Empirical analysis of regulative risk assessment processes of nanomaterials under the Toxic Substances Control Act (TSCA) and European Union regulation concerning the Registration, Evaluation, Authorization and restriction of Chemicals (REACH)

Abstract

An empirical analysis of regulative risk assessment processes of nanomaterials under the Toxic Substances Control Act (TSCA) and Regulation (EC) No 1907/2006 of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) was performed. Risk assessment that has regulatory applicability must be based on legally binding norms, and “process” refers here to the approach taken by the regulatory bodies in the U.S. and the EU to implement those norms. Data consisted of the number of notifications/dossiers for the nanomaterials or the substances that contain also nanoform received by the Environmental Protection Agency (EPA) and the European Chemicals Agency (ECHA), and decisions of the Agencies. The data was analyzed using descriptive statistics and classification. The analysis focused on the challenges in detection of nanomaterials and information collection that are the core functions of risk-based regulation and may create dissimilar compliance requirements for companies. The results show that a loophole in detection of nanomaterials and information collection on them exists in the EU under the REACH, and that regulative risk assessment processes performed by the ECHA and EPA under the REACH and the TSCA, respectively, may result in different compliance requirements for companies. The differences arise partly from the legal provisions that determine the authority and obligations of the Agencies, but also from the decision making practices adopted by the Agencies.