The seemingly inexorable expansion of global human population size, significant increases in the use of biofuel crops and the growing pressures of multifunctional land-use have intensified the need to improve crop productivity. The widespread cultivation of high-yielding genetically modified (GM) crops could help to address these problems, although in doing so, steps must also be taken to ensure that any gene flow from these crops to wild or weedy recipients does not cause significant ecological harm. It is partly for this reason that new GM cultivars are invariably subjected to strict regulatory evaluation in order to assess the risks that each may pose to the environment. Regulatory bodies vary in their approach to decision-making, although all require access to large quantities of detailed information. Such an exhaustive case-by-case approach has been made tractable by the comparative simplicity of the portfolio of GM crops currently on the market, with four crops and two classes of traits accounting for almost all of the area under cultivation of GM crops. This simplified situation will change shortly, and will seriously complicate and potentially slow the evaluation process. Nowhere will the increased diversity of GM crops cause more difficulty to regulators than in those cases where there is a need to assess whether the transgene(s) will enhance fitness in a non-transgenic relative and thereafter cause ecological harm. Current practice to test this risk hypothesis focuses on attempting to detect increased fitness in the recipient. In this paper we explore the merits and shortcomings of this strategy, and investigate the scope for developing new approaches to streamline decision-making processes for transgenes that could cause unwanted ecological change.Keywords: environmental risk assessment / fitness / fitness parameters / GM crops / invasiveness / weediness
THE CONTEXT OF ENVIRONMENTAL RISK ASSESSMENTThroughout the world, wherever transgenic crops are grown outside the confines of the laboratory, there is a regulatory system for governing and monitoring the conditions under which experimental field trials and/or commercial cultivation is sanctioned. There is considerable variation between individual countries in the legislative frameworks that dictate how decisions to permit, delay or halt the release of a particular transgenic event are made (Capalbo et al., 2003;Cardwell and Kerr, 2008;Guehlstorf and Hallstrom, 2005; Jepson et al., 2005;Kalaitzandonakes et al., 2007;Nasiruddin and Nasim, 2007;Ramjoue, 2007;Salleh, 2006;Zafar, 2007). Nevertheless, there appears to be a growing harmonization of the underlying process that governs decision-making, * Corresponding author: jjw@aber.ac.uk with all systems adopting a case-by-case approach in which large bodies of evidence are first presented and then evaluated in a reiterative fashion.The documents made in support of individual submissions are usually rather weighty and data-rich; they invariably include substantial information relating to the biology and agr...