EPA Extends Bt Cotton Registration

October 3, 2001

The Environmental Protection Agency has extended for five years the conditional registration for Bt cotton. EPA said the decision came following "a comprehensive and exhaustive review." The agency also said it is requiring additional measures to ensure that use of the product does not pose any unreasonable risks to human health or to the environment.

Bacillus thuringiensis (Bt) is a naturally-occurring soil bacterium that produces a protein that is toxic to certain insects but not to humans or other species. The genetic material from Bt was implanted into the cotton plants which enables the plants to produce the toxin that controls some insect pests.

"As a condition of EPA's approval of the Bt cotton registration, we have adopted several provisions to strengthen insect resistance management, improve grower awareness and stewardship and prevent gene flow from Bt cotton to weedy relatives," said Stephen L. Johnson, assistant administrator for EPA's Office of Prevention, Pesticides and Toxic Substances. "There has been extensive public input in this review process, and the outcome is a registration that safeguards important environmental concerns while providing cotton growers with a significant option to meet their pest-control needs."

EPA determined that there is reasonable certainty that Bt cotton will not pose unreasonable risks to human health or to the environment. In order to reduce the possibility of insects developing resistance to Bt, the amended registration requires that some acres be set aside where non-Bt cotton will be grown to serve as a "refuge."

These refuge fields will support populations of insects not exposed to the Bt toxin. The insect populations in the refuges will help prevent resistance development when they cross-breed with insects in the Bt fields. Four distinct refuge designs have been developed and are available for growers to implement to limit potential development of insect resistance. One, called the "external, unsprayed refuge option" (also known as the 95:5 refuge) has a three year expiration date. By September 2004, EPA will review data on the value of other crops and weed plants as providing additional refuge and will consider whether or not to maintain this option.

Other provisions include an EPA requirement that the company developing this product, Monsanto, conduct monitoring of any potential impacts from its continued use. The registrant must also educate growers about the best methods of planting Bt cotton to minimize any potential development of insect resistance or gene transfer to other plants.

The National Cotton Council applauded the EPA decision. "We are pleased that the EPA has re-registered Bollgard(r) without any significant change in the insect resistance management (IRM) plans as recommended by the industry," said Hollis Isbell, chairman of the NCC's American Cotton Producers.

Isbell added, "Growers need this technology and are keenly aware of the importance for an effective IRM strategy. Consistent refuge options will help promote compliance."