Do current FIFRA testing guidelines protect infants and children? Lead as a case study. Federal Insecticide,...

With implementation of the Food Quality Protection Act (FQPA), questions have been raised concerning the adequacy of current guideline testing under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) to assure compliance with FQPA. Specifically, there have been questions about whether FIFRA testing is adequate to assure protection of the most sensitive individuals in the population that might be exposed to FIFRA-regulated chemicals. In most cases, concern has been expressed about protection of infants and children. One way to examine the adequacy of current testing is to retrospectively examine data generated from tests similar to, or the same as, standard FIFRA tests on chemicals with known effects on developing organisms, effects that occur at doses below the effect level for adults. Lead is an example of a compound that has been widely studied and where infants and children have been shown to be more susceptible than adults to certain types of lead-induced toxicity. A review of the available animal toxicity studies on lead compounds, studies that were similar in design to testing required under FIFRA, was performed and the adequacy of the studies for setting human exposure levels that would be protective of child and infant health was assessed. The assessment demonstrated that current guideline testing under FIFRA would have resulted in setting of an exposure level in humans that is below the current regulatory action level for lead, without the use of an additional FQPA safety factor.