Food Safety Assessments for Bio-Engineered Crops in U.S. Food Aid Donations

Foods produced with modern biotechnology, such as maize (corn) and soybeans, have been rapidly adopted by U.S. farmers since their introduction in 1996. In recent years, up to one-third of U.S. corn acreage and three-quarters of U.S. soybean acreage has been planted with bio-engineered varieties. In the U.S. commodity marketing system, harvested grain and oilseeds from many sources are commonly mixed at several points, and bio-engineered crops are not generally separated from non-bio-engineered crops. Systems to segregate non-bio-engineered crops from the field to the market are costly and have been implemented on a very limited scale in the United States. Approximately 1-2% of corn and 2% of soybean production are currently grown and marketed under such systems, for high-value products and markets. Commodity shipments for food aid, as well as product destined for domestic and export food and feed uses, may contain mixed bio-engineered and non-bio-engineered crops.

U.S. farmers have adopted crop varieties bio-engineered to be resistant to insects, tolerant to herbicides, or both. Insect resistance is derived from a soil bacterium, Bacillus thuringiensis (Bt). Crop plants have been engineered to produce Bt proteins that are toxic to certain insects but are safe for humans and other organisms. Sprayable Bt insecticides are commonly used by organic farmers. Herbicide tolerance is also derived from soil bacteria. Herbicide tolerant crops are engineered to withstand the use of very effective herbicides that would otherwise harm the crop.

The bio-engineered crops that are planted by U.S. farmers, including maize and soybeans, have been rigorously reviewed for environmental and food safety by all relevant U.S. regulatory agencies, including the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service, the Environmental Protection Agency, and the Department of Health and Human Services’ Food and Drug Administration. These assessments were conducted to evaluate food safety for the multi-ethnic U.S. population, and the United States is not aware of any reason to suggest that these foods would be unsafe for populations in other countries.

Outside the United States, bio-engineered maize varieties have been approved for use in human food and animal feed in several other countries as well, including Argentina, Australia, Canada, the European Union, Japan, Korea, Netherlands, Switzerland, and United Kingdom. South Africa has conducted food safety reviews of bio-engineered maize and has approved both yellow and white maize varieties, which are now being planted. Bio-engineered soybean varieties have been approved for food and feed uses in Argentina, Australia, Brazil, Canada, European Union, Japan, Korea, Mexico, Netherlands, Russia, South Africa, Switzerland, and Uruguay.

The food safety reviews of bio-engineered crops are generally focused on the safety of the newly introduced trait, and on the safety of the whole food. The food safety issues considered in the regulatory review include toxicity, allergenicity, nutritional content, and antibiotic resistance.

The safety assessment of bio-engineered crops considers various aspects of the newly introduced genetic material and expressed substances that will be present in food in order to ensure that they are not likely to be toxins or allergens or substances that would otherwise adversely affect the health of consumers. The assessment considers the identity of the substance, its structure and function in the plant, the source from which it is derived, whether it will be normally digestible, the concentration of the substance in food, if any, and whether any significant effects on nutrition would be expected. The use of antibiotic resistance traits in the development of bio-engineered varieties has also been considered in the safety review in order to safeguard against the possibility of compromising the efficacy of orally administered antibiotics. Overall, evaluations consider whether any new substances introduced into the food supply through genetic engineering of crop plants are safe for consumers.

Food safety assessments also examine whether any unintended changes have occurred in the composition of the food due to the bio-engineering process. A primary consideration in the assessment is whether genetic material that is introduced into the plant is incorporated into the plant genome in a stable manner and thus will not rearrange during crosses to develop subsequent generations. Stable inheritance of the introduced trait reduces the likelihood that additional unintended effects from the inserted genetic material will occur in subsequent generations. Analyses are also conducted to ensure that the important components of the food are what would be expected for the particular crop. These tests would include analyses for key nutrients, anti-nutrients, vitamins, minerals, toxicants, and other components that are typical of the plant.

The potential of foods derived from bio-engineered plants to cause allergies in sensitive individuals is an important element in the food safety assessments of bio-engineered crops. The foods derived from bio-engineered crops that are currently on the market and that may be part of U.S. food aid have been evaluated for possible allergenicity. New proteins in crops currently on the market have not been found to resemble allergens, and tests have shown that the native allergens in crops such as soybean have not been increased.

Special labeling to declare the method of development for bio-engineered food products is not required in the United States, because these products do not differ in any significant way from their conventional counterparts solely due to the process through which they were developed. Bio-engineered foods would be subject to labeling if they contained a new allergen; or had altered nutritional characteristics (such as modified oil content); or required altered cooking, preparation, or storage procedures as compared to their traditional counterparts.

The U.S. approach to food safety review is consistent with the approach proposed by the Codex Ad Hoc Intergovernmental Task Force on Foods Derived from Biotechnology and recommended for adoption by the Codex Alimentarius Commission. In particular, the Codex approach provides a scientifically sound basis for determining that food derived from bio-engineered crops is as safe as its traditional counterpart.

In addition to the product-specific food safety assessments that are conducted by U.S. regulatory agencies prior to the commercialization of bio-engineered crops, a committee of the National Research Council, a private nonprofit institute operating under a congressional charter, has reviewed the broad food safety risks and concluded that it "..is not aware of any evidence that foods on the market are unsafe to eat as a result of genetic modification." The Department of Health and Human Services' Food and Drug Administration is confident that foods derived from bio-engineered crops for which food safety reviews have been completed are as safe as their conventional counterparts.

On U.S. regulatory reviews:

On food safety assessment approach recommended by international organizations:

Also see fact sheets on:
-- Environmental Considerations for Bio-Engineered Crops in U.S. Food Aid Donations;
-- Agricultural Development and Trade Issues for Bio-Engineered Crops in U.S. Food Aid Donations.