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Monsanto gets regulators' approval for Bollgard II cotton

(Tuesday, Dec. 24, 2002 -- CropChoice news) -- Monsanto press release: Monsanto (NYSE: MON) announced today that it has received full U.S. regulatory clearance for its Bollgard II insect-protected cotton technology. This announcement means that U.S. cotton producers will have access to cotton seed containing this technology for the 2003 planting season.

"Monsanto is pleased that regulatory agencies in the United States and other countries have confirmed the food, feed and environmental safety of this and other plant biotechnology products, which are delivering tremendous value to growers and the environment," said Robb Fraley, Ph.D., Chief Technology Officer of Monsanto.

Bollgard II is the second-generation of insect-protected cotton developed by Monsanto. This technology contains two different insect-control genes, compared to the single insect-control gene in its predecessor Bollgard. "Bollgard II cotton is expected to provide the grower with additional benefits including a broader spectrum of insect-control, and increased defense against insect-resistance, as well as similar agronomic advantages as its predecessor, Bollgard cotton -- including increased yield and lint potential, improved insect control, reduction in input costs, savings in time, and reduced pesticide sprayings," Fraley said.

As part of the registration conditions, the U.S. Environmental Protection Agency (EPA) will require the same insect resistance management programs that growers have been following the past several years. Insect resistance management plans for Bollgard and Bollgard II cotton are designed to maintain the effectiveness of these products against the target insect pests. These plans require planting a non-Bollgard cotton refuge within a specific distance from each Bollgard cotton field to serve as habitat for susceptible insects.

The United States Department of Agriculture (USDA) and the Food and Drug Administration (FDA) also confirmed the food, feed and environmental safety of this technology earlier this year.

Limited quantities of seed containing Monsanto's Bollgard II technology will be available for the 2003 season.

The clearance of Bollgard II cotton by U.S. regulatory agencies follows the successful completion of regulatory reviews by the Australian government earlier this year. In September, Australia's Office of the Gene Technology Regulator (OGTR) approved the commercial use of Bollgard II cotton in the growing regions of New South Wales and southern Queensland.

Monsanto's original Bollgard insect-protected cotton product, first marketed in 1996, is being sold commercially in nine countries -- the United States, China, India, Mexico, Australia, Argentina, Colombia, South Africa and Indonesia. The International Service for the Acquisition of Agri-Biotech Applications (ISAAA) recently noted that biotech cotton acreage was approximately 6.8 million hectares in 2001 or 16.8 million acres. This is an increase of 28 percent from the 2000 biotech cotton acreage, which was approximately 5.3 million hectares.