The implementation of genetic engineering in animals is a rapidly developing field. In January 2009, the US FDA issued the final version of its Guidance on the Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs. This document clarifies the FDA’s statutory and regulatory authority, and provides recommendations to producers of GE animals to help them meet their obligations and responsibilities under the Federal Food, Drug, and Cosmetic Act. The FFDCA defines “articles (other than food) intended to affect the structure or any function of the body of man or other animals” as drugs. Because an rDNA construct in a GE animal is intended to affect the animal's structure or function, it meets the definition of a new animal drug, whether the animal is intended for food, or used to produce another substance. The FDA has developed a risk-based approach to the regulation of these rDNA constructs in GE animals.

Two techniques, cloning and transgenesis, offer new possibilities to improve the exploitation of farm animal genomes. Cloning is a way to generate genitors having the same genome as that of their genetic parents. This allows the prolonged use of genitors having a high value genome validated by the properties of their offspring born after sexual reproduction. Transgenesis is a way to introduce known new traits into genitors in only one generation. This implies foreign gene addition to a genome or specific inactivation of endogenous genes. Among the current projects are the generation and the study of animals having resistance to diseases, accelerated growth, improved milk or meat composition, milk containing anti-pathogen proteins or reducing pollution. Cloning and transgenesis are thus opposite but complementary techniques.

In order to increase the efficiency of the risk/safety assessment process and to reduce duplication of effort, OECD countries have recognised the value of working together to harmonise approaches and share information used in safety assessment.

The European Food Safety Authority (EFSA) is the keystone of European Union (EU) risk assessment regarding food and feed safety. In close collaboration with national authorities like the German Federal Office of Consumer Protection and Food Safety (BVL) and in open consultation with its stakeholders, the EFSA provides independent scientific advice and clear communication on existing and emerging risks. The GMO Panel provides independent scientific advice on the safety of GMOs such as plants, animals and micro-organisms, on the basis of Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms; and of genetically modified food and feed, on the basis of Regulation (EC) No 1829/2003 on genetically modified food and feed.