02 December 1999

FDA Holds Public Meetings on Bioengineered Foods

By Jim Fuller
USIA Science Writer

Washington -- U.S. officials report that foods from plants produced through biotechnology must be as safe as traditional foods entering the market, and that bioengineered products failing to meet the safety standards of conventional foods face regulatory action.

The remarks were made November 30 at the second of three public meetings being held by the U.S. Food and Drug Administration (FDA) to discuss if any changes are needed in regulating genetically altered foods. The FDA heard from more than 100 representatives of industry, academia and consumer groups at both the first public meeting, held November 18 in Chicago, and at the meeting in Washington. A third meeting is scheduled for December 13 in Oakland, California.

Speakers at the Washington meeting expressed widely differing views on the subject, ranging from scientists who defended the FDA's regulations as adequate to protect the public to consumer group advocates who called for stepped up scrutiny of bioengineered foods to avoid the kind of public protest that occurred in Europe earlier this year.

Joseph Levitt, director of FDA's Center for Food Safety and Applied Nutrition, told the more than 300 people attending the meeting that the use of modern biotechnology to produce new varieties of food crops had "raised a number of questions about the environmental effects of these crops, and about the safety and labeling of food derived from them."

"Because of the recent attention and controversy that has arisen...we want to hear your suggestions on how we might improve our approach to safety assessment and how disclosure of information to the public would be best achieved," he said.

Several university scientists at the meeting strongly supported the FDA's policy of holding bioengineered crops to the same standard of safety testing as crops produced from conventional breeding techniques.

"And the FDA has chosen to focus on the product rather than the process by which it is produced," said Peter Day, director of the Biotechnology Center for Agriculture and Environment at Rutgers University. "I think this is sound and I know of no information that suggests that the process itself is dangerous."

Day said that European consumers have balked at bioengineered food due to lax regulations that failed to contain mad cow disease and dioxin-contaminated animal food.

"The consultative process is better here than in Britain," he said. "This kind of meeting, for example, allows people to express their concerns."

Day said the most important contribution of biotechnology is the potential it holds for the developing world. He cited the development of golden rice, which has an increased iron and Vitamin A content, and wheat that has been engineered to grow in aluminum-toxic soils, which limit food production in many parts of the developing world.

"I don't think we can afford to ignore or set aside the potential of this tool to do some remarkably important things to safeguard the world's food supply," he said.

Carol Tucker Foreman, director of the Consumer Federation of America's Food Policy Institute, told FDA officials that public confidence in genetically engineered foods "has been eroded by the sense that government has been too sensitive to the needs of industry."

"People are not confident about the FDA regulatory process," she said. "Good data and sound science are vital elements of public policy, but they are not the only consideration."

Foreman said that unless the FDA requires companies to submit test data and detailed information about proposed biotech foods, Americans may follow the lead of Europe and reject genetically modified foods.

Foreman called for creation of a special consumer advisory committee on genetically engineered foods that "could help shape the necessary questions in policy and keep it transparent. For consumers, access to adequate information to make a rational decision in the marketplace is absolutely essential."

Foreman said that labels should also be required on foods with bioengineered ingredients to give consumers more information. The FDA only requires labels when biotechnology results in a significant change in the composition of the food product or when allergens have been added.

James Maryanski, the FDA's biotechnology coordinator, said the agency's current policy for regulating foods from plants developed through biotechnology was formulated in 1992, at which time it was determined that bioengineered foods must adhere to the same standards of safety as conventional foods under the Federal Food, Drug and Cosmetic Act.

"This means that these products must be as safe as the traditional foods in the market," he said. "FDA has broad authority to initiate regulatory action if a product fails to meet the safety standards of the act."

Maryanski said the FDA policy focuses on the product, the food or food ingredients rather than on the plant development processes used in their production, as the basis for regulation.

The FDA has established a process under which companies developing plant-based biotech foods are responsible for conducting a series of tests that enable them to anticipate safety concerns. The process also makes it possible for companies to consult with the FDA on food safety issues before bringing new products to the market. FDA scientists evaluate the data provided by firms to determine whether any unresolved issues exist.

"Examples of such issues may include the potential for significantly increased levels of plant toxicants or anti-nutrients, reduction of important nutrients, new allergens, or the presence in the food of an unapproved food additive," Maryanski said. "FDA considers a consultation to be complete when all safety and regulatory issues are resolved."

The first whole food produced through modern biotechnology was introduced in 1994 when the FDA determined that the so-called Flavr Savr tomato was as safe as those bred by conventional means. Unlike conventional tomatoes, which are harvested when they are still green and ripen during the trip to market, the Flavr Savr tomato stays on the vine longer to ripen to full flavor before it is harvested.

Other food biotechnology products either available or soon to be available in the United States include grains, fruits and vegetables with pesticide-resistant and environmentally friendly herbicide-tolerant characteristics, and rice and fruit that resist viruses that cause - diminished yield and crop quality.

"Today's techniques...give scientists the ability to isolate genes and to introduce new traits into foods without simultaneously introducing many other undesirable traits, as may occur with traditional breeding," Maryanski said. "This is an important improvement over traditional breeding."

Several dozen protesters marched outside the government office building where the public meeting was held to demand a halt to any more federal approvals of bioengineered foods until more is known about the long-term health and environmental risks. Demonstrators have also protested genetically modified food in Seattle, Washington, where the World Trade Organization has begun a new round of talks on farm trade and other issues.

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