ToxSci Advance Access published online on April 10, 2009
Toxicological Sciences, doi:10.1093/toxsci/kfp075
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Published by Oxford University Press 2009.
Safety Assessment of Biotechnology Products for Potential Risk of Food Allergy: Implications of New Research
U.S. EPA, Office of Research and Development a National Health and Environmental Effects Research Laboratory b National Center for Environmental Assessment Research Triangle Park, NC c National Center for Environmental Research, Washington, D.C d DuPont Co., DuPont Crop Genetics, Wilmington, DE e BASF Plant Science, Research Triangle Park, NC
Correspondence: Dr. MaryJane K. Selgrade, MD-B143-01, U.S. Environmental Protection Agency, Research Triangle Park, NC 27711, Phone: 919-541-1821, Fax: 919-541-0026, selgrade.maryjane{at}epa.gov
Received February 14, 2009; revision received April 6, 2009; accepted April 7, 2009
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Abstract |
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Food allergy is a potential risk associated with use of transgenic proteins in crops. Currently, safety assessment involves consideration of the source of the introduced protein, in silico amino acid sequence homology comparisons to known allergens, physicochemical properties, protein abundance in the crop, and, when appropriate, specific IgE binding studies. Recently conducted research presented at an ILSI/HESI hosted workshop adds to the scientific foundation for safety assessment of transgenic proteins in 5 areas: Structure/activity, serum screening, animal models, quantitative proteomics, and basic mechanisms. A web based tool is now available that integrates a database of allergenic proteins with a variety of computational tools which could be used to improve our ability to predict allergenicity based on structural analysis. A comprehensive strategy and model protocols have been developed for conducting meaningful serum screening, an extremely challenging process. Several animal models using oral sensitization with adjuvant and one dermal sensitization model have been developed and appear to distinguish allergenic from non-allergenic food extracts. Data presented using a mouse model suggests that pepsin resistance is indicative of allergenicity. Certain questions remain to be addressed before considering animal model validation. Gel-free mass spectrometry is a viable alternative to more labor-intensive approaches to quantitative proteomics. Proteomic data presented on 4 non-transgenic varieties of soy suggested that if known allergen expression in genetically modified crops falls within the range of natural variability amongst commercial varieties, there appears to be no need to test further. Finally, basic research continues to elucidate the etiology of food allergy.
Disclaimer: This paper has been reviewed by the National Health and Environmental Effects Research Laboratory, U.S. Environmental Protection Agency and approved for publication. Approval does not signify that the contents necessarily reflects the views and policies of the Agency, nor does mention of trade names or commercial products constitute endorsement or recommendation for use.