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Biotechnology, or more specifically, recombinant DNA (rDNA) technology, has demonstrated real promise for managing plant diseases through genetic means. To date, however, few of these rDNA-derived products have realized commercial success. The use of viral coat protein or other viral sequences as modulators of RNA interference mechanisms have worked well in potato, papaya, yellow squash and European plum for viral resistance. Of these, only papaya and squash are currently in commercial use with plum to follow soon. Other disease resistant plants are in development, such as peanut expressing oxalate oxidase providing resistance to <i>Sclerotinia minor</i>, and inverted repeat transgenes using an RNAi-based approach to silence mycotoxin production by <i>Aspergillus</i> and <i>Fusarium</i> in maize. These types of products would be licensed under FIFRA as plant-incorporated protectants (PIPs), which are registered as pesticides by the US EPA. PIPs consist of the genetic material and their expression products as expressed <i>in planta</i> for the management of pests, including plant disease organisms. Insect resistant maize plants expressing the d-endotoxin from <i>Bacillus thuringiensis</i> have demonstrated reductions in fumonisin content of seed as a consequence of reduced insect feeding damage and subsequent fungal colonization. This presentation will focus on the regulatory aspects of the development of biotech derived products for plant disease management.<p><p>Keywords: