Forum discussions

The guiding question for theme 5 is "Which should be the main target groups for capacity-building on socio-economic considerations (e.g. policy-makers, decision-makers, regulators, technical personnel such as risk or impact assessors, other professionals, interest groups, etc.)?"

General Comments
- Capacity building/strengthening has to be a response to a careful evaluation/inventory of human, financial and technical capacities in country. See McLean et al for a conceptual framework for biosafety capacity building which is quite useful for this type of evaluation in a biosafety regulatory setting.

- Developing capacity building/strengthening activities that will develop functional capacity have to be carefully based on the current status and level of experience that the country has at that particular stage.

For example, there is very little sense in developing capacity for conducting socio-economic studies in a specific country, when the country is only able to implement confined field trials, a regulatory step which is not likely to require socio-economic assessments.  Once the country is ready to move on to the next stage of commercialization then it obviously makes sense to develop/strengthen such capacity as it may be required by the competent authority.

Same issue if country has already decided not to allow regulated products such as LMOs into its jurisdiction. What would be the purpose of developing capacity to assess socio-economic considerations when the regulatory outcome is by definition a “no” in any case.

- The necessary capacity for implementation of socio-economic assessments has to respond to the policy and political decision of what will be required for the assessment. Different capacities will be required in a country that only requires a relatively narrow economic assessment such as impacts on trade or financial impact incurred by farmers, when compared to another country that will require broader social and economic assessments.

- Our experience at the International Food Policy Research Institute (IFPRI) and the Program for Biosafety Systems (PBS) as a capacity building/strengthening program is that introducing regulatory issues prematurely before countries have been exposed to all the potential issues and consequences from a proposed regulatory structure introduces a lot of confusion. The later is usually connected to a pending application in country.

If country is ready to deal with an issue (e.g. socio-economics) then it should handle the issue in a systematic manner once it becomes a need, usually when there is an application pending at the competent authority. Creating capacity prematurely, may lead to resources’ waste when there is no demand for such services.

- Providing an integrated and systematic approach to capacity building/strengthening usually works best. This implies a sustained and medium to long term effort to build assessment capacity if required.

- Finally, socio-economic assessments when required for decision making in a regulatory setting, will likely follow the path observed for most regulatory systems in human history, that is, there will a learning curve involved which will have its own set of implications in terms of cost and resources.

Here I propose a set of potential approaches for two distinct sets of development stages where one may be able to map countries based on assessment capacity and policy/regulatory  development.

Stage 1. Supporting and contributing to countries discussions on the potential inclusion and implementation of socio-economic consideration and its assessment in biosafety and/or technology decision making processes

Target countries
The target audience for these activities are those  countries which have not expressed publicly their intention of including socio-economic considerations, who are in preliminary internal talks about doing so, or who have included such requirement in draft National Biosafety Frameworks documents and/or policy but not on law.

We may want to differentiate those countries who have already incorporated or who are likely to incorporate socio-economic assessments in their national policies, laws and/or regulations.

The target objective recognizes that inclusion in formal legislation is a formal step in the process of considering socio-economic considerations into decision making. 

Target groups
• Policy and decision makers
• Regulators
• Practitioners
• Developers/operators especially those in the public sector
• General public

Some key messages/issues
- Under the Protocol Article 26.1 is not mandatory
- Article 26.1 has a  very specific scope, target and objectives focused on biodiversity
- Emphasize that Article 26.1 recognizes that national regulations may incorporate approaches beyond Protocol, but suggest the need of thinking carefully about implementation and consequences from such actions

For those countries who may be more advanced in their inclusion decisions
- Focus on alternative policy options and in the development of a feasible/functional system
- Focus on implementation issues especially on what will be covered in such assessment
- Analyze tradeoffs between knowledge gains, cost of compliance and technology deployment

Approach 2. Developing functional capacity to conduct socio-economic assessments
Target countries
- Countries who have already incorporated socio-economic assessments in their national policies and/or laws
- Need to be careful about state in which the country is in terms of inclusion and how firm the decision is at the particular intervention time (In a Law vs. NBF document)

Specific target groups
• Policy and decision makers
• Regulators
• Practitioners
• Developers/operators especially those in the public sector
• General public

Key messages
- Focus on implementing regulations
- Address transparency, feasibility, decision making standards
- Ensure capacity to conduct feasible socio-economic studies in a cost efficient and timely manner

From Ossama El-Tayeb, Cairo University.
This contribution indeed outlines the sequence of approaches responding to special needs under different country set-ups. One point which needs to be included is the influence of trade interests - national and international - and commercial production systems on decision-making.  Often this becomes paramount and perhap on case will be Brazil.

The McLean et al. reference is:

McLean, M. A., Frederick, R. J., Traynor, P. L., Cohen, J. I., & Komen, J. (2002). A conceptual framework for
implementing biosafety: Linking policy, capacity, and regulation. International Service for National Agricultural
Research (ISNAR) Briefing Paper #47, The Hague, The Netherlands.

I can send you a copy of this file which is quite useful as an overall conceptual framework.

The main objective of capacity building/strengthening activities for those countries who have decided to implement socio-economic considerations in any of the modalities described in Falck Zepeda and Zambrano (2011), should be to develop FUNCTIONAL capacity for the assessment, analysis and evaluation of LMOs based on requirements set forward by policies/laws/regulations and national capacities.

The need will arise for different actors developing different levels of competency and understanding about the process, methods, decision making standards and the decision documents themselves.

Some critical examples include:

1) Assessors/evaluators:
If a country requires a (narrow) economic approach to assessments the need of course will be on economists and maybe sociologists who will need to be competent on state-of-the-art methods and issues related to the economic assessments of LMOs. These professionals will likely need to understand some of the particularities of LMOs, especially the institutional context and issues related to adoption/diffusion/impact, while getting a working understanding of the issues and limitations encountered in the literature as reviewed by Smale et al. 2009.

If the country requires the assessment of broader social and economic issues, then a multi-disciplinary team will need to be assembled that includes potentially sociologists, anthropologists, political scientists,biophysical scientists, and yes economists. Obviously the experience with such multi-disciplinary teams is quite spotty and will introduce issues of its own. For an example of an assessment using the sustainable livelihoods framework using DFIDs approach see Adato and Meinzen-Dick (2002). The need for method triangulation and for a robust capacity to do such research are noteworthy.

2) Regulators/decision makers
Although in some cases the biosafety regulators may be the decision makers, these are usually two distinct sets of actors. Regardless both groups will need to undergo capacity building activities that will build their understanding on how to judge the quality of submissions by the assessors, to get a general understanding on the issues and limitations with regard to methods and with results presented in the assessments.

This capacity obviously does not have to have the depth that an assessor will need, this is more of a general overview to enable a decision making process. This group is not really interested in the nuts and bolts of a specific methods, only needs to know what the results and conclusions mean in a specific  study and what are the issues and limitations of such results...which are directly connected to the methods used in the assessment.

3) General public and other stakeholders:
The general public will likely need gaining an understanding of the assessment and scientific peer review process, the decision making approach, and the overall regulatory process including the risk assessment and the socio-economic assessment if required. This group is even less likely compared to regulators/decision makers in their need for understanding specifics about the methods and issues related to the assessments itself. Therefore, capacity strengthening and/or communication/education efforts should be tailored to such needs.

Efforts targeting this group raises important issues such as transparency and quality standards for conducting research. It is important that all the materials (research protocol, data, literature review, methods, computer routines/programs) used in the assessments be accessible to anybody who may want to replicated and/or examine more in depth what was done in such assessment.

Here the need will arise of course for striking a balance between protecting confidentiality, confidential business information and the right to know by all parties. Having some limitations in terms of protecting individual information (such as that collected in farmer survey) or having a time window for the researcher or assessor to allow formal peer review  and eventual publication before making all information available can be considered.

In the end, what one should strive is indeed scientific and research excellence and quality in order to guarantee as much as possible that the evaluation is as good as it gets, while ensuring the public's confidence in the process,which in turn has to protective,transparent, scientifically robust while ensuring democratic engagement in a cost efficient manner.

Consulting the experience of those countries who have a functional and demonstrated capacity for the regulation of LMOs will be critical. I am thinking of those countries who have reviewed multiple application and who have approved, rejected and who have requested more information from the applicants. Although there may be some gains by learning from countries who have mostly academic or theoretical capacity (i.e. "experience of inclusion in our laws") , I believe these gains are limited and thus we need to have exchanges with those countries who have a proven a track record of such regulatory experiences.

With regard to the inclusion of socio-economics into biosafety decision making, literature reviews and articles presented in previous threads (Falck Zepeda 2009, Falck Zepeda, Wesseler and Smyth 2010) and in those contributions posted on other threads of this online discussion, actual experience with the inclusion of socio-economics into biosafety decision making is quite limited. There are certainly many countries who have included socio-economic in their policies, laws and regulations, but very few have actually considered socio-economics. As the old saying goes "the proof is in the pudding".


Citations

Adato, M. and R. Meinzen-Dick. 2002. Assessing the impact of agricultural research on poverty using the sustainable livelihoods framework. Discussion Paper 128, Food Consumption and Nutrition Division of the International Food Policy Research Institute. http://www.ifpri.org/sites/default/files/publications/fcnbr128.pdf

Smale, Melinda; Zambrano, Patricia; Gruère, Guillaume; Falck-Zepeda, José; Matuschke, Ira; Horna, Daniela; Nagarajan, Latha; Yerramareddy, Indira; Jones, Hannah. 2009. Measuring the economic impacts of transgenic crops in developing agriculture during the first decade: Approaches, findings, and future directions. (Food policy review 10) Washington, D.C.: International Food Policy Research Institute (IFPRI) 107 pages.

Falck Zepeda, J. B. Socio-Economic Considerations, Article 26.1 of the Cartagena Protocol on Biosafety: What are the Issues and What is at Stake?” 2009. AgBioForum. 12(1):90-107.

Falck Zepeda, J., J. Wesseler, S. Smyth. “The Current Status of the Debate on Socio-Economic Assessments and Biosafety Highlighting Different Positions and Policies in Canada and the US, the EU and Developing Countries”. Paper presented at the World Environmental and Resource Economics Congress in Montreal, Canada, July 2, 2010. Paper can be downloaded from http://www.webmeets.com/WCERE/2010/Prog/ (look under second day Parallel session 1).

Dear all,

We consider that especially policy-makers, decision-makers, regulators and technical personnel are target groups for capacity-building.

One important challenge with regard to capacity-building on socio-economic considerations is that most of the previous initiatives for capacity building have been framed with the intention to build competence in RA –which influences the choice participants ( main target group has been those with a scientific background within natural science and in law) as well the approach. Socio-economics is a multidisciplinary field, which may therefore be new for most present groups involved in biosafety. 

Accordingly it is a great need for training.

There is also a need for inclusion of policy-makers, decision-makers and regulators, as well as technical personnel with a background in socio-economics or in economics and sociology.

The requirement for socio-economic analysis has received new dimensions in recent times especially in the context of climate change, demand for green energy and emerging carbon market. The Intergovernmental Panel on Climate Change estimated the global technical mitigation potential for agriculture at 5.5 to 6 Gt of CO2 equivalent per year by 2030. A more comprehensive view of agriculture, would require the exploration of the potential of the conventional farming practices as well while taking decisions on LMOs. Perhaps, LMOs could be more useful if it can be accommodated in the conventional farming practices. This would also have a bearing on sustainability of livelihoods. Farmers would be in a better position to provide the decision makers with vital inputs on this. However, in most cases they have been left in the whole process of decision making. So, the capacity building requirements need to include improving (a) the ability of the decision makers in undertaking assessments which include various options and combinations involving conventional practices, (b) involvement of farmers in the process of decision making.
---------------------------------
Reji K Joseph
Consultant
Research and Information System for Developing Countries
Lodi Road, New Delhi
India
Email: [email protected]; [email protected]

I completely agree with Anne, that a distinction need to be made between RA and the assessment of SOC. She pointed out that many (technical) capacity building activities have been targeted to reach experts educated in agriculture or natural science. For assessing possible socio economic effects we need a much broader expertise, and the main challenge for the near future will be to identify the relevant target groups and to start building capacity for those, who have so far never worked in the field of biosafety, like economists, social scientists or experts in communication.
However, I also think that this might be only the second step. As it has been pointed out before, the different countries are at different stages of implementing Art 26, and many have no respective provisions in their NBFs or biosafety laws. In other cases (like in the EU) there might be the legal possibility to take SOC into account when making decisions on the authorization of LMOs, but there is no practical example or no procedure in place on how to do this.
Therefore in my point of view it is very important to target capacity building activities related to SOC to regulators (in order to enable them to develop their national legislation and/or procedures) and to decision makers. The latter being very important in identifying the data and assessment categories related to SOCs they need for making decisions, taking into account the regional, national and local situation. This might in a second step facilitate to identify the areas/field of expertise where capacity building is necessary.

Broad socio-economic assessments in practice

I think we do need to examine more in detail how in practice some of the proposals that have been put on the table on this online forum will work from the standpoint of a practitioner and a regulatory process.

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 fungicides are not affordable by most farmers. 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

Based on the many contributions to this forum, let’s assume for this exercise that the regulatory authority are interested in examining  the socio-economic impacts on farm labor, indirect farm labor, children and pregnant women nutrition, farm income, effects on financial and production “down side” risk, impacts on cultivation patterns for indigenous banana varieties, impacts on human health and potential impact on community production skills and practices, on community resiliency and on the sustainability of livelihood under the LMO production system and/or mixed conventional/LMO systems.

Note that we are selecting already for a limited amount of issues for the evaluation and at this point in time we do not have data on producer, household nor community use of LMOs as none has been released.  The most that we could obtain is careful quantitative and qualitative measurements on production practices, economic and social status and from there attempt to project how some of this factors will evolve over time (see note below). We know that getting robust data on households communities is a tedious and difficult process and if we interested in finding longer term and sustainability impacts the likelihood is that we will multiple observations.

Obvious questions for defining 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 societal nature will likely take multiple cycles or years. Just as an illustration Glenn Stone an anthropologist examining Bt cotton issues in one region in India, has been visiting the place for I think is a period of 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?

Note that the minimum qualifications here for a multi-disciplinary team to examine these issues are 1 economist, 1 sociologist and 1 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 this forum) 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 a minimum of 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 needs taking 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.

As I have presented in other threads of this online forum, 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 US$ 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 process is obviously here focused 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 conducted by Kikulwe in Uganda (which we at IFPRI/PBS supported) 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 complying with such 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 for implementation.

Note: We at IFPRI have done a couple of studies (more are on the way) where we have conducted quantitative and qualitative approaches to gather data for 1 cycle, and through different methods we have attempted to answer a set of questions related to potential adoption and use of LMOs. This approach obviously can be criticized for not capturing multiple year variations, although we have attempted to use available secondary data for trying to assess such variation over time. The later is not always available or is too aggregated such as using data from FAOSTAT or COMTRADE.

References:
1. 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.
2. 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.

At this point I agree with the proposals of colleagues in the discussion group. I only would emphasize the communities as a main target group; capacity-building on socio-economic considerations will be enriched with the interchange with stakeholders.

Thanks again to all participants in this constructive forum on that
important and complex issue !

That it is important, obviously in somehow different ways for different
Parties, is reflected in the existence of Art. 26.& that resulted from
long and motivated discussions on this issue.

That it is complex has again been reflected enough in the messages of
this forum.

Capacity building surely is necessary for the various concerned
stakeholders ( assessors, evaluators of assessments, regulators,
decidors, .... ).

But I rather agree with Andreas Heissenberger that the group desserving
maybe the more and more urgent capacity building is that of the
regulators, who would have to develop regulatory frameworks integrating
the various aspects of that complexity, at the level of the elements to
take into account, " assessments endpoints ", political goals,
stakeholders to involve, weighing and eventually counterbalancing
various impacts. Besides, as mentionned during the forum, various
stakeholders would have to work together during the elaboration of such
frameworks in order to draw frameworks while thinking at the same time
at their practical implementation

Best regards.


Lucette Flandroy





Disclaimer : http://www.health.belgium.be/eportal/disclaimer/index.htm

It is critical to have capacity building for regulators and policymakers.  Those groups will be establishing the rules that govern the national biosafety regulatory system and implement the Biosafety Protocol in that country.  Developers of LMOs, both public and private, want to know in advance the rules that will govern their products so they can assess whether they want to go ahead in a particular country.  Knowing whether the system includes a socio-economic assessment and what that assessment entails will be important to their decisions about research, confined field trials, and possible commercialization.  Thus, it is important that the regulators and policymakers understand this area so they can set forth rules that are transparent, predictable, functional and feasible.  Even those a socio-economic assessment might not occur at the research and field trial stage, it is important to know at that time if one is required for commercialization as that will impact the decision to move forward with the research and field trials.  It also allows for the start of the SEA while those other activities are being performed.

Gregory Jaffe
Director, Biotechnology Project
Center for Science in the Public Interest

Dear all,



In relation to the main target groups for capacity building on SEC, we think
they are:



-       Regulators

-       Biosafety decision makers

-       Multidisciplinary groups of practitioners and assessors

-       The general public



Additional remarks in relation to the target groups (some of them in
reaction to previous posts) are:



-       Regulations and decisions related to LMOs can also consider existing
knowledge and experiences from neighboring countries. This is consistent
with precautionary approaches. This to say that a country / Party can take
preventive measures when SE adverse effects related to LMOs are observed or
reported in other countries.



-       Because the quality of the results are connected to the quality of
the methods, policy makers need also to know how to assess the quality of
the information they are receiving from assessors. This in terms of the
relevance of the assessment criteria chosen, the parameters used and
adequacy of the methods applied. This will improve the assessment process
and contribute to achieve transparency.



-       The public is not a uniform mass of people. Hence, it is very
important to identify the different groups existing within “the local
public” to build capacities in a differentiated manner.



-       One of the groups of the public is composed by practitioners,
ranging from scholars to civil society groups. They also need to understand
the criteria, parameters and methods used for SE assessment. As one of the
previous points, this will also contribute to the transparency of the
process.



-       Considering that LMOs are not restricted to LM crops the target
groups --mainly practitioners and the public -- might be different for each
case of LMO introduction (following the logic of “case-by-case assessment
according to the environmental and socioeconomic context where LMOs are
introduced”). This is important also to take into account in decision-making
and capacity building processes.



Regards to all,



Georgina C.V.