ToxSci Advance Access originally published online on April 10, 2009
Toxicological Sciences 2009 110(1):31-39; 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
* National Health and Environmental Effects Research Laboratory
National Center for Environmental Assessment, U.S. Environmental Protection Agency, Office of Research and Development, Research Triangle Park, North Carolina 27711
DuPont Co., DuPont Crop Genetics, Wilmington, Delaware 19880
BASF Plant Science, Research Triangle Park, North Carolina 27709
¶ National Center for Environmental Research, U.S. Environmental Protection Agency, Office of Research and Development, Washington, DC 20004
1 To whom correspondence should be addressed at U.S. Environmental Protection Agency, Research Triangle Park, NC 27711. Fax: (919) 541-0026. E-mail: selgrade.maryjane{at}epa.gov.
Received February 14, 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 immunoglobulin E binding studies. Recently conducted research presented at an International Life Sciences Institute/Health and Environmental Sciences Institute–hosted workshop adds to the scientific foundation for safety assessment of transgenic proteins in five 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 suggest 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 four nontransgenic varieties of soy suggested that if known allergen expression in genetically modified crops falls within the range of natural variability among commercial varieties, there appears to be no need to test further. Finally, basic research continues to elucidate the etiology of food allergy.
Key Words: Food Allergy; biotechnology; genetically modified crops; plant incorporated pesticides; safety assessment.
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 reflect the views and policies of the Agency nor does mention of trade names or commercial products constitute endorsement or recommendation for use.