CMTL Testing

 

DEPARTMENT OF HEALTH

RULE NO.:RULE TITLE:

64ER20-3CMTL 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 64ER20-3 provides conditions applicable to analyses by a Certified Marijuana Testing Laboratory (CMTL) and requirements for CMTLs to participate in Proficiency Testing or to add Testing Fields.

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

 

THE FULL TEXT OF THE EMERGENCY RULE IS:

 

64ER20-3 CMTL Testing

(1) A CMTL may only perform analyses of Testing Fields within Matrix Groups under the following conditions:

(a) Analyses of Testing Fields within Matrix Groups must have been documented within the Certified Marijuana Testing Laboratory’s application for certification;

(b) Analyses of Testing Fields within Matrix Groups must be covered by the Certified Marijuana Testing Laboratory’s ISO/IEC 17025:2017 (revised March 2018) accreditation that is compliant with rule 64ER20-2, F.A.C.;

(c) Analyses of Testing Fields within Matrix Groups must be supported by documentation of two satisfactory analyses of the three most recent Proficiency Tests administered by an ISO/IEC 17043:2010 accredited complaint with rule 64ER20-2, F.A.C.  Proficiency Test results that are within the Acceptable Limits established by the contracted ISO/IEC 17043 accredited body are satisfactory;

(d) A CMTL must participate in at least two Proficiency Testing rounds from an ISO/IEC 17043:2010 accredited body for each field of accreditation (Matrix Group-Testing Field-Target Analyte combination) per calendar year beginning on the date of issuance or renewal of certification; and

(e) A CMTL may only perform analyses at its Testing Facility identified and documented in its application.

(2) A CMTL seeking to add Testing Fields within Matrix Groups must request approval from the department via email to [e-mail].  The Certified Marijuana Testing Laboratory must provide documentation demonstrating the additional Testing Fields within Matrix Groups have been added to the scope of their ISO 17025:2017 accreditation, documentation of the satisfactory completion of two consecutive Proficiency Test results administered by an ISO/IEC 17043:2010 accredited body for the additional Testing Field, and a Standard Operating Procedure evidencing the use of a validated Analytical Method for each requested Testing Field. A CMTL must direct the ISO/IEC 17025:2017 accredited body to deliver the results of this accreditation directly to the department by email to [e-mail]. The department will notify the CMTL in writing if its request is approved. 

(3) A CMTL that fails to satisfactorily complete two of the three most recent Proficiency Testing rounds must not test or provide results to MMTCs for any Target Analyte, Matrix, or other measurement for which its analysis was unsatisfactory.  The CMTL must undertake an internal investigation to determine the reason for the unsatisfactory Proficiency Test result and must obtain satisfactory results on additional Proficiency Testing for any Target Analyte, Matrix, or other measurement that failed.  A CMTL must provide the satisfactory Proficiency Testing Results from an ISO/IEC 17043:2010 accredited body to the department via email to [e-mail], before the CMTL may resume testing for any Target Analyte, Matrix, or other measurement for which its analysis was unsatisfactory.

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 21, 2020