Common to all of the countries where genetically engineered (GE) crops are cultivated is a system to regulate these products and particularly to ensure their evaluation for human health and environmental safety (commonly referred to as biosafety) prior to any commercial release. This paper explores how the Cartagena Protocol to the Convention on Biological Diversity, as well as other important drivers, have affected the regulation of GE crops in developing countries. It examines the impact of biosafety regulation on research and development of GE crops and on product approvals. Finally, it identifies opportunities to advance biosafety regulation in those developing countries that wish to access the potential benefits of agricultural biotechnology.
The early adopters of GE crops, like the United States, Canada, and Argentina, developed regulatory systems to respond to the impending release of GE crops for cultivation. In most developing countries, however, the establishment of national biosafety regulatory systems was a by-product of the ratification of the Cartagena Protocol on Biosafety and its entry into force in 2003. The Cartagena Protocol is the only international environmental agreement that is concerned exclusively with products of modern biotechnology. Its interpretation and implementation have had a significant impact on biosafety regulation, especially in developing countries. Over the past decade, more than 140 developing countries or countries with transitional economies have received assistance to develop or implement national biosafety frameworks. Only a small number of developing countries have moved beyond these projects to operationalize their biosafety regulatory systems effectively, so that they may be considered functional—that is, they implement regulatory submission, assessment, and decision-making processes in a consistent, transparent, and predictable manner.
As is true for capacity development in other regulatory arenas, progress in biosafety regulation in developing countries is often impeded by limited political and financial commitments from national governments and by insufficient technical, human resource, and institutional capacity for implementation. It is also confounded by competing or redundant capacitybuilding projects and the absence of products to regulate. Only a limited number of developing countries have substantive public sector research programs in agricultural biotechnology or are considered markets of interest for private sector investments in this area. In effect, there is limited demand to drive regulatory development (or reform) forward, and policy makers’ attention is necessarily redirected to other priorities. Private sector developers of GE crops are generally disinterested in entering markets, even those in which farmers demand GE crops, unless the biosafety regulatory system is operational and predictable. More critically, public sector and donor initiatives that focus on improving the productivity of staple crops using biotechnology will be unsuccessful unless there is a clear path for improved crop varieties actually to move from laboratories to field trials to farmers.
Even with these challenges, there are opportunities to advance biosafety regulation in ways that could particularly benefit developing countries. These opportunities include:
Revisiting the context for biosafety regulation of GE crops to ensure that both the risk assessment and any non-safety considerations that are used to inform decisions are not defined solely by environmental protection goals but also by other development priorities, such as improving agricultural productivity, food security, and rural development.
Rationalizing environmental risk assessment information and data requirements to focus exclusively on issues that are relevant to assessing plausible adverse environmental impacts of GE crops. Improved and cost-effective approaches to biosafety regulation generally, and risk assessment particularly, can be pursued without compromising environmental protection and management goals.
Incorporating the assessment of environmental benefits of GE crops in agricultural ecosystems in addition to the standard evaluation of potential adverse environmental impacts.
Aggressively pursuing harmonization of risk assessment requirements and processes between countries—for example, by recognizing scientific opinions arising from risk assessments by other regulatory authorities, establishing regional approaches to risk assessment, or, more ambitiously, adopting decisions taken by other governments where appropriate.
Improving biosafety capacity building so that it moves past the development of national biosafety frameworks and associated short-term technical training to pursue sustained commitments to operationalize, monitor, and improve the regulatory systems that are put into place. Capacity-building programs should promote the rationalization of biosafety regulation and opportunities to strengthen the scientific and knowledge base in ways that will provide benefits that extend beyond the often transient need for biosafety risk assessment and decision making.