EFSA Issues New Guidance for Environmental Risk Assessment of GM Animals

The European Food Safety Authority (EFSA) has published new guidance on ways of assessing the potential risks of producing genetically modified (GM) animals, including fish, insects, mammals, and birds. Although EFSA reports that it has not yet received any applications for GM animals, the European Commission evidently requested that the agency develop environmental risk assessment (ERA) guidance because scientific developments indicate that “future submissions may be made for a number of species.”

According to EFSA, the guidance will provide a “clear framework” for evaluating potential adverse effects of living GM animals on the environment and on human and animal health. “The core of the guidance is that ERAs for GM animals must be carried out in a scientifically sound and transparent manner,” said Elisabeth Waigmann, head of EFSA’s GMO Unit. “They must be based on sufficient scientific and technical data that enable conclusions to be drawn on possible environmental risks posed by a living GM animal. The inclusion of a comprehensive uncertainty analysis is of central importance given the current limitations in the availability, relevance and quality of data relating to GM animals.

The guidance document states that ERAs for GM animals would be performed on a case-by-case basis, depending on the animal type, the trait being introduced and the animal’s intended use. See EFSA News Release, May 23, 2013.