title: Transportability of confined field trial data for environmental risk assessment of genetically engineered plants: a conceptual framework.
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.
authors.affiliation: Estel Consult Ltd., 5 Hillside Drive, Binfield, Berkshire, RG42 4HG, UK.
authors.forename: Monica
authors.initials: M
authors.lastname: Garcia-Alonso
authors.forename: Paul
authors.initials: P
authors.lastname: Hendley
authors.forename: Franz
authors.initials: F
authors.lastname: Bigler
authors.forename: Edgar
authors.initials: E
authors.lastname: Mayeregger
authors.forename: Ronald
authors.initials: R
authors.lastname: Parker
authors.forename: Clara
authors.initials: C
authors.lastname: Rubinstein
authors.forename: Emilio
authors.initials: E
authors.lastname: Satorre
authors.forename: Fernando
authors.initials: F
authors.lastname: Solari
authors.forename: Morven A
authors.initials: MA
authors.lastname: McLean
mesh_terms: D003257:Consumer Product Safety; D004781:Environmental Exposure / Q000517:prevention & control*; D006801:Humans; D030821:Plants, Genetically Modified / Q000009:adverse effects*; D018570:Risk Assessment / Q000379:methods*; D013223:Statistics as Topic
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