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|EPA/OCSPP||RIN: 2070-AK90||Publication ID: Fall 2022|
|Title: Procedures for Chemical Risk Evaluation Under the Toxic Substances Control Act (TSCA)|
|Abstract: As required under section 6(b)(4) of the Toxic Substances Control Act (TSCA), EPA published a final rule on July 20, 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 is now considering revisions to that final rule and will solicit public comment through a notice of proposed rulemaking.|
|Agency: Environmental Protection Agency(EPA)||Priority: Other Significant|
|RIN Status: Previously published in the Unified Agenda||Agenda Stage of Rulemaking: Proposed Rule Stage|
|Major: No||Unfunded Mandates: No|
|CFR Citation: 40 CFR 702|
|Legal Authority: 15 U.S.C. 2605 Toxic Substances Control Act|
Statement of Need:
EPA’s 2017 final rule that established a process for conducting risk evaluations under TSCA was challenged by a group of environmental and public health organizations. In November 2019, the court in Safer Chemicals, Healthy Families v. US EPA, 943 F.3d 397 (9th Cir. 2019) remanded to EPA without vacatur certain provisions of the rule. 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 direction by the 9th Circuit and incorporating lessons learned in the process carrying out the first ten TSCA risk evaluations, the Agency is now considering revisions to the final rule and will solicit public comment 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 9th Circuit’s opinion in Safer Chemicals, Healthy Families v. US EPA, 943 F.3d 397 (9th Cir. 2019) 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 amendments.
Alternatives will be developed as part of the development of a proposed rule.
Anticipated Costs and Benefits:
EPA will prepare a regulatory impact analysis as part of the development of a proposed rule.
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.
|Additional Information: .|
|Regulatory Flexibility Analysis Required: Undetermined||Government Levels Affected: None|
|Included in the Regulatory Plan: Yes|
|RIN Information URL: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca|
|Sectors Affected: 324110 Petroleum Refineries; 325 Chemical Manufacturing|
|RIN Data Printed in the FR: No|
Environmental Protection Agency
Office of Chemical Safety and Pollution Prevention
1200 Pennsylvania Avenue NW, Mail Code 7401M,
Washington, DC 20460