GlobalChem: Industry Engagement with U.S. EPA Facilitates Accurate Risk Evaluation

The U.S. Environmental Protection Agency’s (EPA) efforts to identify chemicals that may pose unreasonable risks to human health and the environment have long been a hot topic among industry leaders, with the frequently changing U.S. administrations shaking up those efforts, making risk assessment tedious and confusing.

At the American Chemistry Council’s (ACC) 38th Annual Global Chemical Regulations Conference and Exhibition (GlobalChem), industry experts Mark Duvall, principal partner at Beveridge & Diamond, P.C., and Derek Swick, manager of product stewardship with the Occidental Chemical Corporation, emphasized the importance of proactive industry engagement with the EPA to ensure accurate risk assessments.

Understanding Risk Determination in TSCA

Under the Toxic Substances Control Act (TSCA), the EPA is mandated to pinpoint substances that pose an “unreasonable risk” to human health or the environment. Unreasonable risk has no clear definition because substances are assessed on a case-by-case basis. It is assessed, however, using several factors, including:

• Risk to human health
• Risk to the environment
• Populations exposed
• Severity of the hazard
• Aggregate exposures and cumulative risk

Aside from unreasonable risk, the EPA also determines the occupational exposure value (OEV). Duvall said by definition, OEVs “are a representation of the exposure concentration below which workers and occupational non-users are not expected to exhibit any appreciable risk or adverse effects.” He said appreciable risk encompasses a lot more substances than those determined to possess unreasonable risk, leading to more conservative assessments than many in the industry deem necessary.

“That’s pretty clearly not unreasonable risk; it’s a more conservative number,” Duvall said. “The Biden EPA has generally gone in the direction of appreciable risk rather than unreasonable risk, so there is room for adjustment in how unreasonable risk is determined [in the Trump EPA].”

Although there has been much discussion and speculation around changes in the Trump administration’s approach to EPA regulations, Duvall said the administration has not said much when it comes to risk assessment. Although the Trump EPA said it plans to reconsider the risk evaluation rule, the details have not been made clear.