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United States Department of Agriculture

Agricultural Research Service

Title: Statistical aspects of environmental risk assessment of GM plants for effects on non-target organisms)

Author
item Joe, Perry
item Ter braak, Cajo
item Dixon, Philip
item Duan, Jian
item Hails, Rosie
item Huesken, Alexandra
item Lavielle, Marc
item Marvier, Michelle
item Scardi, Michele
item Schmidt, Kerstin
item Tothmeresz, Bela
item Schaarschmidt, Frank
item Van de voet, Hilko

Submitted to: Environmental Biosafety Research
Publication Type: Peer reviewed journal
Publication Acceptance Date: 6/25/2009
Publication Date: 10/2/2009
Publication URL: www.ebr-journal.org/index.php?option=article&access=standard&Itemid=129&url=/articles/ebr/pdf/2009/02/ebr0905.pdf
Citation: Joe, P.N., Ter Braak, C.J., Dixon, P.M., Duan, J.J., Hails, R.S., Huesken, A., Lavielle, M., Marvier, M., Scardi, M., Schmidt, K., Tothmeresz, B., Schaarschmidt, F., Van De Voet, H. 2009. Statistical aspects of environmental risk assessment of GM plants for effects on non-target organisms. Environmental Biosafety Research. 8:65-78.

Interpretive Summary: This paper suggests several statistical approaches to analyzing data on environmental risk assessment of genetically modified plants for effects on non-target organisms. One approach explored is the 'biological-equivalence' test, which has the advantage that the experimental error of most concern to the consumer (public) 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. 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.

Technical Abstract: 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.

Last Modified: 8/24/2016
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