Final document published
USA: Guidance for the regulation of genetically engineered animals

(20 January 2009) The US Food and Drug Administration (FDA) has published the final guidance for the regulation of genetically engineered animals and their derived products. In September 2008, the FDA released the draft guidance for public consultation and received around 28,000 comments.

To date worldwide, no genetically modified animals have been approved, except for fluorescent zebrafish (GloFish) for aquariums and rodents kept in secure research labs. Particular progress is underway in the development of transgenic animals to be used for the production of pharmaceuticals.

To receive commercial authorisation in the USA in future, producers must demonstrate that such animals or their derived products present no risk to the health or safety of humans or animals and that any derived food products are as safe as conventional counterparts. Such proof would be conducted in a similar manner to that which currently is required of genetically modified plants. It also must be certified that the husbandry or market placement of such animals poses no risk to the environment. Applicants must declare to the FDA the process through which the new gene is introduced, as well as the constituents of the gene construct and that the new characteristic is passed on in a stable manner.

As a rule, every transgenic animal must undergo this approval process before being marketed. Nonetheless, there are exceptions: for example, laboratory animals that exclusively are used for purposes of research will not be reviewed in every case. Within the FDA, the Center for Veterinary Medicine (CVM) is responsible for the review of transgenic animals. In the case that an animal is prompted by its genetic modification to produce pharmaceutical compounds, the safety of these compounds will be assessed separately. Currently, the FDA is reviewing the safety of the product Antithrombin III that is produced with the aid of transgenic goats. This product has been on the market in Germany since 2008.

Labelling for foodstuffs and products from GM animals is not planned. The FDA has been criticised sharply with regard to this issue: consumer organisations have cited polls in which a large majority of purchasers in the USA demand labelling for foodstuffs derived from GM animals.

Further information:

• FDA: Genetically Engineered Animals