Adoption of New Guidelines and Data Requirements for More Extensive Neurotoxicity Testing under Fifra

Abstract

In 1987 the Center for Science in the Public Interest (CSPI) and others petitioned EPA to, “issue testing methods necessary to fully assess the neurotoxic and neurobehavioral effects of pesticide active and inert ingredients. ” In response OPP convened a meeting of an expert subpanel on neurotoxicity of the Scientific Advisory Panel to review its proposed response. The petitioners proposed specifically that OPP use the neurotoxicity guidelines developed by EPA's own Office of Toxic Substances. They asserted that the scope of potential neurotoxic hazards is broad and that current guidelines will neither adequately identify nor characterize these effects. A series of expert panels have endorsed the use of more extensive neuropathological evaluations, better clinical examinations, explicit unconditioned and conditioned behavioral testing, testing of prenatally exposed animals for neurological deficits, and development of a means for evaluation of the broad range of potential neurotoxic effects. In response to this petition the following additions to the assessment of pesticides were proposed by OPP and approved by the SAP: expanded functional observation neuropathology, and motor activity into an acute and subchronic screening battery; addition of tests of operant behavior or other tests of sensory or cognitive function as conditional data requirements; and addition of a conditional requirement of postnatal neurofunctional and neuropathological evaluation of offspring.