International Regulation Of Gene Editing Technologies In Crops

This open access book analyzes the regulation and governance of gene editing in the global agrifood system as applications of gene editing, regulations and the intellectual property landscape continue to evolve. The primary focus of the manuscript is the dynamic interactions between regulatory frameworks and agricultural applications of gene editing in plant breeding. The goal is to give readers a holistic perspective on why the status of gene editing in agricultural applications is in a state of flux in some jurisdictions (e.g., the European Union) while more settled in others (e.g., Canada). Readers are provided with a clearer picture of what the future might hold for the use of gene editing in agriculture as a means to address food insecurity as the climate crisis grows and amid global geopolitical and economic turbulence.

This book provides in-depth insights into the regulatory frameworks of five countries and the EU concerning the regulation of genome edited plants. The country reports form the basis for a comparative analysis of the various national regulations governing genetically modified organisms (GMOs) in general and genome edited plants in particular, as well as the underlying regulatory approaches.The reports, which focus on the regulatory status quo of genome edited plants in Argentina, Australia, Canada, the EU, Japan and the USA, were written by distinguished experts following a uniform structure. On this basis, the legal frameworks are compared in order to foster a rational assessment of which approaches could be drawn upon to adjust, or to completely realign, the current EU regime for GMOs. In addition, a separate chapter identifies potential best practices for the regulation of plants derived from genome editing.

Neue Pflanzenzüchtungstechnologien wie CRISPR/Cas haben das Potenzial zur Verbesserung der Nachhaltigkeit in der Landwirtschaft. Mit den Techniken des Genome Editing können die Erträge bei gleichzeitig reduziertem Pestizideinsatz gesteigert werden. Auch an der Verbesserung des Nährwerts von Pflanzen wird weltweit geforscht. Ob die neuen Techniken allerdings in Europa zum Einsatz kommen, ist gegenwärtig fraglich. Soll Genome Editing wie die "klassische" Gentechnik reguliert werden? Und wie kann eine verantwortliche Auslegung des Vorsorgeprinzips beim Einsatz der neuen Technologien aussehen? Die politische Diskussion um die Bewertung der neuen Pflanzenzüchtungstechnologien ist in vollem Gange. Die Beiträge dieses Sammelbands präsentieren rechtliche, soziale und ethische Aspekten zum Thema, die auf einer Summer School des Instituts Technik-Theologie-Naturwissenschaften (TTN) an der Ludwig-Maximilians-Universität München zur Diskussion standen. Mit Beiträgen von Stephan Schleissing; Sebastian Pfeilmeier; Christian Dürnberger; Jarst van Belle; Jan Schaart; Robert van Loo; Katharina Unkel; Thorben Sprink; Aurélie Jouanin; Marinus J.M. Smulders; Hans-Georg Dederer; Brigitte Voigt; Felix Beck; João Otávio Benevides Demasi; Bartosz Bartkowski; Chad M. Baum; Alexander Bogner; Helge Torgersen; Sebastian Schubert; Anne Friederike Hoffmann; Ksenia Gerasimova; Karolina Rucinska

Genome editing is a powerful new tool for making precise alterations to an organism's genetic material. Recent scientific advances have made genome editing more efficient, precise, and flexible than ever before. These advances have spurred an explosion of interest from around the globe in the possible ways in which genome editing can improve human health. The speed at which these technologies are being developed and applied has led many policymakers and stakeholders to express concern about whether appropriate systems are in place to govern these technologies and how and when the public should be engaged in these decisions. Human Genome Editing considers important questions about the human application of genome editing including: balancing potential benefits with unintended risks, governing the use of genome editing, incorporating societal values into clinical applications and policy decisions, and respecting the inevitable differences across nations and cultures that will shape how and whether to use these new technologies. This report proposes criteria for heritable germline editing, provides conclusions on the crucial need for public education and engagement, and presents 7 general principles for the governance of human genome editing.

Genetically engineered (GE) crops were first introduced commercially in the 1990s. After two decades of production, some groups and individuals remain critical of the technology based on their concerns about possible adverse effects on human health, the environment, and ethical considerations. At the same time, others are concerned that the technology is not reaching its potential to improve human health and the environment because of stringent regulations and reduced public funding to develop products offering more benefits to society. While the debate about these and other questions related to the genetic engineering techniques of the first 20 years goes on, emerging genetic-engineering technologies are adding new complexities to the conversation. Genetically Engineered Crops builds on previous related Academies reports published between 1987 and 2010 by undertaking a retrospective examination of the purported positive and adverse effects of GE crops and to anticipate what emerging genetic-engineering technologies hold for the future. This report indicates where there are uncertainties about the economic, agronomic, health, safety, or other impacts of GE crops and food, and makes recommendations to fill gaps in safety assessments, increase regulatory clarity, and improve innovations in and access to GE technology.

OMICs-based Techniques for Global Food Security Forward-thinking resource discussing how to integrate OMICs and novel genome editing technologies for sustainable crop production OMICS-based Techniques for Global Food Security provides an in-depth understanding of the mechanisms of OMICs techniques for crop improvement, details how OMICs techniques can contribute to identifying genes and traits with economic benefits, and explains how to develop crop plants with improved yield, quality, and resistance to stresses through genome editing technologies, providing evidence on the developments of climate resilient crops via applications of genome editing techniques throughout. The text covers the application of OMICs in crop plants, the integration of bioinformatics and multi-OMICs for precision breeding, de-novo domestication, CRISPR/Cas system for crop improvement, hybrid seed production, transgene free breeding, regulation for genome edit crops, bioinformatics and genome editing, and other topics related to OMICs and genome editing. The text also includes a chapter on global regulations for genome edited crops, and explains how these regulations influence novel plant breeding techniques in their adopted countries. Edited by two highly qualified academics, OMICs-based Techniques for Global Food Security covers topics such as: Crops genome sequencing and their application for crop improvement, and functional characterization of cereal genome The role of OMICs-based technologies in plant sciences and utilization of different multi-OMICs approaches for crop improvement Genomic database and genetic resource of cereals, speed breeding for rapid crop improvement, and evolution of genome editing technologies CRISPR system discovery, history, and future perspective, and CRISPR/Cas system for biotic and abiotic stress resistance in cereals Providing a collection of recent literature focusing on developments and applications of OMICs-based technologies for crop improvement, OMICs-based Techniques for Global Food Security is an important read for plant breeders, molecular biologists, researchers, postdoctoral fellows, and students in disciplines for developing crops with high yield and nutritional potential.

Over the last few decades, various techniques have been developed to alter the properties of plants and animals. While the targeted transfer of recombinant DNA into crop plants remains a valuable tool to achieve a desirable breeding outcome, integration of transgenes into the host genome has been random, which in part, leads to reduced acceptance of GMOs by the general population in some parts of the world. Likewise, methods of induced mutagenesis, such as TILLING, have the disadvantage that many mutations are induced per plant, which has to be removed again by expensive backcrossing. Advances in genome sequencing have provided more and more information on differences between susceptible and resistant varieties, which can now be directly targeted and modified using CRISPR/Cas9 technology. By selecting specific gRNAs occurrence of off-target modifications are comparatively low. ZFNs and TALENs- based approaches required re-engineering a new set of assembled polypeptides for every new target site for each experiment. The difficulty in cloning and protein engineering prevented these tools from being broadly adopted by the scientific community. Compared to these technologies, designing the CRISPR toolbox is much simpler and more flexible. CRISPR/Cas9 is versatile, less expensive and highly efficient. It has become the most widely used technology for genome editing in many organisms. Since its inception as a powerful genome-editing tool in late 2012, this breakthrough technology has completely changed how science is performed. The first few chapters in this book introduce the basic concept, design and implementation of CRISPR/Cas9 for different plant systems. They are followed by in-depth discussions on the legal and bio-safety issues accompanying commercialization and patenting of this emerging technology. Lastly, this book covers emerging areas of new tools and potential applications. We believe readers, novice and expert alike, will benefit from this all-in-one resource on genome editing for crop improvement. Chapter 17 is available open access under a Creative Commons Attribution 4.0 International License via link.springer.com.