The safety of GMOs in respect to health and the environment depends on the characteristics of the recipient organism (or parent organism), the inserted genetic material, the final organism that is produced, the recipient environment and the interaction between the GMO and the environment. The objective of the environmental risk assessment is to identify and evaluate potential adverse effects of the GMO(s). These include direct or indirect, immediate or delayed effects, taking into account any cumulative and long term effects on human health and the environment which may result from the deliberate release or placing on the market of the GMO(s). The environmental risk assessment also requires evaluation in terms of how the GMO was developed and examines the potential risks associated with the new gene products produced by the GMO (for example toxic or allergenic proteins), and the possibility of gene-transfer (for example of antibiotic resistance genes).
The risk assessment methodology, reproduced in Annex II to Directive 2001/18/EC, is as follows:
- identification of any characteristics of the GMO(s) which may cause adverse effects;
- evaluation of the potential consequences of each adverse effect;
- evaluation of the likelihood of the occurrence of each identified potential adverse effect;
- estimation of the risk posed by each identified characteristic of the GMO(s)
- application of management strategies for risks resulting from the deliberate release or placing on the market of GMO(s);
- determination of the overall risk of the GMO(s).