[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6756 Introduced in House (IH)]
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118th CONGRESS
1st Session
H. R. 6756
To amend the Federal Food, Drug, and Cosmetic Act to establish limits
on certain toxic elements in infant and toddler food, and for other
purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
December 13, 2023
Mr. Krishnamoorthi (for himself, Mr. Cardenas, and Mrs. Sykes)
introduced the following bill; which was referred to the Committee on
Energy and Commerce
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to establish limits
on certain toxic elements in infant and toddler food, and for other
purposes.
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 ``Baby Food Safety Act of 2023''.
SEC. 2. DEFINITION OF INFANT AND TODDLER FOOD.
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) The term `infant and toddler food'--
``(1) means foods intended for infants and children less
than two years of age; and
``(2) includes infant formula.''.
SEC. 3. TOXIC ELEMENTS IN INFANT AND TODDLER FOOD.
Chapter IV of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
341 et seq.) is amended by adding at the end the following:
``SEC. 425. TOXIC ELEMENTS IN INFANT AND TODDLER FOOD.
``(a) In General.--The Secretary, by administrative order--
``(1) shall establish limits for lead, cadmium, mercury,
and inorganic arsenic in infant and toddler food; and
``(2) if determined by the Secretary to be appropriate upon
review of relevant health data and other relevant information,
may--
``(A) establish limits for additional toxic
elements in infant and toddler food; and
``(B) revise limits established pursuant to
paragraph (1) or subparagraph (A).
``(b) Procedure.--In establishing or revising any limit under
subsection (a), the Secretary shall--
``(1) evaluate relevant health data and other relevant
information;
``(2) take into account relevant differences among infant
and toddler food types, groups, or categories, as appropriate,
including--
``(A) the feasibility of achieving the limit based
on the food type, group, or category; and
``(B) the extent to which the level of a toxic
element in infant and toddler food is as low as
reasonably achievable; and
``(3) notwithstanding the requirements of subchapter II of
chapter 5 of title 5, United States Code, and chapter 6 of
title 5, United States Code--
``(A) publish any administrative order under
subsection (a) in the Federal Register following--
``(i) publication of a proposed order in
the Federal Register; and
``(ii) consideration of comments to a
public docket open for no fewer than 45
calendar days; and
``(B) set forth in any proposed or final
administrative order under subsection (a) a substantive
summary of the valid scientific evidence concerning the
proposed or final limit.
``(c) Timeframe for Initial Limits.--
``(1) In general.--Subject to the deadlines for final
orders under paragraph (2), the Secretary shall issue orders
for limits under subsection (a) as follows:
``(A) For each of lead, inorganic arsenic, and
cadmium, a proposed order not later than December 31,
2025, and a final order not later than June 30, 2027.
``(B) For mercury, a proposed order not later than
April 30, 2029, and a final order not later than
October 31, 2030.
``(2) Final orders.--The Secretary shall issue each final
administrative order for a limit established pursuant to
subparagraph (a)(1) not later than the earlier of--
``(A) the applicable deadline for a final order
specified in paragraph (1); and
``(B) 18 months after issuance of the respective
proposed order.
``(d) Criteria.--The limits established under this section shall
represent the level at which the toxic element may render the infant
and toddler food injurious to health, taking into account--
``(1) the protection of the public health; and
``(2) the extent to which the level of the toxic element is
as low as reasonably achievable.
``(e) Guidance.--Whenever the Secretary publishes a new or revised
limit for a toxic element under this section, the Secretary shall
publish, together with the administrative order establishing or
revising such limit, guidance concerning compliance with such limit.
``(f) Periodic Review.--The Secretary shall periodically, or as
relevant data is made available, review the limits and guidance
established under this section to consider whether such limits and
guidance should be revised, following the applicable procedures and
criteria under this section.''.
SEC. 4. ADULTERATION.
Section 402 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
342) is amended by adding at the end the following new subsection:
``(j) If it is an article of infant and toddler food in final
product form that bears or contains any toxic element in excess of a
limit established under section 425(a) taking into consideration
variability of the validated method of analysis.''.
SEC. 5. MANDATORY RECALL AUTHORITY.
Section 423(a) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 350l(a)) is amended by inserting after ``animals,'' the
following: ``or if the Secretary determines through any means that an
article of infant and toddler food (other than infant formula) bears or
contains a toxic element that renders the product adulterated under
section 402(a)(1) or 402(j),''.
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