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.
| Parameter | Value |
|---|---|
| Action level | 100 ppb iAs (100 µg/kg) |
| Matrix | Rice cereals for infants (dry, as sold) |
| Issued | August 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 |