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Heavy Metal Index

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

Regulation

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).

Page snapshot
Referenced by30 pages
JurisdictionUS
MetaliAs
Effective2020-08-06

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

Works cited in this page’s text, in first-appearance order. This is not the full corpus for this page; it is only what the prose above draws on. The complete set of sources is listed under Sources below. Each title links to its source record, which carries the ingest receipt, the extracted values, and the file hash of the document it was built from.

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

Update history

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.

CommitDateChangeDescription
a8052bb2026-08-09major1 source added; contamination-profile values revised; 6 sections added