FDA 2016 - Infant/Toddler Foods Inorganic Arsenic

FDA’s 2016 inorganic-arsenic dataset reports sample-level iAs (with paired total arsenic, DMA, and MMA) across product categories commonly eaten by infants and toddlers. The Index routes the dataset’s sample-level subsets to the relevant locked HMTc rows: cereal-rice and multigrain-with-rice samples (n=82 combined) to baby-cereals-dry-rice-based; non-rice infant cereal (n=30, no rice ingredients) to baby-cereals-dry-non-rice; the Juice - Grape category (n=61) to fruit-juices-non-apple as grape-category context and to fruit-juice-not-canned as broader juice context. Per the corrected row-fit rule (CLAUDE.md Part 6), the rice / non-rice cereal subcategorization is exact on both matrix axis (rice-presence) and format axis (dry infant cereal as sold) because FDA’s footnotes 4-6 define each subcategory by ingredient composition.

Structured Extracts

  • data/evidence/category1_fda2016_infant_cereal_ias_samples.csv: sample-level iAs for FDA’s Cereal - Infant/Toddler (rice) (n=76, all rice as only grain), Cereal - Infant/Toddler (multigrain) (n=6, contains rice and other grains), and Cereal - Infant/Toddler (non-rice) (n=30, oats/corn/wheat/multigrain with no rice). Trace TR (x.x) values preserved as reported.
  • data/evidence/category1_fda2016_infant_cereal_ias_summary.csv: per-row p30, p50, p90, p100 for the rice-based and non-rice cereal subcategories under the Part 19 clean/dirty subcategory framework.
  • data/evidence/category5_grape_juice_inorganic_arsenic_samples.csv: sample-level extract for the FDA Juice - Grape rows.
  • data/evidence/category5_grape_juice_inorganic_arsenic_summary.csv: deterministic quantified-cell iAs summary rows for non-apple juice and broader not-canned fruit-juice context.

Key Numbers

Cereal subsets (Category 1)

ScopeFDA categorynmean iAsp30p50p90p100 (max)Source range
Rice-based subcategory pool (rice + multigrain-with-rice)Cereal - Infant/Toddler (rice) + Cereal - Infant/Toddler (multigrain)8297.8 ppb90.62 ppb99.40 ppb124.90 ppb176 ppb20.8 - 176 ppb
FDA rice subset alone (rice as only grain)Cereal - Infant/Toddler (rice)76103.1 ppb94.55 ppb100.50 ppb125.50 ppb176 ppb20.8 - 176 ppb
FDA multigrain subset alone (rice + other grains)Cereal - Infant/Toddler (multigrain)630.1 ppb26.40 ppb26.80 ppb39.20 ppb49.6 ppb22.2 - 49.6 ppb
Non-rice subcategory pool (oats/corn/wheat/multigrain with no rice)Cereal - Infant/Toddler (non-rice)3013.9 ppb7.21 ppb10.35 ppb25.71 ppb68.3 ppb3.5 - 68.3 ppb

Computed values match FDA’s published category averages exactly (rice 103, multigrain 30.0, non-rice 13.9), confirming the sample-level extraction is faithful to the source table. p30, p50, p90, and p100 are computed by linear interpolation between sorted samples; trace TR (x.x) values are preserved as the reported numeric (FDA’s table convention for trace at value x.x).

Juice subset (Category 5)

ScopeSource NQuantified iAs rowsQuantified-cell p50Quantified-cell p90Quantified-cell p95Max
FDA Juice - Grape category615811.2 ppb22.6 ppb25.6 ppb49.6 ppb

FDA’s summary table reports a category average of 12.4 ppb for Juice - Grape. Three full-table rows are NS for inorganic arsenic; the generated percentile summary does not substitute total arsenic for iAs and calculates deterministic nearest-rank percentiles only from the 58 quantified inorganic-arsenic cells.

Evidence Fitness

EF-2 reconstructable A-tier sample-level evidence for the cereal subsets (rice + multigrain-with-rice; non-rice). EF-3 limited/reconstructable for the juice subset (the FDA grape category includes grape juice, white grape juice, grape blends, apple-grape blends, cranberry-grape blends, and one white-grape-peach mixed juice that FDA included in grape calculations).

Limitations

  • The cereal samples were collected during FDA’s 2010-2013 surveys leading to the 2016 report; FDA has issued additional surveys since.
  • Most non-rice infant cereal samples are at trace (TR) levels; the lower-bound percentile treatment retains TR values as numeric per FDA’s convention rather than zeroing them.
  • The Juice - Grape category includes apple-grape and white-grape-peach blends; rows must remain visible in the sample extract and not be silently treated as pure non-apple juice.
  • Total arsenic is paired with iAs in the underlying full-results table but is not substituted for iAs anywhere in the structured extract.

Implications

Certification: Direct A-tier sample-level iAs evidence for the rice-based and non-rice infant cereal subcategories under HMTc Category 1, sufficient to support per-analyte clean/dirty classification per Part 19. Combined with signes-pastor2016-inorganic-arsenic-rice-products-infants (CC-BY peer-reviewed iAs in baby rice and rice cereals; n=29 baby rice + 53 rice cereals), FDA 2016 brings n_a_tier to 2 for iAs in rice-based cereal under the Part 19 readiness bar. Final HMT&C value remains capped by the FDA action level of 100 ppb iAs for infant rice cereal (fda2020-inorganic-arsenic-infant-rice-cereal).

Courses: Strong example for teaching rice-vs-non-rice contamination differentials in infant foods and for the trace-value handling convention in regulatory data tables.

App: Supports rice-cereal vs non-rice-cereal differentiation in the contamination_profile cascade for the rice and non-rice ingredient pages.

Microbiome: No direct microbiome endpoint.

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