Biotechnology and Safety Assessment

Contributors

Preface

Chapter 1. Using Plant Biotechnology to Reduce Allergens in Food: Status and Future Potential

Introduction

Characteristics of Food Allergens

Traditional Plant Breeding Methods for Reducing Allergenicity

Use of Genetic Engineering to Reduce Allergenic Potential

Concluding Remarks

References

Chapter 2. Experience with Biosafety Research and Postmarket Environmental Monitoring in Risk Management of Crops Derived from Plant Biotechnology

Introduction

End Points and Definitions

Regulatory Aspects

Biosafety Research on Virus-Resistant Sugar Beet

Using Biogeographical Data for Biosafety Research

Monitoring of Insect-Resistant Maize

Concluding Remarks: Linking Biosafety Research and Monitoring

References

Chapter 3. Safety Assessment of Foods and Food Ingredients Produced by Genetically Modified Microorganisms

Introduction

Issues in Food and Food Ingredients Produced From rDNA

Concepts in Safety Testing

Regulatory Requirements

Case Studies in Safety Assessment

Concluding Remarks

References

Chapter 4. Food Safety Assessment of Current and Future Plant Biotechnology Products

Introduction

Safety Evaluation and the Substantial Equivalence Paradigm

How are Genetically Modified Foods Evaluated for Food Safety?

Future Trends in Food Safety Assessments

Concluding Remarks and Future Prospects

References

Chapter 5. Plant Biotechnology Products with Direct Consumer Benefits

Introduction

Improved Nutritional Qualities

Products with Enhanced Quality Traits

Concluding Remarks

References

Chapter 6. Animal Feeds from Crops Derived through Biotechnology: Farm Animal Performance and Safety

Introduction

Crops Fed to Farm Animals in the United States

Characteristics of Intake and Digestion by Farm Animals

Performance, Health, and Nutrient Utilization for Farm Animals Consuming Biotechnology-Derived Crops

Composition of Meat, Milk, and Eggs from Farm Animals Consuming Biotechnology-Derived Crops

Detecting Plant Source Proteins and DNA in Animal Products

Concluding Remarks: Future Directions

References

Chapter 7. Preclinical Immunotoxicology Assessment of Cytokine Therapeutics

Introduction

Cytokines and Their Role in Health and Disease

Modulation of Cytokine Activity as a Therapeutic Modality

Clinical Toxicity Associated with Modulation of Cytokine Activity

Immunotoxicolcogy Assessment of Cytokine Therapeutics

Concluding Remarks

References

Chapter 8. Ecological Assessment of Crops Derived through Biotechnology

Introduction

Terminology

Ecological Risk Assessment Principles

Ecological Risk Assessment Principles for Genetically Modified Plants

Concluding Remarks

References

Chapter 9. Ribozyme Technology and Drug Development

Introduction

Nonenzymatic Antisense Oligonucleotides as Inhibitors of Specific Gene Expression

RNA-based Enzymes

Catalytic DNAs

Therapeutic Applications of Catalytic Oligonucleotides

Ribozyme Delivery, Pharmacokinetics, and Metabolism

Concluding Remarks: Future Prospects

References

Chapter 10. Biotherapeutics: Current Status and Future Directions

Introduction

Recombinant Proteins: Approved for Clinical Use

Interferon Alfa

Recombinant Proteins in Clinical Development

Natural Biological Response Modifiers

Chemically Defined Biological Response Modifiers

Combination Chemotherapy, Immunotherapy, and Cellular Therapy

Concluding Remarks

References

Chapter 11. Food Allergy Assessment for Products Derived through Plant Biotechnology

Introduction to Food Allergies and Allergens

Novel Proteins: Justification for Allergenicity Assessment

Allergy Assessment in the Gene Discovery Phase

Decision Tree Approach: The 2001 FAO/WHO Decision Tree

Example Applications of Allergenicity Assessment

Concluding Remarks

References

Chapter 12. Biotechnology: Safety Evaluation of Biotherapeutics and Agribiotechnology Products

Introduction

Biotherapeutics

Agribiotechnology

Concluding Remarks

References

Chapter 13. The Potential of Plant Biotechnology for Developing Countries

Introduction

Agriculture in Africa

African Crops and their Problems

Vaccines for Africa

Genetically Modified Crops in South Africa

Genetically Modified Crops in Developing Countries

The Anti-GMO Lobby and Developing Countries

Future Directions

Concluding Remarks

References

Chapter 14. Preclinical Safety Evaluation of Vaccines

Introduction

Regulatory Framework

Outline of the Proposed Studies

Concluding Remarks

References

Chapter 15. Gene Flow from Transgenic Plants

Introduction

Initial Hybrid Formation

Transgene Introgression

Transgene Spread

Concluding Remarks

References

Chapter 16. Safety Assessment of Insect-Protected Cotton

Introduction

Molecular Characterization of Bollgard Cotton

Cry1Ac and NPT II Protein Levels in Bollgard Cotton Plants

Safety Assessment of the Cry1Ac and NPT II Proteins in Bollgard Cotton

Compositional Analysis and Nutritional Assessment of Bollgard Cotton

Horizontal Gene Transfer and the Assessment of Marker Genes

Environmental Assessment

Concluding Remarks

References