Biotech Foods Rule Fails to Protect American Public

By Cat Lazaroff

WASHINGTON, DC, January 18, 2001 (ENS) - Consumers concerned about the potential health and environmental effects of genetically engineered foods will not find much to like in new federal regulations released this week. The regulations, which provide guidance for the release and marketing of food developed through biotechnology, do not require labeling or premarket testing of engineered foods.


Geneticist Ann Blechl looks at root growth on genetically engineered wheat plants that may carry new genes for resistance to a bacteria (Two photos by Jack Dykinga, courtesy Agricultural Research Service)
After months of controversy, the Food and Drug Administration (FDA) released its proposed biotechnology foods rule on Wednesday. Despite receiving tens of thousands of comments supporting mandatory labeling of genetically engineered (GE) foods, the FDA opted to support voluntary labeling guidelines.

The proposed rule, if finalized, would require food developers to notify the FDA at least 120 days in advance of their intent to market a food or animal feed developed through biotechnology. The FDA agency said it would post information submitted by manufacturers, as well as FDA's responses, in the agency's electronic reading room, located at:

Manufacturers would also need to provide information to demonstrate that the product is as safe as its conventional counterparts, but the FDA did not set out requirements for how that information is obtained. Critics of GE foods and many scientists had pushed for minimum research requirements, such as 90 day safety tests, before new GE foods could be approved for the market.

In a separate but related action, FDA issued a draft guidance document which would provide direction to manufacturers who wish to label their food products as being made with or without ingredients developed through biotechnology. Labeling of GE foods would be entirely voluntary, and would focus largely on "truth in advertising" requirements that the labels accurately reflect the foods' contents.


Half the soybeans planted in the U.S. in 2000 came from genetically modified seeds (Photo by Scott Bauer, four photos courtesy Agricultural Research Service)
"These initiatives will further assure that all food products developed using the tools of modern biotechnology are known to the Food and Drug Administration, so that FDA can continue to examine these products before they reach the market" said FDA commissioner Jane Henney, MD. "These measures will permit the review process to be more transparent to the public, one of the primary issues voiced during FDA's public hearings on this issue."

But the new rule has come under heavy criticism from science and environmental groups who say that the FDA's proposal fails to protect public health and the environment.

"This is a terrible day for American consumers - the government has failed to protect their health and their interests," said Kimberly Wilson, a Greenpeace genetic engineering campaigner in San Francisco. "While the rest of the world is moving to label genetic foods, U.S. consumers are still denied free choice in the grocery store. Americans deserve to know what's in their food, yet FDA is working with industry to keep genetic engineering a secret ingredient."


This bioengineered barley carries a gene that may help the plants resist attack by barley yellow dwarf virus (Photo by Jack Dykinga)
Labeling of genetically engineered foods is required throughout Europe, and in Japan, Russia, Australia, New Zealand and other countries.

"These powerless proposals fly in the face of public and expert input. In 1999 FDA received 35,000 letters making it clear that consumers want genetically engineered foods to be safety tested and to be labeled. These proposals do not require either," said Environmental Defense senior scientist Dr. Rebecca Goldburg.

Environmental groups charge that the industry backed studies that the FDA relies on for information about the safety of GE foods are rarely rigorously conducted or peer reviewed, nor are they available for public scrutiny. The FDA's pledge to post information on its own website does not correct this problem, critics said.

"Clearly the FDA doesn't have a taste for regulating genetically engineered foods and continues to avoid industry oversight that has any substance," said Goldburg. "This consultation process is watered down consumer protection, calling only for notification, not true regulatory review. 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."


Plant physiologist Ken Gross examines tomato fruit used in a genetic engineering research program (Photo by Keith Weller)
Doctors and scientists have warned that genetically engineered foods could trigger allergies, have increased levels of toxins, or could hasten the spread of antibiotic resistance. The medical journal "Lancet" has stated: "It is astounding that FDA has not changed their stance on genetically modified food…. Governments should never have allowed these products into the food chain without insisting on rigorous testing for effects on health."

Last year, StarLink genetically engineered corn, which is not approved for human consumption, was found in tacos shells and other corn products on grocery store shelves. The Genetically Engineered Food Alert, a campaign endorsed by scientists, religious leaders, doctors, chefs, environmental and health leaders, as well as farm groups, uncovered the presence of the GE corn through independent testing, only later confirmed by the FDA and other federal agencies.

The Starlink debacle prompted over three hundred food product recalls, causing millions of dollars in losses to food processors, grain mills and farmers across the country.

Many countries will not accept shipments of American corn, fearing that even corn labeled as organic may be contaminated by one of the handful of GE varieties now on the market.


Corn engineered to produce the Bt toxin reduces the impact of European corn borers ...
"Regulation, labeling, and an open decision making process are vital for consumer confidence abroad as well as at home," said Goldburg. "FDA's proposals can only hurt U.S. food exports and the U.S. economy."

Currently, developers of food and feed developed through biotechnology participate in a voluntary consultation program with FDA. To date, all such food and feed marketed in the U.S. have gone through the consultation program before they have entered the market.

These voluntary consultations have not reassured foreign markets of the safety of GE foods, and the FDA's new rule does not provide substantial additional protections, critics charge.


... but pollen from Bt corn could harm monarch butterfly larvae (Photo by Kent Loeffler, courtesy Cornell University)
"This policy means that the FDA will not require any mandatory testing on genetically engineered food," said Andrew Kimbrell, executive director of the Center for Food Safety and member of the Genetically Engineered Food Alert coalition. "Under these rules, American consumers will still be the guinea pigs testing the safety of these foods. Voluntary labeling means consumers won't see any labels out of this, and won't have a right to choose."

In fact, the burden of proof will fall largely on those companies who wish to market their products as "GE free." These companies will be forced to perform a battery of tests, at their own expense, in order to prove that their "GE free" labels are not "false advertising."

"FDA's new voluntary labeling policy serves the interests of a few biotechnology companies at the expense of the rest of the food industry and millions of consumers," said Richard Caplan, environmental advocate at the State Public Interest Research Groups.

The full text of the FDA proposal is available at:, under the listing for January 18, 2001

The draft guidance on voluntary labeling is available at:, under "Food Labeling"