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CONDITIONAL REGISTRATION OF BT COTTON REAFFIRMED
Release Date: 10/02/2001
Contact Information:
Note to Correspondents
FOR RELEASE: TUESDAY, OCTOBER 2, 2001
CONDITIONAL REGISTRATION OF BT COTTON REAFFIRMED
Dave Deegan 202-565-7839 / deegan.dave@epa.gov
CONDITIONAL REGISTRATION OF BT COTTON REAFFIRMED
Dave Deegan 202-565-7839 / deegan.dave@epa.gov
Following a comprehensive and exhaustive review, the conditional registration of cotton containing a gene from a common soil bacterium called Bacillus thuringiensis (Bt) has been extended for five years, but with some limitations. As part of the continued conditional registration of Bt cotton, EPA 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,” Johnson continued.
After a thorough review process, 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 to maximize protection of the public and environment include an EPA requirement that the company developing this product, Monsanto, will 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.
Before reaching this decision, EPA undertook an extensive evaluation of the previous time-limited registration for this plant-incorporated protectant. The Agency consulted with an independent panel of scientific experts from the academic and medical communities, which conducted scientific peer review on key issues. Adhering to a process that emphasized up-to-date scientific data and methodologies, numerous opportunities for public involvement, and balanced decision-making, EPA maintained a transparent review process to ensure that the decision was based on sound science.
EPA remains committed to ensuring that use of Bt cotton does not lead to unreasonable adverse effects to human health or to the environment. The Agency will continue to collect data and monitor any potential environmental or health effects of this product. Further, to ensure compliance with the Agency’s registration guidelines for Bt cotton, an independent, third party compliance survey will be conducted annually for the duration of this registration. Detailed information on EPA’s decision will be available at: www.epa.gov/pesticides/biopesticides .
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