Directly From The EPA

Kevin Ancell kancell at
Sat Oct 20 07:36:10 EDT 2001

Headquarters Press Release
Washington, DC
. Date Published: 10/16/2001


Note to Correspondents


Dave Deegan 202-564-7839 / deegan.dave at

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

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: .

R-200 # # #


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