Regulation and application of biotechnology products for use in veterinary medicine *

In pursuing the dynamics of the marketplace of biotechnology in animal health and the impact that regulatory issues might have today, I would like to tell you how the United States Department of Agriculture (USDA) is responding to some of the regulatory challenges that the "new biotechnology" has posed. I will briefly review our policy on and authority for regulating veterinary biological products produced through biotechnology; the challenges posed by the persistent myths surrounding biotechnology; the commercial and agricultural impact of biotechnology; our procedures for and experience in the licensing of biological products; and, finally, I will take a close look at the promise we have seen in one class of these products .