U.S.
Food and Drug Administration
FDA Consumer magazine
July-August 2002
Table of Contents
My concerns involve the use of biotechnology in agriculture. Biotechnology used in our food supply has become widespread in the United States. In 1999, more than half of the U.S. soybean crop was genetically modified to be resistant to the herbicide Round Up and about one-third of the corn crop contained the Bacillus thuringiensis (Bt) gene to resist damage by corn borers. Food manufacturers use corn and soy in many reprocessed foods; thus, use of biotechnology-derived ingredients is widespread in the U.S. food supply.
Public opinion about food biotechnology has not yet coalesced because the adoption of the technology has moved faster than the public's ability to fully understand the process and its implications. The FDA reported that most participants in consumer focus groups assembled in March 2000 expressed great surprise that food biotechnology has become so pervasive in the U.S. food supply. The typical participant reaction was outrage that such a change could happen without them knowing about it.
I would like the public to be informed about what they are eating and be able to read labels to have a choice whether they want to buy biotech foods. As it stands, we are unaware whether our food is tainted or pure.
Back in the 1950s, DDT was deemed to be safe and we, as babies, ingested many products sprayed with this pesticide. Do we have to take more risks again? How is biotechnology going to affect our ecological balance with nature?
Please respond with your position on this very controversial subject.
Heidi Naud, Ph.D., R.D.
Mason, Ohio
A reply from the FDA's Center for Food Safety and Applied Nutrition:
The FDA does not require special labeling for foods to indicate whether or not a food or food ingredient is a bioengineered product, just as it does not require labeling to indicate which breeding technique was used in developing a food plant. Rather, any significant differences in the food itself have to be disclosed in labeling. The agency's 1992 policy statement on bioengineered foods asserts that labeling requirements that apply to foods in general also apply to foods produced using biotechnology. However, if genetic modifications materially change the composition of a food product, these changes must be reflected in the food's labeling. For example, if a bioengineered food is significantly different from its traditional counterpart such that the common or usual name no longer adequately describes the new food, the name must be changed to describe the difference. Also, the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that the label of the food must reveal all "material facts" about the food. This means that the label must make clear any other differences between a bioengineered food and its conventional counterpart, including any significant differences in nutritional properties, the presence of an allergen that consumers would not expect in the food, or any other issues that would affect how the food is used or the consequences of its use.
Historically, the agency has interpreted the requirement for labels to reveal "material facts" to mean information about the attributes of the food itself, not how it was produced. The FDA has required special labeling when the absence of such information may: 1) pose special health risks, such as a warning statement on protein products used in very low calorie diets; 2) mislead the consumer in light of other statements made on the label, such as the requirement for quantitative nutrient information when certain nutrient content claims are made about a product; or 3) in cases where a consumer may assume that a food, because of its similarity to another food, has the same nutritional content, looks and smells the same, or has functional characteristics of the food it resembles when in fact it does not (for example, stating that reduced fat margarine is not suitable for frying).
The FDA has received comments suggesting that foods developed through modern biotechnology should bear a label informing consumers that the food was produced using bioengineering. While we have given careful consideration to these comments, we do not have data or other information that would lead us to conclude that bioengineered foods are materially different from conventional foods as defined by the FD&C Act. Hence, we believe that we have neither a scientific nor a legal basis to require disclosure in the labeling. Food processors can voluntarily label either the presence or absence of bioengineered food in food products. The FDA announced the availability of draft guidance for this voluntary labeling in the Federal Register of January 18, 2001.
The FDA is confident that the bioengineered plant foods on the U.S. market today are as safe as their conventionally bred counterparts. This conclusion was echoed by a report published in 2000 by the National Resource Council of the National Academy of Sciences that stated, "The committee is not aware of any evidence that foods on the market are unsafe to eat as a result of genetic modification." Since the FDA's 1994 evaluation of the Flavr Savr tomato, the first genetically engineered plant food to reach the U.S. market, the FDA has reviewed the data on more than 50 other products, ranging from herbicide-resistant soybeans to a canola plant with modified oil content.
Although the FDA believes that it has been consulted regarding the safety of the bioengineered foods currently in the U.S. food supply, it has proposed that manufacturers be required to consult with the agency about new bioengineered foods before they are marketed. This will further assure that all such products are known to the FDA and that we have had input regarding any need for special labeling or a premarket safety review.
Find more information on the FDA's Web site at www.cfsan.fda.gov/~lrd/biotechm.html.
Regarding concerns for the ecological consequences of bioengineered crop plants: All such plants are required to be field tested by the U.S. Department of Agriculture (USDA), and the USDA is required to consider the environmental impact of permitting the use of new crop plants.