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Approaches to the Safety Assessmentof Novel Foods and Novel Gene Products

The safety of genetically modified foods should be considered and assessed at all stages of the developmental process. The introduction of foods produced through agricultural biotechnology has generated considerable concern among certain consumers in many countries. The safety of these novel products has often been called into question during the ongoing public debate. So, safety assessment of these novel foods is absolutely crucial to their acceptance by consumers. Safety assessment must be a consideration at all stages of the development of a genetically modified food: gene discovery, line selection, and product advancement to commercialization. This article focuses on the role that safety assessment plays in all three of those stages. Particular emphasis is placed upon allergenicity assessment, but we must recognize that allergenicity is but one factor to consider in a comprehensive safety assessment approach. In many countries, the safety assessment for genetically modified foods is mandatory and a review of the safety assessment data is conducted by the regulatory authorities. Some concern has arisen because the safety assessment process in the United States has been voluntary, but the U.S. Food & Drug Administration has announced its intent to create a mandatory safety assessment for genetically modified foods. However, the genetically modified foods allowed on the U.S. market thus far have been subjected to a de facto mandatory safety assessment system because governmental regulatory agencies have reviewed the available safety assessment information. Thus far, all 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