FDA 2020 - Supporting document for the inorganic arsenic action level in infant rice cereals

This FDA supporting document gives the public-health and achievability rationale for FDA’s 100 ug/kg (100 ppb) action level for inorganic arsenic in rice cereals for infants. It is the companion rationale document to the FDA guidance page, not a new primary laboratory study. It draws on FDA’s 2016 arsenic-in-rice risk assessment and three infant-rice-cereal surveillance datasets covering 2011-2013, 2014, and 2018.

Key numbers

Final action level:

Infant-rice-cereal surveillance datasets:

Manufacturer achievability at hypothetical iAs limits:

Modeled risk and concentration effects cited from FDA’s 2016 risk assessment:

The document states that the 2011-2013 dataset combined 69 FDA-analyzed samples with 12 samples analyzed by Consumer Reports. The 2014 and 2018 datasets comprised 76 and 149 FDA-analyzed samples, respectively.

Methods

This is a regulatory supporting document. FDA used surveillance data, a risk assessment, and an achievability assessment to support the action level. The risk assessment included a qualitative non-cancer component for pregnancy, infancy, and childhood, and a quantitative lifetime-cancer component for lung and bladder cancer. The dose-response model used Taiwanese drinking-water exposure data for inorganic arsenic and lung/bladder cancer.

The achievability assessment calculated the proportion of infant-rice-cereal samples in each dataset that met modeled limits of 75, 100, 125, and 150 ppb iAs. FDA states that its official method for inorganic arsenic in rice is posted separately.

Speciation and methods caveats

• The supporting document is specific to inorganic arsenic, not total arsenic.
• FDA notes that iAs can represent as little as 12% and up to 100% of total arsenic in rice samples from the 2011-2013 survey. Because tAs and iAs are measured separately with different measurement uncertainty, calculated percentages can exceed 100%.
• The action level is guidance. FDA describes action levels as thresholds that field staff and industry consider when evaluating whether a food may be regarded as adulterated, rather than as a rulemaking tolerance.
• The document does not provide brand-specific contamination values. It aggregates surveillance data by sampling period.

Implications

Standards work: This document is the FDA rationale source for the US 100 ppb iAs action level in infant rice cereals. The achievability tables show both the market state before the final action level and the downward shift in mean, 90th-percentile, and maximum iAs concentrations through 2018.

Courses: The document is useful for teaching the difference between risk assessment and achievability assessment, and the difference between an FDA action level and a formal tolerance.

App: The 2018 dataset provides a recent FDA surveillance context for US-market infant rice cereal iAs in this source: mean 85 ppb, 90th percentile 107 ppb, and range 22-142 ppb.

Wiki pages updated on ingest

• arsenic-inorganic
• rice
• rice-cereal
• baby-cereals-dry-rice-based
• fda-iAs-rice-cereal-100ppb
• fda-closer-to-zero

Verification notes

• Merge-enhanced 2026-05-18 from the full manual-fetch PDF path and SHA-256 recorded in frontmatter.
• Fresh-context audit (Codex, 2026-05-18) caught a stale source-page link in the taxonomy-style page-touch list; removed it because source-page cross-references are not part of the ingredient/product/metal/regulation vocabulary.
• Replaced the older invalid regulation link fda-ctz-iAs-cereal-100ppb with the live regulation page fda-iAs-rice-cereal-100ppb.
• Replaced older certification-limit language with source-only implications for standards work, courses, and app context.
• Strict brand-firewall check: the source references 12 Consumer Reports samples as part of the 2011-2013 dataset, but this page does not report any brand-specific values or rankings.

Page history

The five most recent substantive edits to this page. 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.