Environmental Protection Agency (EPA) protects human health and the environment from adverse effects.
EPA has jurisdiction over planting and food⁄feed uses of pesticidal plants, new uses of existing pesticides, and novel microorganisms. These laws direct the EPA to regulate many kinds of “pollution,” including pesticides, with a focus on how they affect different aspects of the environment.
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA; (7 U.S.C. §135 et seq., 1972)
Before a pesticide, including a GE pesticide, can be registered for use and commercialized,
the EPA must determine that the pesticide is able to perform its intended function without unreasonable adverse effects on human health and the environment.
Plant incorporated protectants (PIPs), such as the Bt toxin in corn, are considered pesticides under FIFRA because they are introduced into plants with the intention of preventing, destroying, repelling, or mitigating a pest.
In contrast to the APHIS process of “deregulation,” a developer of a crop that contains a pesticidal property must submit an application to the EPA to register a PIP. This involves regulating GE plants with obvious herbicide-tolerance, designed to be sprayed with a pesticidal chemical, as well as GE virus-resistant plants that are not to be sprayed with new pesticidal substances or have them synthesized internally.
Additionally, the EPA requires data on mammalian toxicity, the effects on non-target organisms, environmental metabolism, and an insect resistance management program for plants
specifically expressing PIP products.
Since most PIPs are proteins, the issue of mammalian allergenicity ('environmental allergens') is highly important. Acute digestibility assays and amino acid sequence homology are necessary to demonstrate the absence of allergenicity concerns. The EPA is also concerned with gene flow issues as they may result in expanded exposure to novel pesticidal substances, as well as the environmental fate of PIP substances and their effect on non-target organisms.
As of 2011-2012, an application that requests an experimental use permit, the registration of an active ingredient, and the establishment or waiver of tolerances with review by an independent science advisory panel requires a fee of more than $390,000 (Federal Register 75–154, pp. 48672–48683).