Policy and Regulation in Bioengineering and Biotechnology
Author: Andrea Wilcks
Publisher: Frontiers Media SA
Published: 2023-12-13
Total Pages: 166
ISBN-13: 2832540988
DOWNLOAD EBOOK →Author: Andrea Wilcks
Publisher: Frontiers Media SA
Published: 2023-12-13
Total Pages: 166
ISBN-13: 2832540988
DOWNLOAD EBOOK →Author: National Research Council
Publisher: National Academies Press
Published: 2002-12-29
Total Pages: 201
ISBN-13: 0309084393
DOWNLOAD EBOOK →Genetic-based animal biotechnology has produced new food and pharmaceutical products and promises many more advances to benefit humankind. These exciting prospects are accompanied by considerable unease, however, about matters such as safety and ethics. This book identifies science-based and policy-related concerns about animal biotechnologyâ€"key issues that must be resolved before the new breakthroughs can reach their potential. The book includes a short history of the field and provides understandable definitions of terms like cloning. Looking at technologies on the near horizon, the authors discuss what we know and what we fear about their effectsâ€"the inadvertent release of dangerous microorganisms, the safety of products derived from biotechnology, the impact of genetically engineered animals on their environment. In addition to these concerns, the book explores animal welfare concerns, and our societal and institutional capacity to manage and regulate the technology and its products. This accessible volume will be important to everyone interested in the implications of the use of animal biotechnology.
Author: United States. General Accounting Office
Publisher:
Published: 1992
Total Pages: 20
ISBN-13:
DOWNLOAD EBOOK →Author: Karinne Ludlow
Publisher: Springer Science & Business Media
Published: 2013-12-03
Total Pages: 311
ISBN-13: 1461494400
DOWNLOAD EBOOK →Within the context of the Convention on Biological Diversity (CBD), the Cartagena Protocol on Biosafety (CPB) was established as an implementing agreement. The CPB is an international agreement establishing the rights of recipient countries to be notified of and to approve or reject the domestic import and/or production of living modified organisms (LMOs). Decisions regarding import/production are to be on the basis of a biosafety assessment. Article 26.1 of the CPB allows for the (optional) inclusion of socio-economic considerations (SECs) into that biosafety assessment process. This book compiles expert assessments of the issues relevant to SEC assessment of LMOs and fundamental for decisions regarding whether to undertake such assessments at all. It includes an overview of the inclusion of SEC assessment in the regulation of LMOs that looks at the rationale for the inclusion of SECs, in the context of the existing science-based risk assessment systems. This book reviews the various factors that can and have been suggested for inclusion in SEC assessment, and provides a meaningful dialogue about the contrasts, benefits and tradeoffs that are, and will, be created by the potential move to the inclusion of SECs in the regulation of LMOs, making it of interest to both academics and policy-makers.
Author: Han Somsen
Publisher: Edward Elgar Publishing
Published: 2007-01-01
Total Pages: 291
ISBN-13: 1847204414
DOWNLOAD EBOOK →. . . a compilation of 12 invaluable contributions on this issue by internationally known experts in their respective fields. . . a valuable resource for academic professionals, policy makers and legislators, advocacy groups and scholars in legal and development studies. It is a storehouse of learning and practical knowledge for anyone interested in environmental policy, biosafety issues, biotechnology processes and associated regulatory constraints. Marcelin Tonye Mahop, Review of European Community and International Environmental Law For bioethicists, legal scholars and regulators struggling with what controls to place on biotechnology, this is required reading. John Avellanet, Journal of Commercial Biotechnology Biotechnology has prompted a revolution in science and society in the truest sense of the word. For what superficially appears to be a revolution in biotechnology, in effect touches upon the fundamentals of life and the way in which humans relate to it. This book will make a significant contribution to the debate surrounding the effective regulation of biotechnology. The contributing authors assess how regulatory regimes can accommodate the many different and often conflicting issues to which biotechnology is giving rise to (including a very tainted public image). The book s ultimate aim is to explore ways of designing a regulatory regime that takes heed of these different demands whilst, at the same time, answering to the imperatives of effectiveness and efficiency. The book synthesizes three fields of legal analysis; the first focuses on the risk-dominated regulation of GM food and bio-agriculture; the second involves human genetics as a field dominated by considerations of ethics. Finally, patent law has been chosen as an area captured by notions of property. With its holistic approach, The Regulatory Challenge of Biotechnology will be of great interest to academics, policymakers and regulators as well as biotechnology and law students.
Author: Alessandro Stasi
Publisher:
Published: 2023
Total Pages: 0
ISBN-13: 9789819921362
DOWNLOAD EBOOK →This book covers an extensive range of issues raised by biotechnological advancements from a regulatory perspective. Written in a clear and readable style, its main objective is to give readers an idea of the relationship between biotechnology and law. Biotechnology advancements and their ethical, moral, economic, and social implications in different fields and the consequential normative demands on the law are crucial to this book. The chapters cover a multitude of themes and some of the most important legal issues arising in relation to biotechnology, including the historical development of a legal framework sufficient to protect public safety, the current biotechnology regulatory system, and the rules directing the primary agencies that regulate the products of biotechnology, namely the US Food and Drug Administration, the US Department of Agriculture, and the US Environmental Protection Agency, patents and IP rights in biotechnology, the regulation of human genome editing and its impact on health research, law and emerging genome editing technologies from recombinant DNA to CRISPR/Cas9, the development of legal principles to protect property rights in the human body and allow the efficient use of human tissue, organs, DNA, and cell-lines in medical research, and legal issues arising from the use of genetic engineered plants and animals. Presenting arguments that have been drawn from careful examination of various international documents and decisions made by legal institutions and judicial bodies, this book would be a valuable read for practitioners as well as academics of biotechnology law.
Author: United States. Office of Science and Technology Policy
Publisher:
Published: 1984
Total Pages: 52
ISBN-13:
DOWNLOAD EBOOK →Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
Published: 2017-07-28
Total Pages: 231
ISBN-13: 0309452058
DOWNLOAD EBOOK →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.
Author: Alessandro Stasi
Publisher: Bentham Science Publishers
Published: 2023-01-17
Total Pages: 165
ISBN-13: 9815080636
DOWNLOAD EBOOK →Biotechnology, a branch of science and a fast-growing source of developing technologies, has shown immense potential for its utility across all the dimensions of our lives. Its applications range from drugs and therapeutics, industrial, household applications, biofuels, and information technology to almost all resource-based sectors, such as manufacturing, aquaculture, agriculture, and forestry. Biotechnology offers outstanding potential to meet the growing demand for food and energy production in a sustainable way. Recognizing its economic and strategic value, countries have implemented several measures to generate a homegrown biotechnology sector and help science-based companies develop. This book covers some of the most important legal issues arising in relation to biotechnology. Topics covered in chapters include 1) the historical development of a legal framework sufficient to protect public safety, 2) the current biotechnology regulatory system and the rules directing the primary agencies that regulate the products of biotechnology (namely the FDA, USDA and EPA), 3) the regulation of human genome editing and its impact on health research, 4) law and emerging genome editing technologies from recombinant DNA technology to CRISPR/Cas9 editing, 5) the development of legal principles to protect property rights in the human body and allow the efficient use of human tissue, organs, DNA, and cell-lines in medical research, and 6) legal issues arising from the use of genetic engineered plants and animals. The authors have ensured that the contents are easy to understand, making this an accessible reference for a broad range of readers. This book, therefore, serves as a quick summary of the prominent legal and regulatory issues in the biotech industry for professionals, as well as scholars in legal study programs.