Clinical Pharmacist and Master’s student in Clinical Pharmacy with research interests in pharmacovigilance, behavioral interventions in mental health, and AI applications in clinical decision support. Experience includes digital health research with Bloomsbury Health (London) and pharmacovigilance practice in patient support programs. Published work covers drug awareness among healthcare providers, postpartum depression management, and patient safety reporting. 
Clinical Pharmacist and Master’s student in Clinical Pharmacy with research interests in pharmacovigilance, behavioral interventions in mental health, and AI applications in clinical decision support. Experience includes digital health research with Bloomsbury Health (London) and pharmacovigilance practice in patient support programs. Published work covers drug awareness among healthcare providers, postpartum depression management, and patient safety reporting. What was reviewed?
This FDA supporting document reviews the scientific and regulatory basis for establishing an inorganic arsenic action level for infant rice cereals, synthesizing toxicology, exposure, risk modeling, market sampling, and achievability analyses. It explains why a 100 µg/kg (100 ppb) action level protects infant health and how industry can feasibly meet it through current good manufacturing practices, especially selective sourcing and ingredient testing. The document consolidates FDA risk assessment outputs, trend data from 2011–2013, 2014, and 2018 surveillance, and policy rationale tied to action levels as enforcement guidance under the FD&C Act. It concludes that a 100 ppb level is both health-protective and achievable across white- and brown-rice infant cereals.
Who was reviewed?
The review focuses on infants and young children as the most susceptible population due to higher food intake per body weight and potential neurodevelopmental vulnerability, and on U.S. infant rice cereal manufacturers whose products are a major dietary source of inorganic arsenic for infants. It leverages the FDA’s Total Diet Study and targeted sampling of infant rice cereals to characterize exposure distributions and examines manufacturer performance against hypothetical limits over time to assess achievability. The scope spans all infant rice cereals, white, brown, organic, and conventional, and situates action levels as guidance informing adulteration decisions by FDA field staff.
Most important findings
| Critical point | Details |
|---|---|
| Action level set at 100 ppb | FDA establishes a 100 µg/kg action level for inorganic arsenic in infant rice cereals to reduce exposure while remaining achievable with current practices. Applies across white, brown, organic, and conventional products. |
| Health basis prioritizes neurodevelopment | Systematic review up to Feb 2015 highlights neurodevelopmental toxicity concerns in infants/young children; reducing iAs in cereals is expected to lower such risks. |
| Cancer risk modeling | Dose-response modeling (Taiwan drinking-water data) indicates lifetime lung/bladder cancer risk increases from iAs in rice; a 100 ppb limit reduces lifetime cancer risk by 37% (brown-rice cereals) and 18.8% (white-rice cereals). |
| Exposure reductions with 100 ppb | Modeling removal of products above 100 ppb lowers mean iAs in brown-rice cereals from 119.0 to 79.0 ppb and white-rice cereals from 103.9 to 83.5 ppb, decreasing infant exposure. |
| Achievability improved over time | % of infant cereals meeting 100 ppb rose from 36% (2011–2013) to 47% (2014) and 76% (2018), demonstrating market feasibility through selective sourcing/testing. |
| Declining concentration trends | Mean iAs levels fell from 116.7 ppb (2011–2013) to 103.1 ppb (2014) to 85 ppb (2018), with lower 90th percentiles and maxima over time. |
| Infant vulnerability and exposure | FDA underscores selective sourcing of lower-IAs rice and routine testing of incoming rice/derivatives as primary levers to meet the action level. |
| Manufacturing controls | FDA underscores selective sourcing of lower-IAs rice and routine testing of incoming rice/derivatives as primary levers to meet the action level. |
| Regulatory meaning of action levels | Action levels are FDA guidance that can define contamination levels at which a food may be regarded as adulterated under FD&C §402(a)(1). |
| Breadth of applicability | The action level and rationale encompass all infant rice cereals irrespective of grain type or production method. |
Key implications
For regulators, the 100 ppb inorganic arsenic action level standardizes enforcement decisions and aligns risk reduction with feasibility; for HTMC certification, routine lot-level iAs testing, validated methods, and supplier qualification become baseline requirements; for industry, selective sourcing and verification testing operationalize compliance; research gaps include quantifying non-cancer neurodevelopmental benefits and refining infant intake distributions; practical recommendations include supplier mapping by regional iAs profiles, batch release specifications at ≤100 ppb with safety margins, and continuous surveillance to document downward trends and maintain certification.
Citation
U.S. Food and Drug Administration. Supporting Document for Action Level for Inorganic Arsenic in Rice Cereals for Infants. August 2020.
