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Maria Reyes Gil-Delgado
University Pontificia Comillas, Madrid

Biosafety Regulations and Enviromental Liability in the Biotechnology field

Biosafety regulations in Europe establish general obligations for the Member States like ensure appropriate measures to avoid adverse effects on human health and the environment which might arise from the deliberate release or the placing on the market of GMOs and particularly ensure that potential adverse effects on human health and the environment are accurately assessed on a case-by-case basis. Also Member States have to accomplish with precise rules lay down by on control procedures relating transboundary movements, risk assessment and management, handling, transport, packaging and identification of living modified organisms stated by the Cartagena protocol. In other case, responsibility of operators may be retained.

Directive 2004/35/EC, on environmental liability with regard to the prevention and remedying of environmental damage, recently approved, establish in Article 8.4 that the operator will not bear the cost of remedial actions taken if he demonstrates that he was not a fault or negligent and the environmental damage was cause by an emission or event expressly authorised by and fully in accordance with the conditions of an authorisation conferred by or given under applicable national laws and regulations which implement those legislative measures.

The aim of this article is to analyse the legal framework of biosafety and the rules of environmental liability in the biotechnology field.

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Sociology of Science and Technology NETwork - last update: April 2006