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

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.

The beneficiaries identified here who will be benefit from this project are based on ESRC, JeS and RCUK guidance on this topic. Beneficiaries will include firms in the agriculture and biotechnology industries; UK, and EU policy stakeholders (including NGOs) in agriculture, environment, and innovation policy; as well as other industries facing regulatory challenges or unknown risk due to emerging technologies.
The goals of the project are directly geared towards providing utility to users, as the main activity of the project goal is to apply and refine the AGIT and CSE approaches to improve evidence based-policy making and analysis, increase public awareness and understanding of science and related economic and social issues, and enhance the performance of industry dealing with regulatory issues and public engagement.

Regulation in Agricultural Biotechnology and Synthetic biology
The project will have an impact on "users" in the area of agricultural biotechnology by identifying the problems in the regulatory system and risk management processes that may be preventing safe, innovative products from entering the market due to poorly outlined risk management objectives, or social and political concerns based on inaccurate evidence or subjective policy goals. In the long run we hope to inform interventions (via smarter regulatory systems) and behaviour (via smarter regulators).
It will also help to develop an approach to communicating with stakeholders while being aware of different, potentially conflicting views and goals, and how to navigate these relations. Future resolution of the issues addressed in this project will depend on the interactions between industry, government and civil society, and we will engage with NGOs as part of the project, building on Syngenta's existing good relationships with scientists based at the Royal Society for the Protection of Birds and the British Trust for Ornithology

General AGIT Methodology Impact
The potential impact will go beyond the agricultural biotechnology sector. The approaches refined through this study will help policymakers to see the links between different regulatory structures, and how features of one structure may or may not benefit or restrict innovation because of problematic incentives created for actors interacting with other structures. For example, regulators must consider what implications regulations might have for intellectual property; implications for the cost of development and type of firm best able to develop a product. These implications are important as what may seem like sensible regulations at the present may severely constrain an innovation system in the future.
Industrial users will improve their ability to understand the governance systems they interact with and determine how to navigate or influence governance structures across a multitude of economic or political settings. Insights into how to treat different sources of evidence, conflicting stakeholder interests, and unforeseen circumstances will enhance user activity directly.

While policymakers and firms will have mechanisms to engage with and improve regulatory systems and governance systems more generally, investors in the life sciences and biotechnology may also potentially benefit from the insights generated by this study regarding how regulatory system issues may impede (or fast track) new products to market. Considering that many new products are stalled, and small companies potentially stifled, by the heavy regulatory burden in the life science industries, such understanding would help investors better determine the probability of success; like firms and policymakers, it would also help investors engage in the creation/improvement of governance systems.