Approval for controversial GM grain ?
canola variety that sparked a product recall in Canada.
US biotechnology company Monsanto said on Monday it was seeking full US 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 US Environmental Protection Agency (EPA) but has not yet received approval from the US Department of Agriculture or the Food and Drug Administration, said Loren Wassell, a spokesman for St. Louis-based Monsanto.
The USDA is in charge of approving the sale and use of the variety while the FDA is responsible for reviewing product safety. The USDA published a proposal in the Federal Register on 28 February to exempt GT200 from its regulations. An FDA spokeswoman said the agency had nearly completed its review of GT200 and it was only a formality to announce its decision."We have no safety questions (on GT200)," she said.
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 on Monday that Monsanto, in a bid to avoid a massive recall, had asked US 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 US 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 the 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GT200 was an early attempt to create an herbicide-tolerant canola, later superseded by other Monsanto varieties."This is really just an echo of what happened a year ago," Wassell said, referring to the pending FDA and USDA approvals."We're in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."
