RESUMEN
The Conference of the Parties serving as the meeting of the Parties (COP-MOP) to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity decided years ago to undertake the development of guidance on risk assessment of living modified organisms (LMOs) resulting from modern biotechnology, in order to assist the Parties to the protocol to conduct risk assessments in line with the principles and methodology described therein. After many years of working through ad hoc technical expert groups (AHTEG) and open-ended online forum discussions, including an extensive process to test and revise the guidance document, the COP-MOP did not decide to endorse the last version of the document when it was finally presented to them. A failure to achieve consensus that the guidance, as it had evolved, is relevant and useful is seen as a potential setback for many Parties to the protocol with little to no experience with risk assessment. There are a number of reasons for the lack of success in this attempt to develop useful guidance on risk assessment, including a poorly defined and shifting purpose, misplaced expertise, and a misguided testing process, mostly perpetuated by the constraints of using processes of the Convention. These problems with the development of the Guidance on Risk Assessment of LMOs are explored here in an effort to elucidate the missteps that should be avoided and the lessons that can be learned. Most prominent is a need to rely upon the expanding past and present experiences with actual cases of risk assessments of LMOs, if there is to be any further attempt to develop guidance on risk assessment under the Convention and its protocol.
RESUMEN
Panels of experts with specialized knowledge and experience are often convened to identify and analyze information relevant for risk assessments of GM crops. A perspective on the use of such scientific expert panels is shared here based on panels convened to inform the regulatory strategy for three separate projects developing GM crops for cultivation in Africa: a nutritionally enhanced sorghum, an insect resistant cowpea, and a virus resistant cassava. The panels were convened specifically to consider the risks associated with gene flow from a genetically modified (GM) crop to naturally occurring 'wild' relatives of that crop. In these cases, the experts used problem formulation to identify effects that regulatory authorities may consider to be harmful ("harms") and formulate plausible scenarios that might lead to them, and the availability of information that could determine the likelihood of the steps in the pathway. These panels and the use of problem formulation worked well to gather the existing information and consider the likelihood of harm from gene flow in centers of diversity. However, one important observation from all of these cases is that it is outside the remit of such scientific expert panels to make decisions dependent on policy, such as which harms should be considered and what information should be considered essential in order for a regulatory authority to make a decision about the acceptable level of risk. These experiences of expert panels to inform GM crop risk assessment demonstrate the challenge of integrating science and policy for effective regulatory decision-making.
RESUMEN
The probability and consequences of gene flow to wild relatives is typically considered in the environmental risk assessment of genetically engineered crops. This is a report from a discussion by a group of experts who used a problem formulation approach to consider existing information for risk assessment of gene flow from cassava (Manihot esculenta) genetically engineered for virus resistance to the 'wild' (naturalized) relative M. glaziovii in East Africa. Two environmental harms were considered in this case: (1) loss of genetic diversity in the germplasm pool, and (2) loss of valued species, ecosystem resources, or crop yield and quality due to weediness or invasiveness of wild relatives. Based on existing information, it was concluded that gene flow will occur, but it is not likely that this will reduce the genetic diversity in the germplasm pool. There is little existing information about the impact of the virus in natural populations that could be used to inform a prediction about whether virus resistance would lead to an increase in reproduction or survival, hence abundance of M. glaziovii. However, an increase in the abundance of M. glaziovii should be manageable, and would not necessarily lead to the identified environmental harms.