1. (1) Approved Analytical Methods. A CMTL must use approved Analytical Methods, as provided in this rule.

   1. (a) Approved Analytical Methods applicable to Microbiological Testing include:

      1. United States Food and Drug Administration (FDA), 2016. Bacterial Analytical Manual (BAM), Chapters 1, 2, 4, 5, and 18, incorporated by reference herein and available at https://knowthefactsmmj.com/rules-and-regulations/;

      2. Association of Analytical Communities (AOAC), 2016. Salmonella in Foods with a Low Microbial Load, 2000.06, incorporated by reference herein and available at https://knowthefactsmmj.com/rules-and-regulations/;

      3. International Standards Organization (ISO), 2002. ISO 6579:2017 Microbiology of the Food Chain – Horizontal Method for the Detection, Enumeration, and serotyping of Salmonella, incorporated by reference herein and available at https://knowthefactsmmj.com/rules-and-regulations/;

      4. International Standards Organization (ISO), 2012. ISO 13136:2012 Microbiology of Food and Animal Feed, incorporated by reference herein and available at https://knowthefactsmmj.com/rules-and-regulations/;

      5. United States Department of Agriculture: Food Safety and Inspection Services (USDA FSIS), 2016. Microbiology Laboratory Guidebook, Method Numbers 4.10 and 5C.00, incorporated by reference herein and available at https://knowthefactsmmj.com/rules-and-regulations/.

      6. Association of Analytical Communities (AOAC), 2016. Yeast and Mold Counts in Foods, 997.02, incorporated by reference herein and available at https://knowthefactsmmj.com/rules-and-regulations/;

   2. (b) Approved Analytical Methods applicable to Residual Solvent testing include:

      1. Environmental Protection Agency (EPA). 624.1 Purgeable by GC/MS, incorporated by reference herein and available at https://knowthefactsmmj.com/rules-and-regulations/;

      2. The U.S. Environmental Protection Agency Testing Methods for Evaluating Solid Waste: Physical/Chemical Methods Compendium (SW-846) 3500 Series, Methods 3500C, 3535A, 3550C, 3580A, and 3585, incorporated by reference herein and available at https://knowthefactsmmj.com/rules-and-regulations/;

      3. The U.S. Environmental Protection Agency Testing Methods for Evaluating Solid Waste: Physical/Chemical Methods Compendium (SW-846) 3600 Series, Method 3600C, incorporated by reference herein and available at https://knowthefactsmmj.com/rules-and-regulations/;

      4. The U.S. Environmental Protection Agency Testing Methods for Evaluating Solid Waste: Physical/Chemical Methods Compendium (SW-846) 8000 Series, Methods 8000D and 8260D, incorporated by reference herein and available at https://knowthefactsmmj.com/rules-and-regulations/.

   3. (c) Approved Analytical Methods applicable to Heavy Metals testing include:

      1. U.S. Food and Drug Administration, Elemental Analysis Manual for Food and Related Products, (March 2015), Method 4.7, incorporated by reference herein and available at https://knowthefactsmmj.com/rules-and-regulations/;

      2. United States Department of Agriculture: Food Safety and Inspection Services (USDA FSIS), 2016. Chemistry Laboratory Guidebook, Method Number CLG-TM3, incorporated by reference herein and available at https://knowthefactsmmj.com/rules-and-regulations/;

      3. The U.S. Environmental Protection Agency Testing Methods for Evaluating Solid Waste: Physical/Chemical Methods Compendium (SW-846) 3000 Series, Methods 3005A, 3015A, 3031, 3040A, and 3050B, incorporated by reference herein and available at https://knowthefactsmmj.com/rules-and-regulations/;

      4. The U.S. Environmental Protection Agency Testing Methods for Evaluating Solid Waste: Physical/Chemical Methods Compendium (SW-846) 6000 Series, Method 6010D, 6020D incorporated by reference herein and available at https://knowthefactsmmj.com/rules-and-regulations/;

      5. The U.S. Environmental Protection Agency Testing Methods for Evaluating Solid Waste: Physical/Chemical Methods Compendium (SW-846) 7000 Series, Methods 7000B, 7010, 7061A, 7470A 7471B, incorporated by reference herein and available at https://knowthefactsmmj.com/rules-and-regulations/.

   4. (d) Approved Analytical Methods s applicable to Agricultural Agent testing include:

      1. Association of Analytical Communities (AOAC), 2016. Pesticide Residues in Foods by Acetonitrile Extraction and Partitioning the Magnesium Sulfate, 2007.01, incorporated by reference herein and available at https://knowthefactsmmj.com/rules-and-regulations/;

      2. Food and Drug Administration (FDA), 2016. Pesticide Analytical Manual (PAM), Chapters 2, 3, 4, 5, and 6, incorporated by reference herein and available at https://knowthefactsmmj.com/rules-and-regulations/;

      3. United States Department of Agriculture: Food Safety and Inspection Services (USDA FSIS), 2016. Chemistry Laboratory Guidebook, Method Number CLG-PST5, incorporated by reference herein and available at https://knowthefactsmmj.com/rules-and-regulations/;

      4. The U.S. Environmental Protection Agency Testing Methods for Evaluating Solid Waste: Physical/Chemical Methods Compendium (SW-846) 3500 Series, Methods 3500C, 3535A, 3550C, and 3580A, incorporated by reference herein and available at https://knowthefactsmmj.com/rules-and-regulations/;

      5. The U.S. Environmental Protection Agency Testing Methods for Evaluating Solid Waste: Physical/Chemical Methods Compendium (SW-846) 3600 Series, Method 3600C, incorporated by reference herein and available at https://knowthefactsmmj.com/rules-and-regulations/;

      6. The U.S. Environmental Protection Agency Testing Methods for Evaluating Solid Waste: Physical/Chemical Methods Compendium (SW-846) 8000 Series, Methods 8270E, and 8275A, incorporated by reference herein and available at https://knowthefactsmmj.com/rules-and-regulations/.

   5. (e) Approved Analytical Methods applicable to Water Activity and Moisture testing include:

      1. The U.S. Food and Drug Administration, Water Activity (Aw) in Foods (April 1984), incorporated by reference herein and available at https://knowthefactsmmj.com/rules-and-regulations/; and

      2. United States Department of Agriculture: Food Safety and Inspection Services (USDA FSIS), 2016. Chemistry Laboratory Guidebook, Method Number CLG-MOI, incorporated by reference herein and available at https://knowthefactsmmj.com/rules-and-regulations/.

   6. (f) Approved Analytical Methods Applicable to Cannabinoid Profile testing include:

      1. Backer, Benjamin De, et al., 2009. Innovative development and validation of an HPLC/DAD method for the qualitative and quantitative determination of major cannabinoids in cannabis plant material. Journal of Chromatography B, 887 4115-4124, incorporated by reference herein and available at https://knowthefactsmmj.com/rules-and-regulations/;

      2. Recommended Method for the Identification and Analysis of Cannabis and Cannabis Products: Manual for Use by National Drug Analysis Laboratories. United Nations, incorporated by reference herein and available at https://knowthefactsmmj.com/rules-and-regulations/;

      3. Gambaro, Veniero, et al., 2002. Determination of primary active constituents in Cannabis preparations by high-resolution gas chromatography/flame ionization detection and high-performance liquid chromatography/UV detection. Analytica Chimica Acta 468, 245-254, incorporated by reference herein and available at https://knowthefactsmmj.com/rules-and-regulations/;

      4. Stolker, A.A.M., et al., 2004. Determination of cannabinoids in cannabis products using liquid chromatography-ion trap mass spectrometry. Journal of Chromatography A, 1058, 143-151, incorporated by reference herein and available at https://knowthefactsmmj.com/rules-and-regulations/; and

      5. Upton, Roy, et al., 2014. Cannabis Inflorescence Cannabis Spp.: Standards of Identity, Analysis, and Quality Control. American Herbal Pharmacopoeia. The department has determined that posting the incorporated material on the internet would constitute a violation of the federal copyright law. The materials incorporated herein have been deemed copyright protected and are available for inspection at the Department of Health, 2585 Merchants Row Boulevard, Tallahassee, Florida 32399-1710, or at the Department of State, R.A. Gray Building, 500 South Bronough Street, Tallahassee, Florida 32399-0250.

   7. (g) A CMTL may request to use an alternative, scientifically validated testing methodology. All requests for alternative, scientifically validated testing methodologies must be made in writing via email to OMMUlabs@flhealth.gov and are subject to the department’s written approval.

   8. (h) A CMTL may request to use an alternative testing methodology, subject to the following requirements:

      1. Any alternative testing methodologies must be validated in accordance with one of the following:

      a. The U.S. Food and Drug Administration, Guidelines for the Validation of Methods for the Detection of Microbial Pathogens in Foods and Feeds (3rd edition, 2019), incorporated by reference herein and available at https://knowthefactsmmj.com/rules-and-regulations/;

      b. The U.S. Food and Drug Administration, Guidelines for the Validation of Chemical Methods for FDA FVM Program (3rd edition, 2019), incorporated by reference herein and available at https://knowthefactsmmj.com/rules-and-regulations/;

      c. Association of Analytical Communities (AOAC), 2012. Methods Committee Guidelines for Validation of Microbiological Methods for Food and Environmental Surfaces, incorporated by reference herein and available at https://knowthefactsmmj.com/rules-and-regulations/;

      d. Association of Analytical Communities (AOAC), 2002. Guidelines for Single Laboratory Validation of Chemical Methods for Dietary Supplements and Botanicals, incorporated by reference herein and available at https://knowthefactsmmj.com/rules-and-regulations/;

      e. Food and Drug Administration (FDA), 2015. Analytical Procedures and Methods Validation for Drugs and Biologics, incorporated by reference herein and available at https://knowthefactsmmj.com/rules-and-regulations/;

      f. International Conference on Harmonization (ICH), 1996. Harmonized Tripartite Guideline Validations of Analytical Procedures: Text and Methodology, incorporated by reference herein and available at https://knowthefactsmmj.com/rules-and-regulations/; or

      g. United States Department of Agriculture Food Safety and Inspection Services (USDA FSIS), 2010. Guidance for Test Kit Manufacturers, Laboratories: Evaluating the Performance of Pathogen Test Kit Methods, incorporated by reference herein and available at https://knowthefactsmmj.com/rules-and-regulations/.

      2. The CMTL may only utilize an alternative testing methodology upon the successful completion of subparagraphs (h)1., and the submission to the department of documentary evidence that the requirements of subparagraphs (h)1. have been met. Such documentation must be submitted to the department via email at OMMUlabs@flhealth.gov. Upon receipt of the documentation, the department will notify the CMTL in writing whether use of the alternative, scientifically valid testing methodology is approved.

2. (2) Competency. An Analyst must demonstrate an Initial Display of Competency (IDOC) for a testing method prior to analyzing any Analytical Sample using that method. An IDOC is comprised of one Method Blank and four Laboratory Fortified Blanks amended with the method specified Spike Solution, and prepared and analyzed according to the same SOPs as Testing Samples. To be acceptable, the calculated Relative Percent Difference must be less than or equal to 20%, the recovery of each Target Analyte in each Laboratory Fortified Blank must be between 80% and 120% of the amended concentration, and the Method Blank must not have any Target Analytes test above the LOD, if applicable for that analysis. The IDOC must be repeated every time there is a change in the method, or when the method has not been performed by the Analyst within a 12-month period.
3. (3) Equipment. CMTLs must use testing equipment that satisfies the requirements of all required accreditation pursuant to CMTL rules. If any piece of equipment is not suitable for a specific method, it must not be engaged for that method or purpose. Testing equipment must be used and maintained according to the manufacturer’s instructions and must be calibrated pursuant to the requirements of all accreditation under which the CMTL is operating. CMTLs must retain records of all equipment repairs, maintenance, and Calibrations for a minimum of three years.

4. (4) Proficiency Testing. A CMTL must authorize any contracted ISO/IEC 17043 accredited Proficiency Test provider to submit all Proficiency Testing results to the department and the CMTL concurrently. After the Proficiency Testing data is submitted, no modification to any aspect of the reported results, method/technology, measurement units, or the associated report information shall be made unless it is necessary due to a documented error made by the accredited Proficiency Testing provider.

   1. (a) CMTLs must manage, analyze, and report all Proficiency Testing samples in the same manner as MMTC Testing Samples, including adherence to the same sample tracking, sample preparation, analysis methods, Standard Operating Procedures, Calibrations, Quality Control, and Acceptance criteria used in testing MMTC Testing Samples.
   2. (b) The Matrix of the Proficiency Testing sample must be of the same complexity as the Matrix type designated in the SOPs being used to prepare and analyze the Proficiency Testing sample. The same Proficiency Testing sample may be used for multiple methods if those methods are within the same Testing Field and Matrix Group. A method used for multiple Matrix groups need only pass Proficiency Testing for one Matrix Group to be acceptable for all Matrix Groups approved for that method. If a CMTL reports multiple Proficiency Testing results for a Testing Field and Matrix Group by more than one method using the same technology, an unsatisfactory result for any test method will result in an unsatisfactory result for all test methods for that Proficiency Testing sample.
   3. (c) Rounds of Proficiency Testing may not occur at greater than six-month intervals, as determined by the closing dates of each Proficiency Testing round. If a CMTL reports more than one result for a field of accreditation (Matrix Group-Testing Field-Target Analyte combination) from a Proficiency Testing round, any unsatisfactory result constitutes a failed testing attempt for the corresponding approved or pending field of accreditation. The results of all Proficiency Testing must be sent from the ISO/IEC 17043 accredited body directly to the department. The CMTL must direct the ISO/IEC 17043 accredited body to deliver the results directly to the department via email at OMMUlabs@flhealth.gov.

   4. (d) To contest the results of a Proficiency Test, the CMTL must submit to the department, within seven days of the CMTL’s receipt of the results, the name of the Proficiency Test provider, the method and Target Analyte or Analytes in question, a detailed description of the discrepancy, and any supporting documentation.

      

      

      

      

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