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.

How Industry Can Engage

For now, the EPA measures the OEV with what industry leaders feel are “overly conservative measures,” often worst-case scenarios, leading to what many in the industry deem as “overly conservative” risk evaluations. Swick said it is industry's responsibility to provide what he says is the correct data to the EPA and communicate with the agency to help develop what he considers to be more accurate risk assessments and to convey the impacts regulations have on chemicals and industry.

“We as industry need to tell a regulative narrative story on how our chemicals are regulated. EPA doesn't know, and don't assume EPA knows, that there are air, water, [and] waste regulations that impact your chemical or regulate your chemical,” Swick said. “EPA's TSCA office likely doesn't know. We have to educate EPA's TSCA office from an industry perspective and help EPA [connect] the dots internally across the agency, but then also across other federal partners.”

Echoing Swick's advice, Duvall suggested the industry experts in attendance should start engaging with the EPA as soon as possible to provide data on real use cases and exposure expectations.

“The earlier the better if you're going to do advocacy,” Duvall said. “I would suggest now is a great time for industry to pull itself together, look at the list of chemicals … and provide that kind of information to EPA so that it can make the judgements that reflect what Congress has in mind about balancing the probability of risk and the severity of harm that occurs.”

Duvall said companies should be assessing their processes for data related to chemical risk evaluations that are completed, are in progress, and most importantly for those that have been prioritized for future risk evaluations.

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