Note: DuPont scientists conducted a review of current scientific literature related to the potential allergenicity of foods developed through biotechnology. This information will be updated from time-to-time. We welcome new scientific information and, of course, your perspective.

1. Introduction - Food Allergies
2. DuPont Product Development and Allergenicity
3. Background: Assessing Food Allergens
4. Current DuPont Products and Allergenicity
5. Future Steps

All foods, whether developed through conventional means or biotechnology, are potential sources of allergens. Food allergies are relevant to products developed through biotechnology because the improvements often involve adding or changing genes. Genes make proteins, and nearly all food allergens are proteins. Our diet contains hundreds of thousands of proteins, but very few (about 200) proteins cause food allergies. Even though the incidence of food allergies is low, the potential consequences can be serious. Therefore, biotechnology products are tested for potential allergenicity before they are marketed.

Physicians distinguish food allergies from other adverse food reactions, such as lactose intolerance. A food allergy is a reaction of the immune system to an otherwise harmless food or food component. In the U.S., about 1 to 2.5 percent of adults and 6 to 8 percent of children have food allergies that can result in mild to severe consequences. Worldwide, 90 percent of food allergies stem from eight major allergens: peanuts, soybeans, tree nuts, milk, eggs, fish, crustacea (for example, shrimp) and wheat. The remaining 10 percent are food allergies that affect very few people, sometimes only one. About 180 foods are included in this minor allergen category.Since it is often not possible to separate the allergic protein from the thousands of proteins present in food, the only way to prevent food allergies is avoidance.  »  More

DuPont treats every introduced protein as a possible allergen and therefore conducts tests during the early stages of product development, before the product is marketed. These tests are done according to procedures developed by scientists and medical experts, and set by the International Food Biotechnology Council and the Allergy and Immunology Institute of the International Life Sciences Institute (IFBC-ILSI). The procedures were also formalized in collaboration with the Allergy and Immunology Institute. Therefore, most regulatory entities around the world use these tests to determine the potential allergenicity of biotechnology crops.

These tests are based on what scientists know about food allergens; molecular structures (especially amino acid sequence similarity) and other characteristics of proteins, such as breakdown during digestion and processing.  » More

No single test can determine whether proteins are allergens. So, scientists perform a number of tests that give clues for allergenicity. The testing procedure depends on the original source of the introduced gene. If the gene is from a known food allergen, a series of clinical tests are conducted using serum samples from people who are allergic to that food.

If the gene has no history of food allergenicity or is a rare food allergen where few, if any, serum samples exist, the testing is based on what scientists know about existing allergens. This includes a comparison of the amino acid sequence of the new protein to all known allergens, and an assessment of protein stability during digestion, as well as at temperatures typically used in food processing. If tests show no sequence similarity or that the protein breaks down quickly during digestion or at temperatures typically used during food processing, the protein is less likely to trigger an allergic reaction.  » More

DuPont biotech crops on the market do not contain genes from known allergens. In fact, DuPont abandoned commercialization work when test results indicated we were working with an allergenic protein. In our work to improve the nutritional quality of soybeans, we investigated a gene from the Brazil nut, a known allergenic food. All commercialization work on this project was stopped when clinical tests on the protein produced positive results for allergenicity. Since enhancing the nutrition of soybeans is valuable, DuPont invested in another approach using proteins from sunflower. However, when tests demonstrated a significant risk of allergenicity, this project was stopped as well.

Even so, our research identified one of the proteins that causes allergic reactions to Brazil nuts - the 2S albumin - a fact not previously known. This would not have been possible without the tools of biotechnology.

(The DuPont products on the market are sold under the Pioneer® brand).  » More

The IFBC-ILSI tests are the best available and have been effective for establishing the potential of allergenicity. However, DuPont and others are using advanced technologies to evaluate testing methods. 

In addition, we are conducting research on a number of fronts. For example, DuPont scientists are working with industry and public researchers to identify potential allergenic proteins in crops known as minor allergens, such as corn. Our work will lead to an understanding of the specific proteins that create allergic reactions and set benchmarks for future products of biotechnology. It will also lead to the development of a serum databank that can be used for testing allergenicity of new corn products.

In addition, to better predict potential allergens, a validated model to directly test allergenicity is needed. DuPont researchers are evaluating several proposed models.  » More