Evaluations of Harm From Phthalates Should Be Based on Shared Health Impacts
Pew recommends that FDA broaden its approach to assessing combined effects of groups of chemicals
On July 26, The Pew Charitable Trusts provided comments to the U.S. Food and Drug Administration (FDA) regarding the agency’s scientific review of phthalates—a class of chemicals frequently used in food-related applications.
Pew’s letter encouraged the FDA to move forward with a cumulative risk assessment (CRA)—a type of analysis that evaluates combined health risks—for phthalates, but it also recommended that the agency adopt a broad approach that addresses substances with shared adverse health outcomes. By expanding its methodology in this way, FDA would set a strong foundation for CRAs involving other groups of similar chemicals for which data has shown at least one common health effect—but has not necessarily identified the underlying or shared mechanisms causing those effects.
Phthalates are used primarily to make plastic more flexible, often for food packaging, manufacturing, and processing purposes. These chemicals have known endocrine-disrupting effects—meaning they interfere with the production and function of hormones—during pregnancy, with implications for maternal and fetal health, including risks to reproductive health and behavioral neurodevelopment as well as increased likelihood of preterm birth.