This guide has been prepared by the IUCN Environmental Law Programme and the Foundation for International Environmental Law and Development (FIELD), in cooperation with the World Resources Institute (WRI). The main goal of the guide is to facilitate the understanding of the obligations of Parties to the Protocol, by providing an information base on the content and origin of the Protocol provisions, accessible to the non-specialist and useful for those who will be involved in the development and implementation of national safety frameworks.
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.
From fisheries to persistent organic pollutants to climate change itself, no other environmental principle in environmental law has produced as much controversy as the precautionary principle. Unlike a preventive approach in which action is taken provided that the threats to the environment are tangible, with a precautionary approach, authorities are prepared to tackle risks for which there is no definitive proof that the damage will materialize. The ramifications of this increasingly apparent approach are profound and cut across all areas of risk assessment and management, environmental law, policy and regulation in every major sector. However, to date little thought has been dedicated to the implementation of the precautionary principle in a wide array of environmental circumstances. This authoritative handbook addresses the legal aspects of how the precautionary principle is implemented in different sectors, and examines its successes, failures, strengths and weaknesses. Sectors and subjects covered include chemicals, GMOs, marine pollution, fisheries and nature conservation, and the book draws on cases in the EU, in the USA, and Nordic countries, where the use of precaution has been gathering momentum. Ultimately, the book provides an indispensable appraisal of the question - increasingly important in the era of human-induced climate change - of whether the precautionary principle is relevant, indeed essential, to avert major environmental and health risks, and how and when it can be used successfully. Published with MARIE CURIE ACTIONS
Written in a practical, didactic format designed to deliver point-of-care information to practitioners of cardiology as well as assist non-cardiologists with the efficient management of cardiac disease, this highly illustrated manual is an essential reference.
In recent years, food law has taken on an increasingly prominent role in political discourse, with calls for a more sustainable food system challenging the legal status quo. A thorough legal perspective is thus indispensable for grasping the complexities of the EU food system and political quests for change. In the first monograph of its kind, Hanna Schebesta and Kai Purnhagen offer an authoritative and comprehensive overview of EU food legislation. Drawing on the authors' experience researching and teaching in the field, EU Food Law explores how political paradigms have shaped the development of laws in a variety of domains, including food technology, food safety, food information, food quality, nutrition, and sustainability. The book begins with insightful analyses of the historical foundations of EU food law and two existing umbrella frameworks: the General Food Law Regulation and the Official Controls Regulation. The book then presents an in-depth discussion of the food law acquis before contextualising EU law against international food law. Schebesta and Purnhagen have created the definitive resource on EU food law, offering a balanced treatment of the subject across eighteen carefully structured chapters. This volume is essential reading for students, academics, and practitioners alike.
This volume details generation of gene-edited cell lines and organisms as models for human diseases, pest control, and large animal welfare and production outcomes. Chapters guide readers through gene regulation, editing, screening of cell lines, genome editing, and an overview of the tools for efficient genome editing including; ZFNs, TALENs, and CRISPR. Written in the format of the highly successful Methods in Molecular Biology series, each chapter includes an introduction to the topic, lists necessary materials and reagents, includes tips on troubleshooting and known pitfalls, and step- by-step, readily reproducible protocols. Authoritative and cutting-edge, Applications of Genome Modulation and Editing aims to be a useful and practical guide for researchers to commence or advance their study in this field.
Challenges and Opportunities with GM Crops in Vietnam: the Case of Bt Cotton; Cotton Production in Vietnam; Consideration of Problem Formulation an Option Assessment (PFOA) for Environmental Risk Assessment: Bt Cotton in Vietnam; Transgene Locus Structure and Expression; Non-target and Biological Diversity Risk Assessment; Potential Effect of Transgenic Cotton on Non-target Herbivores in Vietnam; Invertebrate Predators in Bt Cotton in Vietnam: Techniques for Prioritizing Species and Developing Risk Hypotheses for Risk Assessment; Potential Effects of Transgenic Cotton on Non-target Insect Parasitoids in Vietnam; Potential Effects of Transgenic Cotton on Flower Visitors in Vietnam; Potential Effects of Transgenic Cotton on Soil Ecosystem Processes in Vietnam; Environmental Risks Associated with Gene Flow from Transgenic Cotton in Vietnam; Resistance Risk Assessment and Management for Bt Cotton in Vietnam; Challenges and Opportunities with Bt Cotton in Vietnam: Synthesis and Recommendations.
Between 1973 and 2016, the ways to manipulate DNA to endow new characteristics in an organism (that is, biotechnology) have advanced, enabling the development of products that were not previously possible. What will the likely future products of biotechnology be over the next 5â€"10 years? What scientific capabilities, tools, and/or expertise may be needed by the regulatory agencies to ensure they make efficient and sound evaluations of the likely future products of biotechnology? Preparing for Future Products of Biotechnology analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making. This report identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the products of biotechnology are well understood.
This book discusses the different regulatory pathways for gene therapy (GT) and cell therapy (CT) medicinal products implemented by national and international bodies throughout the world (e.g. North and South America, Europe, and Asia). Each chapter, authored by experts from various regulatory bodies throughout the international community, walks the reader through the applications of nonclinical research to translational clinical research to licensure for these innovative products. More specifically, each chapter offers insights into fundamental considerations that are essential for developers of CT and GT products, in the areas of product manufacturing, pharmacology and toxicology, and clinical trial design, as well as pertinent "must-know" guidelines and regulations. Regulatory Aspects of Gene Therapy and Cell Therapy Products: A Global Perspective is part of the American Society of Gene and Cell Therapy sub-series of the highly successful Advances in Experimental Medicine and Biology series. It is essential reading for graduate students, clinicians, and researchers interested in gene and cell therapy and the regulation of pharmaceuticals.
