6-5 |
A regulatory perspective: The FDA and aquatic biotechnology |
W. J. WARREN, Office of New Animal Drug Evaluation, U.S. Food & Drug Administration, 7500 Standish Pl., HFV-151, Rockville, MD 20855 The FDA regulates, in whole or in part, new animal drugs, including animal biotechnology products. The Agency anticipates that emerging biotechnology developments will become an even greater source of products in the future. The Center for Veterinary Medicine (CVM) must approve new animal drugs before they may be legally marketed. For each new animal drug, whether derived from traditional or biotechnology approaches, a number of technical areas are evaluated: human food safety, environmental safety, target animal safety and effectiveness. New animal drugs derived by biotechnology are a growing proportion of the animal health products regulated by CVM. The spectrum of new animal drugs being presented to CVM for review includes biotechnology products from plants and microbes, and biotechnology products directly from bioengineered animals. Genetic modifications fall into two types: non-heritable modifications (a.k.a.: somatic cell therapy and gene therapy) and germ line transgenic modifications. Non-heritable modifications are still in early stages of development for animals, although this is a very active area in human medicine. Germ line transgenic modifications of animals, including fish and shellfish, have already begun to receive public attention in the U.S. and abroad. Most of the modifications currently relate to improving animal productivity. Aquatic agriculture is currently focused on the improvement of agronomic traits. This talk will attempt to: 1) put transgenic fish in the context of other biotech products that are regulated at FDA, 2) discuss what information CVM considers in evaluating transgenic fish with animal drug modifications, 3) focus on some food safety questions as they relate to transgenic fish, and 4) summarize what role other Federal agencies may play in regulating biotechnology in aquaculture.
Session 6, Marine biotechnology
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