Biotech Rice Saga Yields Bushel of Questions for Feds

USDA Approval Shortcut Emerges as Issue

When the biotech company Bayer CropScience AG requested federal permission in August to market a variety of gene-altered rice, it assured itself a small, unwanted place in history: the first to seek approval for a genetically engineered food that was already -- illegally -- on the market.

Now, as federal regulators consider that belated application, they are finding themselves under scrutiny, too -- from scientists and others who say the 20-year-old system of biotech crop oversight is failing.

The Bayer lapse is the latest in a string of problems, critics note, including taco shells and other foods contaminated in 2000 with unapproved StarLink corn, the accidental release in 2002 of crops engineered to make a pig diarrhea vaccine, and the growing prevalence of "superweeds" that have acquired biotech genes that make them impervious to weed killers.

Federal officials are still investigating how the experimental "LLRICE601" escaped from Bayer's test plots after the company dropped the project in 2001. When they announced 10 weeks ago that the unapproved variety had become widespread in the nation's long-grain-rice supply, countries around the world blocked imports from the United States, rice futures plummeted and hundreds of farmers sued Bayer.

Bayer's response -- a hasty application for government approval, expected to be granted within weeks -- has been greeted with concern by many agriculture experts who fear that the action, though likely to ease Bayer's legal woes, will make matters worse for farmers and the environment.

"Are we going to do this every time a new transgene that we didn't intend to get out gets out?" asked Norman Ellstrand, who directs the Biotechnology Impacts Center at the University of California at Riverside.

LL601 contains a bacterial gene that protects rice from Bayer's Liberty weed killer, allowing farmers to use the chemical without harming their crop. The prospect of widespread cultivation worries many experts, who say the key gene is sure to move via pollen into red rice, a weedy relative of white rice and the No. 1 plant pest for rice farmers in the South.

Thus endowed, red rice would become immune to the herbicide, increasing its economic havoc.

Experts point to other troubling elements of the Bayer petition.

Nearly 40 percent of its pages, for example, are blacked out as "CBI," or confidential business information, even though the approval process is by federal statute supposed to be public.

Also at issue is the regulatory shortcut that Bayer is using, which allows a company to skip many of the usual safety tests by claiming that the new variety is similar to ones already approved -- in this case, two approved varieties of biotech rice that Bayer never commercialized because farmers did not want it around their fields.

Bayer, with U.S. headquarters in Research Triangle Park, N.C., is adamant that LL601 poses no risk, and even critics generally agree that it is safe to eat. The bacterial gene that is in LL601 is also in several approved varieties of engineered corn, canola and cotton.