-The adoption of genetically modified (GM) crops in the European Union (EU) raises questions on the feasibility of coexistence between GM and non-GM crops. Regulations to ensure that different cropping systems can develop side-by-side without excluding any agricultural option are currently implemented or developed by member states. The aim of this review is to explore whether nationally or regionally proposed coexistence strategies comply with the general principles established by the European Commission that ask for science-based and proportionate coexistence measures. In the first part, existing legal requirements and potential sources of adventitious mixing are reviewed. It is discussed what type of coexistence measures might be necessary to keep GM inputs below the legal tolerance threshold of 0.9%. Concentrating on cross-fertilisation as the major biological source of adventitious mixing in maize, it is then assessed to which extent available scientific data on cross-fertilisation can explain the diversity of currently proposed isolation distances by several member states. In the second part, it is analysed whether currently proposed isolation distances reflect contending policy objectives towards GM crops that largely exceed the economic scope of coexistence. It is investigated how coexistence is intersecting with a wider debate about the role of GM crops in agriculture. Based on the analysis of existing cross-fertilisation data, it is concluded that some of the currently proposed isolation distances are not in line with the coexistence principles laid down by the European Commission: they are (i) excessive from a scientific point of view; (ii) difficult to implement in practice; (iii) rarely proportional to the regional heterogeneity in the agricultural landscape; and (iv) not proportional to the farmers' basic economic incentives for coexistence. Hence, the range of proposed isolation distances cannot simply be explained by different interpretations of available scientific data, possible error intervals and remaining uncertainties inherent in the scientific process. It is argued that other than scientific issues must be at play. One might thus claim that coexistence has become an arena of contending values and visions on the future of agriculture and on the role GM crops might play therein.adventitious mixing / Bt-maize / coexistence / cross-fertilisation / flexible measures / genetically modified (GM) crops / isolation distances / liability / fixed measures / sustainable development

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A major concern related to the adoption of genetically modified (GM) crops in agricultural systems is the possibility of unwanted GM inputs into non-GM crop production systems. Given the increasing commercial cultivation of GM crops in the European Union (EU), there is an urgent need to define measures to prevent mixing of GM with non-GM products during crop production. Cross-fertilization is one of the various mechanisms that could lead to GM-inputs into non-GM crop systems. Isolation distances between GM and non-GM fields are widely accepted to be an effective measure to reduce these inputs. However, the question of adequate isolation distances between GM and non-GM maize is still subject of controversy both amongst scientists and regulators. As several European countries have proposed largely differing isolation distances for maize ranging from 25 to 800 m, there is a need for scientific criteria when using cross-fertilization data of maize to define isolation distances between GM and non-GM maize. We have reviewed existing cross-fertilization studies in maize, established relevant criteria for the evaluation of these studies and applied these criteria to define science-based isolation distances. To keep GM-inputs in the final product well below the 0.9% threshold defined by the EU, isolation distances of 20 m for silage and 50 m for grain maize, respectively, are proposed. An evaluation using statistical data on maize acreage and an aerial photographs assessment of a typical agricultural landscape by means of Geographic Information Systems (GIS) showed that spatial resources would allow applying the defined isolation distances for the cultivation of GM maize in the majority of the cases under actual Swiss agricultural conditions. The here developed approach, using defined criteria to consider the agricultural context of maize cultivation, may be of assistance for the analysis of cross-fertilization data in other countries.

Genetically modified plants (GMPs) may soon be cultivated commercially in several member countries of the European Union (EU). According to EU Directive 2001/18/EC, post-market monitoring (PMM) for commercial GMP cultivation must be implemented, in order to detect and prevent adverse effects on human health and the environment. However, no general PMM strategies for GMP cultivation have been established so far. We present a conceptual framework for the design of environmental PMM for GMP cultivation based on current EU legislation and common risk analysis procedures. We have established a comprehensive structure of the GMP approval process, consisting of pre-market risk assessment (PMRA) as well as PMM. Both programs can be distinguished conceptually due to principles inherent to risk analysis procedures. The design of PMM programs should take into account the knowledge gained during approval for commercialization of a specific GMP and the decisions made in the environmental risk assessments (ERAs). PMM is composed of case-specific monitoring (CSM) and general surveillance. CSM focuses on anticipated effects of a specific GMP. Selection of case-specific indicators for detection of ecological exposure and effects, as well as definition of effect sizes, are important for CSM. General surveillance is designed to detect unanticipated effects on general safeguard subjects, such as natural resources, which must not be adversely affected by human activities like GMP cultivation. We have identified clear conceptual differences between CSM and general surveillance, and propose to adopt separate frameworks when developing either of the two programs. Common to both programs is the need to put a value on possible ecological effects of GMP cultivation. The structure of PMM presented here will be of assistance to industry, researchers, and regulators, when assessing GMPs during commercialization.

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Regulatory decision-making over the use of products of new technology aims to be based on science-based risk assessment. In some jurisdictions, decision-making about the cultivation of genetically modified (GM) plants is blocked supposedly because of scientific uncertainty about risks to the environment. However, disagreement about the acceptability of risks is primarily a dispute over normative values, which is not resolvable through natural sciences. Natural sciences may improve the quality and relevance of the scientific information used to support environmental risk assessments and make scientific uncertainties explicit, but offer little to resolve differences about values. Decisions about cultivating GM plants will thus not necessarily be eased by performing more research to reduce scientific uncertainty in environmental risk assessments, but by clarifying the debate over values. We suggest several approaches to reveal values in decision-making: (1) clarifying policy objectives; (2) determining what constitutes environmental harm; (3) making explicit the factual and normative premises on which risk assessments are based; (4) better demarcating environmental risk assessment studies from ecological research; (5) weighing the potential for environmental benefits (i.e., opportunities) as well as the potential for environmental harms (i.e., risks); and (6) expanding participation in the risk governance of GM plants. Recognising and openly debating differences about values will not remove controversy about the cultivation of GM plants. However, by revealing what is truly in dispute, debates about values will clarify decision-making criteria.