Forum discussions

The second guiding question for theme 3 is “What experience has been gained to date with methods for assessing socio-economic impacts?”

We conducted a literature review in 2008 of 137 economic impact assessment studies published between 1996-2007. The 137 publications were chosen from those in an initial Google Scholar search that yielded more than 10,000 hits.

The large number of hits had to be reduced to a more manageable number by establishing the criteria of selecting only those formal publications with an identifiable peer review process and stated economic assessment method, as a requisites for inclusion in our review. We classified studies depending on the unit of assessment studied including measuring impacts on farmers/households, trade, industry/national, and consumers. Results from this literature review are not too different than the results from other economic assessments of technologies in the past.

The literature review showed that:
• Most studied crop  and trait combination is Bt cotton

• Most of the studies conducted in China, India and South Africa

• On average, economic impact from the adoption of Genetically Modified crops was profitable—but averages mask variability by agro-climate, host cultivar, and farmer

• This collection of studies identified that too few traits have been studied and too few cases/authors implementing such studies. Taking this into considerations lesson generalizations to all GM crops should not be drawn yet…

• Assessment methods need improvement especially those dealing with household decision making processes, risk and uncertainty, different types of selection bias and endogeneity

• Need more time to describe adoption and better methods to describe adoption in an ex ante setting

• Next decade need to concentrate more on
    o Information and knowledge flows (to/from farmer )
    o gender, generational and other cross-cutting issues
    o impacts on poverty and inequality, and impacts of lower income farmers.
    o externalities and other institutional issues

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

Our review of 137 published papers in the economics literature was disaggregated by the typical sampling levels used in field research examining adoption and impact of Genetically Engineered technologies. The levels for the literature review include farmer, consumer, trade and industry. Here we present salient notes from the impact on farmers.

During the first decade of their use by smallholder farmers in developing economies, peer-reviewed research has indicated that, on average, transgenic crops—and in particular Bt cotton—provide economic advantages for adopting farmers.

There are several methodological limitations associated with the first generation studies which have been identified in most cases by the authors themselves. These limitations have implications for findings and for policy formulation. They should also be addressed (and are been addressed) in the next generation of studies.

• Majority of studies reviewed used primary field data collected from farmers, farm records or from field trials conducted by researchers
• Most ex post (after deliberate release) studies have used methods such as partial budgeting/farm accounting and a specification of a model grounded on theoretical economics frameworks such as production functions or random utility models.
• Few studies have been ex ante (before deliberate release). Most of these use field data and a econometric estimation to then project potential economic impacts.
• Most studies focused on bt cotton and were conducted in India, China and South Africa.  This outcome is not surprising as this was one of the first and most widely diffused technology in developing countries.
• A set of studies in Mexico and Argentina examined the implications of intellectual property rights on economic benefits earned by farmers.

Literature review caveats:
• In average, across all studies reviewed, farmers gained from the introduction and use of GM technologies. This does not mean that all farmers profited from its adoption. Furthermore, magnitude of economic benefits varies widely across geography and the nature of the cropping season. These outcomes are neither surprising nor specific to transgenic technologies.
• Length of study period has a dramatic impact on findings. The nature of adoption, technology impact and innovation processes usually develops over time and in some cases may take decades for such processes to completely unfold. This has major implications for technology assessments and for technology assessments within a regulatory process such as biosafety.
• Since the majority of studies were conducted early in the adoption process, they focused on first round impacts on yields, pesticide changes and impacts on other inputs such as labor.
• Some attention has been given to impacts on poverty, inequality, health and the environment. Due to the nature of when the studies were conducted, the later assessments were done in fairly simple ways, mostly using indicators rather than formal economic theory or frameworks.
• Few authors and few events studied to date. Cannot make generalizations to other events.
• Most studies reviewed need to address selection, measurement and estimation biases and thus endogeneity. Researchers have to consider such sampling and statistical issues when designing field surveys especially in ex post studies and when using data collected for baselines and/or the basis to conduct projections/estimations in ex ante studies. 

Important to re-emphasize that these caveats are not specific nor inherent to Genetically Engineered crops or technologies. In fact, they reflect the adoption state in which they were conducted, as well as, an evolution in economic practitioner's method development and use.

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

My understanding is that most of these sorts of studies occur within a year or two of the adoption of the LMO crop.  However, if one uses a longer timeframe, studies by Benbrook, for example, show that productivity for most LMOs falls off considerably as the pest develops resistance via Darwinian evolution. thus, higher costs to the farmer would not be resulting in higher incomes 9allother factors being equal).

The problem with using Benbrook is that his studies have never been peer reviewed and therefore, his claims are extremely skeptical. In fact, Benbrook bases his assumptions on an increase in GM crop adoption of 5% annually. With adoption rates at or above 90% for cotton and soybeans in the US, it is impossible to have 5% increases in adoption on an annual basis in perpetuity. Hence, Benbrook’s data is not deemed as a reliable source of information.

Peer reviewed studies have shown dramatic environmental and economic benefits. Through a series of peer reviewed studies, Brookes and Barfoot have shown dramatic advantages from GM crops. In their most recent study (2010), the authors estimate that the environmental benefits of GM crops are equal to the removal of nearly 7 million vehicles from the roads. They estimate the reduction in pesticide applications are 350 million kg.

One advantage of doing research in Canada and the US is that after 15 years of production, the benefits of GM crops are very evident and researchable. We surveyed GM canola farmers in Canada regarding economic impacts, environmental impacts and changes in herbicide use.

GM canola farmers identified that the economic benefits of producing GM canola range from C$350 to C$400million annually. While there are direct production benefits for farmers of C$11/acre, such as earlier seeding dates, increased production and fewer weeds, the level of spill-over benefits are even higher. We found that the second year benefits average C$15/acre. This is because the farmers get such excellent weed control from growing herbicide tolerant canola, that their cost for weed control the following year is substantially reduced. Some farmers do not even have to spray their fields for weeds in the following year. This paper has been accepted by AgBioForum and is attached below.

Environmental benefits from GM canola production are tremendous given that 65% of the production is now done using zero-tillage or minimum-tillage land management systems. This is up from 11% in 1998. Over 80% of farmers reported reduced soil erosion and increased moisture conservation (Smyth et al., 2011). The reduction in tillage also has impacts for climate change and carbon sequestration. We have estimated that 1 million tonnes of carbon is either sequestered through the production of GM canola or no longer released from tillage on an annual basis.

The changes in herbicide use also have dramatic benefits for the environment. Using the Environmental Impact Quotient, we estimate that the environmental impact of GM canola production has decreased by 53% when compared to the situation in 1995, prior to the commercialization of GM canola. The amount of herbicide active ingredient that is applied decreased by 38%, which is equal to 1.3 million kg. The herbicides that were used in 1995 had to be soil incorporated to achieve the most effective level of weed control and herbicides are now done as a foliar application. This paper will be published by Weed Technology and is attached below.

Given that conventional and organic farmers have to include tillage as their leading form of weed control, based on our research, we concluded that the production of GM crops are the most environmentally sustainable form of crop production currently in practice. 

References
Brookes, B. and P. Barfoot. 2010. Global Impact of Biotech Crops: Environmental Effects, 1996-2008. AgBioForum 13: 1: 76-94. Available online at: http://www.agbioforum.org/v13n1/v13n1a06-brookes.pdf

Smyth, S. J., M. Gusta, K. Belcher, P. W. B. Phillips and D. Castle. (In Press) Environmental Impacts from Herbicide Tolerant Canola Production in Western Canada. Agricultural Systems. Available online at: http://www.sciencedirect.com/science?_ob=MImg&_imagekey=B6T3W-5259HT0-1-1&_cdi=4957&_user=1069128&_pii=S0308521X11000151&_origin=browse&_zone=rslt_list_item&_coverDate=02%2F12%2F2011&_sk=999999999&wchp=dGLbVlz-zSkWA&md5=9e1a523838beb1d084078a9a8f7e32e3&ie=/sdarticle.pdf

My name is Eric Sachs, Regulatory Lead, Scientific Affairs, at Monsanto Company.  I am a leader for pest resistance management programs at Monsanto and within the biotechnology industry.  The expression of Bt proteins in crops such as corn and cotton, and most recently soybean in Brazil, protect these crops from damage caused by pest feeding, which results in higher productivity. Farmers net benefits include reduced input costs, lower pesticide use, higher yield returns and reduced applicator exposure to pesticides. 

In order to minimize the risk of pest resistance and provide sustainable pest management, technology providers combine multiple complementary Bt proteins, known as pyramiding, to dramatically reduce the risk of pest resistance.  In addition, Bt products are planted in conjunction with non-Bt crop or alternate host plants (typically 5%-20% of area), known as a refuge, to limit the potential for resistance evolution.

Bt corn and Bt cotton in the US has been grown for over 15 years with no associated resistance in target pests. The only cases of field-evolved resistance to a Bt crop have occurred to Bt crops with only one Bt gene in the Puerto Rico, South Africa and India, after many years of use.  The most important factor contributing to the evolution of resistance has been poor compliance with refuges by farmers.  While this is important and stewardship remains a high priority for Bt crops, Bt crops with multiple Bt genes continue to provide pest protection and farmer benefits, even where resistance has occurred to single Bt gene products (e.g., India).

As a result, effective strategies have been developed based on research by the public and private sectors, consequently Bt crops continue to provide sustainable protection from target pests throughout the world where they are grown.  To address the potential for stewardship failures to lead to resistance in the future, technology providers soon will deploy refuge and Bt seed together in the bag, known as refuge-in-the-bag, so that compliance with the refuge is guaranteed and the risk of resistance due to poor stewardship remains low.

It is a bit embarrasing but I must correct my own posting.  I did not intend to say that resistance to a single-gene Bt crop had occurred in the Philippines.  That is incorrect.  No resistance to Bt maize, even with a single Bt gene, has occurred in the Philippines.

What I meant to say is that resistance to a single-gene Bt crop has occurred in Puerto Rico, as a result of poor stewardship. 

Both countries begin with the letter 'P' but that's not really an excuse.

I want to appreciate the centrality of socio-economic considerations in biosafety decision making especially for developing countries. It appears to me that most of the postings that have been done so far have to do with economic assessments and not socio-economic assessments. Socio-economic issues are multidimensional and multidisciplinary. Economic assessments per se are a part of and not a complete package of socio-economic impact assessment. There is therefore need to share experiences in ex ante and ex post socio-economic impact assessment, assessments that include social as well as economic dimensions.

There are studies we undertook in Southern Africa on ex ante and ex post evaluations of LMOs. We should be able to share the full reports of the findings in a month's time. These studies although prelimary in nature highlight important points about for example what issues to assess, possible tools for the assessments, the capacity building issues that require attention for the effective implementation of these tools, the possible options for integrating these issues into biosafety frameworks and the possible options for taking them into account in biosafety decision making processes.

Concerning what issues to take into account, in our experience, this varies from place to place and technology to technology. It will not therefore be possible to come up with a generalised list of issues to consider, but the issues will be determined on a case by case basis. There are situations for example where the issues of labour dynamics have an overiding effect or market access issues dominate etc. The issues to consider therefore will be picked out in the actual assessments, needless to say that one can develop a checklist of possible issues that are likely to be topical(speculative).

On possible tools for assessment, based on our limited experience, what may be important is to come up with a checklist of possible tools and where they are likely to be appropriate. For example, there are situations in which social impact assessment tools such as Sustainable Livelihoods Analysis will prove handy and situations where simple economic assessment tools such as economic modeling, partial budgeting and gross margin analysis will be useful. Such tools must be developed or adapted to meet the socio-economic impact assessment needs of LMOs.

It is also pertinent to highlight that because of the multidisciplinary nature of such assessments, there is need to train a team of cadres from as diverse fields as economics, sociology and athropology, genetics/molecular biology, agronomy, ecology etc to work together to accomplish the task. No single discipline or field should be allowed to dominate this process.

We have also realised that what issues to cover and how to cover them will depend on policy and regulatory provisions and protection goals. These therefore vary from country to country. In some cases the provisions are very general requiring further work, in other cases they are very specific and detailed enough highlighting priorities and processes.

Abisai Mafa

Thank you again for the interesting discussions.

I agree with Mr Abisai Mafa that “economic assessments per se are a part of and not a complete package of socio-economic impact assessment”. 

I would like to share the attached paper (Glover, 2010), published in the Journal of Agrarian Change, which takes a broader approach and critically reviews the peer-reviewed literature (largely focused on economic impact assessments) on Bt cotton in China, India and South Africa. It concludes that “the technology’s impacts have been evaluated and represented in selective and misleading ways. The performance and impacts of GM crops have in fact been highly variable, socio-economically differentiated and contingent on a range of agronomic, socio-economic and institutional factors.”

I think that the paper provides important lessons for us. It shows that while valuable information is obtained from economic assessments, there are methodological weaknesses and limitations which need to be recognized and communicated to policy makers: “The efforts of analysts have been largely confounded, though, not only by the sheer complexity of the factors involved but because the external variables they have struggled to control and exclude are actually essential to understanding the impacts of the new crop varieties on farms. In other words, the strenuous effort to rule out the effects of ‘externalities’ is not merely a methodological challenge to be over-come, but can be seen as a reflection of a basic failure to appreciate the fundamental importance of those contextual factors in a complex socio-technical system like a small farm in a developing country.”

I believe an appreciation and analysis of these contextual factors are part and parcel of socio-economic impact assessment. A wider range of approaches, research questions and methods than have been used so far in economic studies are needed in order to understand and properly assess the impacts of GM crops, and on different groups of people. I will share some further thoughts on this in the “methods” thread of the forum.

Lim Li Ching
Third World Network

The literature review provided buy Jose is an excellent document. I only want to mention two additional articles (both came out after the publication posted by Jose).  Both use a micro social accounting matrix (SAM) with the intention to simulate impacts on household income generation and distribution at the micro level. I think  that tool as well as village computable general equilibrium (CGE) models could be a great tool for assessing potential socioeconomic impacts.

On a related note, does anybody know if agent-based models (ABM) have been used for this purpose? It seems to me that they might help to gain some understanding about adoption by farmers and the impacts of those decisions at the local level.

Alejandro

SUBRAMANIAN, A. QAIM, M. (2010).  The Impact of Bt Cotton on Poor Households in Rural India. Journal of Development Studies, 46(2) : 295–311.

SUBRAMANIAN, A. QAIM, M. (2010). Village-wide Effects of Agricultural Biotechnology: The Case of Bt Cotton in India. World Development, 37(1): 256–267.

I tried to post this yesterday but the 2 files I tried to attached are creating a problem. If you are interested in Gusta, et al, Forthcoming or Smyth et al Forthcoming, let me know and I'll send them.


The problem with using Benbrook is that his studies have never been peer reviewed and therefore, his claims are extremely skeptical. In fact, Benbrook bases his assumptions on an increase in GM crop adoption of 5% annually. With adoption rates at or above 90% for cotton and soybeans in the US, it is impossible to have 5% increases in adoption on an annual basis in perpetuity. Hence, Benbrook’s data is not deemed as a reliable source of information.

Peer reviewed studies have shown dramatic environmental and economic benefits. Through a series of peer reviewed studies, Brookes and Barfoot have shown dramatic advantages from GM crops. In their most recent study (2010), the authors estimate that the environmental benefits of GM crops are equal to the removal of nearly 7 million vehicles from the roads. They estimate the reduction in pesticide applications are 350 million kg.

One advantage of doing research in Canada and the US is that after 15 years of production, the benefits of GM crops are very evident and researchable. We surveyed GM canola farmers in Canada regarding economic impacts, environmental impacts and changes in herbicide use.

GM canola farmers identified that the economic benefits of producing GM canola range from C$350 to C$400million annually. While there are direct production benefits for farmers of C$11/acre, such as earlier seeding dates, increased production and fewer weeds, the level of spill-over benefits are even higher. We found that the second year benefits average C$15/acre. This is because the farmers get such excellent weed control from growing herbicide tolerant canola, that their cost for weed control the following year is substantially reduced. Some farmers do not even have to spray their fields for weeds in the following year. This paper has been accepted by AgBioForum and is attached below.

Environmental benefits from GM canola production are tremendous given that 65% of the production is now done using zero-tillage or minimum-tillage land management systems. This is up from 11% in 1998. Over 80% of farmers reported reduced soil erosion and increased moisture conservation (Smyth et al., 2011). The reduction in tillage also has impacts for climate change and carbon sequestration. We have estimated that 1 million tonnes of carbon is either sequestered through the production of GM canola or no longer released from tillage on an annual basis.

The changes in herbicide use also have dramatic benefits for the environment. Using the Environmental Impact Quotient, we estimate that the environmental impact of GM canola production has decreased by 53% when compared to the situation in 1995, prior to the commercialization of GM canola. The amount of herbicide active ingredient that is applied decreased by 38%, which is equal to 1.3 million kg. The herbicides that were used in 1995 had to be soil incorporated to achieve the most effective level of weed control and herbicides are now done as a foliar application. This paper will be published by Weed Technology and is attached below.

Given that conventional and organic farmers have to include tillage as their leading form of weed control, based on our research, we concluded that the production of GM crops are the most environmentally sustainable form of crop production currently in practice. 

References
Brookes, B. and P. Barfoot. 2010. Global Impact of Biotech Crops: Environmental Effects, 1996-2008. AgBioForum 13: 1: 76-94. Available online at: http://www.agbioforum.org/v13n1/v13n1a06-brookes.pdf

Smyth, S. J., M. Gusta, K. Belcher, P. W. B. Phillips and D. Castle. (In Press) Environmental Impacts from Herbicide Tolerant Canola Production in Western Canada. Agricultural Systems. Available online at: http://www.sciencedirect.com/science?_ob=MImg&_imagekey=B6T3W-5259HT0-1-1&_cdi=4957&_user=1069128&_pii=S0308521X11000151&_origin=browse&_zone=rslt_list_item&_coverDate=02%2F12%2F2011&_sk=999999999&wchp=dGLbVlz-zSkWA&md5=9e1a523838beb1d084078a9a8f7e32e3&ie=/sdarticle.pdf

I would like to point out that even though I wholeheartedly agree with broad and inclusive assessments for assessing and understanding all the socio-economic considerations relevant to any potential technology adoption and diffusion -after all I am technology assessor- here we are talking about technology assessments within the framework of a regulatory process. Furthermore, we need to carefully review when the assessment may take place as it has profound implications in terms of methods and approaches to the assessments that can and do have an impact on the research outcome.

All of us, perhaps only those of us, who have conducted repeated assessments of genetically engineered crops know the many difficulties and data limitations especially when dealing with an ex ante assessment (before deliberate release) where there is no adoption and very little data on the technology’s performance and social, institutional and even management practices that may change when dealing with the technology introduction.

This is why it is important to consult about the issues, limitations, methods and pluri-disciplinary approaches to evaluations with those experts with a demonstrated track record of assessments specifically with GM technologies and other emerging technologies, in order to ensure that proposed regulations for socio-economic assessments are feasible, transparent, protective and certainly cost effective.

Yes, we, as well as other practitioners, can and have performed a number of quantitative measurements such as randomly or purposely stratified surveys in the field, have done or are doing qualitative assessments and even institutional analyses, to understand the existing context in which these technologies may be released. There may be some scope for using -really carefully- data coming from the confined field trials and other advanced field trials, but experience has shown the critical limitation of this approach. The lesson here is to conduct and understand the outcomes of socio-economic assessments with extreme care.

Secondary data and contextual/institutional assessments done before deliberate release (ex ante) may help frame the projections and simulations (or forecasting in the strict sense of the word) that may be performed to quantify/qualify the potential issues that may occur in real life. In the end there is no replacement for actual data collected from adoption and farmer decision making processes. 

By the way, the later situation where data is collected under field conditions, has a whole host of issues, especially for identification, attribution and endogeneity in the earlier stages of the adoption process. I will share later my experiences with one of our projects that examined early adoption processes in Honduras, Colombia and Philippines; a bit later.

As social and economic assessment practitioners, we do what we can with the data, methods, and information available at the moment of conducting the specified research. These valuable –in most situations scarce- information assets, in conjunction with our best judgments as practitioners on how to conduct the research and interpret the results of the evaluation process, have to be evaluated in terms of scientific quality, evidence sufficiency and other measurements of excellence and completeness.

From a regulatory standpoint, this judgment will have to be done or facilitated by the competent authority who will make a decision for the potential release of GE technology or for reaffirming the provisional permit for release in an ex post framework.

I agree with Jose that the socio-economic assessments of a new technology such as LMOs should be done in the context of a given regulatory framework. As to when the assessment should be triggered, I see two avenues: (1) as a precondition for the introduction of an LMO (ex ante), and as a follow-up to an introduced technology (ex post).The first as a means of anticipating impact and the later as a means of assessing actual impact. Both exercises are crucial in the biosafety of LMOs.From my experiences in agriculture and the environment, such assessments now constitute standard practice in many development projects.

I appreciate very well that the assessments will cost money and hence the need to structure them in a cost effective way. However, I dont see any other options especially in a smallholder farming setting where access to information and the capacity to assimilate such information is limited. These farmers also live in very marginal areas where vulnerability is extremely very high. Informed decision making is therefore very crucial as a simple lapse in decision making can drive the whole family into starvation. It is therefore imperative that when introducing a new technology to such communities due deligence be exercised.

My experience with farmers is that socio-economic impact assessment is not a new practice per se, farmers practice it everyday when arriving at pertinent decisions affecting their lives. What formal socio-economic impact assessments do is to bring structure and methodology to simplify complexity.

I also appreciate that formal socio-economic impact assessment is not easy. However, the benefits of the exercise are worth the effort. It was neither cheap nor easy to send men to the moon. However, men's determination brought the results.The complexity of assessing socio-economic impacts are no more difficult than the challenges small farmers face each day in erking a living out of the soil. After working for more than 20 years with both large scale and smallholder farmers sharing views and experiences, I appreciate more their challenges and the role of policy.Some of these farmers require support from government agencies to make policy choices.

In my view, science is never meant to be used to predict the future with exact precision. However, it allows us to minimise error and choose more attractive options. I am therefore for evidence-based decision making. Decision making that is informed by risk assessment and socio-economic impact assessment. We can either follow this route or speculate. Or worse still act ignorantly.

The knowledge achieved is to assume that the introduction of a new technology is a complex process that requires stakeholders participation and this needs a detailed job of sharing information with communities. For example, when we did workshops in Oaxaca with the indigenous communities, after the biologist Jorge Larson explained what transgenic maize is, he received the following statement from a small holder producer: “Now I understood the ADN is the soul of maize!” In those workshops, at the end we ask to the participants to write their recommendations and in several sheets they claimed for more activities like that and for having permanent mechanism of communication in order to be informed about transgenic maize. Unfortunately this claim we was not attended.
 
I agree with Abisai Mafa and Li Ching Lim when they say that socioeconomic issues are multidimensional and multidisciplinary so the assessment most include social issues not only economic ones and the case by case method is the correct, however I disagree with the proposal of a check list, this is a different issue of a risk assessment. We are dealing with social processes, and as Jose Falck-Zepeda mentioned, may take decades to see social impacts. I prefer to think in preparing an ad-hoc methodological guide, flexible, because it can not fit all cases and regions.

I would be interested in your response to the article by Missmer et al (2006) that found a drop in the rate of neural tube defects (NTDs) in infants along the Mexico-US border. NTDs are a result of mycotoxins found in corn that occur naturally and when GM corn was introduced into the diets of people living in this region, that level of corn mycotoxins dropped and the rate of NTDs followed. This is an ex-post benefit that would have been virtually impossible to predict or measure ex-ante. I see this as a huge socio-economic benefit, but am deeply worried that benefical impacts like this would be ignored or drastically undervalued through the use of a ex-ante socio-economic risk assessment.

Hi Michelle,

Your observation of not supporting a checklist approach and deciding on a flexible set of general guidelines on socio-economics for countries to choose, is at the heart of the matter for a regulatory system.

In the end, the question that countries -trying to decide on a biosafety regulatory system- need to answer is whether they are prepared to delay regulatory approvals for research, commercial propagation and/or food and feed for processing for as many years as it will take to sort out all the multi-dimensional socio-economic issues and questions related to the potential adoption of LMOs in their jurisdiction. After all, we are still debating many of the socio-economic issues related to the Green Revolution technologies in rice, maize and other crops.

An answer of "we need to do whatever it takes to define the product not impacting socio-economic status" is quite broad and not very useful in terms of defining procedures within a regulatory system.

Although a time delimited process for conducting socio-economic studies may seem to be too blunt and incomplete in terms of gaining "full information", we do have precedents of other parts of the risk assessment that ares time delimited for completion in several systems. In my mind, the issue at hand is then for countries or society deciding how much information needs to be gathered in order to make a regulatory decision.

I do not think that it is a correct interpretation of the precautionary principle (or approach depending on whom talks to...) to say that we as a society should conduct infinite amount of risk assessment activities as this would imply infinite amount of resources or to say that we have to disregard the cost involved in such activities. We have a finite amount of resources to invest in biosafety and thus we have to make choices in terms of information sufficiency.

Using the argument of the precautionary principle/approach to guide the implementation of socio-economics inclusion when there is no clear definition of what the decision making rule guiding its application, leads to many conflicts.

The later is true especially if countries decide on the pursuance of a strict interpretation of the precautionary principle/approach which seems to require pursuance of zero risk. The later implies of course pursuing an impossibility, an outcome not achievable in practice. The later is why boundaries are put to regulatory systems as there are decreasing return to biosafety investments in terms of additional knowledge gained over time.

Here I also desire to clarify a bit of a misunderstanding when talking about “economic” studies. Even though the economics literature clearly reflects a disciplinary approach, it is not exclusively about “economic” results like estimating profitability or net returns to farmers through monetary gains, although these are one of the many indicators used in the analysis.

The fact of the matter is that those studies that examined the first generation of LMOs where there were many limitations such as very little data, information and experience with assessments available, economists felt comfortable and confident in the results from first order indicators such as net profit and level of analysis (direct economic impacts) when dealing with a new innovation such as LMOs.

Most papers have pointed out these limitations especially with regard to representativeness and drawing generalizations from their research. In fact, as time went by, you could see more issues and more complex methods being employed as we gained experience and access to data.

Those economists - like me - who are working with developing countries are particularly interested in researching many different aspects relevant to developing countries’ agriculture. Issues such as impacts on smallholder farmers, labor, food security, relationship to broader poverty alleviation strategies, gender and generational dimensions, impacts on public health, distributional aspects, relationship between developing countries public and private sector research and development and innovation, access to productive and protective inputs. Furthermore, we are interested in the impact of intellectual property regimes on access and conversely on how to use IPR regimes to promote use, issues with biodiversity and its role in providing ecosystems services and as a risk management instrument for climate change and commodity price fluctuations, addressing freedom to choose and freedom to operate issues and many more.

IFPRI where I work, as an international non-governmental organization, is particularly interested in those crops and traits of a public good nature where the public sector will take a large role in their development. Those products released to date, with a few exceptions such as those Bt cotton events developed by the public sector in India and China, have been private sector developed product for producers in industrialized countries. The opportunity arose to diffuse these technologies to farmers in some developing countries with outcomes such as the ones we have described in our literature review (Smale et al. 2009). This was an incidental development.

What I am particularly concerned are the many public sector developed technologies by national research systems in developing countries and the international research community which are likely to address crops and traits of interest to farmers. Here I am talking about the Black Sigatoka resistant bananas in Uganda, the Bt cowpea, the Bt eggplant, viral resistant cassavas and sweet potatoes, water efficient maize and sorghum, biofortified products, and others documented in Atanassov et al. (2003) and for Latin America in Falck Zepeda, et al. (2009) and Trigo et al. (2010). The consequences of regulatory development to the public sector and the budding domestic private sector in developing countries are at the heart of my concerns.

The issue in my opinion is not whether we need to research and gain familiarity and knowledge about these issues. The matter at hand is deciding what to include within the boundaries of a regulatory process focused originally on environmental risk assessment and now expanded to other areas. As I have outlined there are other decisions to make in terms of scope, timing, implementation entity, decision making rules; which need a lot of discussion. There are decisions for countries to make, hopefully fully informed about all options, alternatives, and trade-offs involved in such decisions.

References:
Falck-Zepeda, Jose´ Benjamin; Falconi, Cesar; Sampaio-Amstalden, Maria José; Solleiro Rebolledo, José Luis; Trigo, Eduardo; Verástegui, Javier. 2009. La biotecnología agropecuaria en América Latina: Una visión cuantitativa. IFPRI Discussion Paper 860SP. Washington, D.C. International Food Policy Research Institute (IFPRI). http://www.ifpri.org/sites/default/files/publications/ifpridp00860sp.pdf


Trigo, E. J. Falck-Zepeda, and C. Falconi. 2010. Biotecnología Agropecuaria  para el Desarrollo en América Latina: Oportunidades y Retos. Documento de Trabajo LAC/01/10, Programa de Cooperación, FAO/Banco Interamericano de Desarrollo, Servicio para América Latina y el Caribe, División del Centro de Inversiones.

Atanassov, A., A. Bahieldin, J. Brink, M. Burachik, J. I. Cohen, V. Dhawan, R. V. Ebora, J. Falck-Zepeda, L. Herrera-Estrella, J. Komen, F. C. Low, E. Omaliko, B. Odhiambo, H. Quemada, Y. Peng, M. J. Sampaio, I. Sithole-Niang, A. Sittenfeld, M. Smale, Sutrisno, R. Valyasevi, Y. Zafar, and P. Zambrano. 2004. To Reach The Poor: Results from the ISNAR-IFPRI Next Harvest Study on Genetically Modified Crops, Public Research, and Policy Implications.” EPTD Discussion Paper 116. Washington, D.C.: International Food Policy Research Institute

ON BEHALF OF KOFFY DANTSEY

De: Koffi DANTSEY <koffidantsey@yahoo.fr>
Date: Mercredi 13 avril 2011, 20h43

First of all, I would like to thank CBD secretariat for allowing me to participe in the second round of discussion.

[...]

Transgenic cropping has produced transformation over environment and society.Migration from rural areas , concentration of agribusiness and loss of food diversity and food sovereignty are some of the consequences at socio-economic level (Pengue,2005).

Studies demonstred that in developing countries there are fears about loss of exports by adopting GM crops wich could affect organic production(Fransen, 2006, IAASTD,2008).

The positive socio-economic impact reported in the literature reviewed by Frasen refers to an increase in producer's income due to cost saving or increased yield. Also there are studies that reported different impacts from those espected from an agronomic point of view orfor both developed and developing countries.

At the level of case study the survey to 334 farmers in 6 communities in Cuba , Guatemala and Mexico in which farmers ranked 4 real and hypothetical maize variety for eating and sowing. The results showed that most farmers preferred varieties for farmer sowing and especially for eating , avoiding Transgenic cropvarietiesa preference associated with being risk averse and with non monetary preference.

The conclusion  is that recent studies in developing countries find positive or nagative ,  . So case by case study seems to be correct way to approach socio-economic considerations .

Dear Colleagues:

Thanks for this very interesting exchange. It is useful and enriching to read about so many different experiences and points of view. At this stage we would like to offer some comments, firstly in regards to the Argentine experience in this field:

In Argentina the main pillars of governmental decisions on the use of GM organisms of agricultural use are the environmental biosafey and food safety assessments, both “carried out in a scientifically sound and transparent manner” (CPB, Annex III, General Principles, 3.). In addition, as it has been mentioned earlier in this discussion, the regulation entails a third technical assessment, namely, that of the potential impacts derived from the commercial release of the GMO.

Initially, the scope of this analysis mostly covered the potential hampering of our international trade; such impact could be derived from what we would call today a situation of “asymmetric authorizations” with trade partners (particularly in regards to one crop and one main partner imposing an unjustified ban on GM products). This was and continues to be a relevant socio-economic issue for Argentina, as a great proportion of our economy relies on exports of primary agricultural commodities;

The international situation and domestic experience has evolved during the last decade and, therefore, the current administration has engaged in updating this practice. In connection with earlier questions in this forum, the most important features of the current practice are highlighted next:

-  The analysis is not focused on socioeconomic considerations necessarily arising of (hypothetical) impacts of GMOs on biodiversity, i.e. the kind of considerations mentioned in first paragraph of article 26. Actually, most of the potential issues considered in the analysis would arise straight from human factors (regulations, choices, etc.). Although some methodological or empirical aspects of the Argentine experience may be useful for the present exercise, it cannot be presented as a paradigm of that paragraph of the Protocol.

- The analysis is completely separated from the environmental biosafety and the food safety assessments. It has different goals, it is performed within the context of different disciplines in a different timeframe, it is reviewed by a dedicated staff and it is handled in a separate dossier.

- The scope of the analysis has recently been broadened to include consideration of both the potential negative and positive impacts along the production and commercialization chain. The benefits cannot be just “alleged”; the applicant has to provide its base information which sustains every benefit claim, in such a way that it can be critically analyzed by technical experts.

- Although the initial information is provided by the applicant, there are third governmental sources (e.g. on trade intelligence), and also the representatives of the production chain are gathered to provide other information and points of view, as well as to help in analyzing, validating and filling any gaps in that initial information package.

- The study is mainly economic but this concept does not restrict to profitability or net returns to farmers through monetary gains. The analysis has also covered other issues that have been mentioned earlier, like impacts on labor, food security, sustainability of production practices, public health, distributional aspects or intellectual property, as well as non-economic factors. For instance, a genetically pest-protected crop would likely reduce the farmer’s costs (and ultimately, the cost of food for the consumer, in Argentina and abroad), and this may be considered in the economic aspects. However, also the reduction in the use of chemical insecticides (and their broad negative effects on non-target organisms) is taken into account as a potential benefit of the technology for the environment and, potentially, public health.

- It must be clarified that potential “benefits” are not the leading criteria of the analysis, they are only considered as a weight of potential non-safety (e.g. commercial) partial pitfalls. It should not be required that a technology shows advantages over others before allowing it to be in the market. That would constitute discrimination between similar products (with potential WTO implications) and also an illegitimate intervention in the freedom to choose and try technologies that may help to meet the future demands of food and other agriproducts.

And now we would like to offer some additional considerations regarding the current debate in general:

- In no moment during this debate there has been any offering of sound reasons why genetic engineering should be selected, against others, for an ex-ante analysis influencing governmental authorization (as compared with conventional breeding). What would be the basis of applying such practice to genetic engineering and not to other plant improvement techniques like radiation-mutagenesis, or even others in agriculture like new watering systems or others in general like smarter cell phones? This aspect of the debate should not be given for granted; on the contrary, it should be the base of any further work on the subject. It also has great implications regarding the WTO issues already raised.

- Previously in this forum it has been offered an example of farmers that supposedly committed suicide because of debts contracted to buy GM seeds. We do not support that allegation since it has been rebated elsewhere but, hypothetically speaking, if farmers also contract debts to acquire watering systems… should we also submit that technology to ex-ante socio-economic assessments?? Similarly, for COP-MOP4, the Secretariat of the Protocol compiled an official reference document, and choose to make explicit reference to a ridiculous allegation linking the use of GM soy and a supposed increase of sex trade (derived from a single anonymous opinion, of a “local leader”, published in a non-peer reviewed article, whose author belongs to an organization with a clear ex-ante bias on this subject). Therefore, we pledge that the earlier proposals of developing quality standards for this kind of analysis are given priority.

- We also find quite regrettable interventions like those comparing these issues with the latest problems related to nuclear energy in Japan. Such tendentious comparison is not fair with the actual situation of genetic engineering, which is not inherently dangerous and whose hypothetical risks are less significant and easier to sort out by a biosafety assessment. In addition, such banal comparison actually seems disrespectful of the current unfortunate situation in that country. Therefore, we also pledge for remaining within the boundaries of an intellectually honest and thoughtful debate, avoiding rhetorical exaggerations in any trend.

Finally, we would like to congratulate organizers, donors and participants for adopting this format of electronic exchanges for dealing with this topic, thus reducing the ecological footprint associated with other Protocol intersessional works that demanded several ad hoc physical meetings.

Martin Lema: Ministry of Agriculture, Livestock and Fisheries and National University of Quilmes, Argentina.
Moises Burachik: Ministry of Agriculture, Livestock and Fisheries, Argentina.

Note: This contribution is offered in our personal capacity only; it does not necessarily constitute official information nor necessarily reflect the official position of any Argentine institution.-

To colleague Lema, the issue of why GE is subjected to scrutiny and other techniques are not was decided in Madrid in 1995 at a meeting under the CBD when the Parties agreed that it should be done and by means of an international protocol.

Also, the phrase "asynchronous approval" implies that both countries are going to approve the LMO but one is laggard.  In reality, the second country may never approve the LMO, so such a phrase is inherently inaccurate.  The Codex Alimentarius adopted a specific guidance for GE foods in this situation; it is available on the Codex website, and emphasizes that no country is obligated to accept an LMO just because another one has.  It also says that the procedures set out for risk assessment under the Codex should be employed in making the decision of whether to import.   The Codex, for those who don't follow it, allows for the consideration of "other legitimate factors" affecting the food trade and these are indicated in the Codex manual (and include socio-economic aspects, such as forbidding misleading representations of the food--eg, that GE food is the same as non-GE food without accurate testing to back up such a claim)

Dear all,

I would like to repeat contribution by Dr. Nina Vik where she acknowlegdes that Norway has implemented socioeconomic criteria in national legislation Norway. In the Norwegian Gene Technology Act of 1993 the national decision making process regarding deliberate release of LMOs is comprised of 5 criteria that must be considered before an eventual approval: 1) health risk; 2) environmental risk; 3) benefit to society; 4) contribution to sustainable development; and 5) ethical considerations. The Norwegian Regulations relating to impact assessment (IA) pursuant to the GeneTechnology Act (latest revision from 2005) includes all the five criteria mentioned above. Appendix 4 in the IA regulation contain guidelines/elements relevant for the assessment of the three criteria benefit to society, sustainable development and ethical considerations. The list of elements listed in Appendix 4 is not exhaustive and not all elements may be relevant in all cases.

Norway is at present working with further development of methods for assessing socio-economic impacts. For Norway one important challenge has been One of the major challenges regarding the national follow up of the criteria benefit to society, sustainability and ethics is the lack of relevant information in the LMO applications/notifications. As pointed out by Armin Spoek: The lack of socioeconomic information in the dossiers is a particular problem. It is neither possible to force applicants to provide such information nor to comment on such aspects in the EU authorization procedure because they are considered by EFSA to be out of scope. This may change, as pointed out by Andreas Heissenberger since the legislation gives the possibility to take "other legitimate factors" into account.

Moreover, as pointed out in several of the previous contribution in this online discussion is the lack of publications both on socio-economic impacts and on methods. Important aspects of SEC with regard to environmental and agricultural aspects can be identified in information required in RA, however RA is to limited to provide all information needed. There is a great need of development of methods. Such methodological framework needs to take into account:

1. Assement of the introduction of an LMO (ex ante), and that this assessment needs to be follow-up with experience of the introduced LMO (ex post). This will need definitions of factors to capture the ex ante and ex post SEC of cultivation of LMOS as well as deliberate relase of LMOs that are not plants. This will provide a learning process since it will involve both anticipation of SEC impacts and assessment of the actual impacts. This will also give feedback to the adequacy of the methods used.


2. A case-by case approach (with guidance as for ERA) since both the LMO in question and contexcual factors (environmental, agricultural and socio-economic) will have implications for SEC impacts and assessment methods.

3. There have been published studies from Mexico (see contribution from Michelle Chauvet), USA (see Benbrook and Jorge Fernandez-Cornejo et al.), South-Africa (Goouse et al.), as well as others that provide good examples of methodologies used. One important reflection from these studies is that they all provide different approaches. These studies also show that SEC need to be multidimensional. The critics posted in these discussions to some of these studies are also relevant as input to how previous methods can be further developed.

4. We are also aware of that there are reports provided by research institutes and NGO´s on SECs (both qualitative and/or quantitative empirical collections and assessment) that are available but not easy to find. We hope that the authors of these reports can in the future also aim for publishing these reports as scientific papers in journals so that they can be more easily found, discussed and hence also contribute so that SEC can also be a scientific field.

5. Previous reports on SEC also indicate that there are problems related to technology transfer to farmers growing LMOs (as experienced with problems related to co-existence, refugees, contamination etc) -Can such problems be considered as SEC? Moreover this gap in technology transfer also indicates that there may be difficult to assess actual experience with cultivation of LMOs.

6. One important challenge in assessment of SEC are also how to differentiate effects by cultivation of LMOs, by change in agriculture practise and effects by the transfer from small-scale -agriculture. How to acknowledge this complexity in SEC? (for instance it has been reported that LMOs causes migration from rural areas, concentration of agribusiness and loss of food diversity (Pengue,2005)).

I wasn’t able during the last week to follow this item and I appreciate a lot the experience with LMOs of all colleagues involved in this discussion. What I want to add is that if for GMOs we prefer a case by case approach than for each GMO we should adopt also a case by case approach for socio-economic consideration.
I would suggest that general principles and guidelines to be adopted at the global level but in the end such procedures development should rests on the Parties at their national level to further develop these measures in such a manner that it should not impede the implementation of art. 10 of the Protocol in close cooperation with other international instruments.
I strongly suggest that such socio-economic considerations should work synergic with those of the Rio Conventions and the Plant Treaty http://www.planttreaty.org/meetings/gb3_en.htm .

Dear participants,

As mentionned previously, I did not participate in this session of the "
socio-economic considerations on LMOs " online discussion because not
being an expert in such studies and methods, and being moreover
unavailable this last week.

I went rapidly through the various messages posted this week. I
sincerely thank the participants for these interesting and well
documented postings.

I notice and approve, as already announced in the previous discussion
session, that socio-economic studies on the impacts of LMOs should be
multidisciplanary taking into account the complexity of the issues to
tackle; as such, for ex., obviously not only methods for economical
studies but also anthropological methods should be used to touch some of
the worthwile socio-economic aspects .

As well ex ante as ex post assessments were again mentionned in this
session, leaning of course respectively on different methods and able to
answer different questions.
And whereas ex post studies are supposed to be based on more real data,
their time-scale is till now very short and can thus give information
only mainly on short-term impacts, moreover somewhat biased by the
nature of the participant stakholders. 
Facing such uncertainties, "evidence-based" information should thus not
be neglected, as notice some participants, and in this context
discussions/meetings/fora confronting various experimented stakeholders
could be part of the socio-economic assessment.

Obviously, like for the information brought by the biosafety risk
assessment, ex ante "scientific" socio-economic studies could bring part
but not all of the information needed to take advisedly decisions for
authorizations or refusal or management of risks of LMOs; all possible
risks, taking into account protection goals, should be considered; but
methodological limits could restrain part of the investigations.
Decisions should thus be taken as a responsability of the political
decidors, weighing the various certainties, uncertainties, taking into
acount the precautionary principle, and foreseeing, in the case of
authorizations, serious monitoring systems aimed at an early detection
and allowing then the prevention of extension of unforeseen or possible
adverse impacts. Ex post socio-economic assessment could be considered
as the equivalent of post-marketing monitoring for biosafety. 

The precise elements to consider as socio-economic impacts could indeed
be different in different countries and parts of the world. But it seems
to me that a generic list of elements to consider could be established,
the details and importance of which being indeed potentially different
in different countries.

The topics of the 1st and 2nd sessions of discussions on socio-economic
considerations have been partly mixed in the course of the discussions.
I hope that the Secretariat will take this into account and will, when
making a synthesis of the discussions, pick up in the 2 sessions the
relevant comments linked to the specific issues.

With best regards.

Lucette Flandroy




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

Dear all,



Many thanks again for very interesting comments. First of all, we would like
to share some concerns on the discussion of the experience gained with
methods for assessing SE impacts. In general terms, we perceive the tendency
of:



-       Qualifying the proper assessment of SE issues related to LMOs as a
factor for complicating the biosafety regulation processes and specifically
delaying approvals. To us this is approach for analyzing SE issues is not
appropriate and value-laden. The introduction of technologies into the
environment and societies with multiple impacts (either beneficial or
adverse) require regulatory processes and multidisciplinary assessments that
try to capture the complexity of the dynamics that such technologies
trigger. In this sense, the main point of identifying the proper
methodologies to assess impacts (SE in this case), should not be if
countries are re: “prepared to delay approvals” of LMOs but it they are
prepared to deal with the potential adverse effects and bare the potential
environmental and socioeconomic cost. This is the basis of a socially and
environmentally responsible policy making, in our view.



-       Amount vs. quality of the information needed for decision-making.  A
Party or a country applying precautionary approaches in its decision-making
process does not (or should not) mean re: “deciding how much information
needs to be gathered in order to make a regulatory decision”; but deciding
on the quality of the information available based on its protection goals.
Here we would like to stress that precautionary approaches is not about
asking for more and an unfeasible amount of information, since more
information do not necessarily imply the reduction of uncertainty but
sometimes increase of the number of un-answered questions on the
environmental and social safety of certain technologies (e.g. LMOs).
Implementation of precautionary approaches is up to Parties / countries
according to their sovereign right to: i) set their priorities and
protection goals; and ii) apply precautionary measures if there is lack of
certainty or relevant information.



-       Discussion on methods for assessing impacts of LMOs will benefit
from putting aside misleading issues. To us, are of special concern: i) the
focus on monetary evaluations to assess what is beneficial to society. Using
the example on GM potato in Bolivia shared in other discussion thread, the
cultural value of the local varieties of potato cannot be assessed in
monetary terms for three main reasons. First, the intrinsic value of
biodiversity. Second, methodological limitations. Third, the limitations of
external assessors to understand and value the habits and customary uses of
local biodiversity and their relevance for the local livelihood. Following
on our concerns on monetary assessments, another pitfall that we see is the
strong focus of making monetary valuation of activities that usually do not
imply a monetary transaction, such as peasant or indigenous agricultural
labor. ii) Interpretation of precautionary approaches as approaches aiming
to zero risk in technology development and introduction. In our view, such
an interpretation is misleading and technically incorrect. Minimizing,
preventing or avoiding adverse effects, is not synonymous of “zero risk”.
iii) Over emphasis on selective and optimistic interpretation of results of
economic assessments carried out in specific conditions, which are used to
draw on general conclusions. Under the Bolivian view, this is an
inappropriate interpretation of specific findings that may lead to
inappropriate policy and decision-making.



Based on the previous concerns, taking into account the impacts seen at
national level, considering the existing information on impacts in our
neighboring countries, and the analysis of the experience gained in methods
for SE impacts of LMOs, our suggestion for improving the current SE impacts
of LMOs are to:



-       Make efforts to include the environmental and social externalities
of LMO introductions, with particular emphasis in centers of origin and
genetic diversification. This is very important to have a more comprehensive
understanding of potential SE impacts in the medium and long term, and will
require a multi and transdisciplinary assessment.



-       Link to the previous, to include in the SE assessments the
contextual factors where LMOs are introduced. This would imply, inter alia:



o   The characterization of the profile of adopters and non-adopters of
LMOs, including their access to production and financial resources,
commercial orientation (e.g. market oriented or subsistence), livelihood
strategy, etc. This would be very useful to identify the potential impacts
(either beneficial or adverse) and make a broader analysis in relation to
sustainability (e.g. to which extent the different adopters of LMOs are
capable of baring the downside risks?).



o   The social and economic factors that shape adopters and non-adopters
decisions.



o   Customary uses and practices of existing technologies that LMOs intend
to replace.



o   Characterization of existing and potential alternatives.



o   Characteristics of the most disadvantage or vulnerable groups that might
be impacted by the LMO introduction.



Thanks and regards to all,



Georgina Catacora-V.

Let me reiterate the set of principles by which I and my organization work.

1) Respect for countries’ sovereign rights
2) Acknowledge and support countries’ rights to full information including alternatives, costs, benefits, risks and tradeoffs for policy and decision making processes.
3) Need to generate, compile and collect data and to implement evidence based analysis that inform countries

Based on these principles I have outlined in the online discussion threads hosted by the CBD Secretariat, a set of issues, alternatives/options and potential consequences to the potential inclusion of socio-economic considerations into biosafety assessment and/or decision making.I hope that countries weigh all of these components into their own decision making processes. 

In my opinion it is prudent for countries to start from the very basic question of why do they want to include socio-economics and then answer the question what will be gained by including socio-economic considerations?. Answering these questions is extremely important as it will provide the basis by which countries decide on implementation, even if done after the decision has been made.

Furthermore, I would encourage countries to not only think about regulatory framework development and/or laws or policies drafting, but simultaneously think about implementation. The more independent socio-economic assessors are involved in developing implementing  regulations the better the outcome, as  true experts and practitioners will be able to pinpoint issues and implementation limitations before obtaining a final document that will be difficult to modify later on.

I would encourage regulators and decision makers to get them involved in these discussions in order to understand issues presented by socio-economic assessors and other stakeholders. 

I am making the following specific comments raised in this thread.

1) I do not follow the argument that the inclusion of socio-economics does not lead to a more complex regulatory systems when compared to those that do not include socio-economics or those that include a relatively simple economic assessment.

I fail to see the situation in a decision making process, where the addition of more elements to the assessments such as:
- Addition of complex issues that are not measurable by outside assessors
- Addition of a set of additional complex issues may require multi-disciplinary collaborations for the assessment
- Overcoming those situations where perhaps it may not be appropriate to use a monetary valued metrics. What are the alternatives and how will they be used in practice?
- Use outcomes from an assessment approach(economics) which may be difficult to directly compare with other assessment approaches (cultural values)to support a regulatory decision.
- Overcoming those situations where existing assessment methods may be inadequate to examine more complex situations. This usually implies using state of the art and innovative assessment methods which tend to be more complex and data intensive, but not always.

does not lead to a more complex assessment and/or decision making process. This certainly enters into a conflict with my assessment experience and perhaps logic.

Those of us who have conducted social and/or economic assessments of LMOs are cognizant -and have recognized in this and other forums- that the research, development, deployment and use of these crops by farmers including smallholder farmers, is quite complex in itself. The reality of LMOs complexity is not that different than any other technology in the history of humanity. The issue here is deciding within the scope of a regulatory decision making process, how complex the assessment approaches needs to be in order to allow the competent authority making a regulatory decision. If the objective is to examine technology adoption in detail,the sky is the limit for our imagination.

Obviously, if a country's decision is that it rather have an exhaustive socio-economic assessment that will study and explore all potential consequences from potential adoption, then this is a decision that is of course a right of all countries, but one which does have consequences from inclusion of such alternative.

2) Quantity vs. quality of information: Certainly information quality is a critical in the decision making process. That is why in other threads I have proposed the need for including in the discussion the issue of determining the standards and decision making rules for evidence quality, sufficiency and effectiveness, which includes prominently scientific peer review.

In fact, since most regulatory systems are learning processes, as regulators and decision makers gain experience and knowledge over time, there is a “natural” progression to requesting and receiving better quality information as the regulatory systems focuses on more critical concerns and discard those that are not.

The issue is not determining the quantity of information, rather the issues is how much and what information is necessary and feasible to come up within a biosafety regulatory decision.  One cannot have open ended processes in the sense that there is no regulatory triggers nor decision making standards as this will likely lead to an unworkable system that will be unable to render a decision or one which will likely reject applications or postpone decisions in definitively.

Certainly, questions may arise as technologies are being assessed under containment, confinement, field trials and during commercial release. This is the nature of technology development and adoption, the question is then how much risk and/or uncertainties are we as society willing to endure to gain access to potentially beneficial technologies when deployed.

3) Application of the precautionary principle does not imply asking for zero risk. It is worthwhile clarifying that I presented the limiting approach of those relatively few groups that push for zero risk.

Let me explain. There are several definitions of the precautionary principle ranging from the “weak” definition contained in the Rio Declaration to the “strong” definition as that of the Wingspread Declaration. There are even more interpretations of what those definitions mean in practice.

There have been some groups that have interpreted the precautionary principle as implying a stance of demanding zero risk. The later view has been categorically rejected by most scholars and assessment practitioners (ranging from Sunstein, Marchant to Kysar) as this interpretation is illogical, impractical and un-implementable unless the objective is of course not to release new technologies.

4) The conceptual framework outlined by Georgina Catarova clearly outlines the many issues and difficulties for implementation that countries will need to address if they have already put such framework as a mandate waiting for the implementation procedures to be drawn. Let me point out some of these issues:

a) Need for clear and consistent definitions. What does sustainability, livelihoods, impacts, downside risk (production, finance or minimal production to ensure survival), benefits, most vulnerable groups, replacement of other production methods; mean in practice? How will assessors deal with these definitions? As these definitions may differ between countries, they will have to be codified in national laws and regulations.

b) Need to address a decision making process that will incorporate results from different assessment paradigms, noting that inter alia, the proposed conceptual framework incorporates economic, social, cultural and religious issues for consideration.

c) Since many of the issues may be contextualized to local indigenous communities, how are the issues of balancing protection of one group against the potential gains of another group addressed in practice?

d) Need to address issues which are not even measurable by outside assessors, issues that may not be measurable via monetary value or a common metric to other paradigms, issues that may be subjective or subject to different interpretations pending on the observer or the observed.

e) Need to define the conditions under which a study may be described as done in a specific context and those applying to a more general context. Here I am talking for example about describing the factors that may describe a specific stratified random sample study as representative of a region or country in the analysis. Of course we know that the only sure way to know what is the general context is to sample each and every individual in the population. As this is not necessary due to improvements in sampling techniques and is obviously expensive, then it is not usually done in practice.
  
Other example may be under which conditions one can (judiciously) use data and results from similar agro-ecological situated studies to the one being conducted in a current study.  In many cases, if there is no data available to conduct an analysis as there is no experience in country, this may be one of the only practical choices available.

f) Most importantly, the need exist to clearly define how this conceptual framework will be implemented in practice udner the purview of the biosafety national competent authority and/or decision making body in terms of socio-economic assessments especially for intentional release for commercialization.

Whether these issues can be assessed in a robust and scientifically defensible manner that will maintain the desirable characteristics of a working biosafety system described by Greg Jaffe including transparency, proportionate response, protectiveness, feasibility and so on, especially when there is nothing to measure in the field as the product has not been released, is still a debatable point.

In the end, and after making a decision for inclusion, the more countries discuss the many complex issues and implications from inclusion of socio-economic considerations,the more likely that they realize that they will require clear decision making rules and standards for implementation.

I explicitly include in my discussion the issue of those cost/benefits that cannot always be valued using monetary values. In those situations, some jurisdictions have allowed the use of qualitative assessments in cost/benefit analysis which moves such approach closer to a multi-attribute assessment and multi-criteria decision making processes, which may be acceptable to broader set of stakeholders.

My point here is that these issues need to be defined and agreed upon in advance so that all stakeholders are clear about what will be done in an socio-economic assessments and what the outcomes of such assessments truly say about the observed phenomena.

There is a relationship between issue of socio-economic considerations inclusion and opportunities and experience gained by countries in decision making and implementation.This will include active participation of assessors like socio-economic experts from various sectors, universities,research institutes government institutions,NGOs and other competent stakeholders in strategies and action plans elaboration.
The question is what guidance materials are available for issues( cost/ benefit) that value may not be measurable .

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 seven 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