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-10.006Hemp 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 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 department’s proposed rules do not increase fees or otherwise impose any other costs, directly or indirectly, on the regulated industry.

Based on this information, the department determined there will be no adverse impact to small businesses and the potential regulatory costs of the proposed rule chapter does not exceed any of the criteria established in Section 120.541(2)(a), F.S. Additionally, no interested party submitted additional information regarding the economic impact.

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: 502.014, 502.053, 570.07(23), 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.

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: Jennifer Lester by email at

[e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

5K-10.006 Hemp Extract

(1) No Change.

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

(a) No Change.

(b) ”Batch Number” or “Lot Number” means the Substitute Milk, Substitute Milk Products, and Frozen Desserts containing 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 Section 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) through (j) No Change

(3) No Change.

(4) Requirements.

(a) Substitute Milk, Substitute Milk Products, and Frozen Desserts containing Hemp Extract must originate be obtained from an Approved Source. The Hemp Frozen Dessert 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) No Change.

(c) Substitute Milk, Substitute Milk Products, and Frozen Desserts containing Hemp Extract shall not contain a Total delta-9 tetrahydrocannabinol concentration of more than 0.3% on a dry weight basis.

(5) No Change.

(a) through (e) No Change.

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

(g) No Change.

(6) Labeling.

(a) Substitute Milk, Substitute Milk Products, and Frozen Desserts containing Hemp Extract must be labeled in accordance with Chapter 502, F.S., Section 581.217(7), F.S., and 21 CFR 101 and must declare the number of milligrams of Hemp Extract. The label must also contain the name and address of the manufacturer. 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.

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

(c) No Change.

(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- 11460.

(b) Substitute Milk, Substitute Milk Products, or Frozen Desserts containing a Total delta-9 tetrahydrocannabinol concentration that exceeds 0.3% on a dry weight basis 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% on a dry weight basis 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 dispose of the Substitute Milk, Substitute Milk Products, or Frozen Desserts 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 Substitute Milk, Substitute Milk Products, or Frozen Desserts shall be disposed of in accordance with the Hemp Waste Disposal Manual FDACS-08115, 06/21 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. Upon destruction of the product, the establishment shall notify the department via Notice of Disposal FDACS-14419, 10/19, incorporated in paragraph 5K-4.034(7)(c), F.A.C.

(8) No Change.

Rulemaking Authority 502.014, 502.053, 570.07(23) 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              _____.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Jennifer Lester, Bureau Chief.

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

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: 1/28/2022

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: June 10, 2020, Vol. 46 No. 113