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Adds a new subsection (n) to 21 U.S.C. 350a establishing environmental monitoring requirements for powdered infant formula to detect Cronobacter spp. and Salmonella, including program elements, sampling location/number, timing/frequency, records access and retention, inspector access, and a delayed applicability provision.
Amends subsection (a) of 21 U.S.C. 350l by inserting additional text after an unspecified point (the section text does not provide the inserted language or exact insertion point).
Adds a new subsection (j) to 21 U.S.C. 342 (Section 402 of the Federal Food, Drug, and Cosmetic Act) that deems an article of food adulterated when the owner, operator, or agent in charge of the food facility that manufactures or processes the food is subject to the requirements of section 425 and fails to comply with those requirements with regard to that article.
Amends 21 U.S.C. 374(a)(4) by (1) redesignating existing subparagraphs (B)-(D) as (C)-(E); (2) inserting a new subparagraph (B) that authorizes the Secretary to request records or other information in advance of or in lieu of an inspection (to be provided within a reasonable timeframe, within reasonable limits, and in a reasonable manner, in electronic or physical form, at the expense of the person) and lists covered activities; and (3) adding subparagraph (F) clarifying that section 703 does not apply to requests made under this new subparagraph.
Adds a new section 425 to Chapter IV of the Federal Food, Drug, and Cosmetic Act establishing mandatory sampling and testing for contaminants in foods (including infant and toddler foods), requirements for written sampling plans, required contaminants to be tested, minimum testing frequency, recordkeeping retention and content requirements, laboratory accreditation requirements, records availability to the Secretary, and a delayed applicability tied to issuance of guidance.
Adds a new paragraph (tt) to Section 201 (21 U.S.C. 321) defining the term 'infant and toddler food'.
Sets new food safety rules to better protect babies and toddlers. It defines “infant and toddler food” (up to 24 months, including infant formula), requires food makers to test finished products for contaminants, speeds up reporting of positive pathogen tests in infant formula, and mandates environmental monitoring in powdered formula plants. FDA must issue guidance on the new testing program within 18 months; routine product testing would begin 180 days after that guidance. FDA also gains clearer authority to request records before inspections. Manufacturers must alert FDA within 24 hours of certain positive tests in infant formula and take corrective actions the agency confirms within 90 days.
Adds subsection (tt) to Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) to define the term "infant and toddler food" as: "food which purports to be or is represented as food for children up to 24 months of age, including infant formula."
Owners, operators, or agents in charge of food facilities that manufacture or process food (including infant and toddler food) in final product form intended for sale must collect representative samples of each such food and conduct testing of those samples for contaminants, including toxic elements.
The owner, operator, or agent in charge must prepare a written sampling plan for all required sampling and testing and ensure all sampling and testing is conducted according to that plan.
A facility’s sampling plan must identify the number of sampling units and sample unit size (based on appropriate criteria to represent contaminant levels) and identify one or more appropriate test methods and procedures to analyze samples.
The Secretary must issue guidance to help food facilities develop sampling plans not later than 18 months after the date of enactment; the guidance may address when samples should be tested for specific species of contaminants.
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Referred to the House Committee on Energy and Commerce.
Introduced March 27, 2025 by Emilia Strong Sykes · Last progress March 27, 2025
Referred to the House Committee on Energy and Commerce.
Introduced in House