R66. Agriculture and Food, Specialized Products.

R66-2. Cannabis Processing.

R66-2-1. Authority and Purpose.

Pursuant to Subsections 4-41a-103(5), 4-41a-302(3)(b)(ii), 4-41a-404(3), 4-41a-405(2)(b)(iv), 4-41a-701(3), 4-41a-801(1), and 4-2-103(1)(i), this rule establishes the application process, qualifications, and requirements to obtain and maintain a cannabis processing license.

R66-2-2. Definitions.

(1) "Advertised Cannabinoid" means a cannabinoid listed on the product face.

(2) "Appealing to children" means:

(a) has a likeness bearing resemblance to a cartoon character or fictional character; or

(b) imitates a food or other product that is typically marketed toward or is appealing to children.

(3) "Brand name" means a name given to a product by the manufacturer that does not include an image or symbol. "Brand name" does not mean strains or flavors.

(4) "Cannabinoid isolate" means the same as the term is defined in Subsection R66-3-2(11).

(5) "Cannabis fact panel" means a part of the label that contains the information described in Subsections R66-2-13(10) and R66-2-13(12).

(6) "COA" means Certificate of Analysis from an independent cannabis testing laboratory.

(7) "Complaint" means any negative feedback received from a medical cannabis patient or medical cannabis or industrial hemp licensee.

(8) "Descriptive product name" means a common name used for the dosage form.

(9) "Directions for use" means recommended routes of administration for a medical cannabis treatment and suggested usage guidelines, and may include:

(a) THC percentage;

(b) strain names;

(d) dietary restrictions.

(10) "Label" means a written, printed, or graphic display on the immediate container of a product.

(11) "Labeling" means a label and other written, printed, or graphic display:

(a) on the product or the product's container or wrapper; or

(b) accompanying the product.

(12) "Logo" means symbols, stylized text, or both that represent a company through a visual image that can be easily understood and recognized.

(13) "Lot" means the quantity of:

(a) flower produced on a particular date and time, following clean up until the next clean up during which the same materials are used; or

(b) trim, leaves, or other plant matter from cannabis plants produced on a particular date and time, following clean up until the next clean up.

(14) "Product face" means the part of a label that is on the outer packaging and most likely to be displayed, presented, or shown under customary conditions of display for retail sale.

(15) "Total THC" means the sum of the determined amounts of delta-9-THC and delta-9-THCA, according to the formula: Total THC = delta-9-THC + (delta-9-THCA x 0.877).

R66-2-3. Cannabis Processing Facility License.

(1) A cannabis processing facility license allows the licensee to receive cannabis from a licensed cannabis cultivator or processor.

(2) A cannabis processing facility license allows the licensee to manufacture cannabis products and send them to medical cannabis pharmacies for sale.

(3) Each cannabis processing facility license shall expire one calendar year from the date of licensure.

R66-2-4. Cannabis Processing Facility Requirements.

(1) A cannabis processing facility operating plan shall meet the requirements described in Section 4-41a-204 and contain a blueprint of the facility containing the following information:

(a) the areas where cannabis is to be extracted;

(b) the areas where cannabis or cannabis products are to be packaged and labeled;

(d) location of storerooms for cannabis awaiting extraction;

(e) location of storerooms for cannabis awaiting further manufacturing;

(f) the area where finished cannabis and cannabis products are stored;

(g) the location of toilet facilities and hand washing facilities;

(h) the location of a break room and location of personal belonging lockers; and

(i) the location of the areas to be used for loading and unloading of cannabis and cannabis products.

(2) A cannabis processing facility shall have a written plan to handle potential recall and destruction of cannabis due to contamination.

(3) A cannabis processing facility operating plan shall include a waste disposal plan that complies with 4-41a-405.

(4) A cannabis processing facility shall use a standardized scale that is registered with the department when cannabis is:

(a) packaged for sale by weight;

(b) bought and sold by weight; or

(5) A cannabis processing facility creating cannabis derivative product shall develop standard operating procedures.

(6) Pursuant to Subsection 4-41a-403(4)(b), a cannabis processing facility may use signage on the property that includes a logo, as long as the logo does not include:

(a) terms, slang, phrasing, or verbiage associated with the recreational use of cannabis;

(b) any image bearing resemblance to a cartoon character or fictional character whose target audience is children or minors;

(d) imagery featuring a person using the product in any way;

(e) any recreationally oriented subject; or

(f) any statement, design, or representation, picture, or illustration that is obscene or indecent.

(7) A cannabis processing facility shall keep records verifying that each time they receive a batch of vaporizer cartridges a sample is tested for heavy metals by an independent cannabis testing laboratory pursuant to Section 4-41a-603 or have a certificate of conformance from the manufacturer.

R66-2-5. Separation of Cannabis and Hemp Processed in a Single Facility.

(1) Any facility that has both an industrial hemp processing license and a license for medical cannabis processing shall ensure physical separation of medical cannabis and industrial hemp in its facility at all times.

(2) Processing of industrial hemp material and cannabis material may not occur on the same equipment on the same day, unless cleaned between runs.

(3) The licensee shall provide the department with an operating plan detailing how separation of materials is implemented, including the facility's separation procedures for raw material, extract, and final products that ensures:

(a) only one material is processed at a time;

(b) packaging tables are only used for the material being processed each day; and

(i) cleaning logs shall be kept and provided to the department upon inspection of the facility; and

(ii) cleaning logs shall include the machines used, the date cleaned, and the name of the employee that conducted the cleaning.

(4) Cannabis and hemp material shall be clearly labeled pursuant to the requirements of this rule and Rule R66-30 and shall be in sealed containers.

R66-2-6. Cannabis Extraction Requirements.

(1) A cannabis processing facility shall ensure hydrocarbons n-butane, isobutane, propane, or heptane are of at least 99% purity.

(2) A cannabis processing facility shall use a professional grade extraction system designed to recover the solvents, work in an environment with proper ventilation, and control each source of ignition where a flammable atmosphere is or may be present.

(3) A cannabis processing facility using carbon dioxide (CO2) gas extraction system shall use a professional grade closed loop CO2 gas extraction system where each vessel is rated to a minimum of six hundred pounds per square inch and CO2 shall be at least 99% purity.

(4) Closed loop hydrocarbon, alcohol, or CO2 extraction systems shall be commercially manufactured and bear a permanently affixed and visible serial number.

(5) A cannabis processing facility using a closed loop system shall, upon request, provide the department with certification from a licensed engineer stating the system is:

(a) safe for its intended use;

(b) commercially manufactured; and

(i) the American Society of Mechanical Engineers (ASME);

(ii) American National Standards Institute (ANSI);

(iii) Underwriters Laboratories; or

(iv) The American Society for Testing and Materials.

(6) The certification document shall contain the signature and stamp of the certifying professional engineer and the serial number of the extraction unit being certified.

(7) A cannabis processing facility may use an alternative extraction method with prior approval from the department.

(8) A cannabis processing facility shall use food grade ingredients to create cannabis derivative product.

(9) A cannabis processing facility may use heat, screens, presses, steam distillation, ice water, and other mechanical methods which do not use solvents or gases.

(10) A cannabis processing facility shall ensure each solvent, with the exception of CO2, is extracted in a manner to recapture the solvent and ensure that it is not vented into the atmosphere.

(11) A cannabis processing facility agent using solvents or gases in a closed loop system shall be fully trained in the use of the system and have direct access to applicable material safety data sheets.

(12) Parts per million for one gram of finished extract cannot exceed residual solvent or gas levels provided in Rule R66-3.

R66-2-7. Cannabinoid Isolate.

(1) A licensed Tier 1 cannabis processing facility may use cannabinoid isolate from a licensed industrial hemp processing facility.

(2) A Tier 1 cannabis processing facility may not receive more than 120 kilograms of cannabinoid isolate in a single license year.

(3) Any transfer of cannabinoid isolate shall be accompanied by a full panel COA.

(4) The cannabis processing facility shall maintain a record of each transfer of cannabinoid isolate that is available for review by the department, including:

(a) the source of the cannabinoid isolate and verification that it was derived from certified industrial hemp;

(b) the intended use of the cannabinoid isolate; and

(5) Upon receipt of cannabinoid isolate, a cannabinoid processing facility shall submit a sample of the isolate to a licensed independent cannabis testing laboratory for cannabinoid and adulterant testing, pursuant to the requirements of Rule R66-3.

R66-2-8. Security Requirements.

(1) At a minimum, a licensed cannabis processing facility shall have a complete video surveillance system:

(a) with minimum camera resolution of 1280 x 720 pixels or pixel equivalent for analog; and

(b) that allows for the clear and certain identification of any person and activity.

(2) Each visitor to a cannabis processing facility shall be required to display an identification badge issued by the facility while on the premises.

(3) At any time, visitors shall be escorted by a cannabis processing facility agent.

(4) A cannabis processing facility shall keep and maintain a visitors log showing:

(a) the full name and age of each visitor entering the facility;

(b) badge number issued;

(d) the time of departure; and

(e) the purpose of the visit.

(5) The cannabis processing facility shall keep the visitors log for a minimum of one year.

(6) The cannabis processing facility shall make the visitor log available to the department upon request.

R66-2-9. Inventory Control.

(1) Each batch or lot of cannabis, cannabis derivative product, cannabis product, test sample, or cannabis waste shall be entered into the inventory control system. Recorded information shall include:

(a) unique identification number;

(b) batch or lot number;

(d) facility name and license number; and

(e) date entered into the inventory control system.

(2) Each batch or lot of cannabis, cannabis derivative product, cannabis product, sample, or cannabis waste shall be traceable to the lot.

(3) Unique identification numbers may not be reused.

(4) Each batch, lot, or sample of cannabis, cannabis derivative product, cannabis product, or cannabis waste shall have a physical tag containing information listed in Subsection R66-2-9(1).

(5) The tag shall be legible and placed in a position that can be clearly read.

(6) A receiving cannabis processing facility shall;

(a) document in the inventory control system any material containing cannabis received, and any difference between the quantity specified in the transport manifest and the quantity received; and

(b) within one working week, notify the department if disparities in the quantity of cannabis received are greater than 10% from the manifest recorded amount.

R66-2-10. Cannabis Processing Facility Agents.

(1) A cannabis processing facility is responsible for ensuring that each agent has received any task specific training as outlined in the operating plan submitted to the department.

(2) A cannabis processing facility agent shall have a properly displayed identification badge which has been issued by the department at all times while on the facility premises or while engaged in the transportation of cannabis.

(3) Each cannabis processing facility agent shall have their state issued identification card in their possession to certify the information on their badge is correct.

R66-2-11. Processing of Cannabis and Cannabis Products.

A licensee that manufactures cannabis products shall be registered with the Division of Regulatory Services within the department.

R66-2-12. Irradiated Plant Product From Cannabis Cultivators.

(1) A cannabis processor may use methods of irradiation for the remediation of cannabis if:

(a) the method is approved in their operating plan, which includes:

(i) type of radiation or ionizing energy source;

(ii) equipment; and

(iii) documentation of state approval by the Utah Department of Environmental Quality;

(b) the product has failed quality assurance testing for microbial contaminants; and

(2) Batches or lots of cannabis remediated by radiation shall be noted in the inventory control system, and each container of the batch or lot shall have a sticker with the Radura symbol until the batch is completely used or destroyed.

(3) The processor shall maintain records required by this section for three years after the final disposition of the irradiated cannabis, and shall make the records available for inspection and copy by the department. Records shall include:

(a) the cannabis batch treated;

(b) lot identification;

(d) ionizing energy source;

(e) source calibration;

(f) dosimetry;

(g) dose distribution in the product;

(h) the date of irradiation;

(i) final products that were made by the irradiated cannabis; and

(j) pharmacies the product was sent to.

(4) The label of a cannabis product that contains irradiated cannabis shall display:

(a) the Radura symbol; and

(b) the statement: "Treated with radiation" in text as prominent as the ingredients.

(5) The Radura symbol and statement shall be placed prominently and conspicuously on the label.

(6) Processors shall notify a pharmacy that the product has been irradiated before purchase.

(7) Processors that receive irradiated cannabis from a cultivator shall follow Subsections R66-2-12(4)(a), R66-2-12(4)(b), R66-2-12(5), and R66-2-12(6).

R66-2-13. Labeling and Packaging of Cannabis and Cannabis Products.

(1) Cannabis product labeling shall contain the following information:

(a) the medicinal dosage form identified on the product face along with the words "THC or Cannabis Infused":

(i) "gummies" may be used instead of "gelatinous cube";

(ii) "tincture" may be used instead of "sublingual preparation" or "liquid suspension";

(iii) a descriptive product name, that is not appealing to children, recreational, or contain adjectives;

(b) the name and license number of the cannabis processing facility;

(c) directions for consumers to contact the department with product complaints by going to medicalcannabis.utah.gov/production;

(d) for products containing THC, a warning symbol provided by the department that contrasts conspicuously with the background; and

(e) the amount of total THC contained in the package, in milligrams.

(2) A cannabis processing facility may include a QR code on the cannabis product labeling that links to a COA from a licensed independent cannabis testing laboratory. The QR code may not link to any other information.

(3) Any information appearing on the cannabis product labeling shall be:

(a) displayed in any legible font, that is not a script or decorative font, provided that the lowercase letter "o" is at least one-sixteenth inch in height;

(b) displayed in a color that contrasts conspicuously with its background; and

(4) A cannabis processing facility shall place a cannabis fact panel on a cannabis product before the sale of the cannabis product to a medical cannabis pharmacy.

(5) The cannabis fact panel shall be printed in black and white.

(6) The cannabis fact panel shall be securely affixed to the package.

(7) The cannabis fact panel for cannabis plant product shall include the following information, from top to bottom, in the order as listed:

(a) the name of the cannabis cultivation facility, identified as the cultivator;

(b) the lot number;

(d) the date of final testing;

(e) the batch number;

(f) the date on which the product was packaged;

(g) the quantity of any cannabinoid listed as present on the COA that is greater than 1% of total cannabinoids;

(h) the expiration date; and

(i) the net weight displayed in grams.

(8) THC potency levels for cannabis flower shall be listed as total THC in milligrams per gram.

(9) The cannabis fact panel for a cannabis derivative product shall include the following information, from top to bottom, in the order listed:

(a) the batch number;

(b) the date of the final testing;

(d) for products intended to be ingested, the amount of total THC and any advertised cannabinoid in milligrams per serving;

(e) the quantity of any cannabinoid listed as present on the COA that is greater than 1% of total cannabinoids;

(f) the expiration date;

(g) the total amount of THC measured in milligrams per gram;

(h) a list of each ingredient and each major food allergen as identified in 21 U.S.C. 343;

(i) the identity of any artificially derived cannabinoid present in the product;

(j) the net weight of the product displayed in grams or milliliters and the number of pieces, if applicable; and

(k) a disclosure of the type of extraction process used and any solvent, gas, or other chemical used in the extraction process.

(10) A cannabis processing facility may include a QR code affixed to the product that is scannable for inventory control at the pharmacy. The QR code may not link to any other information.

(11) The label of a cannabis derivative product may include a flavor name if it is not candy-like or a name that appeals to children.

(12) The label of a cannabis product that contains an artificially derived cannabinoid shall clearly display the following text: "This product contains artificially derived cannabinoids."

(13) Any terpene listed on a cannabis product package shall be verified as present by a licensed independent cannabis testing laboratory and have its quantity listed on the fact panel.

(14) A cannabis processing facility may include a logo and product brand name on the cannabis product face that is exempt from the requirements of Subsection R66-2-13(5) and that:

(a) does not obscure the information required on the label; and

(b) does not include:

(i) terms, slang, phrasing, or verbiage associated with the recreational use of cannabis;

(ii) any image bearing resemblance to a cartoon character or fictional character whose target audience is children or minors;

(iii) content, symbol, or imagery that appeals to children;

(iv) imagery featuring a person using the product in any way;

(v) any recreationally oriented subject; or

(vi) any statement, design, or representation, picture, or illustration that is obscene, sexual, or criminal.

(15)(a) No other information, illustration, or depiction with the exception of directions for use or an item required by state law shall appear on the labeling.

(b) Any warnings required in Chapter 4-41a may be added to the label of any product.

(16) Shapes on cannabis product packaging or labeling may not resemble the product or real-world items.

(17) Labeling may not contain medical claims.

(18) Cannabis product packaging, logos, and brand names shall be pre-approved by the department.

(19) The department reserves the right to deny any label, logo, or brand name if the department reasonably believes it is in conflict with Chapter 4-41a or this section.

R66-2-14. Recall Protocol.

(1) The department may initiate a recall of cannabis or cannabis products if:

(a) evidence exists that pesticides not approved by the department are present on or in the cannabis or cannabis product;

(b) evidence exists that residual solvents are present on or in cannabis or cannabis product;

(d) the department believes or has reason to believe the cannabis or cannabis product is unfit for human consumption.

(2) The recall plan of a cannabis processing facility shall include, at a minimum:

(a) a designation of at least one member of the staff who serves as the recall coordinator;

(b) procedures for identifying and isolating product to prevent or minimize distribution to patients;

(d) a communications plan to notify those affected by the recall.

(3) The cannabis processing facility shall track the total amount of affected cannabis or cannabis product and the amount of affected cannabis or cannabis product returned to the facility as part of the recall.

(4) The cannabis processing facility shall coordinate the destruction of the cannabis or cannabis product with the department and allow the department to oversee the destruction of the affected product.

(5) The department has authority to monitor the progress of the recall until the department declares an end to the recall.

(6) A cannabis production facility shall notify the department before initiating a voluntary recall.

R66-2-15. Change in Operation Plans.

(1) A cannabis processing facility shall submit a notice, on a form provided by the department, before making any changes to the facility's operating plan, including:

(a) ownership or financial backing of the facility;

(b) the facility's name;

(d) any modification, remodeling, expansion, reduction, or physical, non-cosmetic alteration of a facility;

(e) changes or adds processing or extraction equipment;

(f) adds a new product or dosage form; or

(g) any information requested by the department that shall allow the department to determine if requirements will be met.

(2) A cannabis processing facility may not implement changes to the initial approved operation plan without approval.

(3) The board shall approve of requested changes unless approval would lead to a violation of the applicable laws and rules of the state.

(4) The department shall specify the reason for the denial of approval for a change to the operation plan.

(5) Before the board's review of a cannabis production establishment license under Subsection 4-41a-201.1(7)(e), the cannabis production establishment shall provide the board with:

(a) blueprints that show that there will be physical separation between medical cannabis and industrial hemp produced in their facility, including demonstrating storage and packaging areas are separate; and

(b) any information requested by the board that shall allow the board to determine if the requirements of Section R66-2-5 will be met before the medical cannabis production establishment processes industrial hemp or industrial hemp products.

R66-2-16. Renewals.

(1) A cannabis processing facility shall submit a notice of intent to renew and the licensing fee to the department within 30 days of license expiration.

(2) The licensee shall report the information required for renewal under Subsection 4-41a-201.1(10)(b)(iii) to the board.

(3) If the licensing fee and intent to renew are not submitted by the day of license expiration, the licensee may not continue to operate.

(4) The board may take into consideration significant violations issued in determining license renewals.

R66-2-17. Targeted Marketing.

(1) A medical cannabis processor may engage in targeted marketing of the processor's medical cannabis product, medical cannabis brand, or a medical cannabis device pursuant to Section 4-41a-604.

(2) Targeted marketing may not:

(a) include deceptive, false, or misleading statements;

(b) contain any health-related statement that is untrue or tends to create a misleading impression as to the effects on health of cannabis consumption;

(d) contain a statement, design, illustration, picture, or representation that:

(i) encourages or represents the recreational use of cannabis;

(ii) displays the use of cannabis, including the consumption, smoking, or vaping of cannabis;

(iii) encourages or promotes cannabis for use as an intoxicant;

(iv) is obscene or indecent;

(e) include any image designed or likely to appeal to children, such as:

(i) cartoons;

(ii) toys;

(iii) animals;

(iv) children; or

(v) any other likeness to images, characters, or phrases that are popularly used to advertise to children;

(f) contain any language or imagery that is likely to mislead patients to believe that the medical cannabis product has been endorsed, made, or used by the state or any of its representatives, except where specifically authorized; or

(g) display medical cannabis products or images of products where the advertisement is visible to members of the public.

(3) Targeted marketing shall accurately and legibly identify the medical cannabis processor responsible for its content and include a statement that cannabis products are for use by patients only.

(4) Any targeted marketing for medical cannabis products that is related to the benefits, safety, or efficacy of the product, including therapeutic or medical claims, shall:

(a) be supported by substantial, current clinical evidence or data; and

(b) include information on side effects or risks associated with the use of cannabis.

(5) A medical cannabis processor may have a link on their website to allow individuals to sign up to receive targeted marketing electronically.

R66-2-18. Violation Categories.

(1) Public Safety Violations: $3,000- $5,000 per violation. This category is for violations which present a direct threat to public health or safety including:

(a) cannabis sold to an unlicensed source;

(b) cannabis purchased from an unlicensed source;

(d) failure to comply with testing requirements;

(e) a test result for high pesticide residue in the cannabis produced or cannabis product;

(f) a test result for high residual solvents, heavy metal, microbials, molds, or other harmful contaminants;

(g) failure to maintain required cleanliness and sanitation standards;

(h) unauthorized personnel on the premises;

(i) permitting criminal conduct on the premises;

(j) possessing, manufacturing, or distributing cannabis products that the person knows or should know appeal to children;

(k) failure to follow an approved recall protocol; or

(l) engaging in or permitting a violation of the Title 4, Chapter 41a, Cannabis Production Establishments, which amounts to a public safety violation as described in this subsection.

(2) Regulatory Violations: $1,000-$5,000 per violation. This category is for violations involving this rule and other applicable state rules including:

(a) failure to maintain alarm and security systems;

(b) failure to keep and maintain records for at least two years;

(d) failure to follow transportation requirements;

(e) failure to follow the waste and disposal requirements;

(f) failure to maintain separation between cannabis and hemp;

(g) failure to follow labeling and packaging requirements;

(h) failure to meet extraction requirements;

(i) distributing a final cannabis product with an actual weight that is lower than the net weight listed on the cannabis fact panel;

(j) engaging in or permitting a violation of Title 4, Chapter 41a, Cannabis Production Establishments or this rule which amounts to a regulatory violation as described in this subsection; or

(k) failure to maintain standardized scales.

(3) Licensing Violations: $500- $5,000 per violation. This category is for violations involving licensing requirements including:

(a) an unauthorized change to the operating plan;

(b) failure to notify the department of changes to the operating plan;

(d) failure to follow the operating plan as approved by the department;

(e) engaging in or permitting a violation of this rule or Title 4, Chapter 41a, Cannabis Production Establishments which amounts to a licensing violation as described in this subsection; or

(f) failure to respond to violations.

(4) The department shall calculate penalties based on the level of violation and the adverse effect or potential adverse effect at the time of the incidents giving rise to the violation.

(5) The department may enhance or reduce the penalty based on the seriousness of the violation.

KEY: cannabis processing, cannabis production establishment, violations, targeted marketing, qualifications, and requirements