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PLANT-INCORPORATED PROTECTANT RULES ISSUED; COMMENTS INVITED ON SUPPLEMENTAL NOTICE AND REPORT

Release Date: 01/17/2001
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Today, three final rules were made available that explain EPA’s framework for federal oversight of plant incorporated protectants, which include plants engineered through biotechnology to express pesticidal properties. Plant-incorporated protectants are substances that act like pesticides which are produced and used by a plant to protect it from pests, such as insects, viruses, and fungi. These rules define the type of plant-incorporated protectants (PIPs) which are required to undergo scientific evaluation to ensure protection of human health and the environment.

EPA’s current system of rigorous scientific evaluation for plant-incorporated protectants will continue. The rules announced today finalize many regulatory provisions proposed by the Agency in a 1994 notice of proposed rulemaking. Since publishing the proposed rule, EPA has consulted with independent panels of scientists and solicited public comments on a variety of issues related to the rules. By undergoing an open and transparent process of scientific consultation and public comment, EPA has ensured that these rules reflect the Agency’s commitment to sound science and tough, but fair, regulatory standards.

In cases where the Agency determines that plant-incorporated protectants pose little or no health or environmental risk, they will be exempted from certain regulatory requirements. For example, plant-incorporated protectants developed through conventional breeding will remain exempt from all requirements under the Federal Insecticide, Fungicide, and Rodenticide Act and under the Federal Food, Drug, and Cosmetic Act, with the exception of adverse effects reporting requirements for manufacturers. In addition, as proposed in 1994, the rules will exempt from tolerance requirements the genetic material DNA involved in the production of the pesticidal substance in the plant. EPA is also requesting further comment on three exemptions originally proposed in 1994 but not included in today’s rules. These proposed exemptions are:

• PIPs derived through genetic engineering from plants that naturally propogate;
• PIPs that act primarily by affecting the plant (such as causing the plant to have thicker wax cuticles); and
• PIPs based on viral coat proteins (substances that encapsulate and protect the genetic material of certain plant viruses).

In a supplemental notice also available today, EPA is inviting public comments and data on the appropriate regulatory oversight of PIPs in the above categories. EPA is also requesting 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.

The Federal Register notices are available at: www.epa.gov/scipoly/new.htm and will be published in the Federal Register shortly. For more information on EPA’s biotechnology program, you may visit: www.epa.gov/pesticides/biopesticides .

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