Requirements for CMTL Certification and Application

 

DEPARTMENT OF HEALTH

RULE NO.:RULE TITLE:

64ER20-2Requirements for CMTL Certification and Application

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 64ER20-2 provides the requirements for certification as a Certified Marijuana Testing Laboratories and adopts the application form.

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

 

THE FULL TEXT OF THE EMERGENCY RULE IS:

 

64ER20-2 Requirements for CMTL Certification and Application

(1) This rule establishes the application and ongoing requirements for CMTLs. Any Applicant seeking certification as a CMTL must apply for certification as provided for in this rule.

(2) Certification will be on a per-Testing Facility basis. Separate applications must be submitted for each Testing Facility.

(3) To apply for certification, an Applicant must submit a completed Form DH8022-OMMU-01/2020, “Application and Instructions for Certified Marijuana Testing Laboratory Certification,” incorporated by reference herein and available at https://knowthefactsmmj.com/rules-and-regulations/ together with the application fee of $62,945.25.

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

(a) Accreditation. A CMTL must possess ISO/IEC 17025:2017 accreditation (revised March 2018) by an accrediting body recognized by the International Laboratory Accreditation Cooperation (ILAC). The accreditation must establish the CMTL is qualified to analyze one or more of the following Testing Fields:

1. Microbes;

2. Mycotoxins;

3. Residual Solvents;

4. Heavy Metals;

5. Agricultural Agents;

6. Water Activity;

7. Moisture;

8. Filth and Foreign Material; and

9. Cannabinoid Profile.

(b) Proficiency Testing. A CMTL must have received satisfactory results on two of the three most recent Proficiency Tests administered by an ISO/IEC 17043:2010 accredited body covering one or more of the Testing Fields within one or more of the following three 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 Agent;

f. Water Activity; and

g. Cannabinoid Profile.

(c) Personnel:

1. Laboratory 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 its equivalent.

c. CMTL Employees must not work for an MMTC, regardless of whether compensation is received; nor shall CMTL Employees receive any form of compensation or benefits 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 Standard Operating Procedures 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 Standard Operating Procedures 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 CMTL 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 physically independent Testing Facility operated by the CMTL.

c. All CMTL Directors must have a minimum of three (3) years of experience in an ISO, CAP, TNI, or similarly accredited laboratory environment.

(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 Standard Operating Procedures, which must be 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 area;

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

c. Recorded images legibly and accurately display 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 stored in a secured, locked room or a vault in a manner that does not accelerate spoilage or promote other degradation.

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 wears 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 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.

(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 Standard Operating Procedures and be in accordance with any accreditation required by this rule.

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 Managers and supervisors of personnel;

c. Employee training;

d. Employee responsibilities;

e. Objectives for measurement data;

f. Data and result traceability;

g. Preventative maintenance and calibration of equipment;

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

i. Corrective action;

j. Recordation and maintenance of Quality Assurance records; and

k. Transport, receiving, handling, 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 [e-mail], by the internal auditor that conducted the audit within five 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 [e-mail], by the internal auditor that conducted the audit within five business 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. Chain of custody entries must show the date, time, name of Employees handling the samples, the condition of the samples, the condition of any container or packaging the samples were transported or stored in, the location of the samples, the unique identifier assigned to each sample, and the seed to sale information from the MMTC. The CMTL’s tracking system will be required to be integrated with the department’s seed to sale tracking system once implemented.

(f) Background Screening. A CMTL’s Owners, Investors, Managers, and Employees must successfully pass a background screening in accordance with rule 64ER20-13, F.A.C.

(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 must be provided to the department for approval.

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 381.988(2), 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 21, 2020