title: Application of current allergy assessment guidelines to next-generation biotechnology-derived crops.
abstract: In any single day, our immune systems are exposed to thousands of different proteins from the environment and the food we eat. In a portion of the human population, some of those proteins will stimulate the immune systems to synthesize immunoglobulin E in an allergenic response. The discrepancy between the vast numbers of proteins we encounter and the limited number of proteins that actually become allergens have led scientists on a quest to discover what unique features exist that make proteins destined to be allergens. The information gained from these studies has led to an allergy assessment strategy that characterizes the potential allergenicity of biotechnology products prior to their commercialization. This testing strategy appears to be effective as shown by the fact that there have been no clinically documented food allergic reactions to any of the biotechnology proteins introduced into food crops, to date. The next generation of biotechnology products will most likely contain more complex traits, including nutritionally enhanced food crops, and the question arises as to whether the current allergy assessment strategy will be sufficient to protect the health of the consuming public. In this paper, we discuss general allergen characteristics in order to better understand how proteins become allergens, summarize the current allergy assessment process, evaluate the different aspects of this process for their adequacy in determining the allergenic potential of engineered functional foods, and, finally, we assess the possibility of new technologies having a positive impact on the allergy assessment of nutritionally enhanced crops.
authors.affiliation: Monsanto Co., Global Regulatory Sciences, 800 N. Lindbergh Blvd, St. Louis, MO 63167, USA. gary.a.bannan@monsanto.com
authors.forename: Gary A
authors.initials: GA
authors.lastname: Bannon
authors.forename: Susan
authors.initials: S
authors.lastname: Martino-Catt
mesh_terms: D000485:Allergens / Q000737:chemistry; D000818:Animals; D001709:Biotechnology / Q000379:methods* / Q000639:trends; D019295:Computational Biology / Q000379:methods; D018556:Crops, Agricultural / Q000235:genetics*; D005502:Food; D005512:Food Hypersensitivity / Q000235:genetics; D030841:Food, Genetically Modified; D017408:Guidelines as Topic; D006801:Humans; D006967:Hypersensitivity / Q000175:diagnosis*; D006969:Hypersensitivity, Immediate / Q000235:genetics; D007073:Immunoglobulin E / Q000378:metabolism; D030821:Plants, Genetically Modified; D011506:Proteins / Q000032:analysis / Q000737:chemistry
chemical_list: D000485:Allergens; D011506:Proteins; D007073:Immunoglobulin E