The U.S. Environmental Protection Agency (EPA) has implemented sweeping reforms to its chemical review process under the Toxic Substances Control Act (TSCA). Effective immediately, the updated regulations aim to strengthen public health protections by eliminating exemptions for per- and polyfluoroalkyl substances (PFAS) and persistent, bioaccumulative, and toxic (PBT) chemicals. These changes align with the 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act and include comprehensive safety evaluations, stricter review requirements, and improved efficiency in the submission process.
Comprehensive Reforms Target PFAS and PBT Risks
The reforms categorically remove low-volume and low-release exemptions (LVE and LoREX) for PFAS and PBT chemicals, substances that have been flagged for their potential long-term health and environmental hazards. PFAS, often referred to as "forever chemicals," are notorious for their persistence in the environment and association with severe health risks. This move aligns with the Biden-Harris Administration’s PFAS Strategic Roadmap, which seeks to confront these chemical risks more aggressively.
Enhanced Review and Submission Processes
Under the updated rules, manufacturers must now comply with stricter requirements when submitting premanufacture notices (PMNs), significant new use notices (SNUNs), and microbial commercial activity notices (MCANs). The EPA is required to deliver one of five possible safety determinations for all chemical submissions before production can begin, addressing gaps in pre-2016 regulations where many chemicals bypassed formal safety reviews.
To streamline compliance, the EPA has introduced new prescreening processes and automated tools to prevent incomplete submissions. These measures will reduce delays caused by insufficient data and enable faster, more accurate risk assessments.
Innovation with Safety in Focus
The EPA’s reforms also promote innovation, particularly in critical industries such as semiconductors and renewable energy. Chemicals used in these sectors will receive expedited review under the agency’s prioritization framework. Additionally, the reforms underscore the EPA’s commitment to environmental justice by assessing the risks posed to vulnerable and disproportionately impacted communities.
Economic and Operational Impacts
The elimination of exemptions for PFAS and PBT chemicals demonstrates the EPA’s commitment to prioritizing health and environmental safety over convenience. While the updates impose additional compliance costs on manufacturers, the EPA estimates an annual cost saving of over $1 million for the agency itself, highlighting the long-term benefits of these reforms.
