1. (1) This rule establishes the application and ongoing certification requirements for CMTLs. Any Applicant seeking certification as a CMTL must apply for certification as provided for in this rule.
2. (2) Certification will be on a per-Testing Facility basis. Separate applications must be submitted for each Testing Facility.
3. (3) To apply for certification, an Applicant must submit a completed Form DH5062-OMMU-12/2025 (Eff. 01/2026), “Certified Marijuana Testing Laboratory Application Instructions, Requirements, and Forms,” incorporated by reference herein and available at HYPERLINK "https://www.flrules.org/Gateway/reference.asp?No=Ref-19177"https://www.flrules.org/Gateway/reference.asp?No=Ref-19177, together with the application fee of $78,000.00.

4. (4) To become a CMTL, an Applicant must meet and maintain, and continue to maintain during certification, all of the following requirements pertaining to CMTLs:

   1. (a) Accreditation. A CMTL must possess a separate ISO/IEC 17025:2017 accreditation for each Testing Facility, by an accrediting body recognized by the International Laboratory Accreditation Cooperation (ILAC). A CMTL must maintain compliance with all parts of ISO/IEC 17025:2017 and AOAC Laboratory Accreditation Guidelines (ALACC) at all times. Beginning on the effective date of this rule, the CMTL shall have until their next licensure renewal, or ISO/IEC 17025:2017 renewal, whichever occurs first, to comply with ALACC requirements. The accreditation must establish that the CMTL is qualified to analyze all Testing Fields in one or more of the following Matrix groups:

      1.Usable Whole Flower Marijuana

      a. Microbes;

      b. Mycotoxins;

      c. Heavy Metals;

      d. Agricultural Agents;

      e. Water Activity;

      f. Moisture;

      g. Filth and Foreign Material; and

      h. Cannabinoid Profile.

      2. Derivative Products

      a. Microbes;

      b. Mycotoxins;

      c. Residual Solvents;

      d. Heavy Metals;

      e. Agricultural Agents;

      f. Water Activity;

      g. Filth and Foreign Material; and

      h. Cannabinoid Profile.

      3. Edibles

      a. Microbes;

      b. Mycotoxins;

      c. Residual Solvents;

      d. Heavy Metals;

      e. Agricultural Agents;

      f. Water Activity;

      g. Filth and Foreign Material; and

      h. Cannabinoid Profile.

   2. (b) Proficiency Testing. A CMTL must create, maintain, and submit a Proficiency Test plan and schedule to OMMULabs@flhealth.gov. The plan and schedule must be for a duration of no less than 24 months. A CMTL must have received satisfactory results for a minimum of 80% of all Target Analytes in Agricultural Agents, Residual Solvents, and Cannabinoid Profile Testing Fields and 50% of all Target Analytes for all other Testing Fields in each Proficiency Test administered by an ISO/IEC 17043:2023 accredited body. A CMTL must have received satisfactory results for each Target Analyte on two of the three most recent Proficiency Tests administered by an ISO/IEC 17043:2023 accredited body covering all Testing Fields within one or more of the following Matrix Groups:

      1.Usable Whole Flower Marijuana

      a. Microbes;

      b. Mycotoxins;

      c. Heavy Metals;

      d. Agricultural Agents;

      e. Water Activity;

      f. Moisture; and

      g. Cannabinoid Profile.

      2. Derivative Products

      a. Microbes;

      b. Mycotoxins;

      c. Residual Solvents;

      d. Heavy Metals;

      e. Agricultural Agents;

      f. Water Activity; and

      g. Cannabinoid Profile.

      3. Edibles

      a. Microbes;

      b. Mycotoxins;

      c. Residual Solvents;

      d. Heavy Metals;

      e. Agricultural Agents;

      f. Water Activity;

      g. Cannabinoid Profile.

   3. (c) Personnel:

      1. Employees:

      a. All CMTL Employees must be 21 years of age or older.

      b. All CMTL Employees must have, at a minimum, a high school diploma from a state-approved and accredited public or private school, or secondary school equivalent.

      c. CMTL Employees must not work for an MMTC, regardless of whether compensation is received from the MMTC; nor shall CMTL Employees receive any form of compensation, gratuity, benefit, or gift of any kind, from an MMTC while employed by a CMTL.

      2. Samplers:

      a. All CMTL Samplers must meet the requirements for an Employee of a CMTL.

      b. All CMTL Samplers must be trained by the CMTL on the minimum requirements for sampling and the SOPs for sampling and security.

      3. Analysts:

      a. All CMTL Analysts must meet the requirements for an Employee of a CMTL.

      b. All CMTL Analysts must be trained by the CMTL on the minimum requirements for sampling and the SOPs for sampling and security.

      c. All CMTL Analysts must have, at a minimum, a bachelor’s degree in a natural science, to include, but not be limited to, biology, chemistry, physics, engineering, or environmental sciences; or hold a current license as a Clinical Laboratory Personnel, as defined in s. 483.803, F.S., from the Florida Board of Clinical Laboratory Personnel.

      4. Laboratory Directors:

      a. All Laboratory Directors must meet the requirements for an Employee and for an Analyst of a CMTL.

      b. A CMTL must employ a Laboratory Director for each Testing Facility operated by the CMTL.

      c. All Laboratory Directors must have a minimum of three (3) years of experience in an International Standards Organization (ISO), College American Pathologists (CAP), or The NELAC Institute (TNI) accredited laboratory environment.

   4. (d) Infrastructure and Security. A CMTL must have the ability to maintain adequate controls against the diversion, theft, or other loss of marijuana, the tampering or compromise of samples, and the tampering or compromise of testing equipment and materials. A CMTL must have documented security controls together with written SOPs, in accordance with any accreditation required by this rule, and must comply with the following security requirements to ensure the safety and security of all proposed Testing Facilities and Secure Storage areas:

      1. A fully operational security alarm system that secures all entry points and perimeter windows and is equipped with motion detector and duress, panic, and hold-up alarms.

      2. A fully operational video surveillance system that records continuously 24 hours a day, and meets the following criteria:

      a. Cameras are fixed in a place that allows for the clear identification of persons and activities in controlled areas of any Testing Facility and Secure Storage areas;

      b. Cameras are fixed at entrances and exits to the premises, record from both indoor and outdoor, or ingress and egress, vantage points;

      c. Records images legibly and accurately displays the time and date; and

      d. Video surveillance recordings are retained for at least 45 days.

      3. Fully operational dusk-to-dawn safety lighting on the exterior of the Testing Facility that provides illumination to the areas directly around the premises, including all points of ingress and egress.

      4. All marijuana and marijuana samples are safely stored in a Secure Storage area under sanitary conditions and temperatures to protect against Contaminants Unsafe for Human Consumption as defined by Rule 64-4.300, F.A.C.

      5. At least two Employees are on the Testing Facility premises when marijuana is received, when marijuana is tested, when marijuana is disposed of, and during the CMTL’s normal business hours.

      6. Each Employee must wear a legible photo identification badge visible at all times while on the premises.

      7. Any non-Employee persons with access to the premises of the CMTL must prominently display an identification badge clearly indicating their visitor status, and be accompanied by an Employee;

      8. Each Employee has training in and access to the CMTL’s alcohol and drug-free workplace policy.

      9. Each Employee has training in and access to the CMTL’s theft and diversion policies and procedures which must require reporting to local law enforcement within 24 hours of notification or knowledge of any apparent theft, diversion, or loss of marijuana.

   5. (e) Operations and Accountability. A CMTL must have written Quality Assurance and Quality Control procedures. Quality Assurance and Quality Controls must be contained within written SOPs and be in accordance with any accreditation required by this rule.

      1. (I) Traceability of all sample data and metadata;
      2. (II) Protection of all calculations used to report data and the reported data;
      3. (III) Calculation of the final Testing Sample concentration, LOD, and LOQ;
      4. (IV) Automatic flagging of all results above the Acceptable Limit for the purposes of internal sample management and COA generation; and

      5. (V) Automatic flagging of a Retail Batch which has already been sampled for Regulatory Compliance Testing by the CMTL.

         b. The CMTL’s tracking system must contain the following information:

      6. (I) Date, time, and name of Employees handing the samples;
      7. (II) The condition of the samples;
      8. (III) The condition of any container or packaging the samples were transported or stored in;
      9. (IV) The location of the samples;
      10. (V) The Unique Identifier assigned to each sample; and
      11. (VI) The seed-to-sale information from the MMTC.

      1. A CMTL’s written Quality Assurance Manual must address every aspect of its Quality Assurance program, including without limitation:

      a. Quality Control procedures;

      b. Organizational structure, to include all Employees

      c. Employee training and IDOCs;

      d. Employee responsibilities;

      e. Objectives for measurement data;

      f. Testing Sample preparation for each Testing Field;

      g. Testing Sample analysis for each Testing Field;

      h. Data and result traceability;

      i. Data Reduction;

      j. Chromatography and Manual Integration;

      k. Preventative maintenance and calibration of equipment;

      l. Performance audits, to include internal and external auditing;

      m. Corrective action;

      n. Recordation and maintenance of Quality Assurance records; and

      o. Transport, receiving, handling, destruction, and Secure Storage of samples.

      2. At least once a calendar year, or whenever a change of method, equipment, or Laboratory Director occurs, the Laboratory Director or authorized Employee must review, amend as necessary, and approve the Testing Facility’s Quality Assurance Manual and Quality Assurance program.

      3. Internal Quality Assurance and Quality Control audits must occur at least once every calendar year. Internal audit results, including any and all remedial actions, must be provided to the department via email to OMMUlabs@flhealth.gov, by the internal auditor that conducted the audit within five (5) business days of the completion of the audit.

      4. A CMTL must use testing equipment that satisfies the requirements of any accreditation required by this rule.

      a. Equipment that is not suitable for a specific method must not be used for that purpose.

      b. Testing equipment must be used and maintained according to the manufacturer’s instructions and must be calibrated pursuant to the requirements of any accreditation under which it is operated. CMTLs must retain records of all equipment repairs, maintenance, and Calibrations.

      5. Internal audits of all CMTL equipment, facilities, personnel, and security must occur at least once every calendar year. Audit results must be provided to the department via email to OMMUlabs@flhealth.gov, by the internal auditor that conducted the audit within seven (7) calendar days of the completion of the audit.

      6. A CMTL must have a tracking system to document the complete chain of custody of marijuana samples, and all testing data attributed to those samples, from receipt through disposal. The CMTL’s tracking system will be required to be integrated with the department’s seed-to-sale tracking system.

      a. The CMTL’s tracking system must have the following capabilities:

   6. (f) Background Screening. A CMTL’s Employees, Owners, and Managers must pass background screening in accordance with Rule 64-4.314, F.A.C.

   7. (g) Ownership. A CMTL must not be owned or Controlled by an MMTC, and must provide to the department the following:

      1. A fully diluted capitalization table that must:

      a. List all share types and the aggregate sum of shares associated with any natural persons, whether considered Owners or Investors;

      b. Sum to one hundred percent (100%) of all shares issued and outstanding; and

      c. List only natural persons as Owners and Investors.

      2. A CMTL must notify the department in writing of all contractual relationships to change Control of the entity holding the certification, or to change its Managers, Owners, or Investors prior to the execution of the change. Such contractual relationships, along with an updated fully diluted capitalization table, must be provided to the department for approval before the change of Control.

      3. Publicly-traded companies are not exempt from any requirements of this rule and must maintain documentation identifying all Owners and Investors that are considered Non-Objecting Beneficial Owners (“NOBOs”).

Rulemaking Authority Art. X, § 29, Fla. Const., 381.988(2), 381.988(3), 381.988(9) FS. Law Implemented Art. X, § 29, Fla. Const., 381.988 FS. History–New 5-28-26.