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Release Date: 11/16/94
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EPA PROPOSES REGULATIONS TO ADDRESS PLANT-PESTICIDES To further protect public health and the safety of the nation's food supply, the U.S. Environmental Protection Agency is proposing a number of actions to regulate certain novel pesticidal substances genetically introduced into plants for the purpose of protecting the plants against pests and disease. The Agency has designated these substances, along with the genetic material necessary to produce the substances, as plantpesticides. The proposed regulations will address plant-pesticides, not the plants themselves.
The ability to deliberately introduce into plants desirable characteristics has been greatly enhanced in the past five to l0 years making it possible today to transfer the ability to produce pesticide substances from many sources directly into plants. These pesticidal substances can come from bacteria, insects, viruses, animals or other plants. Thus, plants can be engineered to produce pesticidal substances they could not previously produce.

"Today's action will establish a program that will ensure the safety of the food supply and safeguard the environment," said Carol M. Browner, EPA Administrator. "This pesticide control technology holds a promise of reduced use of pesticides because the plant will produce its own defense against pests."

The proposed regulations for plant-pesticides consist of several parts:

The Agency will focus its attention on those plant-pesticides posing new exposures and having the greatest need to be evaluated for potential adverse effects.

    To achieve this scope, EPA is proposing to exempt three categories of plant-pesticides from regulation under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Under FIFRA, EPA is proposing to exempt:
    Those plants-pesticides that are derived from a closely related plant; e.g.;, those taken from one corn plant and engineered into another corn plant.
    Those plant-pesticides that would not result in adverse effects to non-target organisms because they act primarily by affecting the plant; e.g., plants that have been engineered to produce a thicker cuticle or a thicker layer of wax.
    Coat proteins from plant viruses when produced in plants for virus-coat protein mediated resistance; i.e., a piece of genetic material from the virus which encodes (carries the instructions for making) for the coat protein is inserted into the plant, thus the plant produces the protein and is protected against future viral infections.
Under FFDCA, EPA is proposing to exempt from the requirement of a tolerance:
    Those plant-pesticides that are derived from closely related plants.
    Those plant-pesticides that are not derived from closely related plants but for which there is experience with dietary exposure because both plants are part of the food supply; e.g., those taken from a highly consumed crop such as corn and engineered into another highly consumed crop such as wheat.
    Coat proteins from plant viruses.
Under FFDCA, EPA is also proposing to exempt from the need for a tolerance the genetic material produced in plants as part of the plant pesticide active or inert ingredient.
    The Agency is also suggesting general guidance to plant-pesticide developers on the types of information EPA would need to evaluate a plant-pesticide.
    In order to create a more "user-friendly" code of Federal Regulations, EPA is proposing to create a new part in the Code especially for plantpesticides.
Comments on the proposal are due in 60 days and should be addressed to: Program Resources Section, Public Response and Program Resources Branch, Field Operations Division (7506C), Environmental Protection Agency, 401 M St. S.W., Washington, D.C. 20460.

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