It’s time to examine in more detail how–in practice–some of the proposals put forward on this blog will work from the standpoint of a practitioner and the regulatory process. Let me conduct a simple mental exercise.
Let’s assume for a minute that we have a pending application for deliberate release for a fungal resistant (FR) banana in a developing country, where it is a staple crop and the fungal disease devastates the crop as most farmers can’t afford fungicides. The FR banana has been submitted by a public sector organization that will charge a nominal fee for the LMO variety above the normal fees charged for conventional varieties.
The biosafety assessment completed to date indicates that it is “safe” from the standpoint of environmental and food/feed safety purposes. The regulatory decision-making process is to determine if to approve the FR banana for deliberate release in the country.
Let’s assume for this exercise that the regulatory authority is interested in examining the socio-economic impacts of the proposed LMO production system and/or mixed conventional/LMO systems on:
- farm labor and indirect farm labor
- human health, including the nutrition of children and pregnant women
- farm income
- financial production “down side” risk
- cultivation patterns for indigenous banana varieties
- community production skills and practices
- community resiliency
- the sustainability of livelihoods
Note that we are already selecting a limited number of issues for the evaluation, and at this point in the process, we do not have data on producer, household, or community use of LMOs as none has been released. The most that we could obtain is careful quantitative and qualitative measurements on existing production practices and economic and social status and, from there, attempt to project how some of these factors will evolve over time (see note below). We know that getting robust data on household communities is a tedious and difficult process and if we interested in finding longer-term and sustainability impacts the likelihood is that we will need multiple observations.
Obvious questions to define are:
1) How many crop cycles and years we may gather data upon?
The minimum to collect data will be one crop cycle to gather information on production practices and farm/household/community socio-demographic data. Collecting data to develop trends and define nuances of a societal nature will likely take multiple cycles or years. An illustration: Glenn Stone, an anthropologist examining Bt cotton issues in one region in India, has been regularly visiting the place for what I think has been 7 years.
2) What will be the decision-making standard or rule that will define whether to approve the FR bananas for deliberate release for commercial purposes?
3) Will the country have this level of capacity?
At a minimum, the multi-disciplinary team assigned to examine these issues should comprise one economist, one sociologist, one anthropologist, 1 nutritionist and 1 biophysical scientist to understand the complexity of the questions at hand. These will have to be quite experienced in order not to lose time developing protocols for the assessment and ones that will deliver a report that will stand expert and regulatory scrutiny.
4) What are the likely impacts of the requirement for broad and more complex socio-economic considerations? Is society willing to wait 3 to a number of years before approving a technology that has been deemed safe? Who are better prepared to make such decision? Farmers , consumers, regulators, decision makers, activist and proponent groups?
The more complex the issues that will be required for the assessment, the more likely that the analysis will be complex (holistic has been used in many discussion forums) and thus the approaches and methods (and combinations thereof) will likely be complex, thus taking longer time for completion. Obviously, the cost of conducting the assessment will increase directly with the complexity of the assessment. The time commitment increases even further if one requires the research to be peer-reviewed and/or published before submission. The more likely scenario is that of a third party review of the report submitted to authorities.
So, in practical terms, an assessment of the nature described above will likely require two years for data collection and one year for analysis and peer review in order to ensure a high quality research report. This assumes there are no logistical delays for collecting data such as floods, civil unrest, political issues…they happen, believe me. If decision makers believe that having two years of data is not enough, then the time for completion increases.
Is society then willing to wait at least three years (or several) until a broad (or holistic) socio-economic assessment is done? This question need to take into consideration that these delays may cost society in terms of potential gains due to the technology adoption. In this exercise, the example used is obviously not chosen at random.
The research by Kikulwe (see references) has estimated that for every year that Uganda does not approve a black sigatoka resistant banana developed by NARO-Uganda, the University of Leuven, and ABSPII (all public organizations, by the way), the country loses $200 million even when considering irreversible costs and benefits. This magnitude is quite important as banana is a staple crop and thus important for food security purposes. The impact of increasingly more complex regulations and decision-making processes is obviously focused here on public sector institutions and those crops of a public good nature.
I do not intend to make an emotional appeal with this example, although the study we conducted in Uganda does make a compelling case to examine technologies case-by-case and that there are measurable potential benefits that could be captured by resource-poor farmers in developing countries. Rather my intention is for countries to carefully consider the implications of deciding whether to include socio-economics and, if the decision has been made, what are the implications and issues related to the implementation of such approaches to the assessment.
Once the policy/political decision of whether to include socio-economics, and, if included, under what requirements has been made, then it is up to us practitioners to attempt compliance with these requirements in a manner that is scientifically robust and peer-review-defensible. I hope that such decision making processes will consider all the trade-offs involved in the implementation of broader impact assessments approaches, with the advice of those who are true practitioners to help them make a decision that will be feasible, cost efficient, timely, that leads to better regulatory outcomes, and who contributes to society in the end. Proposing holistic and quite broad socio-economic considerations may be an ideal alternative, but this has to be tempered by how feasible it will be in practice.
- Kikulwe, E.M., E. Birol, J. Wesseler, J. Falck-Zepeda. A latent class approach to investigating demand for genetically modified banana in Uganda Agricultural Economics. Publication Forthcoming 2011.
- Kikulwe, E.M. 2010.”On the introduction of genetically modified bananas in Uganda:Social benefits, costs, and consumer preferences” A published Ph.D. dissertation at Wageningen University, The Netherlands. Thesis committee Prof. dr. E.C. van Ierland, Dr. J.H.H. Wesseler, Dr. J.B. Falck-Zepeda, Prof. dr. ir. A.G.J.M. Oude Lansink, Prof. dr. R.L. Paarlberg, Dr. M. Smale, Prof. E. Tollens.