Human Food Safety Evaluation of rDNA Biotechnology-Derived Foods

All foods produced using rDNA biotechnology to date have undergone a science-based safety assessment focusing on the product characteristics prior to entering the marketplace. Crops modified by modern molecular and cellular methods do not pose risks any different from those modified for similar traits by earlier genetic methods. Because the molecular methods are more specific, users of these methods will be more certain about the traits they introduce into the plants. The science that underlies rDNA biotechnology- derived foods does not support more stringent safety standards than those that apply to conventional foods.

Substantial Equivalence

FDA’s risk-based safety assessment framework for rDNA biotechnology-derived foods concentrates on the products’ characteristics and is intended to apply to all foods “derived from new plant varieties” regardless of the plant’s derivation, i.e., conventional breeding or modern biotechnology. This approach, based on the concept of “substantial equivalence,” compares the new plant variety to its traditional counterpart to focus the scientific assessment on potential differences that might present safety or nutritional concerns.

Product characteristics that trigger further scrutiny to establish safety include introduction of a substance that is completely new to the food supply, an allergen expressed in an unusual circumstance, changes in the concentrations of major dietary nutrients, and higher concentrations of antinutritional factors and toxicants inherent to the food.

Safety of Introduced Genetic Material and Gene Product

To assess the level of any potential risk, the FDA expects the safety assessment to include detailed information about: 1) the gene(s) introduced to modify the plant; 2) the protein(s) encoded by the introduced gene(s), known as the gene product; and 3) other gene products that may be produced or altered by the presence of the introduced protein in the plant.

Unintended Effects

There is no scientific evidence of the occurrence of unexpected toxic or antinutrient factors or of enhanced production of known toxic constituents in any rDNA biotechnology- derived foods brought to market. In conventional crop breeding, unintended effects have been observed infrequently but in such cases the source of the toxic constituent can typically be traced back to a related species used in the cross breeding process. Given the more precise and predictable nature of genetic change accomplished using rDNA techniques, such effects would be less likely in foods derived from rDNA biotechnology.


Allergic reactions can range from mild cutaneous or gastrointestinal symptoms to life-threatening anaphylactic shock reactions. Potential allergenicity is a key safety assessment component. If the gene(s) is obtained from a known allergenic source and the encoded protein is expressed in the edible portion of the rDNA biotechnology-derived food, then the protein must be considered to be an allergen unless proven otherwise.

Products Without Conventional Counterparts

No rDNA biotechnology-derived foods without conventional counterparts have been introduced to date. When such foods are developed, they will need to be evaluated on a case-by-case basis and subject to toxicity assessment.

Scientific Consensus

The safety of rDNA biotechnology-derived foods has been considered extensively by numerous national and international scientific groups, with a striking congruence in the resulting conclusions and recommendations. These organizations—National Academy of Sciences; National Research Council; National Institutes of Health; Food and Agriculture Organization/World Health Organization of the United Nations; and Organization for Economic Cooperation and Development—have considered and reconsidered the safety of the foods and the adequacy of the risk-based safety assessment.

The use of rDNA biotechnology in itself has no impact on the safety of foods derived using these techniques. The related risks are not unique and tend to be associated with particular products and their applications, not with the production process or technology per se. In fact, biotechnology processes tend to reduce risks because they are more precise and predictable than conventional techniques.

In an effort to contribute to a meaningful dialogue on scientific issues and consumer concerns about rDNA biotechnology, the Institute of Food Technologists, a non-profit society for food science and technology, conducted a comprehensive review of biotechnology. IFT convened three panels of experts, consisting of IFT members and other prominent biotechnology authorities, to evaluate the scientific evidence and write a report divided into four sections: Introduction, Safety, Labeling, and Benefits and Concerns.