HB921 amended the definition of Hemp extract to include products intended for inhalation. The purpose of this rulemaking is to adopt requirements for the manufacture and sale of Hemp extract products intended for inhalation.

 

DEPARTMENT OF AGRICULTURE AND CONSUMER SERVICES

Division of Food Safety

RULE NO.:RULE TITLE:

5K-4.036Hemp Extract Intended for Inhalation

PURPOSE AND EFFECT: HB921 amended the definition of Hemp extract to include products intended for inhalation. The purpose of this rulemaking is to adopt requirements for the manufacture and sale of Hemp extract products intended for inhalation.

SUBJECT AREA TO BE ADDRESSED: Products, definitions, permit requirements, requirements for products consisting of Hemp Extract intended for Inhalation, contaminants, labeling requirements, disposal requirements, self-service merchandising restrictions, ingredients requirements, and penalties and violations.

RULEMAKING AUTHORITY: 500.09, 500.12, 570.07(23), FS.

LAW IMPLEMENTED: 500.03, 500.04, 500.09, 500.10, 500.11, 500.12, 500.121, 500.13, 500.172, 581.217, FS.

A RULE DEVELOPMENT WORKSHOP WILL BE HELD AT THE DATE, TIME AND PLACE SHOWN BELOW:

DATE AND TIME: Wednesday, August 26, 10:00 a.m. – 12:00 p.m. (EDT)

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THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE DEVELOPMENT AND A COPY OF THE PRELIMINARY DRAFT, IF AVAILABLE, IS: Chris Hilliard at [e-mail].

 

THE PRELIMINARY TEXT OF THE PROPOSED RULE DEVELOPMENT IS:

 

5K-4.036 Hemp Extract Intended for Inhalation

(1) Products. Products consisting of or containing Hemp Extract Intended for Inhalation are subject to the requirements of Chapter 500, F.S., Section 581.217, F.S., and Rules 5J-22.003(2); 5K-4.002; 5K-4.004; 5K-4.020; 5K-4.021, 5K-4.034(5), and 5K-4.035, F.A.C., in addition to the requirements of this rule.

(2) Definitions. The definitions provided in Sections 500.03 and 581.217, F.S., and the following shall apply to this rule:

(a) “Approved Source” means an establishment manufacturing, processing, or preparing products containing Hemp Extract Intended for Inhalation that meets or exceeds the standards of the responsible regulatory agency.

(b) “Batch Number” or “Lot Number” means the product containing Hemp Extract Intended for Inhalation produced during a period of time under similar conditions and identified by a specific code that allows traceability.

(c) “Expiration Date” means the month and year as determined by the manufacturer, packer, or distributor on the basis of tests or other information showing that the product, until that date, under the conditions of handling, storage, preparation, and use per label directions, will when consumed, contain not less than the quantity of each ingredient as set forth on its label.

(d) “Hemp” is defined in Section 581.217(3)(d), F.S.

(e) “Hemp Extract” is defined in Section 581.217(3)(e), F.S.

(f) “Hemp Food Establishment” means an establishment as defined in Section 500.03(1)(p), F.S.

(g) “Inhalation” means the process or act of taking in substances into the respiratory system through the mouth or nasal passages.

(h) “Manufacturer” means the last facility that manufactured/processed the food, as defined in 21 CFR 1.276.

(i) “Manufacturing/processing” means making food from one or more ingredients, or synthesizing, preparing, treating, modifying or manipulating food, including food crops or ingredients, as defined in 21 CFR 1.227.

(j) “Processor” or “Extractor” means the entity that extracts the hemp extract from the hemp plant.

(k) “Total delta-9 tetrahydrocannabinol concentration” means [delta-9 tetrahydrocannabinol] + (0.877 x [tetrahydrocannabinolic acid]). 

(3) Permits.

(a) Each person selling products containing Hemp Extract Intended for Inhalation must be permitted as a Hemp Food Establishment pursuant to Section 500.12, F.S., and Rule 5K-4.020, F.A.C.

(b) The annual permit fee for a Hemp Food Establishment is $650.00.

(4) Requirements.

(a) Products consisting of or containing Hemp Extract Intended for Inhalation must originate from an Approved Source. The Hemp Food Establishment shall provide to the department, upon request, the most recent inspection report from the Approved Source.

(b) Products consisting of or containing Hemp Extract Intended for Inhalation may not be manufactured, processed, packed, held, prepared, or sold under the Cottage Food Operations Law in Section 500.80, F.S.

(c) All products containing Hemp Extract Intended for Inhalation must be packaged in containers minimizing exposure to light to prevent degradation of the Cannabinoids. Containers must also comply with the requirements enumerated in 21 CFR 170, which is adopted and incorporated by reference in Rule 5K-4.002, F.A.C.

(d) Any retailer that sells Hemp Extract Intended for Inhalation shall post a clear and conspicuous sign in each place of business where such products are sold which states the following:

THE SALE OF HEMP EXTRACT INTENDED FOR INHALATION TO PERSONS UNDER THE AGE OF 21 IS PROHIBITED. PROOF OF AGE IS REQUIRED FOR PURCHASE.

(e) A wholesale dealer or distributing agent of Hemp Extract Intended for Inhalation may only sell or deliver such products to establishments who are required to have, and hold, a valid “Hemp Food Establishment” permit, establishments licensed for food operations by the Florida Department of Business and Professional Regulation, or establishments licensed for food operations by the Florida Department of Health.

(5) Contaminants. In addition to the requirements listed in Chapter 500, F.S., and Rule 5K-4.002, F.A.C., products containing Hemp Extract Intended for Inhalation shall be considered adulterated pursuant to Section 500.10(1)(a), F.S., if contaminants are detected at levels greater than those listed in this rule.

(a)  The following substances may not be present in any products containing Hemp Extract Intended for Inhalation:

1. Vitamin E acetate.

2. 2,3-butanedione (Diacetyl).

(b) Pesticide Limits. The following list of contaminants does not constitute authorization to use or apply any of the following during Hemp cultivation or processing.

1. Abamectin, 100 parts per billion.

2. Acephate, 100 parts per billion.

3.Acequinocyl, 100 parts per billion.

4. Acetamiprid, 100 parts per billion.

5. Aldicarb, 100 parts per billion.

6. Azoxystrobin, 100 parts per billion.

7. Bifenazate, 100 parts per billion.

8. Bifenthrin, 100 parts per billion.

9. Boscalid, 100 parts per billion.

10. Captan, 700 parts per billion.

11. Carbaryl, 500 parts per billion.

12. Carbofuran, 100 parts per billion.

13. Chlorantraniliprole, 1,000 parts per billion.

14. Chlordane, 100 parts per billion.

15. Chlorfenapyr, 100 parts per billion.

16. Chlormequat chloride, 1,000 parts per billion.

17. Chlorpyrifos, 100 parts per billion.

18. Clofentezine, 200 parts per billion.

19. Coumaphos, 100 parts per billion.

20. Cyfluthrin, 500 parts per billion.

21. Cypermethrin, 500 parts per billion.

22. Daminozide, 100 parts per billion.

23. DDVP (Dichlorvos), 100 parts per billion.

24. Diazinon, 100 parts per billion.

25. Dimethoate, 100 parts per billion.

26. Dimethomorph, 200 parts per billion.

27. Ethoprop(hos), 100 parts per billion.

28. Etofenprox, 100 parts per billion.

29. Etoxazole, 100 parts per billion.

30. Fenhexamid, 100 parts per billion.

31. Fenoxycarb, 100 parts per billion.

32. Fenpyroximate, 100 parts per billion.

33. Fipronil, 100 parts per billion.

34. Flonicamid, 100 parts per billion.

35. Fludioxonil, 100 parts per billion.

36. Hexythiazox, 100 parts per billion.

37. Imazalil, 100 parts per billion.

38. Imidacloprid, 400 parts per billion.

39. Kresoxim-methyl, 100 parts per billion.

40. Malathion, 200 parts per billion.

41. Metalaxyl, 100 parts per billion.

42. Methiocarb, 100 parts per billion.

43. Methomyl, 100 parts per billion.

44. Methyl parathion, 100 parts per billion.

45. Mevinphos, 100 parts per billion.

46. Myclobutanil, 100 parts per billion.

47. Naled, 250 parts per billion.

48. Oxamyl, 500 parts per billion.

49. Paclobutrazol, 100 parts per billion.

50. Pentachloronitrobenzene, 150 parts per billion.

51. Permethrin, 100 parts per billion.

52. Phosmet, 100 parts per billion.

53. Piperonyl butoxide, 3,000 parts per billion.

54. Prallethrin, 100 parts per billion.

55. Propiconazole, 100 parts per billion.

56. Propoxur, 100 parts per billion.

57. Pyrethrins, 500 parts per billion.

58. Pyridaben, 200 parts per billion.

59. Spinetoram, 200 parts per billion.

60. Spinosad A & D, 100 parts per billion.

61. Spiromesifen, 100 parts per billion.

62. Spirotetramat, 100 parts per billion.

63. Spiroxamine, 100 parts per billion.

64. Tebuconazole, 100 parts per billion.

65. Thiacloprid, 100 parts per billion.

66. Thiamethoxam, 500 parts per billion.

67. Trifloxystrobin, 100 parts per billion.

(c) Residual Solvent Limits.

1. 1,2-Dichloroethane, 2 parts per million.

2. 1,1-Dichloroethene, 8 parts per million.

3. Acetone, 750 parts per million.

4. Acetonitrile, 60 parts per million.

5. Benzene, 1 parts per million.

6. Butane, 5,000 parts per million.

7. Chloroform, 2 parts per million.

8. Ethanol, 5,000 parts per million.

9. Ethyl Acetate, 400 parts per million.

10. Ethyl Ether, 500 parts per million.

11. Ethylene Oxide, 5 parts per million.

12. Heptane, 5,000 parts per million.

13. Hexane, 250 parts per million.

14. Isopropyl Alcohol, 500 parts per million.

15. Methanol, 250 parts per million.

16. Methylene Chloride, 125 parts per million.

17. Pentane, 750 parts per million.

18. Propane, 5,000 parts per million.

19. Toluene, 150 parts per million.

20. Trichloroethylene (1,1,2- Trichloroethane), 25 parts per million.

21. Xylenes, Total (ortho-, meta-, para-), 150 parts per million.

(d) Metals Limits.

1. Cadmium, 200 parts per billion.

2. Lead, 500 parts per billion.

3. Arsenic, 200 parts per billion.

4. Mercury, 200 parts per billion.

(e) Biological Limits.

1. Shiga toxin-producing Escherichia coli (STEC E. coli) none present.

2. Listeria monocytogenes, none present.

3. Salmonella, none present.

4. Aspergillus, none present.

(f) Mycotoxin Limits.

1. Total Aflatoxin (B1, B2, G1, G2), 20 parts per billion.

2. Ochratoxin, 20 parts per billion.

(g) Contamination limits prescribed herein may not be present in the product or during the inhalation process.

(h) Cannabinoid Limits. Total delta-9 tetrahydrocannabinol concentration shall not exceed 0.3%.

(i) If a testing sample is found to contain levels of any pathogen, toxicant, residual solvent, metal, or pesticide not enumerated in this rule or by Florida law, then the product shall be considered adulterated.

(6) Labeling of prepackaged liquids for human inhalation.

(a) Hemp Extract Intended for Inhalation must be labeled as required by Chapter 500, F.S., Section 581.217(7), F.S., and Rule 5J-22.003(2), F.A.C. The label must also contain the name and address of the manufacturer.

(b) If cannabinoids are marketed, the number of milligrams of each cannabinoid per unit must be declared on the label.

(c) The label and advertisement shall not contain claims indicating the product is intended for diagnosis, cure, mitigation, treatment, or prevention of disease, rendering it a drug as defined in 21 U.S.C. 321(g)(1). Pursuant to Section 500.03(1)(n)4., F.S., such articles are considered misbranded.

(d) Products intended only for human inhalation must be labeled with the following statement “This Hemp Extract product is not intended for ingestion.”

(7) Disposal.

(a) Laboratory samples of Hemp Extract Intended for Inhalation found to contain more than a Total delta-9 tetrahydrocannabinol concentration of 0.3% shall be disposed of in accordance with 21 CFR 1317. 21 CFR 1317 (Revised April 1, 2019), incorporated by reference in Rule 5K-4.034, F.A.C.

(b) All other Hemp Extract Intended for Inhalation containing a Total delta-9 tetrahydrocannabinol concentration that exceeds 0.3% shall be detained pursuant to Section 500.172, F.S.  Hemp Extract Intended for Inhalation containing a Total delta-9 tetrahydrocannabinol concentration that exceeds 0.3% which has been detained pursuant to Section 500.172, F.S., shall not be further subdivided or renumbered in order to maintain the integrity of the lot. The hemp food establishment shall not dispose of the Hemp Extract Intended for Inhalation in any manner until written permission is given by the department or a court of competent jurisdiction.

(c) Upon receipt of written permission by the department or a court of competent jurisdiction, the Hemp Extract Intended for Inhalation detained pursuant to Section 500.172, F.S., shall be disposed of in accordance with the Hemp Waste Disposal Manual FDACS-08115, 12/19, incorporated in Rule 5B-57.014, F.A.C., or in a manner approved by a court of competent jurisdiction. 

(8) Self-Service Merchandising.

(a) A retailer that sells Hemp Extract Intended for Inhalation may not sell, permit to be sold, offer for sale, or display for sale such products or devices by means of self-service merchandising.

(b) A retailer that sells Hemp Extract Intended for Inhalation may not place such products or devices in an open display unit unless the unit is located in an area that is inaccessible to customers.

(9)  Violations of this rule will be evaluated and penalties imposed in accordance with Rule 5K-4.035, F.A.C.

Rulemaking Authority 500.09, 500.12, 570.07(23) FS. Law Implemented 500.03, 500.04, 500.09, 500.10, 500.11, 500.12, 500.121, 500.13, 500.172, 581.217 FS. History–New              .