The report of the FAO/WHO Expert Consultation on the Safety Assessment of Foods derived from Genetically Modified Animals, including Fish (GM animals) provides advice on the topic to FAO and WHO and their Member States. The consultation focused on discussing what strategies are appropriate and applicable to the food safety assessment of GM animals and addressed issues originating from the production of GM animals as well as environmental and ethical issues. The consultation did not include all environmental issues but focused on the connection between environmental entry of GM animals and food safety. It also addressed ethical considerations that relate directly to the scientific assessment of foods derived from GM animals.