title: Assessing environmental impacts of genetically modified plants on non-target organisms: The relevance of in planta studies.
abstract: In legal frameworks worldwide, genetically modified plants (GMPs) are subjected to pre-market environmental risk assessment (ERA) with the aim of identifying potential effects on the environment. In the European Union, the EFSA Guidance Document introduces the rationale that GMPs, as well as their newly produced metabolites, represent the potential stressor to be evaluated during ERA. As a consequence, during several phases of ERA for cultivation purposes, it is considered necessary to use whole plants or plant parts in experimental protocols. The importance of in planta studies as a strategy to address impacts of GMPs on non-target organisms is demonstrated, to evaluate both effects due to the intended modification in plant phenotype (e.g. expression of Cry proteins) and effects due to unintended modifications in plant phenotype resulting from the transformation process (e.g. due to somaclonal variations or pleiotropic effects). In planta tests are also necessary for GMPs in which newly expressed metabolites cannot easily be studied in vitro. This paper reviews the scientific literature supporting the choice of in planta studies as a fundamental tool in ERA of GMPs in cultivation dossiers; the evidence indicates they can realistically mimic the ecological relationships occurring in their receiving environments and provide important insights into the biology and sustainable management of GMPs.
authors.affiliation: ENEA, DTE-BBC, Research Centre Trisaia, Rotondella (MT), Italy. Electronic address: salvatore.arpaia@enea.it.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Arpaia
authors.affiliation: The James Hutton Institute, Dundee, UK.
authors.forename: A Nicholas E
authors.initials: ANE
authors.lastname: Birch
authors.affiliation: Plant Protection Institute, Szent Istvan University, Gödöllö, Hungary.
authors.forename: Jozsef
authors.initials: J
authors.lastname: Kiss
authors.affiliation: Laboratory of Entomology, Wageningen University and Research, Wageningen, The Netherlands.
authors.forename: Joop J A
authors.initials: JJA
authors.lastname: van Loon
authors.affiliation: INRA, Eco-Innov, Grignon-Paris, France.
authors.forename: Antoine
authors.initials: A
authors.lastname: Messéan
authors.affiliation: University of Pisa, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Nuti
authors.affiliation: University of Greenwich, UK.
authors.forename: Joe N
authors.initials: JN
authors.lastname: Perry
authors.affiliation: Sweet Environmental Consultants, Cambridge, UK.
authors.forename: Jeremy B
authors.initials: JB
authors.lastname: Sweet
authors.affiliation: Thünen Institute of Biodiversity, Braunschweig, Germany.
authors.forename: Christoph C
authors.initials: CC
authors.lastname: Tebbe
mesh_terms: D004463:Ecology; D004777:Environment; D004784:Environmental Monitoring; D005062:European Union; D030821:Plants, Genetically Modified; D018570:Risk Assessment
keywords: Bacillus thuringiensis; Ecosystem services; Environmental risk assessment; Insect resistance; Insect-plant interactions; Non-target organisms; Risk management