Hemp Extract

 

DEPARTMENT OF AGRICULTURE AND CONSUMER SERVICES

Division of Food Safety

RULE NO.:RULE TITLE:

5K-4.034Hemp Extract

NOTICE OF CHANGE

Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 47 No. 62, March 31, 2021 issue of the Florida Administrative Register.

5K-4.034Hemp 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 581.217 shall be considered adulterated or misbranded pursuant to Chapter 500, F.S. As such, products consisting of or containing Hemp Extract intended for Human Consumption 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 or Ingestion must meet all of the requirements for products intended for both Inhalation and Ingestion as provided in this rule. In the event that there are different requirements, the stricter standard shall apply.

(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” for the purposes of this rule means an establishment manufacturing products consisting of or containing Hemp Extract intended for Ingestion that meets local, state, or federal regulatory food safety or health standards from the jurisdiction of origin. that meet or exceed the standards of the responsible food or health regulatory agency.

(b) through (f) No change.

(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) “Ingestion” means the process of consuming Hemp Extract through the mouth, whether by swallowing into the gastrointestinal system or through tissue absorption. and into the gastrointestinal tract.

(i) through (k) No change.

(l) "Self-service merchandising" means an open display of Hemp Extract products to which the public has access without the intervention of the vendor or a store employee. “Responsible Party” means the manufacturer, packer, or distributor as displayed on the exterior of the retail packaging.

(m) through (n) No change.

(3) No change.

(4) Requirements.

(a) Food consisting of or containing Hemp or Hemp Extract intended for Ingestion must be manufactured by an Approved Source. The Hemp Food Establishment Responsible Party shall provide a valid food license/permit and the most recent food safety or health 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 or Hemp Extract intended for Inhalation must be manufactured by a source permitted to manufacture Hemp or Hemp Extract intended for Inhalation. tested in accordance with section 581.217(7)(a) and Rule 5K-4.034(5). The Hemp Food Establishment shall provide a valid license/permit and the most recent inspection report from the permitting source to the department upon request. 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) through (i) No change.

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

(a) through (b) No change

(c)(b) Residual Solvent Limits for Ingestion or Inhalation.

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

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

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), 2 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 for Inhalation.

(d)(c) Metals Limits.

1. Cadmium, 500 parts per billion 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 Ingestion or Inhalation.

3. Arsenic, 1,500 parts per billion 1.5 micrograms/gram for Ingestion; 200 parts per billion for Inhalation.

4. Mercury, 3,000 parts per billion 3.0 micrograms/gram for Ingestion; 200 parts per billion for Inhalation.

(e)(d) Biological Limits for Ingestion or Inhalation.

1. Shiga toxin-producing Escherichia coli (STEC E. coli) and other pathogenic E. coli, 1 CFU per gram none present.

2. Listeria monocytogenes, none present.

2 3. Salmonella, 1 CFU per gram none present.

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

(f)(e) Mycotoxin Limits.

1. through 2. No change.

(g) Total Combined Yeast and Mold - 100,000 CFU per gram for Ingestion or Inhalation.

(f) through (h) reordered (h) through (j) No change.

(6) Labeling.

(a) Hemp Extract intended for Human Consumption must be labeled as required by Chapter 500, F.S., and section 581.217(7), F.S., and Rule 5J-22.003(2), F.A.C.

(b) through (d) No change.

(7) No change.

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

(a) through (c) No change.

(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) No change.

(9) Penalties.

(a) through (b) No change

(c)Hemp or Hemp Extract Products must meet the requirements of this rule.  Such products not meeting the requirements of this rule or without the documentation required in Section (4)(a) – (b) of this rule may not be sold in this state. 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) through (e) No change.

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                        .