A Screening Level Approach for Nontarget Insect Risk Assessment: Transgenic Bt Corn Pollen and the Monarch Butterfly (Lepidoptera: Danaidae)

Quantitative risk assessment affords an objective approach for assessing ecological risk from crops produced using biotechnology. Ecological risk assessment for plant-incorporated insecticidal proteins necessitates consideration of risks to nontarget insects when species-speciÞc hazard information may be lacking. Screening-level risk assessment methods afford a means by which risks to species of concern may be evaluated conservatively using exposure estimates, host-range information, and a probabilistic estimate of toxicity to sensitive species. This approach was applied to the special case of Bt corn pollen risk tomonarch butterßy,Danaus plexippus (L.), populations; the results were compared with more highly reÞned risk assessment techniques in terms of the risk conclusions which can be developed with more highly certain information. Exposure analysis based on readily available literature showed pollen interception by the host for monarch butterßy larvae (common milkweed, Asclepias syriaca L.) declined exponentially with distance from the pollen source. Intraand inter-genera sensitivity of lepidopteran species was used to project effect to monarch butterßy larvae. When the 90 percentile of effect (LC50) was used to estimate monarch butterßy sensitivity to Bt corn pollen expressing Cry1A(b) protein, the risk of lethality to individual larvae was negligible at 1 m from the edge of source corn Þelds. Subsequent Þeld measurements of pollen distribution, interception bymilkweed, and especially effects determinations formonarch butterßy larvae exposed to Cry1A(b) toxin indicate that the screening-level approach was effective in focusing the scope of the problem to exposure from high-expressing Cry1A(b) events occurring within source cornÞelds or at thenear-Þeld edge. Screening level risk assessment conservatively identiÞes the scopeof concern and the uncertainties that need clariÞcation so that subsequent research canbe appropriately focused.