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Assuming that the levels of known toxicants in the regulated article reported in Section V are in acceptable range; that there were no notable differences reported in Section V between transgenic and nontransgenic plant; and that the gene(s) engineered into the recipient plant have no known reported toxic properties; then, toxicological data on effects of the plant on nontarget organisms and threatened and endangered species will usually not be required


SAMPLE PETITIONHerbicide-Tolerant Plants

G. Horizontal Transfer of the New Genes

Nonsexual, horizontal transfer of transgenes from genetically engineered plants into other organisms is not well documented and is difficult to measure (Harding, 1995). Horizontal gene transfer of transgenes from higher transgenic plants via the soil to a soil microorganism (the filamentous fungus Aspergillus niger), however, has been reported (Hoffmann et al., 1994). Genetic transfer across taxa of eukaryotes is suggested in only a few cases (Lewin, 1982; Houck et al., 1991), and of these the only one suggesting a transfer, even over evolutionary time scale (excepting Agrobacterium) from unrelated taxa to higher plants is with the case of vertebrate hemoglobin and legume hemoglobin (Wiborg et al., 1983). During the field testing of these plants, there was no evidence of horizontal transfer of the transformed genes to adjacent nonsexually compatible plants. This observation is based on sensitivity to glyphosate of weeds in the nearby fields.

VII. Adverse Consequences: New Cultivar Introduction

With respect to the herbicide-tolerant cotton, the use of glyphosate may increase if the transgenic cultivar is widely accepted by farmers. The increased use of glyphosate will be offset by the decreased use of organic arsenate-based herbicides used in conjunction with other herbicides.

The example given does not refer to a plant with a new pesticidal phenotype. For such plants, however applicants should indicate to APHIS whether they have applied for or been granted registration of the pesticide with the Environmental Protection Agency.

Applicants should also consult with APHIS on data the agency would deem to be appropriate and sufficient to demonstrate no significant impact on threatened and endangered species and beneficial nontarget organisms. This data should be submitted in the appendix of the petition application. However, brief summaries of data should appear in the petition application.


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