Toward product-based regulation of crops.

Current process-based approaches to regulation are no longer fit for purpose.

Opportunities for Orphan Crops: Expected Economic Benefits From Biotechnology.

An enabling, evidence-based decision-making framework is critical to support agricultural biotechnology innovation, and to ensure farmers' access to genetically modified (GM) crops, including orphan crop varieties. A key element, and often a challenge in the decision-making process, involves the balancing of identified potential risks with expected economic benefits from GM crops. The latter is particularly challenging in the case of orphan crops, for which solid economic data is scarce. To address this challenge, the International Food Policy Research Institute (IFPRI) in collaboration with local economists analyzed the expected economic benefits to farmers and consumers from the adoption of GM crops in 5 sub-Saharan African countries. This paper focuses on case studies involving insect-resistant cowpea in Nigeria and Ghana; disease-resistant cassava in Uganda and Tanzania; and disease-resistant banana in Uganda. Estimations from these case studies show substantial economic benefits to farmers and consumers from the timely adoption and planting in farmers' fields of GM orphan crops. Our analysis also shows how the benefits would significantly be reduced by regulatory or other delays that affect the timely release of these crops. These findings underscore the importance of having an enabling policy environment and regulatory system-covering, among other elements, biosafety and food/feed safety assessment, and varietal release registration-that is efficient, predictable, and transparent to ensure that the projected economic benefits are delivered and realized in a timely manner.

Genome Editing, Gene Drives, and Synthetic Biology: Will They Contribute to Disease-Resistant Crops, and Who Will Benefit?

Genetically engineered crops have been grown for more than 20 years, resulting in widespread albeit variable benefits for farmers and consumers. We review current, likely, and potential genetic engineering (GE) applications for the development of disease-resistant crop cultivars. Gene editing, gene drives, and synthetic biology offer novel opportunities to control viral, bacterial, and fungal pathogens, parasitic weeds, and insect vectors of plant pathogens. We conclude that there will be no shortage of GE applications totackle disease resistance and other farmer and consumer priorities for agricultural crops. Beyond reviewing scientific prospects for genetically engineered crops, we address the social institutional forces that are commonly overlooked by biological scientists. Intellectual property regimes, technology regulatory frameworks, the balance of funding between public- and private-sector research, and advocacy by concerned civil society groups interact to define who uses which GE technologies, on which crops, and for the benefit of whom. Ensuring equitable access to the benefits of genetically engineered crops requires affirmative policies, targeted investments, and excellent science.

Investment, regulation, and uncertainty: managing new plant breeding techniques.

As with any technological innovation, time refines the technology, improving upon the original version of the innovative product. The initial GM crops had single traits for either herbicide tolerance or insect resistance. Current varieties have both of these traits stacked together and in many cases other abiotic and biotic traits have also been stacked. This innovation requires investment. While this is relatively straight forward, certain conditions need to exist such that investments can be facilitated. The principle requirement for investment is that regulatory frameworks render consistent and timely decisions. If the certainty of regulatory outcomes weakens, the potential for changes in investment patterns increases.   This article provides a summary background to the leading plant breeding technologies that are either currently being used to develop new crop varieties or are in the pipeline to be applied to plant breeding within the next few years. Challenges for existing regulatory systems are highlighted. Utilizing an option value approach from investment literature, an assessment of uncertainty regarding the regulatory approval for these varying techniques is undertaken. This research highlights which technology development options have the greatest degree of uncertainty and hence, which ones might be expected to see an investment decline.

Estimates and implications of the costs of compliance with biosafety regulations in developing countries.

Estimating the cost of compliance with biosafety regulations is important as it helps developers focus their investments in producer development. We provide estimates for the cost of compliance for a set of technologies in Indonesia, the Philippines and other countries. These costs vary from US $100,000 to 1.7 million. These are estimates of regulatory costs and do not include product development or deployment costs. Cost estimates need to be compared with potential gains when the technology is introduced in these countries and the gains in knowledge accumulate during the biosafety assessment process. Although the cost of compliance is important, time delays and uncertainty are even more important and may have an adverse impact on innovations reaching farmers.

Attitudes, perceptions, and trust. Insights from a consumer survey regarding genetically modified banana in Uganda.

Genetically modified (GM) crops and food are still controversial. This paper analyzes consumers' perceptions and institutional awareness and trust toward GM banana regulation in Uganda. Results are based on a study conducted among 421 banana-consuming households between July and August 2007. Results show a high willingness to purchase GM banana among consumers. An explanatory factor analysis is conducted to identify the perceptions toward genetic modification. The identified factors are used in a cluster analysis that grouped consumers into segments of GM skepticism, government trust, health safety concern, and food and environmental safety concern. Socioeconomic characteristics differed significantly across segments. Consumer characteristics and perception factors influence consumers' willingness to purchase GM banana. The institutional awareness and trust varied significantly across segments as well. The findings would be essential to policy makers when designing risk-communication strategies targeting different consumer segments to ensure proper discussion and addressing potential concerns about GM technology.