Swiss biotech firm Syngenta AG said yesterday that over a four-year period it inadvertently sold U.S. farmers an unapproved strain of genetically modified corn seed that may have also entered the food supply and international export channels.
Syngenta, as well as three federal regulatory agencies investigating the sales, cautioned that the mistake posed no health risks because the unapproved strain is virtually identical, genetically, to an approved strain of corn seed that the company markets.
The firm said the amount of unapproved corn planted from 2001 until it discovered and reported the mistake to regulators last December was "very little," amounting to 37,000 acres out of the 320 million acres planted during that period across the United States.
Despite the small amount of corn involved, as well as the lack of public health risk, industry observers said Syngenta's problems would likely stoke long-simmering concerns over the biotech industry's ability to control the technology.
"Although I'm glad there was no risk to human health, this situation proves again that this technology is hard to control and there must be better oversight of the industry," said Greg Jaffe, director of the Center for Science in the Public Interest. "This situation certainly doesn't give any assurances to consumers."
Jaffe said he was particularly concerned that the company was selling the unapproved seeds for four years without knowing it.
Yesterday afternoon, shortly after the journal Nature reported the situation in an article on its Web site, senior executives at Syngenta held a conference call with reporters and offered a complicated explanation of how the inadvertent sales occurred.
Jeff Stein, Syngenta's director of regulatory affairs, said the unapproved strain of corn seed, called Bt10, was developed at the same time as an approved strain, called Bt11. Both were developed to make corn insect resistant.
The same DNA was used in both strains, but it was inserted into different parts of the corn genome. This resulted in minor changes to how each seed grew in the environment, and it prompted the company to pursue development and marketing of Bt11.
Syngenta, based in Basel, Switzerland, received U.S. regulatory approval for Bt11 in 1996. Bt10 seeds were kept around for further research, Stein said, and at some unknown point they were mistaken for Bt11 seeds, inserted into five seed production lines, and sold in lots to farmers beginning in 2001.
The firm discovered the problem only after recently revamping its quality control program to screen the DNA of its products, instead of relying on field observations and a less specific test that examined specific proteins. The change will help ensure similar problems do not happen again, said Sarah Hull, a spokeswoman for the company.
In mid-December, Syngenta notified the Environmental Protection Agency, the Department of Agriculture, and the Food and Drug Administration about the problem. The agencies are investigating. The company could be fined up to $500,000 by the USDA.
Hull said the affected lots of seed have been traced and that all current plantings, as well as seed stock, have been either been destroyed or isolated for future destruction.
Stein added that because farmers buy new corn seed every year, the unapproved corn, Bt10, will not grow again.
Nevertheless, Jaffe said effects of the situation will linger -- both in the United States and, perhaps, in Europe. European consumers have been cool to the adoption of modified food products. And Nature noted that U.S. and European Union officials are in disagreement over whether strict European rules to track genetically modified crops are necessary.
"This violation will not help with international acceptance of safe applications of this technology," Jaffe said. "Instead of building international confidence, the industry continues to shoot itself in the foot."
But Jaffe also cautioned that Syngenta's error was not as significant as Aventis SA's error in 2000, when an unapproved genetically modified corn seed called StarLink mixed with other varieties of corn.
Consumers said StarLink caused allergic reactions, and several food companies recalled products. A worldwide drop in corn prices followed. Farmers and consumers sued Aventis and other companies involved with its development and distribution.
Syngenta shares closed yesterday at $21.45, down 39 cents.