The purpose of this rulemaking is to implement statutory changes passed during the 2023 Legislative Session.

 

DEPARTMENT OF AGRICULTURE AND CONSUMER SERVICES

Division of Food Safety

RULE NO.:RULE TITLE:

5K-10.006Hemp Extract

PURPOSE AND EFFECT: The purpose of this rulemaking is to implement statutory changes passed during the 2023 Legislative Session.

SUMMARY: The proposed rule updates definitions, penalties for violations and the requirements regarding dairy products that contain hemp and hemp extract for human consumption.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will not 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 not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: The proposed changes to Rule 5K-10.006, F.A.C., clarify existing fine authority for certain violations and clarify existing statutory requirements, including prohibitions on product labeling, packaging, and advertising that is attractive to children. Fines are only imposed in the event of a violation, so there is no additional cost to regulated entities. Furthermore, the prohibitions on labeling and packaging that is attractive to children and on advertising that targets or is attractive to children are already in statute, so there is no additional cost to businesses as a result of this rule. Therefore, no adverse impact or regulatory cost is associated with this rule that exceeds the criteria in section 120.541(2)(a), F.S. Based upon this analysis, the Department has determined that the proposed rule is not expected to require legislative ratification.

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), 581.217(12), F.S.

LAW IMPLEMENTED: 500.03, 500.04, 500.09, 500.10, 500.11, 500.12, 500.121, 500.13, 500.172, 581.217(7), F.S.

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: Brenda Noble, [e-mail]

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

5K-10.006 Hemp Extract

(1) Products. Milk, Milk Products, and Frozen Desserts containing Hemp or Hemp Extract for Human Consumption are subject to the requirements of Chapter 502, F.S., Section 581.217, F.S., and Chapter 5K-10, F.A.C., in addition to the requirements of this rule. Grade “A” milk and milk products to which Hemp or Hemp Extract for Human Consumption has been added shall be considered “Substitute Milk” or “Substitute Milk Products” as defined in Chapter 502, F.S. In addition to the requirements in Section 502.165, F.S., Substitute Milk and Substitute Milk Products containing Hemp or Hemp Extract for Human Consumption are subject to the requirements of Chapter 5K-10, F.A.C.

(2) Definitions. The definitions provided in Sections 502.012 and 581.217, F.S., and the following shall apply to this rule:

(a) “Approved Source” for the purposes of this rule means Hemp Frozen Dessert Plant Manufacturer, Hemp Substitute Milk Manufacturer, or Hemp Substitute Milk Product Manufacturer manufacturing, processing, packing, holding, or preparing or selling Substitute Milk, Substitute Milk Products, or Frozen Desserts at wholesale or retail that meet the requirements of Section 581.217(7)(a)1.d., F.S. meets local, state, or federal food safety standards from the jurisdiction of origin.

(b) “Attractive to Children” is defined in Section 581.217(3)(a), F.S.

(c)(b) “Batch” or “Lot” means the Substitute Milk, Substitute Milk Products, and Frozen Desserts containing Hemp or Hemp Extract for Human Consumption produced during a period of time under similar conditions and identified by a specific code that allows traceability.

(d) “Color Additive” is as defined in s. 500.03(1)(g), F.S. Food additives which contribute their own natural color when mixed with foods or other food ingredients are not regarded as color additives, except when used for the purpose of adding color to a food product.

(e)(c) “Expiration Date” means the month and year as determined by the processor, plant, manufacturer, packer, or distributor based 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.

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

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

(h)(f) “Hemp Frozen Dessert Plant Manufacturer” means a Frozen Dessert Plant person who manufactures, processes, converts, partially freezes, or freezes any mix or frozen dessert containing Hemp or Hemp Extract for Human Consumption for distribution or sale.

(i)(g) “Hemp Substitute Milk Manufacturer” means any place, premises, or establishment where Substitute Milk containing Hemp or Hemp Extract for Human Consumption is collected, handled, processed, stored, pasteurized, ultra-pasteurized, aseptically processed and packaged, retort processed after packaging, condensed, dried, packaged, bottled, or prepared for distribution at wholesale.

(j)(h) “Hemp Substitute Milk Product Manufacturer” means any place, premises, or establishment where Substitute Milk Products containing Hemp or Hemp Extract for Human Consumption is collected, handled, processed, stored, pasteurized, ultra-pasteurized, aseptically processed and packaged, retort processed after packaging, condensed, dried, packaged, bottled, or prepared for distribution at wholesale.

(k) “Human Consumption” includes products intended for human Ingestion and/or human Inhalation but does not include topical applications.

(l)(i) “Ingestion” means the process of consuming Hemp or Hemp Extract taking food into the body through the mouth whether by swallowing and into the gastrointestinal or through tissue absorption tract through eating or drinking.

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

(3) No change.

(4) Requirements.

(a) Substitute Milk, Substitute Milk Products, and Frozen Desserts containing Hemp or Hemp Extract for Human Consumption must originate from an Approved Source. The Hemp Frozen Dessert Plant Manufacturer, Hemp Substitute Milk Manufacturer, or Hemp Substitute Milk Product Manufacturer shall provide to the department, upon request, a valid dairy or food safety license/permit and the most recent dairy or food safety inspection report from the Approved Source.

(b) Substitute Milk, Substitute Milk Products, and Frozen Desserts containing Hemp or Hemp Extract for Human Consumption must be stored and transported in accordance with Chapter 5K-10, F.A.C. Substitute Milk, Substitute Milk Products, and Frozen Desserts containing Hemp or Hemp Extract for Human Consumption must be packaged in containers minimizing the exposure to light to prevent degradation of the Cannabinoids.

(c) Substitute Milk, Substitute Milk Products, and Frozen Desserts containing Hemp or Hemp Extract for Human Consumption shall not contain a Total delta-9 tetrahydrocannabinol concentration of more than 0.3%.

(5) Contaminants. In addition to the requirements listed in Chapter 502, F.S., and Rule 5K-10.004, Substitute Milk, Substitute Milk Products, and Frozen Desserts containing Hemp or Hemp Extract for Human Consumption shall be considered adulterated pursuant to Section 502.181(2), F.S., if contaminants are detected at levels greater than those listed in this rule.

(a) through (f) No change.

(g) Color additives prohibited for Substitute Milk, Substitute Milk Products, and Frozen Desserts containing Hemp or Hemp Extract for Human Human Consumption: 

1. FD&C Blue No. 1 

2. FD&C Blue No. 2 

3. FD&C Green No. 3 

4. Orange B 

5. Citrus Red No. 2 

6. FD&C Red No. 3 

7. FD&C Red No. 40 (Allura Red)

8. FD&C Yellow No. 5 

9. FD&C Yellow No. 6 

10. FD&C Red No. 3

11. Cochineal extract 

12. Carmine 

13. Mica-based pearlescent pigments 

14. Quinoline Yellow (FD&C Yellow No. 10) 

15. Yellow 2G 

16. FD&C Green No. 1

17. FD&C Green No. 2

18. FD&C Red No. 1

19. FD&C Red No. 2, Amaranth

20. FD&C Red No. 4, Ponceau SX

21. FD&C Violet No. 1

22. Azorubine Carmoisine 

23. Ponceau 4R, Ponceau Red, Cochineal Red A 

24. Patent Blue V 

25. Green S 

26. Brilliant Black BN, Black PN 

27. Brown FK

28. Brown HT, Chocolate Brown

29. Cuttlefish Black

30. Cuttle Black

31. Alkanet (Alkane)

32. Carbon Black, Vegetable Carbon 

33. Charcoal-NF XI

34. Cudbear

35. Ferric Chloride

36. Ferrous Sulfate

37. Logwood, Chip & Extract

(h)  The following substances are prohibited for use in Substitute Milk, Substitute Milk Products, and Frozen Desserts containing Hemp or Hemp Extract for Human Consumption when used as a color additive:

1. Annatto extract 

2. Dehydrated beets (beet powder) 

3. Butterfly pea flower extract 

4. Calcium carbonate 

5. Canthaxanthin 

6. Caramel 

7. β-Apo-8'-carotenal 

8. β-Carotene 

9. Sodium copper chlorophyllin 

10. Toasted partially defatted cooked cottonseed flour 

11. Ferrous gluconate 

12. Ferrous lactate 

13. Grape color extract 

14. Grape skin extract (enocianina) 

15. Synthetic iron oxide 

16. Fruit juice 

17. Vegetable juice 

18. Carrot oil 

19. Paprika 

20. Paprika oleoresin 

21. Riboflavin 

22. Saffron 

23. Soy Leghemoglobin 

24. Spirulina extract 

25. Titanium dioxide 

26. Tomato lycopene extract 

27. Tomato lycopene concentrate 

28. Tumeric 

29. Tumeric oleoresin 

(i)(g) If a testing sample is found to contain levels of any pathogen, toxicant, residual solvent, metal, color additive, controlled substance, drug, or pesticide not enumerated in this rule or by Florida law the Substitute Milk, Substitute Milk Product, or Frozen Dessert containing Hemp or Hemp Extract for Human Consumption shall be considered adulterated.

(6) Product, Packaging, Labeling, and Advertisement.

(a) Substitute Milk, Substitute Milk Products, and Frozen Desserts containing Hemp or Hemp Extract for Human Consumption must comply with and be packaged and be labeled in accordance with Chapter 502, F.S., Section 581.217(7), F.S., Rule 5K-4.034, F.A.C., and 21 CFR 101. The label must also contain the name and address of the manufacturer or plant. 21 CFR 101 (Revised April 1, 2019) is hereby incorporated by reference and available online at http://www.flrules.org/Gateway/reference.asp?No=Ref-11459 and by email request to the department at [e-mail]. Advertisements for Substitute Milk, Substitute Milk Products, and Frozen Desserts containing Hemp or Hemp Extract for Human Consumption shall comply with Section 581.217, F.S., and Rule 5K-4.034, F.A.C.

(b) 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).

(7) Disposal.

(a) Laboratory samples 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) is hereby incorporated by reference and available online at http://www.flrules.org/Gateway/reference.asp?No=Ref-11460 and by email request to the department at [e-mail].

(b) Substitute Milk, Substitute Milk Products, or Frozen Desserts containing a Total delta-9 tetrahydrocannabinol concentration that exceeds 0.3% shall be detained pursuant to Section 502.014, F.S. Substitute Milk, Substitute Milk Products, or Frozen Desserts containing a Total delta-9 tetrahydrocannabinol concentration that exceeds 0.3% which have been detained pursuant to Section 502.014, F.S., shall not be further subdivided or renumbered such that the integrity of the lot for identification is not maintained. The establishment shall not shall not dispose of the Substitute Milk, Substitute Milk Products, or Frozen Desserts in any manner until written permission for removal, use, or disposal 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 Substitute Milk, Substitute Milk Products, or Frozen Desserts shall be disposed of in accordance with the Hemp Waste Disposal Manual FDACS-08115, 10/19, incorporated in paragraph 5B-57.014(6)(b), F.A.C., or in the manner provided for by a court of competent jurisdiction.

(8) Penalties. Violations of this rule will be evaluated, and penalties imposed in accordance with Rule 5K-10.005, F.A.C.

(a) Violations of this rule will be evaluated, and penalties imposed in accordance with Rule 5K-10.005, F.A.C.

(b) Substitute Milk, Substitute Milk Products, and Frozen Desserts containing Hemp or Hemp Extract for Human Consumption sold in violation of this rule shall be considered adulterated pursuant to subsection 502.181(2), F.S.

(c) The sale of Substitute Milk, Substitute Milk Products, and Frozen Desserts containing Hemp or Hemp Extract for Human Consumption to persons under the age of 21 is punishable as provided in paragraph 581.217(7)(d), F.S., and shall result in an administrative fine of $5,000 per occurrence.

Rulemaking Authority 502.014, 502.053, 570.07(23), 581.217(12) FS. Law Implemented 502.012, 502.014, 502.032, 502.042, 502.053, 502.091, 502.121, 502.165, 502.231, 581.217(7) FS. History–New 1-1-20, Amended 5-22-22,_______.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Matthew D. Curran, Ph.D., Director, Division of Food Safety

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Wilton Simpson, Commissioner of Agriculture

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: September 24, 2024

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: 10/27/2023