[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)).
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