119-s1906

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 1906 Introduced in Senate

    (IS) ]

<DOC>

119th CONGRESS
 1st Session
 S. 1906

 To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
 regulation of zootechnical animal food substances.

_______________________________________________________________________

 IN THE SENATE OF THE UNITED STATES

 May 22, 2025

 Mr. Marshall (for himself, Ms. Baldwin, Mr. Moran, Mr. Bennet, Mr. 
 Grassley, Mr. King, and Ms. Klobuchar) introduced the following bill; 
 which was read twice and referred to the Committee on Agriculture, 
 Nutrition, and Forestry

_______________________________________________________________________

 A BILL

 To amend the Federal Food, Drug, and Cosmetic Act with respect to the 
 regulation of zootechnical animal food substances.

 Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

 This Act may be cited as the ``Innovative Feed Enhancement and 
Economic Development Act of 2025'' or the ``Innovative FEED Act of 
2025''.

SEC. 2. REGULATION OF ZOOTECHNICAL ANIMAL FOOD SUBSTANCES.

    (a) 

=== Definition. ===
-

Section 201 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321) is amended by adding at the end the 
following:
 ``

    (tt)

    (1) The term `zootechnical animal food substance' means a 
substance that--
 ``
        (A) is added to the food or drinking water of animals;
 ``
        (B) is intended to--
 ``
            (i) affect the byproducts of the digestive 
 process of an animal;
 ``
            (ii) reduce the presence of foodborne pathogens 
 of human health significance in an animal intended to 
 be used for food; or
 ``
            (iii) affect the structure or function of the 
 body of the animal, other than by providing nutritive 
 value, by altering the animal's gastrointestinal 
 microbiome; and
 ``
            (C) achieves its intended effect by acting solely within 
 the gastrointestinal tract of the animal.
 ``

    (2) Such term does not include a substance that--
 ``
        (A) is intended for use in the diagnosis, cure, 
 mitigation, treatment, or prevention of disease in an animal;
 ``
        (B) is a hormone;
 ``
            (C) is an active moiety in an animal drug, which, prior 
 to the filing of a petition under 

section 409, was approved 
 under 

section 512, conditionally approved under 

section 571, 
 indexed under 

section 572, or for which substantial clinical 
 investigations have been instituted and for which the existence 
 of such investigations has been made public;
 ``
            (D) is an ionophore; or
 ``
        (E) is otherwise excluded from the definition based on 
 criteria established by the Secretary through notice and 
 comment rulemaking.
 ``

    (3) A zootechnical animal food substance shall be deemed to be a 
food additive within the meaning of paragraph

    (s) and its introduction 
into interstate commerce shall be in accordance with a regulation 
issued under 

section 409. A zootechnical animal food substance shall 
not be considered a drug under paragraph

    (g)

    (1)
            (C) solely because the 
substance has an intended effect described in subparagraph

    (1) .''.

    (b) Food Additives.--

Section 409 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 348) is amended--

    (1) in subsection

    (b) --
        (A) by redesignating paragraphs

    (3) through

    (5) as 
 paragraphs

    (4) through

    (6) , respectively; and
        (B) by inserting after paragraph

    (2) the following:
 ``

    (3) In the case of a zootechnical animal food substance, such 
petition shall, in addition to any explanatory or supporting data, 
contain--
 ``
        (A) all relevant data bearing on the effect the 
 zootechnical animal food substance is intended to have and the 
 quantity of such substance required to produce the intended 
 effect; and
 ``
        (B) full reports of investigations made with respect to 
 the intended use of such substance, including full information 
 as to the methods and controls used in conducting such 
 investigations.'';

    (2) in subsection
            (c) --
        (A) by amending subparagraph
        (A) of paragraph

    (1) to read as follows:
 ``
        (A)
            (i) by order establish a regulation (whether or not in 
 accord with that proposed by the petitioner) prescribing--
 ``
            (I) with respect to one or more proposed uses of 
 the food additive involved, the conditions under which 
 such additive may be safely used (including 
 specifications as to the particular food or classes of 
 food in or on which such additive may be used, the 
 maximum quantity which may be used or permitted to 
 remain in or on such food, the manner in which such 
 additive may be added to or used in or on such food, 
 and any directions or other labeling or packaging 
 requirements for such additive as the Secretary 
 determines necessary to assure the safety of such use); 
 and
 ``
            (II) in the case of a zootechnical animal food 
 substance, the conditions under which such substance 
 may be used to achieve the intended effect; and
 ``
            (ii) notify the petitioner of such order and the reasons 
 for such action; or''; and
        (B) in paragraph

    (3) --
            (i) in subparagraph
        (A) , by striking ``; 
 or'' and inserting a semicolon;
            (ii) in subparagraph
        (B) , by striking the 
 period and inserting ``; or''; and
            (iii) by adding at the end the following:
 ``
            (C) in the case of a zootechnical animal food substance, 
 fails to establish that the proposed use of the substance, 
 under the conditions of use to be specified in the regulation, 
 will achieve the intended effect.''; and

    (3) by adding at the end the following:
 ``
            (l) Zootechnical Animal Food Substances.--The labeling of a 
zootechnical animal food substance--
 ``

    (1) shall include the statement: `Not for use in the 
 diagnosis, cure, mitigation, treatment, or prevention of 
 disease in animals.'; and
 ``

    (2) may include statements regarding the intended effect 
 of the substance on the structure or function of the body of 
 animals, as set forth in 

section 201

    (tt)

    (1) .''.
            (c) Misbranded Food.--

Section 403 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 343) is amended by adding at the end the 
following:
 ``

    (z) If it is a zootechnical animal food substance and the 
labeling of the food does not include the statement required by 

section 409
            (l) (1) .''.
            (d) Rule of Construction.--Nothing in this section, or the 
amendments made by this section, shall be construed to authorize the 
Secretary of Health and Human Services to require the use of any 
zootechnical food substance or food additive (as those terms are 
defined in 

section 201 of the Federal Food, Drug, and Cosmetic Act, as 
amended by subsection

    (a) ).
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