230 R.I. Code R. 230-RICR-80-10-1.11

Current through October 15, 2024

Section 230-RICR-80-10-1.11 - Operational Requirements

A. Traceability

1. Licensees shall track hemp from seed to sale in accordance with their approved application and § 1.6(E)(4) of this Part.

2. Plant material from one lot is prohibited from being commingled with plant material from any other lot.

B. Limitation on Sales and Transfers

1. Licensed growers, handlers and distributors shall only, transfer and transport hemp including hemp derivatives, hemp-derived consumable CBD products and seeds to another licensee or such other persons who are in compliance with applicable laws regarding the possession, processing and sale of industrial hemp. A licensee may only receive hemp including hemp derivatives, hemp-derived consumable CBD products and seeds from another licensee or certified source whether intrastate or interstate, provided the licensee's or certified source's products comply with the Act, these regulations, and all other applicable laws.

2. Any transfer to or from an approved testing facility shall be in accordance with transfer procedures adopted by the licensee and the approved testing facility and which comply with any applicable rules and regulations contained in Licensing Analytical Laboratories for Sampling and Testing Cannabis, 216-RICR-60-05-6.

3. Nothing in these regulations shall be construed to prohibit wholesale or retail sale of hemp, hemp seeds, hemp derivatives and/or products provided the hemp, hemp seeds, hemp derivatives and/or products comply with the Act, these regulations, and all other applicable laws.

4. Licensees may only send, sell, buy and/or receive industrial hemp, hemp seeds, hemp derivatives and hemp-derived consumable CBD products from another licensee or a certified source whether interstate or intrastate provided the sender and/or recipient's products comply with the Act, these regulations and other applicable laws.

5. § 1.11(B)(4) of this Part shall not be construed as a prohibition on the transportation or shipment of hemp, hemp derivatives, or hemp products through the State of Rhode Island, nor shall it be construed to prevent the sale of hemp products or hemp-derived consumable CBD products from a retail licensee to a consumer.

C. Inventory Tagging

1. Pursuant to R.I. Gen. Laws § 2-26-5(c)(3), every hemp crop or production batch possessed by a licensee must be tracked from seed to sale. A unique identifier must accompany industrial hemp through any production the licensee is undertaking, from harvest through packaging, distribution and sale to a consumer.

2. Upon direction by DBR, labels and any other tracking method required shall be placed in a manner to clearly display their association with a particular parcel of land, plant material, or product. This may include but is not limited to affixing the label/other tracking display to a post or sign on the parcel of land where hemp is grown, affixed to a drying rack, affixed to a container, or package containing product.

3. Each acre or parcel of land, as defined by DBR, containing hemp must be labeled with the following information:

a. DBR license number;

b. Unique identifier;

c. Licensed premises location; and

d. Any other information or technical functions DBR deems appropriate (such as radio frequency identification).

4. Any container intended for the storage and/or transport of hemp and/or hemp derivatives must:

a. Protect the product from contamination;

b. Not impart any toxic or deleterious substance to the hemp or hemp product;

c. Be labeled with the following information:

(i) DBR license number;

(ii) Unique identifier that tracks hemp through each stage of growth, production, distribution and sale;

(iii) Quantity;

(iv) Licensed premises location; and

(v) Any other information or technical functions DBR deems appropriate (such as radio frequency identification).

5. Seed to sale tracking, payment of the biennial license fee, and compliance with the requirements of § 1.11(C) of this Part shall be deemed to satisfy the requirements of R.I. Gen. Laws § 2-26-5(c)(3).

D. Inventory Control

1. A licensee shall follow inventory control measures, which may include but are not necessarily limited to the licensee being directed to:

a. Conduct an initial comprehensive inventory of all hemp, including hemp plants, hemp seedings, hemp-derived products and hemp-derived consumable CBD products.

b. Conduct subsequent comprehensive inventories at intervals not to exceed twelve (12) months from the date of the previous comprehensive inventory.

c. Conduct a monthly inventory review of hemp plants, stored hemp, hemp-derived products and hemp-derived consumable CBD products.

2. Licensees shall conduct and provide the results of the inventory control measures specified in § 1.11(D)(1) of this Part if required by DBR regardless of the availability and use of the Program Tracking System.

E. Security

1. General Security Requirements

a. Use or carry of firearms on the premises and/or perimeter of the licensee 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 licensee and by law enforcement personnel during duty.

2. Emergency Plan

a. The licensee 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 Program Tracking System. The plan shall include training for employees on crime prevention and personal safety techniques.

3. Record-Keeping

a. The licensee shall maintain the following documentation on-site and with digital back-up for a period of at least thirty-six (36) months as applicable:

(1) 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.

(2) Testing results, all certificates of analysis and sampling records;

(3) Any pesticide use as required by § 1.11(L)(4) of this Part.

(4) Emergency notification reports as required by § 1.11(E)(4) of this Part.

(5) A description of the land on which licensee's hemp is grown including the requirements of § 1.6(D) of this Part.

(6) All sales.

(7) All documentation for the intrastate transfer and receipt of hemp, hemp-derivatives and hemp-derived consumable CBD products demonstrating the products' compliance with the sending or receiving state's licensing of industrial hemp and/or hemp-derived products, including but not limited to any document regarding certification as defined in § 1.5(E) of this Part.

(8) Any documentation of or relating to the destruction of hemp plants or hemp material.

4. Emergency Notifications and Reports

a. Licensees shall provide notification of emergency events to DBR and municipal and/or state law enforcement as outlined below.

b. Immediately upon discovery of the event, the licensee shall provide telephone notification to the appropriate municipal and/or state law enforcement authorities regarding any of the following "emergency events":

(1) Theft or burglary or an attempt thereof.

(2) Any fire.

(3) A natural disaster that results in the destruction of or damage to hemp or hemp products.

(4) Any other event which requires response by law enforcement or public safety personnel.

c. The licensee shall provide e-mail notification to DBR immediately upon discovery of any data breach or cybersecurity threat to the Program Tracking System, and within twenty-four (24) hours of discovery of any other emergency event as defined above. A follow-up telephone notification to DBR shall be provided not later than the next business day.

d. The licensee shall submit a follow-up written report to DBR within five (5) business days 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.

e. Any notification and report of an emergency event required to be made to DBR pursuant to these regulations shall be made using the mailing address, telephone number, and/or e-mail address provided by DBR to approved licensees.

f. Upon written direction to the licensee, DBR may require that the written and telephone notifications and reporting must be replaced or supplemented by notifications and reporting through the Program Tracking System or any other electronic system or means DBR mandates the licensee to utilize.

F. Food Safety

1. Any hemp-derived product or hemp-derived consumable CBD product that may be used for consumption purposes must be produced and distributed consistent with any applicable state or local food processing and safety regulations, and the applicant shall be responsible to ensure its compliance with such regulations and any applicable licensing requirements.

G. Allowable Product Types

1. Licensees shall be permitted to produce, manufacture distribute and/or dispense at retail to a consumer:

a. Raw hemp flower which may include raw hemp in pre-roll form;

b. Infused Pre-Packaged Products intended to be consumed orally;

c. Infused Unpackaged Products intended to be consumed orally; and

d. Concentrates intended for inhalation.

e. Any other product type designated as allowable for sale by DBR.

H. Product Prohibitions

1. No hemp-derived consumable CBD product intended for retail sale shall:

a. 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;

b. Be in the shape of a cannabis plant or leaf;

c. Be combined with alcohol, tobacco, nicotine, and/or any synthetic cannabinoids;

d. Cause a reasonable consumer confusion as to whether the product is a trademarked product;

e. Violate any state or federal trademark law or regulation; and/or

f. Contain more than the Acceptable Hemp THC level, as applicable based on product type.

I. Packaging and Labeling Requirements for allowable Hemp-Derived Consumable CBD Products available for sale to a consumer at retail.

1. Packaging Requirements.

a. Any container or packaging containing hemp-derived consumable CBD products must:

(1) Be opaque and light resistant;

(2) Fully enclose the product;

(3) Protect the product from contamination;

(4) Be Child-Resistant as defined in § 1.5(F) of this Part; and

(5) Not impart any toxic or deleterious substance to the hemp product.

2. Labeling Requirements

a. Any container or packaging containing hemp-derived consumable CBD products must be 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 licensee selling the product;

(3) Unique identifier;

(4) Total weight in ounces and grams or volume as appropriate. Weight and volume must be determined using accurately calibrated equipment which equipment must also comply with any other applicable state laws;

(5) Total contents of total THC, CBD and any other advertised naturally occurring cannabinoid, if applicable, must be stated per serving unit and per package in milligrams (mgs) as determined by an approved testing facility and in font larger than size 6, bolded, underlined and in red, so as to stand out from surrounding text to the consumer;

(6) The serving size;

(7) The number of servings per package;

(8) If solvents were used in production, statement that discloses the type of extraction method, including any solvents, gases, or other chemicals or compounds used to produce or that are added to the extract;

(9) Any applicable instructions for use and safe storage; and

(10) If dispensing unpackaged hemp-derived consumable products, the information required by § 1.11(I)(2) of this Part must be prominently displayed and made directly available to the consumer prior to purchase.

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 readable.

(3) Clearly written or printed in the English language. 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.

3. Packaging and Labeling Prohibitions.

a. Packaging and labeling of hemp-derived consumable CBD products shall not:

(1) Make any medical claims;

(2) 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;

(3) Make any false or misleading statements including false or misleading statements regarding health or physical benefits or as to the composition and profiles;

(4) Contain 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, produced or manufactured by the State of Rhode Island or any agency thereof or municipality within;

(5) Include images of children or minors;

(6) Include words, a design or brand that resembles a product that is commonly associated with children or minors or marketed to children or minors;

(7) Include symbols or celebrities that are commonly used to market products to minors;

(8) Include the word or make any reference to "candy" or "candies."

4. Warnings

a. All hemp-derived consumable CBD products intended for retail sale must include a label affixed to the package or an insert provided with the packaging containing the following warnings, prominently displayed and in a clear and legible English language font.

(1) "Warning: This product is not certified to be free of contaminants, is derived from industrial hemp, and has not been analyzed or approved by the FDA."

(2) If applicable, a warning regarding use or contact with any nuts or other known allergens as defined in the federal Food Allergen Labeling and Consumer Protection Act of 2004, as administered by the FDA.

(3) If dispensing unpackaged hemp-derived consumable products, the information required by § 1.11(I)(4) of this Part must be prominently displayed and made directly available to the consumer prior to purchase.

J. Advertising and Marketing.

1. No advertising and marketing of hemp, hemp derivatives or hemp-derived consumable CBD products shall without prior written approval of the U.S. Food and Drug Administration ("FDA"), be marketed for, or make claims regarding the use or benefit in diagnosis, cure, mitigation, treatment, or prevention of diseases, or any other therapeutic, dietary or medical benefits or claims.

2. No advertising and marketing of hemp, hemp derivatives or hemp-derived consumable CBD products shall contain any content that can reasonably be considered to target individuals under the age of twenty-one (21) years, 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.

3. No licensee shall advertise in any way which may lead a consumer to believe that the licensee is using marijuana or engaged in an activity which is illegal under state law.

K. Retail Sales

1. A retail licensee shall only allow persons twenty-one (21) years of age or older to purchase hemp-derived consumable CBD products, in accordance with R.I. Gen. Laws § 2-26-3(9).

2. Pursuant to DBR's authority under R.I. Gen. Laws § 2-26-6(b), a retail licensee must verify that every purchaser of a hemp-derived consumable CBD product is compliant with § 1.11(K)(1) of this Part by a review of the intended purchaser's government-issued identification.

3. A retail licensee shall place and/or store all hemp-derived consumable CBD products in a location separate from all other products sold by that retail licensee and that location must be prominently identified as containing hemp-derived consumable CBD products. DBR may, in its discretion approve alternative placement.

L. Pesticide Use and Record-Keeping

1. The cultivation process shall use best practices to limit contamination of industrial hemp and hemp products, including but not limited to mold, mildew, fungus, bacterial diseases, rot, pests, pesticides, and any other contaminant identified as posing potential harm.

2. The use of pesticides on industrial hemp plants in Rhode Island by licensed growers will not be considered a violation of these regulations provided that the product is registered and properly labeled under Section 3 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and satisfies §§ 1.11(L)(2)(b)(1) and 1.11(L)(2)(f) and (g) of this Part below; or the product must satisfy all of the following criteria:

a. The product must be a "minimum risk pesticide" under 40 C.F.R. § 152.25(f), incorporated above at § 1.4(A) of this Part.

b. The product must be labelled for use on either:

(1) "Cannabis," "hemp,"; or

(2) "All plants," "other plants," bedding plants, unspecified plants, or unspecified crops.

c. The label must not prohibit indoor or greenhouse use, as applicable.

d. All active ingredients must be eligible for food use as determined by the federal Environmental Protection Agency ("EPA") Active Ingredients Eligible for Minimum Risk Pesticide Products, incorporated above at § 1.4(B) of this Part. https://www.epa.gov/sites/production/files/2018-01/documents/minrisk-active-ingredients-tolerances-jan-2018.pdf.

e. All inert/other ingredients must be eligible for food use. See EPA's Inert Ingredients Eligible for FIFRA 25(b) Pesticide Products, incorporated above at § 1.4(C) of this Part. https://www.epa.gov/sites/production/files/2016-11/documents/minrisk_inert_ingredients_w_tolerances_2016-11-16.pdf.

f. 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. See http://npirspublic.ceris.purdue.edu/state/state_menu.aspx?state=RI.

g. The product must be used in accordance with any and all use instructions on the label.

3. Pesticides shall be identified, held, stored and disposed of in a manner that protects against contamination of industrial hemp and industrial hemp products and in a manner that is in accordance with any applicable local, state, or federal law, rule, regulation, or ordinance.

4. As a DBR record-keeping requirement, licensees must keep detailed records of any pesticide products used and application regimens. This record-keeping requirement is independent of that required of commercial pesticide applicators by the DEM, and is intended to apply in addition to that requirement, where relevant.

M. Recalls

1. Licensed growers, handlers, distributors and retailers shall have policies and procedures for handling voluntary and mandatory recalls of all hemp, hemp derivatives and hemp-derived CBD products. 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 grower, handler, distributor or retailer to remove defective or potentially defective hemp, hemp derivatives or hemp-derived consumable CBD products from the market, as well as any action undertaken to promote public health and safety.

2. DBR or RIDOH may require a licensee to recall any hemp, hemp derivatives or hemp products 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 recall plan; and

b. The licensee must comply with any additional instructions made by DBR.

N. Destruction

1. Prior to disposal, the hemp must be made unusable and indistinguishable from other plant material. This may be accomplished by grinding and incorporating the offending material with other non-consumable solid waste or other ground materials, so the resulting mixture is at least fifty percent non-hemp waste by volume.

a. Other methods to render the hemp unusable must be approved by DBR before implementation.

b. Hemp that is 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. All destructions must be documented by the Licensee.

2. Grower licensees must submit to DBR documentation of any destruction conducted, which may include photos or videos of, and/or DBR employee attendance at, the destruction.

230 R.I. Code R. 230-RICR-80-10-1.11

Amended effective 10/10/2021
Amended effective 6/11/2022
Amended effective 8/14/2024