The FQPA 10X safety factor: How traditional risk assessment practices play a role in its application

The history and origin of the 1996 Food Quality Protection Act (FQPA) 10X Safety Factor for infants and children, descriptions of the policy papers issued by the U.S. Environmental Protection Agency (Office of Pesticide Programs) in 1996 and 1998, and the Agency's interoffice 10X Task Force are discussed in this paper. There is an overlap of the FQPA 10X Safety Factor with some aspects of traditional risk assessment practices, in particular within the process of RfD calculation, where the use of the database modifying factor and the intraspecies variability factors address uncertainties regarding potential toxicity to children. However, although the RfD process, as described, is entirely hazard-based, the Office of Pesticide Programs has defined the FQPA 10X Safety Factor determination as a process occurring in risk characterization, when both the toxicity and exposure profiles are addressed. It is at this point that other uncertainties or concerns pertaining to the toxicity profile, or that originate in the exposure assessment, may lead to the decision to retain an FQPA Safety Factor, and it is at this juncture that there may be a divergence from traditional risk assessment practices. Additionally, issues regarding expanded application of the database modifying factor are still under consideration by the Agency. Therefore, while maintaining some commonality with traditional risk assessment practice, the FQPA 10X Safety Factor embodies a new and unique opportunity to ensure adequate protection to infants and children.