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Heavy Metal Index

FDA Closer to Zero — 100 ppb Inorganic Arsenic Action Level for Infant Rice Cereal

Under the Closer to Zero program, the US Food and Drug Administration has established an action level of 100 parts per billion inorganic arsenic in rice cereals for infants, finalized in the August 2020 Federal Register notice (Docket FDA-2016-D-1099) (FDA iAs 2020).

Overview

Under the Closer to Zero program, the US Food and Drug Administration has established an action level of 100 parts per billion inorganic arsenic in rice cereals for infants, finalized in the August 2020 Federal Register notice (Docket FDA-2016-D-1099) (FDA iAs 2020). This is the first matrix-specific action level under the Closer to Zero program, predating the January 2025 lead action levels (FDA iAs 2020). Rice and rice-based infant cereal is the dominant single dietary source of inorganic arsenic for US infants (FDA iAs 2020).

Rule

ParameterValue
Action level100 ppb iAs (100 µg iAs/kg)
MatrixRice cereals for infants (dry, as sold)
IssuedAugust 6, 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
Analytical methodICP-MS with HPLC speciation (per FDA validated methods)

Parent program

Sources

  • FDA iAs 2020 — FDA, August 2020. Inorganic Arsenic in Rice Cereals for Infants Action Level.

References

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  1. Inorganic Arsenic in Rice Cereals for Infants: Action Level, Guidance for IndustryU.S. Food and Drug Administration · 2020 · www.fda.govGuidance

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