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). 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
| Parameter | Value |
|---|---|
| Action level | 100 ppb iAs (100 µg iAs/kg) |
| Matrix | Rice cereals for infants (dry, as sold) |
| Issued | August 6, 2020 (final guidance) |
| Docket | FDA-2016-D-1099 |
| Authority | 21 CFR 109.6(d); FD&C Act § 402(a)(1) |
| Status | Non-binding guidance; defines threshold at which FDA may regard food as adulterated |
| Analytical method | ICP-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.