Fla. Admin. Code R. 64-4.308 – CMTL Sample Testing

(1) CMTLs shall test Final Products for the following as specified in Rule 64-4.301, F.A.C.: tetrahydrocannabinol (THC) potency, concentration of cannabidiol (CBD), Cannabinoid Profile, Contaminants Unsafe for Human Consumption, Moisture, and Water Activity.
1. (a) Notwithstanding the Acceptable Limits associated with paragraphs (2)(a)-(h), results must be reported accurately to three (3) significant figures as the concentration in parts per million (ppm) or parts per billion (ppb) for Usable Whole Flower Marijuana, Derivative Products, and Edibles. Microbial Testing must be reported as presence/absence for Aspergillus spp., E. coli, Salmonella, Listeria spp., Staphylococcus aureus, and bile-tolerant, Gram-negative bacteria. Microbial Testing must be reported accurately to three (3) significant figures as CFU/g for total aerobic count and Total Combined Yeast and Mold.
  1. All Usable Whole Flower Marijuana analyses except Potency Testing and Terpene Analysis must be dry weight corrected using the CMTL-tested Moisture content. Usable Whole Flower Marijuana Potency and Terpene Analysis must be tested as received and not corrected to dry weight.
  2. All Derivative and Edible products are assumed to be 100% solid and no dry weight corrections are permitted.
  3. Products consisting of mechanically separated trichomes with no solvent extraction step (i.e., kief, bubble hash, pressed rosin) are to be tested to the same requirements as Usable Whole Flower Marijuana.
2. (b) Any test result that exceeds enumerated Acceptable Limits constitutes a failure.
  1. All failures for Microbes, Mycotoxins, Residual Solvents, Heavy Metals, and Agricultural Agents must be confirmed by the CMTL through reanalysis of the failed Target Analyte using a portion of stored sample equal in size to the portion of the sample used in the first test.
  2. Reanalysis of a failed Target Analyte must occur after the first test that registered the initial failure is completed. If reanalysis results are below the Acceptable Limit, the CMTL must perform a second reanalysis using a portion of the stored sample, equal in size to the first sample, to determine the final test result and document the cause of the inconsistent results.
  3. Failure confirmations must begin preparation within 72 hours of the Sample injection time of the analysis being confirmed. If a failure is confirmed, the highest value must be reported on the COA. If failure is overturned, the highest value which is below the Acceptable Limit must be reported.
  4. A CMTL must reanalyze any Target Analyte with results less than 10% below the Acceptable Limit for Heavy Metals, Agricultural Agents, Residual Solvents, Mycotoxins, and Total Combined Yeast and Mold. If the reanalysis fails, the laboratory must follow the above procedure for confirmation of a failed Target Analyte.
3. (c) Analytical Batches which include a previously failed sample being retested, either for reanalysis of a failed Target Analyte, or resampling and retesting of a previously failed Retail Batch, must include the failing Target Analyte in the Spike Solution for Laboratory Fortified Blanks and Matrix Spikes at a concentration between the Acceptable Limit and the instrument LOQ of the failing analyte.
4. (d) Any test result that meets the requirements of an enumerated Acceptable Limit is satisfactory. Any product that may be administered via multiple routes of administration is subject to the more stringent Acceptable Limit contained herein. A Retail Batch that meets the requirements of all enumerated Acceptable Limits may not be resampled and retested after the COA is generated and verified. All resampling and retesting must meet the requirements in the MMTC Regulatory Compliance Testing rule.
5. (e) All testing results must be verified and reported on a COA. A CMTL must not conduct additional analytical testing of the Testing Sample after the CMTL verifies the testing results on the COA. However, if Quality Control criteria is found to be outside of documented limits, a CMTL may continue analytical testing after verifying the testing results on the COA. A CMTL must notify the department in writing at OMMULabs@flhealth.gov before any Retail Batch can be tested after the CMTL verifies the testing results on the COA.
  1. The written notification must include:
  a. The original COA;
  b. Testing Field(s) which require reanalysis;
  c. Reason for resuming testing; and
  d. Documentation of the Quality Control outside of criteria requiring resuming analytical testing.
  2. All COAs reporting a testing failure must clearly show the Target Analyte which failed and its concentration.
  3. Testing results must be reported by the CMTL to the MMTC by providing the COA for the Retail Batch within 24 hours of verification of the COA. All failures must be reported to the department by providing the COA for the failed Retail Batch via the online licensing portal at https://fldohommu.force.com/cmtl or by email to OMMUlabs@flhealth.gov within 24 hours of verification of the COA and concurrently or before providing results to the MMTC for the failed Retail Batch.
  4. Passing results must be uploaded to the department’s seed-to-sale system in accordance with department rules and emergency rules. For the purposes of this rule, a test result is considered verified when the Laboratory Director, or other qualified and authorized Employee, confirms the accuracy of the results in the COA. If a CMTL makes any updates or corrections to a COA after the COA has been reported to the MMTC and the department, the updated or corrected COA must be provided to the Department via email to OMMULabs@flhealth.gov or the department’s licensing portal within 24 hours of the update or correction and in accordance Rule 64-4.311, F.A.C.
6. (f) After resampling and retesting a previously failed Retail Batch, the CMTL must provide the following to the department via email to OMMULabs@flhealth.gov or the department’s licensing portal within 24 hours of verification of the COA:
  1. The COA (whether passing or failing) of the previously failed Retail Batch; and
  2. The Data Package (whether passing or failing) for the failed Testing Field(s).
(2) The following are Acceptable Limits:
1. (a) Microbes; Acceptable Limits for Usable Whole Flower Marijuana and Derivative Products including Edibles with a minimum sample size of 1 gram:
  1. Shiga toxin producing Escherichia coli, none present;
  2. Any Salmonella species, none present;
  3. Aspergillus species:
  a. A. niger, none present;
  b. A. fumigatus, none present;
  c. A. flavus, none present; and
  d. A. terreus, none present.
  4. Listeria monocytogenes, none present (in Usable Whole Flower and Edibles only).
  5. Total Aerobic microbial count, less than 100 CFU/g in Non-Oral Transmucosal Products only.
  6. Staphylococcus aureus, none present in Non-Oral Transmucosal Products only.
  7. Bile tolerant gram-negative bacteria, none present in Non-Oral Transmucosal Products only.
  8. Total Combined Yeast and Mold; Acceptable Limits for Usable Whole Flower Marijuana and Derivative Products including Edibles:
  a. Less than 100,000 CFU/g.
  b. Less than 10 CFU/g in Non-Oral Transmucosal Products only.
2. (b) Mycotoxins; Acceptable Limits for Usable Whole Flower Marijuana and Derivative Products including Edibles:
  1. Aflatoxins:
  a. B1 (CAS No. 1162-65-8), less than 20 ppb.
  b. B2 (CAS No. 7220-81-7), less than 20 ppb.
  c. G1 (CAS No. 1165-39-5), less than 20 ppb.
  d. G2 (CAS No. 7241-98-7), less than 20 ppb.
  e. Sum of all Aflatoxins, less than 20 ppb.
  2. Ochratoxin A (CAS No. 303-47-9), less than 20 ppb.
3. (c) Residual Solvents; Acceptable Limits:

	Analyte	CAS No.	Acceptable Limit for Usable Whole Flower Marijuana Derivative Product Meant for inhalation	Acceptable Limit for Derivative Product not meant for inhalation including Edibles
1.	Acetone	67-64-1	less than 750 ppm	less than 5,000 ppm
2.	Acetonitrile	75-05-8	less than 60 ppm	less than 410 ppm
3.	Benzene	71-43-3	less than 1 ppm	less than 1 ppm
4.	Butane	106-97-8	less than 5,000 ppm	less than 5,000 ppm
5.	Chloroform	67-66-3	less than 2 ppm	less than 2 ppm
6.	1,2-dichloroethane	107-06-2	less than 2 ppm	less than 2 ppm
7.	1,1-dichloroethene	76-35-4	less than 8 ppm	less than 8 ppm
8.	Ethanol	64-17-5	less than 5,000 ppm	less than 5,000 ppm
9.	Ethyl acetate	141-78-6	less than 400 ppm	less than 5,000 ppm
10.	Ethyl ether	60-29-7	less than 500 ppm	less than 5,000 ppm
11.	Ethylene oxide	75-21-8	less than 5 ppm	less than 5 ppm
12.	Heptane	142-82-5	less than 5,000 ppm	less than 5,000 ppm
13.	Hexane	110-54-3	less than 250 ppm	less than 250 ppm
14.	Isopropyl alcohol	67-63-0	less than 500 ppm	less than 5,000 ppm
15.	Methanol	67-56-1	less than 250 ppm	less than 3,000 ppm
16.	Methylene chloride	75-09-2	less than 125 ppm	less than 125 ppm
17.	Pentane	106-66-0	less than 750 ppm	less than 5,000 ppm
18.	Propane	74-98-6	less than 5,000 ppm	less than 5,000 ppm
19.	Trichloroethylene	79-01-6	less than 25 ppm	less than 25 ppm
20.	Toluene	108-88-3	less than 150 ppm	less than 890 ppm
21.	Total xylenes (m-, p-, o-xylenes	1330-20-7	less than 150 ppm	less than 2170 ppm

22. Products for topical administration, oral administration, and MDIs are exempt from the ethanol Acceptable Limit. The CMTL must report the testing concentration of ethanol on the COA.

(d) Heavy Metals; Acceptable Limits:

	Analyte	CAS No.	Acceptable Limit for Usable Whole Flower Marijuana Derivative Product Meant for inhalation	Acceptable Limit for Derivative Product not meant for inhalation including Edibles
1.	Lead	7439-92-1	less than 500 ppb	less than 500 ppb
2.	Arsenic	7440-38-2	less than 200 ppb	less than 1500 ppb
3.	Cadmium	7440-43-9	less than 200 ppb	less than 500 ppb
4.	Mercury	7439-97-6	less than 200 ppb	less than 3000 ppb
5.	Nickel	7440-50-8	less than 500 ppb	less than 3000 ppb
6.	Tin	7440-31-5	less than 4000 ppb	less than 4000 ppb

(e) Agricultural Agents; Acceptable Limits using Liquid Chromatography:

	Analyte	CAS No.	Acceptable Limit for Usable Whole Flower Marijuana Derivative Product Meant for inhalation	Acceptable Limit for Derivative Product not meant for inhalation including Edibles
1.	Abamectin	65195-55-3	less than 100 ppb	less than 300 ppb
2.	Acephate	30560-19-1	less than 100 ppb	less than 3000 ppb
3.	Acequinocyl	57960-19-7	less than 100 ppb	less than 2000 ppb
4.	Acetamiprid	135410-20-7	less than 100 ppb	less than 3000 ppb
5.	Aldicarb	116-06-3	less than 100 ppb	less than 100 ppb
6.	Azoxystrobin	131860-33-8	less than 100 ppb	less than 3000 ppb
7.	Bifenazate	149877-41-8	less than 100 ppb	less than 3000 ppb
8.	Bifenthrin	82657-04-3	less than 100 ppb	less than 500 ppb
9.	Boscalid	188425-85-6	less than 100 ppb	less than 3000 ppb
10.	Carbaryl	63-25-2	less than 500 ppb	less than 500 ppb
11.	Carbofuran	1563-6-2	less than 100 ppb	less than 100 ppb
12.	Chlorantraniliprole	500008-45-7	less than 1000 ppb	less than 3000 ppb
13.	Chlormequat chloride	999-81-5	less than 1000 ppb	less than 3000 ppb
14.	Chlorpyrifos	2921-88-2	less than 100 ppb	less than 100 ppb
15.	Clofentezine	74115-24-5	less than 200 ppb	less than 500 ppb
16.	Coumaphos	56-72-4 100	less than 100 ppb	less than 100 ppb
17.	Cyfluthrin	68359-37-5	less than 500 ppb	less than 1000 ppb
18.	Cypermethrin	52315-07-8	less than 500 ppb	less than 1000 ppb
19.	Daminozide	1596-84-5	less than 100 ppb	less than 100 ppb
20.	Diazinon	333-41-5	less than 100 ppb	less than 200 ppb
21.	Dichlorvos	62-73-7	less than 100 ppb	less than 100 ppb
22.	Dimethoate	60-51-5	less than 100 ppb	less than 100 ppb
23.	Dimethomorph, sum of isomer E and Z	11321-97-2 11321-98-3	less than 200 ppb	less than 3000 ppb
24.	Ethoprophos	13194-48-4	less than 100 ppb	less than 100 ppb
25.	Etofenprox	80844-07-1	less than 100 ppb	less than 100 ppb
26.	Etoxazole	153233-91-1	less than 100 ppb	less than 1500 ppb
27.	Fenhexamid	126833-17-8	less than 100 ppb	less than 3000 ppb
28.	Fenoxycarb	72440-01-8	less than 100 ppb	less than 100 ppb
29.	Fenpyroximate	134098-61-6	less than 100 ppb	less than 2000 ppb
30.	Fipronil	120068-37-3	less than 100 ppb	less than 100 ppb
31.	Flonicamid	158062-67-0	less than 100 ppb	less than 2000 ppb
32.	Fludioxonil	131341-86-1	less than 100 ppb	less than 3000 ppb
33.	Hexythiazox	78587-05-0	less than 100 ppb	less than 2000 ppb
34.	Imazalil	35554-44-0	less than 100 ppb	less than 100 ppb
35.	Imidacolprid	138261-41-3	less than 400 ppb	less than 3000 ppb
36.	Kresoxim-methyl	143390-89-0	less than 100 ppb	less than 1000 ppb
37.	Malathion	121-75-5	less than 200 ppb	less than 2000 ppb
38.	Metalxyl	57837-19-1	less than 100 ppb	less than 3000 ppb
39.	Methiocarb	2032-65-7	less than 100 ppb	less than 100 ppb
40.	Methomyl	16752-77-5	less than 100 ppb	less than 100 ppb
41.	Mevinphos	7786-34-7	less than 100 ppb	less than 100 ppb
42.	Mycobutanil	88671-89-0	less than 100 ppb	less than 3000 ppb
43.	Naled	300-76-5	less than 250 ppb	less than 500 ppb
44.	Oxamyl	23135-22-0	less than 500 ppb	less than 500 ppb
45.	Paclobutrazol	76738-62-0	less than 100 ppb	less than 100 ppb
46.	Permethrin, sum of isomers cis- and trans-permethrin	52645-53-1	less than 100 ppb	less than 1000 ppb
47.	Phosmet	732-11-6	less than 100 ppb	less than 200 ppb
48.	Piperonyl Butoxide	51-03-6	less than 3000 ppb	less than 3000 ppb
49.	Prallethrin	23031-36-9	less than 100 ppb	less than 400 ppb
50.	Propiconazole	60207-90-1	less than 100 ppb	less than 1000 ppb
51.	Propoxur	144-26-1	less than 100 ppb	less than 100 ppb
52	Pyrethrins, sum of compounds Pyrethrin I and II, Cinerin I and II, Jasmolin I and II	8003-34-7	less than 500 ppb	less than 1000 ppb
53.	Pyridaben	96489-71-3	less than 200 ppb	less than 3000 ppb
54.	Spinetoram, sum of isomers J and L	187166-40-1 187166-15-0	less than 200 ppb	less than 3000 ppb
55.	Spinosad, sum of isomers A and D	168316-95-8 131929-60-7	less than 100 ppb	less than 3000 ppb
56.	Spiromesifen	283594-90-1	less than 100 ppb	less than 3000 ppb
57.	Spirotetramat	203313-25-1	less than 100 ppb	less than 3000 ppb
58.	Spiroxamine	118134-30-8	less than 100 ppb	less than 100 ppb
59.	Tebuconazole	107534-96-3	less than 100 ppb	less than 1000 ppb
60.	Thiacloprid	111988-49-9	less than 100 ppb	less than 100 ppb
61.	Thiamethoxam	153719-23-4	less than 500 ppb	less than 1000 ppb
62.	Trifloxystrobin	141517-21-7	less than 100 ppb	less than 3000 ppb

The list above of Agricultural Agents does not constitute authorization to use or apply any of those Agricultural Agents during the cultivation or processing of marijuana.

(f) Agricultural Agents; Acceptable Limits using Gas Chromatography or Liquid Chromatography utilizing an atmospheric-pressure chemical ionization (APCI) detector:

	Analyte	CAS No.	Acceptable Limit for Usable Whole Flower Marijuana Derivative Product Meant for inhalation	Acceptable Limit for Derivative Product not meant for inhalation including Edibles
1.	Chlordane, sum of isomers cis- and trans- Chlordane in a mix of isomers	57-74-9	less than 100 ppb	less than 100 ppb
2.	Chlorfenapyr	122453-73-0	less than 100 ppb	less than 100 ppb
3.	Methyl Parathion	289-00-0	less than 100 ppb	less than 100 ppb
4.	Pentachloronitrobenzene	82-68-8	less than 150 ppb	less than 200 ppb

The list above of Agricultural Agents does not constitute authorization to use or apply any of those Agricultural Agents during the cultivation or processing of marijuana. Agricultural Agents not required to be analyzed by Gas Chromatography may be analyzed by Gas Chromatography if all Acceptable Limit and Quality Control requirements are met and the analytes are listed on the CMTLs ISO/IEC 17025:2017 scope of accreditation as being tested by Gas Chromatography. When reporting the concentration of Chlordane in a mix of isomers, the response sum of cis- and trans-chlordane peaks must be used.

(g) Total Contaminant Load; Acceptable Limits for:
1. Usable Whole Flower Marijuana and Derivative Product meant for inhalation, five (5) ppm or less;
2. Derivative Product, not meant for inhalation, including Edibles, 30 parts per million or less; and
(h) A Testing Sample containing levels of any Microbe, Residual Solvent, Heavy Metal, or Agricultural Agent, that is not otherwise enumerated in this rule and that could be toxic if consumed or applied by a qualified patient, may be deemed to fail testing for Acceptable Limits by the department.
(i) Water Activity; Acceptable Limits for Usable Whole Flower Marijuana, Derivative Product, and Edibles:
1. Usable Whole Flower Marijuana, Water Activity 0.65 Aw or less. A testing result of greater than 0.65 Aw in Usable Whole Flower Marijuana constitutes a failure for Water Activity.
2. Derivative Product or Edible, Water Activity of 0.85 Aw or less, with the exception of products with water listed as an ingredient, which are exempt from Water Activity testing. A testing result of greater than 0.85 Aw in a solid and semi-solid derivative product or edible constitutes a failure for Water Activity.
3. Results must be reported accurately to two (2) significant figures.
(j) CMTLs must test Usable Whole Flower Marijuana for Moisture content. Usable Whole Flower Marijuana that has a Moisture content below 15.0% is acceptable for Moisture content testing. A testing result of greater than or equal to 15.0% in Usable Whole Flower Marijuana constitutes a failure for Moisture. Results must be reported to the nearest tenth of a percent.
(k) Filth and Foreign Materials. Each Final Product sampled must be visually inspected by the CMTL for Filth and Foreign Materials before being used to create a Testing Sample. Usable Whole Flower Marijuana must have both the interior and exterior of flower buds inspected. A testing result greater than the Acceptable Limit constitutes a failure for Filth and Foreign Material. Acceptable Limits for Usable Whole Flower Marijuana and Derivative Product, including Edibles:
1. Filth and Foreign Material (to include hair, insects, packaging contaminants, manufacturing waste, or other similar marijuana cultivation and manufacturing by-products), not more than an average of 1% by weight, or cover more than 10% of the total sample area.
2. Any visible feces; and
3. Any visible mold, mildew, and/or fungus.
(l) The CMTL shall have 60 days from the effective date of this rule to report Listeria monocytogenes, tin, and nickel on a Regulatory Compliance Testing COA and submit Proficiency Testing results for those Target Analytes in accordance with Rules 64-4.311 and 64-4.303, F.A.C. Beginning on the effective date of this rule, the CMTL shall have until their next ISO/IEC 17025:2017 renewal or the next requested update to their ISO/IEC 17025:2017 certification, whichever occurs first, to include Listeria monocytogenes, nickel, and tin on their ISO/IEC 17025:2017 certification.
(3) Potency Testing.
1. (a) Potency Testing must include the amount, in milligrams, accurate to three (3) significant figures of Total Active THC and Total Active CBD in the Final Product.
2. (b) A CMTL must only report Usable Whole Flower Marijuana potency at the CMTL-tested Moisture content.
3. (c) Usable Whole Flower Marijuana potency percentage must be calculated as follows: Usable Whole Flower Marijuana Potency percentage = (mg Total Active THC/Total Active CBD ÷ product weight in mg) x 100.
4. (d) All potency calculations for Usable Whole Flower Marijuana and Derivative Products must use the labeled weight of the Final Product.
5. (e) All Usable Whole Flower potency results reflecting more than 32% Total Active THC must be reported to the department via email to OMMULabs@flhealth.gov or the department’s licensing portal, to include the passing COA and Data Package for the Potency Testing Field.
6. (f) Edibles must use the measured weight of the Final Product for potency calculations.
7. (g) The CMTL shall have one (1) year from the effective date of this rule to include d8-Tetrahydrocannabinoid (d8-THC) in the calculation of Total Active THC as defined in Rule 64-4.300, F.A.C.
(4) Cannabinoid Profile. The Cannabinoid Profile results for each cannabinoid must be reported as concentration in mg/g, accurate to three (3) significant figures, and percent, accurate to three (3) significant figures relative to the total weight or volume of the product. A CMTL must only report Usable Whole Flower Cannabinoid Profile at the CMTL-tested Moisture content. A CMTL must utilize the homogenized Testing Sample when conducting Cannabinoid Profile Regulatory Compliance Testing of Edibles. The CMTL must test for the following cannabinoids:
1. (a) d9-Tetrahydrocannabinoid (d9-THC), CAS No. 1972-08-3.
2. (b) d8-Tetrahydrocannabinoid (d8-THC), CAS No. 5957-75-5.
3. (c) d9-Tetrahydrocannabinolic acid (THCA), CAS No. 23978-85-0.
4. (d) Tetrahydrocannabivarin (THCV), CAS No. 31262-37-0.
5. (e) Cannabidiol (CBD), CAS No. 13956-29-1.
6. (f) Cannabidiolic acid (CBDA), CAS No. 1244-58-2.
7. (g) Cannabidivarin (CBDV), CAS No. 24274-48-4.
8. (h) Cannabigerol (CBG), CAS No. 25654-31-3.
9. (i) Cannabigerolic acid (CBGA), CAS No. 25555-57-1.
10. (j) Cannabinol (CBN), CAS No. 521-35-7.
11. (k) Cannabichromene (CBC), CAS No. 20675-51-8.
(5) Samples are not required to be labeled for potency at the time of testing. If included on the Sample label and/or packaging by an MMTC at the time of testing, potency concentrations and ratios must meet the following criteria:
1. (a) For Usable Whole Flower Marijuana and Derivative Products, if the tested concentration per Final Product of total active THC, total active CBD, or any individual cannabinoid is greater than 25 milligrams, the tested concentration may vary by no more than 10% from the concentration printed on the Final Product packaging.
2. (b) For Usable Whole Flower Marijuana and Derivative Products, if the tested concentration per Final Product of Total Active THC, Total Active CBD, or any individual cannabinoid is 25 milligrams or less, the tested concentration may vary by no more than 50% from the concentration printed on the Final Product packaging
3. (c) For Usable Whole Flower Marijuana and Derivative Products, if the tested concentration per Final Product of Total Active THC, Total Active CBD, or any individual cannabinoid is 10 milligrams or less, the tested concentration printed on the Final Product packaging must also be 10 milligrams or less.
4. (d) For Edibles, the tested concentration for Total Active THC, Total Active CBD, and any other labeled cannabinoid may vary by no more than 15% from the concentration printed on the Final Product packaging.
5. (e) Labeled potency concentrations that fall outside of these specifications result in a failure for labeled potency.
6. (f) Usable Whole Flower Marijuana labeled potency will be compared to the potency at the CMTL tested moisture content in order to determine a failure for labeled potency.
7. (g) For all Usable Product. If a cannabinoid ratio is claimed on the packaging or product label, the following equation must be used, , where the ratio labeled on the Final Product packaging is x:y and x<y, and the percent difference between the smaller cannabinoid result and the result of the equation must be less than or equal to 10%.
8. (h) CMTLs must receive evidence of the corrected potency label prior to amending the COA to reflect a passing result. The CMTL must provide the department with the new COA as amended with an updated image of the corrected label before the product can be transported to an MMTC’s department-approved dispensing facility.
(6) When conducting Regulatory Compliance Testing for Edibles, CMTLs must test for potency and must perform homogeneity testing for multi-serving edibles.
1. (a) A multi-serving edible may not contain more than 200 milligrams of Total Active THC. A single serving edible or a single serving portion of a multi-serving edible may not exceed 10 milligrams of THC. Edibles may have a potency variance of up to 15% from the 200 milligram and 10 milligram THC thresholds. An edible that exceeds the allowable variance constitutes a failure.
2. (b) Homogeneity sampling and testing of multi-serving Edibles shall be in accordance with the following table.

TOTAL NUMBER OF FINAL PRODUCTS IN THE RETAIL BATCH	NUMBER OF FINAL PRODUCTS TO BE SAMPLED	SINGLE SERVINGS TESTED PER FINAL PRODUCT	TOTAL NUMBER OF SINGLE SERVINGS TESTED
1-249	1	3	3
250-499	2	3	6
500-749	3	3	9
750-999	4	3	12
1,000-1,249	6	2	12
1,250-1,499	7	2	14
1,500-1,749	8	2	16
1,750-1,999	9	2	18
2,000-2,499	10	2	20
2,500-2,999	11	2	22
3,000-3,999	12	2	24
4,000-4,999	13	2	26
5,000-7,499	14	2	28
7,500-9,999	15	2	30
10,000-14,999	16	2	32
15,000-19,999	17	2	34
20,000-29,999	18	2	36
30,000-39,999	19	2	38
40,000-49,999	20	2	40
50,000-59,999	21	2	42
60,000-69,999	22	2	44
70,000-79,999	23	2	46
80,000-89,999	24	2	48
90,000-100,000	25	2	50

(c) For batches over 100,000 units, the Retail Batch may be sampled as a 100,000-unit Retail Batch for every 100,000 units. Any remaining units under 100,000 will need to be tested again using the chart in paragraph (7)(b) above.
(d) The percent relative standard deviation of each Retail Batch of Edibles must be calculated using Total Active THC and Total Active CBD values from all servings tested using the following formula:
A percent relative standard deviation greater than 25% and/or a single serving deviation of more than 50% from the average constitutes a failure of homogeneity testing.
(e) For the purposes of homogeneity testing only, each Retail Batch may be run as one Analytical Batch. Homogeneity testing must still adhere to all requirements in Rule 64-4.309, F.A.C., to include a final CCV at the end of the analysis.
(7) CMTLs must report any Testing Sample that is found to contain a significant level of any contaminant not listed in this rule. The CMTL must report such findings to the MMTC from which the sample was collected and to the department at OMMUlabs@flhealth.gov within 24 hours of the finding. Test results of samples tested for research and development purposes only are not required to be reported to the department.
1. (a) Any COA generated for research and development samples must be clearly labeled “R&D ONLY NOT FOR RETAIL.” A Retail Batch that has already been sampled for Regulatory Compliance Testing cannot be sampled as R&D. R&D Testing cannot be used to generate a Regulatory Compliance COA for a Final Product.
2. (b) Any COA generated by the testing of non-marijuana products (water, growth medium, nutrients, product ingredient, product packaging) must accurately describe the material tested.
3. (c) Final Products submitted for Regulatory Compliance Testing cannot also be submitted as R&D or amended to be classified as R&D.
(8) Any analyte tested at multiple dilutions must be reported to the lowest dilution factor still within the calibration curve. If samples are run at duplicate dilutions, the highest in-matrix concentration value is reported.
(9) CMTLs must maintain at least two untested portions of each Testing Sample, whether having passed or failed any testing, one of which must be in unopened Final Product packaging to maintain sterility. These Testing Samples must be securely stored for a minimum of 45 days before being destroyed. Every Testing Sample that is destroyed must be logged by the CMTL. Testing Samples that have been stored a minimum of 45 days may be used by the CMTL for in-house method development and validation prior to being destroyed. Stored Testing Samples may be collected by the department for testing purposes.

Rulemaking Authority Art. X, § 29, Fla. Const., 381.986(8)(k), 381.986(8)(e)11.d., 381.988(3), 381.988(9) FS. Law Implemented Art. X, § 29, Fla. Const., 381.986, 381.988 FS. History–New 5-28-26.