I 118th CONGRESS 1st Session H. R. 6756 IN THE HOUSE OF REPRESENTATIVES December 13, 2023 Mr. Krishnamoorthi (for himself, Mr. Cárdenas , 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.

1. Short title This Act may be cited as the Baby Food Safety Act of 2023 . 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. . 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: 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. . 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. . 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), .