230 R.I. Code R. 230-RICR-80-05-1.1

Current through November 7, 2024

Section 230-RICR-80-05-1.1 - Definitions and Authority

1.1.1Definitions

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.

1.1.2Limitations 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.

1.1.3DBR'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.

1.1.4DBR 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.

1.1.5Procedural 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.

1.1.6Acceptance 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.

1.1.7Incorporated 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.

230 R.I. Code R. 230-RICR-80-05-1.1

Amended effective 3/25/2020