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EPA/OCSPP RIN: 2070-AK20 Publication ID: Fall 2017 
Title: Procedures for Evaluating Existing Chemical Risks Under the Toxic Substances Control Act 
Abstract:

As part of EPA's ongoing efforts to implement the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which amended the Toxic Substance Control Act (TSCA) with immediate effect upon its enactment on June 22, 2016, EPA promulgated a final rule to implement TSCA section 6(b)(4). As required under section 6(b)(4) of TSCA, the final rule 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 incorporated the science requirements of the amended statute, including best available science and weight of the scientific evidence. Risk evaluation is the second step, after Prioritization, in a new process of existing chemical substance review and management established under recent amendments to TSCA. This rule identified the steps of a risk evaluation process including: scope, hazard assessment, exposure assessment, risk characterization, and finally a risk determination. This process will be used for the first ten chemical substances undergoing evaluation from the 2014 update of the TSCA Work Plan for Chemical Assessments (to the maximum extent practicable). Chemical substances designated as High-Priority Substances during the prioritization process and those chemical substances for which EPA has initiated a risk evaluation in response to a manufacturer request, will always be subject to this process. The final rule also included the required "form and criteria" applicable to such manufacturer requests.

 
Agency: Environmental Protection Agency(EPA)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: No  Unfunded Mandates: No 
EO 14192 Designation: Fully or Partially Exempt 
CFR Citation: 40 CFR 702   
Legal Authority: 15 U.S.C. 2601 et seq Toxic Substances Control Act   
Legal Deadline:
Action Source Description Date
Final  Statutory  Under TSCA section 6(b)(4)(B), EPA must establish the risk evaluation process by rule within 1 year of enactment.  06/22/2017 
Timetable:
Action Date FR Cite
NPRM  01/19/2017  82 FR 7562   
NPRM Comment Period End  03/20/2017 
Final Rule  07/20/2017  82 FR 33726   
Final Rule Effective  09/18/2017 
Additional Information: Docket #:EPA-HQ-OPPT-2016-0654. A summary of the recent amendments to TSCA is available at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/frank-r-lautenberg-chemical-safety-21st-century-act.
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Information URL: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca   Public Comment URL: https://www.regulations.gov/document?D=EPA-HQ-OPPT-2016-0654-0001  
Sectors Affected: 32411 Petroleum Refineries; 325 Chemical Manufacturing 
RIN Data Printed in the FR: No 
Agency Contact:
Susanna Blair
Environmental Protection Agency
Office of Chemical Safety and Pollution Prevention
1200 Pennsylvania Avenue NW, Mail Code 7401M,
Washington, DC 20460
Phone:202 564-4371
Email: blair.susanna@epa.gov