The Bioethics and Biosafety of Gene Transfer

  • Kathrine H. Madsen
  • Peter Sandøe

From the early stages of genetic engineering legal frameworks were set up to ensure the safe development of this technology. These regulatory frameworks focus primarily on risks to human health and the environment, and the concepts of substantial equivalence and familiarity seem to be the two universally adopted principles on which risk assessments are based. Despite this focus on risk prevention, genetically modified (GM) crops have given rise to controversies over the last 10–15 years. It is argued that one reason for this is that the early regulatory frameworks did not adequately address the concerns that seem to underlie public resistance to GM crops. Some of these concerns are about risks which lie beyond the issues addressed by the authorities who approve GM crops. Awareness of these concerns has led to a tightening of the regulatory requirements in the European Union where, among other things, indirect and long-term environmental effects are now included. Other major socio-economic concerns — e.g. lack of demonstrated usefulness to society, and the consumer’s right to choose non-GM food products — have been debated. This debate has led to regulations designed to permit the co-existence of GM growers and non-GM growers in several EU Member States. The discussion about GM crops therefore relates both to risks to human health and the environment and a wider range of concerns such as usefulness, risks to society and a number of other ethical concerns.


Risk Assessment Genetically Modify Genetically Modify Crop European Food Safety Authority Environmental Risk Assessment 
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Copyright information

© Springer Science+Business Media, LLC 2008

Authors and Affiliations

  • Kathrine H. Madsen
    • 1
  • Peter Sandøe
    • 2
  1. 1.Danish Centre for Bioethics and Risk Assessment (CeBRA)Danish Institute of Agricultural Sciences. Research Centre FlakkebjergSlagelseDenmark
  2. 2.Danish Centre for Bioethics and Risk Assessment (CeBRA)Royal Veterinary and Agricultural UniversityFrederiksberg CDenmark

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