September 29, 2000

A biotechnology advocate told a Senate committee this week that a coming Food and Drug Administration requirement for companies to notify the agency about specific biotech products coming to market already has been exceeded by companies' performance in the past.

FDA has said it soon will publish a proposed rule mandating that developers of bioengineered foods and animal feeds notify the agency when they intend to market such products. FDA will in turn require that specific information be submitted to help determine whether foods or animal feeds pose any potential safety, labeling, or adulteration issues.

Specifically, FDA will propose to strengthen the process by requiring developers to notify the agency of their intent to market a food or animal feed from a bioengineered plant at least 120 days before marketing.

However, Michael J. Phillips, executive director for food and agriculture for the Biotechnology Industry Organization (BIO) told the Senate Committee on Health that BIO member companies typically consult with FDA one to three years in advance of marketing a food or animal feed.

Phillips noted that this year, about a fourth of the corn, and more than half the soybeans and cotton consist of varieties improved through biotechnology. "The fact of this rapid market penetration speaks eloquently of the benefits provided to farmers in terms of reduced input costs, increased yields, and reduced chemical inputs," he added.

Benefits to consumers and the environment also are significant, he added. "We already have genetically improved oilseeds that have given us improved cooking oils that lead to foods healthier for the heart -- holding promise to reduce the 500,000 deaths among American citizens from heart disease every year."

Complementary improvements in food qualities are also being pursued, such as potato starch modified so that french fries absorb less oil in cooking and coming on stream are fruits and vegetables modified to improve flavor, nutritional quality, and significantly reduce wastage, processing costs, and energy requirements, Phillips said.

"On the horizon are foods modified to contain increased amounts of anti-cancer compounds, or with enhanced levels of such essential dietary components as iron and vitamin A. Foods responsible for common or widespread allergens are being modified to reduce or eliminate their allergenicity. And plants, such as the widely publicized `Golden Rice' are being modified safely to eliminate nutritional or dietary deficiencies such as vitamin A deficiency that leads to night blindness or inadequate iron uptake that results in anemia."

Rigorous testing and government regulations are in place to ensure the safety of these products so that the benefits of biotechnology can be realized, he added. "In fact, crop varieties enhanced through the use of biotechnology are tested more thoroughly than conventional varieties before they ever come to market."

To make sure that consumers also have extensive access to product information, FDA will propose that submitted information and the agency's conclusions be made available to the public, consistent with applicable disclosure laws, by posting them on the FDA Web site for easy viewing. "BIO is fully in favor of this proposal and in our comments to FDA during the public outreach meetings urged the FDA to place this type of information on its Web site," he said.

Consumer acceptance, he added, "is the first and most important issue for the biotechnology industry." Even the Kraft recall of Taco Bell shell products because of the possibility that StarLink corn may have been an ingredient should be put in perspective, Phillips said.

"It should be noted that StarLink is only one of eight biotechnology corn varieties on the market today and is grown on less than half of 1% of the total U.S. corn acreage. All of the other corn varieties improved through biotechnology have been thoroughly tested and fully reviewed by EPA and FDA for human consumption," he said.

BIO supports Kraft's voluntary recall even though there are no known health risks associated with the protein. "We believe that confidence in the safety of all food products must be the first and only priority," said Phillips.