WASHINGTON - Last week's admission that Syngenta AG had been selling an unapproved corn product raised a couple of fundamental but perhaps troubling questions about genetically modified foods: How did this happen and who is at fault?
"The nature of that mistake," said Anne Burt, a spokeswoman at Syngenta, "has not been identified."
But aside from the blame game, some in the industry said this case illustrates that a self-check system works. The Geneva-based agricultural company, which employs about 19,000 people around the world, noted that the accident caused no human health or environmental concerns, conclusions later drawn by the U.S. Department of Agriculture and Environmental Protection Agency after receiving word of the oversight late last year.
Syngenta had informed those regulatory bodies, as well as the FDA, upon realizing that its Bt10 corn borer product had been unintentionally included in five of its corn breeding lines between 2001 and 2004. Specifically, the company said the mistake happened during early Bt development. Bt10 mistakenly was identified as Bt11 and used as a source material for breeding lines primarily used for pre-commercial development.
Syngenta concluded that the error could have resulted in plantings of a maximum of only 1/100th of 1 percent of U.S. corn acres over a four-year period. At the same time, a smaller share, 2/1,000th of 1 percent, could have entered U.S. export channels and been exported to countries where Bt11 is approved for import. In addition to the U.S., it is approved for food and feed use and for cultivation in Canada, Argentina, Japan, South Africa and Uruguay. Also, it is approved for import for food and feed use in the European Union, Switzerland, Australia, New Zealand, Taiwan, the Philippines, China, Russia and Korea.
"They self-reported, which is the appropriate action" per government guidelines, said Lisa Dry, a spokeswoman at the Biotechnology Industry Organization in Washington. "It's very clear that there are no safety issues according to the federal government."
The company noted that the Bt protein produced by those lines is identical to that produced by already-commercialized varieties containing an approved corn borer product, Bt11. Only a few nucleotides make up the difference between Bt10 and Bt11, but because the proteins are the same, Bt10 is covered by the existing tolerance exemptions for Bt11.
Syngenta said all current plantings and seed stock containing the Bt10 material have been identified and destroyed, or otherwise contained. Still, the company could be found in violation of U.S. law.
"We support a rigorous regulatory system," Dry told BioWorld Today, noting that because the matter remains under investigation by both the EPA and USDA, she can't comment specifically about the matter.
Burt told BioWorld Today that Syngenta expects government inquiries to lead to some sort of remedy, such as fines or other actions. Already, the company has converted its quality-control program to DNA-based analytical methods from protein-based tests and lab and field observations to prevent similar missteps down the road, Syngenta said.
Last week, the news was published in the scientific journal Nature. That same report noted that the last time such a mistake occurred was in 2000, when another Bt corn called Starlink accidentally was planted for human food despite the fact that it was approved only for cattle feed.
Syngenta's shares, which trade on U.S and Swiss stock exchanges, have not suffered since the news was released and, instead, have traded within a point since then.