Statistical Aspects of Environmental Risk Assessment of GM Plants for effects on Non-Target Organisms

Perry, Joe N.; Ter Braak, Cajo J.F; Dixon, Philip M.; Duan, Jian J.; Hails, Rosie S.; Huesken, Alexandra; Lavielle, Marc; Marvier, Michelle; Scardi, Michele; Schmidt, Kirstin; Tothmeresz, Bela; Schaarschmidt, Frank; van der Voet, Hilko. 2009 Statistical Aspects of Environmental Risk Assessment of GM Plants for effects on Non-Target Organisms. Environmental Biosafety Research, 8. 65-78. https://doi.org/10.1051/ebr/2009009

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Abstract/Summary

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.

Item Type:	Publication - Article
Digital Object Identifier (DOI):	https://doi.org/10.1051/ebr/2009009
Programmes:	CEH Topics & Objectives 2009 - 2012 > Biodiversity > BD Topic 3 - Managing Biodiversity and Ecosystem Services in a Changing Environment CEH Topics & Objectives 2009 - 2012 > Biodiversity > BD Topic 1 - Observations, Patterns, and Predictions for Biodiversity
UKCEH and CEH Sections/Science Areas:	Hails
ISSN:	1635-7922
Additional Keywords:	environmental risk assessment, statistical analysis, experimental design, equivalence test, genetically modified plant, statistical power
NORA Subject Terms:	Ecology and Environment
Date made live:	26 Nov 2012 13:53 +0 (UTC)
URI:	https://nora.nerc.ac.uk/id/eprint/20401

Item Type:

Publication - Article

Digital Object Identifier (DOI):

https://doi.org/10.1051/ebr/2009009

Programmes:

CEH Topics & Objectives 2009 - 2012 > Biodiversity > BD Topic 3 - Managing Biodiversity and Ecosystem Services in a Changing Environment
CEH Topics & Objectives 2009 - 2012 > Biodiversity > BD Topic 1 - Observations, Patterns, and Predictions for Biodiversity

UKCEH and CEH Sections/Science Areas:

Hails

ISSN:

1635-7922

Additional Keywords:

environmental risk assessment, statistical analysis, experimental design, equivalence test, genetically modified plant, statistical power