Kaleigh Harrison
The U.S. Environmental Protection Agency (EPA) has finalized two major chemical risk evaluations that reset how chemical risks are assessed and managed under the Toxic Substances Control Act (TSCA). The reviews—covering 1,3-butadiene and five high-use phthalates—signal a shift toward targeted regulation grounded in exposure-specific science rather than sweeping restrictions across all uses.
For industry players in chemicals, manufacturing, and plastics, the signal is clear: EPA is focusing regulatory scrutiny where occupational or environmental exposure is highest. The agency’s evaluations found no unreasonable risks to the general population or consumers for either chemical group. Instead, identified concerns are confined to specific industrial scenarios, particularly where workers may face elevated inhalation or dermal exposure, and in some cases, where emissions impact the environment.
EPA’s revised approach draws on expanded use of facility-specific emissions data and updated exposure models, including dermal assessments using human data. For phthalates, a cumulative risk analysis was also added, recognizing how multiple substances could interact within occupational environments. Even in the absence of biomonitoring data for young children, EPA applied additional modeling layers to ensure protective thresholds.
These refined assessments move away from precautionary overestimates, instead leveraging real-world data—such as stack height, emission temperatures, and release points—to improve accuracy. The result is a more precise understanding of when and where health risks may arise, particularly for frontline workers.
What It Means for Compliance, Risk Management, and Operations
As EPA transitions from risk evaluation to risk management, regulated companies should anticipate rules that reflect specific use cases and operating conditions rather than blanket chemical bans. Personal protective equipment, engineering controls, process changes, or safer substitutes are all on the table, but will likely be tailored to distinct industrial functions.
Notably, the presence of a chemical in a product will not automatically trigger regulatory action. For consumer goods, where phthalates and butadiene are present at trace levels—often well below 0.001%—EPA did not find unreasonable risks under current use conditions. Instead, the focus is on areas where exposure thresholds, informed by peer-reviewed science, are exceeded.
For companies across the supply chain—from chemical producers to manufacturers of plastics and automotive materials—the implications are both operational and strategic. Compliance will depend less on chemical content alone and more on demonstrating detailed exposure control measures, both in workplace settings and in environmental releases.
EPA has also emphasized collaboration as part of its risk management rulemaking. Input from industry, labor, and technical experts will be critical in shaping regulations that are both protective and feasible. Importantly, the agency has noted that rules will be designed with adaptability in mind—capable of evolving if new data becomes available.
This approach underscores a broader trend in environmental regulation: smarter oversight based on exposure science, with a focus on protecting high-risk scenarios rather than applying a one-size-fits-all solution.