Current and future EPA requirements concerning good laboratory practices relative to vertebrate pesticides

In this paper I present a discussion of current Environmental Protection Agency (EPA) policy on ensuring compliance with the Good Laboratory Practice (GLP) regulations as applied to health effects studies submitted to the EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The EPA has recently proposed extending these regulations to essentially all studies submitted to the Office of Pesticide Programs (OPP) in support of a request for a new registration or in response to data requirements issued under Section 3(c) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The potential impact of these proposed regulations as they may apply to vertebrate pesticide efficacy testing is presented and discussed