[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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