The Food Quality Protection Act of 1996 (FQPA) requires a default 10x factor to be added to the traditional interspecies and intraspecies uncertainty factors, resulting in an initial 1000-fold UF in deriving the acute and chronic RfD's. This FQPA factor is retained if there are (a) �Residual concerns for susceptibility given the available evidence on pre- and postnatal toxicity� or (b) �Residual concerns or uncertainties in the exposure assessment� (US EPA, 2002). In practice, the FQPA factor has been reduced to '1' for over 90% of approximately 352 pesticides listed in EPA's Human Health Benchmarks for Pesticides (http://iaspub.epa.gov/apex/pesticides/f?p=HHBP:home). This talk focuses on a weight-of-evidence approach US EPA OPP uses to evaluate the potential for pre- and postnatal toxicity and the completeness of the toxicology databases. Specifically, US EPA considers human epidemiology and animal published literature on developmental toxicity and mode of action in its deliberation of residual concerns for infants and children. Criteria are needed for evaluating developmental studies that have not been conducted according to general principles outlined by GLP and EPA test guidelines.

FQPA and health effects

246th National Meeting (2013)

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