Best practices for acceptability of GM crops field trials conclusions: lessons for Africa.

The ability to transfer information about the performance, safety, and environmental impacts of a genetically modified (GM) crop from confined field trials (CFTs) conducted in one location to another is increasingly gaining importance in biosafety regulatory assessment and decision-making. The CFT process can be expensive, time-consuming, and logistically challenging. Data transportability can help overcome these challenges by allowing the use of data obtained from CFTs conducted in one country to inform regulatory decision-making in another country. Applicability of transported CFT data would be particularly beneficial to the public sector product developers and small enterprises that develop innovative GM events but cannot afford to replicate redundant CFTs, as well as regulatory authorities seeking to improve the deployment of limited resources. This review investigates case studies where transported CFT data have successfully been applied in biosafety assessment and decision-making, with an outlook of how African countries could benefit from a similar approach.

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.

Biosafety Regulatory Reviews and Leeway to Operate: Case Studies From Sub-Sahara Africa.

While modern biotechnology and, specifically, genetic modification are subject of debate in many parts of the world, an increasing number of countries in Sub-Sahara Africa are making important strides towards authorizing general releases of genetically modified (GM) crop varieties for use by farmers and agribusinesses. Obviously, the documented economic and environmental benefits from planting GM crops-based on a track record of over two decades-are a major driver in the decision-making process. Another key factor is the increasing alignment of biosafety regulatory policies with progressive agricultural and rural development policies in Africa, resulting in-compared to past experiences-greater emphasis on anticipated benefits rather than risks in biosafety regulatory reviews. In several cases, this has led to expedited reviews of GM crop release applications, either for confined field trials or general environmental release, taking experiences and data from other countries into account. Such regulatory approaches hold promise as the pipeline of relevant, pro-poor GM crop applications is expanding as are the opportunities provided by novel plant breeding techniques. This review article analyses the shifting policy context in select African economies, resulting in adoption of new agricultural technology, and novel regulatory approaches used in biosafety decision-making. Case studies will be presented for Ghana, Kenya, Malawi, Nigeria and Uganda to analyze challenges, distill lessons learned and to present general policy recommendations for emerging economies.

The emerging international regulatory framework for biotechnology.

Debate about the potential risks of genetically modified organisms (GMOs) to the environment or human health spurred attention to biosafety. Biosafety is associated with the safe use of GMOs and, more generally, with the introduction of non-indigenous species into natural or managed ecosystems. Biosafety regulation--the policies and procedures adopted to ensure the environmentally safe application of modern biotechnology--has been extensively discussed at various national and international forums. Much of the discussion has focused on developing guidelines, appropriate legal frameworks and, at the international level, a legally binding international biosafety protocol--the Cartagena Protocol on Biosafety. The Protocol is one among various international instruments and treaties that regulate specific aspects relevant to agricultural biotechnology. The present article presents the main international instruments relevant to biosafety regulation, and their key provisions. While international agreements and standards provide important guidance, they leave significant room for interpretation, and flexibility for countries implementing them. Implementation of biosafety at the national level has proven to be a major challenge, particularly in developing countries, and consequently the actual functioning of the international regulatory framework for biotechnology is still in a state of flux.

Biosafety legislation and biotechnology development gains momentum in Africa.

Opinion in Africa over the use of genetically modified crops for food has been divided, honed by more than a decade of arguments in Europe and elsewhere. Fortunately, the perceived image of a passive Africa in this game is changing rapidly with clear positions on how to harness modern biotechnology. This article examines the status of biosafety regulation across Africa, pertinent challenges and the extent to which regulation fosters or constrains the development of agricultural biotechnology.