The proposed rules have been developed in response to the creation of s. 581.217, F.S., which directs the Department of Agriculture and Consumer Services to adopt rules to regulate the cultivation of hemp in this state. This rulemaking will align ...  

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    DEPARTMENT OF AGRICULTURE AND CONSUMER SERVICES

    Division of Agricultural Environmental Services

    RULE NOS.:RULE TITLES:

    5E-3.003 Inspection; Sampling; Analysis; Reporting Rejected Feed and Feedstuff; Reduced Sampling Requirements; Laboratory Certification/Exemption Requirements and Fees

    5E-3.004Ingredient Statement

    5E-3.005Labels

    PURPOSE AND EFFECT: The proposed rules have been developed in response to the creation of s. 581.217, F.S., which directs the Department of Agriculture and Consumer Services to adopt rules to regulate the cultivation of hemp in this state. This rulemaking will align Chapter 5E-3, Florida Administrative Code (F.A.C.), with the provisions of s. 581.217, F.S., to regulate the distribution and retail sale of pet and specialty pet food, and pet and specialty pet treat products containing hemp extract.  The proposed changes will establish necessary product definitions and testing requirements, address hemp-derived products intended for use as feed ingredients, and establish tolerances relating to hemp derivatives in animal feed.

    SUMMARY: The proposed rules will change existing rules and policies as follows:

    Rule 5E-3.003 is being revised to establish relevant terms, analysis requirements, restrictions on total delta-9-tetrahydrocannabinol (THC) content, and conditions for disposal of non-compliant products that are comprised of or formulated with hemp extract.

    Rule 5E-3.004 will be updated to include hemp extract as an allowable ingredient in pet and specialty pet food and pet and specialty pet treat products.  References to the Official Publication published by the Association of American Feed Control Officials (AAFCO), which specifies the names and definitions for AAFCO-approved feed ingredients, will also be updated in the proposed rule.

    Rule 5E-3.005 will be modified to delineate labeling requirements specific to hemp-based ingredients and feeds containing hemp-derived products. 

    SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS (SERC) AND LEGISLATIVE RATIFICATION:

    The Agency has determined that this rule 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 information expressly relied upon and described herein: There are no adverse regulatory impacts associated with implementing these rules.  Distributors electing to manufacture or distribute pet food, pet treats, specialty pet food or specialty pet treats consisting of or containing Hemp Extract will be required to hold a master registration pursuant to ch. 580, F.S. The Department recognizes that costs and expenses related to compliance including fees pursuant to ch. 580, F.S., waste disposal pursuant to s. 581.217(12)(b), F.S., laboratory testing pursuant to s. 581.217(7)(a), F.S., and labeling and packaging pursuant to s. 581.217(7)(b), F.S., pose additional costs to registrants. However, those costs are prescribed by statute and do not originate from rules of the Department. Therefore, these costs are not regulatory costs of the proposed rule pursuant to s. 120.54(3)(b), F.S. The adverse impact or potential regulatory costs of the proposed rule modifications did not exceed any of the criteria established in s. 120.541(2)(a), F.S. Additionally, no interested parties have submitted information regarding the economic impact of the proposed changes. 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: 570.07(23), 580.036(2), 580.065, 581.217(12)(b), FS.

    LAW IMPLEMENTED: 580.031(9), 580.036(2), 580.051, (1)(f), 580.065, 580.071, 580.081, 580.091, 580.111, 580.112, 580.121, 580.131, 581.217(3)(e), (7), (7)(a), FS.

    A HEARING WILL BE HELD AT THE DATE, TIME, AND PLACE SHOWN BELOW.

    DATE AND TIME: October 18, 2019, 9:00 a.m.

    PLACE: Cabinet Meeting Room, The Capitol, Lower Level, 400 South Monroe Street, Tallahassee, Florida 32399

    DATE AND TIME: October 21, 2019, 9:00 a.m.

    PLACE: Florida State Fairgrounds, 4800 US-301, Tampa, FL 33610

    THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Patricia Lucas, Bureau Chief, Bureau of Agricultural Environmental Laboratories, 3125 Conner Boulevard, Bldg. 7, Tallahassee, FL 32399; (850)617-7830; patricia.lucas@fdacs.gov

     

    THE FULL TEXT OF THE PROPOSED RULE IS:

    5E-3.003 Inspection; Sampling; Analysis; Reporting Rejected Feed and Feedstuff; Reduced Sampling Requirements; Laboratory Certification/Exemption Requirements and Fees.

    (1) Definitions.

    (a) through (j) No change.

    (k) The term “expiration date” means the month and year as determined by the manufacturer, packer, or distributor 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 contain not less than the quantity of each ingredient as set forth on its label.

    (l) The term “Hemp” is defined in s. 581.217(3)(d), F.S.

    (m) The term “Hemp extract” is defined in s. 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 s. 893.03(1)(c)190., F.S.

    (n) The term “pet food” means any commercial feed prepared and distributed for consumption by dogs or cats.

    (o) The term “pet treats” means any treat as defined in 5E-3.003(1)(i), F.A.C., prepared and distributed for consumption by dogs or cats.

    (p) The term “specialty pet” means any animal normally maintained in a household, including, rodents, ornamental birds, ornamental fish, reptiles and amphibians, ferrets, hedgehogs, marsupials, and rabbits not raised for food or fur. (q) The term “specialty pet food” means any commercial feed prepared and distributed for consumption by specialty pets.

    (r) The term “specialty pet treats” means any treat as defined in 5E-3.003(1)(i), F.A.C., prepared and distributed for consumption by specialty pets.

    (s) The term “total delta-9-tetrahydrocannabinol concentration” means [delta-9-tetrahydrocannabinol] + (0.877 x [tetrahydrocannabinolic acid)].

    (2) through (4) No change.

    (5) Hemp extract in pet food, pet treats, specialty pet food and specialty pet treats.

    (a) Hemp extract as defined in s. 581.217(3)(e), F.S. used in pet food, pet treats, specialty pet food and specialty pet treats must be tested and have a certificate of analysis prepared by an independent testing laboratory as required in s. 581.217(7), F.S.

    (b) Pet food, pet treats, specialty pet food and specialty pet treat products shall not contain more than 0.3% total delta-9-tetrahydrocannabinol concentration on a dry weight basis.

    (c) Pet food, pet treats, specialty pet food and specialty pet treat products having a total delta-9-tetrahydrocannabinol concentration that exceeds 0.3% on a dry weight basis, shall be detained pursuant to s. 580.111, F.S. Those products having a total delta-9-tetrahydrocannabinol concentration that exceeds 0.3% on a dry weight basis which have been detained pursuant to s. 580.111, F.S., shall not be further subdivided or renumbered such that the integrity of the lot for identification is not maintained. The manufacturer or distributor shall not dispose of the pet food, pet treats, specialty pet food and specialty pet treats in any manner until written permission is given by the Department or a court of competent jurisdiction.

    (d) Upon receipt of written permission by the Department or a court of competent jurisdiction, the pet food, pet treats, specialty pet food and specialty pet treats 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. Upon destruction of the product, the manufacturer or distributor shall notify the Department via Notice of Disposal FDACS-13411, 10/19, incorporated herein by reference and available online at https://www.flrules.org/Gateway/reference.asp?No=Ref-XXXX.

    (5) through (6) renumbered (6) through (7) No change.

    (8)(7) Commercial Laboratory Certification; Fees.

    (a) through (b) No change.

    (c) Definitions.

    1. through 7. No change.

    8. Decertification – Revocation of certification by the department for one or more of the reasons provided in paragraph 5E-3.003(8)(7)(e), F.A.C.

    9. through 11. No change.

    (d) through (g) No change.

    (9)(8) Quality Assurance/Quality Control Requirements for Registrants Requesting Exemption from Laboratory Certification for In-house Laboratories; Exempt Laboratory’s Quality Assurance/Quality Control Plan Fees.

    (a) Quality Assurance/Quality Control Plan – The in-house laboratory plan submitted for approval by the department that exempts the laboratory from the certification requirements set forth in subsection 5E-3.003(8)(7), F.A.C.

    (b) No change.

    (c) The laboratory shall prepare and follow a written quality assurance/quality control plan including a quality assurance/quality control manual as defined in subparagraph 5E-3.003(8)(7)(c)10., F.A.C. A copy of this plan including a quality assurance/quality control manual must be included with the original application for exemption. A registrant’s quality assurance/quality control plan shall be approved upon determination that the plan meets the requirements of this rule and is being implemented at the registrant’s facility.

    (d) through (f) No change.

    Rulemaking Authority 570.07(23), 580.036(2), 580.065 581.217(12)(b) FS. Law Implemented 580.036(2), 580.051, 580.065, 580.071, 580.091, 580.111, 580.121, 580.131, 581.217(7)(a)  FS. History–New 12-30-70, 5-14-85, Formerly 5E-3.03, Amended 3-4-87, 6-1-95, 11-14-01, 8-31-06,             .

     

    5E-3.004 Ingredient Statement.

    (1) Each ingredient shall be specifically named (the names and definitions identified in “Official Publication 2019 2001” published by the Association of American Feed Control Officials shall be used as the common or usual names unless the Department of Agriculture and Consumer Services designates otherwise by rule), except that collective terms for a group of ingredients which perform a similar function may be used on labels for all commercial feed except horse feed. Collective terms recognize a general classification of ingredient origin but do not imply equivalent nutritional values. The following collective terms may be used in lieu of each ingredient term provided that only those ingredients defined by Association of American Feed Control Officials within each collective term are included:

    Animal Protein Products

    Grain Products

    Plant Protein Products

    Processed Grain By-Products

    Forage Products

    Roughage Products

    Molasses Products

    (a) through (b) No change.

    (2) through (6) No change.

    (7) Pet food, pet treats, specialty pet food and specialty pet treat products may contain Hemp extract as defined by s. 581.217(3), F.S. provided the product is not a drug as defined in s. 580.031(9), F.S.

    (8)(7) “Official Publication 2019 2001” published by The Association of American Feed Control Officials is hereby incorporated by reference. Copies may be obtained from AAFCO, 1800 South Oak Street, Suite 100, Champaign, Illinois 61820 or http://www.aafco.org/publications, and are also available for public inspection during regular business hours at the Florida Administrative Code and Register, R.A. Gray Building, 500 South Bronough Street, Tallahassee, FL 32399-0250 and at the Florida Department of Agriculture and Consumer Services, Division of Agricultural Environmental Services, 3125 Connor Boulevard, Tallahassee, FL 32399-1650. Posting of the aftermentioned materials on the internet for purposes of public examination would violate federal copyright law. Assistant Secretary-Treasurer, P. O. Box 478, Oxford, IN 47971.

    Rulemaking Authority 570.07(23), 580.036(2) FS. Law Implemented 580.031(9), 580.051(1)(f) , 581.217(3)(e)  FS. History–New 12-30-70, 4-1-76, Formerly 5E-3.04, Amended 6-1-95, 11-14-01,          .

     

    5E-3.005 Labels.

    (1) through (3) No change.

    (4) Pet food, pet treats, specialty pet food and specialty pet treats consisting of or containing Hemp extract must be labeled as required in s. 581.217(7), F.S, and must declare the number of milligrams of Hemp extract.

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

    (6) The label and labeling for pet food, pet treats, specialty pet food and specialty pet treats consisting of or containing Hemp extract shall not contain claims indicating the product is intended for diagnosis, cure, mitigation, treatment, or prevention of disease rendering it a drug as defined by s. 580.031(9), F.S.

    (7) Pet food, pet treats, specialty pet food and specialty pet treats consisting of or containing Hemp extract shall be labeled “Not for human consumption.”

    Rulemaking Authority 570.07(23), 580.036(2) FS. Law Implemented 580.031(9), 580.051, 580.081, 580.112, 581.217(7) FS. History–New 12-30-70, Formerly 5E-3.05, Amended 3-5-89, 9-19-94, 6-1-95,         .

     

    NAME OF PERSON ORIGINATING PROPOSED RULE: Kelly Friend, Director, Division of Agricultural Environmental Services

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

    DATE PROPOSED RULE APPROVED BY AGENCY HEAD: October 8, 2019

    DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: June 6, 2019

     

Document Information

Comments Open:
10/10/2019
Summary:
The proposed rules will change existing rules and policies as follows: • Rule 5E-3.003 is being revised to establish relevant terms, analysis requirements, restrictions on total delta-9-tetrahydrocannabinol (THC) content, and conditions for disposal of non-compliant products that are comprised of or formulated with hemp extract. • Rule 5E-3.004 will be updated to include hemp extract as an allowable ingredient in pet and specialty pet food and pet and specialty pet treat products. ...
Purpose:
The proposed rules have been developed in response to the creation of s. 581.217, F.S., which directs the Department of Agriculture and Consumer Services to adopt rules to regulate the cultivation of hemp in this state. This rulemaking will align Chapter 5E-3, Florida Administrative Code (F.A.C.), with the provisions of s. 581.217, F.S., to regulate the distribution and retail sale of pet and specialty pet food, and pet and specialty pet treat products containing hemp extract. The proposed ...
Rulemaking Authority:
570.07(23), 580.036(2), 580.065, 581.217(12)(b), F.S.
Law:
580.031(9), 580.036(2), 580.051, (1)(f), 580.065, 580.071, 580.081, 580.091, 580.111, 580.112, 580.121, 580.131, 581.217(3)(e), (7), (7)(a), F.S.
Contact:
Patricia Lucas, Bureau Chief, Bureau of Agricultural Environmental Laboratories, 3125 Conner Boulevard, Bldg. 7, Tallahassee, FL 32399; 850-617-7830; patricia.lucas@fdacs.gov
Related Rules: (3)
5E-3.003. Inspection; Sampling; Analysis; Reporting Rejected Feed and Feedstuff; Reduced Sampling Requirements; Laboratory Certification/Exemption Requirements and Fees
5E-3.004. Ingredient Statement
5E-3.005. Labels