4.1 Introduction 103

4.2 Commercial History of Plant Insecticidal Proteins 104

4.3 Framework for Ecological Safety Assessment of Insecticidal Proteins 105

4.4 Regulatory Perspective on Insecticidal Protein Ecological Safety 107

4.5 Problem Formulation: Characterization of the Nature of Insecticidal Proteins and Their Anticipated Ecological Effects 108

4.6 Characterization of Exposure and Effects of Insecticidal Proteins on Nontarget Species 110

4.6.1 Lepidopteran-Active Corn: Cry1Ab and Cry1F 110

4.6.2 Coleopteran-Active Corn: Cry3Bb1 and Cry34Ab1/Cry35Ab1 113

4.6.3 Lepidopteran-Active Cotton: Cry1Ac 116

4.6.4 Lepidopteran-Active Cotton Pyramids: Cry1Ac + Cry2Ab2

and Cry1Ac + Cry1F 116

4.7 Nontarget Risk Characterization Relevance to Ecological Safety 118

4.8 Insect Resistance Management in Relation to Ecological Safety of Insecticidal Proteins 120

4.9 Future Needs and Considerations for Insecticidal Protein Ecological

Safety Evaluations 120

References 121

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