FDA Announces New Biotech Regs

WASHINGTON--On May 3, the Clinton Administration announced a program that would address biotechnology in food through a program designed to test for safety. The Food and Drug Administration (FDA) will be responsible for conducting a formal review process of new biotech foods or crops at least 120 days before they go to market. The process will focus on peer-reviewed, competitively awarded research. There will also be a voluntary labeling effort. Ultimately, the FDA will enlist the aid of the U.S. Department of Agriculture (USDA) and the Environmental Protection Agency (EPA) to support the program.

The program would also include setting standards for labeling, which will require food processors to use labels that are "truthful and informative." The voluntary labels will tell consumers if the food is free from genetically modified (GM) material. However, the labels do not have to say if there is GM material present.

For its part, the USDA will offer testing procedures to farmers and industry to differentiate between GM and non-GM crops, and provide farmers with information about markets to help them with their planting decisions. The FDA will use consumer focus groups and public comment to determine the wording of the draft guidance.

All three organizations (FDA, USDA, EPA) will also work to improve foreign relations regarding biotech crops. According to the White House this endeavor will involve increasing the "understanding of the nature and strength of our regulatory process."

According to the FDA, the process is a result of input received from its public outreach meetings held in late 1999. The FDA asserts it has answered consumer concerns, but some find fault with the agency's actions.

"Surveys have consistently shown that a vast majority of Americans want genetically engineered foods to be labeled," said Craig Winters, executive director of The Campaign to Label Genetically Engineered Foods. "We're very disappointed that the FDA is going against the wishes of the American people in favor of the interests of a few wealthy biotech companies."

Despite the hundreds of thousands of consumer submissions sent to the FDA requesting labeling for GM foods during the comment period, said Winters, the FDA ignored the will of the public and instead gratified the biotech industry. Instead of public-supported mandatory labeling, all labeling will remain voluntary and manufacturers can provide their own testing data. It is just these caveats that concern those who oppose biotechnology in food.

"The voluntary labeling guidelines now under Administration consideration would be a hollow step because the decision to label is left up to the manufacturers, most of whom have already chosen not to label," said Senator Barbara Boxer (D-CA).

That sentiment, tinged with mistrust, is echoing throughout the anti-GM community. "This announcement means the FDA will not be doing any testing on genetically engineered food, but instead relying solely on industry data," said Andrew Kimbrell, executive director of the Center for Food Safety.

The Grocery Manufacturers of America (GMA), however, has a different perspective. "We are very pleased the FDA has heard our industry's recommendations, which we believe will make an effective biotech review process even better," said GMA vice president Dr. Stacey Zawel. "This will help ensure continued consumer confidence in science-based regulatory oversight that's open and transparent. Most importantly, there is again renewed acknowledgement that food biotechnology is safe."

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