Rules and Regulations Related to the Medical Marijuana Program Administered by the Department of Business Regulation

Regulation Authority:

Chapter 21-28.6 of the Rhode Island General Laws entitled “The Edward O. Hawkins and Thomas C. Slater Medical Marijuana Act,” as amended, including amendment by the 2016 Public Laws, Chapter 142

Purpose and Reason:

Statement of Purpose: These proposed regulations create a new regulatory framework for the medical marijuana program as administered by the Department of Business Regulation in order to ensure program stability, increase safe and dependable access to medical marijuana, and increase oversight and accountability in the program to curtail diversion to the black and grey markets. 1. In response to commentary received from the Rhode Island Department of Environmental Management, Division of Agriculture and Resource Marketing (DAG), the following changes were made: a. Sections 1.4(J)(9)(b)(6) and 1.7(I)(8)(b)(6) have been changed to delete the sentence “The product must be registered for sale in Rhode Island” and replace it with “The product must be a currently registered pesticide product eligible for sale in Rhode Island as determined by the Rhode Island Department of Environmental Management.” b. New Sections 1.4(J)(9)(b)(7) and 1.7(I)(8)(b)(7) have been added to provide: “The product must be used in accordance with any and all use instructions on the label.” c. Section 1.4(J)(9)(e) has been revised to read as follows: “As a DBR record-keeping requirement, compassion centers 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 the Rhode Island Department of Environmental Management, and is intended to apply in addition to that requirement, where relevant." The same change has been made to Section 1.7(I)(8)(e) for licensed cultivators. 2. Also regarding the pesticide provisions, another commenter suggested using light as a proxy for determining whether the plant is at a stage during which pesticides should no longer be applied for safety reasons. Based on this comment, the second sentence was added to the following quoted provisions of 1.4(J)(9)(c) and 1.7(I)(8)(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.” 3. Cultivator Micro-license. In response to commentary criticizing high cultivator license costs and suggesting a smaller scale cultivator license, DBR changed the Regulations to include a micro-license which would have the following features: 0 – 2,500 sq. feet facility limit; $5000 non-refundable application fee; $5000 annual license fee; inventory limits of 50 mature plants and 50 seedlings until the Medical Marijuana Program Tracking System is in place; and an uncommitted inventory limit of 2.5 lbs. See Sections 1.5(C)(1), 1.5(E)(2), and 1.7(C)(1) as revised. 4. Destruction of uncommitted inventory by licensed cultivators. In response to commentary suggesting that the thirty (30) day period given for cultivators to sell or destroy excess uncommitted inventory was too short, DBR changed Section 1.7(C)(3)(c) to extend this period to forty-five (45) days. Relatedly, commentary was also received suggesting that cultivators be permitted to “give” excess uncommitted inventory to patients; however, this would be prohibited by the Act which in R.I. Gen. Laws § 21-28.6-16 provides that a cultivator may only deliver or transfer medical marijuana to a registered compassion center. 5. Cooperative Cultivations. a. Commentary was received advancing a differing interpretation of the Act with respect to how cooperative cultivations should be defined. The Act does not define “cooperative cultivation”, “cooperative cultivation license” or “cooperatively cultivating” in statute but it does give DBR regulatory authority to promulgate regulations clarifying the licensing and operation of cooperative cultivations in R.I. Gen. Laws § 21-28.6-14(a)(10). DBR is confident that the cooperative cultivation regulations it has adopted under this statutory authority are reasonable and in furtherance of the intent of the Act. In reviewing this comment, DBR made a determination to simplify and clarify the definition of cooperative cultivation in Section 1.8(B)(1) which now reads as follows: “Cooperative cultivation” shall mean two (2) or more qualifying patient or primary caregiver cardholders that elect to cooperatively cultivate marijuana in the same dwelling unit or commercial unit within the limits and subject to the requirements of a cooperative cultivation license under the Act and these regulations. This excludes the situations of two (2) or more qualifying patient or primary caregiver cardholder(s) who are primary residents of the same dwelling unit where the medical marijuana plants are grown and who do not elect to grow together within the limits and subject to the requirements of a cooperative cultivation license under the Act and these regulations; provided nothing herein should be deemed to absolve persons in such a situation from complying with the requirements that all medical marijuana plants must be properly tagged and not exceed the plant limits of R.I. Gen. Laws § 21-28.6-4(q)(if election to grow as a licensed cooperative cultivation is not made, no more than twenty-four (24) plants may be grown at a single dwelling unit or commercial unit). See also R.I. Gen. Laws § 21-28.6-14(entitled “Cooperative Cultivations”); R.I. Gen. Laws § 21-28.6-3(10)(defining “dwelling unit”); R.I. Gen. Laws § 21-28.6-3(3)(defining “commercial unit”). b. In response to commentary critical of the prohibition on firearms as a security measure for non-residential cooperative cultivations, Section 1.8(G)(4) was changed to permit use of security guards licensed by the Office of the Rhode Island Attorney General pursuant to R.I. Gen. Laws § 5-5.1-13 and who are under written contract to provide security services to the non-residential cooperative cultivation. Reasonable alternative security and safety measures in the Regulations, as posted, also include locks, lighting, written security and emergency plans, and coordination with law enforcement. 5. Licensed Premises Siting Comments. a. In response to commentary requesting clarification as to how distance is to be measured for purposes of the restriction on siting a medical marijuana facility within 1000 feet of a preexisting public or private school, the following language was added to Sections 1.2(C)(2)(d)(2) and 1.5(D)(4)(b)(4): “For purposes of this paragraph, the 1000 foot distance shall be measured from the secured [compassion center/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.” b. In response to commentary expressing concern with ambiguity in local zoning laws for licensed cultivator applicants, DBR added the following language to the Regulations in Section 1.5(D)(4): “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.” Relatedly, commentary was received suggesting that DBR pre-empt municipalities from banning cultivator licenses through zoning ordinances. While DBR has provided the above-cited guidance relative to zoning concerns, a request for complete municipal pre-emption would need to be addressed to the legislature. Also related, commentary was received indicating that the Regulations should require training of municipalities on issuance of local approvals for medical marijuana businesses such as zoning. DBR does not have the regulatory authority to require that municipalities undergo training. Municipalities may contact DBR if they have any questions about the program. 6. Licensed Premises Inspections. In response to commentary suggesting the regulation provide for a regular frequency of inspections for compassion centers and cultivators at least on an annual basis and that annual renewals should include a recent inspection, DBR added Sections 1.2(H)(4) and Sections 1.5(H)(3) to read: “An annual inspection shall be part of the annual renewal process.” 7. Packaging and Labeling. On the one hand, commentary was received opining that packaging and labeling requirements were overly restrictive. On the other hand, commentary was received suggesting more stringent and comprehensive labeling and packaging requirements. DBR has determined that the Regulations, with the changes listed below, achieve a reasonable balance considering patient safety concerns and curtailing risk of use by minors and unauthorized individuals while recognizing that packaging and labeling requirements that are too restrictive may be cost-prohibitive and with respect labeling may prevent product recognition which can stifle the steady supply and variety of medicine and further achieve a balance of being sufficiently clear for compliance guidance while recognizing that not every conceivable packaging and labeling scenario can be addressed in regulatory language. Specifically the changes to the Regulation regarding packaging and labeling are as follows: a. Sections 1.4(I)(8)(e) and 1.7(H)(8)(e) were edited to grammatically clarify language posted with the clear intent that both the total estimated amount of THC and total estimated amount of CBD are required to be listed on the label. b. Sections 1.4(I)(8)(d) and 1.7(H)(8)(d), which require the label list the total weight in ounces and grams or volume as appropriate, were changed by adding: “Weight and volume must be determined using accurately calibrated equipment which equipment must also comply with any other applicable state laws.” c. New Sections 1.4(H)(10) 1.7(H)(10) were added to read: “Notwithstanding any of the product labeling requirements set forth in this Section [1.4 (H)/1.7(H)], application may be made to DBR for approval to affix a two inch (2”) by two inch (2”) logo or graphic, which may be colored, for the purpose of identifying the compassion center selling and/or the cultivator producing the product.” d. Sections 1.4(H)(5)(b) and 1.7(H)(5)(b) were amended by adding “or other similar sealing method pre-approved by DBR” to the requirement that “liquid marijuana products may also be packaged in a bottle and sealed using a metal crown cork style bottle cap.” 8. Work place safety and sanitation at licensed premises. Commentary was received expressing concerns over compassion center and licensed cultivator worker safety and sanitation. The following changes were made to the Regulations to address these concerns: a. New Section 1.4(J)(7)(m) was added to provide: “In addition to the safety and sanitary equipment including personal protective equipment that the compassion center is required to furnish its employees involved in marijuana manufacturing and extraction pursuant to Section 1.4(J)(4)(D) of these regulations, the compassion center must also furnish its employees with proper safety equipment for other types of work assigned as part of the compassion center operations.” A corresponding change was made by adding Section 1.7(I)(6)(m). b. In response to a comment suggesting the compassion center and licensed cultivator manufacturing and extraction provisions expand the requirement that work surfaces where medical marijuana products are manufactured be non-porous, non-absorbent, and easily cleanable, Sections 1.4(J)(4)(f) and 1.7(I)(4)(g) were changed to add in “the walls and floors in the areas in which such products are manufactured.” c. With respect to medical conditions that may pose a risk of contamination to trigger compassion centers and licensed cultivators to exclude an employee from operations until the condition is cleared, commentary was received suggesting that the list of examples be expanded to specifically include the flu, colds, strep or pulmonary disease. In response to this commentary, DBR made technical amendments to Sections 1.4(J)(7)(k) and 1.7(J)(7)(k) to add additional clarity to the clear intent of the posted regulations to be a non-exhaustive list of medical conditions, changing the terms “include” to “include but not necessarily limited to.” Compassion centers and licensed cultivators will have to use their best judgment with respect to these provisions as DBR Regulations cannot specifically account for every conceivable existing or future medical contamination threat nor does it have the subject matter expertise to do so. 9. Authorized medical marijuana transports by licensees. In response to commentary indicating alternatives to the two person per authorized transport vehicle requirement that were represented as recommended by security professionals, Sections 1.4(J)(3)(g) and 1.7(I)(3)(f) of the Regulations were amended to provide: “Authorized transports must be in compliance with one of the following minimum requirements: (i) an authorized transport may use a single authorized transport vehicle so long as it is operated/occupied by a minimum of two authorized transport cardholders and is subject to the requirement that at least one such cardholder shall remain in the authorized transport vehicle at all times; or (ii) an authorized transport may use two or more authorized transport vehicles that are operated/occupied by authorized transport cardholders provided the authorized transport vehicles are traveling together at all times during the authorized transport.” 10. Fine for failure of employee to return registry card when no longer employed. In response to commentary suggesting that there be a penalty for failure of a compassion center employee to return his or her registry identification card within ten (10) days of termination of the employment, Section 1.3(H)(3) was changed by adding the following sentence: “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.” The $150 is consistent with the fine the legislature set for failure of a compassion center employee to update name and address information within ten days under R.I. Gen. Laws § 21-28.6-12(c)(9) and is a reasonable deterrent to prevent invalid cards from being in circulation. The same change was made for licensed cultivator employees for the same reasons. See Section 1.6(H)(2) as revised. 11. Compassion center patient outreach activities. In response to commentary suggesting editing Section 1.4(J)(5)(c) regarding required compassion center patient outreach activity so as not to specifically describe smoking techniques as “safe,” the Regulations were changed to read as follows: “Providing applicable usage techniques and any corresponding safety information to registered qualifying patients.” Furthermore, it should be noted that the Regulations, as posted, had also addressed concerns about smoking safety by requiring the following label warning in Sections 1.4(I)(9)(i) and 1.7(H)(9)(i): For product to be smoked, “Warning: Smoking is hazardous to your health.” 12. Compassion center customer service. In response to commentary expressing concern about compassion centers refusing entry to registered patients, caregivers, and authorized purchasers, DBR changed the Regulation to add that the Operations Manual must include “customer service protocols.” Compassion centers should be guided by such protocols and security policies when handling the issue of refusing entry. See Section 1.2(H)(2)(J). 13. Illegal marijuana transaction advertising by holders of plant tags. Commentary was received regarding advertising restrictions, including a request that DBR address the issue of patients and caregivers illegally selling marijuana online on Craigslist. In response, DBR has added Section 1.9(G)(6) to provide: “As a continuing condition of holding plant tags, plant tag holders may not pursue any marijuana transaction that is in violation of the Act, including pursuing such a transaction by online advertising.” 14. Plant Tag Fines. In response to commentary expressing concern about DBR’S discretion to impose a fine between $25 and $5000 per plant for plant tag violations where the number of plants exceed the statutory limit, DBR developed the following tiered fine approach: Number of plants exceeding the relevant possession limits of the Act Fine assessed per plant 1 – 3 plants over limit $25 assessed per plant 4 – 8 plants over limit $100 assessed per plant 9 – 12 plants over limit $250 assessed per plant 13 – 15 plants over limit $1000 assessed per plant 16 – 24 plants over limit $2500 assessed per plant 25 or more plants over limit $5000 assessed per plant 15. Non-substantive changes included fixing punctuation and text formatting errors and adding several cross-references between related sections of the Regulations.