EPA Issues Rules on Biotech Plants

July 20, 2001

Environmental Protection Agency Administrator Christie Whitman has signed three final rules that clarify and strengthen the framework for EPA to oversee "plant-incorporated protectants." Plant-incorporated protectants are materials that enable a plant to protect itself from pests, such as insects, viruses and fungi, because the plant produces its own pesticide.

Under the rules plant-incorporated protectants derived from biotechnology will be regulated by EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and under the Federal Food, Drug, and Cosmetic Act (FFDCA) to ensure protection of human health and the environment.

"Developing this framework means that EPA's current system of rigorous scientific evaluation for plant-incorporated protectants will continue," said Whitman. "There has been an open and transparent process of scientific consultation and public comment leading to the finalization of these rules. They reflect EPA's commitment to sound science and an even-handed regulatory process."

Whitman's action finalizes several regulatory steps first proposed by EPA in 1994 and largely followed by the agency since that time. In the intervening years, EPA consulted with independent panels of scientists and solicited public comments on a variety of issues related to the rules. Whitman's approval also follows a thorough review of the regulations by the Bush administration to ensure that EPA's actions continue to provide strong protections for public and environmental health in biotechnology issues. These rules had been approved in January by former EPA Administrator Carol Browner but were subsequently withdrawn to provide the incoming Bush administration with an opportunity for their review.

The new rules ensure that genetically engineered plant-incorporated protectants will meet federal safety standards through as rigorous EPA evaluation as traditional pesticide registrations. If the agency determines that plant-incorporated protectants (PIPs) pose little or no health or environmental risk, they will be exempted from certain regulatory requirements.

For example, PIPs developed through conventional breeding will be exempt from requirements under FIFRA and FFDCA. However, manufacturers must still report any adverse effects should any occur. The rules also exempt genetic material (i.e., DNA) that creates the pesticidal substance in the plant from maximum residue levels (called a "tolerance") in food. This exemption does not apply to the actual pesticidal substance, which will continue to be fully evaluated by the agency to ensure that it is safe for human health and the environment.

EPA is also seeking public comments on the National Academy of Sciences report, published in April 2000, entitled "Genetically Modified Pest-Protected Plants: Science and Regulation" as it relates to plant-incorporated protectants derived through genetic engineering. More information on all of these actions is available at: www.epa.gov/pesticides/biopesticides.