Baby Food Safety Act of 2021

To amend the Federal Food, Drug, and Cosmetic Act to limit the presence of toxic elements in, and otherwise regulate, infant and toddler food, and for other purposes. 1. Short title This Act may be cited as the Baby Food Safety Act of 2021 2. Definition of infant and toddler food Section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 (ss) The term infant and toddler food . 3. Infant and toddler food hazard analysis and risk-based preventive controls (a) Preventive controls Section 418(c) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 350g(c) (1) in paragraph (2), by striking and (2) in paragraph (3), by striking the period at the end and inserting ; and (3) by adding at the end the following: (4) the infant and toddler foods manufactured, processed, packed, or held by such facility will comply with the performance standards and action levels for toxic elements in infant and toddler foods required under section 104 of the FDA Food Safety Modernization Act. . (b) Verification Paragraph (4) of section 418(f) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 350g(f) (4) the preventive controls implemented under subsection (c) are effectively and significantly minimizing or preventing the occurrence of identified hazards, including through the use of environmental and product testing programs and other appropriate means, including representative testing by manufacturers of infant and toddler foods that are finished products; and . (c) Biannual reporting Section 418(h) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 350g(h) The owner, operator, or agent in charge of a facility that manufactures infant and toddler foods shall make publicly available on a webpage a biannual report summarizing the results of monitoring under subsection (d), and verification results under subsection (f), with respect to such facility and infant and toddler foods. 4. Infant and toddler food action levels (a) Performance standard guidance documents and regulations Section 104(b) of the FDA Food Safety Modernization Act ( 21 U.S.C. 2201(b) (1) in the matter preceding paragraph (1), by striking reduce the risk of serious illness or death reduce the risk of serious illness, including neurological impairment, or death (2) in paragraph (1), by inserting and toxic elements in infant and toddler foods (b) Action levels Section 104 of the FDA Food Safety Modernization Act ( 21 U.S.C. 2201 (e) Action levels (1) In general Beginning not later than 1 year after the date of enactment of the Baby Food Safety Act of 2021 (2) Initial levels The initial action levels under this subsection are the following: Toxic Element Action Level Inorganic arsenic 10 ppb for infant and toddler food (except cereal) and 15 ppb for infant and toddler food that is cereal Cadmium 5 ppb for infant and toddler food (except cereal) and 10 ppb for infant and toddler food that is cereal Lead 5 ppb for infant and toddler food (except cereal) and 10 ppb for infant and toddler food that is cereal Mercury 2 ppb (3) Interim action levels Not later than 2 years after the date of enactment of the Baby Food Safety Act of 2021 (A) review relevant health and dietary data; and (B) by guidance, lower the initial action levels established by paragraph (2) to further minimize exposure to toxic elements in infant and toddler food to further reduce potential clinical or population-level health effects as indicated by the Secretary’s review of relevant health and dietary data. (4) Final regulatory limits; periodic review The Secretary shall— (A) not later than 3 years after the date of enactment of the Baby Food Safety Act of 2021 (B) every 5 years thereafter— (i) review the levels established under this subsection to consider whether such levels should be lowered further consistent with the standard described in subparagraph (A); and (ii) if so, by regulation so lower such levels. (5) Toxic elements The Secretary may by guidance or regulation, as applicable, establish interim action levels and regulatory limits for toxic elements in infant and toddler food in addition to the toxic elements specified in the table in paragraph (2) if determined by the Secretary to be appropriate upon review of relevant health and dietary data. (6) Progress reports Not later than 1 year, 2 years, and 3 years after the date of enactment of the Baby Food Safety Act of 2021 (A) a summary of progress towards establishing the required levels under this subsection; (B) an evaluation of the effectiveness of preventive controls for infant and toddler food based on monitoring results and verification results under section 418 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 350g (C) an estimate of progress in reducing the cumulative exposure of children to toxic elements in infant and toddler food. . (c) Definition Section 104 of the FDA Food Safety Modernization Act ( 21 U.S.C. 2201(b) (f) Infant and toddler food defined In this section, the term infant and toddler food . (d) Mandatory recall authority Section 423(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 350l(a) (1) by striking (other than infant formula) (2) by inserting after animals, or the Secretary determines that an article of infant and toddler food contains a toxic element that meets or exceeds the action level applicable under subsection (e) of section 104 of the FDA Food Safety Modernization Act, (e) Public awareness campaign Section 1009 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 399 (1) by redesignating subsection (h) as subsection (i); and (2) after executing the amendment made by paragraph (1), by inserting after subsection (g) the following: (h) Baby food public awareness campaign The Secretary, acting through the Director of the Centers for Disease Control, shall carry out a public awareness campaign to highlight the risks posed by toxic elements in infant and toddler food and make recommendations to the public with respect to such toxic elements and food. . (f) Grants for farming research Section 401 of the FDA Food Safety Modernization Act ( Public Law 111–353 (c) Grants for farming research (1) In general The Commissioner of Food and Drugs shall commission the National Academy of Sciences (or, if the National Academy declines, another appropriate entity) to conduct research on agricultural methods of minimizing levels of toxic heavy metals in crops. (2) Authorization of appropriations To carry out this subsection, there is authorized to be appropriated $50,000,000. .

Summary: Baby Food Safety Act of 2021 This bill imposes certain safety requirements on infant and toddler food. The bill establishes maximum levels of certain toxic elements (cadmium, and lead, mercury, and inorganic arsenic) allowable in infant and toddler food, defined as food intended to be sold for children up to 36 months old. The Food and Drug Administration (FDA) shall periodically review and, if necessary, further lower these levels. The FDA may also establish limits on other toxic elements upon review of relevant health and dietary data. Furthermore, facilities that manufacture, process, pack, or hold infant and toddler food must have certain controls and plans to ensure that their food complies with the limits on toxic elements established by this bill. Such facilities shall also make publicly available certain information, including results from tests for toxic elements in their infant and toddler foods. The bill also expands the FDA's authority to require a recall of adulterated or misbranded food to include infant and toddler food that exceeds limits on toxic elements. The Centers for Disease Control shall carry out a public awareness campaign about the risks of toxic elements in infant and toddler food. The FDA shall commission research on agricultural methods that minimize levels of toxic heavy metals in crops.