RESUMEN
Recently, the U.S. House of Representatives reported on the presence of heavy metals in raw ingredients used in baby foods and in finished baby food products themselves. In light of these concerns, this study aimed to evaluate potential risks associated with the presence of heavy metals in baby food products. We analyzed 36 baby food samples representing four ingredient categories (fruit; leguminous vegetable; root vegetable; or grain) for arsenic (As), cadmium (Cd), mercury (Hg), and lead (Pb). We assessed the potential lifetime cancer and non-cancer health risks posed to infants and toddlers following daily consumption of these chemicals in each food type, based on established daily food-specific ingestion rates. Daily doses were compared against selected reference values and oral slope factors to determine non-cancer hazard indices (HIs) and lifetime cancer risks. Hazard indices indicated a potential for non-cancer risk (e.g., HIs > 1.0) under only a few exposure scenarios, including for As and Pb under selected product type and age/concentration assumptions. Increases in lifetime cancer risks for all analytes across the ingredient categories evaluated ranged from 3.75 × 10-5 to 5.54 × 10-5; cancer risks were primarily driven by As from grain products. Though a limited set of exposure scenarios indicated a potential for health risk, the exposure assumptions in this assessment were conservative, and the heavy metal concentrations we found in baby foods are similar to those observed in similar whole foods. Based on these findings and the limited scenarios under which risks were identified, this study indicates that an infant's typical intake of baby food is unlikely to pose health risks from heavy metals above accepted tolerable risk levels under most exposure scenarios.
RESUMEN
Nitroalkanes are organic aliphatic hydrocarbon compounds with a nitro moiety that are commonly used as solvents or intermediates to synthesize a variety of organic compounds due to their inherent reactivity. In June 2020, a harmonized classification and labeling (CLH) proposal was submitted to the European Chemicals Agency (ECHA) for the following harmonized carcinogenicity, mutagenicity, and reproductive toxicity ("CMR") classifications for nitromethane (NM), nitroethane (NE), and 1-nitropropane (1-NP): NM Carc. 1B and Repr. 1B; NE Repr. 1B; and 1-NP Repr. 2. In this assessment, a weight of evidence (WoE) evaluation of studies on animal carcinogenicity and reproductive and developmental toxicity, genotoxicity, and mode of action for these three nitroalkanes was performed to critically assess the relevance of the proposed CMR classifications. Overall, the WoE indicates that NM, NE, and 1-NP are not carcinogenic, genotoxic, nor selective reproductive or developmental toxicants. Based on our analysis, classifying NM, NE, and 1-NP as Category 2 reproductive toxicants is most appropriate. Furthermore, not classifying NE and 1-NP with respect to their carcinogenicity is appropriate based on the available studies for this endpoint coupled with negative results in genotoxicity studies, metabolism data, and in silico predictions. We determined that the classification for NM of Carc. 1B is not appropriate, based on the fact that rat mammary and harderian tumors are likely not relevant to humans and lung and liver tumors reported in mice were equivocal in their dose-response and statistical significance.