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Transportability of confined field trial data for environmental risk assessment of genetically engineered plants: a conceptual framework

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      Abstract

      It is commonly held that confined field trials (CFTs) used to evaluate the potential adverse environmental impacts of a genetically engineered (GE) plant should be conducted in each country where cultivation is intended, even when relevant and potentially sufficient data are already available from studies conducted elsewhere. The acceptance of data generated in CFTs “out of country” can only be realized in practice if the agro-climatic zone where a CFT is conducted is demonstrably representative of the agro-climatic zones in those geographies to which the data will be transported. In an attempt to elaborate this idea, a multi-disciplinary Working Group of scientists collaborated to develop a conceptual framework and associated process that can be used by the regulated and regulatory communities to support transportability of CFT data for environmental risk assessment (ERA). As proposed here, application of the conceptual framework provides a scientifically defensible process for evaluating if existing CFT data from remote sites are relevant and/or sufficient for local ERAs. Additionally, it promotes a strategic approach to identifying CFT site locations so that field data will be transportable from one regulatory jurisdiction to another. Application of the framework and process should be particularly beneficial to public sector product developers and small enterprises that develop innovative GE events but cannot afford to replicate redundant CFTs, and to regulatory authorities seeking to improve the deployment of limited institutional resources.

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      Most cited references 56

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      Closing yield gaps through nutrient and water management.

      In the coming decades, a crucial challenge for humanity will be meeting future food demands without undermining further the integrity of the Earth's environmental systems. Agricultural systems are already major forces of global environmental degradation, but population growth and increasing consumption of calorie- and meat-intensive diets are expected to roughly double human food demand by 2050 (ref. 3). Responding to these pressures, there is increasing focus on 'sustainable intensification' as a means to increase yields on underperforming landscapes while simultaneously decreasing the environmental impacts of agricultural systems. However, it is unclear what such efforts might entail for the future of global agricultural landscapes. Here we present a global-scale assessment of intensification prospects from closing 'yield gaps' (differences between observed yields and those attainable in a given region), the spatial patterns of agricultural management practices and yield limitation, and the management changes that may be necessary to achieve increased yields. We find that global yield variability is heavily controlled by fertilizer use, irrigation and climate. Large production increases (45% to 70% for most crops) are possible from closing yield gaps to 100% of attainable yields, and the changes to management practices that are needed to close yield gaps vary considerably by region and current intensity. Furthermore, we find that there are large opportunities to reduce the environmental impact of agriculture by eliminating nutrient overuse, while still allowing an approximately 30% increase in production of major cereals (maize, wheat and rice). Meeting the food security and sustainability challenges of the coming decades is possible, but will require considerable changes in nutrient and water management.
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        Mind the gap: how do climate and agricultural management explain the ‘yield gap’ of croplands around the world?

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

          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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            Author and article information

            Affiliations
            [ ]Estel Consult Ltd., 5 Hillside Drive, Binfield, Berkshire, RG42 4HG UK
            [ ]Phasera Ltd., 7 Kenilworth Avenue, Bracknell, Berkshire, RG12 2JJ UK
            [ ]Agroscope Reckenholz-Tänikon, Reckenholzstrasse 191, 8046 Zurich, Switzerland
            [ ]Unidad de Gestión del Riesgo, Ministerio de Agricultura, Asunción, República del Paraguay
            [ ]Environmental Fate and Effects Division, Office of Pesticide Programs, United States Environmental Protection Agency, One Potomac Yard, 2777 S. Crystal Drive, Arlington, VA 22202 USA
            [ ]ILSI Argentina, Av Santa Fe 1145, 4° piso, C1059ABF Buenos Aires, Argentina
            [ ]IFEVA, Cátedra de Cerealicultura, Facultad de Agronomía y Veterinaria, Universidad de Buenos Aires, Avda. San Martín 4453, Buenos Aires, Argentina
            [ ]Monsanto Argentina SAIC, Estacion Experimental Fontezuela, Ruta 8 km 214, Fontezuela, Partido de Pergamino, Buenos Aires, Argentina
            [ ]Center for Environmental Risk Assessment, ILSI Research Foundation, 1156 Fifteenth Street NW, Suite 200, Washington, DC 20005 USA
            Contributors
            +1-202-6593306 , +1-202-6593617 , mmclean@ilsi.org
            Journal
            Transgenic Res
            Transgenic Res
            Transgenic Research
            Springer International Publishing (Cham )
            0962-8819
            1573-9368
            15 April 2014
            15 April 2014
            2014
            : 23
            : 6
            : 1025-1041
            24733670
            4204004
            9785
            10.1007/s11248-014-9785-0
            © The Author(s) 2014

            Open AccessThis article is distributed under the terms of the Creative Commons Attribution License which permits any use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited.

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            © Springer International Publishing Switzerland 2014

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