Gaining perspective on the allergenicity assessment of genetically modified food crops.

Genetically modified plants are created by the insertion of foreign genes into plant cells followed by the generation of reproductively stable stock plants for rapid and precise improvements in agricultural crops. Current products provide resistance to insect pests, plant viruses or herbicides. Future products include nutritionally enhanced crops, salt and draught tolerant crops and plant produced industrial enzymes or pharmaceuticals. The risk that a newly expressed protein might cause serious allergic reactions is real, but the probability is relatively small. Regulatory agencies require a premarket evaluation of the genetically modified crop to reduce the potential for increased risks of food allergy. While absolute proof of safety is not possible, the major risk - transfer of a potent major allergen or nearly identical crossreactive protein - is minimized by allergen-specific serum immunoglobulin E tests that evaluate proteins taken from major allergenic sources or proteins with sequences highly similar to any allergen. Other tests are performed to identify proteins that are likely to sensitize consumers. Experience indicates the current assessment process is working effectively. However, further guidance on bioinformatics and immunoglobulin E assays could increase the reliability of the assessment. Further development of alternative assays may be needed to assess the next generation of products.