Biotechnology and regulatory risk assessment

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1 University Press Scholarship Online You are looking at of 58 items for: keywords : genetic engineering Biotechnology and regulatory risk assessment Matthias Herdegen in Transatlantic Regulatory Cooperation: Legal Problems and Political Prospects Published in print: 2001 Published Online: ISBN: eisbn: acprof:oso/ Biotechnology is possibly the key sector in which divergent regulatory philosophies, as well as their economic impact, are most conspicuous. As this chapter describes it, the divergences are fuelled by different perceptions of risk, notably with respect to genetic engineering. The emphasis in European regulation on risk-prevention has manifested itself economically in the momentous advantage that US enterprises have gained in research, development, and industrial production. The differences in approaches to risk management also raise delicate issues under WTO law. In the hormones dispute between the European Union and the United States, for example, the WTO appeals ruling came down heavily in favour of a requirement for sound empirical justification in support of controversial health standards. Conclusion: Recreating Democracy Dennis Doyle and Takahashi Kelso in Engineering Trouble: Biotechnology and Its Discontents Published in print: 2003 Published Online: ISBN: eisbn: Publisher: University of California Press DOI: / california/ The contributors to this book have explored some of the diverse mechanisms by which genetic engineering is changing the relationships of humans with the rest of nature, the character of commodity production, and conflicts over the content of food. Activists have successfully broadened the discussion about genetically engineered goods by leveraging the role of consumers. The degree of ecological risk depends on a number of factors, including the extent to which fertile Page 1 of 6

2 transgenic fish escape into the ecosystems of wild fish. The economic benefits of output-increasing genetically engineered organisms, whether fish or crops, will likely go primarily to the firms that own the patents on the organisms and to the producers who are early adopters of the technologies. Genetic engineering has increased at a rapid pace and has introduced significant transformations, so that the horizon is rushing toward a complex array of potential benefits and risks for humankind. CONSERVING WILDLANDS Pamela C. Ronald and Raoul W. Adamchak in Tomorrow's Table: Organic Farming, Genetics, and the Future of Food Published in print: 2008 Published Online: May 2008 ISBN: eisbn: acprof:oso/ As the world's population grows (it is expected to increase from the current 6.7 billion to 9.2 billion by 2050), fewer and fewer wild places remain. Today vast areas of Earth resemble the agricultural Central Valley, where a few domesticated species dominate. As the demand for food increases, will it be possible to minimize the impact of food production on what remains of wild nature? Enhancement Technologies: Feeling More Like Myself Donna Dickenson in Me Medicine vs. We Medicine: Reclaiming Biotechnology for the Common Good Published in print: 2016 Published Online: November 2015 ISBN: eisbn: Publisher: Columbia University Press DOI: / columbia/ This chapter demonstrates how the enhancement debate embodies Me Medicine at its most questionable. Enhancement is defined as any medication designed to improve individual human performance, created through science-based or technology-based interventions. Physical and cognitive enhancement technologies are based on the idea that an individual is obliged to create the best possible version of himself, as well as a responsibility to produce the best children. However, even adversaries of enhancement technologies rely on the language of individuality, arguing that the child s autonomy is jeopardized in the enhancement process. In relation to this debate, the chapter focuses on two main areas: neurotechnologies, particularly those affecting the Page 2 of 6

3 cognitive function, as well as neurotransmitters; and genetic engineering, specifically germline genetic modification. Crop Technologies for the Coming Decade Susan McCouch and Samuel Crowell in Food Security and Sociopolitical Stability Published in print: 2013 Published Online: January 2014 ISBN: eisbn: acprof:oso/ Global population and income growth are drastically increasing the demand for food, feed, fiber, and fuel crops. Productivity gains, particularly in Asia and Africa, are essential for mitigating sociopolitical instability as competition for scarce land, water, and genetic resources intensifies in the face of climate change. Further, growing science and technology gaps restrict breeders in national systems from working effectively with innovative crop technologies and delivery strategies that need to be tailored for local, smallholder farmers. Novel partnerships and funding arrangements between private and public institutions represent the best long-term strategies for addressing limitations in agricultural productivity. Such partnerships can facilitate combinations of new and old technologies (plant breeding, genomics, and genetic engineering), increase access to genetic diversity, and provide access to technologies that are otherwise protected by intellectual property rights.. Development Aid: On Ontogeny and Ethics Tim Lewens in The Biological Foundations of Bioethics Published in print: 2015 Published Online: April 2015 ISBN: eisbn: acprof:oso/ Human development is a matter of complex interactions between nutritional regimes, genes, educational regimes, and other diverse developmental resources. There is no ethically salient difference between the contributions made to development by genes and the contributions made by these other resources. Since we think that nutrition and schooling should be included in the calculus of distributive justice, we should include at least some genes in this calculus too. What is more, under the right circumstances genetic engineering may become a useful tool for the distribution of developmental resources. This said, attention Page 3 of 6

4 to the parity of genetic and environmental causation can also help to articulate the legitimate suspicions many groups have of genetic engineering. Genetic Manipulation: How to Strike the Right Balance between Technology and Respect for Human Rights Souheil El-Zein in Realizing Utopia: The Future of International Law Published in print: 2012 Published Online: September 2012 ISBN: eisbn: acprof:oso/ There has been a rapid increase in scientific and technological advances in the areas of genetic manipulation and genetic engineering or biotechnology in the past thirty years, and there is still a great deal that remains to be discovered. Although this fast-growing technology, mainly applied to medicines and foodstuffs, has been promoted for its potential benefit for welfare and growth in the field of life sciences and the economy, it poses considerable risks (to biodiversity, human health, the environment, etc.) on which research is still scarce and thus has raised regulatory challenges under both regional and international law. This chapter considers the reaction of international law to those challenges. The evaluation of the impact of the treatment of biotechnology under international law requires a plurality of approaches and different levels of inquiry, depending on the fundamental legal, social, and cultural distinction between human genetic resources and other genetic resources (plants and animals), even if the gene of animals and human beings are scientifically similar. Behavior and Neurobiology Justin S. Rhodes and Tadeusz J. Kawecki in Experimental Evolution: Concepts, Methods, and Applications of Selection Experiments Published in print: 2009 Published Online: ISBN: eisbn: Publisher: University of California Press DOI: / california/ This chapter presents some of the methods in experimental evolution that can be used to study the evolution of behavior, illustrating how these can be applied toward understanding the origin and mechanisms of behavioral diversity. One method is artificial selection, a powerful tool Page 4 of 6

5 used to explore the question of how behavior evolves; another is mass selection, which relies on an experimental setup that sorts individuals into groups depending on a particular behavior. An alternative approach for identifying mechanisms of behavioral evolution is to use experimental methods to explore genetics and physiology of real behavioral shifts that occurred among populations or species in nature. The chapter describes how laboratory experimental tools, such as genetic engineering and pharmacology, were used to discover the evolution of mating systems in voles. Gene therapy: With Stacey Efstathiou James W. Fawcett, Anne E. Rosser, and Stephen B. Dunnett in Brain Damage, Brain Repair Published in print: 2002 Published Online: ISBN: eisbn: acprof:oso/ Genetic engineering may be defined as the development of techniques to manipulate the genotype of cells or organisms in order to modify their phenotype. Gene therapy is the use of those techniques to alleviate injury, repair damage, or change the course of a disease. These techniques are potentially applicable to all living cells, not just cells of the nervous system, and indeed much of what we presently know about genetic engineering and gene therapy comes from the study of other cells, organs, and systems of the body, such as identifying and manipulating genes that predispose to cell proliferation and cause cancer ( oncogenes ). Gene therapy can have various goals. The two major ones are the correction of genetic disease, and the delivery of genes to the nervous system to alter a disease process. Eating Risk: The Politics of Labeling Genetically Engineered Foods Julie Guthman in Engineering Trouble: Biotechnology and Its Discontents Published in print: 2003 Published Online: ISBN: eisbn: Publisher: University of California Press DOI: / california/ This chapter discusses how the politics of consumption can both enliven and eviscerate broad public participation in technological decision making. It explores the current U.S. regulation of genetically engineered Page 5 of 6

6 organisms (GEOs) by describing the discursive terrain on which the battles are being fought and then providing a brief history of the existing regulatory impasse. The chapter also reviews the labeling and the lessons to be learned from the regulation of organic products. Both the Carter and Reagan administrations were strongly committed to rapid technological development as a vehicle for economic recovery, and they provided substantial tax incentives for investment in biotechnology. GEO labeling has the potential to replicate many of the pitfalls of organic regulation. Regulations must restrict supply not only by maintaining barriers to entry but also by prohibiting substitutes. Genetic engineering technologies do not exist in a vacuum but reflect deeper tendencies in the industrialization of agriculture itself. Page 6 of 6