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COMPARISON OF EUROPEAN AND UNITED STATES APPROACHES TO NEW AND EXISTING SUBSTANCES REGULATION
Citation:
Fairbrother, A. COMPARISON OF EUROPEAN AND UNITED STATES APPROACHES TO NEW AND EXISTING SUBSTANCES REGULATION. Presented at SETAC, Portland, OR, November 11-18, 2004.
Description:
Chemical regulation in Europe and the U.S. share the goal of protection of human health and the environment, but regulatory requirements differ between the two jurisdictions. This presentation will review the approach taken in the U.S. under the Toxic Substances Control Act (TSCA) for new and existing substances (including endocrine disruptors and high production volume chemicals), and under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for pesticides. Comparisons will be made with the European Existing Substances Regulation (ESR) and Council Directive 67/548/EEC for new substances. Priority setting, classification and labeling, risk assessment, and risk management activities under these legislative frameworks will be discussed. Risk assessment frameworks and guidance prepared by the U.S. EPA will be compared with Technical Guidance Documents (TGDs) prepared under Commission Regulation (EC)/488/94. The application of the European Union System for Evaluation of Substances (EUSES) for screening risk assessments will be described. While the U.S. historically has lead in scientific and policy development for assessment and management of chemicals in the environment, since the passage of the 7th Amendment to the ESR in 1993, the EU has moved much more aggressively to update the science used to regulate chemicals.