TABLE 4.3 USDA and EPA Data Requirements for Assessing Effects of Transgenic Pest-Protected Plant Products



Information for review as regulated article

Objective: Assess potential plant pest risk

Objective: Assess potential for health and ecological effects

  • Genetic analysis

  • Molecular biology of transfer

  • Phenotype of article

  • Environmental consequences

  • Description of mode of action

  • Current uses

  • Effect on weediness

  • Gene transfer

  • Potential for adverse effects

  • Toxicology data on nontarget organisms and threatened and endangered species

  • Product identity (construct, characterization, markers, vectors)

  • Protein digestibility

  • Mammalian toxicology (acute oral)

  • Allergenicity potential

  • Gene expression

  • Environmental fate of protein

  • Gene transfer potential

  • Nontarget organism toxicity (avian, fish, terrestrial and aquatic invertebrates)

  • Endangered species considerations

Information for environmental assessment

Objective: Assess potential for environmental impact

  • Effect on agricultural practices

  • Potential impact of pollen escape

  • Effect on susceptibility of pathogens or insect pests

  • Effect on resistance of pests

  • Toxicology data on nontarget organisms (beneficial insects, animals, and humans)

  • Potential change in virulence (viruses)

  • Cumulative environmental effects


a USDA 1996a.

b CFR 158.9(d); EPA (1999a,b,1998a,b, and 1999f).

However, where EPA and USDA assert regulatory authority over the same endpoint, the lack of clarity as to the lead agency and the differing bases for decision-making can, on occasion, lead to confusion both in the agencies and in the regulated community. For example, the record indicates potential confusion in instances where gene transfer is analyzed by EPA and USDA. In the case of Bt cotton USDA and EPA asked for much of the same information to assess gene-flow issues. USDA concluded that gene transfer prompted no concerns and granted deregulated status to Bt

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