title: U.S. EPA regulation of plant-incorporated protectants: assessment of impacts of gene flow from pest-resistant plants.
abstract: The U.S. Environmental Protection Agency licenses pesticide-expressing plants under the authority of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). Transgenes and their pesticidal products represent pesticides under FIFRA and are referred to as plant-incorporated protectants (PIPs). When sexually compatible wild relatives (SCWR) are sympatric with PIP crops, there is a need to assess the potential for adverse effects to man and the environment resulting from transgene introgression in accord with FIFRA requirements. Genetic compatibility, introgression, weediness of SCWR × PIP hybrids, seed dispersal, and dormancy, among other parameters, as well as effects on other species (herbivores and beneficial insects), all need to be considered as part of the risk assessment for experimental use under Section 5 or registration under Section 3 of FIFRA. EPA is currently developing data requirements and guidance toward addressing potential gene flow impacts from PIPs.
authors.affiliation: Office of Chemical Safety and Pollution Prevention, Office of Pesticide Programs, Biopesticides and Pollution Prevention Division, U.S. Environmental Protection Agency, 7511P, 1200 Pennsylvania Avenue, N.W., Washington, D.C. 20460, USA.
authors.forename: Chris A
authors.initials: CA
authors.lastname: Wozniak
authors.forename: Jeannette C
authors.initials: JC
authors.lastname: Martinez
mesh_terms: D000818:Animals; D017753:Ecosystem; D004777:Environment; D051456:Gene Flow; D022761:Gene Transfer, Horizontal; D006801:Humans; D007313:Insecta / Q000502:physiology; D030821:Plants, Genetically Modified / Q000009:adverse effects* / Q000235:genetics* / Q000502:physiology; D018570:Risk Assessment; D014481:United States; D014484:United States Environmental Protection Agency