EPA Finalizes Stronger Risk Evaluations Under TSCA

April 23, 2024

The U.S. Environmental Protection Agency finalized a rule that strengthens its process for conducting risk evaluations on chemicals under the Toxic Substances Control Act (TSCA). These improvements to EPA’s processes advance the goals of this important chemical safety law, ensure that TSCA risk evaluations comprehensively account for the risks associated with a chemical, and provide a solid foundation for protecting public health, including workers and communities, from toxic chemicals. The rule also includes changes to enhance environmental protections in communities overburdened by pollution, complementing the Administration’s environmental justice agenda.

The 2016 TSCA amendments require that EPA establish a procedural framework rule on the process for conducting chemical risk evaluations. TSCA risk evaluations are the basis for EPA’s risk management rules. Although EPA finalized a risk evaluation framework rule in 2017, that rule was challenged in court. EPA’s final rule includes revisions made to respond to the court’s ruling, as well as several changes to improve EPA’s process for TSCA risk evaluations, including:

• Consideration of real-world exposure scenarios such as multiple exposure pathways (e.g., in air and water) to the same chemical, and combined risks from multiple chemicals when EPA has the scientific information to do so, which may be particularly important for communities who face greater exposures or susceptibilities to chemicals than the rest of the general population.
• A requirement that risk evaluations are comprehensive in scope and do not exclude conditions of use or exposure pathways.
• Clarifications to ensure EPA appropriately considers risks to all workers in its risk evaluations.
• Consideration of chemical uses that may be required for national security or critical infrastructure by other Federal agencies.
• Assurance the agency will continue to use the best available science to conduct risk evaluations, that decisions are based on the weight of the scientific evidence and that risk evaluations will be peer reviewed in accordance with both federal and EPA guidance.
• Discussion of chemical-specific fit-for-purpose approaches that allow for varying types and levels of analysis so that risk evaluations focus less rigorously on the conditions of use that are expected to pose low potential risk and can reliably be completed within the timeframes required by the statute.
• A clear requirement for risk evaluations to culminate in a single risk determination on the chemical substance, rather than on individual chemical conditions of use in isolation, and improved communications regarding the uses that significantly contribute to the unreasonable risk.
• New procedures and criteria for whether and how EPA will revise scope and risk evaluation documents, to improve transparency.
• Adjustments to the process for submission and review of manufacturer requests for risk evaluations of chemicals to better align with the process and timeline associated with EPA-initiated risk evaluations, while also ensuring that the agency can use the authorities provided under the law for gathering any needed additional information on such chemicals.
• A requirement that risk evaluations must explicitly consider overburdened communities when identifying potentially exposed and susceptible populations as relevant to the risk evaluation.

EPA announced many of the changes included in the final rule in 2021 and has incorporated them into TSCA risk evaluation activities over the past three years. EPA then proposed a revised procedural framework rule in October 2023 and, after considering public comment on the proposed rule, released today’s final rule. EPA is submitting this document for publication in the Federal Register (FR).

The procedures outlined in the rule apply to all risk evaluations initiated 30 days after the date of publication of the final rule or later. For risk evaluations that are currently in process, EPA expects to apply the new procedures to those risk evaluations to the extent practicable, taking into consideration the statutory requirements and deadlines.

TSCA Risk Evaluation Process

The Risk Evaluation process is the second step, following Prioritization and before Risk Management, in EPA’s existing chemical process under TSCA. The purpose of risk evaluation is to determine whether a chemical substance presents an unreasonable risk to health or the environment, under the conditions of use, including an unreasonable risk to a relevant potentially exposed or susceptible subpopulation. As part of this process, EPA must (1) evaluate both hazard and exposure, (2) exclude consideration of costs or other non-risk factors, (3) use scientific information and approaches in a manner that is consistent with the requirements in TSCA for the best available science, and (4) ensure decisions are based on the weight-of-scientific-evidence. Learn more about the TSCA risk evaluation process.

Additional Resources

• Pre-publication copy of the Procedures for Chemical Risk Evaluation Under the Toxic Substances Control Act (TSCA) 
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