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Heavy Metal Index

Inorganic Arsenic in Rice Cereals for Infants: Action Level; Guidance for Industry

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Summary The August 2020 FDA Federal Register notice (Docket FDA-2016-D-1099) finalizes the action level for inorganic arsenic in rice cereals for infants at 100 ppb (100 µg iAs/kg, dry weight basis).

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Cited by26 pages
Metals measured1
Evidence tierA
Year2020

Summary

The August 2020 FDA Federal Register notice (Docket FDA-2016-D-1099) finalizes the action level for inorganic arsenic in rice cereals for infants at 100 ppb (100 µg iAs/kg, dry weight basis). This is the first matrix-specific action level under the FDA Closer to Zero program (predating the 2025 lead action levels) and is the operational US federal threshold for inorganic arsenic in this baby-food category. Rice and rice-based infant cereal is the dominant single dietary source of inorganic arsenic for US infants because rice efficiently accumulates iAs from flooded-paddy soils and because rice cereal is often the first solid food introduced to infants.

ParameterValue
Action level100 ppb iAs (100 µg/kg)
MatrixRice cereals for infants (dry, as sold)
IssuedAugust 2020 (final guidance)
DocketFDA-2016-D-1099
Authority21 CFR 109.6(d); FD&C Act § 402(a)(1)
StatusNon-binding guidance; defines threshold at which FDA may regard food as adulterated

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The five most recent substantive edits to this page, classified major (evidence or structure moved), correction (a published value or statement was wrong and has been fixed), or minor (narrative rewritten without changing the underlying evidence). Each description is derived from what the edit did to this page; the linked commit is the authoritative record, routine regeneration passes are excluded, and the full version history lives in git. When DOI minting comes online (see schema docs), each entry below will also link to a version-pinned DataCite DOI.

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a8052bb2026-08-09major3 sections added; narrative text revised