1. (1) CMTLs must prepare Calibration Standards pursuant to and in compliance with this rule. Calibration Standards must be prepared by diluting Certified Reference Materials to produce working standards to be used in the Calibration of instruments, the quantitation of analysis samples, and for use in Laboratory Fortified Blanks and Matrix Spike Samples. Certified Reference Materials must be:

   1. (a) Obtained from an independent body that holds ISO/IEC 17034:2017 accreditation; or
   2. (b) Created by the CMTL, if the CMTL holds ISO/IEC 17034:2017 accreditation.

2. (2) The Limit of Detection (LOD) must be calculated for Mycotoxins, Heavy Metals, Residual Solvents, Agricultural Agents, and Cannabinoid Profile in one of the following ways:

   1. (a) The signal-to-noise ratio, as calculated by comparing the measured signals of known Target Analyte concentrations with those within the Method Blanks to establish the minimum concentration a Target Analyte can be consistently detected. Acceptable ratios must be within the range of 3:1 to 2:1;
   2. (b) Based on the standard deviation of the instrument’s response and the slope of the Calibration Curve, calculated as 3.3 × the standard deviation of the response ÷ the slope of the Calibration Curve. The standard deviation of the response must be determined by comparing seven Method Blank samples. The Limit of Detection for chemical methods must be less than 1/10 of the action level for each Target Analyte; or
   3. (c) Any other method published by the U.S. Food and Drug Administration or the U.S. Environmental Protection Agency. A CMTL utilizing a method pursuant to this paragraph must provide the method to the department via email to OMMUlabs@flhealth.gov.

3. (3) The Limit of Quantitation (LOQ) must be calculated for Mycotoxins, Heavy Metals, Residual Solvents, Agricultural Agents, and Cannabinoid Profile in one of the following ways:

   1. (a) The signal-to-noise ratio, as calculated by comparing the measured signals of known Target Analyte concentrations with those of Method Blanks to establish the minimum concentration a Target Analyte can be consistently detected. The minimum acceptable ratio is 10:1;
   2. (b) Based on the standard deviation of the instrument’s response and the slope of the Calibration Curve, calculated as 10 × the standard deviation of the response ÷ the slope of the Calibration Curve. Standard deviation of the response is determined by comparing seven Method Blank samples. The LOQ for chemical methods must be, at a maximum, ½ of the Target Analyte’s Acceptable Limit; or
   3. (c) Any other method published by the U.S. Food and Drug Administration or the U.S. Environmental Protection Agency. A CMTL utilizing a method pursuant to this paragraph must provide the method to the department via email to OMMUlabs@flhealth.gov.

4. (4) The correlation coefficient of the Calibration Standard regression model must be greater than or equal to 0.98. A Calibration Curve must consist of a minimum of five (5) consecutive points if utilizing a linear correlation, and a minimum of six (6) consecutive points of utilizing a non-linear correlation. The Calibration Curve must, at a minimum, span from the Limit of Quantitation to the Acceptable Limit for each individual Target Analyte.

   

   

   

   

Rulemaking Authority 381.988(3), 381.988(9) FS. Law Implemented 381.988 FS. History–New 1-22-20.