View Rule

As required under section 6(b)(4) of the Toxic Substances Control Act (TSCA), EPA published a final rule in 2017 that established a process for conducting risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation, under the conditions of use. This process incorporates the science requirements of the amended statute, including best available science and weight of the scientific evidence. The final rule established the steps of a risk evaluation process including: scope, hazard assessment, exposure assessment, risk characterization, and risk determination. The Agency has reconsidered the procedural framework rule for conducting such risk evaluations and determined that certain aspects of that framework should be revised to better align with applicable court decisions and the statutory text, to reflect the Agency’s experience implementing the risk evaluation program following enactment of the 2016 TSCA amendments, and to allow for consideration of future scientific advances in the risk evaluation process without need to further amend the Agency’s procedural rule.

Statement of Need:

EPA’s 2017 final rule that established a process for conducting risk evaluations under TSCA was challenged by several non-governmental organizations.  In November 2019, the court in Safer Chemicals, Healthy Families v. US EPA , 943 F.3d 397 (9th Cir. 2019) remanded certain provisions of the rule to EPA. Additionally, the 2017 rule was identified for review in accordance with Executive Order 13990, Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis (86 FR 7037, January 25, 2021). Consistent with the Court’s direction and opinion in Safer Chemicals, Healthy Families v. US EPA , and incorporating lessons learned in the process carrying out the first ten TSCA risk evaluations, the Agency is now considering revisions to the procedural framework and will solicit public comment on those changes through a notice of proposed rulemaking.

Summary of the Legal Basis:

TSCA section 6(b)(4) directed EPA to establish the process for conducting risk evaluations on chemical substances under TSCA to identify any unreasonable risk of injury to health or the environment. Agencies have inherent authority to reconsider past decisions and to revise, replace, or repeal a decision to the extent permitted by law and supported by a reasoned explanation. FCC v. Fox Television Stations, Inc., 556 U.S. 502, 515 (2009). EPA is now exercising its inherent authority to reconsider past decisions and as such is considering revisions to that final rule based on the Court’s opinion in Safer Chemicals, Healthy Families v. US EPA to ensure that TSCA risk evaluations are supported by the best available science, aligned with the statutory requirements, and consistent with Congress’ intent in the 2016 TSCA amendments.

Alternatives:

Alternatives will not be developed as part of the development of a proposed rule.

Anticipated Costs and Benefits:

EPA will analyze the incremental impacts associated with proposed amendments to requirements for manufacturer-requested risk evaluations as part of the development of a proposed rule.

Risks:

This is a procedural rule related to risk evaluations and is not intended to directly address any particular risk. However, the rule would establish procedures by which EPA will evaluate whether a chemical substance presents an unreasonable risk of injury to health or the environment, including unreasonable risk to a potentially exposed or susceptible subpopulation. Rigorous procedures that support accurate identification of unreasonable risk are necessary to inform subsequent risk management action.