*EPF310 02/28/01
U.S. Agencies Toughen Regulations for Bioengineered Foods
(Experts counter objections of critics) (1510)
By Jim Fuller
Washington File Science Writer

Washington - U.S. government agencies have renewed efforts to strengthen programs for approving the release of genetically engineered foods as the debate continues over the potential health and environmental effects of these new products.

The U.S. Food and Drug Administration (FDA) recently proposed regulations that would make it mandatory for producers of food and animal feed developed through biotechnology to notify the agency 120 days before they intend to market the products. Currently, developers of such food participate in a voluntary consultation program with the FDA.

The decision to establish mandatory premarket notification is based on information and comments received at public meetings conducted by FDA in four different cities last year. To date, all bioengineered food and feed marketed in the United States have gone through the consultation program before they have entered the market, according to FDA officials.

Last August, the Environmental Protection Agency (EPA) announced plans to undertake a comprehensive scientific and public review of its current approval policies for corn and cotton seeds genetically engineered to make their own pesticides. The agency said the reassessment is intended to assure that decisions on the registration renewal for these crops "are based on the most current health and ecological data."

Under the current regulatory process, the FDA is charged with making sure that genetically engineered foods meet the same rigorous safety standards that are required of all other foods, while the EPA must approve the registration of a new pesticide before it can be sold or distributed in the United States.

Before the development of biotechnology techniques, scientists worked to improve plants for human benefit by using conventional techniques, such as selective breeding. Nectarines, which are genetically altered peaches, are one example of such breeding and selection.

Genetic engineering techniques now enable scientists to insert genetic material into plants from other organisms to produce plants with new, advantageous characteristics -- for example, plants with increased nutritional value or plants that have the ability to make their own pesticides. The new techniques -- which provide the ability to isolate genes -- can be used with greater precision, allowing scientists to introduce new traits into foods without simultaneously introducing undesirable traits, as may occur with traditional breeding.

The FDA's newly proposed rule, if finalized, would require food manufacturers to provide specific information to demonstrate that the bioengineered food -- such as tomatoes or potatoes -- is as safe as the same food produced by conventional means. To make the process more open to the public, the agency will post the information submitted by manufacturers, as well as the agency's responses, on the following Web site: www.fda.gov/foi/electrr.htm

In a separate but related action, the FDA also issued a draft document, which if finalized, would provide guidance to manufacturers who wish voluntarily to label their products regarding whether or not they contain bioengineered ingredients.

"Our goal is to enhance public confidence in the way in which FDA is regulating bioengineered foods," said Joseph Levitt, director of FDA's Center for Food Safety and Applied Nutrition, in recent testimony. "We want the public to know, loud and clear, that FDA stands behind the safety of these products."

But FDA's new rules have come under heavy criticism from some environmental groups who say the proposals fail to protect public health and the environment. These groups charge that the industry-backed studies that the FDA relies on for information about the safety of genetically engineered foods are rarely rigorously conducted or peer reviewed.

The FDA's "consultation process is watered down consumer protection, calling only for notification, not true regulatory review," said Rebecca Goldburg, senior scientist with Environmental Defense, a non-profit group. "FDA will not require industry to demonstrate the safety of new biotech foods before they go on supermarket shelves.

"To make matters worse, consumers may be shut out of the consultations, since industry is allowed to keep safety data confidential until consultations are finished," she added.

The labeling of products made through bioengineering has also become a contentious issue, with activists arguing that consumers need and deserve the information. Democratic Senator Barbara Boxer of California and Democratic Representative Dennis Kucinich of Ohio have introduced bills to make labeling mandatory, a step already taken by the European Union and some Asian countries.

Some scientists have warned that genetic engineering techniques could introduce toxins or human allergens into food crops. Someone with a peanut allergy, for example, could have a bad reaction to a plant engineered to carry a peanut protein. There is concern such techniques could also introduce anti-nutrients, such as molecules that cause alterations in the amounts of nutrients normally found in a food -- for example, a reduction of Vitamin C.

However, most experts emphasize that bioengineered foods on the U.S. market today are as safe as their conventionally bred counterparts. This is the conclusion of a recent report by the National Resource Council of the National Academy of Sciences, which states that "the council is not aware of any evidence that foods on the market are unsafe to eat as a result of genetic modification."

A report released in January by the scientific council of the American Medical Association said genetically modified foods have been available for about 10 years and no long-term effects have been detected to date. The report also concludes that bioengineered foods are "substantially equivalent" to their conventional counterparts.

"Genetic engineering is capable of introducing allergens into recipient plants, but the overall risks of introducing an allergen into the food supply are believed to be similar to or less than that associated with conventional breeding methods," the AMA council said.

FDA officials emphasize that the kinds of testing typically conducted by developers of a bioengineered food crop address all of these concerns. In the event that something unexpected does occur in the process of genetic manipulation, this testing provides a way to detect such changes at the developmental stage, and defer marketing until any concern is resolved.

Since the FDA's 1994 evaluation of the so-called Flavr Savr tomato, the first genetically-engineered plant food to reach the U.S. market, the agency has reviewed data on more than 45 other products, ranging from herbicide resistant soybeans to a canola plant with modified oil content.

According to the Federal Food, Drug, and Cosmetic (FD&C) Act, bioengineered foods must adhere to the same standards of safety that apply to their conventionally-bred counterparts. "It is important to note that the FD&C Act places a legal duty on developers to ensure that the foods they market to consumers are safe and comply with all legal requirements," FDA's Levitt said.

Under the FDA's current consultation process for new bioengineered foods, such as tomatoes or soy beans, the agency advises a company early in the product development stage on what tests would be appropriate to assess the safety of the new food. After the studies are completed, the data on the safety and nutritional assessment are provided voluntarily to FDA for review. The agency evaluates the information for all of the known hazards and also for potential unintended effects on plant composition and nutritional properties.

Also, the FD&C Act requires premarket approval for any food additive. For example, a novel sweetener bioengineered into food would likely require premarket approval.

Linda Kahl, a food expert with FDA's Center for Food Safety and Applied Nutrition, said in an interview that many have a misperception about the voluntary nature of the consultation process. "The companies come voluntarily -- but as a practical matter they are completely unable to market their food or approach a regulatory agency in any other country unless they've been to FDA. In a sense, they have no choice.

"So we believe that the industry has come to us with all bioengineered foods that are currently on the market," Kahl added. "They have conducted appropriate tests. They've shared the results of those tests with us. And I think there is a misunderstanding that because the process is voluntary that nobody is minding the store. As a practical matter, the store has been pretty carefully minded."

On the controversial issue of labeling, Levitt said that consumers expressed a strong desire for mandatory labeling of genetically engineered food during the public meetings held last year. Many consumers expressed concern about the possible long-term environmental and health effects of such foods, and felt that labeling would allow them to make more informed decisions about whether or not to buy a product.

"Views on labeling were very strong and ... polarized," Levitt said. He said that under the FD&C Act, the agency had neither a scientific nor legal basis to require such labeling. Under the Act, genetically engineered foods must adhere to the same standards of safety as traditional foods in the market. Levitt added, however, that draft guidance now existed for companies that wish voluntarily to label either the presence or absence of bioengineered food in food products.

"Companies are going to be pushed by customers to put labeling on their products," Levitt said. "Our job here is to determine what information would be educational without being misleading."

(The Washington File is a product of the Office of International Information Programs, U.S. Department of State. Web site: http://usinfo.state.gov)
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