Regulation of genetically engineered animals

Abstract

The advent of genetic engineering (GE) techniques to produce transgenic animals in the early 1980s held the promise of being able to make precise changes to the genome of an animal to improve production traits and health in a faster and more specific fashion than possible with traditional breeding and selection. However, almost 30 years later, there are still no GE animal derived food products approved for use world-wide. The first, and to date only, product from a GE animal to be approved for use was human antithrobmin (A-Tryn®) produced in the milk of transgenic dairy goats as a human pharmaceutical. This is in stark contrast to the applications of GE plants, which are numerous and were approved very early in their development compared to GE animals. Why is this so? This chapter will give some perspective on the regulatory process for GE animals with respect to research and development of biotechnology-derived products and address issues that have been holding back the implementation of GE livestock. Topics will include methods for producing GE livestock, agricultural and medical applications of GE animals, regulatory guidelines in the US and factors influencing the development and implementation of GE animals.