The purpose of this rulemaking is to revise existing rule text to comply with statutory changes made to Section 581.217, F.S., during the 2020 legislative session and to clarify existing rule text.

 

DEPARTMENT OF AGRICULTURE AND CONSUMER SERVICES

Division of Food Safety

RULE NO.: RULE TITLE:

5K-4.034Hemp Extract

PURPOSE AND EFFECT: The purpose of this rulemaking is to revise existing rule text to comply with statutory changes made to Section 581.217, F.S., during the 2020 legislative session and to clarify existing rule text.

SUMMARY: Definitions, packaging and labeling requirements, disposal requirements.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the economic analysis as described in the statement of estimated regulatory costs.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

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.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Chris Hilliard by email at

[e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

5K-4.034 Hemp Extract for Human Consumption

(1) Products.

(a)Section 581.217(7)(b), F.S., provides that Hemp Extract distributed or sold in violation of section 581.217shall be considered adulterated or misbranded pursuant to Chapter 500, F.S. As such, products consisting of or containing Hemp or Hemp Extract intended for Human Consumption intended to be ingested is a Food as defined in Section 500.03, F.S., and 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, and 5K-4.035, F.A.C., in addition to the requirements of this rule. 

(b)Hemp Extract intended for Human Consumption that is not clearly labeled as intended for Inhalation orIngestion must meet all of the requirements for products intended for both Inhalation and Ingestion as provided in this rule.

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

(a) “Approved Source” for the purposes of this rule means an establishment manufacturing products consisting of or containing Hemp Extract intended for Ingestion that meet or exceed the standards of the responsible food or health regulatory agency. a food establishment manufacturing, processing, packing, holding, or preparing food or selling food at wholesale or retail that meets local, state, or federal food safety standards from the jurisdiction of origin.

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

(c) through (d) No change.

(e) “Hemp Extract” is defined in sSection 581.217(3)(e), F.S. Hemp Extract does not include any material, compound, mixture or preparation that contains any quantity of Synthetic Cannabinoids as defined in Section 893.03(1)(c)190., F.S.

(f) “Hemp Food Establishment” means an establishment as defined in section 500.03(1)(p), F.S. extracting, manufacturing, processing, packing, holding, preparing, or selling Food consisting of or containing Hemp Extract intended for Human Consumption at wholesale or retail.

(g) “Human Consumption” for the purposes of this rule includes products intended for human Ingestion and/or human Inhalation but does not include topical applications.

(h)(g) “Ingestion” means the process of consuming Hemp Extract taking Food into the body through the mouth and into the gastrointestinal tract through eating or drinking.

(i) “Inhalation” means the process of consuming Hemp Extract through the mouth or nasal passages into the respiratory system.

(j) “Manufacturing” for the purposes of this rule means preparing and/or packaging products consisting of or containing Hemp Extract intended for Human Consumption.

(k)“Processor” or “Extractor” means the establishment that removes the Hemp Extract oil from the Hemp plant.

(l) “Responsible Party” means the manufacturer, packer, or distributor as displayed on the exterior of the retail packaging.

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

(n) “Vending machines” for the purpose of this rule are defined as any self-service device which, upon completion of payment, dispense hemp extract products as defined in 581.217(7) F.S. without the necessity of replenishing the device between each operation.

(3) Permits. Food Permit Fees.

(a) Each establishment distributing products consisting of or containing Hemp Extract intended for Human Consumption must be permitted as a Hemp Food Establishments shall obtain a food permit as required in pursuant to section 500.12, F.S., and Rule 5K-4.020, F.A.C., and shall pay an annual fee of $650.

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

(4) Requirements.

(a) Food consisting of or containing Hemp or Hemp Extract intended for Ingestion must be manufactured by obtained from an Approved Source. The Responsible Party shall provide The Hemp Food Establishment shall provide to the department, upon request, a valid food license/permit and the most recent food safety inspection report from the Approved Source to the department upon request for these products offered for sale in the state.

(b) Products consisting of or containing Hemp Extract intended for Inhalation must be tested in accordance with section 581.217(7)(a) and Rule 5K-4.034(5). The Responsible Party shall provide the required documentation of test results to the department upon request for these products offered for sale in the state.

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

(d)(c) If a Food containing Hemp Extract intended for Ingestion is considered a Potentially Hazardous Food (PHF) or a Food requiring Time and Temperature Control for Safety (TCS) Food as defined in Rule 5K-4.0010, F.A.C., it must be stored in accordance with Rule 5K-4.002, F.A.C. All Food products consisting of or containing Hemp Extract must be packaged in containers minimizing the exposure to light to prevent degradation of the Cannabinoids.

(e)Hemp Extract intended Human Consumption must be packaged in containers minimizing the exposure to light to prevent degradation of the Cannabinoids.

(f)Containers used with Hemp Extract intended for Human Consumption must comply with the requirements provided in 21 CFR 170, as incorporated by reference in Rule 5K-4.002, F.A.C.

(g)(d) Food consisting of or containing Hemp Extract intended for Human Consumption shall not contain a Total delta-9 tetrahydrocannabinol concentration of more than 0.3% on a dry weight basis.

(h)Hemp Extract intended for Human Consumption shall not be manufactured, processed, packed, held, or prepared in a private home or in a room used as living or sleeping quarters.

(i) Hemp Extract intended for Human Consumption shall not be offered for sale by means of vending machines.

(5) Contaminants. In addition to the requirements listed in Chapter 500, F.S., and Rule 5K-4.002, F.A.C., Food consisting of or containing Hemp Extract intended for Human Consumption shall be considered adulterated pursuant to sSection 500.10(1)(a), F.S., if contaminants are detected at levels greater than the limits those listed in this rule.

(a)The following substances are prohibited in Hemp Extract intended for Inhalation:

1.   Vitamin E acetate.

2.  2,3-butanedione (Diacetyl).

3. Myclobutanil

(b)(a) 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, 300 parts per billion for Ingestion; 100 parts per billion for Inhalation.

2. Acephate, 3,000 parts per billion for Ingestion; 100 parts per billion for Inhalation.

3 Acequinocyl, 2,000 parts per billion for Ingestion; 100 parts per billion for Inhalation.

4. Acetamiprid, 3,000 parts per billion for Ingestion; 100 parts per billion for Inhalation.

5 Aldicarb, 100 parts per billion for Ingestion or Inhalation.

6. Azoxystrobin, 3,000 parts per billion for Ingestion; 100 parts per billion for Inhalation.

7. Bifenazate, 3,000 parts per billion for Ingestion; 100 parts per billion for Inhalation.

8. Bifenthrin, 500 parts per billion for Ingestion; 100 parts per billion for Inhalation.

9. Boscalid, 3,000 parts per billion for Ingestion; 100 parts per billion for Inhalation.

10. Captan, 3,000 parts per billion for Ingestion; 700 parts per billion for Inhalation.

11. Carbaryl, 500 parts per billion for Ingestion; 500 parts per billion for Inhalation.

12. Carbofuran, 100 parts per billion for Ingestion or Inhalation.

13. Chlorantraniliprole, 3,000 parts per billion for Ingestion; 1,000 parts per billion for Inhalation.

14. Chlordane, 100 parts per billion for Ingestion or Inhalation.

15. Chlorfenapyr, 100 parts per billion for Ingestion or Inhalation.

16. Chlormequat chloride, 3,000 parts per billion for Ingestion; 1,000 parts per billion for Inhalation.

17. Chlorpyrifos, 100 parts per billion for Ingestion or Inhalation.

18. Clofentezine, 500 parts per billion for Ingestion; 200 parts per billion for Inhalation.

19. Coumaphos, 100 parts per billion for Ingestion or Inhalation.

20. Cyfluthrin, 1,000 parts per billion for Ingestion; 500 parts per billion for Inhalation.

21. Cypermethrin, 1,000 parts per billion for Ingestion; 500 parts per billion for Inhalation.

22. Daminozide, 100 parts per billion for Ingestion or Inhalation.

23. DDVP (Dichlorvos), 100 parts per billion for Ingestion or Inhalation.

24. Diazinon, 200 parts per billion for Ingestion; 100 parts per billion for Inhalation.

25. Dimethoate, 100 parts per billion for Ingestion or Inhalation.

26. Dimethomorph, 3,000 parts per billion for Ingestion; 200 parts per billion for Inhalation.

27. Ethoprop(hos), 100 parts per billion for Ingestion or Inhalation.

28. Etofenprox, 100 parts per billion for Ingestion or Inhalation.

29. Etoxazole, 1,500 parts per billion for Ingestion; 100 parts per billion for Inhalation.

30. Fenhexamid, 3,000 parts per billion for Ingestion; 100 parts per billion for Inhalation.

31. Fenoxycarb, 100 parts per billion for Ingestion or Inhalation.

32. Fenpyroximate, 2,000 parts per billion for Ingestion; 100 parts per billion for Inhalation.

33. Fipronil, 100 parts per billion for Ingestion or Inhalation.

34. Flonicamid, 2,000 parts per billion for Ingestion; 100 parts per billion for Inhalation.

35. Fludioxonil, 3,000 parts per billion for Ingestion; 100 parts per billion for Inhalation.

36. Hexythiazox, 2,000 parts per billion for Ingestion; 100 parts per billion for Inhalation.

37. Imazalil, 100 parts per billion for Ingestion or Inhalation.

38. Imidacloprid, 3,000 parts per billion for Ingestion; 400 parts per billion for Inhalation.

39. Kresoxim-methyl, 1,000 parts per billion for Ingestion; 100 parts per billion for Inhalation.

40. Malathion, 2,000 parts per billion for Ingestion; 200 parts per billion for Inhalation.

41. Metalaxyl, 3,000 parts per billion for Ingestion; 100 parts per billion for Inhalation.

42. Methiocarb, 100 parts per billion for Ingestion or Inhalation.

43. Methomyl, 100 parts per billion for Ingestion or Inhalation.

44. Methyl parathion, 100 parts per billion for Ingestion or Inhalation.

45. Mevinphos, 100 parts per billion for Ingestion or Inhalation.

46. Myclobutanil, 3,000 parts per billion for Ingestion; prohibited at any concentration for Inhalation.

47. Naled, 500 parts per billion for Ingestion; 250 parts per billion for Inhalation.

48. Oxamyl, 500 parts per billion for Ingestion or Inhalation.

49. Paclobutrazol, 100 parts per billion for Ingestion or Inhalation.

50. Pentachloronitrobenzene, 200 parts per billion for Ingestion; 150 parts per billion for Inhalation.

51. Permethrin, 1,000 parts per billion for Ingestion; 100 parts per billion for Inhalation.

52. Phosmet, 200 parts per billion for Ingestion; 100 parts per billion for Inhalation.

53. Piperonyl butoxide, 3,000 parts per billion for Ingestion or Inhalation.

54. Prallethrin, 400 parts per billion for Ingestion; 100 parts per billion for Inhalation.

55. Propiconazole, 1,000 parts per billion for Ingestion; 100 parts per billion for Inhalation.

56. Propoxur, 100 parts per billion for Ingestion or Inhalation.

57. Pyrethrins, 1,000 parts per billion for Ingestion; 500 parts per billion for Inhalation.

58. Pyridaben, 3,000 parts per billion for Ingestion; 200 parts per billion for Inhalation.

59. Spinetoram, 3,000 parts per billion for Ingestion; 200 parts per billion for Inhalation.

60. Spinosad A & D, 3,000 parts per billion for Ingestion; 100 parts per billion for Inhalation.

61. Spiromesifen, 3,000 parts per billion for Ingestion; 100 parts per billion for Inhalation.

62. Spirotetramat, 3,000 parts per billion for Ingestion; 100 parts per billion for Inhalation.

63. Spiroxamine, 100 parts per billion for Ingestion or Inhalation.

64. Tebuconazole, 1,000 parts per billion for Ingestion; 100 parts per billion for Inhalation.

65. Thiacloprid, 100 parts per billion for Ingestion; 100 parts per billion for Inhalation.

66. Thiamethoxam, 1,000 parts per billion for Ingestion; 500 parts per billion for Inhalation.

67. Trifloxystrobin, 3,000 parts per billion for Ingestion; 100 parts per billion for Inhalation.

(b) Residual Solvent Limits.

1. 1,2-Dichloroethane, 5 parts per million for Ingestion; 2 parts per million for Inhalation. 1,2-Dichloroethene, 5 parts per million

2. 1,1-Dichloroethane, 8 parts per million for Ingestion or Inhalation.1,1-Dichloroethene, 8 parts per million

3. Acetone, 5,000 parts per million for Ingestion; 750 parts per million for Inhalation.

4. Acetonitrile, 410 parts per million for Ingestion; 60 parts per million for Inhalation.

5. Benzene, 2 parts per million for Ingestion; 1 part per million for Inhalation.

6. Butane, 2,000 parts per million for Ingestion; 5,000 parts per million for Inhalation.

7. Chloroform, 60 parts per million for Ingestion; 2 parts per million for Inhalation.

8. Ethanol, 5,000 parts per million for Ingestion or Inhalation.

9. Ethyl Acetate, 5,000 parts per million for Ingestion; 400 parts per million for Inhalation.

10. Ethyl Ether, 5,000 parts per million for Ingestion; 500 parts per million for Inhalation.

11. Ethylene Oxide, 5 parts per million for Ingestion or Inhalation.

12. Heptane, 5,000 parts per million for Ingestion or Inhalation.

13. Hexane, 290 parts per million for Ingestion; 250 parts per million for Inhalation.

14. Isopropyl Alcohol, 500 parts per million for Ingestion or Inhalation.

15. Methanol, 3,000 parts per million for Ingestion; 250 parts per million for Inhalation.

16. Methylene Chloride, 600 parts per million for Ingestion; 125 parts per million for Inhalation.

17. Pentane, 5,000 parts per million for Ingestion; 750 parts per million for Inhalation.

18. Propane, 2,100 parts per million for Ingestion; 5,000 parts per million for Inhalation.

19. Toluene, 890 parts per million for Ingestion; 150 parts per million for Inhalation.

20. Trichloroethylene (1,1,2 Trichloroethane Trichloroethene), 280 parts per million for Ingestion; 25 parts per million for Inhalation.

21. Xylenes, Total (ortho-, meta-, para-), 2,170 parts per million for Ingestion; 150 parts per million forInhalation.

(c) Metals Limits.

1. Cadmium, 0.5 micrograms/gram for Ingestion; 200 parts per billion for Inhalation.

2. Lead, 0.5 micrograms/gram for Ingestion; 500 parts per billion for Inhalation.

3. Arsenic, 1.5 micrograms/gram for Ingestion; 200 parts per billion for Inhalation.

4. Mercury, 3.0 micrograms/gram for Ingestion; 200 parts per billion for Inhalation.

(d) Biological Limits.

1. through 3. No Change.

4. Aspergillus, none present.

(e)   Mycotoxin Limits.

1. Total Aflatoxin (B1, B2, G1, G2), 20 parts per billion for Ingestion or Inhalation.

2. Ochratoxin, 20 parts per billion for Ingestion or Inhalation.

(f) Cannabinoid Limits. Total delta-9 tetrahydrocannabinol concentration shall not exceed 0.3% on a dry weight basis.

(g) 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 Hemp Extract Food shall be considered adulterated.

(h) Devices used during the Inhalation process must not introduce contaminants over the limits listed in this rule into the Hemp Extract product.

(6) Labeling.

(a) Food consisting of or containing Hemp Extract intended for Human Consumption must be labeled as required by Chapter 500, F.S., sSection 581.217(7), F.S., and Rule 5J-22.003(2), F.A.C. 21 CFR 101, as incorporated by

reference in Section 5K-4.002(4), F.A.C., and must declare the number of milligrams of Hemp Extract.

(b) If specific cannabinoids are marketed, the number of milligrams of each marketed cannabinoid per serving and the serving size must be declared on the label. The serving size shall be displayed on the nutrition facts label of the product.

(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 not considered Food and shall be considered misbranded as Food.

(d) Hemp Extract intended solely for Inhalation must be clearly labeled with the statement “Not Intended For Ingestion - Do Not Eat.”

(7) Disposal.

(a) Laboratory samples found to contain more than a Total delta-9 tetrahydrocannabinol concentration of 0.3% on a dry weight basis shall be disposed of in accordance with 21 CFR 1317. 21 CFR 1317 (Revised April 1, 2019) is hereby incorporated by reference and available online at http://www.flrules.org/Gateway/reference.asp?No=Ref- 11452.

(b) Hemp Extract intended for Human Consumption Food containing a Total delta-9 tetrahydrocannabinol concentration that exceeds 0.3% on a dry weight basis shall be detained pursuant to sSection 500.172, F.S. Hemp Extract intended for Human Consumption Food containing a Total delta-9 tetrahydrocannabinol concentration that exceeds 0.3% on a dry weight basis which has been detained pursuant to sSection 500.172, F.S. shall not be further subdivided or renumbered such that the integrity of the lot is not maintained. The establishment shall not dispose of the Hemp Extract intended for Human Consumption Food 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 Human Consumption Food shall be disposed of in accordance with the Hemp Waste Disposal Manual FDACS-08115, 12/19 10/19, incorporated in Rule paragraph 5B-57.014(6)(b), F.A.C., or in a manner approved by a court of competent jurisdiction. Upon destruction of the product, the Hemp Food Establishment shall notify the department via Notice of Disposal FDACS-14419, 10/19, incorporated herein by reference and available online at http://www.flrules.org/Gateway/reference.asp?No=Ref-11458.

(8) Age Limit for Hemp Extract intended for Inhalation.

(a) Any retailer that sells Hemp Extract intended for Inhalation shall post a clear and conspicuous sign directly adjacent to the display of the product 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.

(b) Hemp Extract intended for Inhalation may not be mailed, shipped, or otherwise delivered to a purchaser unless, before the delivery to the purchaser, the Hemp Food Establishment obtains confirmation that the purchaser is 21 years of age or older.

 

(c) Hemp Food Establishments shall require proof of age from a purchaser of any product containing Hemp Extract intended for Inhalation before selling the product to that person. Hemp Food Establishments shall exercise diligence in the management and supervision of their premises and in the supervision and training of their employees to prevent the underage sale of these products.

(d) Hemp Extract intended for Inhalation shall not be offered for sale by means of self-service merchandising or display units unless proof of age has been verified before allowing access to the self-service merchandising or display.

(e) The giving or sampling of Hemp Extract intended for Inhalation products by a Hemp Food Establishment to any person under the age of 21 is prohibited.

(9)(8) Penalties.

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

(b) Hemp Extract intended for Human Consumption distributed or sold in violation of this rule shall be considered adulterated or misbranded pursuant to Chapter 500, F.S., as provided in section 581.217(7)(b), F.S.

(c) Responsible Parties unable or unwilling to provide documentation that their products meet the requirements of this rule shall not be allowed to distribute their products in the state of Florida until such documentation is provided.

(d) Violations of this rule shall result in the imposition of stop-sale/stop-use orders, an administrative fine of up to $5,000 per violation, permit suspension, permit revocation, or any combination thereof.

(e) The sale of Hemp Extract intended for Inhalation to persons under the age of 21 shall result in an administrative fine of $5,000 per occurrence.

Rulemaking Authority 500.09, 500.12, 570.07(23), 581.217(12), 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 1-1-20, Amended              .

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Chris Hilliard

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Nicole "Nikki" Fried

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: 3/17/2021

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: June 10, 2020 Volume 46/113