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

Monica Garcia-Alonso,Franz Bigler,Emilio Satorre,Ronald Parker,Fernando Solari,Morven A Mclean,Paul Hendley,Edgar Mayeregger,Clara Rubinstein

doi:10.1007/s11248-014-9785-0

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.

Highlights

The development of a genetically engineered (GE) crop plant follows a progression from experimentation in laboratory and other contained facilities, to field studies, and eventually to cultivation after pre-market environmental risk and food/feed safety assessments have been conducted by the appropriate regulatory authorities
In accordance with internationally accepted approaches to environmental risk assessment (ERA) of GE plants (OECD 1992; SCBD 2000), a comparative assessment is followed where the GE plant is compared to its conventional counterpart, usually the isogenic or a near-isogenic line, which is included in the confined field trials (CFTs) as a control
CFTs are regarded as an essential activity in the development of a GE plant intended for commercial cultivation, including for the generation of data to address risk hypotheses relevant to ERA

Summary

Introduction

The development of a genetically engineered (GE) crop plant follows a progression from experimentation in laboratory and other contained facilities, to field studies, and eventually to cultivation after pre-market environmental risk and food/feed safety assessments have been conducted by the appropriate regulatory authorities. Conducting field studies with experimental GE plants, termed confined field trials (CFTs), is a regulated activity, meaning that permission must be obtained from the appropriate competent authorities before trials can be planted. CFTs are regarded as essential for the evaluation of regulated GE plants under realistic environmental conditions and are conducted in agro-ecosystems ( referred to as receiving environments) representative of those where that particular GE crop may be cultivated.

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