Labeling of rDNA Biotechnology-Derived Foods

The information presented on food labels is considered one of the most important sources of information about foods. Labeling initiatives for rDNA biotechnology-derived foods are likely to have substantial effects on the production, distribution, and cost of food to consumers.

U.S. Food Labeling in General

Federal law provides a legal framework to address the public’s right to be informed of significant or material facts about their food by requiring food manufacturers to disclose those material facts by labeling foods in a truthful, nonmisleading manner. This framework is established by the U.S. Constitution, the Federal Food, Drug, and Cosmetic Act (FFDCA; 21 USC §§301- 397) and its implementing regulations. Generally, if a new or modified food is significantly different from its conventional counterpart in composition, nutritional value, or safety, the difference in the food would be considered a material fact, and labeling would be required. Conversely, a fact that does not render a food significantly different from its conventional counterpart is not material and, therefore, is insufficient to require labeling. Nonetheless, when marketplace interest is sufficient, voluntary disclosure programs with certain limitations may be established to provide the desired information. Like mandatory disclosures, voluntary label statements must be truthful and not misleading by implication or omission.

Specific Labeling of rDNA Biotechnology-Derived Foods

U.S. Policies. FDA has not established special labeling requirements for rDNA biotechnology-derived foods. After considering public comments and scientific evidence, the agency concluded that this class of food does not differ materially from conventional foods. However, individual rDNA biotechnology-derived foods may be significantly different from their conventional counterparts and in such cases would require disclosure.

Mandatory Disclosures. Labeling is required for specific rDNA biotechnology-derived foods that differ such that the common name no longer adequately describes the food, that have a safety or usage issue, or that contain an allergen consumers would not expect.

Voluntary Claims. In the event that voluntary labeling is used for rDNA biotechnology- derived foods, it must meet the same standards for truthfulness and accuracy that apply to all labeling.

International Policies. The Codex Alimentarius Commission is the primary international forum for discussion of labeling of rDNA biotechnology-derived foods. The Codex Alimentarius Commission is a joint standard-setting body of the Food and Agriculture Organization of the United Nations and the World Health Organization that was established to harmonize international food requirements to foster public health and international trade.

Two different approaches to labeling of rDNA biotechnology-derived foods are currently under consideration by the Codex Committee on Food Labeling. The first approach, supported by the U.S., Canada, and others, would required only the disclosure of significant differences. European countries and others favor a “mandatory labeling” approach that would identify all foods derived through rDNA biotechnology. In addition to the Codex activities, some countries are considering or have enacted laws requiring labeling of rDNA biotechnology-derived foods, including the European Union, Japan, South Korea, Australia, and New Zealand.

Impact of Market Segmentation of Crops. Labeling of rDNA biotechnology-derived foods must be premised on discrete grainmarketing channels and, therefore, necessitates either product testing or process verification. Depending on the details of the labeling program, product testing would focus on the product attributes and would be subject to the challenges of sampling and testing, e.g., obtaining representative samples, and testing for all possible genetic modifications. In contrast, process verification would require either a producer guarantee of purity and subsequent identity preservation or a third-party certification that the grain handling procedures minimize the possibility of contamination.

The degree of purity demanded would dictate whether the current grain handling and distribution system could be modified or whether a new, dedicated system for non-rDNA biotechnology-derived material would be necessary.

Consumer Reactions. Evidence indicates that most U.S. consumers are not concerned about the safety of foods derived using rDNA biotechnology and support its application in agriculture and food production. Furthermore, a majority believe it does not pose a health hazard. In contrast, many Europeans consider rDNA biotechnology- derived food to be a serious risk. The difference between consumer attitudes may be attributed in part to perceptions of risk, level of knowledge, or trust in regulatory authorities.


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.