Stakeholder engagement to inform the risk assessment and governance of gene drive technology to manage spotted-wing drosophila.

Emerging biotechnologies, such as gene drive technology, are increasingly being proposed to manage a variety of pests and invasive species. As one method of genetic biocontrol, gene drive technology is currently being developed to manage the invasive agricultural pest spotted-wing drosophila (Drosophila suzukii, SWD). While there have been calls for stakeholder engagement on gene drive technology, there has been a lack of empirical work, especially concerning stakeholder engagement to inform risk assessment. To help address this gap and inform future risk assessments and governance decisions for SWD gene drive technology, we conducted a survey of 184 SWD stakeholders to explore how they define and prioritize potential benefits and potential adverse effects from proposed SWD gene drive technology. We found that stakeholders considered the most important potential benefits of SWD gene drive technology to be: 1) Decrease in the quantity or toxicity of pesticides used, and 2) Decrease in SWD populations. Stakeholders were most concerned about the potential adverse effects of: 1) Decrease in beneficial insects, 2) Increase in non-SWD secondary pest infestations, and 3) Decrease in grower profits. Notably, we found that even stakeholders who expressed support for the use of SWD gene drive technology expressed concerns about potential adverse effects from the technology, emphasizing the need to move past simplistic, dichotomous views of what it means to support or oppose a technology. These findings suggest that instead of focusing on the binary question of whether stakeholders support or oppose SWD gene drive technology, it is more important to identify and assess the factors that are consequential to stakeholder decision making - including, for example, exploring whether and under what conditions key potential adverse effects and potential benefits would result from the use of SWD gene drive technology.

The Decision Phases Framework for Public Engagement: Engaging Stakeholders about Gene Editing in the Wild.

Some experts and advocates propose environmental biotechnologies such as genetic engineering, gene drive systems, and synthetic biology as potential solutions to accelerating rates of species loss. While these tools may offer hope for a seemingly intractable problem, they also present potential governance challenges for which innovative decision-making systems are required. Two of the perennial governance challenges include, when are broader stakeholder groups involved in these decisions and who exactly should be involved? We propose the decision phases framework-which includes research and development, regulatory review, and deployment, management, and monitoring-as a framework for identifying which stakeholders might be best suited for different phases throughout the innovation and deployment of emerging environmental biotechnologies for species protection.

Ugandan stakeholder hopes and concerns about gene drive mosquitoes for malaria control: new directions for gene drive risk governance.

BACKGROUND: The African Union's High-Level Panel on Emerging Technologies identified gene drive mosquitoes as a priority technology for malaria elimination. The first field trials are expected in 5-10 years in Uganda, Mali or Burkina Faso. In preparation, regional and international actors are developing risk governance guidelines which will delineate the framework for identifying and evaluating risks. Scientists and bioethicists have called for African stakeholder involvement in these developments, arguing the knowledge and perspectives of those people living in malaria-afflicted countries is currently missing. However, few African stakeholders have been involved to date, leaving a knowledge gap about the local social-cultural as well as ecological context in which gene drive mosquitoes will be tested and deployed. This study investigates and analyses Ugandan stakeholders' hopes and concerns about gene drive mosquitoes for malaria control and explores the new directions needed for risk governance. METHODS: This qualitative study draws on 19 in-depth semi-structured interviews with Ugandan stakeholders in 2019. It explores their hopes for the technology and the risks they believed pertinent. Coding began at a workshop and continued through thematic analysis. RESULTS: Participants' hopes and concerns for gene drive mosquitoes to address malaria fell into three themes: (1) ability of gene drive mosquitoes to prevent malaria infection; (2) impacts of gene drive testing and deployment; and, (3) governance. Stakeholder hopes fell almost exclusively into the first theme while concerns were spread across all three. The study demonstrates that local stakeholders are able and willing to contribute relevant and important knowledge to the development of risk frameworks. CONCLUSIONS: International processes can provide high-level guidelines, but risk decision-making must be grounded in the local context if it is to be robust, meaningful and legitimate. Decisions about whether or not to release gene drive mosquitoes as part of a malaria control programme will need to consider the assessment of both the risks and the benefits of gene drive mosquitoes within a particular social, political, ecological, and technological context. Just as with risks, benefits-and importantly, the conditions that are necessary to realize them-must be identified and debated in Uganda and its neighbouring countries.

Responsible innovation of nano-agrifoods: Insights and views from U.S. stakeholders.

To date, there has been little published work that has elicited diverse stakeholder views of nano-agrifoods and of how nano-agrifoods align with the goals of responsible innovation. This paper aims to fill this research gap by investigating views of nano-agrifoods, how well their development adheres to principles of responsible innovation, and potential challenges for achieving responsible nano-agrifood innovation. Using an online engagement platform, we find that U.S. stakeholder views of responsible innovation were dominated by environmental, health, and safety (EHS) contexts, considerations of societal impacts, opportunities for stakeholder engagement, and responding to societal needs. These views overlap with scholarly definitions of responsible innovation, albeit stakeholders were more focused on impacts of products, while the field of responsible innovation strives for more "upstream" considerations of the process of innovation. We also find that views of nano-agrifoods differed across applications with dietary supplements and improved whitening of infant formula viewed least favorably, and environmental health or food safety applications viewed most favorably. These findings align with the larger body of literature, whereby stakeholders are expected to be more supportive of nanotechnology used in agricultural applications compared to directly within food and food supplements. Overall, participants indicated they held relatively neutral views on research and innovation for nano-agrifoods being conducted responsibly, and they identified key challenges to ensuring their responsible innovation that were related to uncertainties in EHS studies, the need for public understanding and acceptance, and adequate regulation. In light of these results, we recommend future research efforts on EHS impacts and risk-benefit frameworks for nano-agrifoods, better understanding stakeholder views on what constitutes effective regulation, and addressing challenges with effective regulation and responsible innovation practices.

Barriers to responsible innovation of nanotechnology applications in food and agriculture: A study of US experts and developers.

The use of nanotechnology and engineered nanomaterials in food and agriculture (nano-agrifood) sectors is intended to provide several potential benefits to consumers and society, such as the provision of more nutritious processed foods, edible food coatings to extend shelf lives of fresh cut produce, and more sustainable alternatives to traditional agrochemicals. The responsible innovation of nano-agrifoods may be particularly important to pursue given previous case studies involving other agrifood technologies that experienced significant public consternation. Here, we define responsible innovation following Stilgoej et al. (2013) that establishes processes to iteratively review and reflect upon one's innovation, engage stakeholders in dialogue, and to be open and transparent throughout innovation stages - processes that go beyond primary focuses of understanding environmental, health, and safety impacts of nano-enabled products and implementing safe-by-design principles. Despite calls for responsible nano-innovation across diverse sectors, it has not yet been clear what types of barriers are faced by nano-agrifood researchers and innovators in particular. This study therefore identifies and builds the first typology of barriers to responsible innovation as perceived by researchers and product developers working in nano-agrifood sectors in the United States. Our findings report 5 key barriers to responsible innovation of nano-agrifoods: Lack of Data (reported by 70% of all interview participants, and represented 34.6% of all barrier-related excerpts), Lack of Product Oversight (reported by 60% of participants, and represented 28.7% of excerpts), Need for Ensuring Marketability & Use (reported by 70% of participants, and represented 21.3% of all barrier-related excerpts), Need for Increased Collaboration (reported by 40% of participants, and represented 10.3% of excerpts), and finally Lack of Adequate Training & Workforce (reported by 30% of participants, and represented by 5.1% of excerpts). We also relate these key barriers across three main nano-innovation phases, including 1) Scientific and Technical R&D, 2) Product Oversight, and 3) Post-commercialization Marketability & Use, and discuss how these barriers may impact stakeholders as well as present opportunities to align with principles of responsible innovation. Overall, these findings may help illuminate challenges that researchers and innovators face in the pursuit of responsible innovation relevant for the field of nanotechnology with relevancy for other emerging food and agricultural technologies more broadly.

An integrated approach to oversight assessment for emerging technologies.

Analysis of oversight systems is often conducted from a single disciplinary perspective and by using a limited set of criteria for evaluation. In this article, we develop an approach that blends risk analysis, social science, public administration, legal, public policy, and ethical perspectives to develop a broad set of criteria for assessing oversight systems. Multiple methods, including historical analysis, expert elicitation, and behavioral consensus, were employed to develop multidisciplinary criteria for evaluating oversight of emerging technologies. Sixty-six initial criteria were identified from extensive literature reviews and input from our Working Group. Criteria were placed in four categories reflecting the development, attributes, evolution, and outcomes of oversight systems. Expert elicitation, consensus methods, and multidisciplinary review of the literature were used to refine a condensed, operative set of criteria. Twenty-eight criteria resulted spanning four categories: seven development criteria, 15 attribute criteria, five outcome criteria, and one evolution criterion. These criteria illuminate how oversight systems develop, operate, change, and affect society. We term our approach "integrated oversight assessment" and propose its use as a tool for analyzing relationships among features, outcomes, and tradeoffs of oversight systems. Comparisons among historical case studies of oversight using a consistent set of criteria should result in defensible and evidence-supported lessons to guide the development of oversight systems for emerging technologies, such as nanotechnology.

Upstream oversight assessment for agrifood nanotechnology: a case studies approach.

Although nanotechnology is broadly receiving attention in public and academic circles, oversight issues associated with applications for agriculture and food remain largely unexplored. Agrifood nanotechnology is at a critical stage in which informed analysis can help shape funding priorities, risk assessment, and oversight activities. This analysis is designed to help society and policymakers anticipate and prepare for challenges posed by complicated, convergent applications of agrifood nanotechnology. The goal is to identify data, risk assessment, regulatory policy, and engagement needs for overseeing these products so they can be addressed prior to market entry. Our approach, termed upstream oversight assessment (UOA), has potential as a key element of anticipatory governance. It relies on distinct case studies of proposed applications of agrifood nanotechnology to highlight areas that need study and attention. As a tool for preparation, UOA anticipates the types and features of emerging applications; their endpoints of use in society; the extent to which users, workers, ecosystems, or consumers will be exposed; the nature of the material and its safety; whether and where the technologies might fit into current regulatory system(s); the strengths and weaknesses of the system(s) in light of these novel applications; and the possible social concerns related to oversight for them.