Kentucky Marijuana Testing License

Does Kentucky Require Testing for Marijuana and Marijuana Products?

Per 915 KAR 1:110, cultivators, processors, and producers must test medical cannabis as outlined in Kentucky laws to ensure the safety and suitability of medical cannabis and medical cannabis products for human consumption. Harvest batch samples must be tested post-harvest before the sale, transfer, or delivery of the medical cannabis from the harvest batch. Production batch samples must be tested in their final form prepackaging and prior to the sale, transfer, or delivery of medical cannabis from their production batches.

Kentucky requires marijuana intended for sale by dispensaries to cardholders to be tested for:

• Heavy metals
• Mycotoxins
• Water activity (for harvest batches)
• Yeast and mold
• Vitamin E acetate
• Tetrahydrocannabinol and cannabinoid concentration
• Residual pesticides
• Microbial impurities
• Residual solvents and processing chemicals (for production batches)
• Terpenoid type and concentration

Harvest batches consisting of raw plant material not intended for sale to medical cannabis cardholders in its current form must be tested prior to the sale or transfer of the harvest batch to another licensed cannabis business for:

• Residual pesticides
• THC and cannabinoid concentration

Production batches of non-finished medical cannabis products not intended for sale to cardholders must be tested for:

• Residual solvents and processing chemicals
• Heavy metals
• THC and cannabinoid concentration

For THC and cannabinoid concentration, Kentucky requires that the testing must include tests for:

• Total THC
• Total CBD (Cannabidiol)
• Total cannabinoids
• Tetrahydocannabinolic acid (THCa)
• Delta-9 THC
• Delta-8 THC
• CBDA (Cannabidiolic acid)
• Cannabidiol (CBD)
• Cannabinol (CBN)
• Cannabigerol (CBG)
• Cannabigerolic acid (CBGa)
• Tetrahydrrocannabivarin (THCV)
• Cannabichromene (CBC)

For inhaled medical cannabis products, harvest, and production batches must be tested for heavy metal analytes and comply with the maximum allowed concentration:

• Arsenic - maximum allowable concentration of 0.2 ppm
• Cadmium - maximum permissible concentration of 0.2 ppm
• Lead - maximum permissible concentration of 0.5 ppm
• Mercury - maximum permissible concentration of 0.1 ppm

For medical cannabis products not intended to be inhaled, harvest and production batches must be tested for:

• Arsenic - maximum allowable concentration of 0.4 ppm
• Cadmium - maximum permissible concentration of 0.4 ppm
• Lead - maximum allowable concentration of 1 ppm
• Mercury - maximum permissible concentration of 1.2 ppm

Microbial impurity tests include tests to ensure the following:

• Total Escherichia coli is not detected above 100 colony-forming units or gram
• Shiga toxin-producing Escherichia coli is not detected in one gram
• Salmonella spp. is not detected in one gram
• Pathogenic Aspergillus species; A fumigatus, A. niger, A flavus, and A. terreus are not detected in one gram

Harvest and production batch samples must be tested for aflatoxin, B1, B2, G1, and G2 ochratoxin. The total of aflatoxin B1, B2, G1, and G2 must not exceed 20 micrograms per kilogram of substance, while Ochratoxin A must not exceed 20 micrograms per kilogram of substance. Harvest batch samples tested for water activity must have a water activity of less than 0.65. Total combined yeast and mold must not exceed 10,000 colony-forming units per gram. No detectable level of vitamin E acetate is acceptable in production batches.

Does Kentucky License Independent Marijuana Testing Facilities?

Yes. Kentucky issues licenses to independent cannabis testing facilities to perform tests for impurities and contaminants in medical cannabis and medical cannabis products. The state issues safety compliance facility licenses to qualified medical marijuana testing laboratories. Kentucky’s medical cannabis program is accepting applications from independent marijuana testing facilities between July 1, 2024, and August 31, 2024. No limit has been set for the number of licenses to be issued during this initial application window.

What Accreditations Do Marijuana Testing Facilities Need in Kentucky?

Although Kentucky cannabis laws do not require safety compliance facilities in the state to acquire specific accreditations, an ISO/IEC 17025 certification is typically required to conduct marijuana tests to the precision levels mandated by the Kentucky medical cannabis program. Many marijuana testing laboratories also usually have the ISO/IEC 17025 accreditation.

The process of obtaining ISO/IEC 17025 accreditation involves several detailed steps. First, it is essential to understand the ISO/IEC standards and identify the appropriate one for your laboratory. Next, you may conduct a 17025-gap analysis to identify the areas in your existing Quality Management System (QMS) that require modifications; an independent consultant can perform this analysis. Following this, create an ISO/IEC 17025 implementation plan and train laboratory employees to follow it.

Afterward, you should design a new ISO/IEC 17025 QMS and document it thoroughly in the laboratory manual. Once the document is ready, begin using the new QMS, ensuring that all employees adhere to the new procedures, document their work, and continuously seek improvements for at least three months. After this period, you should consider conducting an internal audit to examine the effectiveness of the new QMS and identify any areas for further enhancement. Finally, you can obtain accreditation by selecting an ISO/IEC 17025 accreditation body to audit your facility and the testing processes.

How to Get a Marijuana Testing Laboratory License in Kentucky

In order to be eligible for a Kentucky safety compliance facility license, none of your principal officers, agents, board members, volunteers, or employees may:

• Have a disqualifying felony offense
• Be younger than 21 years of age
• Be a medical cannabis practitioner
• Have served as a principal officer or board member for a cannabis business that has had its license revoked
• Be a principal officer or board member of a cultivator, producer, processor, or dispensary licensed to operate in Kentucky

Prior to the application, you must prepare the following documents:

• A business plan
• An operation plan detailing:
  • Record keeping
  • Security
  • Transportation of medical cannabis
  • Inventory management
  • Storage and labeling of medical cannabis
  • Diversion prevention
  • Workforce development
  • Employee qualifications, supervision, and training
• A site plan
• Business entity formation documents
• Management service agreement, if applicable
• Financial plan
• Resumes or CVs of principal officers and board members
• A timeline showing the steps and estimated amounts of time the applicant will take to start cannabis business activities
• Ownership organizational structure document
• Disclosure of principal officers and board members regarding criminal history form, if applicable
• Summary of instances where the applicant's board members previously served on a board for a business or not-for-profit entity that was convicted, censured, fined, or had a registration or license revoked or suspended in judicial or administrative proceedings, if applicable
• Summary of prior business experience, if applicable
• Documentation of sufficient capital
• Proof of compliance with state and local zoning restrictions for cannabis business. A cannabis processing facility cannot be located within 1,000 feet of an existing school or a daycare center
• Description of the responsibilities, duties, and roles of each principal officer, employee, board member, and other individual or entity with a financial interest in the cannabis business who is not involved in the day-to-day operations of the business
• Disclosure of individuals and entities involved in the cannabis business. This includes those with at least a 10% ownership stake, key management positions (officers and board members), and major financial backers. Additionally, any physicians or advanced practice nurses with ownership, investment, or contractual ties to the business must be disclosed
• The notarized application signature page

Once you have met the state's eligibility requirements and have the necessary documentation ready, you can proceed to the Kentucky medical cannabis portal to create an account and initiate your safety compliance facility license application. Typically, the Cabinet (Cabinet of Health and Family Services) acknowledges the receipt of the application within 15 calendar days. A notice of missing information or errors will be sent to your email address if deficiencies exist in the application.

If deficiencies are required to be remedied, you must provide the requested information or documentation within 10 calendar days from the notification date. Corrections and additional materials must be submitted through the same licensing portal.

The Cabinet will notify you of your application's approval or denial within 45 days of determining that it is complete. If your application is denied, you will receive a notice detailing the reasons for denial. However, you may request an administrative hearing within 30 calendar days from the notice date to appeal the decision on the application.

Note that the initial licensing application window opens on July 1, 2024, and closes on August 31, 2024. However, applicants are advised by the CFHS to submit their applications by August 15, 2024, to allow the Office of Medical Cannabis sufficient time to process applications and maintain the current timelines for license issuance.

If you are awarded a safety compliance facility license, you must pay the applicable license fee within 15 calendar days of notification. An invoice for the payment will be sent to your email address and also available under the Invoices tab on your account on the Kentucky medical cannabis portal.

For more information on completing a safety compliance facility license in Kentucky, refer to the Business Licensing Application Guide, the Resources page, or the Licensing Questions page on the Kentucky Medical Cannabis Program website.

How Much Does a Marijuana Testing Laboratory License Cost in Kentucky?

The following are the financial commitments in obtaining a safety compliance facility license under the Kentucky medical cannabis program:

• Non-refundable application fee: $3,000
• Initial licensing fee: $12,000
• Annual licensing fee: $12,000
• Capital requirements: $150,000

Are there Local Regulations for Cannabis Testing Facilities in Kentucky?

Per Kentucky law, no cannabis business, including safety compliance facilities, may be located within 1,000 feet of a school or daycare center. The Kentucky medical cannabis program provides a tool to help prospective safety compliance facility licensees evaluate where their facilities may be located in the state. Note that other local zoning restrictions may apply for marijuana testing facilities in the jurisdiction where such businesses may intend to be established. Therefore, if you plan on establishing a marijuana testing lab in a Kentucky jurisdiction, you should research any local regulations that may impact your business's location.