mission. On the matter of coordination with USDA, EPA's proposed policy states (EPA 1994a, p. 60513) that

EPA and USDA-APHIS have consulted and exchanged information on plants and plant-pesticides and intend to continue to do so in the coordination of their regulatory activities. The two Agencies also have and intend to continue to consult closely on scientific issues related to the safety considerations associated with the environmental impact of field tests of plant-pesticides.

A similar statement of commitment to coordination is made with respect to EPA-FDA interactions on jurisdictional questions and scientific matters. To minimize potential overlap, the proposed policy states that EPA will address food safety issues associated with plant-pesticides. Any food safety questions beyond those associated with plant-pesticides are under FDA's jurisdiction.

EPA has registered 10 pesticidal substances expressed in transgenic potato, cotton, or corn plants and has established corresponding exemptions from the requirement of a tolerance for these pesticidal substances under the agency's proposed regulations (see section 1.5.3 and section 3.2). Seven additional pesticidal products, also considered by EPA to be subject to its jurisdiction, are exempt from FIFRA registration because they consist of coat proteins of plant viruses. The transgenic pest-protected plants that express the exempt pesticides include potato, watermelon, zuchini, papaya, and cucumber. Indicating the shared responsibility for oversight of these products, USDA has made a determination of non-regulated status for each of the transgenic pest-protected plants. Those plants were formerly considered “regulated articles” under the FPPA.

TABLE 4.1 Regulatory Scheme for Coordinating Reviews of Commercial Biotechnology Products

Product Class

Lead Agency (Other Participating Agencies)

Federal Statutes

Plants and animals

USDA-APHIS (USDA-FSISa, FDA)

FPPA, PQAb, NEPA, FFDCA

Pesticide microorganisms

EPA (USDA-APHIS)

FIFRA, FFDCA, FPPA, PQAb, NEPA

Food and additives

FDA (USDA-FSISa)

FFDCA

a Food Saftey Inspection Service

b Plant Quarantine Act



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