Sec. 4. Infant and toddler food action levels
836 words·~4 min read·
/bill/117/s/1019/is/section-4A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Section 104(b) of the FDA Food Safety Modernization Act ( 21 U.S.C. 2201(b) ) is amended— in the matter preceding paragraph (1), by striking reduce the risk of serious illness or death and inserting reduce the risk of serious illness, including neurological impairment, or death ; and in paragraph (1), by inserting and toxic elements in infant and toddler foods before the semicolon. Section 104 of the FDA Food Safety Modernization Act ( 21 U.S.C. 2201 ) is amended by adding at the end the following:
Beginning not later than 1 year after the date of enactment of the Baby Food Safety Act of 2021 , infant and toddler food is deemed to be adulterated if it meets or exceeds the action level or regulatory limit that is applicable with respect to such food under this subsection. 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 Not later than 2 years after the date of enactment of the Baby Food Safety Act of 2021 , the Secretary shall— review relevant health and dietary data; and 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. The Secretary shall— not later than 3 years after the date of enactment of the Baby Food Safety Act of 2021 , by regulation set regulatory limits lower than the action levels established by paragraphs
(2)and
(3)to levels protective of infant and toddler neurological development, taking into account the most sensitive testing available; and every 5 years thereafter— 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 if so, by regulation so lower such levels. 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. Not later than 1 year, 2 years, and 3 years after the date of enactment of the Baby Food Safety Act of 2021 , the Secretary shall submit a report to the Congress containing— a summary of progress towards establishing the required levels under this subsection; 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 ) compared to levels under this subsection; and an estimate of progress in reducing the cumulative exposure of children to toxic elements in infant and toddler food. . Section 104 of the FDA Food Safety Modernization Act ( 21 U.S.C. 2201(b) ), as amended by subsections
(a)and (b), is further amended by adding at the end the following: In this section, the term infant and toddler food has the meaning given to such term in section 201(ss) of the Federal Food, Drug, and Cosmetic Act. . Section 423(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 350l(a) ) is amended— by striking (other than infant formula) ; and by inserting after animals, the following: 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, . Section 1009 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 399 ) is amended— by redesignating subsection
(h)as subsection (i); and after executing the amendment made by paragraph (1), by inserting after subsection
(g)the following: 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. . Section 401 of the FDA Food Safety Modernization Act ( Public Law 111–353 ; 124 Stat. 3967) is amended by adding the end the following: 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. To carry out this subsection, there is authorized to be appropriated $50,000,000. .
Connectionstraces to 4
2 references not yet in our index
- Pub. L. 111-353
- 124 Stat. 3967
Citation graph
cites case law
Sec. 4
Infant and toddler food action levels
Pub. L.Pub. L. 111-353
Stat.124 Stat. 3967
Cites 6Cited by 0 across 0 sources