Comments on the EFSA draft guidance for the environmental risk assessment of genetically modified animals

On the 21 of June 2012 the European Food Safety Authority (EFSA) launched a public consultation on its draft guidance for the environmental risk assessment (ERA) of genetically modified (GM) animals.

COGEM is of the opinion that the EFSA draft guidance is an impressive and lengthy document, which seems to cover nearly every conceivable aspect of the ERA of GM animals. As such, it is of considerable value for both applicants and risk assessors. The document provides a very useful enumeration of points-to-consider for the ERA of GM animals.

However, the document fails in its intention to provide detailed guidance for applicants. It lacks in identifying clear criteria or methods for the ERA, much of the text is ambiguous, and all the aspects and elements that presumably have to be considered in the ERA of GM animals are dealt with in the same manner, irrespectively of their relative importance for the ERA.

 GM animals are a highly controversial subject in Europe, especially due to moral objections. Although the document focuses on the ERA of GM animals and ethical and socio-economic issues are not part of the scope of the document, COGEM points out that the unfortunate timing of the public consultation does not help to gain public support. The overlap with the summer holidays limits the possibility of stakeholders and interested parties to submit comments and thus fuels public distrust.