Abstract
The scientific Panel of the European Food Safety Authority (EFSA) on genetically modified organisms (GMOs) developed guidelines for the environmental risk assessment of genetically modified (GM) animals that provide specific recommendations for GM fish, GM insects, GM mammals and GM birds. The guidelines advocate that the environmental risk assessment of GM animals is conducted on a case-by-case basis, in a scientifically sound and transparent manner, and follows common methodology for the identification, gathering and interpretation of the data. Besides specific considerations, the guidelines provide generic advice on the choice of comparators, the use of non-GM surrogates, the assessment of long-term effects, uncertainty analysis, modelling requirements and statistical principles. Three dedicated Working Groups of the EFSA GMO Panel were involved in the elaboration of the environmental risk assessment guidelines, which underwent a public consultation before finalisation. Relevant comments received from risk assessment bodies of EU Member States, the scientific community, stakeholders and the public were considered by the Working Groups. The Working Groups also took into account the external scientific reports on GM fish, GM insects, GM mammals and GM birds commissioned by EFSA. These reports provided background information by mapping relevant fields of expertise and identifying essential elements to be considered when performing an environmental risk assessment of GM animals.
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Notes
A RIDL® strain (i.e. Release of Insects carrying a Dominant Lethal genetic system).
The non-GM comparator is the non-modified organism from which the GM animal, also called the ‘conventional counterpart’, is derived. In cases where the conventional counterpart is not present, additional comparators need to be used (for further details, see section 3.3 of EFSA 2013).
A surrogate animal is an individual that does not bear the genetic modification at issue but shares sufficient traits with the GM animal so that it can act as a substitute for the GM animal in risk assessment tests and experiments.
Possible effects of ingestion or intake of GM animals or derived products intended to be commercialised as food and/or feed should be considered according to the EFSA Guidance Document on the risk assessment of food and feed from genetically modified animals and on animal health and welfare aspects (EFSA 2012).
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Acknowledgments
We thank current and previous members of the EFSA GMO Panel,Footnote 9 the experts of the ad hoc Working Groups of the EFSA GMO Panel on GM animals,Footnote 10 as well as EFSA GMO Unit colleagues for their major contributions to the guidance documents on GM animals.
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Conference Proceedings “Science into Policy, improving uptake and adoption of research conference” 11th to 13th November 2013 in Brisbane, Australia, a conference sponsored by the OECD Co-operative Research Programme on Biological Resource Management for Sustainable Agricultural Systems.
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Mestdagh, S., Devos, Y., Ehlert, C. et al. EFSA Guidelines on the environmental risk assessment of genetically modified animals in the EU: the process and risk assessment considerations. J. Verbr. Lebensm. 9 (Suppl 1), 85–91 (2014). https://doi.org/10.1007/s00003-014-0898-4
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DOI: https://doi.org/10.1007/s00003-014-0898-4