U.S. Environmental Protection Agency, Region 7 - 11201 Renner Blvd., Lenexa, KS 66219

Iowa, Kansas, Missouri, Nebraska, and Nine Tribal Nations

EPA Proposes Rule to Strengthen TSCA Risk Evaluation Process to Protect Workers and Communities
 

Contact Information: EPA Press Office (press@epa.gov)

LENEXA, KAN. (OCT. 19, 2023) – Today, the U.S. Environmental Protection Agency (EPA) proposed a rule to strengthen its process for conducting risk evaluations on chemicals under the Toxic Substances Control Act (TSCA). If finalized, the rule would ensure that EPA’s processes better align with the law, support robust evaluations that account for all risks associated with a chemical, and provides the foundation for protecting workers and communities from toxic chemicals. The rule advances President Biden’s ambitious environmental justice agenda which includes enhancements to environmental protections in communities overburdened by pollution.

“Providing workers and communities with meaningful protections from toxic chemical exposures has to be grounded in sound science,” said Assistant Administrator for the Office of Chemical Safety and Pollution Prevention Michal Freedhoff. “This rule will strengthen our chemical risk evaluations which will in turn lead to more protective rules for workers and communities.”

The 2016 TSCA amendments required 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 that protect people and the environment from harmful chemicals. Although EPA finalized a risk evaluation framework rule in 2017, that rule was quickly challenged in court. The United States Court of Appeals for the Ninth Circuit remanded several provisions of the rule back to the Agency for reconsideration. Other aspects of the litigation, such as the policy to categorically exclude the consideration of exposures from breathing polluted air or drinking contaminated water, were deemed not ripe for a decision given that EPA had not yet published any final risk evaluations applying the framework.

In addition to revisions directed by the Court, the proposed rule includes the following changes to improve EPA’s process for TSCA risk evaluations:

• A commitment to considering the disproportionate harms facing overburdened communities as part of risk evaluations such as multiple exposure pathways (e.g. in air and water) to the same chemical, and combined risks from multiple chemicals, when such consideration is supported by the best available science, and consistent with TSCA’s statutory deadlines.
• 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 workers in its risk evaluations;
• Assurance the Agency will continue to use the best available science to conduct risk evaluations and that decisions are based on the weight of the scientific evidence;
• A clear requirement for risk evaluations to culminate in a single determination of whether the chemical presents unreasonable risk, rather than on individual chemical uses in isolation;
• New procedural requirements applicable to substantive revisions of risk evaluation documents to ensure transparency;
• Adjustments to the process for manufacturer requested risk evaluations for 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.

EPA announced many of the changes included in this proposed rule in 2021 and has incorporated them into TSCA risk evaluation activities over the past two years. However, codifying the changes through this rule will create more certainty and predictability moving forward for both the Agency and its stakeholders.

EPA will accept comments on the proposed rule for 45 days following publication at docket EPA-HQ-OPPT-2023-0496 at www.regulations.gov.

Learn more about the TSCA risk evaluation process.

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