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United States Department of Agriculture

Agricultural Research Service

Research Project: BIOLOGICAL CONTROL OF EMERALD ASH BORER AND QUARANTINE SERVICES

Location: Beneficial Insects Introduction Research

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

Authors
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: June 25, 2009
Publication Date: October 2, 2009
Repository URL: http://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: 7/22/2014
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