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FDA 2020 — Inorganic Arsenic in Rice Cereals for Infants Action Level (100 ppb)

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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