Agroscope Reckenholz-Tänikon Research Station ART, Reckenholzstr. 191, 8046 Zürich, Switzerland.
Transgenic Res. 2011 Dec;20(6):1191-201. doi: 10.1007/s11248-011-9524-8. Epub 2011 May 24.
The ability to decide what kind of environmental changes observed during post-market environmental monitoring of genetically modified (GM) crops represent environmental harm is an essential part of most legal frameworks regulating the commercial release of GM crops into the environment. Among others, such decisions are necessary to initiate remedial measures or to sustain claims of redress linked to environmental liability. Given that consensus on criteria to evaluate 'environmental harm' has not yet been found, there are a number of challenges for risk managers when interpreting GM crop monitoring data for environmental decision-making. In the present paper, we argue that the challenges in decision-making have four main causes. The first three causes relate to scientific data collection and analysis, which have methodological limits. The forth cause concerns scientific data evaluation, which is controversial among the different stakeholders involved in the debate on potential impacts of GM crops on the environment. This results in controversy how the effects of GM crops should be valued and what constitutes environmental harm. This controversy may influence decision-making about triggering corrective actions by regulators. We analyse all four challenges and propose potential strategies for addressing them. We conclude that environmental monitoring has its limits in reducing uncertainties remaining from the environmental risk assessment prior to market approval. We argue that remaining uncertainties related to adverse environmental effects of GM crops would probably be assessed in a more efficient and rigorous way during pre-market risk assessment. Risk managers should acknowledge the limits of environmental monitoring programmes as a tool for decision-making.
在对转基因（GM）作物进行上市后环境监测时，能够确定所观察到的环境变化是否构成环境危害，这是规范 GM 作物环境释放的大多数法律框架的重要组成部分。这些决策对于启动补救措施或维持与环境责任相关的赔偿要求是必要的。鉴于尚未就评估“环境危害”的标准达成共识，风险管理者在解释用于环境决策的 GM 作物监测数据时面临诸多挑战。在本文中，我们认为决策中的挑战有四个主要原因。前三个原因与科学数据的收集和分析有关，这些方法存在方法学限制。第四个原因涉及科学数据评估，这在参与 GM 作物对环境潜在影响辩论的不同利益相关者之间存在争议。这导致了关于如何评估 GM 作物的影响以及什么构成环境危害的争议。这种争议可能会影响监管机构触发纠正措施的决策。我们分析了所有四个挑战，并提出了解决这些挑战的潜在策略。我们的结论是，环境监测在减少上市前环境风险评估中遗留的不确定性方面存在局限性。我们认为，GM 作物对环境产生不利影响的剩余不确定性可能会在上市前风险评估中以更有效和严格的方式进行评估。风险管理者应该承认环境监测计划作为决策工具的局限性。
