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Some of my colleagues and I have been struggling with the issues related to socio-economic inclusion in decision making and thus have seen the critical need to focus not only on the development of regulations, but also on the need to evaluate implementation issues which should inform regulatory development.

With this context in mind, and if countries ask my opinion on the matter, I have proposed perhaps -not explicitly as I should- a tiered decision making process for the inclusion of socio-economic considerations.

In the first tier, which to me is the situation of a biosafety/technology decision making process operating closest to an “ideal” context, is the one where the competent authority makes a decision based on a biosafety risk assessment (environmental and food/feed safety) and probably an evaluation of efficacy (product does what it claims to do under field conditions), and then let those who will endure the risk, incur costs and reap the benefits, decide whether it is valuable to them through adoption and use. The later groups are obviously producers and consumers.

The more society provides mechanism by which private contracts arise between interested producers and consumers, the more we will ensure as a society, mutually beneficial arrangements that will meet producer and consumer desires and needs. This is closest to the “no inclusion” scenario in the paper by Falck Zepeda and Zambrano 2011. Obviously, we do not live in a perfect world and there are many externalities and information/knowledge frictions which we have to contend with in practice.

The second tier, would be the situation where the technology undergoes the biosafety assessment and if any socio-economic issue is raised during such assessment, the competent authority commissions a study to examine the specific issues raised. If a conventional cost/benefit study is presented with the initial submission of the regulatory dossier, then this may be considered until the product is rendered as safe.

The third tier, would the situation of those countries who require broader -potentially more complex- socio-economic assessments that include issues beyond conventional economics and socio-demographic factors included in standard assessments. Policy makers in this tier will likely concern themselves with implementation issues, especially if their desire is to evaluate potential long-term effects, which may be ill-posed or defined, and for which there will be the need to develop research protocols. The later will have to learn from the accumulated experience in measuring environmental impacts as included in Strategic Environmental Assessments (See Linacre et al. 2005). There is a considerable likelihood that if this approach is not carefully thought before implementation, there may be considerable negative impacts in terms of time and financial resources used in teh assessments, as well as a negative impact on the release of new technologies.

I strongly encourage developing countries to evaluate whether they want to include broad socio-economic considerations in a biosafety regulatory process as I foresee the many difficulties – in some cases even the possibility that such inclusion may lead to an unfeasible process where no decision can be reached regardless of the process or approach followed- especially if developing countries have not thought through the many implications and issues related to such inclusion. Inclusion of socio-economic considerations does not necessarily lead to an improved regulatory outcome, even when contributing more knowledge to the decision making process.

I would discourage, however, developing countries parties from creating an open-ended system without any decision making rules or standards, where there is no clarity on the part of all stakeholders on what will be done and/or required for the SEC assessment. This is clearly one option that can lead to an unfeasible decision making process, or one which can be questioned due to the uncertainty or lack of transparency in the system.

In the end, countries will need to weigh the cost, benefits and risk from including socio-economic considerations into decision making. If after a careful analysis they decide that benefits outweigh the cost and risks from doing so, then it really becomes a matter of implementation, where the need arises for ensuring an efficient and workable system. This is the second tier regulatory approaches where socioeconomic considerations may be included in decision making.

Note that we need to maintain the distinction between learning about an innovation process for improving society’s knowledge as would be the case for academic and scientific inquiries, and a different one where we are seeking developing knowledge to answer support a regulatory decision making process. Certainly, the different is a time and resources constraint, but most importantly, how much information and knowledge is sufficient to make a decision.