No. 43758 (New Rule): Rule R68-28. Cannabis Processing

(New Rule)

DAR File No.: 43758
Filed: 05/31/2019 03:44:40 PM

RULE ANALYSIS

Purpose of the rule or reason for the change:

This proposed rule sets forth the licensing and operational requirements for an individual seeking to process medical cannabis in accordance with Title 4, Chapter 41a, Cannabis Production Establishments.

Summary of the rule or change:

This proposed rule sets forth the licensing requirements for those interested in processing cannabis into the approved forms to be used by medical cannabis patients. It establishes the facility requirements, as well as the additional requirements for the operation plan. This proposed rule establishes minimum requirements for storage and handling of cannabis and cannabis products, as well as the conditions that shall be maintained in a facility. In addition, this proposed rule establishes violation categories with the range of fines that may be assessed for violations.

Statutory or constitutional authorization for this rule:

• Subsection 4-41a-103(5)
• Subsection 4-41a-404(3)
• Subsection 4-41a-701(3)
• Subsection 4-41a-302(3)(b)(ii)
• Subsection 4-2-103(1)(i)
• Subsection 4-41a-405(2)(b)(iv)
• Subsection 4-41a-801(1)

This rule or change incorporates by reference the following material:

• Adds 21 CFR 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary supplements, published by Department of Health and Human Services, 04/01/2018

Anticipated cost or savings to:

the state budget:

As this is a new program, the state will have the significant start cost for hiring personnel and buying equipment necessary to effectively run the medical cannabis program. The Department of Agriculture and Food (Department) will need to hire and train employees to inspect these facilities. In addition to inspectors, the Department will need to hire administrative staff to help issue the agent registration cards, to do background checks for all employees and those with 2% or greater financial or voting interest in the cannabis processing facility. The inspector will need to be out doing quarterly inspections of the facility and will need the equipment necessary to conduct the inspection. In total, the cost of the employees is estimated at $973,000 for the first year. In addition to the cost of the employees, there is $133,500 cost for the equipment, training, and transportation cost for these employees to effectively regulate this product. Additionally, the Department will need to help with the purchase and upkeep of the electronic verification system as required by Title 4, Chapter 41a. The Department anticipates contributing at least $58,500 to maintaining the system as it is key to the program. Total cost in the first year is anticipated to be $1,165,000. In the second year, the Department anticipates that cost will stay much the same with a slight increase in the amount of inspection that are necessary as more of the facilities reach their capacity. It may be necessary to hire more inspectors as the program grows in the third year, but the Department anticipates that the cost for the program will remain similar to the second year in the third year. The Department anticipates an application fee of $1,250 for each applicant. In addition, a Tier 1 processing license will have $100,000 licensing fee while a Tier 2 processor will have a $35,000 licensing fee. The cannabis processing licenses are not limited. Providing the applicants meet the qualifications, they may be issued a license. The Department has estimated that there will be at least nine qualified Tier 1 processors and seven potential Tier 2 processors. Thus, the amount of revenue generated could be at least $1,165,000 in application and licensing fees for the first year. The licensee will not have to pay the application fee after having successfully received a license. The revenue for years two and three will decreased to $1,145,000, unless additional processors apply.

local governments:

Local governments may experience an increase in law enforcement cost do to the nature of the product being processed. However, the Department cannot adequately estimate the cost or benefits to local governments.

small businesses:

This rule allows for the processing of a controlled substances in the state of Utah. This is a new and controlled industry in the state. As it has not been allowed, the proposed rule does not place any additional cost to businesses aside from the anticipated application fee of $1,250 and the licensing fee of $35,000 or $100,000 depending on the type of processing license.

persons other than small businesses, businesses, or local governmental entities:

This proposed rule allows for the growth of medical cannabis in the state. It will allow for qualified patients to have access to a quality-controlled product. However, due to the nature of the industry, it is impossible for the Department to estimate the costs or benefits to the consumer.

Compliance costs for affected persons:

There is anticipated to be $1,250 application fee for all those who chose to apply for a license. Those who are awarded the license will then have a $35,000 or $100,000 licensing fee. Due to this being a controlled substance and still federally illegal, there has been no prior legal growing in the state. Therefore, the only cost to the affected persons is the application and licensing fees. All other costs are the costs of engaging in the processing of medical cannabis.

Comments by the department head on the fiscal impact the rule may have on businesses:

This is a newly created program which will allow the growth of a controlled substance for medical use. It is necessary for the Department to ensure the safe growing, processing, and transportation of this product for the safety of the qualified patients. The application and licensing fees are necessary for the Department to run the program effectively to ensure that qualified patients receive a quality product.

Kerry Gibson, Commissioner

The full text of this rule may be inspected, during regular business hours, at the Office of Administrative Rules, or at:

Agriculture and Food
Plant Industry
350 N REDWOOD RD
SALT LAKE CITY, UT 84116-3034

Direct questions regarding this rule to:

• Melissa Ure at the above address, by phone at 801-538-4978, by FAX at , or by Internet E-mail at [e-mail]
• Kelly Pehrson at the above address, by phone at 801-538-7102, by FAX at , or by Internet E-mail at [e-mail]

Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:

07/15/2019

Interested persons may attend a public hearing regarding this rule:

• 06/26/2019 02:00 PM, Dept. of Agriculture and Food, 350 North Redwood Road, Salt Lake City, UT

This rule may become effective on:

07/22/2019

Authorized by:

Kerry Gibson, Commissioner

RULE TEXT

Appendix 1: Regulatory Impact Summary Table*

Fiscal Costs

FY 2020

FY 2021

FY 2022

State Government

$1,165,000

$1,165,000

$1,165,000

Local Government

$0

$0

$0

Small Businesses

$1,165,000

$1,145,000

$1,145,000

Non-Small Businesses

$0

$0

$0

Other Person

$0

$0

$0

Total Fiscal Costs:

$2,330,000

$2,310,000

$2,310,000

Fiscal Benefits

State Government

$1,165,000

$1,145,000

$1,145,000

Local Government

$0

$0

$0

Small Businesses

$0

$0

$0

Non-Small Businesses

$0

$0

$0

Other Persons

$0

$0

$0

Total Fiscal Benefits:

$1,165,000

$1,145,000

$1,145,000

Net Fiscal Benefits:

- $1,165,000

- $1,165,000

- $1,165,000

 

*This table only includes fiscal impacts that could be measured. If there are inestimable fiscal impacts, they will not be included in this table. Inestimable impacts for State Government, Local Government, Small Businesses and Other Persons are described in the narrative. Inestimable impacts for Non-Small Businesses are described in Appendix 2.

 

Appendix 2: Regulatory Impact to Non-Small Businesses

Title 4, Chapter 41a,allows for the issuance of processing licenses to qualifying facilities. This rule will allow for the controlled processing, packaging, and labeling of medical cannabis for patients of Utah. As the processing of cannabis has previously been illegal under state law, the full impact to these businesses cannot be estimated as the necessary data is not available to the Department.

 

The Commissioner of the Department of Agriculture and Food, Kerry Gibson, has reviewed and approved this fiscal analysis.

 

 

R68. Agriculture and Food, Plant Industry.

R68-28. Cannabis Processing.

R68-28-1. Authority and Purpose.

1) Pursuant to sections 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.

 

R68-28-2. Definitions.

1) "Applicant" means any person or business entity who applies for a cannabis processing facility license.

2a) "Cannabis" means any part of a marijuana plant;

b) "cannabis" does not mean, for the purposes of this rule, industrial hemp.

3) "Batch" means a quantity of:

a) cannabis extract produced on a particular date and time, following clean up until the next clean up during which lots of cannabis are used;

b) cannabis product produced on a particular date and time, following clean up until the next clean up during which cannabis extract is used; or

c) cannabis flower packaged on a particular date and time, following clean up until the next clean up during which lots of cannabis are being used.

4) "Department" means the Utah Department of Agriculture and Food.

5) "Cannabis cultivation facility" means a person that:

a) possesses cannabis;

b) grows or intends to grow cannabis; and

c) sells or intends to sell cannabis to a cannabis cultivation facility or to a cannabis processing facility.

6) "Cannabis processing facility" means a person that:

a) acquires or intends to acquire cannabis from a cannabis production establishment or a holder of an industrial hemp processor license under title 4 chapter 41, Hemp and Cannabidiol Act;

b) possesses cannabis with the intent to manufacture a cannabis product;

c) manufactures or intends to manufacture a cannabis product from unprocessed cannabis or a cannabis extract; and

d) sells or intends to sell a cannabis product to a medical cannabis pharmacy or the state central fill medical cannabis pharmacy.

7) "Cannabis processing facility agent" means an individual who:

a) is an employee of a cannabis processing facility; and

b) holds a valid cannabis production establishment agent registration card.

8) "Cannabis production establishment agent registration card" means a registration card that the department issues that:

a) authorizes an individual to act as a cannabis production establishment agent; and

b) designates the type of cannabis production establishment for which an individual is authorized to act as an agent.

9) "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.

 

R68-28-3. Cannabis Processing Facility License.

1) A Tier 1 cannabis processing facility license allows the licensee to receive cannabis from a licensed cannabis cultivation facility or to accept THC or THC byproduct from a Utah licensed cannabis processing facility or industrial hemp processor.

2) A Tier 1 cannabis processing facility license allows the licensee to process, manufacture, dry, cure, package, and label cannabis and cannabis products for sale or transfer to another cannabis processing facility, a medical cannabis pharmacy, or the state central fill medical cannabis pharmacy.

3) A Tier 2 cannabis processing facility license allows the licensee to receive cannabis from a licensed cannabis cultivation facility or a cannabis processing facility.

4) A Tier 2 cannabis processing facility allows for the licensee to package and label cannabis and cannabis products for sale or transfer to another cannabis processing facility, a medical cannabis pharmacy, or the state central fill medical cannabis pharmacy.

5) A complete application shall include the required fee, statements, forms, diagrams, operation plans, and other applicable documents required in the application packet to be accepted and processed by the department.

6) Prior to approving an application, the department may contact the applicant and request additional supporting documentation or information.

7) Prior to issuing a license, the department shall inspect the proposed premises to determine if the applicant complies with state laws and rules.

8) Each cannabis processing facility license shall expire on December 31st.

9) An application for renewals shall be submitted to the department by December 1st.

10) If the renewal application is not submitted by December 31st the licensee may not continue to operate.

11) A license may not be sold or transferred.

 

R68-28-4. Cannabis Processing Facility Requirements.

1) A cannabis processing facility operating plan shall contain a blue print of the facility containing the following information:

a) the square footage of the areas where cannabis is to be extracted;

b) the square footage of the areas where cannabis or cannabis products are to be packaged and labeled;

c) the square footage of the areas where cannabis products are manufactured;

d) the square footage of the area where cannabis products are packaged or labeled;

e) the square footage and location of storerooms for cannabis awaiting extraction;

f) the square footage and location of storerooms for cannabis awaiting further manufacturing;

g) the area where finished cannabis and cannabis products are stored;

h) the location of toilet facilities and hand washing facilities;

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

j) the location of the areas to be used for loading and unloading of cannabis and cannabis products; and

k) the total square footage of the overall cannabis processing facility.

2) A cannabis processing facility shall process, manufacture, package, and label cannabis and cannabis products in accordance with 21 CFR 111, "Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operation for Dietary Supplements".

3) A cannabis processing facility shall have written emergency procedures to be followed in case of:

a) fire;

b) chemical spill; or

c) other emergency at the facility.

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

5) A cannabis processing facility shall use a standardized scale which is registered with the department when cannabis is:

a) packaged for sale by weight;

b) bought and sold by weight; or

c) weighed for entry into the inventory control system.

6) A cannabis processing facility shall compartmentalize all areas in the facility based on function and shall limit access between compartments.

7) A cannabis processing facility shall limit access to the compartments to the appropriate agents.

8) A cannabis processing facility creating cannabis extract shall develop standard operating procedures.

 

R68-28-5. Cannabis Extraction Requirements.

1) A cannabis processing facility shall ensure hydrocarbons n-butane, isobutane, propane, or heptane are of at least ninety-nine percent purity.

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

3) A cannabis processing facility using carbon dioxide (CO ₂) gas extraction system shall use a professional grade closed loop CO ₂ gas extraction system where every vessel is rated to a minimum of six hundred pounds per square inch and CO ₂ shall be at least ninety-nine percent purity.

4) Closed loop systems for hydrocarbon or CO ₂ 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

c) built to codes of recognized and generally accepted good engineering practices, such as:

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

ii) American National Standards Institute (ANSI);

iii) Underwriters Laboratories (UL); or

iv) The American Society for Testing and Materials (ASTM).

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

7) A cannabis processing facility may use food grade glycerin, ethanol, and propylene glycol solvents to create extracts.

8) A cannabis processing facility shall remove all ethanol from the extract in a manner to recapture the solvent and ensure that it is not vented into the atmosphere.

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

10) A cannabis establishment agent using solvents or gases in a closed loop system shall be fully trained on how to use the system and have direct access to applicable material safety data sheets.

11) Parts per million for one gram of finished extract cannot exceed residual solvent or gas levels provided in Utah Admin. Code R68-29.

 

R68-28-6. Security Requirements.

1) At a minimum, each cannabis processing facility shall have a security alarm system on all perimeter entry points and perimeter windows.

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

a) with minimum camera resolution of 640 x 470 pixels or pixel equivalent for analog, and

b) that retains footage for at least 45 days.

3) All cameras shall be fixed and placement shall allow for the clear and certain identification of any person and activities in controlled areas.

4) Controlled areas included:

a) all entrances and exits, or ingress and egress vantage points;

b) all areas where cannabis or cannabis products are stored,

c) all areas where cannabis or cannabis products are extracted,

d) all areas where cannabis or cannabis products are manufactured, packaged, or labeled; and

e) all areas where cannabis waste is being moved, processed, stored or destroyed.

5) All cameras shall record continuously.

6) For locally stored footage, the surveillance system storage device shall be secured in the facility in a lockbox, cabinet, closet, or secured in another manner to protect from employee tampering or criminal theft.

7) For footage stored on a remote server, access shall be restricted to protect from employee tampering.

8) Any gate or entry point must be lighted in low-light conditions sufficient to record activity occurring.

9) All visitors to a cannabis processing facility shall be required to have a properly displayed identification badge issued by the facility at all times while on the premises of the facility.

10) All visitors shall be escorted by a cannabis processing facility agent at all times while in the facility.

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

a) the full name of each visitor entering the facility;

b) the badge number issued;

c) the time of arrival;

d) the time of departure, and

e) the purpose of the visit.

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

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

 

R68-28-7. Inventory Control.

1) Every batch or lot of cannabis, cannabis extract, cannabis product, test sample, or cannabis waste shall have a unique identifier in the inventory control system.

2) Every batch or lot of cannabis, cannabis extract, cannabis product, sample, or cannabis waste shall be traceable to the lot used as the base material from a cannabis cultivation facility.

3) Unique identification numbers may not be reused.

4) Each batch or lot of cannabis, cannabis extract, cannabis product, test sample, or cannabis waste that has been issued a unique identification number shall have a physical tag placed on it with the unique identification number.

5) The tag shall be legible and placed in a position that can be clearly read and shall be kept free from dirt and debris.

6) The following shall be reconciled in the inventory control system at the close of business each day:

a) date and time cannabis, cannabis extract, or cannabis product is being transported to a cannabis production establishment, medical cannabis pharmacy, or the state central fill medical cannabis pharmacy;

b) all samples used for testing and the test results;

c) a complete inventory of cannabis, cannabis extract cannabis product, trim, or other plant material;

d) cannabis product by unit count;

e) weight per unit of product;

f) weight and disposal of cannabis waste materials;

g) the identity of who disposed of the cannabis waste and the location of the waste receptacles; and

h) theft or loss or suspected theft or loss of cannabis, cannabis extract, or cannabis product.

7) A receiving cannabis processing facility shall document in the inventory tracking system any cannabis, cannabis extract, or cannabis product received, and any difference between the quality specified in the transport and the quantities received.

8) A cannabis processing facility shall immediately upon receipt of THC extract from a licensed industrial hemp processor enter the following information into the inventory control system:

a) the amount of THC extract received;

b) the name, address, and licensing number of the industrial hemp processor;

c) the weight per unit of product received; and

d) the assigned unique identification number.

 

R68-28-8. Cannabis Processing Facility Agents.

1) A cannabis processing facility shall apply to the department for a cannabis establishment agent on a form provided by the department.

2) An application is not considered complete until the background check has been completed and the facility has paid the registration fee.

3) The cannabis processing facility agent registration card shall contain:

a) the agent's full name;

b) the name of the cannabis processing establishment;

c) the job title or position of the agent; and

d) a photograph of the agent.

4) A cannabis processing facility is responsible to ensure that all agents have received:

a) the department approved training as specified in Utah Code 4-41a-301; and

b) any task specific training as outlined in the operating plan submitted to the department.

5) 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.

6) All cannabis production establishment agents shall have their state issued identification card in their possession to certify the information on their badge is correct.

7) An agent's identification badge shall be returned to the department immediately upon termination of their employment with the cannabis processing facility.

 

R68-28-9. Minimum Storage and Handling Requirements.

1) A cannabis processing facility shall have separate storage for cannabis, cannabis extract, or cannabis products that are outdated, damaged, deteriorated, misbranded, or adulterated, or whose containers or packaging have been opened or breached until the cannabis, cannabis extract, or cannabis products are destroyed.

2) All cannabis, cannabis extract, and cannabis products shall be stored at least six inches off the ground.

3) Storage areas shall:

a) be maintained in a clean and orderly condition; and

b) be free from infestation by insects, rodents, birds, or vermin.

4) A cannabis processing facility shall store all cannabis, cannabis extract, or cannabis products in process in a manner so as to prevent diversion, theft, or loss.

5) A cannabis processing facility shall make cannabis, cannabis extract, or cannabis product accessible only to the minimum number of specifically authorized employees essential for efficient operation and shall return the cannabis or cannabis extract to its secure location immediately after completion of the process or at the end of the scheduled business day.

6) If a manufacturing process cannot be completed at the end of a working day, the processor shall securely lock the processing area or tanks, vessels, bins, or bulk containers containing cannabis inside an area or room that affords adequate security.

 

R68-28-10. Product Appearance and Flavor.

1) A cannabis processing facility may not produce a cannabis product that is designed to mimic a candy product.

2) A cannabis processing facility may not produce a product that includes a candy-like flavor or another flavor the facility knows or should know appeals to children.

3) A cannabis processing facility may use only the following artificial flavors:

a) apple;

b) banana;

c) cherry;

d) grape;

e) lemon;

f) mint;

g) orange;

h) raspberry;

i) strawberry;

j) vanilla; or

k) watermelon.

4) Cannabis or cannabis product may retain the natural flavor provided the flavor is not candy-like or another flavor the facility knows or should know appeals to children.

5) A cannabis processing facility may not shape a cannabis product in any way to appeal to children.

 

R68-28-11. Packaging of Cannabis and Cannabis Product.

1) A cannabis processing facility shall package cannabis or cannabis products in accordance with this rule and Utah Code 4-41a-602 prior to transportation to a medical cannabis pharmacy or the state central fill medical cannabis pharmacy.

2) Cannabis and cannabis product shall be packaged in child-resistant packaging in accordance with 16 C.F.R. Section 1700.

3) Any container or packaging containing cannabis or cannabis product shall protect the product from contamination and shall not impart any toxic or deleterious substance to the cannabis or cannabis product.

 

R68-28-12. Labeling of Cannabis and Cannabis Product.

1) The text used on all labeling shall be printed in at least 10-point font and may not be in italics.

2) A cannabis processing facility shall label all cannabis and cannabis product before it sells the cannabis or cannabis product to a medical cannabis pharmacy or the state central fill medical cannabis pharmacy.

3) The label shall be securely affixed to the package and be in legible English.

4) A label for cannabis flower shall include the following information in the order as listed:

a) the name of the cannabis cultivation facility followed by the name of cannabis processing facility with the cannabis processing establishment licensing number;

b) the lot number;

c) the date of harvest;

d) the date of final testing;

e) the batch number;

f) the date on which the product was packaged;

g) the cannabinoid profile, potency levels, and terpenoid profile as determined by the independent testing laboratory,

h) the expiration date; and

i) the quantity of cannabis being sold.

5) THC potency levels for cannabis flower shall be total potential THC and not include any other calculated level of THC.

6) A label for cannabis products shall include the following information in the order listed:

a) the name of the cannabis processing facility and licensing number;

b) the batch number;

c) the date of production;

d) the date of the final testing;

e) the date on which the product was packaged;

f) the cannabinoid profile, potency level; and terpenoid profile as determined by the independent testing laboratory;

g) the expiration date;

h) the total amount of THC measured in milligrams;

i) a list of all ingredients and all major food allergens as identified in 21 U.S.C. 343;

j) the net weight of the product; and

k) a disclosure of the type of extraction process used and any solvent, gas, or other chemical used in the extraction process or any other compound added to the concentrated cannabis.

7) All cannabis or cannabis product labels shall contain the following warning: "WARNING: Cannabis has intoxicating effects and may be addictive. Do not operate a vehicle or machinery under its influence. KEEP OUT OF REACH OF CHILDREN. This product is for medical use only. Use only as directed by a qualified medical provider."

8) A cannabis processing facility may include a small logo or brand name at the end of the label.

9) No other information , illustrations, or depiction shall appear on the label.

 

R68-28-13. Transportation.

1) A printed transport manifest shall accompany every transport of cannabis.

2) The manifest shall contain the following information:

a) the cannabis production establishment address and license number of the departure location;

b) physical address and license number of the receiving location;

c) strain name, quantities by weight, and unique identification numbers of each cannabis material to be transported;

d) date and time of departure;

e) estimated date and time of arrival; and

f) name and signature of each agent accompanying the cannabis.

3) The transport manifest may not be voided or changed after departing from the original cannabis production establishment.

4) A copy of the transport manifest shall be given to the receiving cannabis processing establishment, independent laboratory, medical cannabis pharmacy, or state central fill medical cannabis pharmacy.

5) The receiving cannabis processing facility, independent laboratory, medical cannabis pharmacy, or state central fill medical cannabis pharmacy shall ensure that the cannabis material received is as described in the transport manifest and shall record the amounts received for each strain into the inventory control system.

6) The receiving cannabis processing facility, independent laboratory, medical cannabis pharmacy, or state central fill medical cannabis pharmacy shall document at time of receipt any differences between the quantity specified in the transport manifest and the quantities received in the inventory control system.

7) During transportation, cannabis shall be:

a) shielded from the public view;

b) secured; and

c) temperature controlled if perishable.

8) A cannabis cultivation facility shall contact the department within 24 hours if a vehicle transporting cannabis is involved in an accident that involves product loss.

9) Only the registered agents of the cannabis processing facility may occupy a transporting vehicle.

 

R68-28-14. 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 products;

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

c) evidence exists that harmful contaminants are present on or in cannabis or cannabis products; or

d) the department believes or has reason to believe the cannabis or cannabis products are unfit for human consumption.

2) A cannabis processing facility's recall plan shall include, at a minimum:

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;

c) procedures to retrieve and destroy product; and

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

3) The cannabis processing facility must 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 shall periodically check on the progress of the recall until the department declares an end to the recall.

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

 

R68-28-15. Cannabis Waste Disposal.

1) Solid and liquid wastes generated during cannabis cultivation shall be stored, managed, and disposed of in accordance with applicable state laws and regulations.

2) Wastewater generated during the cannabis production and processing shall be disposed of in compliance with applicable state laws and regulations.

3) Cannabis waste generated from the cannabis plant, trim, and leaves is not considered hazardous waste unless it has been treated or contaminated with a solvent, or pesticide.

4) All cannabis waste shall be rendered unusable prior to leaving the cannabis processing facility.

5) Cannabis waste, which is not designated as hazardous, shall be rendered unusable by grinding and incorporating the cannabis waste with other ground materials so the resulting mixture is at least fifty percent non-cannabis waste by volume or other methods approved by the department before implementation.

6) Materials used to grind and incorporate with cannabis fall into two categories:

a) compostable; or

b) non-compostable.

7) Compostable waste is cannabis waste to be disposed of as compost or in another organic waste method mixed with:

a) food waste;

b) yard waste; or

c) vegetable based grease or oils.

8) Non-compostable waste is cannabis waste to be disposed of in a landfill or another disposal method, such as incineration, mixed with:

a) paper waste;

b) cardboard waste;

c) plastic waste; or

d) soil.

9) Cannabis waste includes:

a) cannabis plant waste including roots, stalks, leaves, and stems;

b) excess cannabis or cannabis products from any quality assurance testing;

c) cannabis or cannabis products that fail to meet testing requirements; and

d) cannabis or cannabis products subject to a recall.

 

R68-28-16. Change in Operation Plans.

1) A cannabis processing facility shall submit a notice, on a form provided by the department, prior to making any changes to:

a) ownership or financial backing of the facility;

b) the facility's name;

c) a change in location;

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

e) change to the number of production lines.

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

3) The department shall respond to the request for changes within 15 business days.

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

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

 

R68-28-17. Renewals.

1) A cannabis processing facility shall submit a notice of intent to renew and the licensing fee to the department by December 31st.

2) If the licensing fee and intent to renew are not submitted December 31st the licensee may not continue to operate.

3) The department may take into consideration violations issued in determining license renewals.

 

R68-28-18. 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, but not limited to:

a) cannabis sold to an unlicensed source;

b) cannabis purchased from an unlicensed source;

c) refusal to allow inspection;

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 which the person knows or should know appeal to children; or

k) engaging in or permitting a violation of the Utah Code 4-41a 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, but not limited to:

a) failure to maintain alarm and security systems;

b) failure to keep and maintain records;

c) failure to maintain traceability;

d) failure to follow transportation requirements;

e) failure to follow the waste and disposal requirements;

f) engaging in or permitting a violation of Utah Code 4-41a or this rule which amounts to a regulatory violation as described in this subsection; or

g) failure to maintain standardized scales.

3) Licensing Violations: $500- $5,000 per violation. This category is for violations involving licensing requirements including, but not limited to:

a) an unauthorized change to the operating plan;

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

c) failure to notify the department of changes to financial or voting interests of greater than 2%;

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

e) engaging in or permitting a violation of this rule or Utah Code 4-41a 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: cannaibs processing, cannabis production establishment

Date of Enactment or Last Substantive Amendment: 2019

Authorizing, and Implemented or Interpreted Law: 4-41a-103(5); 4-41a-404(3); 4-41a-701(3); 4-41a-302(3)(b)(ii); 4-2-103(1)(i); 4-41a-405(2)(b)(iv); 4-41a-801(1)

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