Forum discussions

The guiding question for theme 7 is "What other relevant issues should be discussed in the online regional conferences and the workshop that are to be held in accordance with decision BS-V/3?"

Most of the discussions on SEA have been on the “possible frameworks”. But equally important are the components or ingredients of the frameworks- what parameters should SEA include? We would propose eight such components based on our assessment of India’s experience with LMOs.

1. Does LMOs result in long term yield benefits? In India, Bt Cotton is the only commercially cultivated GM crop and it has been found that the yield advantages of Bt cotton lasted only for initial 2-3 years. In a matter of few years the secondary pests became primary ones and the yield was affected.
2. Can the adoption of GM technology result in increased income benefits? This in turn would depend on: (a) employment opportunities; (b) wage differences; (c) off-farm income; and (d) working days, i.e., life cycle duration of crops.
3.  Differences in input material requirements in GM and non-GM crops. Data required for this would cover frequency and magnitude of different inputs like fertilizer, water, seed, insecticides and pesticides for GM and non-GM crops.
4. To what extent does the adoption of GM technology result in decline in the use of inputs such as pesticides? It has been observed in India that such declines are very short lived and farmers had to increase the use of pesticides. Squeezing of the income of farmers on account of higher spending on Bt cotton seeds and less than anticipated/assured savings on pesticides, has forced a number of poor farmers into suicides, as many studies would show. 
5. How to carry out the extension services and diffusion of technology for appropriate adoption and monitoring the same for safe and sustainable use of the technology? In India, Bt cotton farmers were found to be not following the mandatory requirement ‘refuge cultivation’ simply because they were not aware of such requirements. Ignorance of farmers on the technical issues of LMOs when combined with inadequate extension services has resulted in “agricultural deskilling” among the farmers.
6. How to arrive at the trait value of LMOs? It has been found that farmers are paying a premium to the seed companies not proportionate to the benefits they are getting. Monsanto, in 2006, charged Rs 1250 for one packet (450gm) of Bt cotton seed while it charged only Rs 180 in China for the same seed. When the MRTP Commission (agency to tackle anti-competitive practices) intervened the price was reduced to Rs 900. What role does anti-trust/competition agencies have in regulating the prices of GM seeds?
7. Is there any provision for compensation in the case of crop failure? Is any form of security available to farmers? In India, Monsanto was required to compensate farmers in 2004 for crop failure on account of spurious seeds. What method should be used for compensating farmers – only the cost of seed or the value of crop?
8. What impact do the byproducts of GM crops have? It was found in India that oil yield from Bt cottonseed was far less than from their non-GM counterparts. What impact does it have on animals that are fed on GM plant residues?

This is a joint submission by Dr. Sachin Chaturvedi, Senior Fellow and Mr. Reji K Joseph, consultant of Research and Information System for Developing Countries (RIS), New Delhi, India.

Important Resources
(a) Lalitha N and Viswanathan P K, “Pesticide Applications in Bt Cotton Farms: Issues Relating to Environment and Non-Tariff Barriers”, Asian Biotechnology and Development review, Vol 12 No 2, July 2010.
(b) Sachin Chaturvedi, Wendy Craig, Vanga Siva Reddy and Decio Ripandelli, “Environmental Risk assessment, Socio-Economic Considerations and Decision making Support for LMOs in India”, joint study by International Centre for Genetic Engineering and Biotechnology and Research and Information System for Developing Countries, 2007.
(c) Glenn Davis Stone, “Field Vs Farm in Warrangal: Bt Cotton, Higher Yields and Larger Questions”, World Development, 39.3, 2011.
(d) Reji K. Joseph, ‘Is Genetically Modified technology desirable? The law and economics of Bt Cotton’, in Raju K D (ed.) Genetically Modified Organisms: Emerging law and policy in India, TERI, 2007.
(e) Reji K. Joseph, ‘Suicide by Cotton Farmers in Andhra Pradesh’, Rights and Development Bulletin, Vol 1, Issue 1, December 2006, Centre for Development and Human Rights, New Delhi. 
(f) Ronald J. Herring, ‘Global Rifts over Biotechnology: What Does India's Experience with Bt Cotton Tell Us?’, V.T. Krishnamachari Memorial Lecture, Delhi University, December 2, 2009 available at http://government.arts.cornell.edu/assets/faculty/docs/herring/KrishnamachariLectureFnlRHv15.pdf

Thank you very much for your contribution as it does open many questions with regard to implementation of socio-economic issues within the scope of a biosafety regulatory system.

I do have a question regarding issues in your proposal.  In your text you write “In India, Bt Cotton is the only commercially cultivated GM crop and it has been found that the yield advantages of Bt cotton lasted only for initial 2-3 years. In a matter of few years the secondary pests became primary ones and the yield was affected.”

I want to understand how can we reconcile this statement with the current status of Bt cotton adoption in India and assessment results presented in Choudhary and Gaur (2010).  In this publication, the authors indicate that the area planted to Bt cotton in India is roughly 82% to total area. Rates of adoption vary from roughly 67% in Gujarat to almost 97% in Karnataka, Madhya Pradesh, Andhra Pradesh and Maharashtra.  Granted the Choudhary and Gaur publication is not peer reviewed itself, yet it cites plenty of peer reviewed publications supporting data and issues included in the report itself, which is one issue for discussion in itself, the validity of competing claims.

If the advantage of Bt cotton lasts only 2-3 years, would we expect that first adopters to abandon the technology and then have an impact on the rest of producers considering potential adoption? In essence, wouldn’t we expect adoption rates to have been stable, declining or even observe that producers just abandoned the technology?

Obviously the story is much more complicated than this, as in the case of India there is the issue of approved, unapproved and counterfeit varieties, as well as those issues identified by Glenn Stone for a community and region in India (Stone 2002) and other discussions in his papers.

Bt cotton is not a monolithic technology, and certainly now India and other countries are adopting and using other events such as Bollgard II and others events, including some that have been produced by the national research system.There should be a consideration of the expected pipeline of products and how to integrate for example LMOs to existing technologies.

Secondary pest in my mind is a classic example, where non-target insects not controlled by the LMOs , in some cases once they overwhelm natural predators will need insecticide applications and/or can be controlled with Integrated Pest Management practices.

Another consideration is the use of management practices such as refugia which has certainly been successful in the US and other countries delaying the onset of resistance. The fact that the U.S. and other countries have been able to manage the technology and preserve its use for the long term, even beyond what the theoretical models for resistance were usually saying (7 years or so until resistance would render the technology useless) opens the discussion indeed to long term issues including how to manage the technology.

Lots of issues to resolve and discuss even before these technologies are released to farmers. As my friend and colleague Marnus Gouse has written for the case of Bt cotton in South Africa, we want to avoid having “technological triumphs but institutional failures”. Similar sentiments have been expressed by Stone and others.

References


Stone, G. 2002.  Both Sides Now – Fallacies in the Genetic-Modification Wars, Implications for Developing Countries, and Anthropological Perspectives. 2002.  Current Anthropology Volume 43, Number 4, August–October 2002.
Choudhary, B. & Gaur, K. 2010. Bt Cotton in India: A Country Profile. ISAAA Series of Biotech Crop Profiles. ISAAA: Ithaca, NY.
Viswanathan,  P. K. and N. Lalitha GM technology and sustainable agriculture future: Empirical evidences from Bt cotton farmers in Maharashtra and Gujarat in India.. Journal of Development and Agricultural Economics Vol. 2(1) pp. 007-017, January, 2010. Available online at http://www.academicjournals.org/JDAE

Issues for regulatory design

Moving in the direction of regulatory design. Let me point out a set of issues that will need careful description and definition in any regulatory system that includes socio-economic issues for decision making. These issues are examples of what Greg Jaffe has suggested for those discussions on how to include socio-economic considerations in this forum and others places.

1) Call for long term impacts
Here decision makers will have to clearly define what this requirement mean in terms of data collection, analysis and decision making. Does this mean, for example, that the regulatory/decision making entity will require long term data collection before authorizing deliberate and/or commercial) release?

Note that this requirement leads into an interesting conundrum. How can one “collect long term data on an LMO release where none has been approved because there is no long term data” AND how can one approve an LMO release without long term data if required?

Obviously a careful definition of what is expected will be critical in this sense.

This requirement also opens a host of questions about how to implement such assessment. Will this long term data collection requirement be made mandatory for all submissions? Will it be required only for the first application of a specific event? Would this long term assessment be done for a class of events (such as insect resistance in cotton or any other crop) as I believe Lucette Flandroy proposed as a potential option?.

Will this assessment be part of a mixed system, where there is a relatively standard period of confined field trials, multi-locational trials and perhaps advanced large trials (such as is required in China) before considering commercial approval followed by a renewable 3-5 year temporary permit – as is done in most countries anyhow- where there is a post-release monitoring  assessment, ending in de-regulation if there are no issues raised?

As I have contributed in previous notes, the regulatory lags introduced by these requirements do have consequences in terms of opportunities lost, information gained and technology flows which society will need to consider in its decision making processes.

2) Evaluating competing claims
The literature available for India shows a very real problem that regulatory systems will likely face when dealing with regulatory decisions involving socio-economics. That is, the fact that there will be a host of competing socio-economic impact claims with regard to a specific technology.

In my experience, it can be even get to the point of difficulty, whereas the decision maker face a set of assessments based on the same or similar set of farmers -even the same source database- and then have the assessments reach contrastingly different results as a consequence of the method used and the implementing teams that will conduct the assessment.

After all, when doing an assessment, be it a an economic or a socio-cultural-anthropological assessment especially in an ex ante (before adoption) assessment where there will be a multitude of assumptions used to forecast or provide estimations (be it Social Impact Assessments, Sustainable Livelihoods or Economic Impact Assessments) there is quite a bit of subjectivity involved in the assumptions and scientific tools used to forecast or estimate potential impacts.

The regulatory/decision making process will require having clearly defined rules and decision making standards to ensure that competing claims are properly evaluated and decided upon. Here it is important to note that it is important to have as much detail as needed in implementing regulations, but we have to be cognizant that too much detail can increase the likelihood of regulations becoming inflexible and thus prescriptive. This reduces the opportunities to include innovative assessment alternatives which may make the process more efficient. 

3) The decision making process and decision making rules and standards

Let’s assume that we have a clear path for the socio-economic assessment which may consider long term impacts and institutional issues related to potential adoption. The regulatory authority/decision making body commissions a third party to perform a social-economics assessment that includes a broad set of issues.

What will the decision making process look like in practice? How and what will the regulatory/decision making body use in its decision on whether to approve, require more information or reject the application dossier for deliberate (commercial) release? Will this decision be different if evaluation post-release monitoring activities and thus decide on deregulation?

Assuming that the event has been deemed “safe” by the environmental or food/feed safety risk assessment processes to the established standard, and any results from the socio-economic assessment show potential socio-economic and institutional issues (access to credit, market concentration, labor displacement) what is the regulatory decision? Would it be contingent upon resolving institutional issues before approving? Can we reconcile this decision with those that may be potentially exacerbated by the technology release as pointed out by Stone?

The issue is foreseeing these implementation issue so that the regulatory process is clear to all stakeholders before implementation.


References

Stone, G. 2002.  Both Sides Now – Fallacies in the Genetic-Modification Wars, Implications for Developing Countries, and Anthropological Perspectives. 2002.  Current Anthropology Volume 43, Number 4, August–October 2002.

Choudhary, B. & Gaur, K. 2010. Bt Cotton in India: A Country Profile. ISAAA Series of Biotech Crop Profiles. ISAAA: Ithaca, NY.

Viswanathan,  P. K. and N. Lalitha GM technology and sustainable agriculture future: Empirical evidences from Bt cotton farmers in Maharashtra and Gujarat in India.. Journal of Development and Agricultural Economics Vol. 2(1) pp. 007-017, January, 2010. Available online at http://www.academicjournals.org/JDAE

Again, as I have mentioned in previous contributions, it might be very useful to have a look at those cases in which already now SEC are part of governmental decision making. In many European legislatures SEC need to be included in land-planning processes, larger constructions with implications on environment and biodiversity etc. This is also the case I guess in many other countries outside of the EU. Socioeconomic analyses are performed according to certain standards and rules and the outcome is part of that information that is used by the authorities to make their decision. This does not mean that a specific negative outcome of the socioeconomic analysis would automatically top the whole project. I would like to suggest that we should be a bit more relaxed about the matter.

The same is true for the regulatory system we are currently thinking about. If a country decides to actually start with SEC there are many possible ways how to do it. A light system in a preparatory phase, starting to get experiences, there might be different steps foreseen in such a system what obligations for the authorities arise from the outcome of SEC etc. And we need to acknowledge that also the system of environmental risk assessment when it was introduced started with methodologies that were imperfect - and today even judged as inappropriate. But still decisions were taken while the system was developed further. I miss sometimes the call for flexibility and adaptability of a system that is often heard in the biosafety discussion in the debate on SEC. The impression is created that we onyl can start taking SEC into account if we can provide a full-fledged, almost perfect system. Experience shows that - if there is political will to include SEC at all - the building up of system takes part in a step-by-step procedure.

In the end, we need to get more information about the existing ways how SEC are used in environmental and developmental decision making procedures. This should be one issue dealt with at the workshop.

Thank you very much for your contribution as it does open many questions with regard to implementation of socio-economic issues within the scope of a biosafety regulatory system.

I do have a question regarding issues in your proposal.  In your text you write “In India, Bt Cotton is the only commercially cultivated GM crop and it has been found that the yield advantages of Bt cotton lasted only for initial 2-3 years. In a matter of few years the secondary pests became primary ones and the yield was affected.”

I want to understand how can we reconcile this statement with the current status of Bt cotton adoption in India and assessment results presented in Choudhary and Gaur (2010).  In this publication, the authors indicate that the area planted to Bt cotton in India is roughly 82% to total area. Rates of adoption vary from roughly 67% in Gujarat to almost 97% in Karnataka, Madhya Pradesh, Andhra Pradesh and Maharashtra.  Granted the Choudhary and Gaur publication is not peer reviewed itself, yet it cites plenty of peer reviewed publications supporting data and issues included in the report itself, which is one issue for discussion in itself, the validity of competing claims.

If the advantage of Bt cotton lasts only 2-3 years, would we expect that first adopters to abandon the technology and then have an impact on the rest of producers considering potential adoption? In essence, wouldn’t we expect adoption rates to have been stable, declining or even observe that producers just abandoned the technology?

Obviously the story is much more complicated than this, as in the case of India there is the issue of approved, unapproved and counterfeit varieties, as well as those issues identified by Glenn Stone for a community and region in India (Stone 2002) and other discussions in his papers.

Bt cotton is not a monolithic technology, and certainly now India and other countries are adopting and using other events such as Bollgard II and others events, including some that have been produced by the national research system.There should be a consideration of the expected pipeline of products and how to integrate for example LMOs to existing technologies.

Secondary pest in my mind is a classic example, where non-target insects not controlled by the LMOs , in some cases once they overwhelm natural predators will need insecticide applications and/or can be controlled with Integrated Pest Management practices.

Another consideration is the use of management practices such as refugia which has certainly been successful in the US and other countries delaying the onset of resistance. The fact that the U.S. and other countries have been able to manage the technology and preserve its use for the long term, even beyond what the theoretical models for resistance were usually saying (7 years or so until resistance would render the technology useless) opens the discussion indeed to long term issues including how to manage the technology.

Lots of issues to resolve and discuss even before these technologies are released to farmers. As my friend and colleague has written for the case of Bt cotton in South Africa, we want to avoid having “technological triumphs but institutional failures”. Similar sentiments have been expressed by Stone and

References


Stone, G. 2002.  Both Sides Now – Fallacies in the Genetic-Modification Wars, Implications for Developing Countries, and Anthropological Perspectives. 2002.  Current Anthropology Volume 43, Number 4, August–October 2002.
Choudhary, B. & Gaur, K. 2010. Bt Cotton in India: A Country Profile. ISAAA Series of Biotech Crop Profiles. ISAAA: Ithaca, NY.
Viswanathan,  P. K. and N. Lalitha GM technology and sustainable agriculture future: Empirical evidences from Bt cotton farmers in Maharashtra and Gujarat in India.. Journal of Development and Agricultural Economics Vol. 2(1) pp. 007-017, January, 2010. Available online at http://www.academicjournals.org/JDAE

I believe an important issue to discuss is how to incorporate socio-economic considerations into a national biosafety regulatory system in a transparent, predictable and fair manner. 

Many national biosafety regulatory systems state in their enabling law and/or regulations that socio-economic considerations will form a part of their decision process for authorizing LMOs.  However, those legal documents (laws, regulations, guidance, and guidelines) don’t provide any detail on what socio-economic considerations will be considered and how they should be assessed (the socio-economic assessment).  By contrast, many national biosafety regulatory systems include significant detail about the environmental risk assessment that needs to be performed – they usually include the information needed about the receiving environment, the tests and research that needs to be performed, as well as how the results from the tests and research should be analyzed in the assessment.  They also include detail about any food safety assessment with information about the tests to be performed and how to interpret the data in the assessment.

Most biosafety regulatory systems need to define the “socio-economic considerations” that will need to be assessed as well as what constitutes the “socio-economic assessment.”  The national regulations, guidance, and guidelines need to specify what information and analysis will be required by the importer and/or developer of an LMO relating to socio-economic considerations and how they will be used by the government decisionmaker in the authorization process.  Developers, importers, interested stakeholders, and the public deserve to know the how socio-economic considerations will factor into the authorization process.  Answering the following questions is critical:  who will do it?  How will it be done?  What will it include?  And how will it impact any decision?  Unfortunately, most national biosafety regulatory systems provide little, if any detail, on socio-economic considerations and their assessment.  Until the answers to these questions are spelled out, however, a national biosafety system is not transparent, predictable and fair.  Therefore, I believe it would be useful to have additional discussion and capacity building around the drafting of documents that will spell out for developers, importers, interested stakeholders, and the public the details about the socio-economic assessment as one part of the biosafety regulatory system’s authorization process.

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

Thanks for rich and important contributions. I agree with Gregory, it is very important to discuss in the on line regional conference on the inclusion of SEC into national biosafety regulatory system in an adequate and efficient manner particularly transparency.
I want also to add capacity building in developping countries around guidance materials, decision making process,information, awareness for decision makers,regulators,research institutes, NGOs.

I would direct you to the paper I wrote with a colleague (Falck Zepeda and Zambrano 2011) which is directly focused on issues to consider for the inclusion of socio-economics. I can send you a reprint copy of the paper if you need one. Offer extensive to anybody in the forum and to all publications I have referenced before.Missing from that paper would be some of the legal aspects in terms of instruments and drafting of laws, policies and implementing regulations; which is in the realm of Greg Jaffe's expertise.

Just wanted to related a couple of experiences I have had with some colleagues in developing countries.

I am providing technical support to the RAEIN-Africa (The Regional Agricultural and Environment Initiatives Network-Africa http://www.raein-africa.org)based in Namibia and the University of Pretoria in their efforts for the development of a road map and eventually guidelines for the potential inclusion of socio-economic considerations in biosafety decision making. This is being drafted by a multi-disciplinary, multi-country, multi-experienced team.

With the LAC Biosafety (Latin American Countries Biosafety http://www.lacbio.org) project facilitated by CIAT in Colombia and implemented in four countries (Colombia, Peru, Brazil, Costa Rica) I am also providing technical support on socio-economic issues to their efforts in testing different methods and examining their relationship/integration with environmental risk assessment methods.

Reference
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

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. http://agbioforum.org/v12n1/v12n1a09-falckzepeda.htm

RE: What other relevant issues should be discussed in the online regional conferences and the workshop that are to be held in accordance with decision BS-V/3?

We need to appreciate that new technology in the agricultural sector has brought in new actors and new requirements for regulation. Developing countries are working on new opportunities and policy options for effective and rationale regulatory framework but equally important is to analyze how socio-economic dimension is often overlooked while evolving regulatory frameworks both for biosafety as well as for price control of seeds. There is systemic lack of technological sensitivity in the agricultural R&D system. We fail to appreciate the kind of technological support farmers are looking for and how best a delivery system for new technologies should be put in place. In this regard, India would have to evolve a dynamic innovation and technology policy to address diverse agricultural challenges and growing environmental concerns. There is need to do is to overhaul the institutional set-up and its linkages with ground-level experiences. This includes gearing up of decision making process for newer crops; setting up of necessary infrastructure and trained manpower for any eventuality related to biohazard; and, on top of that, identifying correctly the technological expectations from agricultural R&D systems.
My following paper has undertaken this exercise for India.

Technological Change and New Actors: Debate on Returns and Regulations by Sachin Chaturvedi  http://www.ris.org.in/images/RIS_images/pdf/dp-168_pap.pdf


************************************
Dr. Sachin Chaturvedi
Senior Fellow
Research and Information System for Developing Countries (RIS)
Zone IV B, 4th Floor India Habitat Centre, Lodhi Road, New Delhi 110003 (India)
Tel: 91-11-24682177-80; Telefax: 24620051
Fax: 91-11-24682173-74
Email: sachin@ris.org.in; chaturvedi_S@hotmail.com

Posted on behalf of Vibha Dhawan:

My apologize for the late submission. Although, I have been enjoying the discussions and diverse view points of colleagues. I personally feel that while there are many references to socioeconomic assessments, but most studies had different data sets for analysis. The results also vary with the attitude of the person who is doing the assessment. Further, in many countries (including India), commercial release of food crops is still awaited and the only GM crop that is commercially cultivated is cotton. The actual analysis will come once GM technology percolates down to the level of small and marginal farmers with land holdings that are less than a hectare.

My own impression is that these studies play a negligible role in decision making/policy formulation. The debate is more emotional than on the basis of science or economic data. There is no answer to the perceived risks to human health or the environment.

As mentioned by Gregory Jeffes, Socio-economic consideration must be defined by the national regulatory system. It is important to have some uniformity and know what the expectations are. At present, regulatory systems in most countries are not geared up to evaluate studies on socioeconomic considerations ( or even biosafety analysis). Same is true with risk management. All this points out to need of capacity building at all levels and among all the stakeholders be it policy makers, corporates, extension workers and even the consumers.

The inclusion of socio-economic considerations in decisionmaking and the conduct of socio-economic assessments in not new but has been done in other contexts.  It would be interesting to hear about those experiences in the on-line discussions and the workshop.  By understanding what has been done in other areas, it may help countries and policymakers determine both what is feasible and also what is valuable for LMO decisionmaking.  It also may provide examples of how to write regulations, guidance, and guidelines that address socio-economic considerations for biosafety issues.  Government decisions involving environmental, food safety, and/or agricultural areas would be logical places to look for examples of socio-economic assessments that might have some relevance to LMOs and biosafety.

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

Dear all,

Before closing the online discussion we want to share three points with you that may be of interest with regard to "other relevant issues" to be discussed in the online regional conferences.

1. We suggest that the regional online conferences and the workshop discuss the way forward with regards to what kind of tool/guidance document that would be most useful for the Parties. What tool is needed to assist in implementing article 26(1)? We suggest considering if a roadmap similar to the one developed by the AHTEG on risk assessment and risk management would be an appropriate tool. Or perhaps a combination of a roadmap and in-depth guidance documents? Based on such a roadmap regulators and decision makers can elaborate their national assessment framework and identify capacity building needs, which can and should form the basis for capacity building activities.

2. Much focus in the present discussions has been on GM crops, therefore we also would like to suggest that we also include other LMOs as GM vaccines, GM biocontrol strategies and GM animals (especially fish) in future discussions since they may pose other relevant socio-economic issues.

3.We appreciate Gregory Jaffes point on identification of experiences from other areas involving environmental, food safety and/ or agricultural areas ( or other fields as dam constructions, power planst etc) with the intention to learn what is feasible and identify what can be valuable for LMOs (as main SE assessment endpoints and parametres ( as emphasised by Andreas Heissenberger)). Such initiatives can also help to identify protection goals and context (which as posted by Georgina Catacora-Vargas includes SE needs, biological and cultural characteristics, local livelihood strategies etc.)

Dear all

I agree with Dr Anne Myhr that apart from the necessary substantive issues, some discussion on the modalities of implementation could lead to a more sustained process that would help meet the capacity-building needs of Parties.

In addition, as has been raised several times already, I believe that the close inter-relationship of public participation and socio-economic considerations and the value of incorporating public participation in socio-economic assessments, would warrant some further discussion for guidance/capacity building on this topic, which would also assist Parties in both implementing their public participation obligations as well as enrich the socio-economic assessment process.

Further, I believe it would be beneficial for some information sharing and analysis to be done on the cases where socio-economic considerations have been taken into account in decision making.

Lim Li Ching
Third World Network

Dear all,

Here some reflexions after recent messages posted by various participants in this forum.

Dr. Jose Falck Zepeda and some other participants, a.o. Stuart Smith, mention that SEC studies will make the autorisation procedure still more complex, long, and costly.
It is of course the duty of the political decidors to overweigh the various costs and benefits, following their political goals.

Anyway, it seems that there are still other ways ( in addition to making the SEC studies by categories of LMOs and taking into account direct participatory approaches, as I proposed in previous messages ) to reduce the supplementary lenght and costs that can generate the SEC assessment.

For ex., the SEC experience and data collected from SEC studies in other fields in the same region ( as commented by Gregory Jaffes and Anne Myrh ) can already constitute a partial ready-made information. 

Also, as underlined by Georgina Catacora-Vargas, the biosafety risk assessment must include an analysis of the "context" where the LMO will be cultivated, as one of the first issue to consider when performing a risk assessment.
Obviously, the "context" includes socio-economic parameters; it was even agreed, during the recent parallel online forum on Risk Assessment and Risk Management, that the section relative to the Context and Scoping of the RA in the Roadmap should more specifically refer to socio-economic considerations.

Indeed, while one can agree that the global general adverse effects ( the "hazards" ) would be the same whatever would be the context, the adverse effects really taken into account ( Scoping ) will depend on the political goals, that will determine the assessment endpoints ( to thus firstly determine, as said by Andreas Heissenberger ) ; and the probability of the adverse effects to occur partly depend on the socio-economical context, beside the fact that they depend on the natural context where the LMO would be released and on the intended use.
The socio-economic context can itself partly determine the political goals and assessment endpoints, and besides, can influence the probability of potential adverse effects to happen, and can influence the importance of adverse effects if they do occur ( e.g. 1) influence, in the probability of a negative effect to happen, of a) the general socio-economic conditions of the country, b) the socio-economic and educational conditions of the various stakeholders along the lifechain of a LMO, c) the habits in the former/traditional agricultural system, to respect the technical advices along the chain in order to get positive results and avoid negative effects; 2) relative direct importance of adverse impacts on biodiversity if negative effects arise can depend on the direct importance, for ex. for their daily survival, of that biodiversity for the concerned local population  , ... ). These considerations can be of still greater importance when talking about GM pharmaplants, for ex. , than when talking about GM plants cultivated for food. These considerations are also of great importance to frame and develop, in case of a LMO agreement, the different capacity building needs, following the regions, in order to really get positive results and the different capacity-building needs following the regions for a proper risk management, including monitoring. 

In summary, while experts in RA and officials often want to clearly separate the RA process from the SEC, both issues are actually intrinsically linked if one admits, following the concerns related in the preceding § , that the risk itself ( = hazard x probability ) is partly depending on socio-economic considerations. 

And thus, when properly performing a biosafety risk assessment, part of the SEC study should already be made.

On another side, the assessment endpoints, determined by political goals, and partly influenced by the socio-economic context of each concerned region, should not in all cases necessarily include all potential SEC; this also can reduce the job to do in comparison to the one needed for a complete theoretical socio-economic study. Of course, as mentioned several times in this forum, the assessment end-points taken into acount and the limitations of the process should be very clear and transparent for the different stakeholders .
The process itself for specifying the relevant assessment endpoints in each country is obviously important, and can need capacity-building and exchanges of existing experience in other countries. But, as previously said, the experience gained in other countries is only partially transposable, because can depend on specific local conditions.  



Another point:

Being not myself an expert in socio-economic studies and methodologies, I feel perplex ( while not totally naive.... ) by some statements of Dr. Jose Falck Zepeda in his message posted on Wednesday 4 May at 16:53, in the § " Evaluating competing claims" . I read that " ....it can get to the point of difficulty, whereas .......assessments based on the same or similar set of farmers - even the same source database - and then have the assessments reach contrastingly different results as a consequence of the method used and the implementing teams that will conduct the assessment. " .
Does that mean that:
1) some methodologies should be rejected; there should be a kind of official international agreement to value some methods ( like is partly done, little by little, for RA methods ), while other methods would be consensually recognized internationnaly as non valuable. ( But that rigidity can also be a frame for the use of new and renewed methodologies, if the agreed methods are not very regularly actualized ).
2) one can get the results one likes by selecting the right methods, which, as underlined by some participants in the forum, would mean that there is never total objectivity, even with scientific methods ( and this could thus also apply to the biosafety RA ). That would also undermine the general super-value of what are called "scientific methods" in comparison to methods that are not officially recognized as such.
3) there is a mix of these 2 possibilities that I mention hereabove, or still another explanation. 


Thanks a lot in advance for an eventual answer. 


Coming at the end of this long forum, I thank again and already the Secretariat for having organized these discussions, and all the well informed, informative, and motivated participants in these 7 weeks discussions where I took great interest and pleasure to participate, in the limits of my available time, experience, and professional competence and function.
Beside unavoidable repetitions along these 7 weeks, I feel that this forum was really useful as a step forward on this issue in the context of the Cartagena Protocol.

With best regards.

Lucette Flandroy









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

Lucette,

You perfectly capture the main concern about socio-economic considerations in your most recent post, when you say the following. "It is of course the duty of the political decidors to overweigh the various costs and benefits, following their political goals."

This is precisely the problem. Governments will politicize the regulatory decision making process. For example, Company A develops a LMO in Country B and applies for regulatory approval in Country C. This is denied due to politics and so Country B responds, say by putting a tariff on one of Country C's exports into Country B, thereby making this product more expense for consumers and reducing the level of trade between the two countries. This creates a lose-lose situation.

This scenario was representative of international trade prior to the General Agreement on Tariffs and Trade that was created in 1947. One country would make a policy decision that angered the government of another country and so a tit-for-tat trade war escalated in products, commonly agricultural products. In 1995, the GATT was replace by the WTO.

Is the WTO perfect? No, of course not. Is it better than the situation that existed prior to the GATT? Without a doubt.

So much of the debate about SEC can not be quantified in a scientific process that independent, unbiased regulators are able to make a science-based decision upon. So, what happens is that the decision becomes a political one. This opens the regulatory system up to all kinds of manipulation, depending on which party is in power at any given point in time. Removing politics from international trade was the driving reason behind the establishment of the GATT and now the whole discussion about the inclusion of SEC is driving the world back to the environment that it sought to escape 65 years ago.

Without science-based decision making as a basis for every regulatory system, the politicization of the process will naturally lead to manipulation of the system and a deterioration in international trade of agriculture products.

Dear Lucette:

Does that mean that:
1) some methodologies should be rejected; there should be a kind of official international agreement to value some methods (like is partly done, little by little, for RA methods ), while other methods would be consensually recognized internationally as non valuable. ( But that rigidity can also be a frame for the use of new and renewed methodologies, if the agreed methods are not very regularly actualized ).

MY RESPONSE:
Methods or tools should be rejected (or discarded from use) only if they have been proven to be fundamentally flawed or if there is a more efficient/better method out there that can be used instead. This is what I would call method evolution.

I agree with your point that we need to develop/strengthen -in fact already mentioned in one of the online forums- a robust evaluation of the benefits and limitations of available methods and approaches for socio-economic assessments in the case of LMOs, as well as, the many method and tools gaps we have in terms of examining broader issues such as poverty, food security, differential impacts and other cross-cutting issues on the table.

Some inroads have been taken in the social-economic assessments literature, including that of the elements of best practice. Examples include the Alston, Norton and Pardey book “Science under Scarcity...” and the “Principles and guidelines for social impact assessment in the USA.” By the Interorganizational Committee on Principles and Guidelines for Social Impact Assessment, Impact Assessment and Project Appraisal, volume 21, number 3, September 2003, pages 231–250.

I firmly believe that this evaluation has to be tied to a qualitative/quantitative assessment of feasibility, type of resources needed for implementation, data and info requirements and even an idea of relative costs. Furthermore, we need to map the issues to methods and to timing of the assessments. This is the type of work that the community of practitioners should and could do to help inform decision makers in their deliberations. We at IFPRI have taken some inroads into this type of assessment; hopefully can now give it a stronger push for expanding this activity.

By the way, the whole idea of mapping methods to issues is to give a sense of feasibility pending upon the timing of the assessments. The choice of issues for inclusion in a biosafety regulatory process will be in the end a policy/political decision which should be the first item to define when designing such system. Choice of methods follows after.  In contrast, for a “pure” academic/research technology evaluation process the issues relevant are those that significantly explain our research evaluation objective (i.e. examination of adoption, diffusion, impact)

2) one can get the results one likes by selecting the right methods, which, as underlined by some participants in the forum, would mean that there is never total objectivity, even with scientific methods ( and this could thus also apply to the biosafety RA ). That would also undermine the general super-value of what are called "scientific methods" in comparison to methods that are not officially recognized as such.

MY RESPONSE:
This is indeed a possibility but I think it is more obvious on how a method is used or applied. The application of a method can define the outcome of the assessment especially if applied in a manner inconsistent with the elements of what can be considered to be best practice. The later is another part of this puzzle that needs careful definition, as any misapplication of methods to pre-define an outcome is clearly un-ethical and un-professional. In fact, I can argue that all methods could be misused to support a pre-defined outcome especially in the right hands.

Let me give you two quick examples of how a method can be misused. The two examples relate to a method (economic surplus) and the other is an indicator (Net Present Value) in a cost benefit analysis. If we are talking about a technology that increases yield or reduces production costs, this has an impact on the supply curve. In any estimation using the economic surplus method, the choice of the elasticity of supply directly impacts the level of producer benefits. The elasticity of supply is an uncertain parameter, even when one has estimated values from the literature. It is thus an element of best practice to conduct a sensitivity analysis to examine how the value of this parameter affects outcome. In fact, I always recommend using stochastic simulations to examine this in greater detail and thus become an ipso facto measurement of variability (risk). Same thing happens with the choice of interest rate used in the NPV estimation. The later may be tempered a bit as there may be an “official” interest rate that has to be used for project formulations. 

Social and economic methods or tools used in the assessment indeed incorporate a lot of subjectivity in terms of how they are applied and even the choice of methods. Certainly, we need to stick as much as possible to the classical scientific method as a paradigm for conducting socio-economic (or other biosafety) assessment as it helps guide the assessment process itself and the quality control that will ensure elements of best practice have been followed. Yes, socio-economic assessments incorporate subjective aspects in their assessments, and I believe that implementation of biophysical sciences do so themselves.

This is one of the reasons I am a strong believer in the need for method and disciplinary triangulation and to have peer review for the socio-economic assessments as one of the quality control indicators. This is especially useful if done by experienced peers who will be able to detect methodological and implementation issues upfront. Peer review in this sense serves to ensure compliance with the elements of best practice in such evaluations.

This is also a reason why I am also an agnostic of the outcomes of social and economic assessments especially those done in an ex ante situation. This includes my own work and research, even when my works has –I think- evolved over time and are a stickler for the elements of best practice.

As one of my Macroeconomic professors Dr. John D. Jackson, used to say to us neophytes in the science or art of economics: "I use macroeconomic methods and tools, but do not believe them.." I think this is a healthy attitude to have in the end.

One final issue is the matter of decision making standards and rules. Defining this is in manner so that the inclusion of socio-economic considerations is transparent, fair, feasible and protective is paramount to a functional biosafety and/or a decision making process.

Let me present a set of decision making situations that I as a social/economics assessor will need clear definition and guidance by policy and decision makers on how these will be applied in practice. These may be extreme examples but not too far from what we will be facing later on in a regulatory process.

1) What will the decision making process look in the situation were the biosafety risk assessment has determined the product to be safe according to society’s standard AND the socio-economic assessment shows that there may be a sub-set of producers (let’s say 20 percent of producers) who may not gain or even lose from adopting the innovation? Will this decision change if the 20% is concentrated amongst the poorest-of-the poor versus the amongst the export/commercial oriented farmers?

2) What happens if the outcome is expressed as a probability? For example, there is a 20% probability that the lowest income quintile will lose income from the adoption of a specific LMO? Yet the other 80% of producer have more than a 70% of gaining from such adoption…

3) Will the decision making take into consideration “oral” claims of negative socio-economic impacts? or will it require a higher burden of proof such as determination of socio-economic damage quantified in a study before approving a technology?

For example, if a community of 600 persons in a 7 million inhabitant country claim they have a cultural, ethical, religious or aesthetic norm objections to the potential release of an LMO, is this enough not to consider approving the technology for release? Will this be enough to trigger a socio-economic assessment and what will be done after the socio-economic assessment is done? How will this be incorporated into decision making and potentially on socio-economic mitigation measures (co-existence, segregation, identity preservation, etc. ). 

4) What happens if there is an outstanding technology that will ensure food security (for example a drought tolerant /viral resistant/ insect resistant/vitamin A  and protein enhanced /fungal resistant cassava) for millions of persons but it is likely to cause a significant decrease in the population levels of a set of non-target organisms. How will society decide? 

The issue here is thinking about the decision making standard and rules so that they are clear to all stakeholders well in advance of any evaluation process. In other words, what we need is national dialogues in terms of how will the democratic engagement and participation process work in relationship to a regulatory and technology decision making process and the inclusion of socio-economic considerations. The issues and the decision making rules have to be determined by the policy and decision makers, with hopefully input from practitioners.

Dear all,

Just a short closing comment from my side on this last day of the on-line discussion forum. I have found all the submissions very interesting to read and believe that the diversity and different views will make for a productive process with the regional conferences and the workshop as agree by the Parties in decision BS-V/3.

I believe that the guiding questions of the present discussion forum have been well suited to provide background information for the agreed main objectives of the workshop (BS-V/3, para 26, a) and b)):

(a)Analysis of the capacity-building activities, needs and priorities regarding socio-economic considerations submitted to the Biosafety Clearing-House by Parties and other Governments, and identification of options for cooperation in addressing those needs;

(b)Exchange and analysis of information on the use of socio-economic considerations in the context of Article 26 of the Protocol;

For me some of the key words are "the use of socio-economic considerations" and "the context of Article 26 of the Protocol". It is my belief that in order to, in due course, narrow the discussions down to the "HOW" (what methods could/should be used in order to achieve knowledge on socio-economic impacts, how should the knowledge be assessed and implemented into th edecision making process) we need to start with considering the "WHAT". This "WHAT" I believe is what several participants have termed "assessment endpoints" and which other colleagues in the forum have examplified by listing assessment endpoints important to their country.

The "WHAT" and the "HOW" (in that order) is to me the most important elements as a basis for a type of guidance document and which furthermore will give a good pinpoint for capacity building needs. This is of course a simplified recipie and other considerations exist.

I look forward to the continuence of the constructive process of "unraveling" Article 26 that has now been initiated by the Parties!

Best regards,
Nina Vik
Norwegian Directorate for Nature Management

Dear Nina and colleagues,

I would also use this last day of our discussion forum to thank all the participants to have been deeply engaged during the last weeks! I am very happy that the decision of MOP-5 to conduct a SEC workshop and the decision of the secretariat to undertake these preparative discussion forum evoked such an interest. We also had other experiences with our discussion fora in the BCH...

And I am also convinced that the work we have undertaken in the coordination meetings for biosafety capacity building and in Nagoya to start these debate will initiate a broader debate on SEC in the following months on a topic that have never been discussed in substance under the CPB.

Finally I would like to add a remark to Nina's message. In the workshop we should not forget to work on the first part of the MOP-5 mandate: "Analysis of the capacity-building activities, needs and priorities regarding SEC ...". This part of the mandate will give us the opportunity to address all those SEC needs and priorities which are not captured by the more or less narrow wording of Art. 26 - and which were the basis of most of the contributions in our messages during the previous weeks.

With my best regards,
Hartmut Meyer

Dear all,
I was following the very interesting discussions on the various threads. Unfortunately I was not able to contribute more  to the discussion due to time constraints.
However, I want to take the opportunity to share my thoughts on the topics of the planned workshop:
I realized that many inputs to the discussion under this thread are already discussing in detail substantive issues and concrete examples of the use or non use of SEC in decision making process. In my point of view this is very relevant, and a discussion on these issues could definitely form one part of the workshop.
I also agree with what some others (e.g. Hartmut Meyer, or Nina Vik) have pointed out: The decision from COP/MOP5 talks about exchange and experience of Capacity Building needs, activities and priorities. This analysis should also include examples from other regulatory regimes, where there is already experience on how to take SEC into consideration in the decision making process. I think that the workshop should focus on these issues rather than on the inclusion of SEC in NBFs and decision making itself (as it has been discussed extensively in this thread and others).
As I have also posted previously, I think that there is still no common understanding on what we are talking about, when we are talking about SEC. Also the discussions have shown (at least to me) that there is some disagreement, on which topics should be dealt with and how they should be weighted when it comes to decision making, e.g. priority to purely economic evaluation or the need to take public awareness/information into account.
So in summary I would suggest as topics for the workshop:
1) Analysis of experiences gained with the assessment of SEC in the field of LMOs but also in other regulatory areas, using case studies (these can be presented in introductory lectures and discussed in groups)
2) Definition of parameters and assessment endpoints for an assessment of possible socio-economic impacts with regard to LMOs, taking into account the different regional and national  situations.
3) Based on these case studies and the identification of relevant parameters the identification of needs for Capacity building in implementing the Art26 of the Protocol.

Dear all,



Before sharing our list of specific topics suggested to the online regional
conferences and workshops, we would like to mention that:



-       We agree with Anne Myhr that forthcoming discussions should also
consider key issues for effective implementation of SEC in regulatory and
decision-making processes.



-       What was mentioned by H. Mayer is very important in the sense that
we need some flexibility/adaptability in SEC in decision-making. This not
only because building appropriate mechanisms for SEC will follow a
step-by-step process, but also because SEC are very much context specific.
In line of this, it is also very important: i) what was mentioned by Lucette
Flandroy re: "It is of course the duty of the political decidors to
overweigh the various costs and benefits, following their political goals."
The question of what if governments politicize the regulatory decision
making process is also very valid; however, here is where public
participation and mechanisms to improve transparency in biosafety
decision-making play an important role; and ii) while the scientific method
provides some important research tools, it is not fully suitable to SE
research. A broad pool of research methods is required to better capture the
multi-dimensionality of SEC. This requires inclusion of qualitative and
participatory research / assessment methodologies.



We believe that Nina Vik put in very simple terms the adequate sequence of
SEC discussions (WHAT before the HOW). In relation to this and our previous
comments, our suggestions on additional issues for the upcoming discussions
are:



In relation to WHAT is relevant in SEC:



-       Key parameters / assessment endpoints in SEC related to LMOs (not
restricted to LM crops).



-       Key parameters for SE post-release monitoring in the short and long
term.



In relation to HOW to assess SEC:



-       Cases of SEC in environmental legislation (existing experiences and
lessons learned).



-       Analysis of provisions and lessons learned from countries that
included SEC in their NBF.



-       Ecological and socioeconomic risk assessment interface.



-       Public participation in relation to: i) effective mechanisms in
decision-making and ii) SE research.



-       Mechanisms for transparency in biosafety decision-making with
particular emphasis to SEC.



-       Key issues for effective implementation of SEC into biosafety
decision-making.



An additional suggestion (mainly to the workshop) is the discussion on
suggested terms of reference for an AHTEG on SEC.



Finally, the Plurinational State of Bolivia would like also to thank to the
Secretariat for the opportunity of participating in this e-forum, and also
to all the participants for their enriching comments. We look forward to
continuing contributing to the discussion and implementation of SEC in the
context of the CPB.



Kind regards to all,



Georgina Catacora-Vargas

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.