ISBGMO12

Transgenic Research

, Volume 23, Issue 6, pp 1025-1041

First online:

Open Access This content is freely available online to anyone, anywhere at any time.

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

  • Monica Garcia-AlonsoAffiliated withEstel Consult Ltd.
  • , Paul HendleyAffiliated withPhasera Ltd.
  • , Franz BiglerAffiliated withAgroscope Reckenholz-Tänikon
  • , Edgar MayereggerAffiliated withUnidad de Gestión del Riesgo, Ministerio de Agricultura
  • , Ronald ParkerAffiliated withEnvironmental Fate and Effects Division, Office of Pesticide Programs, United States Environmental Protection Agency
  • , Clara RubinsteinAffiliated withILSI Argentina
  • , Emilio SatorreAffiliated withIFEVA, Cátedra de Cerealicultura, Facultad de Agronomía y Veterinaria, Universidad de Buenos Aires
  • , Fernando SolariAffiliated withMonsanto Argentina SAIC, Estacion Experimental Fontezuela
  • , Morven A. McLeanAffiliated withCenter for Environmental Risk Assessment, ILSI Research Foundation Email author 

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.

Keywords

Genetically engineered plant Confined field trial Regulatory framework Transportability Agro-climatic zone