Defining Environmental Risk Assessment Criteria for Genetically Modified (GM) Mammals and Birds to be placed on the EU market
The present document has been produced and adopted by the bodies identified above as authors. In accordance with Article 36 of Regulation (EC) No 178/2002, this task has been carried out exclusively by the authors in the context of a grant agreement between the European Food Safety Authority and the authors. The present document is published complying with the transparency principle to which the European Food Safety Authority is subject. It may not be considered as an output adopted by EFSA. EFSA reserves its rights, view and position as regards the issues addressed and the conclusions reached in the present document, without prejudice to the rights of the authors.
Globally, GM mammals and birds are being developed for a range of purposes, including use as food, pets or for production of pharmaceuticals. There is a requirement, therefore, for an analysis of the type of expertise and data required to conduct an environmental risk assessment (ERA) of GM mammals and birds to be commercially released into the EU environment.
A searchable database of expertise relevant to an ERA was established – information was collated against scientific disciplines, fields of expertise, research institutes, and academics/experts. A database of GM species and traits where substantial progress has been made towards commercial use was compiled; theoretical case studies were also used to allow the development of a comprehensive list of criteria to be considered in an ERA.
The potential adverse effects of GM mammals and birds on the environment, their consequences and likelihood were identified. Crucial mammal and bird characteristics, baseline information about receiving environments and approaches using modelling and surrogate non-GM species were evaluated for their utility in an ERA.
The identification of the characteristics of GM mammals and birds that influence their potential risk to the environment has a corollary in the evaluation of risk posed by non-native species. It was concluded, therefore, that criteria should be considered at each stage of an invasion process (introduction, establishment and spread) and consider the inherent risk posed by the non-GM parent species and the effect that the genetic modification may have on that inherent risk. Consideration should also be given to any infectious diseases, or agents, that may be carried by the species and how these may be influenced by the genetic modification.