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EPA/OCSPP RIN: 2070-AK23 Publication ID: Fall 2016 
Title: ●Procedures for Prioritization of Chemicals for Risk Evaluation Under the Toxic Substances Control Act 
Abstract:

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.

 
Agency: Environmental Protection Agency(EPA)  Priority: Other Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: uncollected 
CFR Citation: 40 CFR NYD     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 15 U.S.C. 2605 Toxic Substances Control Act   
Legal Deadline:  None

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.

Timetable:
Action Date FR Cite
NPRM  12/00/2016 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Federal, State, Tribal 
Federalism: No 
Included in the Regulatory Plan: Yes 
RIN Information URL: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca  
Sectors Affected: 325 Chemical Manufacturing 
RIN Data Printed in the FR: No 
Agency Contact:
Ryan Schmit
Environmental Protection Agency
Office of Chemical Safety and Pollution Prevention
1200 Pennsylvania Avenue NW, Mail Code 7404T,
Washington, DC 20460
Phone:202 564-0610
Fax:202 566-0471
Email: schmit.ryan@epa.gov