This rule provides definitions necessary for interpreting certified marijuana testing laboratory rules being promulgated.

 

DEPARTMENT OF HEALTH

RULE NO.:RULE TITLE:

64-4.300Certified Marijuana Testing Laboratory Definitions

PURPOSE AND EFFECT: This rule provides definitions necessary for interpreting certified marijuana testing laboratory rules being promulgated.

SUBJECT AREA TO BE ADDRESSED: Definition of terms related to certified marijuana testing laboratories

RULEMAKING AUTHORITY: 381.988(2), 381.988(3), FS

LAW IMPLEMENTED: 381.988, FS

IF REQUESTED IN WRITING AND NOT DEEMED UNNECESSARY BY THE AGENCY HEAD, A RULE DEVELOPMENT WORKSHOP WILL BE NOTICED IN THE NEXT AVAILABLE FLORIDA ADMINISTRATIVE REGISTER.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE DEVELOPMENT AND A COPY OF THE PRELIMINARY DRAFT, IF AVAILABLE, IS: Courtney Coppola [phone] or [e-mail].

 

THE PRELIMINARY TEXT OF THE PROPOSED RULE DEVELOPMENT IS:

 

64-4.300 Certified Marijuana Testing Laboratory Definitions

The following words and phrases have the following meaning and apply to Rules 64-4.301 through 64-4.313:

(1) Acceptable Limit – The maximum concentration allowed for a specified Target Analyte.  Any Target Analyte measured above its concentration limit constitutes a failure for that analysis.

(2) Agricultural Agents – Any pesticide, herbicide, fungicide, fertilizer, synergist, or root stimulant applied to the plant or substrate, at any stage of cultivation or manufacturing, for the purpose of increased growth, vigor, or pest resistance.

(3) Analyst – An Employee of an Applicant or Certified Marijuana Testing Laboratory whose duties include conducting analyses on analytical instrumentation, analyzing and recording results, maintaining testing-related workspaces and equipment, and maintaining marijuana samples.

(4) Analytical Batch – a group of no more than 20 Analytical Samples, which behave similarly with respect to the sampling or the testing procedures being employed, that are prepared together.

(5) Analytical Method – An approved procedure used for the testing and analysis of Analytical Samples.

(6) Analytical Sample – A Testing Sample which has gone through all the necessary preparatory procedures and are in a form to be analyzed.

(7) Applicant – An individual or entity that seeks certification as a Certified Marijuana Testing Laboratory pursuant to section 381.988(2), F.S., and Rule 64-4.301.

(8) Calibration – Set of analyses that establish, under conditions specified in the analysis Standard Operating Procedure, the relationship between values of quantities indicated by the measuring instrument or measuring system, or values represented by a material measure of a Certified Reference Material, and the corresponding values realized by standards.

(9) Calibration Curve – The mathematical relationship between the known values, such as the concentrations of a series of Calibration Standards, and their instrument response, prepared at multiple concentrations which cover the working range of the instrument.

(10) Calibration Standard – A Certified Reference Material used to calibrate an instrument.

(11) Cannabinoid Profile – An analysis conducted to determine the level of concentration of d9-THC, d8-THC, THCA, THCV, CBD, CBDA, CBDV, CBG, CBGA, CBN, and CBC in all Final Product meant for sale to qualified patients.

(12) Certificate of Analysis – A document created by a Certified Marijuana Testing Laboratory which certifies the quality and purity of the tested Final Product.

(13) Certified Marijuana Testing Laboratory – A laboratory that meets the requirements of section 381.988, Florida Statutes and Rules 64-4.301 through 64-4.313, and is certified by the department.

(14) Certified Reference Material – A material characterized by a metrologically valid procedure for one or more specified properties, accompanied by a certificate that provides the value of the specified property, its associated uncertainty, and a statement of metrological traceability.

(15) Contaminants Unsafe for Human Consumption – Any Microbe, Mycotoxin, Agricultural Agent, Residual Solvent, Heavy Metal, or Filth and Foreign Material found in an amount that exceeds any of the department’s accepted limitations.

(16) Continuing Calibration Verification – A standard solution from a source that is certified and traceable. These standards are used to check the accuracy of a Calibration Curve on a daily basis (before the run and every 12 hours thereafter or every 10 samples, whichever occurs first.

(17) Control – Voting power which includes the power to vote, or to direct the voting, of an owner’s interest

(18) Cultivar – A variety, strain, or race that has originated and persisted under cultivation and has been developed through artificial selection for specific morphological, physiological, or chemical characteristics.

(19) Data Packages – Analytical testing data that is prepared by a Certified Marijuana Testing Laboratory and which contains information about the testing performed, Quality Assurance and Quality Control data, and the results of any tests performed.

(20) Derivative Product – Product created from an extract of Usable Whole Flower Marijuana

(21) Edible – Commercially produced food items made with marijuana oil, but no other form of marijuana, that are produced and dispensed by a Medical Marijuana Treatment Center.

(22) Employee – Any person whose duties involve activities or responsibilities include handling Usable Whole Flower Marijuana or Derivative Products, whether or not they are compensated for their work.

(23) Environmental Testing – Physical and biological analyses, to include chemistry and biochemistry in compliance with Rule 64E-1.005 F.A.C.

(24) Filth and Foreign Materials – Mold, mildew, hair, insects, feces, packaging contaminants, manufacturing waste, or other marijuana cultivation and manufacturing by-products.

(25) Final Product – Any sealed marijuana or Derivative Product in its final container intended for use by a qualified patient.

(26) Formulation – The specific combination of ingredients combined to produce a Final Product

(27) Heavy Metals – A metallic chemical element that has a relatively high density and is toxic or poisonous at low concentrations.

(28) Increment – A subsample taken from an Edible product for the purposes of homogeneity testing.

(29) Initial Calibration Verification – A Calibration Standard from a second source or production lot different from the Calibration Curve lot, that is certified and traceable. These standards are used to check the accuracy of a Calibration Curve.

(30) Initial Display of Competency (IDOC) – An assay, administered by a Certified Marijuana Testing Laboratory, undertaken by an Analyst to determine whether he or she can correctly, accurately, and repeatedly perform a specific analysis or analyze a specific measurement.

(31) Interest – Any form of ownership in or Control of an Applicant, a Certified Marijuana Testing Laboratory, or Medical Marijuana Treatment Center including, but not limited to, ownership of stock, membership Interests, partnership Interests, a sole proprietorship or otherwise which convey to the holder thereof an ownership right or an Interest in or right to the profits, capital, or voting with respect to such Applicant, Certified Marijuana Testing Laboratory, or Medical Marijuana Treatment Center.

(32) Internal Standard – A pure Target Analyte of known concentration, not expected to be found in the Testing Samples, added to the Analytical Samples prior to analysis used to measure the relative response of other Target Analytes and Surrogates to correct for variations.

(33) Investor – Any person who, directly or indirectly, owns a legal or equitable Interest (actually or beneficially), or Controls less than a 5% share of Interests of an Applicant or Certified Marijuana Testing Laboratory.

(34) Laboratory Batch – A series that includes the Analytical Batch as well as all applicable Quality Control samples, to include one Method Blank, duplicate Laboratory Fortified Blanks, duplicate Matrix Spike Samples, and at least one duplicate sample, for Mycotoxins, Residual Solvents, Agricultural Agents, Cannabinoid Profile, and Heavy Metals.

(35) Laboratory Director – An individual who oversees all Analysts, Employees, Managers, and functions of testing Usable Whole Flower Marijuana, Derivative Product, and Edibles at only one physically independent Testing Facility operated by the Certified Marijuana Testing Laboratory.

(36) Laboratory Fortified Blank – A Quality Control sample, created using a Matrix similar to the sample Matrix, and initially without Target Analytes, prepared along with Testing Samples, that have been amended with a known concentration of a Target Analyte or Analytes for competency assessment purposes.

(37) Limit of Detection (LOD) – The lowest quantity of a Target Analyte that can be distinguished from the absence of that Target Analyte within a stated confidence limit. The LOD must be 10% of the Acceptable Limit or less for the Target Analyte tested.

(38) Limit of Quantitation (LOQ) – The minimum concentration of a Target Analyte in a specific Matrix that can be reliably quantified while also meeting predefined goals for bias and imprecision. The LOQ must be equal to the Acceptable Limit or less for the Target Analyte tested.

(39) Manager – Any person with direct or indirect authority to exercise or contribute to the operational Control, direction, or management of an Applicant or a Certified Marijuana Testing Laboratory or who has direct or indirect authority to supervise any Employee of an Applicant or a Certified Marijuana Testing Laboratory. The term includes all officers, Laboratory Directors, and members of the board of directors, as well as any other person engaged to undertake management or Control of the Applicant or a Certified Marijuana Testing Laboratory or any person in Control of an entity engaged to undertake management or Control of the Applicant or Certified Marijuana Testing Laboratory.

(40) Matrix – The component or substrate containing a Target Analyte or Analytes.

(41) Matrix Group – The components of a Testing Sample other than the Target Analytes.

(42) Matrix Spike Sample – An aliquot from a Testing Sample, which has been amended with a known concentration of a Target Analyte or Analytes to test for potential Matrix interference.

(43) Method Blank – A Target Analyte-free Matrix, (Reagent water or appropriate solvent), which is carried through the complete preparation and analytical procedure, used to evaluate contamination resulting from the complete analytical procedure.

(44) Microbe – Any microscopic organism, to include bacteria and fungi.

(45) Microbiological Testing – The analysis of microbes.

(46) Medical Marijuana Treatment Center (MMTC) – An entity certified by the department pursuant to 381.986, Florida Statutes.

(47) Moisture – The total amount of water present in a sample, calculated as percent Moisture

(48) Mycotoxins – Any toxin substance produced by a fungus.

(49) Non-Oral Transmucosal Product – A Derivative Product with administration routes other than oral and heated inhalation, to include, but not limited to, nasal sprays, inhalers, suppositories, and similar transmucosal administration routes.

(50) Owner – Any person who, directly or indirectly, owns a legal or equitable Interest (actually or beneficially), or otherwise Controls, a 5% or greater share of Interests of the Applicant or Certified Marijuana Testing Laboratory. In the event that one person owns a beneficial right to Interests and another person holds the voting rights with respect to such Interests, both persons are the Owner of such Interests. In determining who are Owners of the Applicant or a Certified Marijuana Testing Laboratory, the attribution of ownership rules set forth in the Treasury Regulations cited as 26 C.F.R. 1.414(c)-4(b) and (c) (4-1-17 edition), incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-XXXXX, apply, but with the following exceptions and additions:

(a) The use of the term “Option” in 26 C.F.R. 1.414(c)-4(b) shall be interpreted broadly to include, but not be limited to, options, warrants, calls, rights of first refusal and any other right to acquire an Interest (as defined herein), whether such right is vested or unvested and regardless of whether such right is then exercisable or becomes exercisable at a future date or upon the occurrence of a future event.

(b) The exception for attribution of a spouse’s Interest, as defined in paragraph (aa) above and as set forth in 26 C.F.R. 1.414(c)-4(b)(5)(ii), does not apply.

(c)The age limitation contained in 26 C.F.R. 1.414(c)-4(b)(6) applies only to children who have not attained the age of 18 years. The term “Interest” as used in 26 C.F.R. 1.414(c)-4(b)(6) shall have the meaning as set forth in paragraph (aa) above.

(d) If a person under the age of 18 owns or is deemed an Owner of an Interest, such person must be disclosed to the department. Persons under the age of 18 must submit to a background screening only in the event that the Interest or ownership was not imputed to another family member or guardian.

(e) To the extent that the above alterations to the provisions of 26 C.F.R. 1.414(c)-4 change the outcome of any of the examples set forth therein, the example does not apply.

(f) As used in 26 C.F.R. 1.414(c)-4(b)(3), the term “Actuarial Interest” shall be interpreted broadly and shall include, but not be limited to, the right of a beneficiary of a trust or an estate to receive either income or principal distributions with respect to an Interest held by such trust or estate.

(g) With regard to publicly-traded companies with ownership Interests in the Applicant, any person who holds 10% or more Interest in the publicly-traded company is an Owner.

(51) Potency Testing – The analysis of the relative strength of cannabinoids, and the total amount, in milligrams, of THC as the sum of (d9-THC + (0.877 x THCA)) and CBD as the sum of (CBD + (0.877 x CBDA)) in the Final Product.

(52) Processed Batch – A portion of Usable Whole Flower Marijuana of uniform Cultivar, cultivated with the same agricultural chemicals, and harvested at the same time, which does not exceed 50 kilograms dry weight, or a Processed Batch of Derivative Product which must contain the same type of product and be produced using the same extraction methods, SOPs, ingredients, and Processed Batch or Batches of Usable Whole Flower.

(53) Proficiency Testing – Testing by an Applicant or Certified Marijuana Testing Laboratory of unknown samples supplied to the labs by an ISO/IEC 17043 accredited body to determine the accuracy of the analysis for specific Target Analytes and Matrix Groups.

(54) Quality Assurance – A set of procedures developed by an Applicant or Certified Marijuana Testing Laboratory to ensure that products and services delivered are as accurate and precise as possible.

(55) Quality Assurance Manual – A written collection of all Quality Assurance systems or protocols to include the management policies, objectives, principles, organizational structure and authority, responsibilities, and implementation of a Certified Marijuana Testing Laboratory to ensure the quality and utility of the service rendered.

(56) Quality Control – A set of procedures developed in accordance with current ISO 17025 standards, to verify that the required level of quality in analyses are met and maintained, including; determination that appropriate equipment and instruments are used, continued inspection and overview of all facets of the testing procedure, and undertaking corrective action as necessary.

(57) Reagent – A compound or mixture added to a system to cause a chemical reaction or test if a reaction occurs.

(58) Relative Percent Deviation (RPD) – A calculation of the precision of the measured recovered concentration of duplicate Laboratory Fortified Blanks, duplicate Matrix Spike Samples, or duplicate Testing Samples, calculated as follows: RPD = |quantitative result A – quantitative result B| ÷ ((quantitative result A + quantitative result B) ÷ 2) x 100.

(59) Residual Solvents – Volatile chemicals that are used during the manufacturing of a Final Product, which have not been completely removed by practical manufacturing techniques.

(60) Retail Batch – The portion of one Processed Batch used to create a Final Product that consists of one product type at one concentration, intended to have uniform character and quality, and is produced during the same cycle of manufacture.

(61) Sampler – An Employee of a Certified Marijuana Testing Laboratory who collects samples of marijuana from a Medical Marijuana Treatment Center for testing and has undergone required training to fulfill this function.

(62) Secure Storage – The segregation of Usable Whole Flower Marijuana, Derivative Product, or Edibles in a manner that prevents access by unauthorized persons, compromise of the product’s integrity, or premature spoilage.

(63) Spike Solution – A solution of Target Analytes of known concentrations that is used to fortify a Laboratory Fortified Blank or Matrix Spike Sample. For Analytical Methods with multiple Target Analytes, a representative number of Target Analytes may be chosen for the Spike Solution.

(64) Standard Operating Procedure (SOP) – Written documents that detail the methods of an operation, analysis or action whose techniques and procedures are thoroughly described, and which is appropriate as a method of performing certain routine or repetitive tasks.

(65) Surrogate – A Target Analyte or mix of Target Analytes, which behave similarly to the Target Analytes but not expected in the Analytical Sample, may be added to all Testing and Quality Control samples before Testing Sample preparation to measure Analytical Method efficiency.

(66) Tamper Evident Device – A device or procedure which makes unauthorized access to protected objects easily detectable.

(67) Target Analyte – A substance or chemical constituent to be quantitatively measured in an Analytical Method.

(68) Testing Facility – The location of a real property or the area within a real property to be utilized as a Certified Marijuana Testing Laboratory.

(69) Testing Field – The suite of Target Analytes tested within a Matrix Group.

(70) Testing Sample – A homogenized sample for analysis created from a Retail Batch.

(71) Total Combined Yeast and Mold – A test to detect yeast, mold, and other fungi in Final Products.

(72) Total Contaminant Load (TCL) – The sum of all Heavy Metals and Agricultural Agents present above the LOQ, but below the Acceptable Limit.

(73) Usable Whole Flower Marijuana – The flowers of the female cannabis plant, including low-THC cannabis, that is suitable to be dispensed from a Medical Marijuana Treatment Center for medical use by a qualified patient.  Usable Whole Flower Marijuana does not include seeds, stems, roots, leaves, resin extracted from any part of the plant, or any compound, manufacture, salt, derivative, mixture, or preparation of the plant or its seeds or resin.

(74) Water Activity – The measure of the quantity of free water in a product that is available and therefore capable of supporting bacteria, yeasts, mold, and fungi.

Rulemaking Authority 381.988(2), 381.988(3), FS. Law Implemented 381.988 FS. History–New      .