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Dry rice and oat cereals, rice grains, rolled oats and smooth porridge illustrating fda iAs rice cereal 100ppb research context.

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

US FDA guidance sets an inorganic arsenic action level for infant rice cereal. The page covers its scope, analytical approach and regulatory status.

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 inorganic arsenic (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

Works cited in this page’s text, in first-appearance order. See Sources for this page’s source inventory. Each title links to a source record with bibliographic details, reported findings, and document provenance.

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

Update history

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