Sec. 3. Contaminants in food, including infant and toddler food
1,812 words·~8 min read·
/bill/118/hr/8385/ih/section-3A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
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: Within the applicable timeframe specified in paragraph (4), the Secretary, by administrative order— shall establish limits on— lead, cadmium, mercury, and total arsenic in infant and toddler food; lead, cadmium, mercury, and total arsenic in food pouches made with fruit or vegetable puree or juice; and lead and arsenic in juice; and if the Secretary determines appropriate upon review of relevant health data and other relevant available information, may— establish limits for additional contaminants in infant and toddler food; establish limits for additional contaminants in juice; establish limits for additional contaminants in food pouches made with fruit or vegetable puree or juice; and revise limits established pursuant to subparagraph (A).
In establishing or revising any limit under paragraph (1), the Secretary shall— evaluate relevant health data and other information the Secretary considers relevant; take into account relevant differences among food types, groups, and categories, as appropriate, including the extent to which the presence of a contaminant cannot be avoided; and notwithstanding the requirements of subchapter II of chapter 5 of title 5, United States Code, and chapter 6 of title 5, United States Code— publish any administrative order under paragraph
(1)in the Federal Register following— publication of a proposed order in the Federal Register; and consideration of comments to a public docket open for not fewer than 45 calendar days; and set forth in any proposed or final administrative order under paragraph
(1)a substantive summary of the valid scientific evidence concerning the proposed or final limit. If the Secretary determines appropriate after review of relevant data and available health information, the Secretary may revise any limit established under this subsection by administrative order published in the Federal Register in accordance with paragraph (2)(C). Subject to the requirements of paragraph (2)(C), the Secretary shall issue proposed orders for limits under paragraph (1)(A) as follows: For lead, not later than December 31, 2025. For total arsenic, not later than December 31, 2025. For cadmium, not later than April 30, 2026. For mercury, not later than April 30, 2028. The Secretary shall issue each final administrative order for a limit established pursuant to paragraph (1)(A) not later than the earlier of— the applicable deadline for a final order specified in paragraph (1); or 18 months after issuance of the respective proposed order. The limits established under this section shall represent the level at which the Secretary finds necessary for the protection of public health. In determining such limits the Secretary shall take into account the extent to which the use of such substance is required or cannot be avoided in the production of each such article, and the other ways in which a consumer may be affected by the same or other contaminants, taking into consideration relevant information and data that has been made available. A food may be determined adulterated, at the final product stage, under section 402(j), if such food bears or contains any contaminant in excess of a limit established under this subsection when considering variability of the validated method of analysis. The Secretary shall periodically review the limits established under this subsection, taking into consideration relevant information and available data to consider whether such limits should be revised, following the procedure described in paragraph (2), in accordance with the criteria specified in paragraph (5). Beginning not later than 180 days after the date of enactment of the Baby Food Safety Act of 2024 , the owner, operator, or agent in charge of a facility engaged in manufacturing or processing infant and toddler food, food pouches made with fruit or vegetable puree or juice, or juice for consumption in the United States shall— have a control program pursuant to section 418 in place for contaminants subject to ordered limits under subsection (a), or be in compliance with the Juice Hazard Analysis Critical Control Points Program of the Food and Drug Administration, as applicable; be in compliance with regulations promulgated under section 420(b); collect representative samples of each such food in final product form in accordance with a sampling plan described in paragraph (2); and conduct testing of the samples collected from the final food product for contaminants, in accordance with such sampling plan. The owner, operator, or agent in charge of a facility described in paragraph
(1)shall— prepare a written sampling plan for all sampling and testing required under this subsection; and ensure that all sampling and testing conducted under this subsection is conducted in accordance with the sampling plan. A sampling plan required by subparagraph
(A)shall identify— the number of sampling units and sample unit size based upon appropriate criteria for identifying, in a representative fashion, the levels of contaminants in each food; and one or more appropriate test methods and procedures to be used to analyze the samples. Not later than 18 months after the date of enactment of the Baby Food Safety Act of 2024 , the Secretary shall issue guidance to assist facilities described under paragraph
(1)with developing sampling plans. Such guidance may, as the Secretary determines appropriate, address when samples should be tested for specific species of contaminants. In carrying out the sampling and testing under this subsection, the owner, operator, or agent in charge of a facility described in paragraph
(1)shall ensure that each sample is tested for levels of— lead, cadmium, mercury, and total arsenic; and any other contaminant that the Secretary may specify by regulation, and in accordance with the sampling plan under paragraph (2). The sampling and testing conducted under this subsection shall be conducted for— infant and toddler foods, in final product form; pouches made with fruit and vegetable puree or juice; juice; and such other foods in final product form as the Secretary may specify, by regulation, as appropriate to protect the public health. The owner, operator, or agent in charge of a facility described in paragraph
(1)shall maintain, for not less than 2 years or the shelf-life of each food product manufactured or processed by the facility, whichever is longer, records documenting the sampling plan and results of testing conducted under this subsection with respect to the food. The owner, operator, or agent in charge of such a facility shall make such records available for inspection by the Secretary upon request by the Secretary. The records maintained as required under subparagraph
(A)shall include— a detailed description of the foods sampled and tested; the number of samples and tests performed; the size and number of items in each sample unit; a copy of the sampling plan required under paragraph (2); identification of the entity conducting the sampling; identification of the entity conducting the testing; and identification of the analytical methods used to perform the sampling and testing. The requirements of this paragraph shall apply to all records of sampling and testing conducted pursuant to this subsection, regardless of the findings. The owner, operator, or agent in charge of a facility described in paragraph
(1)shall ensure that testing required pursuant to this subsection is performed in accordance with international standards by a laboratory that is accredited by an accreditation body that conforms to international accreditation standards. Testing conducted under this subsection is not subject to the requirements regarding laboratory accreditation described in section 422. The Secretary shall develop and implement a sampling and testing program for infant and toddler food for sale to consumers that is sufficient to— support the periodic review under subsection (a)(7) of limits on lead, cadmium, mercury, and arsenic in infant and toddler food; and independently verify the effectiveness of the sampling and testing conducted pursuant to this subsection by the owner, operator, or agent in charge of a food facility. The Secretary shall issue guidance to assist food facilities in complying with this subsection. Upon request by the Secretary, the owner, operator, or agent in charge of a facility described in subsection (b)(1) shall— make all records required under this section available promptly to the Secretary for inspection and copying; and provide within a reasonable time an English translation of such records maintained in a language other than English. Any records that the Secretary may inspect under this section shall, upon the request of the Secretary, be provided to the Secretary by the owner, operator, or agent in charge of a facility described in subsection (b)(1), in advance of or in lieu of an inspection, within a reasonable timeframe, within reasonable limits, and in a reasonable manner, and in either electronic or physical form, at the expense of such owner, operator, or agent. The Secretary’s request shall include a sufficient description of the records requested. Upon receipt of records requested under paragraph
(1)or (2), the Secretary shall provide to the owner, operator, or agent described in paragraph
(2)confirmation of the receipt. Nothing in this subsection supplants the authority of the Secretary to conduct sampling, testing, or inspections otherwise permitted under this Act in order to ensure compliance with this Act. The requirements for sampling and testing under this section shall apply beginning on the date that is 2 years after the date of enactment of this subsection. No State or political subdivision of a State may establish or continue in effect with respect to contaminants in food, including infant and toddler food, food pouches made with fruit or vegetable puree or juice, and juice, any requirement that is different from, or in addition to, or not identical with any requirement under this section, and relates to contaminant sampling and testing, contaminant limits, disclosure of contaminant test results, contaminant labeling, contaminant warnings, or any other matter related to contaminants in food. . Section 805(c)(4) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 384a(c)(4) ) is amended, by inserting , including as described in section 425(b) before the period at the end. Section 402 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 342 ) is amended by adding at the end the following: If it is an article of food in final product form that is an infant and toddler food, a food pouch made with fruit or vegetable puree or juice, or juice and— such food bears or contains any contaminant in excess of limits established under section 425(a); or the owner, operator, or agent in charge of a facility that manufactures or processes the food is not in compliance with subsection
(b)or
(c)of section 425. . Section 301 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331 ) is amended by adding at the end the following: The failure of an owner, operator, or agent in charge of a facility that manufactures or processes food to comply with applicable requirements under subsection
(b)or
(c)of section 425. .
Connectionstraces to 4
Citation graph
cites case law
Sec. 3
Contaminants in food, including infant and toddler food
Cites 4Cited by 0 across 0 sources