CHICAGO - Monsanto Co. , the world leader in developing genetically modified seeds, said yesterday it was seeking full U.S. regulatory approval for a gene-altered canola variety that sparked a product recall in Canada last year.
The variety, GT200, has already been approved by the U.S. Environmental Protection Agency but has not yet received approval from the U.S. Department of Agriculture or the Food and Drug Administration, said Loren Wassell, a spokesman for St. Louis-based Monsanto. "We're in the process of completing an FDA review as well as getting USDA approval," Wassell said. "We're not aware of any issues with either FDA or USDA."
The USDA published a proposal in the Federal Register on Feb. 28 to exempt GT200 from its regulations. USDA said the canola variety had been approved in Canada since 1996 without any harmful environmental impact.
"We are going through the comment process to determine what the government should do if this particular seed is found," said Alisa Harrison, a USDA spokeswoman.
The public comment period for the proposed rule expired on April 1. USDA officials would not say when it would make a final decision on Monsanto's request.
Wassell said Monsanto had no plans to recall any of the company's genetically modified (GMO) canola seeds, which are widely used in the United States and Canada. Canola is a rapeseed variety that produces an edible oil.
The Wall Street Journal reported Monday that Monsanto, in a bid to avoid a massive recall, had asked U.S. regulators to forgive any presence of GMO material that it believes some of its canola seeds might contain.
Monsanto said GT200 was safe to consume and it has not detected any of it in U.S. seed it has tested. But trace amounts of GT200 were found last year in Canadian canola seed, leading the company to believe that the same is possible in the United States, the paper said.
After those trace elements were found, Monsanto replaced hundreds of tons of canola seed for Canadian farmers a year ago as a precaution to avoid the possibility of GT200 canola being imported into Japan. The seed was approved in Canada but had not been approved by Japan, a major Canadian customer. Since then GT200 has been approved for use in Japan.
GT200 was an early attempt to create an herbicide-tolerant canola, later superseded by other Monsanto varieties.
"This is really just an echo of what happened a year ago," Wassell said, referring to the pending FDA and USDA approvals.
"We're in the process of going the extra mile in terms of regulatory clearances to provide assurance based on a seed replacement that we conducted fully a year ago. There's been no new finding of GT200 even in Canada."
GMO crops such as corn, soybeans, cotton and canola have become widely used in North America since 1996, saving farmers money on herbicides and pesticides.
But consumer groups, especially in Europe and Asia, have demanded more research into their health and environmental effects. This in turn has led food companies to demand segregation and labeling of crops grown from the seeds.
The Center for Food Safety, a Washington advocacy group, filed a legal petition with the USDA Monday seeking an investigation of Monsanto and Aventis CropScience . Aventis was the maker of a genetically altered corn, Starlink, that was unapproved for human consumption and recalled in September 2000 after it was detected in more than 300 U.S. food products including taco shells.
U.S. corn exports were disrupted at the time and Aventis was forced to withdraw the Starlink seed and pay millions of dollars in legal settlements to farmers and food companies.
"Monsanto and Aventis are asking the USDA for a cover-up," Joseph Mendelson, the Center for Food Safety's legal director, said in a statement. "We are demanding a full criminal investigation of the two companies, and an inquiry into USDA's actions in not making this matter public."
Wassell said the EPA had granted Monsanto's GT200 an exemption from their tolerance requirements. Aventis had not obtained such an exemption for Starlink.
Monsanto is an 85 percent-owned subsidiary of Pharmacia Corp.:
