Consolidated Approach to Meet Current and Future Needs

Bruce Hammond and Andrew Cockburn CONTENTS

11.1 Introduction 260

11.2 Biochemical Differences between Proteins and Low-Molecular-Weight Chemicals: Impact on Safety Assessment of Proteins 260

11.3 Absorption of Proteins from the GI Tract 262

11.4 Summary of Safety Assessments on Proteins 262

11.5 Safety Assessment Strategy for Proteins Introduced into Food/Feed Crops 268

11.5.1 Mode of Action and Functionality 268

11.5.2 Bioinformatics 269

11.5.3 Digestibility 269

11.5.4 Confirmatory Safety Studies 269

11.6 Dietary Risk Assessment 272

11.7 Threshold of Toxicological Concern 273

11.8 The Future 276

11.8.1 Applications of Protein Engineering for Food-Processing Enzymes 277

11.8.2 Modification of Insect Control Proteins to Improve Potency or Broaden Selective Activity against Targeted Pests 277

11.8.3 Introduction of Transcription Factor Proteins to Modify Endogenous Plant Metabolic Pathways 278

11.9 Conclusion 281

References 281

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