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BIOTECHNOLOGY CORN APPROVED FOR CONTINUED USE
Release Date: 10/16/2001
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Note to Correspondents
FOR RELEASE: TUESDAY, OCTOBER 16, 2001
Based on a comprehensive scientific review, corn genetically modified with Bacillus thuringiensis (Bt) has been approved for an additional seven years. Bacillus thuringiensis is a naturally-occurring soil bacterium that produces a protein toxic to certain insects, which has been used for many years to control insect pests. Incorporating the genetic material from Bt into corn plants enables the plants to produce the same toxin and defend against several pest species. Scientific studies and a history of successful use have demonstrated that Bt is not toxic to humans or other animals.
“Bt corn has been evaluated thoroughly by EPA, and we are confident that it does not pose risks to human health or to the environment. Consumers should be assured that these corn varieties show no signs of any adverse effects to human health,” said Stephen L. Johnson, Assistant Administrator of EPA’s Office of Prevention, Pesticides, and Toxic Substances. “The safeguards incorporated into these registrations will ensure that farmers can continue to use an effective, low-risk pest control alternative, which helps to protect the environment by reducing the amount of conventional pesticides used,” Johnson added.
The renewed registrations of the five Bt corn products continue to include specific requirements for companies to routinely monitor and collect data to ensure that the products’ continued use does not lead to insect resistance or unexpected human health or environmental effects. In order to ensure that Bt corn continues to be a safe and effective tool for farmers, EPA has also mandated several provisions to strengthen insect resistance management, to increase research data on potential environmental effects, and to improve grower education and stewardship.
After a nearly two-year long review process, EPA determined that Bt corn will not pose unreasonable risks to human health or to the environment. Of particular concern during this process were the potential risks to Monarch butterflies. In investigating these risks, the Agency requested extensive data from the scientific community in order to better evaluate the potential concern. The scientific evidence demonstrates that Bt corn does not impact Monarch butterfly populations. EPA has also determined that there will be no effects to endangered species from the use of the currently registered Bt corn products.
In extending the use of Bt corn, EPA has increased environmental and compliance monitoring requirements. Specifically, EPA is requesting additional data on the persistence of the active protein in soil, field studies on non-target insects, studies examining long-term effects on Monarch butterfly population, an additional feeding study for bird species, and monitoring of the behavior of particular pest populations and their north-south movement through the country.
Companies marketing Bt corn seed will be required to monitor for the development of insect resistance, provide annual reports on the efficacy of resistance management plans, and implement remedial action plans in the event that resistance is detected among pest populations. The companies must also educate growers about the best methods of planting Bt corn to minimize any potential development of insect resistance. To enhance grower stewardship and compliance with the insect resistance management provisions, all growers must sign contractual grower agreements. These agreements, coupled with the grower guides, set forth the terms and conditions for use. Companies are now required to implement a system to secure signature of the grower agreements prior to receipt of any seed, and to make the grower agreements available to EPA. To monitor the enhanced requirements, an independent, third party compliance survey of licenced growers will be conducted annually for the duration of the registrations. The companies holding registrations for Bt corn are Monsanto, Syngenta, Pioneer/DuPont and Mycogen/Dow.
Before reaching this decision, EPA undertook an extensive evaluation of the previous time-limited registrations for these plant-incorporated protectants. A careful review of scientific information confirms previous findings that these Bt corn varieties show no evidence of allergenicity. 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. Detailed information on EPA’s decision will be available at: www.epa.gov/pesticides/biopesticides .
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