The allergenicity issue with respect to products derived from biotechnology has been closely considered in the development of the regulatory process for these products. I want to highlight the US Food and Drug Administration's 1992 Statement of Policy - Foods Derived from New Plant Varieties to ensure that relevant scientific, safety, and regulatory issues are resolved prior to the introduction of such products into the marketplace. In this statement, FDA has specifically focused on allergy issues and requires companies to analyze the proteins they are using in the biotech process to determine if they are allergenic. The scenario featured below is a great example of how this process works and shows that a researcher isolated and identified an allergenic protein to be used to improve a soybean crop, but the experiment was cut short and no product was ever developed from this research.
In September 2002 the Society of Toxicology approved a Position Paper titled The Safety of Genetically Modified Foods Produced through Biotechnology. In that Paper, SOT noted that
“The only documented case where a human allergen was introduced into a food component by genetic engineering occurred when attempts were made to improve the nutritional quality of soybeans using a Brazil nut protein, the methionine-rich 2S albumin. Allergies to the Brazil nut have been documented (Arshad et al., 1991), and while still in pre-commercial development, testing of these new soybeans for allergenicity was conducted in university and industrial laboratories. It was found that serum from people allergic to Brazil nuts also reacted to the new soybean (Nordlee et al., 1996). Once this was discovered, further development of the new soybean variety was halted and it was never marketed. This work led to the identification of the major protein associated with Brazil nut allergy which was previously unknown (Nordlee et al., 1996).
It is also important to note that allergens have always been listed on food labels, but this subsequent labeling law allows food manufacturers to use several ways to list allergens on food labels. Additionally, if a product derived from biotechnology should somehow create a new or known allergen, then that product would have to be labeled as such to inform food allergic consumers.
The Food Allergen Labeling and Consumer Protection Act (FALCPA), which took effect January 1, 2006, requires that the labels of foods (including conventional foods, dietary supplements, infant formula, and medical foods) containing major food allergens (milk, eggs, fish, crustacean shellfish, peanuts, tree nuts, wheat and soy) note the allergen in plain language.