US Food and Drug Administration opts against further biotech review

June 18, 2003

As Reported in the News
The Pew Initiative on Food and Biotechnology

Genetically engineered foods from crops that have already been reviewed and approved by two government agencies shouldn't have to jump through a third regulatory hoop at the Food and Drug Administration (FDA), an FDA official told Congress, according to the Associated Press.

FDA Deputy Commissioner Lester Crawford said the agency is inclined to reject a proposal made by the former Clinton administration that would require biotechnology companies to notify the FDA before putting products on the market.

Biotech crops are already regulated by the Agriculture Department and the Environmental Protection Agency.

"The current system is working," Crawford told the House Agriculture Committee's subcommittee on research. "Since there is no public health reason to impose mandatory requirements, FDA is not making this rule a priority."

According to the AP report, Crawford said he knows of no instance where a company has not voluntarily shared field tests and other information on its biotech products with the FDA. But Greg Jaffe, biotechnology director for the Center for Science in the Public Interest, said that without a regulation requiring it, companies could withhold data.

"Under the current system, they could market something without us even knowing it," Jaffe said. "That is not the best way to ensure the safety or instill consumer confidence in these crops."

Lisa Dry, a spokeswoman for the Biotechnology Industry Organization, said companies share their data with the FDA because after a review, the agency gives them a letter approving the products.

Without the letter, a company would never be able to get its biotech crops to market, she said, explaining that food processors require the letter in order to do business. "They treat it as though it were mandatory because if they don't, they won't get a letter of review so that they can sell their
product."

The EPA also has a role in checking food safety if a company is seeking approval to grow a crop genetically designed to contain a pesticide to fight insects. The EPA approves those crops only if they are safe for people to eat and if they won't harm the environment, reports AP.

The Agriculture Department is charged with monitoring the safety of biotech crops from the time they are planted until harvest in small field tests. The department approves the crop to go to market if the test results show it will not harm animals and plants, but it does not determine whether it is safe for
humans. 

The AP reports, subcommittee's chairman, Rep. Frank Lucas, R-Okla., said he's "confident that these three agencies have established a regulatory framework that ensures biotech products are safely developed and field-tested."
 

As Reported in the News
The Pew Initiative on Food and Biotechnology
6047

OTHER RELEASES FROM THIS SOURCE

The news release or news item on this page is copyright © 2003 by the organization where it originated.
The content of the SeedQuest website is copyright © 1992-2003 by SeedQuest - All rights reserved
Fair Use Notice