One more piece of the decision making puzzle that countries parties to the CPB need to consider is whether the inclusion of socio-economic considerations (either the strict or the broader interpretation of Artucke 26.1) will lead to a better regulatory outcome.
In other words, will generating more and/or better information data lead to a better regulatory outcome? Abstracting from the fact that “safety” is a fuzzy concept, this is a heavy question that requires a lot of thinking, we need to ponder many questions about what we are proposing as a biosafety regulatory system. For example, what is the regulatory outcome that we are considering? What type of information will be required? Will society implement a complete a regulatory impact assessments and decision making process that will consider all costs, benefits and risk? In a resource limited environment, how much resources as a society are we willing to invest in biosafety? biotechnology development? innovation? What is the opportunity cost of NOT doing biotechnology or biosafety?
Let me put an explicit example and conduct a simple thought experiment. We at IFPRI conducted a desktop study of the potential economic impact from the introduction of a Bt cotton in West Africa (See Falck Zepeda et al. 2008, and Falck Zepeda Horna and Smale 2008). Being a desktop study done just when the technology had been given the permit for deliberate release by the competent authority in Burkina Faso, this is a typical ex ante study with no primary data collection (no field surveys were done). A conclusion of that specific study was:
“Can farmers in West Africa gain from the introduction of Bt cotton technology? Taking into consideration the limitations of this study and the caveats enumerated, there is a real potential for farmers in the region to gain from adopting the technology. Our model suggests that these farmers would lose by not adopting Bt cotton while farmers in the rest of the world benefit. Although we find the changes in economic surplus to be smaller than those previously reported in the literature, we believe that our estimations are relatively robust because the underlying assumptions are conservative, damage abatement effects have been considered, and we have applied stochastic simulation analysis to capture variability.”
If a competent authority be it in Burkina Faso and/or any other West African country had seen our study as a requirement for approval for deliberate release of a Bt cotton in their jurisdiction, would it had improved the regulatory outcome? I will argue here that it is very debatable whether having this specific study in the hands of a decision-maker, contributes to improving the regulatory outcome of having technologies that can be considered “safe” based on an agreed regulatory standard.
I make this assertion mainly based of the many limitations and uncertainties surrounding this and most ex ante studies. Note all the caveats and assumptions used in our simulations in the Burkina Faso study. Issue then is basing a regulatory decision on studies which are full of uncertainties themselves, which brings us back to the judging the quality of such studies that may be used for regulatory decisions.
Well, our study used some of the state-of-the-art methods explicitly addressing many of the parameter uncertainties, for example we introduce the notion of production and financial risk, as well as, food security and livelihoods into the discussion. It is perhaps as good as it gets with the current state of knowledge, without having hard data. If decision makers then need to judge whether this approach is sufficient for them to make a decision. If they view this study as necessary and sufficient, then this is a case closed…for now.
One final thought. Are issues such as food security or livelihoods under the purview of the Cartagena Protocol on Biosafety? In my mind they belong under the in-country decision making process for technology approval. More on this issue in later posts.
- Falck Zepeda, J.B., D. Horna, P. Zambrano and M. Smale. “Policy and Institutional Factors and the Distribution of Economic Benefits and Risk from the Adoption of Insect Resistant (Bt) Cotton in West Africa.” 2008. Asian Biotechnology Development Review 11(1):1-32.
- Falck Zepeda, J., D. Horna and M. Smale. “Distribution of economic benefits and risk from the adoption of insect resistant cotton in West Africa” 2008. African Journal of Agricultural and Resource Economics.