The US National Academy of Sciences – National Research Council has nominated Jose Falck-Zepeda to be part of the Committee “Genetically Engineered Crops: Past Experience and Future Prospects”. This committee will elaborate a National Academy of Sciences – National Research Council (NRC) report which will likely be used in several policy discussions with a broad readership at the global level. The nomination will be formally declared complete after a 20 day review and public commentary. The NAS-NRC Committee will meet publicly September 15-16 in Washington DC. For more information about the Committee and its membership please visit the following site NAS NRC Committee
Socio-economic Considerations in Biosafety and Biotechnology Decision Making: The Cartagena Protocol and National Biosafety Frameworks
Article 26.1 of the Cartagena Protocol on Biosafety left open the option for member countries to include in their biosafety regulatory and technology approval decision making processes the inclusion of socio-economic considerations. Countries may also decide to consider socioeconomic issues as part of their national legislation or regulations for the approval of genetically engineered technologies for deliberate release into the environment. Countries are debating if and how to implement assessment of socio-economic considerations. This paper contributes to the ongoing policy dialogue by discussing issues related to socio-economic assessment including scope, timing, inclusion modalities, methods, decision making rules and standards, and the integration of socio-economic assessments in biosafety and/or biotechnology approval processes. This paper also discusses the implications of socio-economic considerations inclusion for technology flows and public and private sector R&D. If inclusion is not done properly, it may negatively impact technology flows especially from public sector and render an unworkable biosafety system.
- Inclusion of socioeconomics considerations into decision making can have both positive and negative impacts
- Prudent for countries to evaluate the costs and benefits of socioeconomics inclusion and to reduce the impact of this additional regulatory burden
- Policy makers need to address the issue of regulatory predictability as it can introduce significant negative impacts including the possibility of introducing disincentives for R&D investments.
- If countries pursue the option of including socio-economic considerations in their decision making, then it must be done using clear decision-making rules and standards, while ensuring the biosafety system’s transparency and protectiveness
- Functional approaches include those in Brazil and Argentina. Brazil implements a sequential approach where biosafety assessment is completed by the technical committee and if an issue is raised during consultations and assessments, the approval committee can commission a socioeconomic study or assessment to a third party. Argentina has a mandatory and sequential process focused on specific socioeconomic impacts considering export competivity. Socioeconomic assessments are done after the biosafety assessment is completed and is prepared by a unit within the Ministry of Finance and Trade.
Falck-Zepeda, J.B. and P. Zambrano. 2011. Socio-economic Considerations in Biosafety and Biotechnology Decision Making: The Cartagena Protocol and National Biosafety Frameworks. Review of Policy Research. 28(2): 171-195. http://dx.doi.org/10.1111/j.1541-1338.2011.00488.x
This is an interesting yet somewhat misleading conundrum. I certainly believe we as social and biophysical scientists have real issues in how we communicate with society. In some cases we have failed to gain the trust of many, and even have failed in demonstrating our competency by being too timid about describing what our research has shown in the past. We simply have not taken a step forward to talk with people about their issues and concerns.
I can certainly concur with Fourat from Random Rationality that there have been multiple developments in society which should have triggered a response in terms of our own science communication paradigms. Yet, this has not happened in many of the science and scholarly circles that I am aware. We continue going our own merry way thinking that if we produce high quality publications everybody will be happy. We better change this fast or we risk becoming irrelevant.
Please don’t get me wrong. We need to continue producing the highest quality scholarly output that we can. In fact this is directly related to the point that Fourat in Random Rationality makes in his blog entry. We need to adhere even more to the highest science standards which will determine the strength of evidence and our course our own competency as “experts”.
What I am arguing here is that we do need to actively engage society, even those that may be categorized as “downers” in Fourat’s entry, so that we effectively communicate with those who honestly want to communicate. This is of course a two-way and multiple-way communication process. We do need to hear and understand people’s issues and concerns while building trust relationships over time.
There will be of course, many groups who are not willing to communicate, examine the evidence, nor have a meaningful dialogue.These groups have already defined a position towards an issue and will not bulge nor negotiate. In this case, we can only continue producing great quality science, robust evidence, and then hope that maybe at one point these groups may be willing to even consider other alternatives than their own.
Not all scientific statements have equal weight as Carl Sagan once wrote, and there are differing degrees of evidence. The odds of an answer being correct in the absence of empirical verification—as is the case with the downer hypothesis: vaccines induce autism—are quite small. Science increases the odds that we are right and constantly course-corrects to get closer to the truth until such a time as people couldn’t imagine any other way of thinking.
Science is awesome!
Fourat Janabi –Random Rationality
This is the expected cover of the new IFPRI publication of which I am one of the co-editors. The book title is “Socioeconomic Considerations in Biosafety Decisionmaking: Methods and Implementation.” Daniela Horna, Patricia Zambrano, and Jose Falck-Zepeda edited the book. I will let you know when this book will be available at IFPRI’s web site.
The book uses a case study of the potential introduction of Bt cotton in Uganda to draw lessons on implementing a socioeconomic assessment. This book will be useful for practitioners, regulators and policy/decision makers examining genetically modified crops especially in developing countries. More information to come.
- Evaluate tradeoffs with socioeconomic considerations into decision making.
- Focus on the inclusion and implementation processes
- Consider having a basic requirement of a standard economic review/assessment with a defined evaluation criteria
- Critical allowing completion of biosafety risk assessment/analysis process. We have seen this as an important issue based on the Brazilian experience.
- Ensure there are no authority conflicts between regulatory agencies, In fact, prudent to maximize collaboration synergies between agencies.
- Ensure there are no conflicts with international obligations especially WTO
- Ensure that the overall goal of implementing a functional bioafety system is maintained. This involves considering implementation issues such having a transparent, feasible, fair and time/cost efficient and protective process
The following pretty much summarizes what I know and what is my opinion with regard to the inclusion of socioeconomics in biosafety and/or biotechnology decision making processes.
- The inclusion of socio-economic considerations under article 26.1 of the Cartagena Protocol on Biosafety is voluntary. The scope of what is covered in this article is focused on (but not limited to) the value of biodiversity to indigenous and local communities communities.
- Intent was to consider decision for importing LMOs.
- Countries can (and have) expand the scope of Article 26 and devise implementation procedures in their national legislation.
- There is a wide range of approaches and implementation processes between countries. Range from no inclusion as in the United and Canada, to requiring socio-economic assessments focusing on trade as in Argentina, to (possibly) requiring socio-economic assessments covering a broad set of issues as in the European Union.
- Countries are advised to analyze in detail if the inclusion of socio-economic considerations in their biosafety decision making, as there are many costs, benefits, risks and tradeoffs.
- I advise countries who have decided to include socio-economic considerations in their biosafety decision making; to define socio-economic considerations, context, issues, methods, principles, decision making standards and quality control measures to ensure a viable system.
- A vague/confusing/contradictory process for the inclusion of socio-economic considerations can lead to rendering a biosafety system that is ineffective or one that is paralyzed due to an unworkable system.
- Countries are also advised to ensure that any proposed process for inclusion of socio-economic considerations meets the determinants of a functional system as outlined by Greg Jaffe in a 2005 publication.
- Inclusion of socio-economic considerations will increase the cost of compliance with biosafety regulations and the total cost of development. Inclusion, especially if processes and decision making rules are not clear, can increase the time needed to complete biosafety processes. This will have a negative impact on innovation, especially those crops and traits coming from the international and national public sector, as well as, small private domestic firms.
- The time value of money impact due to time delays is much more important than the increases in the cost of compliance. In other words, regulatory delays induce a loss of opportunity benefits from not releasing products to farmers earlier. These losses can be very high depending on the value of the benefits generated by the technology.
In a previous posting “Broad socio-economic assessments in practice” I have discussed many issues that socioeconomic assessment experts and policy/decision makers are likely to face with real applications and formal socioeconomic assessments.
I would also add that we have to clearly distinguish between including socioeconomic issues during the implementation of the risk (environmental and food/feed) assessment and including a formal socioeconomic assessment process. The later will require a formal study and an evaluation process of such study in order to yield a decision. In the former, specific issues are considered and included in the risk assessment as they modify environmental or food/feed safety profiles. These are two distinct alternatives which I think have not been separated in the discussions and which have separate implications for regulatory design.
I propose that socioeconomic issues, as long as they are relevant to the risk assessment process, have been considered in existing risk assessment procedures and in risk mitigation proposals and post-release monitoring plans such as insect resistance management (IRM) procedures put in place as a requisite for deliberate release.
In a later post I will describe in detail the attributes of a legitimate socioeconomic study and assessment. For now I am proposing what I call (somewhat tongue-in-cheek)… the Falck-Zepeda law of legitimate socioeconomic studies and assessments:
“For any socioeconomic study and/or assessment to be legitimate and credible, it has to have a fair shot of having any outcome possible –positive, negative or neutral- AND follow strictly the standards of excellence for such assessments”
A legitimate study and/or assessment may thus contradict or even negate any or all position or positions held by one or all stakeholders in a debate, even those who will not be convinced by such study regardless of how good the study is or even if the body of evidence contradicts their position.
Those of us who are socioeconomic assessors –and thus may be classified as “experts”- have to maintain research independence and thus have to present results regardless of the outcome. We cannot yield on this aspect of our commitment to science and excellence.
In the socioeconomic assessment arena we may do slightly better than the medical research sphere. We typically conduct studies that have a bit larger samples (typical medical studies have 50 or less individuals) and we may not face the number of potential hypotheses that may be posed in the medical field. Yet we do not have proper treatment and control experiments as in the agronomic sciences which allows the researcher to isolate better the relationship between cause and effect. Thus, socioeconomic assessments are subject to many of the same forces, factors, research dynamics and outcomes as those faced by medical research.
In essence, Ioannidis paper is really a wake up call and a demand for ensuring more high quality research and standards to conduct such research. We cannot rely on perceptions, subjectivities and ill-defined anecdotes to guide policy and decision making. Granted, the later are important in helping frame the hypotheses and with thoroughly and carefully conducted qualitative research, can be quite important resources and knowledge to define policy and decision making. We have to be careful about an indiscriminate call for more research as a way to weed out poor quality research.
As Alex Tabarrok reminds us in the blog Marginal Revolution quality checks such as conducting meta analysis of the literature can help address several issues, yet it can also open new ones. In Tabarrok’s words:
Sadly, things get really bad when lots of researchers are chasing the same set of hypotheses. Indeed, the larger the number of researchers the more likely the average result is to be false! The easiest way to see this is to note that when we have lots of researchers every true hypothesis will be found to be true but eventually so will every false hypothesis. Thus, as the number of researchers increases, the probability that a given result is true goes to the probability in the population, in my example 200/1000 or 20 percent. A meta analysis will go some way to fixing the last problem so the point is not that knowledge declines with the number of researchers but rather that with lots of researchers every crackpot theory will have at least one scientific study that it can cite in it’s support.
Biosafety and biotechnology policy developers/makers cannot continue putting forward policies or other legal instruments without putting at least some consideration to the potential implementation feasibility of such requirements. Effective biosafety and biotechnology policy formulation needs to clearly define the implementation process in order to ensure that in the end you will have a functional regulatory and technology development system that has the ability to approve, reject or ask for more information which describes a functional system.
A functional system thus implies defining who, when , how, assessment trigger, rules and decision making standards, quality controls including peer review /verifiability and other elements of best practice, and even the rationale why you are including socioeconomics, even in the case of a law that has been passed already.
Important to consider inclusion of the option in any assessment process that allows an initial screening that determines whether a specific application can be excluded (Complete Exclusion or Statements of No Significant Impact), have the possibility of a “lighter” assessment or to consider a more complete study.