Expert opinions on the regulation of plant genome editing.

Global food security is largely affected by factors such as environmental (e.g. drought, flooding), social (e.g. gender inequality), socio-economic (e.g. overpopulation, poverty) and health (e.g. diseases). In response, extensive public and private investment in agricultural research has focused on increasing yields of staple food crops and developing new traits for crop improvement. New breeding techniques pioneered by genome editing have gained substantial traction within the last decade, revolutionizing the plant breeding field. Both industry and academia have been investing and working to optimize the potentials of gene editing and to bring derived crops to market. The spectrum of cutting-edge genome editing tools along with their technical differences has led to a growing international regulatory, ethical and societal divide. This article is a summary of a multi-year survey project exploring how experts view the risks of new breeding techniques, including genome editing and their related regulatory requirements. Surveyed experts opine that emerging biotechnologies offer great promise to address social and climate challenges, yet they admit that the market growth of genome-edited crops will be limited by an ambiguous regulatory environment shaped by societal uncertainty.

Data challenges for future plant gene editing: expert opinion.

Agricultural data in its multiple forms are ubiquitous. With progress in crop and input monitoring systems and price reductions over the past decade, data are now being captured at an unprecedented rate. Once compiled, organized and analyzed, these data are capable of providing valuable insights into much of the agri-food supply chain. While much of the focus is on precision farming, agricultural data applications coupled with gene editing tools hold the potential to enhance crop performance and global food security. Yet, digitization of agriculture is a double-edged sword as it comes with inherent security and privacy quandaries. Infrastructure, policies, and practices to better harness the value of data are still lacking. This article reports expert opinions about the potential challenges regarding the use of data relevant to the development and approval of new crop traits as well as mechanisms employed to manage and protect data. While data could be of great value, issues of intellectual property and accessibility surround many of its forms. The key finding of this research is that surveyed experts optimistically report that by 2030, the synergy of computing power and genome editing could have profound effects on the global agri-food system, but that the European Union may not participate fully in this transformation.

Benefits of genome-edited crops: expert opinion.

Innovation in agriculture is pervasive. However, in spite of the success stories of twentieth century plant breeding, the twenty-first century has ushered in a set of challenges that solutions from the past century are unlikely to address. However, sustained research and the amalgamation of a number of disciplines has resulted in new breeding techniques (NBTs), such as genome editing, which offer the promise of new opportunities to resolve some of the issues. Here we present the results of an expert survey on the added potential benefits of genome-edited crops compared to those developed through genetic modification (GM) and conventional breeding. Overall, survey results reveal a consensus among experts on the enhanced agronomic performance and product quality of genome-edited crops over alternatives. The majority of experts indicated that the regulations for health and safety, followed by export markets, consumers, and the media play a major role in determining where and how NBTs, including genome editing, will be developed and used in agriculture. Further research is needed to gauge expert opinion after the Court of Justice of the European Union ruling establishing that site-specific mutagenic breeding technologies are to be regulated in the same fashion as GM crops, regardless of whether foreign DNA is present in the final variety.

How should we regulate products of new breeding techniques? Opinion of surveyed experts in plant biotechnology.

The adoption of genome editing depends among others, on a clear and navigable regulatory framework that renders consistent decisions. Some countries like the United States decided to deregulate specific transgene-free genome edited products that could be created through traditional breeding and are not considered to be plant pests, while others are still challenged to fit emerging technologies in their regulatory system. Here we poll international experts in plant biotechnology on what approach should nations agree upon to accommodate current and future new breeding technologies and derived products. A key finding is product-based models or dual-product/process systems are viewed as potential appropriate frameworks to regulate outcomes of genome editing. As regulation of novel products of biotechnology is expected to impact research and trade, we test the impact of experts' worldviews on these issues. Results show that region influences worldviews of trade but not of agricultural innovation. In contrast, there was no effect of experts' worldviews on how products of novel biotechnologies should be regulated.

Agriculture R&D Implications of the CJEU's Gene-Specific Mutagenesis Ruling.

On 25 July 2018, the Court of Justice of the European Union (CJEU) ruled that gene-specific mutagenesis must be regulated as genetically modified organism (GMO) technologies. However, the costs to agricultural research and development (R&D) innovation will be staggering, not to mention the brain drain to other countries. As a result, Europe can now be known as the deathplace of agricultural breeding innovations.

Estimating the cost of regulating genome edited crops: expert judgment and overconfidence.

Experts are often called on to inform decision makers with subjective estimates of uncertain events. Their judgment serves as the basis for policy-related decision-making. This paper analyzes survey results used to collect experts' opinions of the likely cost to bring genome edited crops to market. We also examine the effect of expertise (scientific experts versus social scientists in plant biotechnology) and possible knowledge mis-calibration, both in terms of overconfidence (i.e., when subjective knowledge is inflated) and under-confidence (i.e., when subjective knowledge is deflated), on the estimation of cost involved in the development and commercial release of genome edited crops. We found that the expected costs of genome edited crops are case specific and depend on whether crops will likely be regulated as genetically modified or accepted as conventional varieties and not subject to any regulatory oversight by federal regulators. While cost evaluation of genome edited crops did not vary among scientific and social experts, it did vary among domains of knowledge. Hence, expert's performance can be described as task-specific in the context of this study.

Regulatory Uncertainty Around New Breeding Techniques.

Emerging precision breeding techniques have great potential to develop new crop varieties with specific traits that can contribute to ensuring future food security in a time of increasing climate change pressures, such as disease, insects and drought. These techniques offer options for crop trait development in both private and public sector breeding programs. Yet, the success of new breeding techniques is not guaranteed at the scientific level alone: political influences and social acceptance significantly contribute to how crops will perform in the market. Using survey data, we report results from an international panel of experts regarding the institutional and social barriers that might impede the development of new plant technologies. Survey results clearly indicate that regulatory issues, social, and environmental concerns are critical to the success of precision breeding. The cross-regional analysis shows heterogeneity between Europeans and North Americans, particularly regarding political attitudes and social perceptions of targeted breeding techniques.