Revisions to Rule 5K-4.034, F.A.C., are needed to address developing industry trends and consumer demand, including regulations for Hemp Extract sold through Self-Service Machines. Additional minor revisions to existing ....

 

DEPARTMENT OF AGRICULTURE AND CONSUMER SERVICES

Division of Food Safety

RULE NO.:RULE TITLE:

5K-4.034Hemp Extract for Human Consumption

PURPOSE AND EFFECT: Revisions to Rule 5K-4.034, F.A.C., are needed to address developing industry trends and consumer demand, including regulations for Hemp Extract sold through Self-Service Machines. Additional minor revisions to existing requirements are needed for clarity and accuracy.

SUMMARY: Industry practices, marketing strategies, and consumer demand for products containing Hemp Extract for Human Ingestion have continued to develop and evolve in the state since the onset of the State Hemp Program in 2020. Ongoing adjustments and clarifications to the department rule are necessary to maintain appropriate and applicable regulatory oversight of the State Hemp Program.

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 proposed rules would allow for the sale of Hemp Extract through Self-Service Machines, which would be regulated as Food Establishments. These entities are subject to a statutorily imposed permit fee and any regulatory costs are de minimis.

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, 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: Trevor Walls by email at [e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

5K-4.034 Hemp Extract for Human Consumption.

(1) Products.

(a) No change.

(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 If 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 processing 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.

(b) No change.

(c) “Common Household Measure” for labeling purposes means cup, tablespoon, teaspoon, piece, ounce (oz), or fluid ounce (fl oz), or other common household equipment used to package food products (e.g., jar, bottle).

(d c) “Expiration Date” means the month and year as determined by the processor, 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.

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

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

(g 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 Hemp Extract intended for Human Consumption at wholesale or retail.

(g) through (i) renumbered (h) through (j) No change.

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

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

(m 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.

(n)“Serving” or “Serving Size” means the amount of product intended to be consumed in a single serving as declared on the label expressed in a Common Household Measure. A serving size shall not be a fraction of a piece.

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

(p n) “Self-Service Vending Mmachines” for the purpose of this rule means a Food Establishment that is an automated vending are defined as any self service device that which, upon completion of payment, dispenses only pre-packaged hemp extract products as defined in Section 581.217(3), F.S., without the necessity of replenishing the device between each operation.

(3) No change.

(4) Requirements.

(a) Hemp or Hemp Extract intended for Ingestion must be processed manufactured by an Approved Source. The Hemp Food Establishment 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.

(b) Hemp or Hemp Extract intended for Inhalation must be processed manufactured by a source permitted to process manufacture Hemp or Hemp Extract intended for Inhalation. 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.

(c) 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) No change.

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

(f) through (g) No change.

(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 held beyond the Expiration Date required in Section 581.217(7)(a)(2), F.S., shall not be further distributed or offered for sale.

(j) All products containing Hemp Extract intended for Human Consumption shall be labeled in accordance with Section 581.217(7), F.S., and subsection 5K-4.034(6), F.A.C., of this rule.

(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) No change.

(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. through 10. No change.

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

12. through 64. No change.

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

66. through 67. No change.

(c) through (j) No change.

(6) Labeling.

(a) through (d) No change.

(e) The label for all retail products containing Hemp Extract intended for Human Consumption must include the serving size and servings per container and must be expressed in Common Household Measures followed by the equivalent metric quantity in parathesis (liquids in milliliters and all other products in grams).

(f) For single serving packages and for individually wrapped products within multi-serving packages, a description of the individual container or wrapped product shall be used for the serving size (e.g., bottle, box, package).

(g) If the label of any container of Hemp Extract intended for Human Consumption is too small to accommodate all the information required by this subsection, labeling information shall be attached to the container.

(h) The label of a product containing Hemp Extract intended for Human Consumption in packaged form shall specify conspicuously the name and place of business of the processor, packer, or distributor.

(i) When Hemp Extract intended for Human Consumption is not sold in package form or sold from bulk, the required labeling information shall be displayed clearly at the point of purchase on a counter card, sign, or tag affixed to the product.

(j) The scannable barcode or quick response code required in Section 581.217(7)(2)(a), F.S., shall link directly to the applicable certificate of analysis.

(k) The scannable barcode or quick response code required in Section 581.217(7)(2)(a), F.S., shall be operational at least 90 days after the expiration date of the product.

(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) and 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 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 Human Consumption 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 such that the integrity of the lot is not maintained. The establishment shall not dispose of the Hemp Extract intended for Human Consumption 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 Hemp Extract intended for Human Consumption shall be disposed of in accordance with the Hemp Waste Disposal Manual FDACS-08115, 12/19, incorporated in paragraph 5B-57.014(6)(b), F.A.C., or in a manner approved by a court of competent jurisdiction.

(8) No change.

(9) Self-Service Machines-

(a) Self-Service Machine Food Establishments must provide the department with access to Self-Service Machines for inspection at all reasonable hours.

1. Access shall be provided within 24-hours of the department’s request.

2. Access shall not include access to any currency stored by the machine.

3. Access shall include the ability to detain products pursuant to Section 500.172, F.S., so as to prevent removal, use or disposal until permission is given by the department or the court.

4. Failure to provide access to the Self-Service Machine will result in the assessment of an administrative penalty pursuant to 5K-4.035(9), F.A.C.

(b) Self-Service Machines must be located inside a climate-controlled environment.

(c) Prior to purchasing products containing Hemp Extract intended for Human Consumption, all labeling information required by Section 581.217(7), F.S., and Section 5K-4.034(6), F.A.C., shall be available to the consumer.

(d) Self-Service Machines must ensure compliance with the age requirements in Section 581.217, F.S.

(e) Self-Service Machines shall be maintained in the following manner:

1. Self-Service Machines shall be designed and constructed to permit easy cleaning and maintenance of all exterior and interior surfaces and component parts in accordance with subsection 5K-4.002(4), F.A.C.

2. Self-Service Machines shall be kept in good repair and shall be maintained in a sanitary condition.

3. All Self-Service Machines shall be so located and installed as to prevent contamination and to facilitate the cleaning of the equipment and of all adjacent spaces.

4. Self-Service Machines shall be equipped with a self-closing, tight-fitting door on the vending compartment so the unit is not accessible to the public.

5. Utility connections shall be made in such a manner to prevent unauthorized or unintentional disconnections.

(f) Self-Service Machine must display permit holder’s name, business address, local or toll-free telephone number that may be called for obtaining further information, reporting problems, or making complaints, and a valid decal furnished by the department, which shall be affixed on each machine in a position clearly visible to the consumer.

(10) (9) Penalties

(a) 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, 9-27-21, Amended           .

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Steve Carmody, Bureau Chief.

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Nicole "Nikki" Fried, Commissioner of Agriculture

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: October 13, 2022

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: June 13, 2022