Proposed Policy; Plant-Pesticides Subject to the Federal Insecticide, Fungicide, and Rodenticide Act and the Federal Food, Drug, and Cosmetic Act

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This notice describes how EPA proposes to address pesticidal substances produced by plants under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA). Substances that plants produce to protect themselves against pests and disease are pesticides under the definition of FIFRA section 2, (i.e., if they are ``. . .intended for preventing, destroying, repelling, or mitigating any pest. . .'') regardless of whether the pesticidal capabilities evolved in the plants or were introduced by breeding or through the techniques of modern biotechnology. These substances, along with the genetic material necessary to produce them, are designated ``plant-pesticides.'' This policy statement: (1) Clarifies the regulatory status under FIFRA and FFDCA of plants and plant-pesticides; (2) stipulates that EPA's regulatory attention will focus on plant-pesticides rather than on plants per se; (3) describes the criteria EPA is proposing to use in determining which plant-pesticides will be subject to regulation and which will be exempt; and (4) describes EPA's proposed procedures and information needs for the regulation of testing and commercial