Island patients at least once every fifteen (15) days. D. Home Delivery product and payment requirements include but are not limited to: 1. Any compassion center authorized transport vehicle carrying marijuana and marijuana products to patients pursuant to an approved patient home delivery plan shall only stop at the patient addresses listed on the detailed transport manifests. 2. All home deliveries must be paid for in advance or through electronic payment at the time of delivery. Compassion centers may not accept any non-electronic payment at the time of delivery. 3. Authorized transport cardholders may not accept tips or compensation of any kind from the Rhode Island patient to whom they are delivering or otherwise in connection with delivery. 4. All orders, payments, and deliveries must be tracked in the compassion center’s Medical Marijuana Program Tracking System and within the limits of the Act. DBR must have real time, and if requested, remote access to these systems and any other logs or systems tracking home deliveries which are approved by DBR. 5. Compassion centers may not charge a delivery fee in excess of twenty dollars ($20.00) per delivery and must implement a discounted or free delivery policy for patients who qualify under § 1.6.9(B)(2) or (3) of this Part. 6. Products available for delivery must follow the same pricing structure as products sold through the compassion center’s retail location. 7. If a patient requires a medical marijuana product that is available at the compassion center’s retail location, but is not offered for delivery, the compassion center must make that product available for delivery to that patient upon their request, provided the requested product is in stock. 1.6.10 Manufacturing and Extraction A. Any manufacturing method using a solvent extraction process must be approved by DBR. If the manufacturing method uses a flammable/combustible material or heat source, the method must also be approved by the State Fire Marshall and/or local fire department. B. Only registered cardholder employees and agents of a licensee may manufacture medical marijuana products on the premises. A registered volunteer for a compassion center may do so only as part of educational programming under the direct supervision of a licensed employee. C. Each compassion center and licensed cultivator must maintain written standard operating procedures for each manufacturing process, including step-by-step instructions. D. Each compassion center and licensed cultivator must ensure that for each manufacturing process, all safety and sanitary equipment appropriate for that manufacturing process, including any personal protective equipment, is provided to any authorized cardholder who will be involved in that manufacturing process. E. All medical marijuana product manufacturing areas must be adequately lit during manufacturing, cleaning, or other use. F. All work surfaces on which medical marijuana products are manufactured and the walls and floors in the areas in which such products are manufactured shall be non-porous, non-absorbent, and easily cleanable. G. No eating or smoking shall be permitted in the manufacturing area. H. The compassion center or licensed cultivator must provide a training manual and instructional training on each manufacturing process to any authorized cardholder who will be involved in that manufacturing process. 1.6.11 Required Patient Outreach Activities - Compassion Centers A. The compassion center’s outreach activities to registered qualifying patients, registered primary caregivers, and authorized purchasers shall, at a minimum, include: 1. Providing each new registered qualifying patient who visits the compassion center with a frequently asked questions sheet that explains the limitations on the right to use medical marijuana under state law in accordance with R.I. Gen. Laws § 21-28.6-12(f)(9); 2. Providing a list of ingestion options for usable marijuana; 3. Providing applicable usage techniques and any corresponding safety information to registered qualifying patients; 4. Communicating potential side effects; and 5. Upon the request of DOH and/or DBR, e-mailing or otherwise disseminating information to compassion center clients regarding changes in the medical marijuana program, or disseminating customer surveys. 1.6.12 Required Employee, Agent, and Volunteer Training A. In accordance with R.I. Gen. Laws §§ 21-28.6-12(f)(14) and 21-28.6-16(b), each compassion center or licensed cultivator shall develop, implement and maintain on the premises an on-site training curriculum, or enter into contractual relationships with outside resources capable of meeting employee, agent and, if applicable, volunteer training needs. Each employee, agent or volunteer, at the time of his or her initial appointment and every year thereafter, shall receive, at a minimum, training in the following: 1. Only applicable to compassion centers: a. Professional conduct, ethics, and state and federal laws regarding patient confidentiality; b. Informational developments in the field of medical use of marijuana; and c. Policies and procedures for dispensing to and transactions with out-of-state patient cardholders. 2. The proper use of security measures and controls that have been adopted. 3. Training on use of the Medical Marijuana Program Tracking System and any other tracking systems used by the compassion center for persons responsible for using the system. 4. Specific procedural instructions for responding to an emergency, including robbery or violent accident. 1.6.13 Minimum Sanitation and Workplace Safety Conditions A. Each compassion center and licensed cultivator shall be maintained in a safe, sanitary, and clean manner, with all operations in the cultivation, receiving, inspecting, transporting, segregating, preparing, manufacturing, packaging, and storing of medical marijuana and marijuana products conducted in accordance with adequate sanitation principles, as further detailed below. B. The facility must meet the following minimum specifications, including having and maintaining: 1. An adequate supply of potable hot and cold water; 2. Non-porous, non-absorbent and easily cleanable floors, walls, and ceilings in areas where marijuana is cultivated, manufactured, and stored; 3. Lavatory facilities that are readily-accessible to employees and that comply with the Rhode Island State Plumbing Code, 510-RICR-00-00-3 ; 4. Adequate hand-washing area(s) with hand washing sinks with effective hand-cleaning and sanitizing preparations (such as soap dispensers) and disposable towels or an air dryer for hands; and 5. Adequate screening or other protection against the entry of pests and environmental contaminants. C. All mechanical and electrical equipment shall be maintained in a safe operating condition. D. Waste disposal equipment shall be adequate and removal schedules timely so as to minimize the risk of contamination to medical marijuana and marijuana products, including the risk of the waste becoming an attractant, harborage, or breeding place for pests. E. All waste (including all liquid, chemical, hazardous, pesticide, manufacturing solvent and chemical waste) must be stored, secured, and managed in accordance with all applicable DEM laws and regulations and all applicable federal, state, and local statutes, regulations, ordinances, or other legal requirements. Specific instructions for safe destruction of any marijuana required to be destroyed and proper disposal of medical marijuana waste are set forth in § 1.6.16 of this Part. F. Floors, walls, and ceilings shall be kept clean and in good repair, free from dust, debris, mold, mildew, and other contaminants and potentially hazardous materials. G. Lavatory facilities and hand washing areas shall be kept clean and sanitary and in working condition at all times. H. Toxic cleaning compounds, sanitizing agents, and other chemicals shall be identified, held, stored and disposed of in a manner that protects against contamination of medical marijuana and marijuana products and in a manner that is in accordance with all applicable DEM laws and regulations and any applicable local, state, or federal law, rule, regulation, or ordinance. I. Each compassion center and licensed cultivator shall comply with all relevant statutes, regulations, and requirements administered by the Federal Occupational Safety and Health Administration (OSHA), including but not necessarily limited to standards for toxic and flammable compounds and air contaminants. DBR may require licensees to undergo third-party inspections or audits to ensure compliance with OSHA. J. All persons working in direct contact with medical marijuana and marijuana products shall conform to hygienic practices while on duty, including but not limited to maintaining adequate personal cleanliness and washing hands thoroughly in an adequate hand-washing area before starting work and at any other time when the hands may have become soiled or contaminated. K. Any person whose medical condition, as determined by medical examination or as observed by a supervisor, poses or reasonably appears to pose a risk of contamination of medical marijuana and/or medical marijuana products shall be excluded from medical marijuana operations until the condition is cleared. Medical conditions posing a risk of contamination include but are not necessarily limited to open lesions, including boils, sores, or infected wounds, or any other abnormal source of microbial infection. L. Each compassion center and licensed cultivator shall not permit the entry of any animal into the premises. Service animals (as defined in the Americans with Disabilities Act) are exempted from this prohibition in retail areas or other areas where there is no cultivation, manufacturing or packaging of medical marijuana products. M. In addition to the safety and sanitary equipment including personal protective equipment that the compassion center or licensed cultivator is required to furnish its employees involved in marijuana manufacturing and extraction pursuant to § 1.6.10(D) of this Part, the compassion center or licensed cultivator must also furnish its employees with proper safety equipment for other types of work assigned as part of the compassion center or licensed cultivator operations. 1.6.14 Odor Control and Mitigation A. Cultivation, manufacturing, packaging and any other area(s) deemed necessary by DBR shall have ventilation and filtration systems installed that prevent medical marijuana plant odors from exiting the interior of the structure to an extent that would significantly alter the environmental odor outside, while addressing the potential for mold. B. The ventilation and filtration system, along with any plumbing improvements, shall be installed in compliance with all applicable codes and ordinances, including obtaining any necessary permits, and inspected by the municipality. C. Measures to assure compliance with this section shall be documented in an odor control and mitigation plan acceptable to DBR. 1.6.15 Pesticide Use and Records A. The cultivation process shall use best practices to limit contamination of medical marijuana and marijuana products, including but not limited to mold, mildew, fungus, bacterial diseases, rot, pests, pesticides, and any other contaminant identified as posing potential harm. B. The use of pesticides on marijuana plants in Rhode Island by registered compassion centers or licensed cultivator will not be considered a violation of these regulations provided that the products satisfy all of the following criteria: 1. The product must be a “minimum risk pesticide” under 40 C.F.R. § 152.25(f), incorporated above at § 1.1.7(C) of this Part. 2. The product must be labelled for use on all plants, other plants, bedding plants, unspecified plants, or unspecified crops. 3. The label must not prohibit indoor or greenhouse use, as applicable. 4. All active ingredients must be eligible for food use as determined by the federal Environmental Protection Agency’s list of (EPA) Active Ingredients Eligible for Minimum Risk Pesticide Products, incorporated above at § 1.1.7(D) of this Part. https://www.epa.gov/sites/production/files/2015-12/documents/minrisk-active-ingredients-tolerances-2015-12-15.pdf . 5. All inert/other ingredients must be eligible for food use in accordance with EPA’s Inert Ingredients Eligible for FIFRA 25(b) Pesticide Products, incorporated above at § 1.1.7(E) of this Part. https://www.epa.gov/sites/production/files/2016-11/documents/minrisk_inert_ingredients_w_tolerances_2016-11-16.pdf . 6. The product must be a currently registered pesticide product eligible for sale in Rhode Island as determined by DEM. To verify a product’s registration in Rhode Island, please consult the online National Pesticide Information Retrieval System through the Center for Environmental and Regulatory Information Systems. http://npirspublic.ceris.purdue.edu/state/state_menu.aspx?state=RI . 7. The product must be used in accordance with any and all use instructions on the label. C. No application of pesticides shall be made after the vegetative stage of growth of the cannabis plant. The vegetative stage of growth should be determined by visual buds or flower or by proxy of the plant receiving less than eighteen (18) hours of light in a twenty-four (24) hour period. D. Pesticides shall be identified, held, stored and disposed of in a manner that protects against contamination of medical marijuana and marijuana products and in a manner that is in accordance with any applicable local, state, or federal law, rule, regulation, or ordinance. E. As a DBR record-keeping requirement, compassion centers and licensed cultivators must keep detailed records of any pesticide products used and application regiments, including video recording during pesticide applications which must cease if there is a failure or disruption of the video surveillance system. This record-keeping requirement is independent of that required of commercial pesticide applicators by DEM and is intended to apply in addition to that requirement, where relevant. 1.6.16 Safe Disposal of Medical Marijuana Waste and Safe Destruction of Usable Medical Marijuana A. Marijuana and marijuana product waste (including all liquid, chemical, hazardous, pesticide, manufacturing solvent and chemical waste containing any traces of marijuana) must be stored, secured, and managed in accordance with all applicable federal, state, and local statutes, regulations, ordinances, or other legal requirements. B. Prior to disposal, marijuana and marijuana product waste must be made unusable and any marijuana plant material made indistinguishable from other plant material. This may be accomplished by grinding and incorporating the marijuana plant waste with other non-consumable solid waste or other ground materials, so the resulting mixture is at least fifty percent non-marijuana waste by volume. Other methods to render marijuana waste unusable must be approved by DBR before implementing. Marijuana waste rendered unusable following an approved method may be delivered to a licensed solid waste disposal facility in Rhode Island for final disposition or disposed of in an alternative manner approved by DBR. C Destruction of marijuana and marijuana materials other than waste generated in the regular course of processing and/or manufacturing (such as destruction of whole plants, wet, or usable marijuana that are found to be in excess of statutory possession limits or destruction of a contaminated batch of medical marijuana product) shall be in a manner acceptable to DBR, which may include consultation with law enforcement. D. Destruction of marijuana and marijuana materials upon revocation or abandonment of the license shall be specifically governed by DBR order or agreement and/or coordinated efforts with law enforcement. E. Each compassion center and licensed cultivators must maintain accurate and comprehensive records regarding waste material that accounts for, reconciles, and evidences all waste activity related to the disposal of marijuana and marijuana products (including any waste material produced through the trimming or pruning of a marijuana plant prior to harvest). DBR may mandate storage of any such records or summaries of such records to be through the Medical Marijuana Program Tracking System or any other electronic system DBR designates. G. All actions in compliance with § 1.6.16 of this Part must comply with any applicable DEM laws, regulations or policies. 1.6.17 Nonprofit Compliance A. All compassion centers have a continuing obligation to be organized, structured and operated as a nonprofit in compliance with R.I. Gen. Laws Chapter 7-6. B. A compassion center shall at all times be operated on a not-for-profit basis for the mutual benefit of its patients in accordance with R.I. Gen. Laws § 21-28.6-12(f). C. Compassion centers shall not be organized, structured or operated in a manner that violates R.I. Gen. Laws § 21-28.6-12(f), or which would cause medical marijuana and medical marijuana products to be priced at unreasonable rates, as determined by DBR, in accordance with R.I. Gen. Laws § 21-28.6-12(d)(2)(iii). D. All licensed compassion centers have a continuing obligation to satisfy the requirements for licensure set forth in § 1.2 of this Part. 1.7 Medical Marijuana Product Designation A. Marijuana may only be used by patient cardholders and may only be sold to or possessed by patient cardholders, or their registered caregivers, or authorized purchasers if it has been designated as “medical marijuana” pursuant to § 1.7 of this Part, the Act and any regulations promulgated thereunder. B. Medical marijuana may not be sold, possessed, manufactured, or used except as permitted under the Act and the DBR Regulations. C. To be designated as medical marijuana, a product must: 1. Comply with a pre-approved designation list of products published by DBR; or 2. Be designated as medical marijuana by DBR prior to sale or distribution of the product. D. At the time of application for medical marijuana designation, the marijuana establishment licensee shall submit any known health impacts, both positive and negative, associated with the product to DBR. E. For smokable and vapable forms, DBR will not designate a product as medical marijuana if: 1. DBR has received information, data or research that such product is not safe for inhalation; 2. The marijuana establishment licensee does not have process validation to produce consistent potency and purity—inconsistency in potency or purity may result in the revocation of medical designation; 3. Flavoring or coloring has been added except for flavors or coloring that are derived solely from cannabis and have been procured in accordance with applicable Rhode Island laws; 4. The form is designed to evade recognition as a marijuana product or otherwise hide the fact that it is a marijuana product; or 5. Anything in the product targets or is appealing to minors. F. As to all other products, DBR will not designate a product as medical marijuana if: 1. The form is designed to evade recognition as a marijuana product or otherwise hide the fact that it is a marijuana product; 2. Anything in the product targets or is appealing to minors; or 3. The product is designed to appear solely as a non-medical or adult-use product for consumption and/or use by the general public. G. Medical marijuana product designation(s) may be withdrawn, denied or revoked by DBR if the product fails to satisfy any provision of the Act or the DBR Regulations or if the product deviates or is altered from its previously approved form. 1.8 Cooperative Cultivation A. Authority 1. Pursuant to R.I. Gen. Laws § 21-28.6-14(d), except as to cooperative cultivator licenses issued by DBR before July 1, 2019, DBR shall no longer accept applications or renewals for licensed cooperative cultivations and cooperative cultivations shall no longer be permitted. 2. Pursuant to R.I. Gen. Laws § 21-28.6-14(a)(10), DBR is charged with promulgating regulations governing the licensing, renewal and operation of cooperative cultivations, and may promulgate regulations that set a fee for a cooperative cultivation license and renewal. B. License Required 1. Pursuant to R.I. Gen. Laws § 21-28.6-14(c), no person or entity shall engage in activities described in R.I. Gen. Laws § 21-28.6-14 and § 1.8 of this Part without a cooperative cultivation license issued by DBR. C. “Member” Requirements, Compliance and Restrictions 1. All “members” of a licensed cooperative cultivation must be listed on the application and approved by DBR. 2. No person other than a “member” may participate in the management or operation of the cooperative cultivation or exert any direct or indirect authority over the management or operations of the cooperative cultivation. 3. The person identified as the primary applicant and the designee of the licensed cooperative cultivation shall be responsible for the verification that each member of the cooperative cultivation is the holder of a valid and active qualified patient or primary caregiver registry identification card. This includes keeping on the premise copies of the qualified patient or primary caregiver cardholder cards printed for the most recent renewal period. 4. If the cooperative cultivation organizes as a legal entity, then all directors/officers and managers/members must be “members” of the cooperative cultivation as defined in § 1.8(C) of this Part. 5. No “member” of a licensed cooperative cultivation may grow medical marijuana at any location other than the licensed cooperative cultivation premises. R.I. Gen. Laws § 21-28.6-4(r). 6. Licensed cooperative cultivations must be organized and operated in a manner to ensure compliance with all relevant state and local laws and regulations and to safeguard against diversion of marijuana to illicit markets. D. Application and Renewal Fees 1. There shall be a non-refundable application fee of fifty dollars ($50) for initial cooperative cultivation license applications. 2. The annual license fee for cooperative cultivations shall be five hundred dollars ($500). 3. The annual license fee shall be in addition to the individual qualifying patient and primary caregiver registration fees and medical marijuana plant tag certificate fees. E. Application Requirements 1. Each initial application for a cooperative cultivation license shall be on such forms and through such submission mechanisms as designated by DBR and shall include: a. The signature of the individual identified as being primarily responsible for the license (“primary applicant”) and one designee. b. A list of the legal name of each qualified patient cardholder and/or primary caregiver cardholder that is or will be a member of the cooperative cultivation and for each such person, their DOH/DBR registry identification card number, date of birth, a mailing address and phone and/or e-mail address at which they can be best reached. c. If the cooperative cultivation chooses to be organized as a legal entity for legal purposes without the intent of generating profit, the cooperative cultivation must also provide the following information regarding any such legal entity: (1) Legal and any d/b/a name(s), certificate of incorporation or organization in Rhode Island or certificate of authority to transact business in Rhode Island, articles of incorporation or organization, and bylaws or operating agreement. (2) The legal name, DOH registry identification card number, date of birth, of any and all directors/officers or managers/members of the cooperative cultivation, including a mailing address and phone and/or e-mail address at which they can be best reached. d. Tax Affidavit in accordance with R.I. Gen. Laws § 5-76-1 et seq . filled out by the “primary applicant” or legal entity who will hold the license, if approved. e. Evidence of compliance with location-specific initial application requirements and security plan requirement as detailed in §§ 1.8(F)(5) and 1.8(G) of this Part, respectively. 2. Only initial applications which DBR has determined to be complete (i.e., adequately address all application requirements above) shall be eligible for review. A primary applicant who submits an incomplete initial application shall receive written notification from DBR regarding the specific deficiencies and shall be allowed to resubmit additional material to address these deficiencies within a reasonable timeframe. 3. When a primary applicant for a licensed cooperative cultivation is notified that the application has been approved by DBR, he or she shall complete the below steps before a license authorizing operation of cooperative cultivation will be issued: a. Pay the annual license fee set forth in § 1.8(D) of this Part. b. Provide any updates to previously submitted application information. c. Provide evidence of compliance with final location-specific application requirements as detailed in § 1.8(F)(6) of this Part. d. Provide a copy of the security plan as required by § 1.8(G) of this Part. e. Provide evidence of completion of divestiture plan pursuant to § 1.8(H) of this Part. F. Location Restrictions and Location-Specific Application Requirements 1. Pursuant to R.I. Gen. Laws § 21-28.6-14(a)(3), a single structural building may only have one cooperative cultivation operating in it. This precludes a structural building with multiple units from having more than one unit with a cooperative cultivation operating in it, unless a single cooperative cultivation has been approved by DBR to occupy two or more connected units provided any such approved occupation of multiple units does not increase the applicable medical marijuana possession limits. 2. Cooperative cultivation licenses will only be issued for “secure indoor facilities.” The secure indoor facility shall satisfy the following parameters: a. Enclosed area with four walls and a roof. b. Equipped with locks and any other appropriate security devices that limit access to the members of the cooperative cultivation. Locks and devices must be sufficient to discourage theft, unauthorized entrance, and access by persons under twenty-one (21) years of age. c. Marijuana is not visible from the street or other public areas. See R.I. Gen. Laws § 21-28.6-14(a)(4). 3. Pursuant to R.I. Gen. Laws § 21-28.6-14(a)(7)(i), a licensed cooperative cultivation must have displayed prominently on the premises documentation from the municipality where the single location is located that the location and the cultivation has been inspected by the municipal building and/or zoning official and the municipal fire department and is in compliance with any applicable state or municipal housing and zoning codes. 4. Pursuant to R.I. Gen. Laws § 21-28.6-14(a)(8), a licensed cooperative cultivation must report the location of the licensed cooperative cultivation to RISP. Cooperative cultivation licensees and applicants may designate DBR to report the location to RISP on their behalf through the application process. If the cooperative cultivation licensee or applicant will self-report, DBR will verify with RISP that they did in fact correctly report the cooperative cultivation location. This reporting shall be made before a cooperative cultivation license is issued. 5. Location-Specific Initial Application Requirements. In order to enable DBR to ascertain compliance with the above location restrictions, the initial application for the cooperative cultivation license must contain the following information regarding the proposed physical location for the cooperative cultivation licensed premises: a. A sufficient description of the location (by plat and lot number, mailing address, etc.). b. A description of objective parameters (such as approximate distances from streets and public areas) and/or proposed measures (such as black-out window shades) that ensure that marijuana at the premises shall not be visible from the street or other public areas. c. Evidence of either ownership of property by the primary applicant person or legal entity applicant (as applicable) or any qualified patient or primary caregiver cardholder that has been listed as associated with the cooperative cultivation applying for the license, or agreement by owner of property to allow the operation of a licensed cooperative cultivation on the property. 6. Location-Specific Final Application Requirements: If an applicant for a licensed cooperative cultivation is notified that the application has been approved by DBR, it shall complete the below steps before a license authorizing operation of cooperative cultivation will be issued: a. Documentation from the municipal building and/or zoning official and the municipal fire department indicating that the location and the cultivation (if the cultivation predates the licensing requirement) has been inspected by and is in compliance with any applicable state or municipal housing and zoning codes. b. A draft diagram of the premises, including where within the facility the medical marijuana will be grown, stored, and processed, and showing the location of the facility relative to streets and other public areas. c. Provide any updates to previously submitted application information regarding the location. d. Contact DBR to coordinate the pre-license DBR inspection. Nothing in this paragraph should be construed as limiting inspections at an earlier time in addition to the final pre-license inspection. G. Security Plan Requirements 1. Cooperative cultivation license applicants must submit and approved licensees must maintain a security plan that includes but is not limited to. a. Security and safety measures (such as locks and lighting) shall be sufficiently designed to deter and prevent theft of marijuana. b. Include an emergency plan component with procedures to be followed to prevent and, if not prevented, to adequately address and mitigate consequences of theft or burglary or attempts thereof, fire, natural disasters, and other emergencies. c. Prohibits the use or carry of firearms on the premises and/or perimeter of the cooperative cultivation and ensures that it is a prohibited form of security, except by security guards licensed by the Office of the Rhode Island Attorney General pursuant to R.I. Gen. Laws Chapter 5-5.1 and who are under written contract to provide security services to the cooperative cultivation and by law enforcement personnel during duty. H. Divestiture of Prohibited Material Financial Interest and Control 1. A licensed cooperative cultivation and interest holders/key persons thereof may not have any “material financial interest or control” in another licensed cooperative cultivation, a compassion center, or a licensed cultivator or vice versa. R.I. Gen. Laws § 21-28.6-14(a)(10). 2. If a licensed cooperative cultivation application is approved and any prohibited material financial interest or control has been identified by DBR or is otherwise known to the applicant, such interest or control must be divested prior to issuance of the cooperative cultivation license. The plan of divestiture shall be filed with DBR. 3. The duty to divest prohibited material financial interests and control is a continuing obligation of licensure. 4. The applicant/licensee has a continuing obligation to disclose any changes and shall provide written notice to DBR within thirty (30) days of any change of the information provided. I. DBR Approved Changes in Licensed Premises, Activities, Ownership and Control 1. The following changes related to a licensed cooperative cultivation must be pre-approved by DBR. a. A licensed cooperative cultivation shall provide DBR with a written request seeking approval at least ten (10) business days prior to the proposed effective date of any disassociation of a member from the licensed cooperative cultivation. b. A licensed cooperative cultivation shall provide DBR with a written request seeking approval at least sixty (60) calendar days prior to the proposed effective date of the any of the following changes: (1) There is a proposed new member of the licensed cooperative cultivation. (2) If organized as a legal entity, any change in such legal entity’s organization (e.g. change in legal form from corporation to limited liability company, change in the board of directors for corporation, change in managers/members for limited liability companies, etc.). (3) Any request for change in the licensed and inspected location. 2. For updates in information other than the categories requiring the above delineated prior notice, the licensed cooperative cultivation has a continuing obligation to update, amend and/or correct any information requested and/or submitted in the application process within ten (10) business days of any change in the information submitted and/or any material change in circumstances related to the application. 3. Requests for change in the licensed and inspected location for the cooperative cultivation are subject to the location-specific application requirements set forth in § 1.8(F) of this Part and no move may take place unless the request is approved by DBR after satisfaction of those application requirements. If a move is approved, DBR will provide specific instructions for movement of medical marijuana, which may involve consultation with law enforcement. J. Possession Limits 1. Marijuana plants possessed by a licensed cooperative cultivation are limited to the number of plants that are properly tagged in compliance with all provisions of § 1.12 of this Part and as specifically capped in accordance with § 1.12 of this Part. 2. Possession of usable marijuana by a licensed cooperative cultivation is limited to the lesser of: a. Ten (10) ounces of dried usable marijuana as capped by R.I. Gen. Laws § 21-28.6-14(a)(6)(i), or its equivalent; or b. The aggregate total maximum amount of dried marijuana or its equivalent that all members of the licensed cooperative cultivation are permitted to possess pursuant to R.I. Gen. Laws §§ 21-28.6-4(a), (f), and (p). K. Odor Control and Mitigation 1. Licensed cooperative cultivations shall take any and all reasonable efforts to prevent marijuana plant odors from exiting the interior of the approved structure to an extent that would significantly alter the environmental odor outside. For example, such reasonable efforts may include ventilation and filtration systems. L. Manufacturing 1. Licensed cooperative cultivations, qualified patient cardholders and primary caregiver cardholders are prohibited from engaging in the manufacture of marijuana products using a solvent extraction process that includes the use of a compressed, flammable gas as a solvent. R.I. Gen. Laws § 21-28.6-4(t). 2. Any other manufacturing method must be approved by DBR. If the manufacturing method uses a flammable/combustible material or heat source, the method must also be approved by the State Fire Marshal and/or local fire department. The licensed cooperative cultivation must provide any information and documentation as required to consider any such requests for approval. M. Safe Disposal of Marijuana and Marijuana Waste 1. Licensed cooperative cultivators must comply with the safe disposal requirements set forth in § 1.6.16 of this Part. N. Prohibited Sales and Transfers 1. A licensed cooperative cultivator, qualifying patient cardholder or primary caregiver is prohibited from selling, giving, or distributing marijuana to any person or entity including a compassion center. R.I. Gen. Laws §§ 21-28.6-4(c) and (i). 2. The transfer of medical marijuana and medical marijuana products for consideration by the licensed cooperative cultivation or any of its members is strictly limited to transfer amongst members of that cooperative cultivation and to transfer by caregiver members to their associated patients. O. Documentation Required to be Posted on the Premises 1. Pursuant to R.I. Gen. Laws § 21-28.6-14(a)(6)(iii), the cooperative cultivation license issued by DBR must be displayed prominently on the premises. The license displayed shall be the document printed for the most recent renewal period. a. “Displayed prominently” shall be deemed satisfied by posting the documentation on a wall with clear visibility and access within or immediately outside the premises. 2. Pursuant to R.I. Gen. Laws § 21-28.6-14(a)(5), each member of the licensed cooperative cultivation shall sign a written acknowledgement of the limitations of the right to use and possess marijuana for medical purposes in Rhode Island. Said acknowledgment shall be on such forms as directed by DBR. This documentation must be displayed prominently in the cooperative cultivation premises. 3. Pursuant to R.I. Gen. Laws § 21-28.6-14(a)(7)(i), a licensed cooperative cultivation must have the municipal inspection/compliance documentation (as further described in § 1.8(F)(4) of this Part) displayed prominently on the premises. P. Documentation Required to be Maintained on the Licensed Premises 1. A licensed cooperative cultivation shall maintain records and document: a. All actual costs of goods, materials, services or utilities for which they have incurred expenses while licensed; b. All reimbursements, contributions, or considerations received; c. The amount of medical marijuana plant material cultivated, harvested, and/or manufactured through the course of their cooperative cultivation activities; and d. A transfer log which must include the amount of medical marijuana supplied and transferred, the date of each transfer and the reimbursement amount the cooperative cultivation received. Each transfer must be initialed and dated by the receiving member. Q. Medical Marijuana Plant Tag Certificate Procedures Upon Termination of License 1. Whether by voluntary dissolution and surrender of license or by revocation of the license by DBR, all members of the cooperative cultivation shall comply with the procedures for returning plant tag certificates set forth in § 1.12(J) of this Part. 1.9 Registered Primary Caregivers 1.9.1 Eligibility A. A caregiver must receive a valid registry identification card from DBR pursuant to § 1.4 of this Part. B. In accordance with R.I. Gen. Laws § 21-28.6-4(d), every registered caregiver prior to growing medical marijuana must: 1. Submit documentation that they own the premises where they will grow medical marijuana and register grow tags in accordance with § 1.12 of this Part; or 2. Submit documentation on forms issued by DBR that shows they have the permission of the landlord/owner of the property to grow medical marijuana on the premises and register grow tags in accordance with § 1.12 of this Part. 1.9.2 Possession Limits and Manufacturing Prohibitions A. Pursuant to R.I. Gen. Laws §§ 21-28.6-4(f) and 21-28.6-4(g), no primary caregiver cardholder shall possess, for each patient cardholder to whom he or she is connected through the DBR’s registration process, an amount of marijuana which exceeds: 1. Twelve (12) mature and twelve (12) immature marijuana plants that are accompanied by valid medical marijuana plant tag certificates purchased from DBR; and a. Two and one-half (2.5) ounces of dried marijuana or its equivalent amount pursuant to § 1.14 of this Part; or b. A combination that does not exceed the usable marijuana limit of two and one-half (2.5) ounces pursuant to R.I. Gen. Laws § 21-28.6-4(f). B. Pursuant to R.I. Gen. Laws § 21-28.6-4(p), regardless of the number of patients a primary caregiver is registered with, no primary caregiver cardholder shall possess an amount of marijuana in excess of: 1. Twenty-four (24) mature and twenty-four (24) immature marijuana plants that are accompanied by valid medical marijuana plant tag certificates purchased from DBR; and a. Five (5) ounces of dried marijuana or its equivalent amount pursuant to § 1.14 of this Part; or b. A combination that does not exceed the usable marijuana limit of five (5) ounces pursuant to R.I. Gen. Laws § 21-28.6-4(p). C. Primary caregiver cardholders are prohibited from engaging in the manufacturing of marijuana products using a solvent extraction process that includes the use of a compressed, flammable gas as a solvent. D. Any other manufacturing method must be approved by DBR. If the manufacturing method uses a flammable/combustible material or heat source, the method must also be approved by the State Fire Marshal and/or local fire department. The primary caregiver cardholder must provide any information and documentation as required to consider any such requests for approval. 1.9.3 Reimbursement Requirements and Documentation A. Reimbursement Requirements – R.I. Gen. Laws § 21-28.6-4(i) 1. A registered primary caregiver cardholder may only receive reimbursement for the actual costs of goods, materials, services and utilities for which they have incurred expenses. 2. A registered primary caregiver may not receive reimbursement or compensation for his or her time, knowledge, or expertise. B Documentation Requirements – R.I. Gen. Laws § 21-28.6-4(i) 1. All registered primary caregiver cardholders shall maintain records and document: a. All actual costs of goods, materials, services or utilities for which they have incurred expenses while assisting their registered patient(s) with the medical use of marijuana; b. All reimbursements, contributions, or considerations received from their registered patient(s) for expenses incurred as their caregiver; c. The amount of medical marijuana plant material cultivated, harvested, and/or manufactured through the course of their caregiver activities; and d. A transfer log which must include the amount of medical marijuana supplied and transferred to their registered/appointing patient(s), the date of each transfer and the reimbursement amount the caregiver received. Each transfer must be initialed and dated by the receiving patient. 2. Registered primary caregivers shall maintain all logs, records and documentation of medical marijuana produced and/or manufactured, expenses, reimbursements, and patient transfers for the entire period that they provide medical marijuana to and are associated with their registered patient(s) and for a period of at least one year thereafter. 3. Caregivers must produce for review all logs, records, and documentation of their expenses, reimbursements, marijuana production and patient transfers to their registered/appointing patient(s), or to DBR, upon request. 1.9.4 Confidentiality Provisions A. Applications and supporting information submitted by qualifying patients, including information regarding their primary caregivers are confidential and protected in accordance with the Act. B. Any list(s) of the persons to whom DOH and/or DBR have issued registry identification card shall be maintained confidentially. 1. Individual names and other identifying information on the list: a. Shall be confidential and not be considered a public record pursuant to R.I. Gen. Laws § 38-2-2(4); and b. Shall not subject to disclosure, except to authorized employees of the DOH and DBR as necessary to perform official duties of the Departments and pursuant to the Act. 2. Pursuant to R.I. Gen. Laws § 21-28.6-6(l), DBR shall verify to law enforcement personnel whether a registry identification card is valid and may provide additional information to confirm whether a cardholder is compliant with the provisions of the Act and any regulations promulgated thereunder. This verification may occur by using a shared database, provided that any medical records or confidential information in this database related to a cardholder's specific medical condition is protected in accordance with the Act. 3. Pursuant to R.I. Gen. Laws § 21-28.6-6(l), DBR may notify law enforcement personnel about falsified or fraudulent information submitted to DBR, violations of the Act or any regulations promulgated thereunder. 1.9.5 Penalties for Violations A. Administrative penalties for violations may be imposed as set forth in § 1.13 of this Part. B. Criminal penalties for violations may be imposed as further described in § 1.13 of this Part. 1.10 Advertising A. Advertising Prohibitions (R.I. Gen. Laws §§ 21-28.6-6(g)(8), 21-28.6-12(f)(1)(viii) and 21-28.6-16(b)) 1. A licensee may not advertise in a manner which is observed by or targets the general public. All advertising must be restricted to a registered patient audience. 2. In the course of promoting a licensee’s brand, medical marijuana or medical marijuana products, a licensee may not advertise or cause any advertising or agent to advertise in a manner that: a. Is attractive to persons under twenty-one (21) years of age; b. Promotes non-medical use; c. Promotes activity that is illegal under Rhode Island law; d. Is contrary to or in direct violation of state or federal consumer protections; or e. Otherwise presents a significant risk to public health and safety. 3. Any advertising by or on behalf of a licensee shall not: a. Contain statements that are deceptive, false or misleading; b. Display images or representations of marijuana plants, marijuana or marijuana products; c. Display the consumption, use or transfer of marijuana or marijuana products; d. Include claims related to potency (beyond listing of cannabinoid content); e. Include any prices or the term “sale,” “discount,” “coupon,” “special” or similar terms; f. Depict activities or persons in conditions under the influence of marijuana, including but not limited to operating a motorized vehicle, boat or machinery, or persons who are pregnant or breastfeeding; g. Contain any content that can reasonably be considered to target individuals under the age of twenty-one (21), including but not limited to images of persons under twenty-one (21) years of age, cartoons, toys or similar images and items typically marketed towards persons under twenty-one (21) years of age or references to products that are commonly associated with persons under twenty-one (21) years of age or marketed to persons under twenty-one (21) years of age; h. Contain any imitation of candy advertising; i. Include the term “candy” or “candies”; j. Encourage the transportation of marijuana or marijuana products across state lines or otherwise encourage illegal activity; k. Assert that marijuana or marijuana products are safe because they are regulated by DBR or have been tested by a testing facility or otherwise make claims that any government agency endorses or supports marijuana; l. Make claims that marijuana has curative or therapeutic effects; m. Contain any health or physical benefit claims, including but not limited to health or physical benefit claims on labels or packaging; or n. Contain material that encourages excessive or rapid consumption. 4. No licensee or agent of a licensee may: a. Make any deceptive, false or misleading assertions or statements on any informational material, any sign or any document provided to a patient, registered caregiver or authorized purchaser; b. Distribute handbills in public areas or on publicly owned property; c. Advertise within the prohibited distance of one thousand (1,000) feet (or such greater distance if prescribed by the municipality in which the advertising is located) of the property line of an existing public or private school; d. Advertise on television, radio, or print media; e. Advertise in any manner that is viewable or can otherwise be perceived in a public space, including but not limited to billboards, bus wraps, benches, adopt a highway signs, or any format that may be viewable from roads or walkways; f. Engage in advertising via marketing directed towards location-based devices or electronic devices, including but not limited to cellular phones, unless the marketing is a mobile device application targeted to a registered patient audience and not a public audience, and that is installed on the device by the owner of the device who is a registered patient and includes a permanent and easy opt-out feature; g. Engage in any form of advertising which promotes application or enrollment into the program or the services of the practitioner or any other party which facilitates patient registration; or h. Permit use of the licensee’s trademarks, brands, names, locations or other distinguishing characteristics for third-party use on advertising in a manner that does not comply with § 1.10 of this Part or any other statute, rule or regulation. 5. In the event a third party has used a licensee’s brand, trademark, brand name, location or other distinguishing characteristics in an advertisement that does not comply with § 1.10 of this Part or any other statute, rule or regulation, the licensee must immediately notify DBR and issue a cease-and-desist notice to such third party. B. Digital, Electronic and Web-based Advertising 1. In addition to complying with the advertisement criteria and prohibitions outlined above, a licensee advertising on a digital, electronic or web-based platform must: a. Utilize appropriate measures to ensure that individuals visiting the platform are over twenty-one (21) years of age and are authorized to use and/or purchase listed products. If appropriate measures to ensure that individuals visiting the platform are over twenty-one (21) years of age are not available, the licensee shall not advertise on such a platform. b. Not utilize unsolicited pop-up or banner advertising on the platform other than on age-restricted websites for people twenty-one (21) years of age and over who consent to view marijuana-related material. C. Required Statements on all Advertising 1. A licensee must include the following statements on all advertising regardless of the medium: a. "For use only by qualified patients”; and b. The license number of the licensee. D. Objectionable and Non-Conforming Advertising 1. DBR reserves the right to take action, including the use of enforcement measures, against any licensee who fails to comply with the advertising provisions of this Part, including, without limitation, specifying a period of time by which the licensee shall cease the non-compliant advertising and remove any advertising still being published or displayed. 1.11 Quarantined Marijuana Products, Retests, Remediation and Recalls A. All marijuana products must undergo and comply with all required testing as stated in the DOH Testing Regulations in order to be designated as medical and be offered for sale by a licensed compassion center. Until the product is designated as medical or upon a recall of a medical product, all marijuana and marijuana products shall be quarantined in accordance with § 1.11 of this Part. B. Product that has yet to sampled for testing: 1. Prior to required testing samples being taken from a batch of marijuana plant material and/or a batch of processed concentrate or extract, a licensee must store the batch in one or more sealed containers enclosed on all sides, so as to: a. Prevent the product from being tampered with, transferred, or sold prior to sampling and compliant test results being reported; and b. Be able to be easily located. 2. Each container in which plant material and/or a batch of processed concentrate or extract is stored must be affixed with a label that includes the following information: a. The licensee’s license number and tradename or business name; b. The unique identifier generated by the Medical Marijuana Program Tracking System; c. Strain name or product name (waste excluded); d. The quantity of the product; and e. In bold, capital letters, no smaller than 12-point font, “PRODUCT NOT SAMPLED FOR TESTING”. C. Product that is awaiting/pending test results: 1. After required testing samples have been taken from a batch of marijuana plant material and/or a batch of processed concentrate or extract, a licensee must store the batch in one or more sealed containers enclosed on all sides, so as to: a. Prevent the product from being tampered with, or transferred, or sold prior to compliant test results being reported; and b. Be able to be easily located. 2. Each container in which the marijuana product is stored must be affixed with a label that includes the following information: a. The licensee’s license number and tradename or business name; b. The batch number generated by the Medical Marijuana Program Tracking System; c. Name and registry identification card number of the person who took the samples; d. Name and license number of the testing facility that will perform the tests; e. The test sample(s) unique identification number; f. The quantity of the product; g. The date the samples were taken; and h. In bold, capital letters, no smaller than 12-point font, “PRODUCT NOT TESTED”. D. Failed Test Batches 1. If a sample’s result exceeds an action level in 216-RICR-60-05-6 or as otherwise adopted by DOH, the testing facility must report to DBR and to the licensee that the sample failed the test for which the result exceeds the action level. 2. The licensee may then request in writing for permission from DBR to have the lab retest the sample. 3. If the sample is approved by DBR for a retest, the laboratory must follow the retesting guidelines outlined in § 1.11(E) of this Part. 4. If a retest is not granted, if the sample failed the retest, or if the batch is not approved for remediation, the batch that the sample was taken from must be immediately destroyed by the licensee. 5. The destruction of the failed test batch must be logged in the Medical Marijuana Program Tracking System. E. Retesting 1. In the event of a retest, the following protocol shall be followed: a. If there is enough remaining material from the initial sample to retest, the testing facility will use that sample material. b. If there is not enough material from the initial sample, the laboratory sample collector will collect another sample from the same batch using the same collection process. c. If the sample passes the retest, the sample will be deemed to have passed that test and the passing results will apply. 2. Within two (2) business days from issuance of final test results, the lab must upload results into the Medical Marijuana Program Tracking System if this system is currently in operation or submit the certificate of analysis to DBR as directed by DBR. F. Remediation 1. In the event a testing facility determines that a sample has failed testing, the compassion center or licensed cultivator may request from DBR in writing an opportunity to remediate the batch before requesting the batch be re-tested. DBR shall review and determine in its sole discretion whether the request to remediate will be approved. 2. The compassion center or licensed cultivator requesting an opportunity for remediation must demonstrate to DBR that the issues identified by the testing facility are of the kind that can be remediated. 3. In determining if remediation is appropriate, DBR shall consider the public health and safety consequences of remediation, as well as the frequency and history of failed tests from the requesting licensee. 4. Any testing of a remediated batch must be conducted by the same testing facility that originally determined that the sample failed testing. 5. No remediated harvest, lots or batches may be sold or transported until the completion and successful passage of quality assurance testing as required in 216-RICR-60-05-6 or as otherwise adopted by DOH. G. Recalls 1. DBR or DOH may require a licensee to recall any marijuana or marijuana product that the licensee has sold or transferred upon a finding that circumstances exist that pose a risk to public health, safety and welfare. a. The recall must be initiated by the licensee immediately as determined by their approved recall plan; and b. The licensee must comply with any additional instructions made by DBR. 2. A recall may be based on, without limitation, evidence that the marijuana, marijuana product, or medical marijuana product: a. Contains unauthorized pesticide(s); b. Failed a mandatory test and was not mitigated pursuant to testing protocols; c. Is contaminated or otherwise unfit for human use, consumption or application; d. Is not properly packaged or labeled; e. Was not cultivated, processed or manufactured by a licensee or otherwise is not in accordance with the Act, DBR regulations or DOH regulations; or f. Otherwise poses a threat to public health or safety as determined by DBR or DOH. 3. DBR may at any time require the destruction of medical marijuana product or marijuana product upon a finding that circumstances exist that pose a risk to public safety and health. 4. If DBR finds that a recall is required, DBR: a. Must notify the public and licensees of the recall; b. Must affect an administrative hold on all affected medical marijuana and/or medical marijuana products in the tracking system; c. May require a licensee to place all marijuana, marijuana product, medical marijuana and medical marijuana product in quarantine itself or with a third-party custodian at the licensee’s expense. d. May require a licensee to notify all individuals to whom such medical marijuana or a medical marijuana product was sold; and e. May require that the licensee destroy the recalled product. 1.12 Medical Marijuana Plant Tag Certificate Program A. Purpose 1. DBR administers all aspects of the medical marijuana plant tag certificate program in order to fulfill the state obligation to monitor and verify compliance with the statutory requirements that cardholders electing to grow: a. Do not exceed plant limits; b. Properly display the plant tag certificate indicating the amount of plants permitted; c. Do not grow at more than one location; and d. Distribute medical marijuana in accordance with the Act. B. Eligibility 1. Qualified patients and registered primary caregivers who have a valid registry identification card must apply to DBR for medical marijuana plant tag certificates in order to grow medical marijuana. 2. Qualified patient and registered primary caregiver cardholders who have been licensed to cooperatively cultivate are further subject to all requirements of § 1.8 of this Part. C. Applications and Renewals 1. Qualified patients and registered primary caregivers shall apply to DBR for medical marijuana plant tag certificates by submitting a completed application along with any applicable fee. 2. Applications to obtain or renew a medical marijuana plant tag certificate shall be on such forms and through such submission mechanisms as directed by DBR. Required application information shall include, but is not limited to: a. The registry identification number of the applicant, and, if the applicant is a caregiver, the registry identification number(s) of the patient(s) the caregiver applicant is authorized to grow for; b. A sufficiently specific identification of the single grow location selected by the applicant; and c. Current contact information. 3. In accordance with R.I. Gen. Laws § 21-28.6-15(a), any registered patient who elects to grow medical marijuana must: a. Submit documentation to DBR that they own the premises where they will grow medical marijuana, or b. Submit documentation to DBR that shows they have the permission of the landlord/owner of the property to grow medical marijuana on the premises; and c. Apply for and obtain the necessary medical marijuana plant tag certificate. 4. Before issuing a medical marijuana plant tag certificate, DBR will verify the validity of the applicant’s registry identification card and, if the applicant is a caregiver, the validity of the registry identification card(s) of the patient(s) the caregiver applicant is authorized to grow for as well as confirm the registration of the grow location in accordance with R.I. Gen. Laws §§ 21-28.6-15(a)(2) and (3). 5. Plant tag certificate fees will be paid in accordance with DBR’s instructions in the application. 6. Once an application has been approved and the plant tag certificate fee is paid to DBR, and the plant tag certificate will be made available by DBR or its approved vendor to the qualified patient or primary caregiver cardholder. D. Program Requirements 1. Every marijuana plant, both mature and immature, possessed by a qualified patient or registered primary caregiver cardholder must be represented by a medical marijuana plant tag certificate purchased through and issued by DBR. R.I. Gen. Laws § 21-28.6-15(a). 2. The number of medical marijuana plant sets for which a certificate can be purchased from DBR must be displayed on the plant tag certificate and shall not exceed the maximum number of mature and immature plants that are possessed by the purchaser under the Act and the DBR Regulations. 3. All qualified patient cardholders who choose to grow for themselves must obtain a medical marijuana plant tag certificate showing they are growing at least one (1) set of plants. 4. All registered primary caregiver cardholders must obtain a medical marijuana plant tag certificate showing they are growing at least one (1) set of plants for each qualified patient cardholder to whom the primary caregiver cardholder is connected through DOH’s or DBR’s registration process. The primary caregiver’s plant tag certificate must display the exact amount of plant sets ordered and in his/her possession. 5. Every member of a licensed cooperative cultivation must be in compliance with the above minimum tag requirements for their respective registration category as a condition of the cooperative cultivation license. 6. A medical marijuana plant tag certificate holder may not grow marijuana at more than one location or have another Rhode Island cardholder grow for them at any other location. R.I. Gen. Laws § 21-28.6-4(r). 7. Medical marijuana plant tag certificates will only be issued under the express and continuing condition that they will only be used for plants that are grown at a registered location and stored in a “secure indoor structure.” A “secure indoor structure” means a structure that satisfies all the following parameters: a. An enclosed area with secure four walls and a secure roof as determined by DBR. b. Equipped with locks and any other appropriate security devices that limit access to the individual authorized to grow the medical marijuana. Locks must be sufficient to discourage theft and unauthorized entrance. c. Medical marijuana is not visible from the street or other public areas. d. Reasonable efforts must be taken to prevent marijuana plant odors from exiting the building to an extent that would significantly alter the environmental odor outside. e. For licensed cooperative cultivations, consult § 1.8(F) of this Part, for any additional location restrictions and/or security requirements. 8. Medical marijuana plant tag certificates may only be used by the individual and/or licensed cooperative cultivation members to whom and at the location for which they were issued. They may not be transferred or assigned. 9. Medical marijuana plant tag certificates shall not be altered or duplicated. 10. Medical marijuana plant tag certificates do not authorize transport of marijuana plants outside the borders of the state of Rhode Island under any circumstances. 11. Medical marijuana plant tag certificates are only applicable to the location for which they were issued and shall not be transferred to another location within the state of Rhode Island unless approved in accordance with § 1.12(H) of this Part. 12. As a continuing condition of holding a plant tag certificate, plant tag certificate holders may not pursue any marijuana transaction or activity that is in violation of the Act, including pursuing any transaction through online advertising. E. Maximum Number of Plant Sets 1. Medical Marijuana Plant Tag Certificates are issued by a count of the medical marijuana plant “set.” A “set” is defined as one (1) mature plant and one (1) immature plant. 2. A qualified patient cardholder may purchase a certificate for no more than twelve (12) medical marijuana plant sets. The total number of plant sets shall be displayed on the plant tag certificate and correspond to the possession limits set by R.I. Gen. Laws §§ 21-28.6-4(a) and 21-28.6-4(f), respectively. 3. A primary caregiver cardholder connected with one (1) qualified patient cardholder through DOH’s or DBR’s registration process may purchase a certificate for no more than twelve (12) medical marijuana plant sets. The total number of plant sets shall be displayed on the plant tag certificate and correspond to the possession limits set by R.I. Gen. Laws §§ 21-28.6-4(f) and 21-28.6-4(g), respectively. 4. A primary caregiver cardholder connected with at least two (2) and up to five (5) qualified patient cardholders through DOH’s or DBR’s registration process may purchase a certificate for no more than twenty-four (24) medical marijuana plant sets. The total number of sets shall be displayed on the plant tag certificate and correspond to the possession limits set by R.I. Gen. Laws §§ 21-28.6-4(f) and 21-28.6-4(g), respectively. 5. No more than twenty-four (24) plant sets that are accompanied by a valid medical marijuana plant tag certificate shall be grown or otherwise located at any one dwelling unit or commercial unit. The number of qualifying patients or primary caregivers residing, owning, renting, growing or otherwise operating at a dwelling or commercial unit does not affect this limit. Pursuant to R.I. Gen. Laws § 21-28.6-4(r) . 6. A cooperative cultivation shall be limited to the purchase of the lesser of the following: a. Certificates for forty-eight (48) medical marijuana plant sets, pursuant to the maximum possession limits for a non-residential cooperative cultivation set by R.I. Gen. Laws § 21-28.6-14(a)(6)(i); or b. Certificates for the number of medical marijuana plant sets which would correspond to the total maximum amount of mature plants that each individual qualified patient cardholder and each individual primary caregiver cardholder growing at the cooperative cultivation is permitted to grow under the mature plant and immature plant possession limits delineated above. F. Fees 1. In accordance with R.I. Gen. Laws § 21-28.6-15(a)(1), a registered cardholder shall pay the following annual fees for each medical marijuana plant set. DBR may also charge processing fees for issuance of plant tag certificates. Category Fee Qualifying Patient Cardholder $25 per plant set reflected on the certificate Reduced-Registration Qualifying Patient Cardholder The fee shall be waived. See § 1.12(F)(2) of this Part. Primary Caregiver Cardholder $25 per plant set reflected on the certificate Primary Caregiver Cardholder – registered to grow for Reduced-Registration Patient(s) Only The fee shall be waived. See § 1.12(F)(3)(a) of this Part. Primary Caregivers registered to grow for 1 or more reduced-registration patients and 1 or more full-registration patients $25 per plant set reflected on the certificate. Eligible for waivers set forth in § 1.12(F)(3)(b) of this Part. 2. Reduced-registration patient – The fee shall be waived for patients for which DOH has determined qualify for reduced-registration due to income or disability status, as may be periodically determined by DOH. 3. Caregiver registered with DOH and/or DBR to grow for reduced-registration patient(s) - The fee shall be adjusted for caregivers registered DOH and/or DBR to grow for one (1) to five (5) qualifying patient cardholder(s) for which DOH has determined qualify for reduced-registration due to income or disability status. Specifically: a. If a primary caregiver is registered with DOH and/or DBR to grow for reduced-registration patients only, the plant tag certificate fees shall be waived entirely. b. If a primary caregiver is registered with DOH and/or DBR to grow for one (1) or more reduced-registration patients and one (1) or more full-registration patients, the primary caregiver shall be required to purchase at least one (1) plant set per full-registration patient at the rate of twenty-five dollars ($25) per plant set. In this case, the remainder of the plant sets up to the numerical limits delineated herein may be obtained with a fee waiver; provided, however, that no more than twelve (12) fee-waived plant sets may be obtained per reduced-registration patient. c. If a primary caregiver has used the plant tag certificate fee reductions cited above and then at any point prior to the next plant tag certificate renewal date that primary caregiver is in the position of having no associations with any reduced-registration patients, the primary caregiver shall take one of the following actions within ten (10) business days: (1) Register with DOH and/or DBR to grow for one (1) or more other reduced-registration patients; (2) Register with DOH and/or DBR to grow for one (1) or more full-registration patients and pay the balance of what would have been paid had the plant sets been obtained or renewed with no reduced-registration patients; or (3) If not registered with DOH and/or DBR to grow for any other existing or new patients within ten (10) business days, destroy the marijuana plants and return the plant tag certificate within an additional ten (10) business day period. G. Plant Tag Certificate Data 1. Medical marijuana plant tag certificates shall be printed and posted clearly and conspicuously in any room that holds medical marijuana plants associated with the plant tag certificate. 2. The certificate shall display, or be electronically embedded with, or otherwise contain the following data: a. Unique numerical, serial or alpha-numerical identifiers. b. A patient’s registration ID number. (1) For a qualified patient cardholder who is growing individually, the identifier shall correspond to his or her DOH patient registry identification card number. c. A primary caregiver’s registration ID number and the associated patient’s registration IDs. (1) For a primary caregiver cardholder who is growing individually, the identifier shall correspond to his or her DOH and/or DBR caregiver registry identification card number and the number(s) of the qualified patient cardholder(s) he or she is registered with DOH and/or DBR to grow for. d. For cooperative cultivations, the medical marijuana plant tag certificate shall contain identifiers that correspond to both the DBR license number for the cooperative cultivation as well as the DOH and/or DBR registry identification card numbers for the qualified patient cardholders and/or primary caregiver cardholders and their associated patients forming the cooperative cultivation. e. Expiration date of the plant tag certificate. f. Registered or licensed grow location. g. The number of plant sets the qualified patient or primary caregiver has lawfully obtained plant tag certificates for. h. Any other information DBR deems appropriate that is not subject to the patient privacy provisions of the Act. 3. DBR and DOH will have access to the above medical marijuana plant tag certificate data, through the Medical Marijuana Program Tracking System, or, if the System is not available, through other data sharing mechanisms. H. Duty to Update Information 1. The medical marijuana plant tag certificate holder has a continuing obligation to update all application information in a timely manner. 2. Contact information (legal name, physical and mailing address, phone number, e-mail address, etc.) must be updated no later than three (3) business days after the change. 3. If an individual qualified patient cardholder or primary caregiver cardholder seeks to change the grow location, they must seek prior approval from DBR in writing at least ten (10) business days before the change. a. The individual must first apply to DBR for transfer of the marijuana plant tag certificates, on such forms and through such mechanisms as DBR designates. b. DBR will verify the continued validity of the registry identification card(s) for which the certificates were issued as well as confirm the registration of the new grow location. c. Once the change of location application is approved by DBR, the transport shall be conducted within the time period prescribed and accompanied by a DBR receipt. I. Replacement of Lost or Stolen Plant Tag Certificates 1. Any stolen or lost medical marijuana plant tag certificates must be reported to DBR and law enforcement within one (1) business day from when the plant tag certificate holder becomes aware of the theft or loss of the plant tag certificate. 2. The circumstances surrounding the loss or theft must be disclosed to DBR. 3. If DBR determines that the loss or theft of the certificate is the result of improper use in violation of the DBR Regulations or the Act, then DBR may refuse to issue a replacement plant tag certificate. 4. For any periodic recall of the plant tag certificate by DBR (circumstances such as wearing out, new technology, etc.), no replacement cost will be assessed to the plant tag certificate holder. J. Return of Plant Tags Certificates 1. When return of plant tag certificate is required by the DBR Regulations, the medical marijuana plants associated with that plant tag certificate shall be destroyed prior to the required return date of the plant tag certificate. 2. A patient shall return his or her medical marijuana plant tag certificate to DBR within ten business (10) business days of any of the following occurrences: a. Election to no longer grow medical marijuana for himself or herself, b. Voluntary surrender of the registry identification card, or c. Revocation of the registry identification card. 3. A primary caregiver shall return the medical marijuana plant tag certificate associated with a particular patient within ten (10) business days of any of the following occurrences concerning that patient: a. Death, b. Termination of the relationship with the primary caregiver, c. Voluntary surrender of the registry identification card, or d. Revocation of the registry identification card. e. If during such ten (10) business day period, the primary caregiver re-associates with another qualified patient cardholder through DOH and/or DBR and re-associates the plant tag certificate to the other existing or new patient by registry identification number through DBR, the plant tag certificate need not be returned. 4. A primary caregiver shall return the plant tag certificate within ten (10) business days of his or her voluntary surrender of or DBR’s revocation of his or her registry identification card. 5. A cooperative cultivation shall return the plant tag certificates within ten (10) business days of surrendering its license (voluntarily or otherwise) or having its license revoked. a. If an individual registered patient or primary caregiver cardholder has medical marijuana, plants and associated plant tag certificate tied to a cooperative cultivation grow location and the cooperative cultivation license for that location is surrendered or revoked, the individual can only retain the medical marijuana, plants and associated tags that are associated with their individual registration (up to the individual maximum number of plants) if the individual’s registration as a patient or caregiver is still in good standing with DOH or DBR. b. A qualifying patient or primary caregiver cardholder who is growing as part of a cooperative cultivation shall comply with the following steps prior to transporting any marijuana plants to a new location: (1) The individual must first apply to DBR for transfer of the marijuana plant tags certificate to a new location, on such forms and through such mechanisms as DBR designates. (2) DBR will verify with DOH, as applicable, the continued validity of the registry identification card(s) for which the plant tag certificates were issued as well as confirm the registration of the new grow location. (3) Once the change of location application is processed, the transport shall be conducted in the time period prescribed and be accompanied by a DBR receipt. 6. The fact that a patient or primary caregiver is a member of a cooperative cultivation shall not in any way relieve his or her individual medical marijuana plant tag certificate return obligations under § 1.12 of this Part. 7. DBR will provide a person returning medical marijuana plant tag certificates with a receipt documenting the return. 8. For additional provisions regarding return of a plant tag certificate associated with licensed cooperative cultivations, consult § 1.8(Q) of this Part. K. DBR Monitoring Process and Requirements 1. If DBR has reasonable grounds to believe that a medical marijuana plant tag certificate holder, a primary caregiver who has not obtained or renewed a plant tag certificate, or a qualified patient cardholder who has made an election to grow but who has not obtained or renewed a plant tag certificate, may be in violation of the plant tag certificate requirements and/or plant possession limits set forth in the Act and/or the DBR Regulations, the below steps may be taken to verify compliance or prompt the person to come into compliance. 2. Written Notice: A written notice may be sent to the person explaining the plant tag certificate requirements and plant possession limits set forth in the Act and the DBR Regulations, why DBR has reason to believe the person may be out of compliance, and outlining the information the person may provide and/or the action(s) the person may take to verify or come into compliance. The recipient will have ten (10) business days from the date of mailing to reply to this notice. 3. Second Written Notice: If the recipient fails to respond to the first written notice with information that verifies compliance or fails to take the necessary actions to come into compliance, a second written notice may be sent, and the recipient will have an additional ten (10) business days from the date of mailing to reply. 4. Alternative Contact Attempt: If the recipient fails to respond to the second written notice with information that verifies compliance or fails to take the necessary actions to come into compliance, DBR may attempt to contact the person utilizing other contact methods through information provided on any plant tag certificate purchasing form submitted to DBR (e.g. telephone) or other contact information reasonably obtained by DBR (e.g. public telephone listings). 5. Reasonable Inspection: If an alternative contact attempt has been unsuccessful or, if after ten (10) business days following an alternative contact, the person has not yet provided information that verifies compliance or taken the necessary actions to come into compliance, then the person may be subject to reasonable inspection by DBR to ensure compliance with the plant tag certificate requirements and plant possession limits set forth in the Act and the DBR Regulations. DBR shall make an effort to schedule inspections in advance. 6. Nothing herein shall prohibit DBR from notifying law enforcement of suspected violations in accordance with § 1.13 of this Part or from scheduling or conducting a reasonable onsite inspection should the nature of the suspected violation require an immediate response. L. Revocation 1. Failure to comply with the plant tag certificates requirements may result in revocation pursuant to § 1.13 of this Part. M. Penalties 1. Administrative Penalties for violations of the plant tag certificate requirements may be imposed as set forth in § 1.13 of this Part. 2. Criminal Penalties for violations of the plant tag certificate requirements may be imposed as further described in § 1.13 of this Part. 1.13 Enforcement A. Inspections and Audits 1. Marijuana establishment licensees are subject to reasonable inspection by DBR. 2. DBR and its authorized representatives have authority to enter a marijuana establishment licensee’s premises at reasonable times to inspect in a reasonable manner the premises and all equipment, materials, containers, and other things therein, including without limitation all records, files, financials, sales, transport, pricing and employee data, research, papers, processes, controls and to inventory any stock of marijuana, labels, containers, packages, paraphernalia and other materials and products. 3. During any inspection, DBR and its authorized representatives may review the marijuana establishment licensee's confidential records, including compassion center dispensing records, which track transactions according to identifying information for the patient, primary caregiver, and/or authorized purchaser. Dispensing records for patient cardholders shall be tracked in accordance with the Act. 4. DBR may review and audit the books and records of marijuana establishment licensees to ascertain compliance with the Act, the DBR Regulations, and/or the DOH Regulations, including continued satisfaction of the statutory criteria considered in granting a license. The marijuana establishment licensee must make such books and records immediately available for reviewing and copying by DBR. DBR may retain an independent auditor to act as its agent for purposes of this section, the cost of which shall be borne by the marijuana establishment licensee. 5. Nothing herein shall be interpreted to limit the real time access of DBR to information stored in the Medical Marijuana Program Tracking System consistent with the Act. 6. DBR may coordinate with law enforcement or other state agencies to conduct inspections to evaluate compliance with the Act, regulations promulgated thereunder or any other applicable state laws. 7. DBR may retain a licensed testing laboratory to act as its agent to conduct testing for an inspection or investigation, the cost of which shall be borne by the marijuana establishment licensee. B. All hearings and enforcement actions shall be conducted in accordance with and subject to the Administrative Procedures Act, R.I. Gen. Laws Chapter 42-35 and the Department’s Rules of Procedure for Administrative Hearings, Part 10-00-2 of this Title. C. Discipline and Penalties 1. Pursuant to R.I. Gen. Laws § 21-28.6-9, DBR may, in accordance with and subject to the Administrative Procedures Act, R.I. Gen. Laws Chapter 42-35, take any combination of the following actions: a. Place on probation, revoke, suspend or refuse to issue any license registration, or card issued under the Act; b. Levy an administrative penalty; c. Order the violator to cease and desist such actions; d. Order testing of marijuana or marijuana products in accordance with § 1.11 of this Part and the DOH Regulations; e. Require a licensee, registrant, cardholder, person or entity conducting any activities requiring licensure or registration under the Act to take such actions as are necessary to comply or ensure compliance with Act and any regulations promulgated thereunder; and/or f. Take any other action authorized by the Act. 2. DBR may take any of the actions set forth above against a licensee or any person or entity conducting activity requiring a license or registration under the Act for any one or more of the following causes: a. Providing materially incorrect, misleading, incomplete, or untrue information in a license or registry identification card application, or in any other communications to DBR; b. Violating any applicable Rhode Island laws, including but not limited to the Act, the DBR Regulations or the DOH Regulations; c. Obtaining or attempting to obtain a license or registry identification card, or any local approval required in connection therewith through bribery, fraud, deceit or misrepresentation; d. Conducting any unlicensed or unregistered activity; e. Having a cannabis or medical marijuana license, registration, card, permit or its equivalent, denied, suspended, revoked or otherwise found to be in violation of any other state, province, district, or territory’s legalized cannabis program; f. Having been convicted, placed on probation, or having a case filed pursuant to R.I. Gen. Laws § 12-10-12 where the licensee or cardholder pleads nolo contendere, or having a case deferred pursuant to R.I. Gen. Laws § 12-19-19 where the licensee or cardholder pleads nolo contendere for any felony offense under R.I. Gen. Laws Chapter 21-28, the Rhode Island Controlled Substances Act, or any similar offense from any other jurisdiction; g. Failing to notify DBR of any disqualifying criminal conviction, plea of nolo contendere, case filing, or deferral as set forth in § 1.13(C)(2)(f) of this Part; h. Only for licensees or licensee-affiliated cardholders, having been convicted of or plead guilty or nolo contendere to any felony or to any crime of, or an act constituting a crime of, forgery, embezzlement, obtaining money under false pretenses, bribery, larceny, extortion, conspiracy to defraud, or any other similar offense or offenses involving cannabis or medical marijuana, in a court of competent jurisdiction of this state or any other state or of the federal government; i. Exceeding the possession limits set forth in the Act or the DBR Regulations; j. Failing to comply with the plant tag certificate requirements in the Act or § 1.12 of this Part; k. Forging another's name to an application or to any document related to a DBR license, registration or card; l. Failing to furnish to DBR or any person acting on behalf of DBR within the time required by any written notice from DBR any information pertaining to a license, registration and/or operations that may be requested by DBR pursuant to the Act or the DBR Regulations; m. Knowingly accepting, purchasing or receiving medical marijuana, medical marijuana products, marijuana or marijuana products from an individual or business entity who is not licensed but who is required to be licensed by DBR; n. Operating, participating in or facilitating a medical marijuana emporium; or o. In conjunction with any violation of §§ 1.13(C)(2)(a) through (n) of this Part, any conduct reflecting adversely upon the licensee's or cardholder’s fitness to engage in the medical marijuana industry. 3. It is sufficient cause to discipline a marijuana establishment licensee in accordance with the above if a principal officer, board member, employee, agent, or volunteer affiliated with a marijuana establishment licensee violates the Act or any regulations promulgated thereunder when acting in their capacity as a principal officer, board member, employee, agent, or volunteer of the marijuana establishment licensee. 4. Possession of Marijuana in Violation of the Act or the DBR Regulations a. Pursuant to R.I. Gen. Laws § 21-28.6-15(b)(3), if any patient cardholder, primary caregiver cardholder, licensed cooperative cultivation, compassion center, licensed medical marijuana cultivator, or any other person or entity is found to have marijuana plants or marijuana material without valid medical marijuana plant tag certificates or which are not tracked in accordance with the DBR Regulations, DBR shall impose an administrative penalty in accordance with the DBR Regulations on the patient cardholder, primary caregiver cardholder, licensed cooperative cultivation, compassion center, licensed medical marijuana cultivator, or any other person or entity for each untagged marijuana plant or unit of untracked marijuana material. 5. Pursuant to R.I. Gen. Laws § 21-28.6-7(a)(4), medical marijuana emporiums are expressly prohibited. 6. Revocation of Plant Tag Certificates a. R.I. Gen. Laws § 21-28.6-15(b)(1) authorizes DBR to revoke medical marijuana plant tag certificates for violation of any provision of the Act, the DBR Regulations, or the DOH Regulations. b. Grounds for revocation of medical marijuana plant tag certificates shall include, but are not limited to: (1) Failure to maintain or timely renew the required underlying qualifying patient, primary caregiver, or cooperative cultivation registration or license, as applicable. (2) Having excess and/or untagged plants; (3) Misrepresentation in applying for plant tag certificates; (4) Permitting unauthorized use of plant tag certificates by another party; (5) Growing in more than one location; (6) Transferring plants from the registered grow location without complying with the rules for said transport; (7) Failing to maintain or produce cultivation records in accordance with § 1.9.3 of this Part; and (8) Other violations of the Act or regulations promulgated thereunder which may result in the suspension of a registry identification card. c. If DBR revokes the registration of a primary caregiver due to disqualifying criminal information as delineated in the Act or for any other reason, that primary caregiver’s medical marijuana plant tag certificate shall be automatically and immediately revoked by DBR. d. If DOH revokes the registration of a patient for any reason, any medical marijuana plant tag certificate issued to that patient and/or issued to any caregiver registered with DBR to grow for that patient shall be automatically and immediately revoked by DBR. e. Before a medical marijuana plant tag certificate is revoked pursuant to this section, the certificate holder will be given ten (10) business days advance notice to destroy the marijuana plants that were previously associated with the plant tag certificate and to then return said plant tag certificate within the 10-day timeframe. f. The fact that a patient or primary caregiver is a member of a cooperative cultivation shall not in any way preclude revocation of their medical marijuana plant tag certificates as provided in § 1.12(L) of this Part. D. Administrative Penalties 1. Pursuant to R.I. Gen. Laws §§ 21-28.6-9(e)(1)(ii), 21-28.6-12(f)(1) and 21-28.6-15(b)(3), DBR adopts the following schedule of administrative penalties with respect to violations of the Act, the DBR Regulations or any other applicable laws pertaining to a license, registration and/or operations in connection therewith: Violation Administrative Penalty Violations by a compassion center or other marijuana establishment licensee, where DBR determines that a violation does not pose an immediate threat to public health or public safety A penalty of not less than $500, but not more than $5,000 per violation per day. Violations by a compassion center or other marijuana establishment licensee, where DBR determines that a violation poses an immediate threat to public health or public safety A penalty of not less than $2,000, but not more than $100,000 per violation per day. Penalties of untagged/untracked plants, marijuana or marijuana products A penalty of up to $5,000 per plant/ounce/unit of product (as applicable) per day Violations by any person or entity who is conducting activities requiring licensure or registration by DBR under the Act or these Regulations without such licensure or registration, or who is otherwise violating any provisions of the Act or these Regulations A penalty of up to $100,000 per violation per day E. Criminal Penalties and Law Enforcement 1. Administrative actions including administrative penalties imposed by DBR on account of violations hereunder may be in addition to criminal penalties provided for under R.I. Gen. Laws Chapter 21-28, the “Rhode Island Controlled Substances Act”. 2. Pursuant to R.I. Gen. Laws § 21-28.6-6(l), DBR shall verify to law enforcement personnel whether a registry identification card is valid and may confirm whether the cardholder is compliant with the provisions of the Act and the regulations promulgated thereunder. 3. Pursuant to R.I. Gen. Laws § 21-28.6-6(m), nothing in the Act or the DBR Regulations shall be construed as to prohibit law enforcement, public safety, fire or building officials from investigating violations of, or enforcing state law. 4. Pursuant to R.I. Gen. Laws § 21-28.6-6(m), DBR may notify law enforcement about falsified or fraudulent information submitted to DBR in violation of the Act or the DBR Regulations. 5 Nothing in the DBR Regulations shall alter or impair the ability of law enforcement to confiscate excess, untagged, and/or invalidly tagged marijuana plants or marijuana material and revoked and/or otherwise invalid plant tags in accordance with applicable criminal law and procedures. 6. DBR may provide information to law enforcement in order to verify the validity of plant tags, tag data, cardholder registration and compliance with the Act and the DBR Regulations through data sharing mechanisms, in accordance with the Act. 1.14 Marijuana Equivalency Table A. The following equivalency table shall be used to ascertain whether the amount of various forms of marijuana is compliant with the dried useable possession limits set forth in the Act and the DBR Regulations. “Single serving unit” as used in the below table means no more than 10 mg of THC per single serving unit. Marijuana Flower Weight Equivalent Number of 10mgs of THC Single Serving Units 5 ounces 415 THC single serving units 2.5 ounces 125 THC single serving units 1 ounce 83 THC single serving units .25 ounces 21 THC single serving units 1 gram 3 THC single serving units Marijuana Flower Weight Equivalent grams of Concentrate 5 ounces 38.5 grams 2.5 ounces 19.25 grams 1 ounce 7.7 grams .25 ounces 1.9 grams 1 gram 0.3 grams Wet Flower Weight Dry Flower Weight (20% of Wet Flower Weight 50 ounces 10 ounces 37.5 ounces 7.5 ounces 25 ounces 5 ounces 12.5 ounces 2.5 ounces 1.15 Compassion Center Application Zones A. Pursuant to R.I. Gen. Laws § 21-28.6-12(c)(3), DBR has conducted an evaluation and analysis with respect to the criteria set forth in § 1.2(C)(1) of this Part and determined, based upon that analysis, that upon DBR’s announcement of the first open application period, DBR will accept applications for six (6) new compassion center licenses in the application zones as indicated in the table below. Zone Geographic Area of Zone Number of New Licenses Available in the Zone During First Open Application Period Zone 1 Burrillville, Cumberland, Glocester, North Smithfield, Smithfield and Woonsocket 1 Zone 2 Central Falls, Johnston, Lincoln, North Providence and Providence 1 Zone 3 Coventry, Foster, Scituate, West Greenwich and West Warwick 1 Zone 4 Cranston, East Greenwich, North Kingstown and Warwick 1 Zone 5 Charlestown, Exeter, Hopkinton, Narragansett, Richmond, South Kingstown and Westerly 1 Zone 6 Barrington, Bristol, East Providence, Jamestown, Little Compton, Middletown, Newport, New Shoreham, Pawtucket, Portsmouth, Tiverton and Warren 1 *There are three (3) compassion center licenses issued, one each in Zone 2, Zone 4, and Zone 6. 1.16 Severability If any provision of the DBR Regulations, or the application thereof to any person or circumstance, is held to be invalid, such invalidity shall not affect other provisions or application of the DBR Regulations which can be given effect without the invalid provision or application, and to this end the provisions are declared to be severable.