Submission of Product for Testing

 

DEPARTMENT OF HEALTH

RULE NO.:RULE TITLE:

64ER20-8Submission of Product for Testing

SPECIFIC REASONS FOR FINDING AN IMMEDIATE DANGER TO THE PUBLIC HEALTH, SAFETY OR WELFARE: Pursuant to Chapter 2019-116, § 41, at 31, Laws of Florida, the Department is not required to make findings of an immediate danger to the public, health, safety, or welfare.

REASON FOR CONCLUDING THAT THE PROCEDURE IS FAIR UNDER THE CIRCUMSTANCES: The Department of Health is directed by Chapter 2019-116, § 41, at 31, Laws of Florida, to adopt emergency rules to implement section 381.988, Florida Statutes.

SUMMARY: Emergency rule 64ER20-8 requires every Medical Marijuana Treatment Center (MMTC) to arrange for a Certified Marijuana Testing Laboratory (CMTL) to test Final Product and prohibits dispensing untested Final Product or Final product that has not been found to comply with Acceptable Limits; outlines sampling requirements; requires each CMTL to establish a chain of custody protocol; provides certain testing requirements; and establishes requirements for transport of samples and reporting transportation and vehicle information to the department.

THE PERSON TO BE CONTACTED REGARDING THE EMERGENCY RULE IS: Courtney Coppola at [e-mail].

 

THE FULL TEXT OF THE EMERGENCY RULE IS:

 

64ER20-8 Submission of Product for Testing

(1) An MMTC must contact a CMTL and arrange for the CMTL to select and collect a random and representative sample of Final Product from every Retail Batch for testing.  An MMTC shall not dispense to a qualified patient any Final Product from any Retail Batch that has not been tested and found to comply with the Acceptable Limits contained in the CMTL rules.

(2) Final Products from each Retail Batch must be selected at random by the CMTL and in compliance with the CMTL’s field sampling protocols.  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) The CMTL must follow its field sampling protocol approved under its scope of ISO 17025 accreditation. 

(a) 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.

(b)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. CMTL’s name and address;

2. Date and time sampling started and ended;

3. MMTC’s name and address where the sample was collected;

4. The Retail Batch number of the batch from which the sample was obtained and the assigned unique sample identifier;

5. Sample matrix;

6. Total Retail batch size, by weight or volume;

7. Total quantity of Final Products in the Retail Batch;

8. Total weight or volume of the sample;

9. Sampling conditions or problems encountered during the sampling process, if any;

10. Printed name and signature of the MMTC representative who was present and granted access to the Final Products for sampling;

11. Printed CMTL Employee ID number and signature of the CMTL Sampler; and

12. 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) The CMTL must homogenize all Final Products into one Testing Sample for each Retail Batch sampled.  The number of Final Products chosen for testing from a Retail Batch must be enough total weight or volume to satisfy the following: 

(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. 

(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 analysis, and 2g or 2ml collected for each additional analysis performed by the same CMTL.

(c) For Total Combined Yeast and Mold in Usable Whole Flower Marijuana, at least 10g must be analyzed.

(5) The CMTL may, if necessary, collect more Final Product in order to ensure all tests are completed accurately.

(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) For Microbiological Testing, Moisture, and Water Activity analyses, a CMTL must begin preparation of Testing Samples for analysis within 48 hours of collection as reflected in the CMTL’s chain of custody log.  For Heavy Metals, Mycotoxins, Residual Solvents, Agricultural Agents, and Cannabinoid Profile analyses, a CMTL must begin preparation of Testing Samples for analysis within seven (7) days of collection as reflected in the CMTL’s chain of custody log.

(8) A CMTL is prohibited from sampling and testing a previously tested and failed Retail Batch.  If a CMTL is unable to complete regulatory compliance testing after sampling and before analyses are completed, the CMTL shall certify to the department in writing via email to [e-mail] why the testing could not be completed and provide a copy of the chain of custody log for the sample. Once a sample from a Retail Batch has been obtained by a CMTL for testing, an MMTC shall not arrange for or allow another CMTL to sample or re-sample the same Retail Batch for testing, except as provided in subsection (9) below. 

(9) If a CMTL is unable to complete the regulatory compliance testing after sampling and before analyses are completed, the MMTC from which the sample was collected may have the impacted Retail Batch(es) re-sampled and tested by another CMTL.  Prior to such resampling and testing, the MMTC must confirm, in writing, with the department that the CMTL certification required in subsection (8) above has been provided to and accepted by the department. 

(10) Nothing in the CMTL rules is intended to prohibit an MMTC from requesting testing of marijuana at any point during cultivation or processing. However, such testing does not exempt compliance with Final Product testing requirements prior to dispensing the Final Product to qualified patients.

(11) 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 alarm system.

(a) The CMTL must require at least two Employees to be in a vehicle transporting samples.

(b) The CMTL must not leave a vehicle containing samples unattended.

(c) The CMTL must ensure that packages or containers holding samples are neither tampered with nor opened during transport.

(d) The CMTL must ensure that all vehicles used to transport samples are in good working order and receive regular maintenance.

(e) The CMTL transporting samples must only travel between MMTCs for whom the laboratory is conducting regulatory compliance testing or quality assurance 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.

(f) The CMTL may at the same time transport multiple samples obtained from different MMTCs.

(g) No person under the age of 21 years old shall be in a vehicle transporting samples.

(h) Only CMTL Employees shall be in a vehicle while transporting samples.

(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:

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

2. Proof of registration and insurance.

3. The CMTL must provide the department with the information required under paragraph (i) in writing via email to [e-mail] for any vehicle that will be used to transport samples prior to using such vehicle.  The department will notify the CMTL in writing if the vehicle is approved for use by the CMTL. 

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

Rulemaking authority 381.988(3), 381.988(9), FS. Law Implemented 381.988, FS. History-New.

 

THIS RULE TAKES EFFECT UPON BEING FILED WITH THE DEPARTMENT OF STATE UNLESS A LATER TIME AND DATE IS SPECIFIED IN THE RULE.

EFFECTIVE DATE: January 22, 2020