Are Bioengineered Foods Safe? : Part 3

by Food and Drug Administration (FDA)

(Page 3 of 3)

In the specific case of foods developed utilizing the tools of biotechnology, FDA set up a consultation process to help companies meet the requirements. While consultation is voluntary, the legal requirements that the foods have to meet are not. To the best of our knowledge, all bioengineered foods on the market have gone through FDA's process before they have been marketed.

Here's how it works. Companies send us documents summarizing the information and data they have generated to demonstrate that a bioengineered food is as safe as the conventional food. The documents describe the genes they use: whether they are from a commonly allergenic plant, the characteristics of the proteins made by the genes, their biological function, and how much of them will be found in the food. They tell us whether the new food contains the expected levels of nutrients or toxins and any other information about the safety and use of the product.

FDA scientists review the information and generally raise questions. It takes several months to complete the consultation, which is why companies usually start a dialog with the agency scientists nearly a year or more before they submit the data. At the conclusion of the consultation, if we are satisfied with what we have learned about the food, we provide the company with a letter stating that they have completed the consultation process and we have no further questions at that time.

FDA Consumer: Since genes are being added to the plant, why doesn't FDA review biotech products under the same food additive regulations that it reviews food colors and preservatives?

Dr. Henney: The food additive provision of the law ensures that a substance with an unknown safety profile is not added to food without the manufacturer proving to the government that the additive is safe. This intense review, however, is not required under the law when a substance is generally recognized as safe (GRAS) by qualified experts. A substance's safety can be established by long history of use in food or when the nature of the substance and the information generally available to scientists about it is such that it doesn't raise significant safety issues.

In the case of bioengineered foods, we are talking about adding some DNA to the plant that directs the production of a specific protein. DNA already is present in all foods and is presumed to be GRAS. As I described before, adding an extra bit of DNA does not raise any food safety issues.

As for the resulting proteins, they too are generally digested and metabolized and don't raise the kinds of food safety questions as are raised by novel chemicals in the diet. The proteins introduced into plants so far either have been pesticides or enzymes. The pesticide proteins, such as BT, would actually be regulated by EPA and go through its approval process before going on the market. The enzymes have been considered to be GRAS, so they have not gone through the food additive petition process. FDA's consultation process aids companies in determining whether the protein they want to add to a food is generally recognized as safe. If FDA has concerns about the safety of the food, the product would have to go through the full food additive premarket approval process.

FDA Consumer: Why doesn't FDA require companies to tell consumers on the label that a food is bioengineered?

Dr. Henney: Traditional and bioengineered foods are all subject to the same labeling requirements. All labeling for a food product must be truthful and not misleading. If a bioengineered food is significantly different from its conventional counterpart--if the nutritional value changes or it causes allergies--it must be labeled to indicate that difference. For example, genetic modifications in varieties of soybeans and canola changed the fatty acid composition in the oils of those plants. Foods using those oils must be labeled, including using a new standard name that indicates the bioengineered oil's difference from conventional soy and canola oils. If a food had a new allergy-causing protein introduced into it, the label would have to state that it contained the allergen.

We are not aware of any information that foods developed through genetic engineering differ as a class in quality, safety, or any other attribute from foods developed through conventional means. That's why there has been no requirement to add a special label saying that they are bioengineered. Companies are free to include in the labeling of a bioengineered product any statement as long as the labeling is truthful and not misleading. Obviously, a label that implies that a food is better than another because it was, or was not, bioengineered, would be misleading.

FDA Consumer: Overall, are you satisfied that FDA's current system for regulating bioengineered foods is protecting the public health?

Dr. Henney: Yes, I am convinced that the health of the American public is well protected by the current laws and procedures. I also recognize that this is a rapidly changing field, so FDA must stay on top of the science as biotechnology evolves and is used to make new kinds of modifications to foods. In addition, the agency is seeking public input about our policies and will continue to reach out to the public to help consumers understand the scientific issues and the agency's policies.

Not only must the food that Americans eat be safe, but consumers must have confidence in its safety, and confidence in the government's role in ensuring that safety. Policies that are grounded in science, that are developed through open and transparent processes, and that are implemented rigorously and communicated effectively are what have assured the consumers' confidence in an agency that has served this nation for nearly 100 years.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.