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Statistical aspects of environmental risk assessment of GM plants for effects on non-target organisms
Environmental Biosafety Research
  • Joe N. Perry, Oaklands Barn, Broome, Norfolk, UK
  • Cajo J. F. ter Braak, Wageningen University and Research Centre, Netherlands
  • Philip M. Dixon, Iowa State University
  • Jian J. Duan, United States Department of Agriculture
  • Rosie S. Hails, Centre for Ecology and Hydrology, Oxford, UK
  • Alexandra Huesken, Julius Kuehn Institute, Germany
  • Marc Lavielle, Universite Paris-Sud
  • Michelle Marvier, Santa Clara University
  • Michele Scardi, University of Rome 'Tor Vergata'
  • Kerstin Schmidt, BioOK GmbH, Germany
  • Bela Tothmeresz, University of Debrecen, Hungary
  • Frank Schaarschmidt, Leibniz University Hannover
  • Hilko van der Voet, Wageningen University and Research Centre, Netherlands
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Previous European guidance for environmental risk assessment of genetically modified plants emphasized the concepts of statistical power but provided no explicit requirements for the provision of statistical power analyses. Similarly, whilst the need for good experimental designs was stressed, no minimum guidelines were set for replication or sample sizes. Furthermore, although substantial equivalence was stressed as central to risk assessment, no means of quantification of this concept was given. This paper suggests several ways in which existing guidance might be revised to address these problems. One approach explored is the `bioequivalence' test, which has the advantage that the error of most concern to the consumer may be set relatively easily. Also, since the burden of proof is placed on the experimenter, the test promotes high-quality, well-replicated experiments with sufficient statistical power. Other recommendations cover the specification of effect sizes, the choice of appropriate comparators, the use of positive controls, meta-analyses, multivariate analysis and diversity indices. Specific guidance is suggested for experimental designs of field trials and their statistical analyses. A checklist for experimental design is proposed to accompany all environmental risk assessments.

This is an article from Environmental Biosafety Research 8 (2009): 65, doi:10.1051/ebr/2009009. Posted with permission.

Works produced by employees of the U.S. Government as part of their official duties are not copyrighted within the U.S. The content of this document is not copyrighted.
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Joe N. Perry, Cajo J. F. ter Braak, Philip M. Dixon, Jian J. Duan, et al.. "Statistical aspects of environmental risk assessment of GM plants for effects on non-target organisms" Environmental Biosafety Research Vol. 8 Iss. 2 (2009) p. 65 - 78
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