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GENETICALLY MODIFIED PEST-PROTECTED PLANTS: SCIENCE AND REGULATION
rules that help clarify the agency's role in the coordinated framework by describing which plant-pesticides would be regulated under FIFRA and FFDCA and which would be exempt from regulation (section 4.1.3). Although the proposal has not been finalized, the agency has been implementing its essential elements in registering or exempting plant-pesticides since 1995. EPA defined a plant-pesticide as “a pesticidal substance produced in a living plant and the genetic material necessary for the production of that pesticidal substance, where the substance is intended for use in the living plant.” The genetic material necessary for production of a pesticidal substance was included in the definition of plant-pesticide to enable regulatory coverage, under FIFRA, of plant parts such as seeds and pollen where the pesticidal substance might not be expressed. However, with regard to regulation under FFDCA, the agency proposed to establish a categorical exemption from the requirement of a tolerance for this genetic material.
EPA's proposed FIFRA regulation establishes three categories of plant-pesticides that would be exempt from regulation under FIFRA. The first category contains plant-pesticides whose genetic material encodes for a pesticidal substance that is derived from plants that are sexually compatible. The second category of plant-pesticides that are exempt from FIFRA regulation are those that act by affecting the plant so that the target pest is inhibited from attaching to and/or invading the plant tissue by, for example, acting as a structural barrier, or by inactivating toxins produced by the target pest. The third category consists of substances that are coat proteins of plant viruses.
Substances that are exempt from regulation under FIFRA are not automatically exempt from the requirement of a tolerance under FFDCA. Therefore, EPA proposed three additional regulations under FFDCA to accomplish this. Similar to the FIFRA exemption, pesticidal substances derived from plants that are sexually compatible are proposed to be exempt from the requirement for a tolerance. In addition, pesticidal substances derived from plants that are not sexually compatible would also be exempt from the requirement of a tolerance provided that the following two conditions are met: (1) the genetic material encoding the pesticidal substance is derived from a food plant; and (2) the pesticidal substance does not result in a new or significantly different human dietary exposure. EPA also proposed to exempt coat proteins of plant viruses and, as noted earlier, to exempt the genetic material that encodes pesticidal substances.
In 1997, EPA published supplemental notices of proposed rulemaking for the FIFRA and FFDCA proposals published in 1994. EPA took this action in order to allow the public to comment on the Agency's evaluation of the requirements imposed by the Food Quality Protection Act of 1996