FDA 2018 — Inorganic arsenic in infant rice cereals (FY2018 assignment, n=149)
This FDA FY2018 assignment collected and analyzed 149 infant and infant/toddler rice cereal samples (all rice-only grain) for total arsenic, inorganic arsenic (iAs), DMA, and MMA, by speciation ICP-MS. The mean iAs across all 149 samples was 85 ppb (µg/kg), with a range of 22–142 ppb — all below FDA’s proposed action level of 100 ppb iAs. The data were collected to assess the extent to which manufacturers could meet the proposed action level through good manufacturing practices (GMPs) such as supplier controls. This dataset is one of FDA’s primary empirical foundations for the 100 ppb iAs action level for infant rice cereals.
Key numbers
- Total samples: n = 149; all products contained rice as the only grain (“all samples contain rice as the only grain”)
- Product types in dataset: Infant Rice Cereal (conventional and organic), Infant Brown Rice Cereal (conventional and organic), Infant Rice & Banana Apple Cereal, Infant Brown Rice Cereal (Organic)
- Summary statistics: mean iAs 85 ppb; range 22–142 ppb (per summary table at head of document)
- All 149 samples fell below the proposed FDA action level of 100 ppb iAs for infant rice cereals
- Sample-level data (selected examples from full analytical table, dry weight as-purchased, speciation by ICP-MS):
- Infant Brown Rice Cereal: total As 128 ppb, iAs 115 ppb, DMA 20.2 ppb, MMA 1.6 ppb
- Infant Rice Cereal: total As 135 ppb, iAs 99.5 ppb, DMA 39.3 ppb, MMA 1.9 ppb
- Infant Rice Cereal (Organic): total As 139 ppb, iAs 108 ppb, DMA 16.8 ppb, MMA <LOD
- Infant Rice Cereal (Organic): total As 74.1 ppb, iAs 47.4 ppb, DMA 20.9 ppb
- Infant Rice Cereal: range iAs observed across samples: 22.4 ppb (minimum in this dataset, Brown Rice Organic) to 142 ppb (Brown Rice Organic, total As 167)
- Serving size: 15 g for all sample descriptions listed
- iAs per serving (from column in dataset): range 0.3–2.1 µg/serving based on 15 g serving
- Highest single-sample iAs: 142 ppb (Infant Brown Rice Cereal, Organic; total As 167 ppb)
- Highest single-sample total As: 348 ppb (Infant Rice Cereal; iAs 102 ppb — notably low iAs fraction despite very high tAs, suggesting high organic arsenic)
- Brown rice products tend toward higher tAs than white rice products, though iAs ranges overlap
- Organic vs. conventional: no systematic difference in iAs visible from the data table
Methods (brief)
FDA FY2018 Arsenic in Infant Rice Cereals Assignment. Analytical method: speciation ICP-MS separating As(III), As(V) (reported as iAs sum), DMA, and MMA. Footnote in document states iAs = sum of As(III) and As(V) as these are the most common oxidation states; adding both values provides a reliable estimate of total inorganic arsenic. Units: ppb = parts per billion = µg/kg. Data purpose: GMPs compliance assessment for proposed 100 ppb action level.
Limitations
Samples sourced under an assignment targeting GMP compliance assessment, not random market surveillance — sample selection may skew toward products where manufacturers had already implemented supplier controls. Product descriptions do not include brand names. No country-of-origin for the rice ingredient is provided. No wet-weight vs. dry-weight basis specified in the document header, but context (dry infant cereal) implies as-purchased (dry) basis. Serving size 15 g is standard FDA reference for this category.
Implications
- Certification: This is the primary FDA dataset supporting the 100 ppb iAs action level for infant rice cereals. The mean of 85 ppb and range of 22–142 ppb with all samples below 100 ppb demonstrates feasibility of meeting the proposed action level through GMP supplier controls. HMT&C limits for infant-grade rice cereal products should reference this dataset when calibrating stringency.
- Courses: Canonical FDA dataset for teaching. The fact that all 149 samples fell below 100 ppb after manufacturers implemented supplier controls is a concrete demonstration that sourcing decisions drive compliance.
- App: Mean 85 ppb iAs (dry weight, as-purchased) for US market infant rice cereals is the anchor value for this product-matrix combination. Brown rice cereals show higher tAs than white rice but comparable iAs range, reinforcing the importance of iAs speciation over total arsenic for this matrix.
- Microbiome: Not primary topic.