Crop Biotech Update

EFSA's Public Consultation on Draft Guidance on ERA of GM Animals

June 22, 2012

The European Food Safety Authority (EFSA) calls all interested stakeholders to comment on the draft guidance on environmental risk assessment (ERA) of GM animals until 31 August 2012. The first part of the task was completed in 2011 with the publication of a guidance document on food and safety and animal health and welfare.

The current draft contains the basic assumption of the comparative assessment using non-GM animals as the baseline with respect to environmental safety. The environmental risk assessment of GM animals will involve collecting, assessing, and generating information about the GM animal to determine, on a case-by case basis, its impact on the environment in comparison with non-GM animals, the news says.

The comparative analysis is specific to GM fish, insects, mammals and birds. It should follow the ERA steps that include: problem formulation, including hazard and exposure identification; hazard characterization; exposure characterization; risk characterization; risk management strategies; and an overall risk evaluation.

For details of this news, see