CMTL Sample Testing

 

DEPARTMENT OF HEALTH

RULE NO.:RULE TITLE:

64ER20-9CMTL Sample 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 64ER20-9 provides the acceptable limits and testing requirements for MMTCs’ final products to be tested by a CMTL.

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

 

THE FULL TEXT OF THE EMERGENCY RULE IS:

 

64ER20-9 CMTL Sample Testing

(1) MMTCs must arrange for a CMTL to test Final Products for the following: tetrahydrocannabinol potency, concentration of cannabidiol, and Contaminants Unsafe for Human Consumption. Contaminants Unsafe for Human Consumption include Microbes, Mycotoxins, Residual Solvents, Heavy Metals, Agricultural Agents, and Filth and Foreign Material.

(a) Notwithstanding the Acceptable Limit associated with paragraphs (2)(c)-(i), results must be reported accurately to three significant figures as the concentration in milligrams per kilogram dry-weight for any test reported in parts per million (ppm) and to three (3) significant figures as the concentration in micrograms per kilogram dry-weight for any test reported in parts per billion (ppb).

(b) Any test result that exceeds enumerated Acceptable Limits constitutes a failure. All failures must be confirmed by the CMTL through reanalysis using a portion of stored sample.  Reanalysis of a failed Target Analyte must occur after the first analysis that registered the initial failure.  If reanalysis testing results are acceptable, the CMTL must report to the department the data for both analyses and the reason for the initial failure. The department will then decide if the Retail Batch may be dispensed or if a third test is necessary for confirmation. 

(c) If a Retail Batch of Usable Whole Flower Marijuana fails any reanalysis, that Retail Batch of Usable Whole Flower Marijuana may thereafter be processed to create Derivative Product not meant for inhalation. Any Final Product created from a failed Retail Batch of Usable Whole Flower Marijuana, if used to create a new Derivative Product, must be tested again as a new Retail Batch. The MMTC must notify the department in writing to [e-mail] prior to processing any failed Usable Whole Flower Marijuana to create a new Derivative Product.

(d) Any test result that meets the requirements of an enumerated Acceptable Limit is acceptable. All testing results must be reported to the MMTC from which the sample was collected. All failures must be reported to the department by providing the Certificate of Analysis via email to [e-mail] in writing within 24 hours of such failure. For the purposes of this rule, a test result is considered verified when the Laboratory Director, or other qualified and authorized Employee, approves the Certificate of Analysis containing the results.

(e) To dispense any Final Product, an MMTC must obtain a Certificate of Analysis from the CMTL demonstrating test results within Acceptable Limits.

(2) The following are Acceptable Limits:

(a) Microbes; Acceptable Limits for Usable Whole Flower Marijuana, Derivative Products, and Edibles:

1. Shiga toxin producing Escherichia coli, less than 1 CFU per gram.

2. Any Salmonella species, less than 1 CFU per gram.

3. Aspergillus niger, Aspergillus fumigatus, Aspergillus flavus, Aspergillus terreus, less than 1 CFU per gram.

4. Total Aerobic microbial count, less than 100 CFU per gram in Non-Oral Transmucosal Products only.

5. Staphylococcus aureus, less than 1 CFU per gram in Non-Oral Transmucosal Products only.

6. Bile tolerant gram-negative bacteria, less than 1 CFU per gram in Non-Oral Transmucosal Products only.

(b) Total Combined Yeast and Mold; Acceptable Limits for Usable Whole Flower Marijuana, Derivative Products, and Edibles:

1. Less than 100,000 CFU per gram.

2. Less than 10 CFU per gram in Non-Oral Transmucosal Products only.

(c) Mycotoxins; Acceptable Limits for Usable Whole Flower Marijuana, Derivative Products, and Edibles:

1. B1 (CAS No. 1162-65-8), 20 parts per billion or less.

2. B2 (CAS No. 7220-81-7), 20 parts per billion or less.

3. G1 (CAS No. 1165-39-5), 20 parts per billion or less.

4. G2 (CAS No. 7241-98-7), 20 parts per billion or less.

5. Ochratoxin A (CAS No. 303-47-9), 20 parts per billion or less.

(d) Residual Solvents; Acceptable Limits for Derivative Products and Edibles:

1. Acetone (CAS No. 67-64-1), 750 parts per million or less.

2. Acetonitrile (CAS No. 75-05-8), 60 parts per million or less.

3. Benzene (CAS No. 71-43-3), one (1) part per million or less.

4. Butane (CAS No. 106-97-8), 5,000 parts per million or less.

5. Chloroform (CAS No. 67-66-3), two (2) parts per million or less.

6. 1, 2- dichloroethane (CAS No. 107-06-2), two (2) parts per million or less.

7. 1, 1- dichloroethene (CAS No. 75-35-4), eight (8) parts per million or less.

8. Ethanol (CAS No. 64-17-5), 5,000 parts per million or less. Products for topical and oral administration only are exempt from ethanol Acceptable Limit.

9. Ethyl acetate (CAS No. 141-78-6), 400 parts per million or less.

10. Ethyl ether (CAS No. 60-29-7), 500 parts per million or less.

11. Ethylene oxide (CAS No. 75-21-8), five (5) parts per million or less.

12. Heptane (CAS No. 142-82-5), 5,000 parts per million or less.

13. Hexane (CAS No. 110-54-3), 250 parts per million or less.

14. Isopropyl alcohol (CAS No. 67-63-0), 500 parts per million or less.

15. Methanol (CAS No. 67-56-1), 250 parts per million or less.

16. Methylene chloride (CAS No. 75-09-2), 125 parts per million or less.

17. Pentane (CAS No. 109-66-0), 750 parts per million or less.

18. Propane (CAS No. 74-98-6), 5,000 parts per million or less.

19. Trichloroethylene (CAS No. 79-01-6), 25 parts per million or less.

20. Toluene (CAS No. 108-88-3), 150 parts per million or less.

21. Total xylenes (m, p, o-xylenes) (CAS No. 1330-20-7), 150 parts per million or less.

(e) Heavy Metals; Acceptable Limits for Usable Whole Flower Marijuana or Derivative Product meant for inhalation:

1. Lead (CAS No. 7439-92-1), less than 500 parts per billion.

2. Arsenic (CAS No. 7440-38-2), less than 200 parts per billion.

3. Cadmium (CAS No. 7440-43-9), less than 200 parts per billion.

4. Mercury (CAS No. 7439-97-6), less than 200 parts per billion.

(f) Heavy Metals; Acceptable Limits for Usable Whole Flower Marijuana or Derivative Product not meant for inhalation, or Edible:

1. Lead (CAS No. 7439-92-1), less than 500 parts per billion.

2. Arsenic (CAS No. 7440-38-2), less than 1500 parts per billion.

3. Cadmium (CAS No. 7440-43-9), less than 500 parts per billion.

4. Mercury (CAS No. 7439-97-6), less than 3000 parts per billion.

(g) Agricultural Agents; Acceptable Limits for Usable Whole Flower Marijuana or Derivative Product meant for inhalation:

1. Abamectin (CAS No.71751-41-2), 100 parts per billion or less.

2. Acephate (CAS No.30560-19-1), 100 parts per billion or less.

3. Acequinocyl (CAS No.57960-19-7), 100 parts per billion or less.

4. Acetamiprid (CAS No.135410-20-7), 100 parts per billion or less.

5. Aldicarb (CAS No.116-06-3), 100 parts per billion or less.

6. Azoxystrobin (CAS No.131860-33-8), 100 parts per billion or less.

7. Bifenazate (CAS No.149877-41-8), 100 parts per billion or less.

8. Bifenthrin (CAS No. 82657-04-3), 100 parts per billion or less.

9. Boscalid (CAS No. 188425-85-6), 100 parts per billion or less.

10. Captan (CAS No. 133-06-2), 700 parts per billion or less.

11. Carbaryl (CAS No. 63-25-2), 500 parts per billion or less.

12. Carbofuran (CAS No. 1563-66-2), 100 parts per billion or less.

13. Chlorantraniliprole (CAS No. 500008-45-7), 1000 parts per billion or less.

14. Chlordane (CAS No. 57-74-9), 100 parts per billion or less.

15. Chlorfenapyr (CAS No.122453-73-0), 100 parts per billion or less.

16. Chlormequat chloride (CAS No. 000-81-5), 1000 parts per billion or less.

17. Chlorpyrifos (CAS No.2921-88-2), 100 parts per billion or less.

18. Clofentezine (CAS No.74115-24-5), 200 parts per billion or less.

19. Coumaphos (CAS No.56-72-4), 100 parts per billion or less.

20. Cyfluthrin (CAS No.68359-37-5), 500 parts per billion or less.

21. Cypermethrin (CAS No.52315-07-8), 500 parts per billion or less.

22. Daminozide (CAS No.1596-84-5), 100 parts per billion or less.

23. Diazinon (CAS No.333-41-5), 100 parts per billion or less.

24. Dichlorvos (CAS No.62-73-7), 100 parts per billion or less.

25. Dimethoate (CAS No.60-51-5), 100 parts per billion or less.

26. Dimethomorph (CAS No.110488-70-5), 200 parts per billion or less.

27. Ethoprophos (CAS No.13194-48-4), 100 parts per billion or less.

28. Etofenprox (CAS No.80844-07-1), 100 parts per billion or less.

29. Etoxazole (CAS No.153233-91-1), 100 parts per billion or less.

30. Fenhexamid (CAS No.126833-17-8), 100 parts per billion or less.

31. Fenoxycarb (CAS No.72440-01-8), 100 parts per billion or less.

32. Fenpyroximate (CAS No.134098-61-6), 100 parts per billion or less.

33. Fipronil (CAS No.120068-37-3), 100 parts per billion or less.

34. Flonicamid (CAS No.158062-67-0), 100 parts per billion or less.

35. Fludioxonil (CAS No.131341-86-1), 100 parts per billion or less.

36. Hexythiazox (CAS No.78587-05-0), 100 parts per billion or less.

37. Imazalil (CAS No.35554-44-0), 100 parts per billion or less.

38. Imidacloprid (CAS No.138261-41-3), 400 parts per billion or less.

39. Kresoxim-methyl (CAS No.143390-89-0), 100 parts per billion or less.

40. Malathion (CAS No.121-75-5), 200 parts per billion or less.

41. Metalaxyl (CAS No.57837-19-1), 100 parts per billion or less.

42. Methiocarb (CAS No.2032-65-7), 100 parts per billion or less.

43. Methomyl (CAS No.16752-77-5), 100 parts per billion or less.

44. Methyl parathion (CAS No.289-00-0), 100 parts per billion or less.

45. Mevinphos (CAS No.7786-34-7), 100 parts per billion or less.

46. Myclobutanil (CAS No.88671-89-0), 100 parts per billion or less.

47. Naled (CAS No.300-76-5), 250 parts per billion or less.

48. Oxamyl (CAS No.23135-22-0), 500 parts per billion or less.

49. Paclobutrazol (CAS No.76738-62-0), 100 parts per billion or less.

50. Pentachloronitrobenzene (CAS No.82-68-8), 150 parts per billion or less.

51. Permethrin (CAS No.52645-53-1), 100 parts per billion or less.

52. Phosmet (CAS No.732-11-6), 100 parts per billion or less.

53. Piperonyl butoxide (CAS No.51-03-6), 3000 parts per billion or less.

54. Prallethrin (CAS No.23031-36-9), 100 parts per billion or less.

55. Propiconazole (CAS No.60207-90-1), 100 parts per billion or less.

56. Propoxur (CAS No.144-26-1), 100 parts per billion or less.

57. Pyrethrins (CAS No.8003-34-7), 500 parts per billion or less.

58. Pyridaben (CAS No.96489-71-3), 200 parts per billion or less.

59. Spinetoram (CAS No.187166-15-0), 200 parts per billion or less.

60. Spinosad A and D (CAS No.168316-95-8, 131929-60-7), 100 parts per billion or less.

61. Spiromesifen (CAS No.283594-90-1), 100 parts per billion or less.

62. Spirotetramat (CAS No.203313-25-1), 100 parts per billion or less.

63. Spiroxamine (CAS No.118134-30-8), 100 parts per billion or less.

64. Tebuconazole (CAS No.107534-96-3), 100 parts per billion or less.

65. Thiacloprid (CAS No.111988-49-9), 100 parts per billion or less.

66. Thiamethoxam (CAS No.153719-23-4), 500 parts per billion or less.

67. Trifloxystrobin (CAS No.141517-21-7), 100 parts per billion or less.

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.

(h) Agricultural Agents; Acceptable Limits for Usable Whole Flower Marijuana and Derivative Product not meant for inhalation, and Edibles:

1. Abamectin (CAS No.71751-41-2), 300 parts per billion or less.

2. Acephate (CAS No.30560-19-1), 3000 parts per billion or less.

3. Acequinocyl (CAS No.57960-19-7), 2000 parts per billion or less.

4. Acetamiprid (CAS No.135410-20-7), 3000 parts per billion or less.

5. Aldicarb (CAS No.116-06-3), 100 parts per billion or less.

6. Azoxystrobin (CAS No.131860-33-8), 3000 parts per billion or less.

7. Bifenazate (CAS No.149877-41-8), 3000 parts per billion or less.

8. Bifenthrin (CAS No. 82657-04-3), 500 parts per billion or less.

9. Boscalid (CAS No. 188425-85-6), 3000 parts per billion or less.

10. Captan (CAS No. 133-06-2), 3000 parts per billion or less.

11. Carbaryl (CAS No. 63-25-2), 500 parts per billion or less.

12. Carbofuran (CAS No. 1563-66-2), 100 parts per billion or less.

13. Chlorantraniliprole (CAS No. 500008-45-7), 3000 parts per billion or less.

14. Chlordane (CAS No. 57-74-9), 100 parts per billion or less.

15. Chlorfenapyr (CAS No.122453-73-0), 100 parts per billion or less.

16.Chlormequat chloride (CAS No. 000-81-5), 3000 parts per billion or less.

17. Chlorpyrifos (CAS No.2921-88-2), 100 parts per billion or less.

18. Clofentezine (CAS No.74115-24-5), 500 parts per billion or less.

19. Coumaphos (CAS No.56-72-4), 100 parts per billion or less.

20. Cyfluthrin (CAS No.68359-37-5), 1000 parts per billion or less.

21. Cypermethrin (CAS No.52315-07-8), 1000 parts per billion or less.

22. Daminozide (CAS No.1596-84-5), 100 parts per billion or less.

23. Diazinon (CAS No.333-41-5), 200 parts per billion or less.

24. Dichlorvos (CAS No.62-73-7), 100 parts per billion or less.

25. Dimethoate (CAS No.60-51-5), 100 parts per billion or less.

26. Dimethomorph (CAS No.110488-70-5), 3000 parts per billion or less.

27. Ethoprophos (CAS No.13194-48-4), 100 parts per billion or less.

28. Etofenprox (CAS No.80844-07-1), 100 parts per billion or less.

29. Etoxazole (CAS No.153233-91-1), 1500 parts per billion or less.

30. Fenhexamid (CAS No.126833-17-8), 3000 parts per billion or less.

31. Fenoxycarb (CAS No.72440-01-8), 100 parts per billion or less.

32. Fenpyroximate (CAS No.134098-61-6), 2000 parts per billion or less.

33. Fipronil (CAS No.120068-37-3), 100 parts per billion or less.

34. Flonicamid (CAS No.158062-67-0), 2000 parts per billion or less.

35. Fludioxonil (CAS No.131341-86-1), 3000 parts per billion or less.

36. Hexythiazox (CAS No.78587-05-0), 2000 parts per billion or less.

37. Imazalil (CAS No.35554-44-0), 100 parts per billion or less.

38. Imidacloprid (CAS No.138261-41-3), 3000 parts per billion or less.

39. Kresoxim-methyl (CAS No.143390-89-0), 1000 parts per billion or less.

40. Malathion (CAS No.121-75-5), 2000 parts per billion or less.

51. Metalaxyl (CAS No.57837-19-1), 3000 parts per billion or less.

42. Methiocarb (CAS No.2032-65-7), 100 parts per billion or less.

43. Methomyl (CAS No.16752-77-5), 100 parts per billion or less.

44. Methyl parathion (CAS No.289-00-0), 100 parts per billion or less.

45. Mevinphos (CAS No.7786-34-7), 100 parts per billion or less.

46. Myclobutanil (CAS No.88671-89-0), 3000 parts per billion or less.

47. Naled (CAS No.300-76-5), 500 parts per billion or less.

48. Oxamyl (CAS No.23135-22-0), 500 parts per billion or less.

49. Paclobutrazol (CAS No.76738-62-0), 100 parts per billion or less.

50. Pentachloronitrobenzene (CAS No.82-68-8), 200 parts per billion or less.

51. Permethrin (CAS No.52645-53-1), 1000 parts per billion or less.

52. Phosmet (CAS No.732-11-6), 200 parts per billion or less.

53. Piperonyl butoxide (CAS No.51-03-6), 3000 parts per billion or less.

54. Prallethrin (CAS No.23031-36-9), 400 parts per billion or less.

55. Propiconazole (CAS No.60207-90-1), 1000 parts per billion or less.

56. Propoxur (CAS No.144-26-1), 100 parts per billion or less.

57. Pyrethrins (CAS No.8003-34-7), 1000 parts per billion or less.

58. Pyridaben (CAS No.96489-71-3), 3000 parts per billion or less.

59. Spinetoram (CAS No.187166-15-0), 3000 parts per billion or less.

60. Spinosad A and D (CAS No.168316-95-8, 131929-60-7), 3000 parts per billion or less.

61. Spiromesifen (CAS No.283594-90-1), 3000 parts per billion or less.

62. Spirotetramat (CAS No.203313-25-1), 3000 parts per billion or less.

63. Spiroxamine (CAS No.118134-30-8), 100 parts per billion or less.

64. Tebuconazole (CAS No.107534-96-3), 1000 parts per billion or less.

65. Thiacloprid (CAS No.111988-49-9), 100 parts per billion or less.

66. Thiamethoxam (CAS No.153719-23-4), 1000 parts per billion or less.

67. Trifloxystrobin (CAS No.141517-21-7), 3000 parts per billion or less.

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.

(i) Total Contaminant Load; Acceptable Limits for:

1. Usable Whole Flower Marijuana and Derivative Product meant for inhalation, five (5) parts per million or less.

2. Usable Whole Flower Marijuana, Derivative Product, and Edible not meant for inhalation, 30 parts per million or less.

(j) 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, shall be deemed to fail Acceptable Limits testing.

(k) Water Activity; Acceptable Limits for Usable Whole Flower Marijuana, Derivative Product, or Edibles:

1. Usable Whole Flower Marijuana, Water Activity 0.65 Aw or less.

2. Solid and semi-solid Derivative Product or Edible, Water Activity of 0.85 Aw or less, with the exception of water-based products which will not be held to Water Activity standards.

3. CMTLs must analyze a minimum Testing Sample size of 0.05% of the total Retail Batch weight or volume or a minimum of 3g or 3ml, whichever is larger, for water-activity levels according to the Acceptable Limits listed above. Results must be reported accurately to two (2) significant figures.

(l) CMTLs must analyze Usable Whole Flower Marijuana for Moisture content analysis. Usable Whole Flower Marijuana that has a Moisture content below 15.0% is acceptable for Moisture-content testing. Results must be reported to the nearest tenth of a percent.

(m) Filth and Foreign Materials. Each Final Product sampled must be inspected by the CMTL for Filth and Foreign Materials before being used to create a Testing Sample. Acceptable Limits for Usable Whole Flower Marijuana, Derivative Product, or Edibles:

1. Filth and Foreign Material (to include mold, mildew, fungus, hair, insects, packaging contaminants, processing waste, or other similar marijuana cultivation and processing by-products), not more than an average of 1% by weight, or cover more than 10% of the total sample area.

2. Any feces, not more than 0.5 mg per kilogram.

(3) Potency Testing. Potency Testing for Usable Whole Flower Marijuana, Derivative Product, and Edibles must include the amount, in milligrams, of total active THC and total active CBD in the Final Product. The total amount of active THC and active CBD in non-inhalation Derivative Products and in Edibles must be reported in milligrams, accurate to three (3) significant figures, as the concentration of THC and CBD in milligrams per gram multiplied by the total weight of the product. For inhalation Derivative Products and Usable Whole Flower Marijuana, total active THC in milligrams must be calculated as the concentration of THC + (concentration of THCA multiplied by 0.877) in milligrams per gram multiplied by the total weight of the product. For inhalation Derivative Products and Usable Whole Flower Marijuana, total active CBD in milligrams must be calculated as the concentration of CBD + (concentration of CBDA multiplied by 0.877) in milligrams per gram multiplied by the total weight of the product. Usable Whole Flower Marijuana must be reported at both dry weight and 12% (±0.5%) Moisture content.

(4) Cannabinoid Profile. The Cannabinoid Profile results must be reported as a percentage, accurate to three significant figures, as the concentration in milligrams per gram of each individual cannabinoid divided by the total concentration of all cannabinoids in milligrams per gram multiplied by 100. The CMTL must test for the following cannabinoids:

(a) d9-Tetrahydrocannabinoid (d9-THC), CAS No. 1972-08-3.

(b) d8-Tetrahydrocannabinoid (d8-THC), CAS No. 5957-75-5.

(c) d9-Tetrahydrocannabinolic acid (THCA), CAS No. 23978-85-0.

(d) Tetrahydrocannabivarin (THCV), CAS No. 31262-37-0.

(e) Cannabidiol (CBD), CAS No. 13956-29-1.

(f) Cannabidiolic acid (CBDA), CAS No. 1244-58-2.

(g) Cannabidivarin (CBDV), CAS No. 24274-48-4.

(h) Cannabigerol (CBG), CAS No. 25654-31-3.

(i) Cannabigerolic acid (CBGA), CAS No. 25555-57-1.

(j) Cannabinol (CBN), CAS No. 521-35-7.

(k) Cannabichromene (CBC), CAS No. 20675-51-8.

(5) The concentration of total active THC and total active CBD or any individual cannabinoid printed on the Final Product packaging must be within 10% of the tested concentration. If the concentration of total active THC or total active CBD or any individual cannabinoid printed on the Final Product packaging varies by more than 10% from the tested concentration, the packaging must be corrected to display the accurate concentration prior to being dispensed to qualified patients. Any cannabinoid that tests less than 1.0% may be labeled as such. If the total cannabinoid concentration is 10mg or less, the concentration of Total Active THC, Total Active CBD, or any individual cannabinoid printed on the Final Product packaging may vary by 50% of the tested concentration.

(6) Testing of Edibles. When testing Edibles CMTLs must perform a homogeneity analysis for concentration of Total Active THC and Total Active CBD. Edibles that do not meet the following criteria fail homogeneity testing and must not be dispensed by an MMTC.

(a) Homogeneity testing of Final Products that are a single serving requires one Final Product be divided into five (5) equal Increments per 100 Final Products per Retail Batch, rounding up to the next 100 (i.e. 101 single serving Final Products would require two (2) individual Final Products to undergo homogeneity testing). The concentration of Total Active THC and Total Active CBD must be tested in two (2) Increments and each must contain 1/5th of the Total Active THC and Total Active CBD measured in the whole Final Product. The two (2) Increments in each Final Product tested must vary by no more than 50% from 1/5th of the Total Active THC and Total Active CBD.

(b) Homogeneity testing of Final Products containing multiple servings requires three (3) servings in one (1) Final Product per 100 Final Products per Retail Batch, rounding up to the next 100 (i.e. 101 multiple serving Final Products would require six (6) servings in two (2) Final Products to undergo homogeneity testing). The concentration of Total Active THC and Total Active CBD must be a maximum of 10mg per serving, and the individual servings must vary by no more than 50% from the Total Active THC and Total Active CBD.

(7) CMTLs must report any Testing Sample that is found to contain a level of any contaminant not listed in this rule that could be injurious to human health if consumed or otherwise introduced to the human body. The CMTL must report such findings to the MMTC from which the sample was collected and to the department at [e-mail] 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.

(a) Any Certificate of Analysis generated by research and development samples must be clearly labeled “R&D ONLY NOT FOR RETAIL.”

(b) Any Certificate of Analysis generated by the analysis of non-marijuana products (water, growth medium, nutrients, product ingredient, product packaging) must accurately describe the material tested.

(8) CMTLs must maintain at least one untested portion of each Testing Sample, whether having passed or failed any Acceptable Limit analysis. 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.

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 22, 2020