[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 1842 Introduced in Senate (IS)]

<DOC>






118th CONGRESS
  1st Session
                                S. 1842

 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

                              June 7, 2023

  Mr. Marshall (for himself, Ms. Baldwin, Mr. Moran, and Mr. Bennet) 
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 2023'' or the ``Innovative FEED Act''.

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)).
                                 <all>