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Transgenic Crops , Risk Assessment and Regulatory Framework in the European Union

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Abbreviations

Biodiversity:

Biodiversity is the quantity and variability among living organisms within species (genetic diversity), between species and between ecosystems. Biodiversity is not itself an ecosystem service, but underpins the supply of services. The value placed on biodiversity for its own sake is captured under the cultural ecosystem service called “ethical values” (according to the Economics of Ecosystems and Biodiversity report [1]).

Deliberate release:

Any intentional introduction into the environment of a genetically modified organism (GMO) or a combination of GMOs for which no specific containment measures are used to limit their contact with, and to provide a high level of safety for, the general population and the environment (according to Directive 2001/18/EC on the deliberate release into the environment of GMOs [2]).

Ecosystem:

An ecosystem is a dynamic complex of plant, animal, and microorganism communities and their non-living environment interacting as a functional unit. Examples of ecosystems include rainforests, grasslands, urban parks, and cultivated farmlands. Ecosystems can be relatively undisturbed by humans, such as virgin rainforests, or can be modified by human activity (according to the Economics of Ecosystems and Biodiversity report [1]).

Ecosystem services:

Ecosystem services are the benefits that people obtain from ecosystems. Examples include food, freshwater, timber, climate regulation, protection from natural hazards, erosion control, pharmaceutical ingredients, and recreation (according to the Economics of Ecosystems and Biodiversity report [1]).

Environmental harm:

Environmental harm can be defined as a measurable adverse change in a natural resource or measurable impairment of a natural resource service which may occur directly or indirectly (according to Directive 2004/35/EC on environmental liability [3]).

Genetically modified/transgenic organisms:

Organisms, such as plants, animals, and microorganisms (with the exception of human beings), in which the genetic material (DNA) has been altered in such a way that does not occur naturally by mating and/or natural recombination (according to Directive 2001/18/EC on the deliberate release into the environment of GMOs [2]).

Living modified organism:

Any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology (according to the Cartagena Protocol on Biosafety [4]).

Modern biotechnology:

The application of (1) in vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct introduction of nucleic acid into cells or organelles, or (2) fusion of cells beyond the taxonomic family, that overcome natural physiological reproductive or recombination barriers and that are not techniques used in traditional breeding and selection (according to the Cartagena Protocol on Biosafety [4]).

Organism:

Any biological entity capable of replication or of transferring genetic material (according to Directive 2001/18/EC on the deliberate release into the environment of GMOs [2]).

Placing on the market:

Making available to third parties, whether in return for payment or free of charge (according to Directive 2001/18/EC on the deliberate release into the environment of GMOs [2]).

Risk assessment:

Process of evaluation of risk, including the identification of scientific uncertainties, of the likelihood and severity of an adverse effect(s) or event(s) occurring to human and animal health or the environment following exposure under defined conditions to a risk source(s). A risk assessment comprises problem formulation (or hazard identification), hazard characterization, exposure characterization, and risk characterization (according to [5]).

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Acknowledgments

The authors wish to thank Salvatore Arpaia, Detlef Bartsch, Adinda De Schrijver, Matty Demont, Achim Gathmann, Rosemary Hails, Jozsef Kiss, Antoine Messéan, Karin Nienstedt, Joe Perry, Dirk Reheul, Olivier Sanvido, and Jeremy Sweet for inspiring discussions that helped to develop this entry.

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Authors and Affiliations

  1. GMO Unit, European Food Safety Authority (EFSA), Largo Natale Palli 5/A, IT-43121, Parma, Italy

    Dr. Yann Devos

  2. Biosafety Unit, International Centre for Genetic Engineering and Biotechnology (ICGEB), Padriciano 99, IT-34149, Trieste, Italy

    Dr. Wendy Craig

  3. Julius Kühn Institute (JKI), Federal Research Centre for Cultivated Plants, Institute for Biosafety of Genetically Modified Plants, Erwin-Baur-Str. 27, DE-06484, Quedlinburg, Germany

    Prof. Joachim Schiemann

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  1. Dr. Yann Devos
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  2. Dr. Wendy Craig
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  3. Prof. Joachim Schiemann
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Correspondence to Joachim Schiemann .

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  1. RAMTECH LIMITED, Larkspur, CA, USA

    Robert A. Meyers

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Devos, Y., Craig, W., Schiemann, J. (2012). Transgenic Crops , Risk Assessment and Regulatory Framework in the European Union . In: Meyers, R.A. (eds) Encyclopedia of Sustainability Science and Technology. Springer, New York, NY. https://doi.org/10.1007/978-1-4419-0851-3_167

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