Technologies like CRISPR and gene drives are ushering in a new era of genetic engineering, wherein the technical means to modify DNA are cheaper, faster, more accurate, more widely accessible, and with more far-reaching effects than ever before. These cutting-edge technologies raise legal, ethical, cultural, and ecological questions that are so broad and consequential for both human and other-than-human life that they can be difficult to grasp. What is clear, however, is that the power to directly alter not just a singular form of life but also the genetics of entire species and thus the composition of ecosystems is currently both inadequately regulated and undertheorized. In Gene Editing, Law, and the Environment, distinguished scholars from law, the life sciences, philosophy, environmental studies, science and technology studies, animal health, and religious studies examine what is at stake with these new biotechnologies for life and law, both human and beyond.

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.

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

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.

Heritable human genome editing - making changes to the genetic material of eggs, sperm, or any cells that lead to their development, including the cells of early embryos, and establishing a pregnancy - raises not only scientific and medical considerations but also a host of ethical, moral, and societal issues. Human embryos whose genomes have been edited should not be used to create a pregnancy until it is established that precise genomic changes can be made reliably and without introducing undesired changes - criteria that have not yet been met, says Heritable Human Genome Editing. From an international commission of the U.S. National Academy of Medicine, U.S. National Academy of Sciences, and the U.K.'s Royal Society, the report considers potential benefits, harms, and uncertainties associated with genome editing technologies and defines a translational pathway from rigorous preclinical research to initial clinical uses, should a country decide to permit such uses. The report specifies stringent preclinical and clinical requirements for establishing safety and efficacy, and for undertaking long-term monitoring of outcomes. Extensive national and international dialogue is needed before any country decides whether to permit clinical use of this technology, according to the report, which identifies essential elements of national and international scientific governance and oversight.

Research on gene drive systems is rapidly advancing. Many proposed applications of gene drive research aim to solve environmental and public health challenges, including the reduction of poverty and the burden of vector-borne diseases, such as malaria and dengue, which disproportionately impact low and middle income countries. However, due to their intrinsic qualities of rapid spread and irreversibility, gene drive systems raise many questions with respect to their safety relative to public and environmental health. Because gene drive systems are designed to alter the environments we share in ways that will be hard to anticipate and impossible to completely roll back, questions about the ethics surrounding use of this research are complex and will require very careful exploration. Gene Drives on the Horizon outlines the state of knowledge relative to the science, ethics, public engagement, and risk assessment as they pertain to research directions of gene drive systems and governance of the research process. This report offers principles for responsible practices of gene drive research and related applications for use by investigators, their institutions, the research funders, and regulators.

A survey of the regulation of human germline genome modification in eighteen countries and the emerging international standards.