The proceedings of the Joint FAO/WHO Expert Consultation on Biotechnology and Food Safety held in Rome, Italy on September 30 to October 4 1996 are outlined. The concept of substantial equivalence and safety in relation to allergenicity, gene transfer from genetically modified plants, gene transfer from genetically modified microorganisms, pathogenicity of microorganisms, genetically modified animals, and food organisms expressing pharmaceuticals or industrial chemicals are discussed. The application of rDNA technology in developing countries is considered.