Development of the Roadmap for Risk Assessment

The general considerations section of the Road Map touches on the importance of the “mechanisms to be implemented to produce a dialogue involving stakeholders”, likewise, the initial outline of the guiding document stemming from the SWG on LM Mosquitoes, includes a section on ethical, legal and societal issues that emphasize the importance of community and stakeholders engagement. Yet, the road map fails to attend to these critical and crucial issues and to incorporate them in the risk assessment culture.

The current taxonomy of risks that are deemed to be relevant to the assessment of the impact of import and use of LMOs does not provide an appropriately exhaustive account of all the relevant risks as it does not attend to the wide range of risks and hazards that go beyond those related to biodiversity and human health, including social, cultural, economic and political risks.
The conventional notion of risk assessment as a primarily technical activity is slowly evolving to include greater attention to a wider range of potential harms (risks) that might arise as living modified organisms are tested, almost always in developing countries. The presumption therefore that the “technical” aspects of risk assessment can be isolated from these broader ethical considerations seems unrealistic. 

Currently, there is no explicit account in the road map or the relevant sections of the Protocol/Annex III itself, of the potential social, economic and cultural harms that might arise as a result of importing LMOs for various uses especially in developing countries (for example, the risk of social and economic disruption (e.g., through disruption of existing food markets, or through exploitation of communities for the testing of LMOs in various contexts, mainly in developing countries, or through the imposition of various cultural values in various products or processes).
A dialogue with the public and all relevant stakeholders therefore would not only promote public awareness, but would also enable the identification and evaluation of these broader ‘non-technical’ aspects of potential risks. Steps outlining these tasks should therefore be included in the road map.

On the other hand, there is inadequate attention in the language of the roadmap to the idea that the perspective of the people assessing the risk influences their assessment. But perhaps more fundamentally, the current framing of the roadmap appears to conflate the conceptual organization of risks and the assignment of measures or weights to these risks (i.e., risk assessment) with, arguably, more important judgments about whether these risks are worth taking. Whereas “experts” may have some facility in presenting, quantifying, organizing and prioritizing risks in various ways, they are not the people who ordinarily make decisions about whether or not they should accept these risks. Likewise, experts are not the people who usually bare the consequences or any potential risks/hazards that might come up from the research, import, or use of LMOs. This is a fundamental problem in the current approach, and is particularly evident in the items related to the “recommendation as to whether or not the risks are acceptable or manageable”. The perspective of all relevant stakeholders, including involved communities, is crucial for the appropriateness of the process of evaluation and determination of acceptability of potential risks.

Depending on the proposed, or anticipated uses of the LMOs in question, it may be reasonable for a government to claim that it has made a legitimate decision about the acceptability of a given suite of risks on behalf of its population. But this will not always be the case (or this decision will not be sufficient in itself to justify the actions in question), particularly in the case of LMOs used for research. A clearer mechanism to ensure a legitimate decision about the acceptability of risks is needed to address this fundamental problem successfully. Increasing “public awareness” of the technical means by which risk assessments are constructed, though likely necessary to ensure fair process, does not amount to a decision on the part of the public to assume various risks, without some broader deliberative process.

This separation between the characterization, measurement and representation of the risks and the decisions whether or not to assume them, is all the more important because of the inherent under-determination of the risks themselves: we are simply unable to provide truly comprehensive account of either the probability or magnitude of the potential harms involved, a point that is obscured to some extent by the focus on expert-driven technical risk assessment.

Through our research on ethical, cultural and social issues, especially community engagement, in the context of research projects on LMOs funded by the Grand Challenges in Global Health Initiative in developing countries, it was found that early and structured engagement of relevant stakeholders in the community is critical for all the phases of development, introduction, and adoption of LMOs, including risk assessment and management. This is not only needed to ensure an ethical, just and fair process, but also to ensure the acceptance and appropriate adoption of these technologies in different contexts.

We therefore highly recommend the consideration of a wide range of social, cultural, political and economic potential risks in any risk assessment process. These risks are best determined and evaluated through consultations and deliberations with relevant stakeholders in respective communities. Community engagement would also enable the assessment of the ‘acceptability’ and ‘manageability’ of these risks. The road map/Annex III should therefore have explicit and guiding sections detailing the objectives, tasks and processes of such endeavors, which surpass and complement the technical expertise, but yet are very challenging and intricate.


Obidima Ezezika
On behalf of the Ethical, Social, and Cultural Program for the Grand Challenges in Global Health Initiative at the McLaughlin-Rotman Center for Global Health