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On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act which amends the Toxic Substance Control Act (TSCA), the Nation's primary chemicals management law. A summary of the new law, which includes much needed improvements to TSCA, is available at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/frank-r-lautenberg-chemical-safety-21st-century-act. This particular rulemaking effort involves the revised TSCA section 6(b)(1), which requires that EPA promulgate a final rule within 1 year of enactment to establish a risk-based screening process, including criteria for designating chemical substances as high-priority substances for risk evaluations or low-priority substances for which risk evaluations are not warranted at the time. As required by statute, the process to designate the priority of chemical substances must include a consideration of the hazard and exposure potential of a chemical substance or a category of chemical substances (including consideration of persistence and bioaccumulation, potentially exposed or susceptible subpopulations and storage near significant sources of drinking water), the conditions of use or significant changes in the conditions of use of the chemical substance, and the volume or significant changes in the volume of the chemical substance manufactured or processed.

Statement of Need: As required by statute, the process to designate the priority of chemical substances must include a consideration of the hazard and exposure potential of a chemical substance or a category of chemical substances (including consideration of persistence and bioaccumulation, potentially exposed or susceptible subpopulations and storage near significant sources of drinking water), the conditions of use or significant changes in the conditions of use of the chemical substance, and the volume or significant changes in the volume of the chemical substance manufactured or processed.

Summary of the Legal Basis: This action is mandated by the Frank R. Lautenberg Chemical Safety for the 21st Century Act which amended the Toxic Substance Control Act (TSCA), on June 22, 2016. This particular rulemaking effort involves the revised TSCA section 6(b)(1), which requires that EPA promulgate a final rule within 1 year of enactment to establish a risk-based screening process, including criteria for designating chemical substances as high-priority substances for risk evaluations or low-priority substances for which risk evaluations are not warranted at the time.

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

Anticipated Costs and Benefits: The EPA will prepare a regulatory impact analysis as part of the development of a proposed rule.

Risks: This action will not address any particular risk. It will establish a risk-based screening process, including criteria for designating chemical substances as high-priority substances for risk evaluations or low-priority substances for which risk evaluations are not warranted at the time.