Introducing food products into the market place requires that the safety aspect be fully analyzed and documented so that healthy transgenic animals will be at least as safe as the traditional animals from which they were derived. The insertion of a transgene into a recipient genome, however, is a safety consideration because the location and manner of insertion may increase or decrease the expression of host genes. The safety of gene products may be reviewed in the same way the safety of drugs or pesticides are classically reviewed, i.e., the important food safety matter is the presence of a pharmacologically or toxicologically active residue. Once the safety of the transgene product is established, transgenic animals may be considered as safe as traditional animals.