Conference Chatter: An Overview of the U.S. EPA's New Cumulative Risk Assessment for Phthalates

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New guidance from the U.S. Environmental Protection Agency (EPA) on phthalates has provided toxicologists and risk mitigation strategists with a new framework in the form of a cumulative risk assessment (CRA) to more accurately weigh the risks associated with using phthalates in various settings, including for workers exposed to chemical stressors governed by the Toxic Substances Control Act (TSCA).

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“What they’re presenting in this guidance document is the approach, not the outcome,” said Bob DeMott, PhD, a board-certified toxicologist and risk assessment expert, during a presentation at the Society for Chemical Hazard Communication (SCHC)'s annual meeting on 3 October 2023 in Arlington, Va.

Phthalates have a wide range of applications in consumer products like cosmetics, as well as building materials. They are also found in some fast foods or foods that are high in fat content.

“Some chemicals are both present ubiquitously in background because they’re naturally occurring, or they’re widely distributed in our industrial society,” DeMott said.

The EPA has long been encouraging a shift away from the use of phthalates, having already issued significant new use rules, or SNURs, on 17 December 2014 and 20 March 2012.

Adverse effects on the development of the reproductive system in male laboratory animals are the most sensitive health outcomes from phthalate exposure, according to the EPA. Several studies have shown associations between phthalate exposures and human health, although no causal link has been established, according to the EPA.

DeMott noted that the CRA is more comprehensive because it draws upon multiple sources and substances.

DeMott, who has 25 years of experience evaluating human health and environmental risks associated with the production, distribution, use, and disposal of ingredients and products containing chemicals like phthalates, added there is strong demand for stakeholders and communities affected by exposure to such chemicals.

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Proactive internal communication from toxicologists to management or leadership can help aid businesses in ensuring they are TSCA-compliant, DeMott added.

“These are useful, incremental advancements,” he said. “As the EPA continues to adopt them, they have the potential to help increase trust and credibility.”