ABSTRACT
I. INTRODUCTION The United States Environmental Protection Agency (USEPA) and other U.S. regulatory agencies historically have used mutagenicity information as part of a weight-of-evidence approach to evaluate the potential for human carcinogenicity. In addition, agencies consider heritable mutation a regulatory endpoint. In the interest of easing the testing burden faced by industry, the USEPA has developed a series of harmonized genetic toxicology guidelines under the Office of Prevention, Pollution and Toxic Substances (OPPTS) for use in the evaluation of toxic substances and pesticides. This provides a single set of guidelines that minimizes variation in the testing procedures needed to meet data requirements under regulatory legislation, such as the Toxic Substances Control Act (TSCA) and the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). Further-
more, to ease the burden on industries with international markets, for many years it has been USEPA policy to accept data produced in accordance with guidelines of the Organisation for Economic Co-operation and Development (OECD), an international organization with its own genetic toxicology guidelines. The harmonization within the USEPA thus extends to OECD: for purposes of regulatory submissions, USEPA requirements are fully satisfied by the OECD guidelines.
