Safety assessment of genetically modified foods.

The development of novel foods produced through agricultural biotechnology is a complex three-stage process: gene discovery, line selection, and product advancement to commercialization. The safety of genetically modified foods is an integral part of the overall developmental process throughout all of the stages. In the discovery stage, the safety of the gene, its source, and the gene products must be considered. If any questions arise at this stage, these questions must be answered later in the developmental process. During the line selection stage, the genetically modified seed progresses through a variety of greenhouse and field trials. At this stage, the biological and agronomic equivalence of the genetically modified crop to its traditional counterpart must be compared. While the evaluations made during this stage are not specifically directed toward a safety assessment, many potential products with unusual characteristics are eliminated during this stage of development. However, the elimination of products with unusual agronomic or biological characteristics enhances the likelihood that a safe product will be generated. Finally, in the pre-commercialization stage, the genetically modified product undergoes a detailed safety assessment process. This process focuses on the safety of the gene products associated with the introduced gene and any other likely toxicological or anti-nutrient factors associated with the source of the novel gene and the crop to which it was introduced. The safety of the genetically modified product for both food and feed uses is considered. Thus far, all of the genetically modified products brought into the marketplace have been subjected to such an intensive safety assessment. The safety assessment data have been reviewed by regulatory authorities around the world. The current generation of genetically modified products are quite safe for human and feed animal consumption.