[Congressional Record Volume 170, Number 75 (Wednesday, May 1, 2024)]
[Senate]
[Pages S3288-S3289]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

  SA 1937. Mr. MARSHALL submitted an amendment intended to be proposed 
to amendment SA 1911 submitted by Ms. Cantwell (for herself, Mr. Cruz, 
Ms. Duckworth, and Mr. Moran) and intended to be proposed to the bill 
H.R. 3935, to amend title 49, United States Code, to reauthorize and 
improve the Federal Aviation Administration and other civil aviation 
programs, and for other purposes; which was ordered to lie on the 
table; as follows:

       At the appropriate place, insert the following:

     SEC. __. 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--

[[Page S3289]]

       ``(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)).
                                 ______