Global Regulatory Outlook for CRISPRized Plants

1st Edition - November 16, 2023
Editors: Kamel A Abd-Elsalam, Aftab Ahmad
Language: English
Paperback ISBN:
9 7 8 - 0 - 4 4 3 - 1 8 4 4 4 - 4
eBook ISBN:
9 7 8 - 0 - 4 4 3 - 1 8 4 4 5 - 1

Global Regulatory Outlook of CRISPRized Plants summarizes CRISPR/Cas systems and applications for precise editing of plant genomes and discusses global regulatory framework… Read more

Global Regulatory Outlook for CRISPRized Plants

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Global Regulatory Outlook of CRISPRized Plants summarizes CRISPR/Cas systems and applications for precise editing of plant genomes and discusses global regulatory frameworks for CRISPR edited crops. While CRISPR technology has become a routine, cheap, and efficient method to generate edited crops with superior traits, how these crops are regulated determines the future of this technology. Understanding the current state of regulation, concerns, issues, and foundations for future decisions are key in determining how this technology is used going forward. This important summary will be vital to the successful commercialization of CRISPR technology and biosafety concerns associated with this technology. The book highlights regulatory classification of CRISPR modifications such as SDN1, SDN2 and SDN3 and their global regulation and discusses the social, ethical, governance, and policy issues related to CRISPR edited crops.

Cover image
Title page
Table of Contents
Copyright
List of contributors
About the editors
Preface to the series
Preface
Chapter 1. Regulations of genome edited plants: notes from editors
Abstract
1.1 Introduction
1.2 Genetically modified organisms versus CRISPR-edited crops
1.3 Regulation of genetically modified organisms (product based, process based, and plant novel traits)
1.4 Regulation and deregulation of CRISPR-edited plants
1.5 Aspects of global regulation concerning CRISPR-edited plants
1.6 Regulatory challenges: questions need answers
1.7 Conclusion
References
Chapter 2. CRISPR/Cas systems and techniques
Abstract
2.1 Introduction
2.2 Evolution of CRISPR-Cas technology
2.3 Action mechanism of CRISPR-Cas9
2.4 CRISPR-Cas systems
2.5 Recent advances in CRISPR technology
2.6 Important applications
2.7 Conclusion and outlook
Acknowledgment
References
Chapter 3. Applications of CRISPR/Cas in plants
Abstract
3.1 Introduction
3.2 Mechanism of CRISPR/Cas-based genome editing
3.3 Application of CRISPR/Cas in plants
3.4 Breeding technologies
3.5 CRISPR biosafety and regulatory concerns
3.6 Conclusions and future outlooks
Acknowledgments
References
Chapter 4. Reagents and their delivery systems in CRISPR/Cas
Abstract
4.1 Introduction
4.2 Delivery via microinjection
4.3 Delivery via electroporation
4.4 Delivery via hydrodynamic injection
4.5 Viral delivery
4.6 Nonviral delivery methods
4.7 Delivery of CRISPR/Cas9 by extracellular vesicles
4.8 Other potential and emerging delivery methods for CRISPR/Cas
4.9 Future perspectives
4.10 Conclusions
Acknowledgments
References
Chapter 5. Regulatory triggers of CRISPR-edited crops
Abstract
5.1 Introduction
5.2 Application of CRISPR/Cas
5.3 Regulatory classification of CRISPR-based modifications
5.4 The regulatory triggers of CRISPR-edited crops
5.5 Delivery of CRISPR reagents
5.6 Potential risks associated with CRISPR edited crops
5.7 Transgene-free CRISPR crops
5.8 Worldwide regulations of genome-edited crops
5.9 Future perspectives
References
Chapter 6. Tracking footprints of CRISPR-based genome editing
Abstract
6.1 Introduction
6.2 Choice for CRISPR reagents and editing systems
6.3 Choice of site-directed nucleases
6.4 Selection of reagents and their delivery systems
6.5 Mechanism of CRISPR/Cas system
6.6 Site-directed nucleases
6.7 CRISPR systems and their applications
6.8 In silico tracking tools
6.9 Postexperiment tools for on and off targets
6.10 PCR-based tracking tools
6.11 DNA sequencing-based methods
6.12 Fluorescence marker-based screening of transgene-free edited plants
6.13 Transgene killer CRISPR technology for DNA-free genome editing
6.14 Conclusion
References
Chapter 7. Genetically modified organisms and their regulatory frameworks
Abstract
7.1 Introduction
7.2 Definition of genetically modified organisms
7.3 Genetically modified organism-applicable acts
7.4 Risk assessment—human/animal and environmental
7.5 Regulatory framework for genetically modified organisms
7.6 Stages of approval and monitoring
7.7 Labeling of genetically modified organisms and public acceptance
7.8 Genetically modified organism regulations for genome-edited organisms
7.9 Challenges and future perspectives
References
Chapter 8. Regulatory framework of CRISPR-edited crops in the United States
Abstract
8.1 Introduction
8.2 Regulatory agencies
8.3 Current regulation of CRISPR-edited crops
8.4 Processes for regulation and potential challenges
8.5 Certain gene-edited crops are exempt from regulation
8.6 The regulatory status review process
8.7 Potential challenges for approval of genome-edited crops
8.8 Risk assessment versus safety
8.9 Currently approved crops
8.10 CRISPR approaches for engineering crops for the future
8.11 Global implications of United States–approved CRISPR-edited crops
8.12 Future prospects of genome-edited crops
8.13 Conclusion
Disclaimer
References
Chapter 9. Regulation of CRISPR-edited plants in Latin America
Abstract
9.1 Introduction
9.2 Gene-editing tools
9.3 CRISPRized plants considered as conventional
9.4 CRISPRized plants regulated as genetically modified organisms and countries that banned their use
9.5 No specific regulation for genetically edited organisms
9.6 Conclusions and future perspectives
Acknowledgements
References
Chapter 10. Regulatory framework for CRISPR-edited crops in Argentina
Abstract
10.1 Introduction
10.2 How the regulation is applied?
10.3 New breeding technology regulatory experience
10.4 Labeling of the products of CRISPR-edited crops in Argentina
10.5 International insertion of Argentina’s evaluative approach to CRISPR
10.6 Conclusions
Acknowledgments
References
Further reading
Chapter 11. Regulatory outlook of CRISPR-edited plants in Canada
Abstract
11.1 Introduction
11.2 The importance of agriculture and innovation in Canada
11.3 The regulation of products of plant biotechnology in Canada
11.4 CRISPR applications in Canada
11.5 Conclusion: the future of genome editing in Canada
References
Chapter 12. Regulatory aspects of plants resulting from new genomic techniques in the European Union
Abstract
12.1 Introduction
12.2 Background on genetically modified organism regulation in the European Union
12.3 Regulatory pathways for genetically modified organisms
12.4 Risk assessment
12.5 Labeling
12.6 Risk management
12.7 Monitoring
12.8 Traceability
12.9 Court of Justice’s ruling
12.10 Court of Justice's ruling aftermath
12.11 Broader outlook
12.12 Final conclusions
Acknowledgments
References
Further reading
Chapter 13. Regulation of CRISPR-edited plants in Australia and New Zealand
Abstract
13.1 Introduction
13.2 Regulation of CRISPR-edited plants in Australia
13.3 The gene technology regulatory system
13.4 Review of the Australian Gene Technology Regulations
13.5 Modernizing and future-proofing Australia’s Gene Technology Regulatory Scheme
13.6 CRISPR regulation in New Zealand
13.7 Conclusions
References
Chapter 14. Regulatory overview of genome-edited plants in Asian countries
Abstract
14.1 Introduction
14.2 Global opinions on genome-editing regulation
14.3 Status of genome-editing regulation in Asia
14.4 Conclusion
References
Chapter 15. Use and regulation of NGT (new genetic technology) in Japan
Abstract
15.1 About genome editing
15.2 Definition
Acknowledgment
References
Chapter 16. Regulatory status of CRISPR-edited crops in Africa
Abstract
16.1 Introduction
16.2 Regulatory frameworks in Africa
16.3 Public knowledge of genome editing and regulatory implications
16.4 Effective communication on CRISPR genome-edited crops
16.5 Benefits of deregulation
16.6 Hope for the future of CRISPR-edited crops and plant biotechnology
Disclaimer
References
Chapter 17. CRISPR/Cas genome editing and applications in forest tree breeding
Abstract
17.1 Introduction
17.2 Diverse CRISPR/Cas systems for forest tree breeding
17.3 Multiplex base- and prime-editing for precise genome modifications
17.4 CRISPR/Cas-mediated manipulations by exploiting DNA double-strand break repair mechanisms
17.5 Potential applications in forest tree breeding
17.6 EU regulatory frameworks for CRISPRed trees
17.7 Concluding remarks and perspectives
References
Chapter 18. CRISPR-edited plants’ social, ethical, policy, and governance issues
Abstract
18.1 Introduction
18.2 Social and ethical concerns of CRISPR-edited plants
18.3 Global policies for CRISPR-edited plants
18.4 Governance and global regulations for CRISPR-edited plants
18.5 Conclusions
References
Chapter 19. Regulations of multiplex genome-edited crops and CRISPR/Cas gene drives
Abstract
19.1 Introduction
19.2 Applications of multiplex genome editing
19.3 Outcomes and detection of SDN1, SDN2, SDN3 systems
19.4 Multiplex approaches in CRISPR/Cas
19.5 Risk associated with CRISPR-edited crops
19.6 Regulatory models for CRISPR-edited crops
19.7 Emerging regulatory guidelines of CRISPR-edited crops
19.8 Regulations of multiplex-edited crops
19.9 Deregulation of CRISPR-edited crops
19.10 CRISPR-based gene drives
19.11 Applications of gene drives in plants
19.12 Ethical considerations
19.13 Environmental and security aspects
19.14 Risk management
19.15 Regulations of gene drives
References
Chapter 20. Challenges and prospects in the regulation of CRISPR-edited crops
Abstract
20.1 Introduction
20.2 The age and promise of new breeding technologies
20.3 Regulatory environment surrounding new breeding technologies
20.4 Recommendations for building an inclusive building design model for genome editing
References
Chapter 21. CRISPR technology commercialization and biosafety
Abstract
21.1 Introduction
21.2 CRISPR-Cas systems
21.3 CRISPR/Cas system innovations
21.4 CRISPR patent
21.5 Global landscape of CRISPR patents
21.6 CRISPR: a renewed opportunity for food security in developing countries
21.7 Biosafety and commercialization
21.8 Biosecurity threats
21.9 Conclusion and future prospects
References
Further reading
Index

Kamel A Abd-Elsalam

Prof. Kamel A. Abd-Elsalam, Ph.D., is currently a research professor at the Plant Pathology Research Institute, Agricultural Research Center, Giza. Kamel earned his Ph.D. in Molecular Plant Pathology from Christian Alberchts University of Kiel (Germany) and Suez Canal University (Egypt). Dr. Kamel’s research interests include developing, improving, and deploying plant biosecurity diagnostic tools; understanding and exploiting fungal pathogen genomes; and developing eco-friendly hybrid nanomaterials for controlling toxicogenic fungi, plant diseases, and agroecosystems applications. He published 20 books related to nano-biotechnology applications in agriculture and plant protection. Since 2019, he has served as the Editor-in-Chief of the Elsevier book series “Nanobiotechnology for Plant Protection.” He also serves as the Series Editor of the Elsevier book series “Genome Modified Plants and Microbes in Food and Agriculture.”

Affiliations and expertise

Molecular Plant Pathologist, Plant Pathology Research Institute, Agricultural Research Center, Giza, Egypt

Aftab Ahmad

Dr Aftab Ahmad is currently working as Assistant Professor at Department of Biochemistry/ US-Pakistan Center for Advanced Studies in Agriculture and Food Security (CAS-AFS), University of Agriculture, Faisalabad (UAF), Pakistan. Dr Aftab’s research interests include developing virus resistant and salt tolerant plants using CRISPR/Cas technology. He has published more than 15 research articles in international peer reviewed journals including Journal of Biomedical Sciences, Scientific Reports-Nature, PLOS One, Journal of Translational Medicine, Plant Molecular Biology Reporter, Molecules, Journal of Cereal Science, and Genetic Resources and Crop Evolution. Dr Aftab pursued his PhD and postdocs in Plant Molecular Biology from University of Shizuoka, Japan under Center of Excellence (COE, 21st Century) program. Dr Aftab also served as visiting scientist in department of plant sciences, University of California, Davis, USA. Dr Aftab has been teaching biochemistry and molecular biology at UAF and his research focuses in the area of CRISPR/Cas based genome editing in plants.

Affiliations and expertise

Biochemistry/Center for Advanced Studies in Agriculture and Food Security (CASAFS), University of Agriculture, Faisalabad, Pakistan