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      Recommendations for the design of laboratory studies on non-target arthropods for risk assessment of genetically engineered plants

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          This paper provides recommendations on experimental design for early-tier laboratory studies used in risk assessments to evaluate potential adverse impacts of arthropod-resistant genetically engineered (GE) plants on non-target arthropods (NTAs). While we rely heavily on the currently used proteins from Bacillus thuringiensis (Bt) in this discussion, the concepts apply to other arthropod-active proteins. A risk may exist if the newly acquired trait of the GE plant has adverse effects on NTAs when they are exposed to the arthropod-active protein. Typically, the risk assessment follows a tiered approach that starts with laboratory studies under worst-case exposure conditions; such studies have a high ability to detect adverse effects on non-target species. Clear guidance on how such data are produced in laboratory studies assists the product developers and risk assessors. The studies should be reproducible and test clearly defined risk hypotheses. These properties contribute to the robustness of, and confidence in, environmental risk assessments for GE plants. Data from NTA studies, collected during the analysis phase of an environmental risk assessment, are critical to the outcome of the assessment and ultimately the decision taken by regulatory authorities on the release of a GE plant. Confidence in the results of early-tier laboratory studies is a precondition for the acceptance of data across regulatory jurisdictions and should encourage agencies to share useful information and thus avoid redundant testing.

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          Most cited references 92

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            Assessment of risk of insect-resistant transgenic crops to nontarget arthropods.

            An international initiative is developing a scientifically rigorous approach to evaluate the potential risks to nontarget arthropods (NTAs) posed by insect-resistant, genetically modified (IRGM) crops. It adapts the tiered approach to risk assessment that is used internationally within regulatory toxicology and environmental sciences. The approach focuses on the formulation and testing of clearly stated risk hypotheses, making maximum use of available data and using formal decision guidelines to progress between testing stages (or tiers). It is intended to provide guidance to regulatory agencies that are currently developing their own NTA risk assessment guidelines for IRGM crops and to help harmonize regulatory requirements between different countries and different regions of the world.
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              Transgenic crops expressing Bacillus thuringiensis toxins and biological control.

              The area devoted to growing transgenic plants expressing insecticidal Cry proteins derived from Bacillus thuringiensis (Bt) is increasing worldwide. A major concern with the adoption of Bt crops is their potential impact on nontarget organisms including biological control organisms. Regulatory frameworks should advocate a step-wise (tiered) approach to assess possible nontarget effects of Bt crops. Laboratory and glasshouse studies have revealed effects on natural enemies only when Bt-susceptible, sublethally damaged herbivores were used as prey or host, with no indication of direct toxic effects. Field studies have confirmed that the abundance and activity of parasitoids and predators are similar in Bt and non-Bt crops. In contrast, applications of conventional insecticides have usually resulted in negative impacts on biological control organisms. Because Bt-transgenic varieties can lead to substantial reductions in insecticide use in some crops, they can contribute to integrated pest management systems with a strong biological control component.

                Author and article information

                [1 ]Agroscope Reckenholz-Tänikon Research Station ART, Reckenholzstr. 191, 8046 Zurich, Switzerland
                [2 ]USDA-ARS, Corn Insects and Crop Genetics Research Unit, Genetics Laboratory c/o Insectary, Department of Entomology, Iowa State University, Ames, IA 50011-3140 USA
                [3 ]Innovative Environmental Services (IES) Ltd, Benkenstr. 260, 4108 Witterswil, Switzerland
                [4 ]Regulatory Science, Pioneer Hi-Bred, 2450 SE Oak Tree Ct., Ankeny, IA 50021 USA
                [5 ]Division Biosafety and Biotechnology, Scientific Institute of Public Health, Juliette Wytsmanstraat 14, 1050 Brussels, Belgium
                [6 ]School of Biology, Institute for Research and Sustainability, Newcastle University, Devonshire Building, Newcastle upon Tyne, NE1 7RU UK
                [7 ]Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268 USA
                [8 ]Monsanto Company, 800 North Lindbergh Blvd., St Louis, MO 63167 USA
                [9 ]Center for Environmental Risk Assessment, ILSI Research Foundation, 1156 Fifteenth St., N.W., 2nd floor, Washington, DC 20005-17432 USA
                [10 ]Syngenta, Jealott’s Hill International Research Centre, Bracknell, RG42 6 EY Berkshire UK
                [11 ]Cornell University/NYSAES, 630 W. North St., Geneva, NY 14456 USA
                [12 ]Office of Pesticide Programs, Biopesticides and Pollution Prevention Division, US Environmental Protection Agency, 1200 Pennsylvania Avenue, NW, Washington, DC 20460 USA
                +41-44-3777299 , +41-44-3777299 ,
                Transgenic Res
                Transgenic Research
                Springer Netherlands (Dordrecht )
                13 October 2010
                13 October 2010
                February 2011
                : 20
                : 1
                : 1-22
                © The Author(s) 2010
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                © Springer Science+Business Media B.V. 2011


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