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ARS Home » Northeast Area » Newark, Delaware » Beneficial Insects Introduction Research Unit » Research » Publications at this Location » Publication #247982
Title: Statistical aspects of environmental risk assessment of GM plants for effects on non-target organisms

Author
item JOE, PERRY - Rothamsted Centre For Sustainable Pest And Disease Management
item TER BRAAK, CAJO - Wageningen University
item DIXON, PHILIP - Iowa State University
item Duan, Jian
item HAILS, ROSIE - Centre For Ecology And Hydrology
item HUESKEN, ALEXANDRA - Julius Kuhn Institute
item LAVIELLE, MARC - University Of Paris
item MARVIER, MICHELLE - Santa Clara University
item SCARDI, MICHELE - University Of Torino
item SCHMIDT, KERSTIN - University Of Rostock
item TOTHMERESZ, BELA - University Of Hungary
item SCHAARSCHMIDT, FRANK - Leibniz University
item VAN DE VOET, HILKO - Wageningen University And Research Center

Submitted to: Environmental Biosafety Research
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 6/25/2009
Publication Date: 10/2/2009
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.