Engaging with Uncertainty and Risk in Agricultural Biotechnology Regulation: Delivering Safety and Innovation

该项目的总体目标是深入了解与农业生物技术相关的监管和政策过程的不完善之处，并将其应用于建议如何通过使用Innogen中心的创新技术适应性治理（AGIT）和关键利益相关者参与（CSE）的方法来改进这些过程。该项目将特别审查专家和非专家在该领域的作用，以及他们如何通过使用证据和意识形态动机影响决策。这项建议建立在Innogen中心工作人员的研究基础上，他们自20世纪90年代初以来一直在这些政策领域工作并发表评论，当时围绕转基因作物发展的影响和安全问题在科学证据方面存在更大的争议。当时的期望是，如果有证据表明转基因作物的安全性和有效性，对转基因作物形成监管的方法，即对新产品有非常严格的测试要求的预防性方法，将会得到修改。然而，尽管越来越多的证据表明转基因作物对环境和人类是安全的，甚至是有益的，但欧洲并没有对预防方法进行修改。该提案来自ESRC Innogen中心和先正达之间关于创新生物技术的监管和治理的讨论，包括目前应用于转基因作物的监管系统以及合成生物学的未来使用和监管，它似乎为该系统中当前的问题提出了一些解决方案。本课题主要研究的问题如下：1.研究方向：如何将Innogen和Syngenta在科学、政策和监管方面的见解结合起来，以改善监管体系，以及创新者、监管机构和社会之间的互动，从而将安全、有效和有利可图的产品推向市场？从这一分析中，公司、政策制定者和利益相关者可以得到什么教训？能否从这个机会中获得新的学术理解，将社会经济见解应用于现实世界的案例研究？因此，该项目将结合Innogen在这一政策领域的见解，以及先正达在监管体系方面的经验，来解决这些问题。该项目为行业代表、政策代表和民间社会代表（如非政府组织）提供了会面和讨论项目结论的机会，并吸取了与政策过程和监管体系互动和改进的一些关键经验教训。此外，该项目还将形成政策简报、评论文章和学术出版物，以便与尽可能广泛的受众分享项目的见解。

The overall aim of this project is to take insights about the imperfections of the regulatory and policy processes related to agricultural biotechnologies, and apply them to recommend how to improve these processes by using the Innogen Centre's approaches to Adaptive Governance of Innovative Technology (AGIT) and Critical Stakeholder Engagement (CSE). The project will particularly examine the role of experts and non-experts in the field, and how they influence decisions through their use of evidence as well as ideological motivations. The proposal builds on research by Innogen Centre staff, who have been working in, and commenting on, these areas of policy since the early 1990s when the questions of impacts and safety surrounding the development of GM crops were much more contested in terms of scientific evidence. The expectation at that time was that the approach taken to form regulation for GM crops, the precautionary approach with very stringent testing requirements for new products, would be modified if and when evidence of the safety and efficacy of GM crops became available. The modification of the precautionary approach in Europe, however, has not taken place, despite increasing evidence that GM crops are safe, and even beneficial, to the environment and to people. The proposal, which arises from discussions between the ESRC Innogen Centre and Syngenta on the regulation and governance of innovative biotechnologies, including current regulatory systems as applied to genetically modified (GM) crops and the future use and regulation of synthetic biology, looks to suggest some solutions to the current problems in the system.The key research questions addressed in the project are the following:1. How can Innogen's and Syngenta's insights on the science, policy and regulatory concerns be combined to improve the regulatory system and the interactions among innovators, regulators and society in delivering to market products that are safe, effective and profitable?2. What lessons can be drawn from this analysis for companies, policy makers and stakeholders?3. Can new academic understanding be drawn from this opportunity to apply socio-economic insights to real world case studies?The project will therefore look to combine the insights from Innogen in this policy area, and Syngenta's experience with the regulatory system, to address these issues. The project provide the opportunity for industry representatives, policy representatives, and civil society representatives (e.g. NGOs) to meet and discuss the project's conclusions, and to take-away some key lessons to interact with and improve policy process and the regulatory system. In addition, the project will result in policy briefs, opinion pieces, and academic publications, in order to share the project insights with as broad an audience as possible.