Forum discussions

The second guiding question for theme 4 is "What are the main capacity-building needs regarding the evaluation of assessments and their integration into a decision on the import of an LMO?"

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

My apologies for the cross posting in a number of threads, but I feel that the questions in this round are quite interlinked. However, I should not have posted the current note in this specific question related to imports and LMOs.

With regard to the issue of LMO import regulations, here it would perhaps be useful to differentiate between commercial imports and emergency/supplemental food aid,as they may have different implications

I think one of the most relevant publications out there and one which gives quite a bit of background on the issue of "asynchronous approvals" or perhaps "asynchronous regulatory decisions" is the 2009 report published by the EU-JRC-IPTS (Institute of Prospective Technical Studies)and its authors Alexander Stein and Emilio Rodriguez-Cerezo. This publication abstract (quoted below) and content summarizes the pressing need to clarify and to develop feasible and efficient regulations as well deal with an quite rapidly increasing pipeline of regulated products, as significant portion of which will come from developing countries (India, China, Brazil and others).

[START QUOTE STEIN AND RODRIGUEZ-CEREZO]
The commercialisation of GM crops is a regulated activity and different countries have different authorisation procedures, i.e. new GM crops do not get simultaneously approved worldwide. This "asynchronous approval" (AA) is of growing concern for its potential impact on international trade, especially if countries operate a "zero tolerance" policy that may result in rejections of imports that contain only traces of such GMOs; a similar problem of "low-level presence" (LLP) of unapproved GM material in imports arises when developers of new GM crops do not seek approval in export markets, i.e. when there is "isolated foreign approval" (IFA) in their home countries only. LLP incidents have already caused trade disruption and economic problems, in particular for the EU feed and livestock sector.

To forecast the future evolution of LLP, a global pipeline of new GM crops was established. While currently there are around 30 commercial GM events cultivated worldwide, by 2015 there could be over 120. If problems with LLP have occurred in the past, these are likely to intensify. Moreover, GM events can easily be combined ("stacked") by conventional cross-breeding, thus creating more "new" GMOs (in countries where stacked crops are regulated like new GMOs). Also the issue of IFA is bound to increase with more GM crops being developed by technology providers in Asia for domestic markets.

For actors in the global agri-food chain the main problem of LLP is the economic risk of rejections of shipments at the EU border. Part of this problem consists of the "destination risk", i.e. the official testing for unauthorised material only in the port of destination. When compliance with a zero tolerance policy for LLP becomes impossible, exporters may only deal with "preferred buyers" who are known to create little problems. Otherwise, if the risk of rejection increases, so will the price. This will affect EU businesses that are dependent on cheap agricultural imports.
[END QUOTE]

I would also like to contribute to the discussion many of the publications from an IFPRI Colleague, Guillaume Gruere, who has published extensively on the issue of trade and trade-related issues with regard to LMO and the Protcol/National Law requirements. His contributions in terms of trade impacts and of Protocol implementation issues are quite relevant for this discussion.




References:

Gruère, Guillaume P.; Mevel, Simon; Bouët, Antoine. Balancing productivity and trade objectives in a competing environment : Should India commercialize GM rice with or without China? 2009.  Agricultural Economics 40 (4): 459–475.
http://dx.doi.org/10.1111/j.1574-0862.2009.00391.x

Gruère, Guillaume; Sengupta, Debdatta.Bt cotton and farmer suicides in India : An evidence-based assessment
2011.  Journal of Development Studies 47(2): 316-337.
http://dx.doi.org/10.1080/00220388.2010.492863

Gruère, Guillaume; Leroy, Laëtitia.From “May Contain” to “Does Contain”? : The price and trade effects of introducing strict information requirements under the biosafety protocol article 18.2(a) in the case of maize
2010.  18. Washington, D.C. International Food Policy Research Institute (IFPRI)
http://www.ifpri.org/sites/default/files/publications/pbsnote18.pdf

Gruère, Guillaume; Kimani, Virginia.Implementing information requirements for GM commodities under the cartagena protocol article 18.2(A) : at the national level: the case of Kenya
2010.  17. Washington, D.C. International Food Policy Research Institute (IFPRI)
http://www.ifpri.org/sites/default/files/publications/pbsnote17.pdf

Kimani, Virginia; Gruère, Guillaume.Implications of import regulations and information requirements under the cartagena protocol on biosafety for GM commodities in Kenya
2010.  AgBioForum 13(3): 222-241.
http://www.agbioforum.org/v13n3/v13n3a02-gruere.pdf

Bansal, Sangeeta; Gruère, Guillaume.Labeling genetically modified food in India : Economic consequences in four marketing channels
2010.  IFPRI Discussion Paper 946. Washington, D.C. International Food Policy Research Institute (IFPRI)
http://www.ifpri.org/sites/default/files/publications/ifpridp00946.pdf

Gruère, Guillaume P.; Sengupta, Debdatta.Reviewing South Africa's marketing and trade policies for genetically modified products
2010.  Development Southern Africa 27(3): 333-352.
http://www.informaworld.com/images/icons/pdf-fulldoc.png
http://dx.doi.org/10.1080/0376835X.2010.498941

Dear all,

Since socio-economics is an interdisciplinary field there is a need to be cautious in the selection of the methods to be used in SE assessments as well in the evaluation of such assessments related to LMOs. Hence, there is a need to learn along the way and evaluate the approaches taken with the intention to build flexible and robust frameworks. It can also be useful to search for experiences from other fields ( as for example building powerstations, dam constructions etc.) and evaluate approaches taken there for assessment of socio-economic effects.

For this issue is important to carry the discussion about when integrate the socioeconomics considerations (SEC).  Before, during or after the environmental release of an LMO? In my opinion, if we take in account the SEC before the release, we can mitigate the side effects or decide to not import an LMO, until some measures were taken. So, some of the social impacts illustrated by Dr. Walter Pengue like: migration or displacement to other land; deforestation; marginalization of indigenous people in the case of GM soybean in Argentina could have been mitigated.

As Social Impact Assessment (SIA) argues the objective of SIA is to ensure that the developments that do occur maximize the benefits and minimize the cost of those developments. The role of SIA goes far beyond the ex-ante (in advance) prediction of adverse impacts and the determination of who wins and who loses: SIA also encompasses empowerment and other disadvantaged members of society; development of capacity building; alleviation of all forms of dependency; increase in equity; and focus on poverty reduction (Becker & Vanclay)

In my opinion the problem is not so much for current developments, but those that are at the global pipeline like biopharmaceuticals, biofuels, transgenic animals and so on. How to protect the biosocial process that communities have? How to ensure the food security?

Reference
Becker, A and Vanclay, F (2003) The international handbook of social impact assessment. Edward Elgar Publishing, UK.

Dear participants,

As previously said in this forum, some methodologies have to be developed especially for ex ante studies, while usefull methods do exist to assess some aspects of these socio-economic considerations, but that were not used till now in this precise field.
But, as understood from the various messages, capacity-building seems to be still more needed to integrate results from various types of relevant studies ( some more based on economic assessments, other ones based more on social, anthropological methods ) than for individual studies themselves.

Capacity-building is surely in particular needed, for all Parties, at the juridic level, in order to elaborate regulatory frameworks taking into account socio-economic considerations relevant for decided political goals while respecting various relevant international obligations and engagements.

I would like to thank in particular Dr. José Falck Zepeda for his long and experimented contributions in this forum.

I however have the impression that his messages tend to discourage Parties to take socio-economic considerations into account, in function of the complexity and the length of the process to elaborate and to make it work, in function of the costs it can generate, in function of doubts about the plus-value of the results of such studies,  in function of supplementary delays it can bring in the decision processes on LMOs.
Maybe these experimented remarks can make a good argument not to develop socio-economic considerations on a case by case basis (which, at least following the EU legislation, should mean on an event by event basis) but rather on a generic basis, per categories of LMOs ( for ex.: the combination of a plant species/transgenic trait/intended use could define a category of LMOs for which each single event should be assessed individually for its biosafety, but there would be a single socio-economic assessment for all those events ); an ex ante study, close to a SEA, could be conducted for all LMOs of the same category.
These remarks could also be good arguments to involve representatives of all relevant stakelholders in a very direct participatory approach, where not only peer-reviewed scientific published studies but also direct experience-, evidence-, lesson-learned based data and testimonies could be taken into account and discussed. Capacity-building for the management and integration of the results of such multidisciplinary groups debates and methods could be necessary.  
In this context, I think that, if indeed tackled from a generic point of view, a pluri-comparative approach of the sustainability of different "technologies" , "methodologies" , "agricultural systems" aimed at solving the same problem, in a given situation, could be envisaged and be useful. This approach would also need capacity-building.

In a first step, I think that a synthesis of this global online forum, reflecting the various aspects that Parties would have to think about if they decide to take socio-economic considerations into acount, and including 
contradictory positions/ comments made in this forum, would be a good capacity-building tool for all Parties. Further on, a more structured and more continued process of capacity-building could be useful in addition to the foreseen Workshop, in view of the complexity of the issues to tackle. 

With best regards.

Lucette Flandroy


P.S. : I am sorry, Stuart, but I must agree with Alejandro Lopez Feldman that the recent European Commission report on socio-economic considerations does not demonstrate the impracticability of the intergration of such considerations in the LMO authorisations processes. It just say that ex ante considerations from EU Member States in the report are essentiallly based on a priori opinions, because very few if any relevant scientific studies have been made till now on this issue in the EU. The ex post studies made in the few EU countries cultivating GMOs are, as mentionned in this forum, essentially made at the level of  farms cultivating GMOs, and show the same results as those mainly revealed by such short/medium term studies at the international level with Bt or HT-GM plants .  



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Dear Lucette:

Putting forward a recommendation for countries to include socio-economic considerations is quite difficult for me or for any social or economic impact assessment practitioner, as it is an extremely complex issue and thus the evaluation and decision making processes are also complex. It is my view that there is no clear winning strategy in terms of selecting an option for including and/or implementing socio-economic considerations (or not) in decision making.  This statement can vary from country to country.

From the standpoint of IFPRI being an international organization supporting developing and emerging countries, we will certainly abide by their policy decisions and will contribute to the development and implementation of food system policies and of course socio-economic assessments if that is the decision. Hopefully it will be a decision done considering full information about all issues and consequences. Certainly, as my good friend and mentor Abisai Mafa on the Protocol and regulatory issues, has indicated in this forum, we should not shy away from up-taking these tough challenges head on.

I do love the challenges involved with implementing socio-economic assessments of new technologies such as LMOs, but am quite aware of the multiple limitations of such assessments, many of which we are seeking addressing methodologically. In fact, I wish I had the time available and resources to spend examining a specific case study in more detail in than what is currently the reality in my institute (3 years or so) as it is feasible in an academic institution.

From another standpoint, I (and my colleagues at IFPRI/PBS) have been in a unique position in many ways, as our work is firmly located at the nexus were biosafety and biotechnology policy development and implementation occurs in developing countries. We at IFPRI and the Program for Biosafety Systems have been working with lawmakers, regulators, assessors, decision makers, competent authorities, scientists, and many other stakeholders, on hands-on capacity building/strengthening issues on the ground since 2003.

Some of my colleagues and I have been struggling with these issues way before the PBS program was launched, 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 paper (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.

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.

I find your proposal of examining “classes” of LMOs with broader /more in detail assessments quite appealing.  Figuring implementation issues will be interesting.

Dear all,



The current guiding question is very much related to the first question of
Theme 4 ("What are the main capacity-building needs of countries regarding
the assessment of socio-economic considerations?"). Accordingly, the points
shared from the Bolivian perspective under the previous question apply to
this one as well. However, we would like to add some specific points in
relation to the evaluation of assessments and their integration into a
decision on the import of an LMO. In this regards, countries / Parties need:



-       Guidelines on “what” to consider (potential assessment
endpoints/parameters) at SE level when making a decision of import. This as
an ex-ante assessment of potential short / long-term and direct/ indirect SE
impacts of LMOs, which should be accompanied by an analysis of the social
justification for the potential introduction of the LMO and other non-LMO
alternatives (including local alternatives).



-       Guidelines on which SE aspects need to be monitored after the LMO
introduction. This should be also part of the information to be integrated
in the decision of import of a LMO since it is important part of the
feasibility analysis for a safe transfer, handling and use of certain LMO.



-       Integration of SEC into ecological risk assessment (RA).



-       Application of the previous (guidelines and integration to RA) on a
case-by-case basis in relation to the ecological and socioeconomic context
where the LMO is intended to be introduced.



Another important issue not directly related to the topic is illegal
introductions. Assessment of ecological and social impacts of illegal
introductions poses particularly difficult challenges to Parties. What and
how to assess SE impacts of illegal introductions should be also a topic of
capacity building.



All these, especially the development of the guidelines, can be the tasks of
an AHTEG.



Many thanks,


Georgina C.V.



Georgina C.V.

Dear colleagues,

when Lucetta mentioned that many message appear to discourage Parties from taking SEC into account I was reminded of the first meeting at which I heard from a representative of U.S.-sponsored biotechnology/biosafety capacity building initiatives that they ouwld support SEC. This was 2003 in Mali on a seminar on Bt cotton when the early publications on the growing of Bt cotton in the Makhatini Flats in South Africa were used to prove the benefits of Bt cotton for marginal African farmers.

We need to be clear that the position toeards SEC - apart from all technical and scientific discussions - has also tactical and strategical elements.

This becomes especially clear when the context of bioafety capacity building activities is analysed. If biosafety capacity building is embedded in broaded activities of technology transfer and the planned introduction of a specific GE crop in a specific country - as for example GE bananas in Uganda - the set-up and sequence of activities will vertainly be very different as if biosafety capacity building is embedded in building up the capacities of a country to deal with future GMO applications as element of the implenetation of the Cartagena Protocol.

If in the first case the outcome of biosafety considerations - including SEC - would slow down or even seriously challenge the larger aim of the project this would cause some problems. Furthermore the outcome of biosafety activities always have to be weighted against the pressure that is produced by the investments already made with regard to human and financial resources - and is some projects (Bt cotton, Bt maize etc) also economic and strategic interests of industrial partners.

In our capacity building discussions and also in the preparations towards the workshop we need to be aware of the different concepts of biosafety capaicty building and the effects they cause. And we need to acknowledge that different donors have different underlying policies for funding and structuring biosafety capacity building initiatives.

Some final words before the closing of the online discussion. But first, I would like to thank the CBS Secretariat for facilitating this online discussion as well as the Governments who supported financially its implementation.

I am looking forward to more interactions and discussions and will be submitting more results from our own socio-economic assessments as well as the work we are doing in terms of developing a roadmap and guidelines for socio-economic considerations with regional and national partners.

1) The starting point of the discussion for countries (Parties or not to the Cartagena Protocol on Biosafety) is defining why they want to include socio-economic considerations. The answer to this basic question will have to consider all the potential benefits, costs and risks associated with this policy/political decision.

2) If countries decide that they want to include the assessment of socio-economic considerations into their decision making then it is advisable that they consider all the issues relevant not only to the development of the regulatory framework but also to its implementation. It is not only important to define the national biosafety framework but also implementing regulations.

3) It is certainly recommended that policy makers consult with those socio-economic experts with demonstrated practical experience in the assessment of LMOs and other emerging technologies for regulatory framework development but also other related technologies such as  conventional plant breeding, integrated pest management, agronomic practices and others.

4) It is important to clearly define the socio-economic assessment AND the decision making process in order to ensure transparency, feasibility, cost effectiveness,and protectiveness of the overall regulatory assessment and decision making process.

Knowing the WHAT and the HOW is not enough to ensure a successful process. Clearly defining upfront the WHO will do the assessment, WHEN, WHAT TYPE of inclusion(voluntary vs. mandatory), the FEASIBILITY, the FLEXIBILITY in the process, the DECISION MAKING RULE/STANDARD by which the decision will be made, are equally important as they are interrelated in any decision making process.

If these aspects of the process are not discussed and decided upon upfront, society runs the risk of developing a process that will not be implementable in practice.

From the standpoint of a socio-economic assessment practitioner the most important aspect is defining the WHAT will be assessed and the WHEN, as these two issues will limit HOW things can be done. Other issues related to the efficiency of the process and to the decision making which usually is out of the control of the assessor.

5) There are very few examples of the inclusion of socio-economic considerations into decision making for the regulation of LMOs. Most of the experience has been related to a few countries (India, China, Argentina, Mexico and few others) and it is not completely clear in all of them how socio-economic considerations have been included in the socio-economic

6) Socio-economic assessments cannot be disassociated from the technological context, the methods used, the assessor, and the motivations behind the different stakeholders involved in the decision making process.

From this standpoint, it is critically important to maintain the absolute standard of disciplinary excellence and the elements of best practice for the socio-economic assessments. This requirement cannot be negotiated to dilute the assessment excellence quality standard.

Elements of best practice include such issues as scientific peer review, double blind reviews, use of state of the art methods, method triangulation including qualitative and quantitative methods/techniques, assessment of data variability, stringent attention to statistical and sampling biases, explicit address of many types of variability, clear definition of research hypotheses/data/methods/assumptions/results/conclusions, mandatory submission of data/programs/routines, etc. are just some of the few issues that will need to be defined and required from such assessors and assessments.

7)If socio-economic assessments are indeed included in decision making, there will be a critical need to develop/strengthen functional capacity to conduct socio-economic assessments, for regulators/decision makers to understand the SEC assessments and its limitations as well as the potential for competing claims, the technology developer to understand the SEC requirements, and for society to understand the overall biosafety/SEC assessment and the decision making process in order to guarantee a fully informed decision in the end that will be accepted by society at large.

As previously noted, this information has to include all the costs, benefits and risk from the inclusion of SEC considerations, its assessment and the gains in information/knowledge. It is one element of best practice to conduct periodical assessments of whether inclusion of socio-economic assessments is indeed leading to better outcomes compared to the counter factual of no inclusion.

8) A final precautionary note. Socio-economic assessments are not magic as they cannot assess everything. They are scientific processes that involve many subjective aspects in terms of their implementation and are a process which have multitude of limitations and issues.

This is why economists of long and distinguished careers such as Carl Pray (Rutgers University), David Zilberman (U.C. Berkeley), Phil Pardey (U. of Minnesota), Julian Alston (U.C. Davis) and others have warned us about the many issues and limitations with the assessment of socio-economic considerations as well as have guided us in terms of addressing many of these issues methodologically.

Furthermore, some of these authors have also extended a precautionary note with the inclusion of socio-economic assessments in regulatory processes that lead to a decision of approval/rejection/postponement for a technology, especially when the recipient of the benefits, costs and risk (i.e. farmers and consumers may not be involved in the assessment and perhaps even the decision itself. I include myself in this group of economists.

However, ff countries, once they have understood all the issues and limitations with regard to the socio-economic assessments, and are completely aware of the potential issues and limitation related to the outcomes of such assessments, and they reach the decision of including socio-economics into decision making, then it becomes an issue for us practitioners to define a process that will still meet the policy/political decision and the goals of ensuring a functional biosafety system.