The safety of foods developed by biotechnology.

Abstract

Recombinant DNA techniques are now being used to develop new plant varieties that will be sources of foods, such as fruits, vegetables, grains, and their by-products. These techniques enable developers to make specific genetic modifications in plants, including modifications that introduce substances into plants that could not be introduced by traditional methods. To ensure the safety of the resulting foods and to foster innovation, the FDA is taking the initiative, before foods from such plants are ready to enter the market, to see that there is an agreed upon scientific basis to evaluate the safety of whole foods and animal feeds derived from new plant varieties. Here, the authors summarize their regulatory framework and their approach to safety assessment and discuss its scientific basis. Their safety assessment approach addresses new varieties of food crops developed by both traditional and newer methods of genetic modification and provides guidance on how safety issues should be addressed.