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DETERMINATION OF THE APPROPRIATE FQPA SAFETY FACTOR(S) IN THE ORGANOPHOSPHOROUS PESTICIDE CUMULATIVE RISK ASSESSMENT: SUSCEPTIBILITY AND SENSITIVITY TO THE COMMON MECHANISM, ACETYLCHOLINESTERASE INHIBITION
Citation:
U.S. EPA. DETERMINATION OF THE APPROPRIATE FQPA SAFETY FACTOR(S) IN THE ORGANOPHOSPHOROUS PESTICIDE CUMULATIVE RISK ASSESSMENT: SUSCEPTIBILITY AND SENSITIVITY TO THE COMMON MECHANISM, ACETYLCHOLINESTERASE INHIBITION.
Impact/Purpose:
Analyze sensitivity of infants and children to cholinesterase inhibiton.
Description:
The Food Quality Protection Act of 1996 (FQPA) directs EPA, in setting pesticide tolerances, to use an additional tenfold margin of safety to protect infants and children taking into account the potential for pre- and postnatal toxicity and the completeness of the toxicology and exposure databases. The statute authorizes EPA to replace this tenfold FQPA safety factor with a different FQPA factor only if reliable data demonstrate that the resulting level of exposure would be safe for infants and children. Consideration of the FQPA safety factor provision applies to individual pesticide risk assessments and to cumulative risk assessments of multiple pesticides. In the December 2001 preliminary cumulative risk assessment on organophosphorus (OP) pesticides, EPA discussed and characterized the potential multiple sources of exposure to children, but did not present hazard information on the pre-and postnatal toxicity to these pesticides. EPA has revised the December 2001 preliminary cumulative risk assessment for OP pesticides. As part of that revision, an analysis was conducted on the sensitivity and susceptibility of infants and children to cholinesterase inhibition (the common mechanism of toxicity) caused by OP pesticides. This report addresses the need for application of uncertainty factors and/or retention of the additional 10X FQPA safety factor for the protection of infants and children. The pertinent hazard and exposure information is presented to evaluate the safety of the OP pesticides for infants and children, and thus discusses: the adequacy of the exposure assessment; whether data deficiencies are present that should be addressed by application of uncertainty factors, which are used to address the FQPA safety factor provision's expressed concern as to the completeness of the data with respect to . . . toxicity to infants and children . . . ; and the concern for sensitivity and susceptibility to cholinesterase inhibition. This report is incorporated in the revised cumulative risk assessment of OP pesticides as a separate section. It is also presented here as a stand-alone document for review in June 2002 by the FIFRA Scientific Advisory Panel.