1. (1) A CMTL must collect from an MMTC a random and representative sample of Final Product from every Retail Batch for regulatory compliance testing. The CMTL must follow its field sampling protocol approved under its scope of ISO 17025 accreditation.
2. (2) At the time of selection, the CMTL must confirm within the MMTC’s seed-to-sale system that the total quantity of Final Products in the Retail Batch from which a sample is being selected matches the total quantity of Final Products in the Retail Batch denoted in the system.

3. (3) A CMTL must develop and implement a chain of custody protocol to ensure accurate documentation is recorded for the transport, handling, storage, and destruction of samples. The protocol must include use of a log form developed by the CMTL. The CMTL must use the CMTL’s chain of custody log to record the following information for each Retail Batch sampled:

   1. (a) CMTL’s name and address;
   2. (b) Date and time sampling started and ended;
   3. (c) MMTC’s name and address where the sample was collected;
   4. (d) The Retail Batch number of the batch from which the sample was obtained and the assigned unique sample identifier;
   5. (e) Sample Matrix;
   6. (f) Total Retail Batch size, by weight or volume;
   7. (g) Total quantity of Final Products in the Retail Batch;
   8. (h) Total weight or volume of the sample;
   9. (i) Sampling conditions or problems encountered during the sampling process, if any;
   10. (j) Printed name and signature of the MMTC representative who was present and granted access to the Final Products for sampling;
   11. (k) Printed CMTL Employee ID number and signature of the CMTL Sampler; and
   12. (l) The date and time the sample departed from the MMTC’s premises and when it arrived at the CMTL, along with the names and signatures of the CMTL Employees involved in the transport of the samples.

4. (4) The CMTL must homogenize all Final Products into one Testing Sample for each Retail Batch sampled, except in the case of homogeneity testing of edibles. A minimum of three (3) Final Products must be sampled from each Retail Batch. The number of Final Products chosen for testing from a Retail Batch must be enough total weight or volume to satisfy the following:

   1. (a) If all testing of a Retail Batch is to be performed by one CMTL, 0.35% of the total volume or weight of the Retail Batch must be collected by the CMTL. In no event, however, may the CMTL collect less than a 15g or 15ml sample.
   2. (b) If testing of a Retail Batch is to be performed by multiple CMTLs, 0.20% of the total volume or weight of the Retail Batch must be collected by each CMTL. In no event, however, may the CMTL collect less than 6g or 6ml for the first test, and 2g or 2ml collected for each additional test performed by the same CMTL.
   3. (c) For Total Combined Yeast and Mold in Usable Whole Flower Marijuana, a minimum of 10g of additional Final Product must be sampled and tested.
5. (5) The CMTL may, if necessary, collect more Final Product in order to ensure all tests are completed accurately.
6. (6) The CMTL must ensure that samples are transported and stored in a manner that prevents degradation, contamination, comingling, and tampering. The CMTL’s original chain of custody log must accompany the samples at all times during transport. Samples must be packaged by the CMTL at the MMTC facility where the sampling takes place, and the package must be sealed with a Tamper Evident Device.
7. (7) For Microbiological Testing, Moisture, Water Activity, and Filth and Foreign Material tests, a CMTL must begin preparation of Testing Samples within 72 hours of collection as reflected in the CMTL’s chain of custody log. For all other required tests, a CMTL must begin preparation of Testing Samples within seven (7) days of collection as reflected in the CMTL’s chain of custody log.
8. (8) If a CMTL is unable to complete regulatory compliance testing after sampling the CMTL shall certify to the department in writing via email to OMMUlabs@flhealth.gov why the testing could not be completed and provide a copy of the chain of custody log for the sample.
9. (9) A CMTL may resample and retest a previously failed Retail Batch as permitted by the MMTC Regulatory Compliance Testing rule. A previously failed Retail Batch is subject to the same sampling requirements as the initial sample and must undergo complete regulatory compliance testing in accordance with the CMTL Sample Testing rule.

10. (10) While transporting samples collected from an MMTC, a CMTL must ensure the samples are not visible to the public. Samples must be locked in a fully enclosed box, container, or cage that is secured to the inside of the vehicle used for transport. No portion of the enclosed box, container, or cage shall be comprised of any part of the body of the vehicle. For the purposes of this subsection, the inside of a vehicle includes the trunk. Vehicles used for transporting samples must be equipped with an operational alarm system.

    1. (a) The CMTL must require at least two Employees to be in a vehicle transporting samples.
    2. (b) The CMTL must not leave a vehicle containing samples unattended. One Employee shall remain with the vehicle transporting samples at all times.
    3. (c) The CMTL must ensure that packages or containers holding samples are neither tampered with nor opened during transport.
    4. (d) The CMTL must ensure that all vehicles used to transport samples are in good working order and receive regular maintenance.
    5. (e) The CMTL transporting samples must only travel between MMTCs for whom the laboratory is conducting regulatory compliance testing or research and development testing and the CMTL’s Testing Facility. A CMTL must not deviate from the travel requirements described herein, except for necessary rest, fuel, or vehicle repair stops.
    6. (f) The CMTL may simultaneously transport multiple samples obtained from different MMTCs.
    7. (g) No person under the age of 21 years old shall be in a vehicle transporting samples.
    8. (h) Only CMTL Employees shall be in a vehicle while transporting samples.

    9. (i) For any vehicle that will be utilized to transport samples that was not approved as part of the CMTL’s initial application, the CMTL must provide the following information to the department, via email at OMMUlabs@flhealth.gov, prior to using such vehicle:

       1. The year, make, model, license plate number, and Vehicle Identification Number (VIN); and

       2. Proof of registration and insurance.

    10. (j) Vehicles transporting samples are subject to inspection by the department at any time in accordance with CMTL Rules.

        

        

        

        

Rulemaking Authority 381.986(8)(k), 381.988(3), 381.988(9) FS. Law Implemented 381.986, 381.988 FS. History—New 11-17-20.