Forum discussions

The guiding question for theme 1 is “What are the socio-economic considerations that Parties may take into account in the context of Article 26 of the Biosafety Protocol?”

Good morning, Kathryn!

let me start with a short reflection about the long and complicated way which finally led to the inclusion of Art. 26 in the CPB. Those who are interested in reading more about the controversies between industrialised countries, especially those developing and growing GM crops, and developing countries, should have a view at chapter 39 of Bail et al. 2002 (The Cartagena Protocol on Biosafety), written by Rajen Habib Khwaja and the chapter on Art. 26 of SCBD 2003 (A record of the negotiations). I try to upload both chapters to the document section.

The approach of Art. 26 builds on two main pillars.

First, the CPB acknowledges that Parties to the CPB "may take into account ... socio-economic considerations arising from the impact of living modified organisms on the conservation and sustainable use of biological diversity". If and how this is done is left to the respective biosafety regulations of each Party. The CPB does not set international minimal standards with regard to the conduct of such assessments. As far as I know, there are several regulative frameworks with provisions on SEC, but only few cases where these provisions have actually been used in decision making. This online discussion could be a good place to list and discuss examples where SEC have been taken into account. Such a discussion could also be useful to elaborate on the capacity building needs in the context of SEC.

Second, Art. 26 contains three qualifiers.

The assessment of SEC needs to be
- "consistent with their international obligations"
(there is a second thread to discuss this topic)

The assessment needs to deal with the effects
- "on the conservation and sustainable use of biological diversity"
This addition has been introduced to limit the scope of Art.26 to the scope of the CBD and not to include classical micro- or macro-level economic analyses.

The assessment needs to specifically consider the specific value that biological diversity plays for ILC
- "especially with regard to the value of biological diversity to indigenous and local communities"
From the wording of Art.26 it is clear that the assessment can also consider the value of biodiversity for all other groups in a country.

In the context of capacity building it will be of specific interest to discuss whether Art. 26 restricts the rights of Parties to consider SEC for aspects beyond the limitations of Art. 26. In this context it is interesting to note that a major part of existing SEC literatur concentrates on these areas beyond the scope of Art.26, namely economic farm level effects or general trade issues. Only few studies so far follow the exact wording of Art.26.

With regard to research and information exchange, the CBP does not contain any limitations with regard to the scope of the socio-economic impacts.
"The Parties are encouraged to cooperate on research and information exchange on any socio-economic impacts of living modified organisms, especially on indigenous and local communities."

I also post the chapter on Art.26 of the IUCN Explanatory Guide to the CPB that sheds some light on the state of the discussion between the adoption and entry into force of the CPB.

Good morning Dr Hartmut
Many thanks for your important contribution in guidance materrials and suggestions particularly the controversies between the industrialised countries and the developing countries where appropriate technologies for LMOs risk assessment are not avaiable.I  agree that capacity building needs in the context df SEC must take into account the international obligations of parties.
In most of developing countries biological resources are the basic of all production systems particularly for local communities. In this context the impact of SEC on the conservation and sustainable use of biodiversity must be taking into account to list the priorities needs of countries.

Thank you very much Dr. Meyer for dis-aggregating Article 26.1 and for highlighting important components relevant to this theme. This is quite an important issue because there are many misconceptions about the applicability of Article 26.1 in different venues. The most relevant being the (erroneous) assumptions that inclusion of socio-economic considerations is actually mandated by the CPB and that it mandates broader considerations beyond impact on biodiversity.

I believe that it is important to point out that even though application of Article 26.1 is voluntary -and as other articles in the CPB it is not self-effecting- many countries have already gone beyond the scope delineated by Article 26.1 either by including additional requirements in national biosafety frameworks, laws, regulations and/or administrative orders.

If countries have made the decision to either follow a literal interpretation of Article 26.1 or will pursue a broader interpretation of Article 26.1; then it is critical to understand the implications and impacts of such requirements and to address issues surrounding implementation as soon as possible.

I attached to this message a paper published in AgBioForum were I describe issues relevant to Article 26.1 in more detail, provide a list of some countries and their approaches. I also include a paper presented at the World Congress of Environmental and Resource Economics in 2010, where my co-authors Justus Wesseler and Stuart Smyth and I, enter into greater detail on how  countries have interpreted Article 26.1 by examining their existing legislation and other law instruments.

My name is Mihaela Antofie and I was officially working for biosafety couples of years for Romania (2004-2009). Today I am working in University Lucian Blaga from Sibiu Romania.
First I congratulate you for taking the lead in further developing Cartagena Protocol on Biosafety to the Convention on Biological Diversity.
According to my opinion we have also refer to the ITPGRFA or Plant Treaty (in force since 2006) and other instruments signed under FAO (for animal) which are targeting the conservation of genetic resources. Conservation means also protection and sustainable use. It is important to have biotechnology but to the same extent it is important to preserve old genetic resources especially for their adaptive capacity to the environment and their cultural connotations to local communities or ILC. We need to explore for example wild corps relatives for their adaptive capacity to the environment and furthermore to the food diversity development. Socio-economic consideration encompasses also values coming from local communities and indigenous local communities such as traditional knowledge (art 8 j of the CBD) and also cultural values of communities relying on their own forces to survive based on their own saved seeds. Society needs to find balance between expensive ex situ conservation (gene banks) and less expensive in situ conservation or on farm conservation for preserving the development of adaptive capacity to the environmental factors of a specific genetic resource – essential for a local community (maintaining know-how and developing local needs through added values for different reasons).
Unfortunately at the international level for farmers rights no legally binding instruments are in place for the Parties. I also propose to fallow for discussions the road map adopted during the Hague Conference in October last year on Agriculture, Food Security and Climate Change
http://beta.searca.org/kc3/index.php/news/global/99-agriculture-food-security-and-climate-change-conference-produces-roadmap-for-action
Food problems become more complicate when we are taking into account climate change considerations, agro-ecosystems vulnerability to climate change and crops vulnerability not to temperature but rather to pedological factors (soil quality).
Depends on what we want for the future: a boring full control over the food or developing new innovative financial services for supporting socio-economic considerations into a landscape approach which includes local communities’ values preservation and new biotechnology results promotion and balanced integration and acceptance in a fast moving world.

Dear Doctor Meyer,

Thank you for the first and puzzling message you posted to initiate these discussions.

When looking at the text of Article 26 of the Protocol, there seems indeed to be some discrepancy between part 1 and part 2 of this Article and thus some question can be raised concerning the scope of socio-economic impacts that could be taken into account.
This discrepancy between the 2 paragraphs can indeed derive from the long and hard history that was needed to reach an agreement on a text in the Protocol on this issue, resulting from the rather divergent views of developing and developped countries on this issue, well reflected in the articles you joined to your message.

But the resulting text indeed a priori looks somewhat inconsistent. Indeed, what would be the meaning and purpose of cooperation and capacity building efforts for research in all kind of socio-economic impacts ( cf. Article 26 § 2) if only some particular kind of impacts may be taken into account in decisions ( cf. Article 26 § 1) ? 

About that, it seems clear from the text of the Art. 26 1. that only socio-economic considerations arising from the impacts of LMOs on the conservation and sustainable use of biological diversity could be "covered" by the Protocol in decisions on imports. 
Whereas the preamble of the Protocol recognizes that " trade and environment agreements should be mutually supportive .... " , the objective of the Protocol ( Art. 1 ) is focused on protection of biodiversity ( including human health ). The capacity-building cooperation efforts should also be primarily dedicated to the strenghtening of capacities in biosafety( cf. Art. 22 ) , thus on protection of biodiversity ( and human health ), and by extension, eventually, to socio-economic studies related to impacts on biodiversity ( ? and health ) .
But this does not impair Parties to cooperate moreover on research and information exchange on other socio-economic aspects ( However, even in this case, Art. 26 § 2 insists especially on the impacts on indigenous and local communities ).

There are indeed till now few socio-economic studies concentrating on the aspects tackled by article 26 § 1 . One of the reasons probably is that these are not the most easy and short-term socio-economic studies that can be done relatively to the impacts of LMOs. As the question of the economic value of biodiversity and ecosystems however is an issue taking a transversal importance in the CBD, methodologies for such studies are developping and the possibility of such studies in the context of the Protocol could also be enhanced in the future. Let us hope that experts in those fields will intervene during these discussions.   

Best regards.

Lucette Flandroy


GMOs & Biosafety expert - National focal Point for the Cartagena Protocol
Federal public Service Health, Food Chain Safety and Environment
1060 Brussels - BELGIUM 






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

Good morning/afternoon/night to everybody,

Let me introduce myself. My name is Jose Falck-Zepeda. I am a Research Fellow at the International Food Policy Research Institute (IFPRI). I have been working with the economic, social and institutional assessments of agricultural biotechnologies, Living Modified Organisms and more conventional agricultural research and development activities such as classical plant breeding since 1991.

I have conducted -or have provided technical backstopping- economic impact studies of these technologies in the U.S., Mexico, Uganda, Ghana, Honduras, Bolivia, Colombia, Philippines and at the regional level in West Africa and the COMESA region. We at IFPRI are now conducting studies examining the potential introduction of insect protected cotton in Kenya and Malawi, as well as, examining the relationship between gender and LMOs adoption and use in Burkina Faso and the Philippines. I have published extensively not only on economic impact methods and studies in different venues, but also on the relationship between economic assessment and Article 26 of the CPB.

I am looking forward to this discussion and will contribute with additional resources as time goes by.

Kind regards,
Jose Falck-Zepeda
Research Fellow
IFPRI
2033 K Street NW
Washington, DC 20006-1002
USA
email: j.falck-zepeda@ccgiar.org
IFPRI personal data site: http://www.ifpri.org/staffprofile/jose-falck-zepeda
List of publications and bio:http://josefalckzepeda.pbworks.com/w/page/9007235/FrontPage
Skype: josefalck

Posted on behalf of Marie Ramanantenasoa:

Regarding socio-economic considerations , I think that before all trade of GMO or derived products of GMO on national territory, a study of impacts of ethical order and socio economic on the local population must be made by National competent  Authority in collaboration of concerned administrations.
And so, this study must include specifically the effects on: traditional market and the advantages of the exportator, health, production systems, ethical, moral and social considerations, real economic value of traditional species ...
This study is made after of delivery of environmental autorisation.

We do need to deepen the discussion on the content of Article 26.1 before we can define issues for inclusion. There are several questions that may impact the portfolio of issues that may be considered in national and regional legislation, even when one follows a literal interpretation of Article 26 of the CPB.

Questions and issues such as:
1) Definition of biodiversity. Which biodiversity are we talking about? That directly impacted the adoption of an LMO? Agricultural biodiversity? Intra and/or inter-specific biodiversity?
2) Which local communities and indigenous communities? Those close to cultivation sites? Or can anybody in those two groups can included in an evaluation. How do you measure value and impact?
3) How do you come up with a decision making standard and rules that balances value of biodiversity with potential gains from the introduction of a technology? Does one consider both potential benefits and risks into consideration?

Article 26 part 1 does leave the option to countries of including (perhaps broader) socio-economic considerations in their decision making.  In fact, many countries have at least indicated that they plan on including such considerations in proposes polices, acts, laws and regulations. As I shown in a couple of papers, there is very little guidance in terms of if, what, how and when to include socio-economic considerations.

However, once the decision has been made of including (broader) socio-economic considerations in the decision-making process to approve LMOs for deliberate release, then one needs to carefully consider implementation issues while designing such regulatory frameworks. If this is not done, then one runs the risk of ending with a regulatory framework that may be unworkable of unfeasible in practice.

Let me suggest that these discussions and those that will likely arise at the CPB and in regional and national forums need to start by discussing the fundamental question: Why do we want to include socio-economic considerations in biosafety decision making? Once this question has been answered in a comprehensive manner and further validated by the public, and the decision has been made whether to include socio-economic considerations, then the discussion can fruitfully proceed to defining such issues as scope and content, methods and decision making standards.

I may also suggest that these discussions need to be evaluated within an evaluation framework that considers whether suggested regulatory procedures such as the inclusion of socio-economic considerations are scientifically robust, feasible, transparent, lead to a predictable regulatory process, and whether such procedures are protective and flexible.

Regardless of the scope (i.e. biodiversity vs. broader socio-economic assessments), most regulatory processes -meaning approval for deliberate release or importation for food/feed and processing- will deal with ex ante assessments These are assessments done without direct observations as there is no product in the field, thus these assessments are based on projections and/or estimates of different kinds. This fact, limits the potential methods and approaches for assessing impact. If we are discussing post-release monitoring then this is covered by conventional socio-economic impact assessment approaches which there is a fairly robust experience.

I like to mention that this discussion forum has been set up in the context of a decision by the members of the CPB at MOP-5. The mandate focusses on "capacity-building needs for research and information exchange on socio-economic considerations", please read more at http://www.cbd.int/decision/mop/?id=12316, para 21-31.

While the experience with the discussions on SEC in the context of the CPB has shown that it is inevitable to discuss the issues as such, we are finally not requested to develop methodologies and regulatory systems by ourselves but to support the members of the CPB in advancing the discussion in these fields through eg. capacity building measures that are oriented along the needs of governments and stakeholders.

One very useful document produced as a first step in our discussion is the SUMMARY REPORT ON THE SURVEY ON THE APPLICATION OF AND EXPERIENCE IN THE USE OF SOCIO-ECONOMIC CONSIDERATIONS IN DECISION MAKING ON LIVING MODIFIED ORGANISMS (attached)

This survey in my opinion gives the so-far best available overview about expectations and needs of many experts and stakeholders in the filed. It can also show the width of possible areas that could be covered by SEC.

As we know and can read in the publications eg. posted by Jose Falck Zepeda many countries have included provisions on SEC in their biosafety regulations. In order to develop targeted capacity building measures it would be necessary to have an overview about the provisions in the NBFs and regulations. For example to be informed about the scope and legal nature of SEC (eg. binding or not-binding outcome), suggested methodologies (if any), or the positioning of SEC in the decision-making process (eg. linked to or independent from risk assessment).

Finally our approach should not be to discuss if and how WE want to include SEC in decision making procedures but to examine what requirements, needs and questions members of the CPB have.

The above mentioned survey provides some insight, for example when comparing the most important socio-economic issues and differentiating between
A) respondents whose countries have an LMO decision-making system that includes socio-economic considerations versus
B) respondents whose countries do not have such a system or who do not know whether their countries have such a system:
A) <---> B)
1 Food security <---> Health-related impacts
2 Health-related impacts <---> Compliance with biosafety measures
3 Coexistence of LMOs <---> Food security
4 Impacts on market access <---> Coexistence of LMOs
5 Compliance with biosafety measures <---> Impacts on biodiversity
6 Impacts on biodiversity <---> Indigenous communities
7 Economic impacts of changes in pest prevalence <---> Macroeconomic impacts
8 Macroeconomic impacts <---> Impacts on market access
9 Farmers’ rights <---> Use of pesticides and herbicides
10 IPRs <---> Economic impacts of changes in pest prevalence
(according to Method I: ranking system)

I hope that in the course of the next months we will receive more input by the members of the CPB themselves.

Dear Dr. Meyer,

I quite agree that the supra goal of this forum and these discussions is equipping countries in making decisions regarding the implementation of Article 26.1. Be it countries' pursuing a literal interpretation or as the same article allows countries' pursuance of a broader scope in their national legislation.

With this intent, I propose here that we cannot disassociate the discussion in this forum from presenting all the regulatory and implementation options and its consequences to countries parties to the CPB. Thus, making countries aware of these options can make the decision making process an informed one. Countries need to know about options for the potential implementation of Article 26.1 such as:

1) voluntary versus mandatory versus optional approaches
2) Deciding at what stage of the regulatory process to perform such analysis
3) Focus on a narrow versus a broader interpretation of Article 26.1 versus a specific application/scope of economic analysis (i.e. impact on trade as is done in Argentina)
4) Requiring such assessment only for new events or for all applications
5) Requirements for regulatory processes such as decision making standards and rules
6) Requiring socio-economic assessments before approval for deliberate release vs. after approval (post-release monitoring) vs. requiring such assessments for both

Note that these options are all interconnected as one decision has an impact on the others. I have already mentioned, for example, that the issues connect directly to the methods and to the approaches.

Perhaps the best way to approach the decision making process is to develop a decision tree starting from the discussion on why a specific country wants to include socio-economic considerations and then move on to discussions about regulatory design and implementation in an integrated manner. Otherwise, countries may endure the risk of developing a regulatory/legal framework that is not implementable in practice.

In the specific context of capacity building/strengthening, it is important for implementing capacity building/strengthening activities; to clearly define these issues so that the regulatory pathway is in the end well defined, transparent, predictable and protective; so that all actors know what to do and how things will be done.

Those of us who have conducted such capacity building activities for practitioners, regulators and/or decision makers know this because there are too many permutations in a broader and not-well defined decision making tree and becomes an unmanageable exercise that becomes too complex too fast for it to be useful in building effective and enabling capacity.

I come at this issue as an international political economist interested in the public policy processes that seek to normalize science for use in international regulation. I have worked on the introduction of GM traits in canola and wheat and done some work on ABS and TK policy. From my perspective Art 26 poses more questions than answers.

It seems this round of discussion already has tripped over at least three main issues.


1.       What is included in SEC? Already the range of perspectives that might be addressed is becoming clearer.  The ELSI/ELSA/GE3LS perspectives many scholars in the US, EU and Canada use offer one place to start:



a.       Economic impact:  Cost-benefit or impact evaluation (probably ex ante), which could identify both the aggregate and disaggregated impacts of a technology on the economic prospects of both the demand and supply side of the market; defining the scale and scope of what is included or excluded, and what methods one might use to estimate the effects on the market, have some generally accepted approaches (e.g. Alston, Pardey and Norton, 1995, Science under Scarcity) but there are a wide range of practices that yield widely different results.

b.      Consumer acceptance:  As we have found in recent years, the results often depend on the questions asked and methods used.  We have seen widely divergent measures of consumer valuation/acceptance for a number of organic and GM crops in recent years, which suggests there is more art than science to some of this work.   What numbers you get from this are critical to any cost-benefit analysis.

c.       Market acceptance:  Having done some work on this in the context of GM canola and wheat, it seems this is an area of both solid empirics and highly politicized strategic game playing.  So there is unlikely to be any clear objective measure of acceptance-competing developers, farmers, commodity groups, various actors in the supply chain, NGOs and governments, among others, all have an interest in gaming the system at times to gain strategic advantage.

d.      Ethics and morality:  There are a range of principles (e.g. the economic principles of Pareto optimality, modified by the Kaldor Hicks principle) and perspectives (common law, philosophical and  secular) that make this an area of divergence rather than convergence.  From my experience there are few bridges between these yet or any agreement on which moral or ethical approach is appropriate.

e.      Social aspects: Having worked on the NAFTA Ch 13 investigation on Bt Corn in Mexican maize landraces, I am fully aware that how one defines social groups, which set of tools or methods one chooses to investigate them and how one engages social actors in the analysis can either focus decision making or compound the diversity of views and perspectives.

f.        The legal aspects: The divergence between common law, civil code and theocratic systems, operating in the context of various international institutions and regimes (e.g. WTO, CPB, Codex, IPPC, OIE, the IP treaties via WIPO ...) at times can lead to conflicting views about the legal import of the same fundamental event.

g.       The environmental effects:  While not a natural scientist, I have been engaged in a range of processes in Canada that have sought to unpack the alternatives for environmental impact evaluation.  The current narrow, comparative model used for new novel trait plants (e.g. GMOs) can and does work for many introductions, but that approach is often criticized as ignoring cumulative or systemic effects that can occur with widespread adoption or multi-generational evolution/stacking of technologies.  The range of analytical approaches to examine the environmental effect is increasing, with recent efforts to develop life-cycle analysis and to quantify environmental services.

h.      Property and ownership:  At root, much of the concern relates to ownership, control and distribution of benefits, which has both a practical effect and a normative set of underlying principles. Much of this debate in practice has assumed the counterfactual to the WIPO based patent/PBR/TM/copyright system is the creative commons.  History suggests that in fact the counterfactual was not open-source or common pool knowledge but highly private trade secrets.  Depending on the counterfactual one takes for an analysis, one would normally get differing conclusions.

In short, there is a long laundry list of questions, concerns and perspectives one might envisage would be included in SEC. The fundamental challenge will be to find some central tendency and create accepted questions and methods that will deliver predictable and transparent decisions.



2.       How can we normalize the methods and approaches to improve transparency of the SEC methods? Jose has done a good job of introducing this.  History shows a range of approaches, including:



a.       Litigation: I am not sure whether one could take comfort in this, but the SPS and TBT agreements in the WTO suffer from the same lack of precision on how to deal with divergent opinions.  They have used dispute settlement/litigation to define the rules. So we could wait for disputes and see what case law creates (the NAFTA corn case offers some insights into how this might work). This could be messy and some argue the uncertainty would discourage private investment in many areas of agrifood research.

b.      Professional and scholarly standardization of knowledge and methods: peer associations, professional bodies, royal societies and national academies of science have done significant work along this line (e.g. NAS, EU, FAO/WHO expert panels and eminent persons groups)

c.       Intergovernmental negotiation of principles and rules (e.g. via IPPC, OIE, Codex and the OECD consensus documents)

d.      Industry leadership via standards:  At times individual firms or sectors have taken the lead and developed the norms that reduce uncertainty; these norms can then either be incorporated into rules through the intergovernmental approaches or via private standards (e.g. ISO, HACCP).



3.       How should SEC matters be adjudicated?  (I am not sure this is part of the first round of discussions, but I am recording it here so I don't lose my thoughts).  In many ways, what we need is going to be determined by what methods of adjudication we establish/accept.



a.       One suggestion is that, as implied by the Art 26, it be a bottom-up process.  The difficulty, is that there is no coherent answer to the question of what are we trying to achieve.  The policy literature does a good job of reminding us that what we seek to achieve will often determine the methods used.  I suspect people have a range of perspectives about what is wanted, and by implication, how one should choose. Governments justify decisions based on a variety of bases, including procedurally (e.g. due process, transparency, fairness..), majority rule, utility (e.g. cost benefit) or common/shared values.   Each of these would tend to draw on different evidence, use different methods  and deliver different results, which could be tricky.  Normalizing SEC would be a long, drawn out process under this approach.

b.      An alternate approach is to follow a principles based approach. One minimalist approach (in the line with WTO practice) is that we could seek to construct a framework for Art 26.2 that would conform to the norms of transparency, national treatment and non-discrimination. In the spirit of the WTO and some other international rules, this would require identification of specific legitimate objectives, a causal argument to be constructed, an analysis of cause and effect of the measure and some proportionality test to be used.  Certainly this is not easy, but it might at least draw a line around the SEC area and begin to frame it in a way that could lead to medium term clarity.



Peter W.B. Phillips
Professor, Johnson Shoyama Graduate School of Public Policy
University of Saskatchewan
101 Diefenbaker Place, Diefenbaker Building
Saskatoon, Canada S7N 5B8
306-966-4021; fax 966-1967

[cid:image005.jpg@01CBE7C7.D81E8CA0]<http://www.valgen.ca/>                                   [cid:image006.jpg@01CBE7C7.D81E8CA0] <http://www.agbio-management.org/>

Thanks Peter for a quite illustrative message. I think we can expand a bit more your messages by discussing the motivations behind SEC assessments. I a sense, one needs to clearly contrast and differentiate between the assessment of socio-economic considerations and the assessment of socio-economic considerations within the scope of a biosafety regulatory approval process.

To understand the later one needs to go beyond discussions of methods and approaches as one would normally do for the former, and start discussing issues such as the collateral impact from inclusion, the relationship between socio-economic assessment and the other risk assessment procedures and how to tie these together in a unified decision making process.

The collateral impact from inclusion has to consider the potential increases in cost to developers and to society in general, gains in information and knowledge by doing the assessments, trade-offs between immediate costs and future knowledge gains, impact on technology flows and who is impacted especially the public sector in developing countries.

Lots of things to discuss...the more integrated the better...

Greetings to all! Thank you for the interesting discussions.

Under Article 26.1 of the Protocol socio-economic considerations can be interpreted to be limited to socio-economic considerations arising from the impact of LMOs on the conservation and sustainable use of biological diversity, especially with regard to the value of biological diversity to indigenous and local communities. However, it should be borne in mind that the Protocol sets minimum standards and Parties have the sovereign right to take stricter action as defined by their national needs.

In this regard several Parties have national biosafety laws that allow them to take into account socio-economic considerations not limited to those arising only from the impact of LMOs on the conservation and sustainable use of biodiversity. Many other Parties have similar provisions in their draft regulatory frameworks. Of course, in framing their national laws, Parties work in the context of their respective realities and this is accordingly reflected in the scope of the socio-economic provisions.

Moreover, Article 26.2 encourages parties to cooperate on research and information exchange on any socio-economic impacts of LMOs.

In the context of our discussions on capacity-building on research and information exchange (as per Decision V/III), I believe that we should cover the wide range of socio-economic considerations that Parties may encounter when taking decisions on import of LMOs under the Protocol or under its domestic measures implementing the Protocol. Such national measures are, inter alia, those dealing with import; risk assessment and risk management; unintentional transboundary movements of LMOs and emergency measures; handling, transport, packaging and identification; capacity building; and transboundary movements of LMOs between Parties and non-Parties. Underlying these measures is the implementation of the precautionary principle.

These then are the elements of Article 26 that should frame our discussions. With respect to the needs of Parties for capacity building, it would be instructive to look at the summary report of the survey that was conducted by the Secretariat (UNEP/CBD/BS/COP-MOP/5/INF/10) for an idea of the range of socio-economic considerations viewed as important and for which further guidance/priority is needed.

I am attaching a TWN briefing paper that was produced for COP-MOP 4 on ‘Some issues for the implementation of Article 26 on socio-economic considerations’ for your information. I am also attaching a TWN booklet on 'Potential Socio-Economic, Cultural and Ethical Impacts of GMOs: Prospects for Socio-Economic Impact Assessment' which provides more detail on some of the socio-ecomomic considerations that may be taken into account.

Lim Li Ching
Third World Network

Dear All,

I agree with Lim Li Ching in the claim that “in the context of our discussions on capacity-building on research and information exchange we should cover the wide range of socio-economic considerations” I also think that the TWN booklet provides a good starting point on some of the topics that could be relevant.

On other issue,in my view whom should be considered as the relevant local and indigenous communitites could be defined in terms of which communities could see their livelihoods affected (in a positive or negative way) by the LMOs.

Best regards,
Alejandro

Good morning again,

At this stage, I would like to answer some remarks or questions of
previous speakers.

Concerning what definition of biodiversity is concerned in the Biosafety
Protocol ( question asked by Jose Falck Zepeda ): we just have to refer
to the CBD ( of which the Protocol is a complementary instrument ):
thus, intra- and inter- specific biodiversity, wild and agricultural
biodiversity, ecosystems and their functions and services ( for heath,
various aspects of environment, habitat, .... ).

Concerning why we would include socio-economic assessments in the
decisions of imports: the fact is that this possibility is now present
in the text of the Protocol, after long discussions and compromises, as
explained in articles - that well summarize reasons, at least for some
Parties, to include these assessments -  joined by Dr. Hartmut Meyer, (
in his 1st participation in the forum yesterday ).  Thus, now, we have
just to deal with this possibility. And it is indeed not an obligation
for Parties to include it, following the text of the Protocol (
......Parties ....may include .... )

It is true that some aspects of socio-economic impacts could only be
evaluated by modelling, projections. But this is also true of biosafety
assessments, where, in particular, long term and indirect impacts cannot
be evaluated by short term direct observations. But projections and
modelling can in both cases take into account previous knowledge and
experience.
It is true that it is not realistic to ask zero risk from a new
technology like it is not from any aspect of life manifestation. 
But it is precisely where a socio-economic evaluation could come in
balance with a biosafety risk evaluation - that can also contain
uncertainties beside the detection of potential risks - in order to come
to a global risks/benefits  evaluation .

In my country, we have not incorporated till now any legislative or
procedural instrument to include socio-economic assessments in the
decision procedures on LMOs. However, discussions already took place
about that, between official representatives but also in a forum
including all stakeholders. Till now, there is no total consensus  on
the fact that we would include such an evaluation, the more that the
issue is in debate at the EU level itself, and that the possible
conformity with the WTO agreements is one of the issues discussed .
But, if we would include such an assessment, there was a rather good
consensus emerging from that national forum that it would be done by an
instance separate from our existing Consultative Biosafety Council; and
it would not furnish a consensual "advice" to the political decidors,
but rather the synthesis of a study ( communicated integrally ), based
on relevant socio-economical analyses, scientifically founded, clearly
reflecting different positions formulated, different aspects of the
issue and their objective basis.
It would then be the duty of the political decidors to integrate the
different aspects of that analysis and of the scientific advice from the
Consultative Biosafety Council to   
take a decision relative to GMO authorisations.
The methodology to use and the criteria to take into account still would
need further work.


I agree with Mihaela Antofie that the ITPGRFA ( Plant Genentic Resources
Treaty of the FAO ) could also be taken into account when discussing on
socio-economic aspects related to LMOs. 

Best regards.

Lucette Flandroy


GMO & Biosafety expert - National focal point for the Cartagena Protocol
Federal public Service Health, Food Chain Safety & Environment
BELGIUM 



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Dear Lucette, thank you for supporting my opinion in referring to ITPGRFA. I also support your ideas. In addition to that I would underline at the moment that according to art. 5 of the Plant treaty – the parties…shall…promote an integrated approach to the exploration, conservation and sustainable use of plant genetic resources for food and agriculture and shall in particular, as appropriate a) survey and inventory plant genetic resources for food and agriculture, taking into account the status and degree of variation in existing populations, including those that are of potential use and as feasible assess any threats to them…My personal opinion is that this article underline in fact the need for conservation which includes sustainable use of plant genetic resources for food and agriculture. The new products coming from modern biotechnology should be integrated up to the local level applying the appropriate biosafety measures in order to avoid to loss of crop biodiversity. My opinion is that we should take care more for conserving, applying appropriate measures, not impacting on the removal of old crops but rather on the maintenance of genetic resources as a whole – which is very important for facing climate change. Also it is important not to resist to LMOs already placed on the market due to the WTO Treaties but find the balance for sustainable use of all plant genetic resources at the point where we may tackle the maintenance for long term of the resilience of agro-ecosystems. Ex situ conservation into gene banks is an option but on the same time according to the provisions of art 6.2.a) pursuing fair agricultural policies that promote, as appropriate, the development and maintenance of diverse farming systems that enhance the sustainable use of agricultural biological diversity and other natural resources
thank you

Apologies that I posted the comment bellow on the discussion of Theme 2.

...

*Theme 1. What are the socio-economic considerations that Parties may take
into account in the context of Article 26 of the Biosafety Protocol?*

Greeting to all! On behalf of the Plurinational State of Bolivia, it is a
pleasure to follow up and participate in these enriching discussions. I
would like to mention that the comments to be posted in this e-forum are
agreed with the Bolivian focal point to the CBD/CPB, reason why they might
not be so frequent and they refer to a common rather than a personal
opinion.



Several questions and comments have been posted on the interpretation,
objective, scope, limitations, etc. of Art. 26 of the CPB. All of them
relevant and useful for further discussions. However, we would like to agree
with Ms. Lucette Flandroy and Dr. Hartmut Meyer in the sense that after a
long process of discussions and compromise, socioeconomic considerations
(SEC) related to LMOs are integral part of the CPB. Accordingly, at this
juncture, Parties (and of course practitioners, as well) need to analyze the
options, experiences and needs to effectively include SEC in their biosafety
decision-making. Here I would like to mention that under the Bolivian view,
SEC is not exclusive to LMO-related issues, but relevant to all
environmental decision-making processes, particularly to biodiversity since
we are a mega-diverse country and center of origin and genetic
diversification of several flora species (this is rooted in the provisions
of the New Political Constitutions of the State  - which recognizes the
close inter-relation Nature-Society - and the Law No 071 on the Rights of
Mother Earth).



Accordingly, going back to the question posted by the Secretariat, as Party
of the CPB we think that the socio-economic considerations that Parties may
take into account in the context of Article 26 of the Biosafety Protocolare,
*inter alia*:


- Changes in livelihood linked to the potential adverse effects along the
transfer, handling and use of LMOs on the conservation and sustainable use
of biological diversity, taking into account human health.



- Changes in the knowledge systems.



- Potential impacts on public health, in light of the objective and scope of
the CPB.

* *

- Potential risks to the environment. SEC play an important role in ecologic
dynamics, e.g. seed saving and exchange that may influence gene flow.



- SEC in light of public participation.



These SE considerations imply that:



- The objective and scope of the CPB should also frame the inclusion of SEC
in biosafety decision-making processes. Meaning that SEC are not restricted
to the potential effects related to the release of LMOs into the environment
only, but to the whole range of activities along the transfer, handling and
use of LMOs. This includes the intrinsic technological package of some LMOs
(e.g. herbicide tolerant crops).



- Application of precautionary approaches in light of sustainable
development and livelihood, which calls for long-term ecological and social
welfare.



-  Particular attention in welfare changes should be given to two social
groups: 1) *local and indigenous communities* in general, but specifically
in mega-diverse countries and countries that are part of centers or origin
and genetic diversity (e.g. potential collateral impacts to local and
indigenous communities from the genetic contamination of native
biodiversity, resulting in the development of new characteristics not
adequate for consuetudinary uses, either as food or in cultural practices).
2) *Vulnerable and marginalized groups*, such us rural women, rural youth,
populations with tendency or chronic health and nutritional disorders.



In terms of methodological approaches for adequately including SEC in
biosafety decision-making, we think that:



-  Economic impacts assessment based on the cost-benefits rationale has
limitations. Can we assess all – or at least the most relevant – SOCIAL
costs related to adverse effects on the conservation and sustainable use of
biodiversity?



-  Based on the previous, we would like to have more input on methodological
pluralism for SE assessment, including quantitative and qualitative
methodologies.



-  The effective inclusion of the “social” component in the “socioeconomic”
considerations in the context of the CPB is restricted. As mentioned by
other participants, currently the majority of the information available in
the literature focuses mostly on “economic” impacts, several times
addressing considerations that (somehow) are not fully in line with the
scope of the CPB (e.g. reduction on production costs, consumer acceptance,
impacts on trade).



-  Normalization of methods and approaches do not necessarily means
improvement in the transparency of SEC methods. Transparency – which we
agree is crucial in ALL biosafety processes – is accomplished by timely
disclosure of information and methods, and public participation.
Normalization of methods does not guarantee this. In fact, we have some
concerns about this notion of normalization since seems to be based in the
notion of “one fits all”. We agree with Mrs. Lim Li Ching that framing
national laws – including assessment approaches – need to be set according
to realities of the different Parties. We support instead the agreement of
principles and guidelines for adequate SE assessment approaches and SEC into
biosafety decision-making.



-  We agree with Dr. José Falck Zepeda that regulatory frameworks need to be
workable and feasible to implement. In this sense, to restrict SEC to robust
scientific information is not feasible to biosafety decision-making
processes. We believe that* *relevant and reliable information, including –
but not restricted to – scientific information is needed in biosafety
decision-making, as well as the application of precautionary approaches.



Many thanks!

Dear Lucette:

Thank you very much for your responses and contribution. I do want to clarify/expand a bit the reason why we need to differentiate ex-ante (before deliberate release) and ex-post (after deliberate release) approaches to the assessment of socio-economic considerations (SEC).

The reason to include this issue in the discussion is not only because of the ability to implement for example a projection or simulation in an ex ante framework or to do an econometric calculation of adoption in ex post situation - I have stated that indeed this will have an impact on the potential methods available for implementation by the practitioner- rather I would expand this focus to tie this issue to decision making standards and rules, as well as, the quality criteria by which to judge studies submitted to the competent authority.

In our review of 187 peer-reviewed papers on the economics literature on adoption and impact (see attached file)we started with a broad literature search where we found literally thousands of publications on this issue. Most of it in the grey literature and others, frankly more of interest groups positions. Many of these "studies" presented diverse and even completely contradictory(opposite) conclusions.

The fact is that at one point the competent authority and/or the decision making body will have to balance these claims using a standard. This is extremely important as these discussions should lead to a more transparent and workable system.

I agree with Jose on the importance of the quality of the studies on socioeconomic impacts.

It will be great if there was some sort of “best practices” for the evaluation (ex-post and ex-ante) of socioeconomic impacts. That document could be used as a benchmark that the relevant authorities (local, national, etc.) could use to value the quality of any given study before using it to make any kind of regulatory decision. My view is that such document should ideally be prepared by a group of academic experts under the coordination of an international research organization (like IFPRI).

Posted on behalf of Marie Ramanantenasoa:

good morning everybody,

I agree with Alejandro lopez and Jose in their idea about the studies on socioeconomic impacts but that need capacity building for the  actors on biosafety.

Thanks.

Dear participants,

In the absence of any message posted till now today ( or are you all
deeply discussing and analyzing documents internally ?? ), I' ll make
some more general remarks/questions.

Concerning the " Assessment trigger " evoked by Jose Falck Zepeda ( in
his message of 23/03, 18h53 ) , another way to consider the "triggering"
of socio-economic evaluations could be at a "generic" level, rather than
on a case by case level. Thus, to make general socio-economic
assessments for specific categories of LMOs, the concerned categories
having then to be defined. This could somehow avoid prolonging the
delays of each authorization procedure. But it seems that the countries
should in this case surely accept to make the assessment largely on the
basis of previous knowledge/experience/familiarity/data from other
countries etc.... .

Concerning a " best practices " guide that surely could be useful, one
question would again be, like for other issues and fields, how and by
whom it would be elaborated in order to avoid, including in a guidance
of good practices, shifts towards specific opinions and/or political
positions.

Concerning the international obligations to take into account when
considering socio-economic impacts, should the Conventions of the
International Labour Organization not also be taken into account ?

Best regards, and already, have a nice end of week.

Lucette Flandroy





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Posted on behalf of Michelle Chauvet:

Dear participants:

These days I'm finishing a project, so I apologize for taking part so far. As Lucette Flandroy mentioned on lines below, I'm actually in the process of reading all the messages and documents sent in order to have an informed participation next week.

Best regards,
Michelle Chauvet

Posted on behalf of Carlos Almendares:

Dear friends,

I worry about a thing, with the aim of clarifying the ideas in this forum, I would like to explain to me what relationship does the Conventions of the International Labour Organization to Article 26 of the Cartagena Protocol?

Carlos Almendares

Dear Fellow Participants,
I am Antonio Turrent, a maize production agronomist working at the National Institute of Forestry, Agriculture and Animal Husbandry of Mexico (http://www.inifap.gob.mx). I am also a founding member of the Mexican Union of Scientists Committed to the well-being of Society (http://www.unionccs.org).  I have been involved in research on production technology for small (fewer than 5 hectares) maize farmers for the last 40 years. I am very much concerned with the process of liberation of maize-LMO in the center of origin and of genetic diversity of maize and teosinte, the direct ancestor of maize. An ad hoc set of laws has recently been enacted in Mexico that seems to pave the road for liberating maize-LMO and other LMO in the name of modernizing farm production. These laws do express concern on protecting native maize landraces and teosinte from flow of transgenic DNA, but I am afraid that they are bound to fail in their explicit objective. It is necessary not only to “save” the native germplasm (which is already done in situ and ex situ), but also to preserve farmer practices (considered archaic by many) and the agroecosystem for farmers to handle the germplasm in their own objectives. Would it suffice to freeze and keep Orangutan semen from Borneo with disregard to the home-ecosystem in order to “save” that species from extinction?    
An introduction to concepts developed collectively through UNEP in COP-MOP and expressed through CBD, CPB, AHTEG-RA & RM and now SEC has been an eye opening experience and raises hope that our generation can progress in preserving our GAIA. Reading posted contributions for building the structure and substance of SEC on biodiversity has been enlightening to me. I apologize for presenting my case to you several days past the initiation date.    
I will make some proposals on SEC by presenting the case of liberation of maize-LMO and its effects on native landraces of maize in the center of origin and of genetic diversity of maize. Please bear with me as I present my case in some detail.
On maize native landraces and sources of local seed
Maize was domesticated some 10,000 years ago by favoring mutations of very few major genes of teosinte grass. Maize ear relics dated 6250 years ago (Guilá Naquitz caves in the state of Oaxaca) show intermediate stages between teosinte and modern maize. Some 200 generations of Mesoamericans developed 59 native maize landraces adapted to a number of agro niches by harnessing the natural genetic diversity of maize and of teosinte. Their objective was to adapt maize to different agro niches and to specialize it into different cultural uses as food. They did this as they developed a set of seed and crop management practices that are now referred to as autochthonous maize breeding (AMB). By the time of the Spanish conquest, modern maize had already been developed. However, efforts to refine native landraces for better adaptation to agro niches and better kernel quality for food continue to be practiced by several million peasant farming units.  
Maize, as a typical case of Allogamy, is a pretty promiscuous species. Some 20 to 30 neighboring males pollinate the ear (female reproductive organ) of each plant. Every plant produces some 25 million grains of pollen and some 500 fertile ovaries. There is an obvious proclivity of the species to DNA flow. Sixty-two Mexican ethnic groups have historically used this characteristic as a means to developing superior phenotypes for their agroecosystem and specific uses as food. Scientists who have studied the ways native maize landraces are handled by small farmers report a ubiquitous set of practices regarded as critical to maintaining plant vigor and developing further adaptation to agro niches and better kernel quality, inter alia:
a) Bringing home a few ears of allopatric (evolutionarily distinct) parent materials (taken from maize fields with or without owner permission) for hybridization with own seed. There is evidence that modern non transgenic hybrids have played a role as allopatric materials in the last 60 years;
b) Mixing both types of seed and allowing out crossing;
c) Pursuing yield stability across agroecosystem stresses rather than high yields; 
d) Imposing rigorous seed selection of progenies on the basis of communally consensed ear and kernel ideotypes;
e) Interchanging same landrace seed within the community; 
f) Seed is normally inherited from family parents or relatives, but can also be bought locally from farmers known for their high seed quality of specific landraces. This may become an important factor after severe crop losses. 
This set of practices constitutes the core of autochthonous maize breeding (AMB). Repetition of this method in over two million small farming units for long periods of time is a kind of parallel breeding that applies simultaneously to 59 native landraces. It should be highlighted here that the “seed-pollen route” rather than the “pollen-only route” is the main factor of genetic interaction for maize in Mexico. It is also important to note that new allopatric parent material may be brought from many kilometers away.    
On maize-LMO and its seed market
Maize-LMOs available in the world seed market share ex ante imprecision in the locus of insertion of each transgenic cassette in each hybrid, although the locus can be known with high precision ex post transformation. Probably in the process of developing the 50 or more independent, transgenic events available in today’s world seed market, almost all transgenic loci were dispersed throughout the chromosome space. This fact makes it possible that all 50 transgenic cassettes could be accumulated into one genotype by planned out crossing. 
Another shared characteristic of maize-LMO is that expression of the transgenic cassette is somatic (in all plant cells) and independent from the resident genome and epigenome, and competes for plant resources.
Pest resistant maize-LMO share same yield potential with its non-transgenic isoline homologous. However operational yield of the former may be higher than that of the latter if untreated, depending on intensity of infestation.
Cultivation of non food, (industrial-pharmaceutical) maize-LMO is explicitly prohibited by the set of Mexican laws recently enacted with regard to Biosafety of LMO. However, non-food, maize-LMO has been liberated in the US, Mexico´s principal source of maize imports.    
Increasingly, examples of developed pest resistance to specific transgenes are becoming known; inter alia:
a) Resistance to Bt maize developed by Busseola fusca (maize stem borer) ten years after commercial liberation in South Africa;
b) Resistance of Sorghum halepense (weed) to Glyphosate in roundup ready soybeans, also ten years after commercial liberation in Argentina.
Notwithstanding powerful strategies to slow down the process of pest resistance, (e.g., refugee-stacked transgenes) it is inevitable that biological warfare “pest vs control of pest” will ensue, meaning new transgenic toxins, new pest resistance, and so on. Consequently, new independent transgenic events will have to be developed, as the obsolete ones are discarded. It is highly improbable that any maize pest will be driven to extinction by sole maize-LMO technology.
The Mexico legal framework on property rights mandates that ownership rights on a transgene apply to any plant that carries that transgene. The route to plant transformation into that transgene (whether intended or not) bears no effect on ownership. Any producer who sells a transgene transformed seed would have to pay royalty to the owner.
Socioeconomic considerations around maize-LMO liberation in Mexico 
Maize is the basic staple food of Mexico. Direct consumption of maize grain provides about 60 percent of the caloric intake and 40 percent of the protein intake of the national diet. In the rest of the world, however, maize is used principally as animal feed. It should be obvious that quality of grain as human food and animal feed is substantially different. 
There are at least two practical reasons why the genetic integrity of native landraces of maize must be protected for the sake of food security in Mexico: 
1) Native landraces of maize have no substitute for the nearly 600 food preparations and beverages. Each of those preparations requires a specific type of maize. Mexican cuisine has recently been declared “intangible patrimony of mankind” by UNESCO. This patrimony is inseparable from Mexican maize native landraces;
2) Only three million hectares out of nine of the maize agroecosystem of Mexico are prime land, while six million hectares have suboptimal geo-edaphoclimatic conditions. The model of industrial agriculture (mechanized, modern hybrid maize production) is successfully practiced at present in the former fraction, while peasant farming dominates in the latter. After sixty years of public and private efforts on maize modern breeding in Mexico, no hybrid or open-pollinated technology competes successfully with native maize in lower quality land. That is why 50 percent of the maize agroecosystem is planted with native landraces, 25 percent is planted with modern hybrids, and the rest is planted with seed that is a product of their genetic interaction. 
A hypothetical commercial liberation of maize-LMO in Mexico would probably extend to the maize agroecosystem’s three million hectares of prime land. Measures for preventing flow of transgenic DNA into native maize would have to be relaxed like elsewhere in the world, only preventing the “pollen-only route” to gene flow. Furthermore, preventing the “seed-pollen route” would be nearly impossible in the center of origin and diversification of maize. Coexistence of maize-LMO and native landraces is nearly impossible in this scenario or any other that involves maize-LMO liberation in Mexico, if genetic integrity of native maize is to be truly protected. 
Native maize coexistence with maize-LMO is nearly impossible in Mexico for at least a number of factors of irreversible and progressive accumulation of transgenic DNA in the former, inter alia: 
a) Autochthonous maize breeding: massive hunt for allopatric parent materials, massive seed exchange at community level, “seed-pollen route” to genetic flow;
b) Transgenic cassette loci dispersal in the chromosome space in more than 50 independent transgenic events in the world seed market;
c) Reproductive biology of maize akin to gene flow; 
d) Increasing number of independent transgenic events due to novel characters or to obsolescence of old transgenes.
The possibility of accumulation of transgenic cassettes in maize would be nearly irrelevant for maize producers who do not grow their own seed. For those who grow their own seed, however, the dispersion of loci in the chromosome space should be a cause of concern, inter alia:
a) There might be a deleterious threshold to transgenic cassette accumulation in successive progenies of transformed native maize affecting genome controlled characters: resistance or adaptation to biotic and abiotic stress, food and feed safety, etc.
b) The diverse genetic context of native maize landraces would probably play a yet unknown role as accumulating transgenic cassettes meet the resident transcriptome, proteome, interactome and metabolome with similar impact as in the previous point.
Finally, ownership rights protected by Mexican law will act against AMB and growing native maize, as small producers and sellers of high quality native maize seed would be eliminated in practice (like elsewhere e.g., “the Monsanto Canada Inc. vs Schmeiser case on canola”) as its seed becomes contaminated with transgenic DNA.  By the way, modern maize growers of northern Mexico are forcefully lobbying the government for maize-LMO liberation. 
Unanswered questions like those mentioned, are critical to Mexico, since maize is the basic staple. Deplorably, no national sources of funding have been opened to pursue those questions so far. However, the lack of scientific knowledge should not be a reason to downplay the risks (Annex III, AHTEG RA&RN). 
Mexico is not the only center of origin and of diversification that is threatened by liberation of LMO. Honduras, like Mexico and Guatemala are part of Mesoamerica sharing maize’s center of origin and diversification. Honduras allowed the liberation of maize-LMO some years ago, probably without an ex ante evaluation of risks. I wonder if ex post evaluation will consider the fate of native maize landraces. Andean countries like Bolivia, Perú, Ecuador, Colombia, and Chile are very important centers of diversification of maize.
India is the center of origin and of diversification of Brinjal (eggplant), a most important vegetable. Like maize in Mexico, there are plans to liberate brinjal-LMO. Liberation of Bt-brinjal in India was postponed by court through a one year moratorium till scientific knowledge on safety as food is gathered. I hope that ex ante evaluation on impacts on the native brinjal landraces are also conducted. Are there more examples I am not aware of?

Regarding the comments of  Dr Antonio Turrent, our colleague from Mexico:
Pienso que el verbo ingles "liberate" no este correcto por su idea.  Que es la palabra espanola Vd quiere usar? Es el idea de libre de regalaciones? O pertiene de contaminacion? Ecc.
Por eso, es dificil para comprender su mensaje. por favor, explica Vd.
Gracias

Dear Dr. Bereano:
Thanks a lot for your observation. I wrongly used a literal translation of the verb we use in the agronomic jargon when a new variety is released for public use in Mexico. The verb "liberar una variedad" means that it can be planted, it can be sold, etc., but it has to comply with regulations including those pertinent to contamination. I believe that the right english verb should be "to release" a new variety.
I am sorry for my poor choice of that word. I hope that I didn't commit to many additional mistakes. 
Saludos y gracias por su esfuerzo aclarativo en español.
Antonio Turrent

<html><body>
<p>Determining what socio-economic considerations can be considered under Article 26 of the Cartagena Protocol is only one part of a national biosafety regulatory system's attempt to address socio-economic considerations from the introduction of LMOs.  Countries must decide a number of important procedural issues related to socio-economic assessments.  First, countries must decide when in the regulatory process they will conduct their socio-economic assessment.  Will it occur as part of the risk assessment?  Will it be part of the risk management?  Or will it occur after the risk assessment but before a decision is made on the submitted application.  <br>
<br>
Second, a country must spell out what information should be used to conduct a socio-economic analysis, how it should be performed, and who should do it.  Annex III of the Protocol spells out the answer to many of these questions for the LMO scientific risk assessment but does not mention any methods, principles or information needed for to address socio-economic considerations.  I believe a document similar to Annex III that addressed this area would be extremely beneficial to countries trying to incorporate such issues into their national biosafety regulatory frameworks.<br>
<br>
Thirdly, a country must also determine which activities with LMOs merit conducting an analysis of socio-economic considerations.  The Protocol treats different activities with LMOs -- transit, contained use, intentional introduction into the environment, and use for food, feed, or processing -- with differnet obligations and requirements.  Similarly, countries implementing Article 26 or their own national policies and laws, need to determine which LMO activities warrant an analysis of socio-economic considerations.  Clearly contained use or transit have different potential impacts on biodiversity than an intentional introduction into the environment and the Protocol reflects those differences.  Similarly, contained use or transit of LMOs could have different potential socio-economic impacts than intentional introductions.  Therefore, determing which LMO activities warrant  an analysis of socio-economic considerations will be important.<br>
<br>
<br>
Gregory Jaffe<br>
Director, Biotechnology Project<br>
Center for Science in the Public Interest<br>
</body></html>

I want to expand a little bit on Greg Jaffe's annotations since I believe this is at the heart of the socio-economic issues to consider as indeed we are discussing a regulatory and a decision making process that will have to yield a decision as an outcome.

Policy and decision makers in countries parties to the CPB can consider the following decision making nodes for regulatory design
1.  Type of inclusion
No inclusion vs.  Mandatory vs.  Voluntary

2. Scope
Narrow interpretation article 26.1
Narrow set of socio-economic issues
Broader set of assessments (Socio-Economic Impact Assessments or Sustainable Livelihoods)

3. Approach
In contrast to the environmental and food/feed safety assessment, SEC assessment is Concurrent but separate vs. Sequential vs. Embedded

Which implementation entity? Independent vs. Proponent vs. Specialized full time unit within regulatory agency or government
Do you allow data from other countries with similar agro-ecological and/or social characteristics?

4. Assessment trigger
Each submission vs. Event-by-event

5. When
Laboratory/greenhouse vs. Confined Field Trials  vs. Commercialization
Post release monitoring
Commercialization and for post-release monitoring?
At all stages?

6. How
Choice of methods for ex ante assessments (before approval for deliberate release) is much more limited than for ex post
Decision making rules and standards
Multi-disciplinary method integration, standards, and the decision-making process tolerance to errors

These options are described in quite detail in a paper I just published at the Review of Policy Research. The citation is:

Falck-Zepeda, J. B. and Zambrano, P. (2011), Socio-economic Considerations in Biosafety and Biotechnology Decision Making: The Cartagena Protocol and National Biosafety Frameworks. Review of Policy Research, 28: 171–195. doi: 10.1111/j.1541-1338.2011.00488.x

I cannot put the article file as an attachment due to restrictions, but can send you the paper directly.

Thanks to all interesting and complementary contributions brought by the participants !

Thanks in particular to the last contributions of Dr. José Zepeda and Gregory Jaffe, who brought some order in the discussion by reminding and synthetising somehow the different aspects that should be considered/decided by the Parties with a view to eventually take socio-economical considerations into account.

Some remarks/questions again after these last and other contributions.

It seems to me that these various aspects to take into account are, obvioulsy, somehow interlinked.

For example, following the scope of socio-economic criteria that countries would like to take into account, they should/could only be evaluated ex ante or ex post.
This has to be taken into account when deciding on both aspects (  scope, and timing of the evaluation ) .
Logically , wouldn' t that mean that, in order to take into account a broad enough scope of socio-economic considerations, the socio-economic evaluation should maybe not be restricted only to ex ante or only to ex post assessment, but be a mixed of both, which of course could complicate the choice of how to take this evaluation into account in an LMO import decision .  

I understand very well that methodologies for ex ante assessment are different from methodologies for ex post assessment, and I read from experts in the field that methodologies for ex ante assessments are indeed more limited till now than for ex post . They should however be developed in that case, if one indeed wants to work with scientific methods, because the impacts to study by ex ante evaluation can be as important as those to study by ex post evaluation. About that, I can also understand some remarks made by Gerorgina Catacora-Vargas: the most important socio-economic considerations to take into account are not necessarily always the most easy to study with scientific methods, but this should not be a reason to neglect them.

This leads me back to the socio-economic considerations that could be taken into account presently, to be in conformity with present WTO rules.
Obviously, by chance, would I say, the socio-economic considerations concerned by Art. 26.1 are included in those that should be accepted by WTO, as noticed by Gregory Jaffe and Ms. Li Ching Lim, and Parties should thus take this into account when they tailor the socio-economic considerations they would decide to reckon with.

And about this, a last remark/question: if the socio-economic considerations that could be allowed to be taken into account are those linked to potential impacts on biodiversity - that should be evaluated ex ante following the Protocol -, wouldn' t these socio-economic considerations also be dealt with ex ante ? ....... 

Best regards.

Lucette Flandroy


P.S. : The establishment of a " best practice " guide could indeed be a good initiative for deciders to value the quality of studies, as well for ex post as ex ante assessments, because, indeed, in that field still more, maybe, than in other ones, one can find what one wants to find following the criteria, sources, and methodologies used. 




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Dear Lucette:

Thank you very much for your critical questions regarding issues and methods. When talking about Ex post and Ex ante as related to technology adoption and regulation, we are really talking about a methods continuum in time and space

Let me explains the relationship between types of methods for assessments (ex ante versus ex post) and the diffusion process of new technologies.When I indicated that the portfolio of methods for ex ante and ex post assessments is different, it really means that the mix of methods will be different.

Certainly, the number and complexity of methods available for ex post (after effective deliberate release approval and subsequent diffusion of an LMO technology) is much larger than with ex ante (before anything is in the hands of farmers that is before deliberate release). The reason that we have a larger portfolio for ex post is simply that we as practitioners have (or can obtain) hard data on yields, pesticide use, labor, other inputs and prices and thus do more and more robust assessments.

In fact, some specific methods and approaches for data collection and assessment can be used both in an ex ante and an ex post situation. Some examples include cost/benefit, Net Present Value, economic surplus, expert consultations, focus groups, gender and generational dimensions assessments, etc.

You open one interesting issue which is that we are not talking about two discrete events in time (ex ante and ex post) as related to technology adoption. In reality we have a continuum in time of these two events. This has interesting implications in terms of SEC assessments and regulatory design as one need to bring clarity into what is expected from an assessment, implying that in a regulatory setting we are talking about a time delimited exercise.

Let me illustrate briefly with an example. We conducted a social and economic assessment of the adoption of Bt maize in the Philippines and Honduras. Our national partners at the University of Philippines-Los Banos were able to conduct a stratified random sample for selecting farmers and were able to conduct quite sophisticated statistical analysis through complex models. In Honduras, with our partners at Escuela Agricola Panamericana -Zamorano University, as this was the second year of availability the number of adopters was quite small. We could not do a random sample rather we had to a census. This of course has implications in terms of what we could do in terms of posterior assessments/analysis.

From a personal standpoint though, I rather have some field data as imperfect as it could be, than have no data a do a complete desk study.

The other option of course is to conduct data collection over several years, but this has a serious implication in terms of time and resources for funding of the research. One more consideration as we do not have unlimited resources to do SEC assessments, and the more complex the research the more expensive it is going to be. As I indicated previously this fact also has an implication in terms of long term innovation, technology diffusion, gains in knowledge, and others.

One quick response to your last question. If the regulatory/decision making process requires a study on the impact on biodiversity to grant the deliberate release permit for the developer to commercialized and/or diffuse the product, this would be an ex ante exercise as there is no LMO in the hands of adopters.

Granted, as a matter of good practice, one can do baseline studies examining the status quo, use secondary data, and exploit familiarity/knowledge with the crop/trait/environment if available. This of course opens the question of whether the regulatory/decision making process accepts this type of assessments.

If the regulatory/decision making process requires both an SEC and biodiversity assessment to grant a deliberate release permit and then have a post-release monitoring requirement, then this becomes a mix of ex ante and ex post analysis.

These requirements and issues need to be clearly spelled out in the implementing regulations as they may need to be modified later on to accommodate changes in experience, knowledge and methods improvement.

Ex-ante studies are designed to measure the risk of an event occurring. It might be the risk of allergenicity, toxicity or impact on non-target organism. Data is collected based on field trials and is then assessed using a standard methodology, that provides consistent decisions across crop varieties and plant species. Through this graduate build-up of data, it is possible to generate a depth of knowledge that adds to the decision making process as it helps to refine the boundaries of acceptable thresholds for safety. Are these studies perfect? No, of course not, but they are the best we have available at the point in time that is prior to commercialization.

To include a socio-economic consideration prior to commercialization (assuming one could be devised that didn’t conflict with WTO principles) is logistically easier but challenging. No product has been commercialized, so socio-economic considerations can only be provided based on hypothetical situations, which is always less reliable than data based on real life experiences. This is proven through comparing consumer attitude surveys to GM food products where a consumer will say in an interview by phone or mail that they would not buy the GM product regardless of price, but do buy the product when placed in a purchase option experiment.  Consumers are notorious for saying one thing and doing the other, just look at election results!

The concern of a SEC at this stage is that it will grossly under-estimate the value of the GM crop. Recent research in Canada shows that GM canola is the most environmentally sustainable method of crop production, including organics. Had a SEC been undertaken prior to commercializing canola, it is doubtful that this vitally important benefit would have been identified anywhere near the level it is occurring.

On the flip side, an ex-post assessment is not a realistic option as at this point in time, there will be adopters that are benefiting from producing and consuming the GM crop and removing this choice from them will most certainly make them worse off. If a SEC is being undertaken to make sure that no one is made worse off from the commercialization of a GM crop, then doing it ex-post undermines the very rational of the process as it will make the adopters worse off, without a doubt.

Stuart Smyth
University of Saskatchewan

Dear participants,

Again, at this stage, I would like to react with some remarks and questions which address a few previous comments of some participants ( mainly Dr. Zepeda, Stuart Smith, Ms. Li Ching Lim, Peter Phillips, Gregory Jaffe and Dr. Antonio Turrent.)

Countries are indeed allowed to extend the socio-economic considerations beyond those included by Art. 26 1. .
But, in the present context of world trade organization, tthe concerned considerations should in any case be in conformity with WTO rules, which is not necessarily the case of all potential socio-economical considerations, in contrast with those framed following Art. 26.1, as noticed previously by Gregory Jaffe.

Among the reasons and measures to limit trade liberalization that can be evoked by member countries and accepted by WTO ( Art. XX of GATT ) , measures " necesssary to protect public morals" , and "relating to the conservation of exhaustible natural resources ", were reminded by Ms. Li Ching Lim . On another side,  as reminded by Stuart Smyth, WTO only accepts sound science based arguments and regulatory standards. Hoping that some participant experts would be familiar with WTO procedures implementation and could answer this question, I would like to know a) if examples exist of countries member of WTO that evoked such arguments to restrict the import of some product and b) how was the issue accepted by WTO and concluded.

Concerning the fact that Conventions of the World Labour Organization should be considered among the international obligations to take into account in implementing Art. 26: I actually did not intend, in a previous message, to affirm that these Conventions have to be taken into account; I just raised the question of the pertinency to maybe take them into account, also hoping that some better expert of these conventions could comment on this; a priori, it did not seem silly to me, in the context of socio-economic considerations, to have to consider these conventions, that also include rights and obligations towards various categories of " local " workers . Can any of the participants comment/answer this ? 

In relation with various comments, I would like to remind that the Cartagena Protocol and implementation national regulations do not pretend to allow to lead to safe products, but to risk assessed products. And the Protocol is based on the precautionary principle, in order to take decisions in case of scientific uncertainties. Thus, once again, as underlined in a previous message, socio-economic considerations, which, I agree, are surely not easy to make seriously and with good scientific basis, are not to oppose to totally confident biosafety risk assessments that would give totally consensual conclusions on all pertinent elements to take into account, and that would lead to certainly safe products in contrast to those issued from other forms of agriculture.
Positive but also negative impacts of LMOs on biodiversity already occured, that had not been officially foreseen or taken into account in the risk asssessment or the risk management.
There is not always consensus among scientists on the conclusions to draw from specific biosafety risk assessments; there is no total consensus on fundamental aspects related to the elements to take into account or to the methodologies to use in biosafety risk assessments; it is also an evolving and debated issue. 
Related to this remark and as previously posted, socio-economical considerations could be complementary to make choices among decisions in face of scientific uncertainties in biosafety risks.
( In addition, indeed, it could be a good idea to assess not only risks but also positive foreseen impacts of candidate LMOs on biodiversity and environment in comparison to various other forms of agriculture, but this again should then be done with sound science basis. In summary, it could be judicious to compare the biosafety and socio-economical risks and advantages of various forms of agriculture in specific countries/regions, to make political choices of the best type of agriculture to develop in some regions; but this can also look like "planified agriculture", which is not presently the main way to manage agricultural politics in democratic countries. In that contexte and in order to allow free choices of farmers - and consumers - , a big issue is then of course "coexistence", which is, by the way, not considered by all stakeholders only as a socio-economical issue, depending on the meaning given to that word ).   

Linked to my last remarks: the message posted by Dr. Antonio Turrent is very illustrative of precise concerns about GM maize in Mexico and Central America in general. These concerns are situated at the junction of socio-economical concerns and biosafety risks concerns. A big part of your considerations, Dr. Turrent, is very bio-scientific, and very linked to biodiversity and biosafety concerns. If you consider that some biodiversity concerns are not enough taken into account in the present risk assessments procedures or guidances, I would advice you to participate and evoke them in the online forum also organized by the SCBD and that has started yesterday on the issue of risk assessement and risk management; the first aim of that parallel forum is to review the guidance elaborated for COP-MOP5 by the AHTEG on RA-RM. The relationship between "contamination" and "coexistence" have precisely been discussed this morning ( for me, at least, it was morning ...) in that RA-RM forum.  

That being said, I think that the a good part of the socio-economic considerations that Parties could take into account in the context of Art. 26 ( which is one of the question in this session of the discussion ) had already, indeed, been summarized in the survey of the SCBD on this issue, and some of them have been reminded and somewhat more detailed in this forum in the light of the international obligations that Parties may need to follow in this context ( which is the other question in this session of the discussion ) ( Please, could in addition relevant experts try to answer my questions in § 3 ? Thanks in advance ) . 
The methodologies to use for socio-economical asessments should be discussed further in a later coming session of discussion. ( They cann 't of course be considered totally separately from the socio-economical elements themselves to take into account ). 

We should think if we do not forget considerations to take into account, reminding that we should consider not only GM plants but also other kinds of LMOs .

With best regards.

Lucette Flandroy





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

Dear Lucette,

In response to your question about WTO cases involving socio-economic considerations and their view as a trade barrier, the best know case is the one that Canada, the USA and Argentina filed against the EU over the 0.9% labeling threshold for products containing GM ingredients. The three countries that filed the claim, argued that this was not based on science and was clearly a barrier against trade. Various speakers at the upper levels of the EU had already publically admitted that 0.9% was not based on science but was a political consensus that the various member states of the EU could agree to. As was widely expected, the WTO ruled that the 0.9% labeling was indeed a trade barrier. However, the EU has not complied with the ruling, thereby serving to undermine the role of the WTO and Canada, the USA and Argentina impose tariffs on a variety of products that Europe exports to these three countries.  In essence we have returned to the pre-GATT days to tax and tariffs.

In response to your point that there is not always consensus among scientists on biosafety risk assessments, you are correct in this, but let me highlight where the disagreements lies. There is agreement on the methodologies used to undertake the risk assessment, where the disagreements enter the debate is on the interpretation of the results and the potential impact of the results. For example, is the presence of an allergen significant at 10 parts per million or 12 parts per million? Through the use of peer reviewed scientific journals, the methodologies have been proven and in fact most of the methodologies for assessing risks in GM crop varieties were used to assess risks in plant varieties and the environment prior to the introduction of GM varieties. Scientists tend to agree that the methodologies of risk assessment are correct. As with anything in life, disagreement arises over what level is safe. As you are no doubt aware, some will argue that there is no level of safety and that the only safe level is zero. However, zero is not achievable in our food production systems, that is why we have thresholds for our food production systems. If zero was truly achievable, then things like e-coli in meat would not be occurring in the marketplace and the fact that it does occur, shows that inspite of best efforts, zero is not an achievable level for risk management.

The biggest challenge I see in the inclusion of SEC into domestic regulatory systems is the strong likelihood that a socio-economic risk assessment will return with a zero level of acceptability for some factor, when the biological reality of this is simply not possible. “Pure”, is a marketing slogan as nothing in nature is pure. No risk assessment system can guarantee the complete absence of risk, that is not, nor never has been the intention of a risk system. Risk assessments are designed to identify the potential level of risk and then compare this to other risks or related risks within the same, or like, products and then decided if this level of risk is acceptable or not. Risks have margins or boundaries at which point something is considered safe if it is under the level and dangerous if it is above. Internationally, there is agreement that risks will exist with any product, be it a LMO, a conventionally derived plant or even an organic product.

There is a difference between an initial finding and subsequent research results. Case in point is the 1999 article by Losey that suggested that monarch butterfly larvae would be killed from the use of GM corn. This created a loud outcry among the NGO community. Subsequent research over the next two years revealed that monarch butterflies only lay eggs on milkweed plants and due to the height of corn plants, milkweed is not found growing in corn fields but in adjacent ditches. It was also found that the larvae hatch on the underside of the leave and it takes close to 48 hours for the larvae to reach the surface of the leaf where GM corn pollen could exist. However, by the 48 hour stage, the larvae gut has matured to the point that the digestion of GM corn pollen is no longer toxic to it.

In this instance, had ex-post SEC been in place, it is foreseeable that GM corn might have been removed from the market following the Losey publication. Would this have been the correct course of action? Within a socio-economic framework, is a single potential threat enough to remove a product from the market? The Losey study was a laboratory experiment, not based on field data.

To the best of the scientific risk assessment ability, the level of safety is further refined through research. New research based on feeding a product to rats regarding allergen research might reveal that the previously thought level of safety of “x” might be too high and that this level should be lowered. Conversely, more knowledge about a potential risk might find that what was thought to be dangerous at a specified level was actually erroneous and that a higher threshold can be established. This research is published in peer review journals, the studies are redone by other researchers to confirm or refute the results, but at the end of the day, there is agreement on the methodology that is used to do this risk assessment and the various researchers or scientists are free to agree or disagree about the results. It is this debate that advances the knowledge about the acceptable levels of risk and safety for our international regulatory bodies, such as the SPS Agreement.

The challenge for SEC is what threshold of acceptability will be acceptable? If an innovative product is acceptable to 50% plus one of a population, is this acceptable? What about the situation where only 40% of a population engaged in the discussion and over half of these people disagreed that it was acceptable, which would be about 20% of the total population. Is this enough to reject the product? The science and methodologies of risk assessment dates back over 50 years. For SEC to be included in regulatory systems, thresholds of acceptability will need to be established, which will take time. Methodologies need to be developed, tested, reviewed, retested and refined. This is not an overnight process, this would take a minimum of a decade. The only guarantee of haste is a bad choice.

Change is often not easily dealt with by society and cultures. The protests in Europe over nuclear energy in the 1970s is evidence of this. Today, nuclear energy is France’s leading source of energy production. Societies adapt to the innovations to their society. If the innovation is not favoured by the society, then the company withdraws it, such as irradiated food products. This is a safe technology that is not accepted and unfortunately people die from eating meat with high bacterial levels, which irradiation would solve. Because a society is struggling over the introduction of an innovation, encumbering that product with the heavy burden of SEC is not the answer. Scientific risk assessments can and will be done, at which point, the product needs to enter the system. Once this happens, consumers can use their purchasing power to decide whether to buy the product or reject it. Couching the fear of change in SEC does not bode well for the future of innovation.

Stuart Smyth
University of Saskatchewan

In response to Smyth, I must point out that his discussion of the WTO dispute is in great error.  The controversy had nothing to do with labeling --it was about a "moratorium" on GMO releases(which the EU said it didn't have BTW). The decision had 3 main parts, but the bottom line was that the EU (and also the member states)  had not shown by risk assessments that a ban on releases  was justified. The EU has refused/been unable to alter its policy and has suffered tariff consequences (this is the same way the US has reacted to a number of rulings which have held it to be in the wrong).

The conclusions:
(1) valid and complete risk assessments might well be upheld under the WTO SPS agreement (the European Food Safety Agency has been greatly criticized for the inadequacy of its assessments)

(2)The WTO has become a bit of a paper tiger in fact (although it still is a big stick waived by developed countries agaist the less developed countries), since its dispute rulings are increasingly disregarded and since its "legislative " functions have been stymied since Doha

(3) there are many other international agreements which countries might want to take into account

Finally, also in regard to Smyth's posting--he is raising many false dilemmas.  As I indicated in my first posting to this discussion, thousands of risk assessments taking into account socio-economic decsions have been performed by scores of governments, including his and my own. There is no mystery to how to do this (although there are various approches and methodologies).

The question of what level of risk is acceptable--ie the definition of "safe" is a public policy decision made by each country or appropriate jurisdiction.  No goal of zero risk should be implied, since we engage in many ordinary activities (from taking aspirins to flying in airplanes) which have well-established risks, yet we each consider them to be "safe enough".  So no red herrings, please (as we say in colloquial English).

BTW, the risk assessment process sketched out in Annex 3 of the Protocol is very broad in covering effects of effects--as we all do in real life (it isn't the rupture of the reactor at Fukushima that is itself the problem, it is the effects of the escape of radioactivity).  These are called "effect-chains" and are well understood and utilized in the literature (and they often include social and economic factors).

Colleagues, we are not inventing the wheel, here.

I differ a bit from Prof. Bereano's statement
"thousands of risk assessments taking into account socio-economic decsions have been performed by scores of governments, including his and my own. There is no mystery to how to do this (although there are various approches and methodologies)."

I presume that Prof. Bereano is writing about the thousands of environmental impact assessment conducted for regulatory and/or project approval purposes (e.g. dam and bridge construction for World Bank projects). As is the case with quite simple cost/benefit analysis, there is a substantial experience with these type of assessments.

However,as we have seen by experience we need better and more sophisticated approaches and methods to evaluate "Genetically Modified" and other LMOs impacts as simple methods can actually provide inaccurate and even misleading results especially when dealing with technology adoption processes that are quite different even with the ones observed not so long ago like with the maize and wheat during the "Green Revolution".

In a relatively narrow field of work such as economics, we are still facing the need for better methods to assess and evaluate LMOs diffusion and adoption impacts especially when dealing with broader social, economic and institutional issues such as food security, poverty alleviation, and livelihoods. While the discipline continues to develop better methods, we still have to use the workhorses such as economic surplus, cost/benefit or Net Present Value with the proviso that we have to carefully point our their limitation and ensure that decision makers understand these carefully. See Smale et al. 2009 for more details on methods and issues.

If we are talking about impacts of LMOs on biodiversity then the field is even thinner. In a narrow set of examining intra-specific agricultural biodiversity (e.g. maize varieties) you can see how methods have been sorely needed for such evaluations for many years. You can see these difficulties in Melinda Smale's book: "Valuing crop biodiversity: on-farm genetic resources and economic change" published by CABI.


References
1. Smale, Melinda; Zambrano, Patricia; Gruère, Guillaume P.; Falck-Zepeda, Jose´ Benjamin; 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. 2009.  Food Policy Review 10. Washington, D.C. International Food Policy Research Institute (IFPRI). http://www.ifpri.org/sites/default/files/publications/pv10.pdf http://dx.doi.org/10.2499/0896295117FPRev10

Thanks for the clarification on the WTO case. You are correct that it was the GM moratorium that was the heart of the case, not the 0.9% labeling threshold.  Apologies to all for the misinformation.

I have written extensively on the Canadian and American regulatory frameworks for transgenic crops and I can assure you, there are no socio-economic considerations in either country’s regulatory requirements. I would encourage you to expand upon what you view as socio-economic aspects of the Canadian and American system.

One point that has not emerged in the discussion thus far is how would a socio-economic consideration deal with the situation where a risk is identified. Would such a discovery simply mean the end of the assessment and the product would be rejected? Thus preventing release and ensuring that farmers are denied access to the beneficial technologies they require.

In the science-based risk assessment framework, when a risk is identified through the risk analysis component of a full risk assessment, the risk management component can then develop a strategy to mitigate the risk. For example, the release of Bt corn created the potential for the increase in resistance to develop in the control of corn borers. The identification of this risk resulted in the EPA requiring that a refugia of 20% be used to mitigate the potential for this risk to develop.

Another example from Canada, is the production of high erucic acid rapeseed (HEAR).  HEAR is not an LMO, but a conventionally created plant variety.  HEAR is not safe for human consumption and so the Canadian Food Inspection Agency (CFIA) requires that HEAR be produced through the use of a segregation system. The production is all contracted and there are specific production requirements that have to be followed and the CFIA has the right to inspect HEAR production at any time to monitor the efficacy of the segregation system.

In both cases, a risk associated with the release and production of both crops was clearly identified. Rather than prevent the release and the ensure that the benefits of the production of these crops could not be realized, a strategy was developed to mitigate the risks. The adoption rate of Bt corn clearly shows the benefits at the farm level, while the demand for HEAR production contracts is strong as well. It would have made no sense to ban farmers from benefiting from the release of these varieties due to the potential for risks to exist.

Further regulatory research revealed that the original buffer zone distance between field trial plots was insufficient. Instances occurred where GM pollen reached conventional varieties. In fact, a Canadian firm (Advanta), in 2000 sent breeder canola seed to Europe that was later discovered to contain 0.4% GM canola. The buffer zones were increased to take situations like this into account and ensure that such instances were minimized.

Current research that I am part of has compiled a database on the costs of regulatory approval for GM canola varieties in Canada. Using an econometric model, we can shock the model and test for the results of certain variable changes. The most interesting result was when we delayed the approval of the release of the new GM variety by 2 years, the resulting loss to farmers was $48 million. The three biotech firms had a combined loss of $65 million for a total loss to Canada of over $110 million. We expected the losses to the biotech firms to be high, but the size of the losses to the Canadian farmers is staggering. We have no reason to believe that similar losses would not be experienced by farmers in nations considering implementing socio-economic considerations as the inclusion of such regulatory requirements would easily add an additional 2 years to the variety release process.

Based on our research, we believe that delays in the regulatory systems for the approval and release of GM crop varieties reduce the benefits of these crop varieties to those that need them most, the farmers. Canadian farmers are not unlike farmers in other parts of the world, they require the best technology available, allowing them to stay in business. Of course the benefits to subsistence farmers are considerably more vital to their survival than is the case in Canada. Needless regulatory delays will simply continue to hurt those that are the poorest, in this case subsistence farmers in developing countries.

Stuart Smyth
University of Saskatchewan

I understand the argument about the costs of delay but I don’t think that in itself is reason enough for not including SEC.  I also disagree on the claim that the poorest will be hurt the most by delays. It is very likely that inside a country there will be winners and losers of adoption/release of LMOs. Some of the losers could be poor farmers or landless rural families (say due to reductions in labor demand) if that is the case a government might want to calculate the SEC impacts ex-ante to decide if the benefits of adoption/release outweighs the costs. Another possibility is that with this information governments can design before adoption/release programs to compensate the losers. If in fact losers are in a situation of poverty implementing these programs beforehand or at the time of LMOs release can be extremely important for preserving the wellbeing of poor households.

Alejandro

Hi Alejandro,

In my opinion, you are quite right. Cost of compliance should not be the only consideration, it is just one more issue to ponder upon in designing a system. In fact, in our paper with Jessica Bayer and George Norton we showed that regulatory delays are much more important than cost.

Furthermore, our paper was a bit abstract (and somewhat naive...well lets call it ceteris paribus) as it did not consider all the aspects involved in the biosafety decision. The issue is that you are in essence buying additional information in hopes of making a better decision where you are investing money now to do so, and you have to weigh this decision against delaying the stream of benefits for a later date. This quasi option problem is at the heart of the real options model. I would recommend the work done by Justus Wesseler, Matty Demont, Sara Scatasta, Ansink and others.

Some references of this full information Bayesian models include:

Ansink, E. and J. Wesseler (2009). Quantifying type I and type II errors in decisionmaking under uncertainty: the case of GM crops. Letters in Spatial and Resource Sciences 2 (1), 61{66.

Wesseler, J., S. Scatasta, and E. Nillesen (2007). The maximum incremental social tolerable irreversible costs (MISTICs) and other benets and costs of introducing transgenic maize in the EU-15. Pedobiologia 51 (3), 261{269.

Demont, M., J. Wesseler, and E. Tollens (2004). Biodiversity versus transgenic sugar beet: the one euro question. European Review of Agricultural Economics 31 (1), 1{18

Potential implications from the inclusion of socio-economic considerations into decision making

• Regulatory costs of compliance with biosafety regulations will increase.

Conducting a socio-economic study will have a cost attached to its implementation. The more complex and broader the selection of issues to include in an assessment, the more expensive a specific study will be to any developer. It is certainly not the same level of complexity to implement an economic study focused on a very specific topic (i.e. impact of exports /trade or impact on small scale producers) versus one that may examine impacts on biodiversity and long term sociological/anthropological issues. Choice in terms of scope will have different cost implications. A broader set of issues incorporated into a study will likely demand a multi-disciplinary team and is likely to have time and other resource implications for capacity strengthening.

Cost in a sense is not as important except in those situations where cost is high enough that it becomes an insurmountable hurdle to a developer. I am thinking specifically on the public sector in developing countries that are likely to develop technologies of a public good nature. In essence, introduction of additional regulatory hurdles can impact national and international public investments in research and development.

Introduction of socio-economic considerations can have another important impact and that is a reduction in the number of potential technologies available to producers and society. This may be a result of additional regulatory complexity, cost implications and/or uncertainty (see below).

• Potential regulatory delays can have a major impact in terms of economic benefits to society.

In a paper that I co-wrote with Jessica Bayer and George Norton (Bayer, Norton and Falck Zepeda 2010, attached to this message) we showed in a simple experiment that delays can have a big impact on the net benefits from four LMO  applications in the Philippines.  In this paper, we showed that even small delays of three years compared to the baseline can decrease significantly net benefits to producers and society. Increases in cost of compliance had a very small effect on net benefits.

• Society does gain knowledge and information on technology impacts and potential issues that may affect such outcome.

The issue is then to compare the immediate costs of compliance with biosafety regulations (this does apply not only to socio-economic considerations but also to the environmental and food/feed safety assessment), the delays in the onset of benefits, with the future gains in knowledge. The examination of these issues should consider the uncertainty surrounding these issues.

In set of papers (see Kikulwe, Wesseler and Falck Zepeda) we examined all of these issues within the scope of cost and benefit irreversibility in a real options model with an application to fungal (Black Sigatoka) resistant bananas in Uganda. Interestingly enough, we found out that even when considering all of these issues, every year that Uganda delays in approving such technologies, society loses 200-300 million US$.  Bananas are a staple crop in Uganda having large food security and poverty impact implications. The fungal resistant banana is being developed by the public sector.

Decision makers/regulators may face two distinct set of situations with increased knowledge. One, where additional knowledge may help weed out unsafe and/or undesirable technology/product as is may have a negative socio-economic impact. Second, a situation may exist were a technology that has been deemed as “safe” by the biosafety assessment process can actually be not approved due to an ex ante socio-economic assessment. These two cases open a lot of discussions in terms of the reliability/verifiability of SEC studies and who is the appropriate entity to make decisions about technology (i.e. producers versus SEC assessors versus regulators/decision makers).

• Potentially introduce more uncertainty to the biosafety regulatory process

A workable system can be defined as one where all elements of society are able to define, describe and trust the process and its outcome.  Society actors can thus judge the system based on transparency, participation ability, predictability and robustness. These attributes are important for society actors’ decision making processes.

For example, if developers (be it public or private sector) face a predictable regulatory system, they can attach a value on outcome and the respective probabilities of success into their decision making process. If developers cannot attach such probabilities the likelihood is that they will not make investments in such jurisdiction. The potential impact of uncertainty on the public sector will be of relevance to many developing countries who have already invested in developing products of their own (See Atanassov 2004). Uncertainty is connected directly with rules and standards for implementation and decision making.

• Inclusion of SEC may lead to an unworkable system if rules and standards are not clear or are open ended and subject to many interpretations

In most situations, the best alternative is to have rules and standards for implementation and decision making in implementing regulations. This is extremely important as the need may arise of changing procedures later on as the regulatory system gains experience and familiarity with products in the regulatory pipeline. Having an unworkable system, or one that cannot render a decision in a timely, cost efficient manner and whose decision is robust, protective and accepted by society; is not a desirable outcome and is a questionable use of scarce societal resources.

Please see the attachment for my comments; I am attempting to preserve a formatting to make my points clear given the size of the dialogue that has already been posted.

Posted on behalf of Koffi Dantsey:

First of all, I wuold like to thank CBD Secretariat to allow me to participe in the discussion on socio-economic considerations.

Article 26(1) focus on the following issues:
First, " Impact... on the conservation and sustainable use of biological diversity" arising from transbondary movement,handling and use of the LMO concerned. The impact may include the poteneffects on biologicaldiversity.
When the introduction of LMOs affects biological diversityin such a way that social or economic conditions may be affected, a Party can use Article 26 to justify taking into account such impacts on its social or economic conditions for purposesof making decision on iport of LMOs or implementing domestic measures.
Second , Article 26 identifies one particular socio economic consideration that Parties may take into account : value of biological diversity to indigenous and local communities. This particular socio economic consideration has a strong link with article 8(j) of CBD wich imposes on the Parties threebasic obligations with respect to knowledgeeees, innovations and practicies of indigenous and local communities embodying traditional lifestyles.
Considering the perspectives discribed ellow it is clear that socio economic considerations can cover different spectrum because they expressed a variety of actors including : farmers, consumers, industry, government, indigenous and local people, and cultural aspects including ethic and religion.
The following  qualitatif aspects of LMOs may be taken into account for study on socio economic study :
- Impacts from the balance of costs and benefits.
- Impacts related to yields- inputs and products(impacts at individual or houseold level).
- Impacts related to employment and labor.
- Environmental impact
- Gene flow and co-existance of LMOs with conventional agriculture.
- Health related impacts
- Impacts on human rights.
- Impacts related to Intellectual Property Right.
- Cultural/ indigenous and local communities impacts:
   * loss of genetic divercity and indigenous knowledges.
   * Impacts on cultural values.
   * Los of food diversity.
   * loss of seed from local varieties.
   * loss of local varieties.

Here are some points I thought would be important for the discussion and for future discussions:

1) Inclusion of socio-economic considerations under Article 26 of the CPB is voluntary. It is not a mandatory requirement.

2) The literal/strict interpretation of Article 26.1 of the Cartagena Protocol is that inclusion may consider impacts on biodiversity especially on local and indigenous communities. The inclusion of broader socio-economic and other considerations may be done under national laws and regulations.

The issue of whether Article 26 allows the inclusion of food/feed safety and public health considerations as part of its scope is a bit unclear to me. On the one hand, the CPB itself has mutated from a strict environmental treaty seeking to protect and enhance biodiversity while allowing the safe use of LMOs to one where it becomes a de facto risk assessment treaty for LMOS covering all general aspects in an evaluation system including environmental, food/feed safety and public health issues. Seems to me like this development is beyond the original intent of the CPB, but it has happened.

On the other hand, countries maintain the sovereign right within the scope of their international obligations to do what they want to do in terms of assessments. The question then becomes, what will the Parties choose a narrow/strict versus a broader interpretation of Article 26?  

3) Countries certainly have the sovereign right o make decisions in their national laws and regulations on:

a) Whether to include (or not) socio-economic considerations in their decision making,
b) Expand on the narrow definition of the article to broader considerations,
c) Define any implementation and decision making process, evaluation scope, implementing agencies and others. This implies that nations have the sovereign right to choose anywhere in between having a system with no requirement whatsoever and having broad assessments that include their choice of issues for considerations…and anything in between.

I believe, all participations in this forum to date have reaffirmed directly or indirectly this basic concept. We hope that countries while making their decisions take into consideration all potential development and implementation implications, both negative and positive.

4) Some countries parties to the CPB are planning to include or have already included socio-economic considerations in their decision making. Modalities vary from “narrow” economic impacts on trade and on their own export competivity to inclusion of broader social, ethical, and religious considerations.

5) Inclusion of socio-economic considerations has many implications which countries need to be aware in order to empower them in making an informed choice. Implications include
a) Increased regulatory compliance costs
b) Gains in knowledge about the potential technology in the hands of farmers
c) Reduction in the number and type of technologies available for release if cost increase binding to developer’s budget. This is of special interest to the public research sector.
d) Potential for selecting the best technologies (and to contrast with other potential alternatives) and to weed out those technologies that are not safe or may have a negative impact on biodiversity and other socio-economic issues.

Alternatively, inclusion of socio-economics issues in the regulatory decision making process can cause the rejection of safe technologies. This fact, calls the attention of how we are going to judge socio-economic studies for quality and robustness. Need to define how scientific peer review will be used in these situations. 

6) Implementation issues:
Developing a list of socio-economic issues for inclusion without considering implementation procedures can lead to an unworkable system. One cannot disassociate legal/policy/regulatory development with implementation; experience has shown that they need to be discussed simultaneously. Those of us who have been involved heavily with socio-economic assessments know the many limitations and issues that methods and approaches have in practice.

Yes, there is a lot of experience dealing with relatively simple assessment procedures such as simple cost/benefit, with different regulated technologies and activities, and yet as we discovered in our review of economic methods (see Smale et al. 2009) we need to develop more our methodological toolkit if we want to examine broader social and economic issues such as gender dimensions, impacts on poverty and food security, on public health and livelihoods. Much more needs to be done in terms of the nexus between LMOs and biodiversity.

In fact, once a practitioner starts dealing with the many complexities of LMOs and other innovative technologies especially in a developing country setting, he/she realizes the many limitations of past approaches. For example, if one conducts a producer survey in the early adoption stages, one runs the risk of introducing sampling and other statistical biases in the analysis.

In this situation the evaluation practitioner may choose the "best" producers simply because they were the majority of the first adopters even when doing a stratified random sample with sufficient observations for finding statistical significance. If one does a cost/benefit analysis with a biased positive bias for example, we can have over estimated positive outcomes. This is why we need to be careful in making decisions even with carefully done studies, as they are subject to variation. Making a decision based on such assessments has to be carefully done in practice.

Reference:
Measuring the economic impacts of transgenic crops in developing agriculture during the first decade : Approaches, findings, and future directions
2009. Smale, Melinda; Zambrano, Patricia; Gruère, Guillaume P.; Falck-Zepeda, Jose´ Benjamin; Matuschke, Ira; Horna, Daniela; Nagarajan, Latha; Yerramareddy, Indira; Jones, Hannah. Food policy review 10. Washington, D.C. International Food Policy Research Institute (IFPRI)
http://www.ifpri.org/sites/default/files/publications/pv10.pdf
http://dx.doi.org/10.2499/0896295117FPRev10

One more piece of the decision making puzzle that countries parties to the CPB need to consider is whether the inclusion of socio-economic considerations (the strict or the broader interpretation of such statements) will lead to a better regulatory outcome. In other words, will generating more and/or better information data lead to a better regulatory outcome?

Abstracting from the fact that “safety” is a fuzzy concept, this is a heavy question that requires a lot of thinking. For example, what is the regulatory outcome that we are considering? What type of information? Will society implement a complete a regulatory impact assessments and decision making process that will consider all costs, benefits and risk?

Let me put an explicit example and conduct a simple thought experiment. We at IFPRI conducted a desktop study of the potential economic impact from the introduction of a Bt cotton in West Africa (See Falck Zepeda  et al. 2008, and Falck Zepeda Horna and Smale 2008). Being a desktop study done just when the technology had been given the permit for deliberate release by the competent authority in Burkina Faso, this is a typical ex ante study with no primary data collection (no surveys were done).  A conclusion of that specific study was:

“Can farmers in West Africa gain from the introduction of Bt cotton technology? Taking into consideration the limitations of this study and the caveats enumerated, there is a real potential for farmers in the region to gain from adopting the technology. Our model suggests that these farmers would lose by not adopting Bt cotton while farmers in the rest of the world benefit. Although we find the changes in economic surplus to be smaller than those previously reported in the literature, we believe that our estimations are relatively robust because the underlying assumptions are conservative, damage abatement effects have been considered, and we have applied stochastic simulation analysis to capture variability.”

If a competent authority be it in Burkina Faso and/or any other West African country had seen this study as a requirement for approval for deliberate release, would it had improved the regulatory outcome? I will argue here that it is very debatable that having this information contributes to improving the regulatory outcome of having technologies that can be considered “safe” based on the agreed regulatory standard. In fact, fail to see how this economic study contributes to the environmental and/or food/feed safety assessment at all in here.

Well, we do introduce the notion of production and financial risk, as well as, food security and livelihoods into the discussion. Are these issues under the purview of the Cartagena Protocol on Biosafety? In my mind they belong under the in-country decision making process for technology approval. Note at the same time all the caveats and assumptions used in our simulations. Issue then is basing a regulatory decision on studies which are full of uncertainties themselves, which brings us back to the judging the quality of such studies that may be used for regulatory decisions.

References
1. Falck Zepeda, J.B., D. Horna, P. Zambrano and M. Smale. “Policy and Institutional Factors and the Distribution of Economic Benefits and Risk
from the Adoption of Insect Resistant (Bt) Cotton in West Africa.” 2008. Asian Biotechnology Development Review 11(1):1-32.
2. Falck Zepeda, J., D. Horna and M. Smale. “Distribution of economic benefits and risk from the adoption of insect resistant cotton in West Africa” 2008. African Journal of Agricultural and Resource Economics.

Many thanks to Dr Zepeda for his important contribution in the quality of discussions. I join the idea of the introduction of the notion of production and financial risk in addition to food security
This will allow to link this proposition with Cartagena Protocol on biosafety particularly dispositions related to SEC .

Just a small clarification. We did include production and financial risk in our assessments and concur that they are important for decision making. Inclusion of such considerations was done within a complete assessment and analysis that included not only risk but also benefits and costs. In this sense it was a decision making under risk approach.

Continuing our simple experiment, if we had submitted a study such as the one we did in Uganda (see Kikulwe et al 2011, and Kikulwe 2010) were we did collect data 450 or so improved and traditional variety-using banana farmer and consumers. Would this have made a difference in a regulatory outcome? 

Note that the Black Sigatoka resistant variety developed by NARO-Uganda/ABSPII and University of Leuven described in Kikulwe's study has been approved only for confined field trials in Uganda. Kikulwe used state-of-the-art real options and latent class models in his simulations and estimates...Lots of social and economic issues, and some regarding banana biodiversity related to technology development.

In our West Africa study we also recommended the following:

“Policies and institutional arrangements in the cotton value chain may also support the continuity of the adoption process in countries, counteracting the fluctuating adoption rates depicted in
Scenario 5. There is a need for West African policy makers to address technical, biophysical and institutional issues that could cause dis-adoption before (rather than after) Bt cotton is released. A drop in producer surplus caused by dis-adoption affects not only total benefits but also the distribution of benefits, shifting a larger share to the innovator.”

The question then becomes, will the biosafety competent authority not approve a technology, because the results from the socio-economic study were not as good as other studies although still positive. Even more, the results from the Bt cotton simulation depended on the institutional setting that the cotton sector operates in those countries. In essence, indicating the fact that the estimated net present value from Bt cotton adoption in our study depended on issues that had nothing to do with the technology itself. Thus, should then the regulatory agency reject the technology based on these facts? Would then the decision be that the technology can be approved when those institutional issues are resolved? Does the regulatory competent authority even have this mandate?

This brings us to the final issue I wanted to put on the table.  In many decisions I have seen regarding the technical biosafety assessment, there is scope for risk mitigation. Then the implication should be that there should be equally an option for the mitigation of socio-economic impacts and/or risk. Will then competent authorities have the mandate to monitor and evaluate compliance with such socio-economic mitigation efforts? More issues to ponder…


References:
1. Kikulwe, E.M., E. Birol, J. Wesseler, J. Falck-Zepeda. A latent class approach to investigating demand for genetically modified banana in Uganda Agricultural Economics. Publication Forthcoming 2011.
2. Kikulwe, E.M. 2010.”On the introduction of genetically modified bananas in Uganda:
3. Social benefits, costs, and consumer preferences” A published Ph.D. dissertation at Wageningen University, The Netherlands. Thesis committee Prof. dr. E.C. van Ierland, Dr. J.H.H. Wesseler, Dr. J.B. Falck-Zepeda, Prof. dr. ir. A.G.J.M. Oude Lansink, Prof. dr. R.L. Paarlberg, Dr. M. Smale, Prof. E. Tollens.

First of all, I would like to thank the CBD Secretariat for allowing me
to take part in the discussion on socio-economic considerations. I have
followed the discussion thoughtfully.

As pointed out in previous comments, under Article 26.1 of the Protocol,
socio-economic considerations can be interpreted to be limited to
socio-economic considerations arising from the impact of LMOs on the
conservation and sustainable use of biological diversity, especially
with regard to the value of biological diversity to indigenous and local
communities. And that the Protocol sets minimum standards and Parties
have the sovereign right to take stricter action as defined by their
national needs.

The introductionof GM crops in Uruguay (maize and soybean) and other
countries in the region, has led to a number of impacts: concentration
of land and production, low level of employment generation and expulsion
of rural producers. It has also generated environmental impacts due to
the massive use of agrochemicals causing contamination of the
populations that live close to these crops or rural schools which are
surrounded by them, as well as destruction of flora and fauna and
natural resources, which ultimately all result in socioeconomic impacts.

I believe that there are enougharguments and impacts that have led to
the introduction of GM crops and most of these impacts are not seen as
socioeconomic, but they are, and should therefore be taken into account
in the context of Article 26.

In relation to the discussion about the use of the word "/release/", I
would like to make a comment. From my point of view the correct word
should be /introduced/ and not "released". The word /"released"/ implies
something positive, which in this case is contested by many people who
argue that the introduction of LMOs to the environment is causing a lot
of negative impacts. On the other hand, the word "introduced" is a
factual neutral word which can be used by both sides of the argument.

María Isabel Cárcamo
Pesticide Action Network Uruguay

--

RAP-AL Uruguay
Red de Acción en Plaguicidas
y sus Alternativas para América Latina
Ana Monterroso de Lavalleja 2112 Ap. 802 - CP 11200
Tel: 598 2401 2834 Fax: 598 2401 2834
e-mail: coord@rapaluruguay.org
Celular: 099 613193
http://www.rapaluruguay.org/

Dear all, I have been on two meetings during the last week and had no time to reply on the messages. There is one issue which I would like to raise and which might be useful to be discussed further. It relates to the dadption of existing formats of socioeconomic analyses to biosafety matters.

It is clear that socioeconomic assessments could be be done ex ante and ex post, in analogy to risk assessment and monitoring. When considering the time point for an ex ante assessment it becomes obvious that there are various time point at which a socioeconomic assessment might be useful. In relation to these time points, the character and purpose of the assessment might vary. As with risk assessment, ex ante socioeconomic assessment could take place at different stages in the LMO development und market introduction. In these cases, the socioeconomic assessment would be more or less closely connected to a certain LMO.

But we could also think about socioeconomic assessments that can be done before a certain LMO will be developed or that can be done within the context of drafting policies or legislation. Such assessment could be used to give guidance to policy makers or to assist companies or public institutions to make better informed decisions which technologies or traits should be used in a specific societal setting to develop certain seeds or food products.

The positioning of the assessment is also of some importance for the question who should bear the costs for the assessment. If it is done early for policy and research advice, the costs are more likely to be covered by governmental budgets. If the assessment is closely linked to a specific LMO approval, the applicant will have to cover some costs - be it directly for a governmental assessment or through providing data and studies.

During the discussion, I had the feeling that many comments were written in a way as if there are no instruments available and as if "we" had to invent and develop a very new system. What is certainly true and had been stated is that obviously no government has yet developed a detailed process how to conduct socioeconomic assessments if required or done ad hoc.

But we should not forget that both the CBD and the OECD have in recent time developed guidance to conduct strategic environmental assessments (SEA)  in environmental decision making. The concept of such SEA have been developed in the 1990s and are applied by many countries meanwhile. In the context of SEA, socioeconomic assessment play a major role.

BUT: although taken up and developed further by the CBD, SEA have not been suggested to be applied in the context of biosafety yet. One reason might be the broader character of SEA in relation to the established risk assessment. SEA have been developed to be applied to policies, programmes and projects while risk assessment in the biosafety context focus on specific organisms. A closer look into the concept and methodologies can certainly reveal to which extent the experience of countries with SEA can also be useful in biosafety matters.

One specific issue in SEA is the task to conduct public consultations to ensure public participation. Since MOP-5 has adopted a programme of work on public participation, there might be even more incentives in trying to look for synergies between the two processes.

A next issue that is different between current SEAs and SEAs in biosafety is the trade-sensitivity of biosafety issues. While SEA on a certain national environmental policy or land-planning process does not necessarily has greater trade impliations, itis more likely to have this in biosafety. Currently, SEA processes are being applied in the field of biofuels. Here we have to deal with import of goods, sustainability criteria that take into consideration the agricultural production in the exporting country etc. These issues are certainly of relevance for trade. A more thorough assessment of SEA for biofuels in relation to biosafety might give ideas how to adapt the concepts and procedures.

I would strongly recommend - and already have done this within GIZ - that there should be a closer contact between those experts working on SEA under the guidance of the CBD and OECD and those discussing the matter of SEC under the CPB.

some references:

CBD (2004) Decision VI/7. Identification, monitoring, indicators and assessments. Guidelines for incorporating biodiversityrelated issues into environmental-impact-assessment legislation or processes and in strategic impact assessment.
http://www.cbd.int/decision/cop/?id=7181

CBD (2006) CBD Technical Series No. 26 - Biodiversity in Impact Assessment. Background Document to CBD Decision VIII/28: Voluntary Guidelines on Biodiversity-Inclusive Impact Assessment. [attached]

OECD (2006) Applying strategic environmental assessment. Good Practice guidance for development cooperation. [attached]

OECD (2008) Strategic environmental assessment and ecosystem services. [attached]

I would like to remind the participants that this discussion forum has a clear aim. The mandate for it was given at MOP-5 by the Members of the CPB in Decision BS-V/3:

24. Requests the Executive Secretary to convene regional online conferences to: (i) facilitate the exchange of views, information and experiences on socio-economic considerations on a regional basis; and (ii) identify possible issues for further consideration;

28. Requests the Executive Secretary to synthesize the outcomes of the online conferences and workshop referred to in paragraphs 24 and 25 above and submit a report to the sixth meeting of the Parties for consideration of further steps;

In addition to that the next meeting of the Liaison Group on Capacity Building next week is also going to discuss the matter and will certainly profit from our discussion in the online forum.

That means that we are participating to support the members of the CPB in further structuring the discussion on capacity building in SEC. We are not here to increase the confusion about the topic - there is enough confusion already in my opinion - or to construct cases to show that SEC will be no option for the members of the CPB before they had the possibility to come to own conclusions.

We all know well that our institutional and economic background will shape our work and the results to a large extent (see below for two interesting publications related to GE crops and biosafety). In this forum, we should use the diversity of our opinions, approaches and knowledge to come up with a good description of the issues which are up for discussion for the CPB members, with a sound analysis of the tasks which will be demanding and may also pose problems if the approaches to SEC are not well thought through. And we need to present existing ways to include SEC into governmental decision making specifically in the field of biodiversity and development, we need to present options for different choices.

In this context the legal requirements for example in Norway or Mexico are of high relevance - this was also the reason why we have choosen these examples to be presented at a previous capacity building meeting on SEC. Norway demands an sustainability impact assessment as part of the approval for GMO importations. In Mexico the plantation of GE maize can be restricted in areas where traditional maize varieties are prevalent. This provision is a result of the deliberations of the commission for environmental cooperation in North America in which SEC where a major topic. We have the example of the South African government that rejected the application for a GE wine yeast on the basis of SEC, the government had also stopped (temporarily?) the approval process for certain GM events for trade reasons. As far as I know, Argentina is/was not approving GE maize events that are not cleared for importation into the EU. We might find more example were SEC are used as one basis for decision making. Non of these laws or decisions have been brought to the WTO by GMO growing/producing WTO members. Such examples need to be compiled and presented to the CPB members to give them a realistic overview about the field.

I am convinced that we can draw a lot from the contributions to this forum - when we have started to use this method to prepare the discussion in the Coordination Mechanism for Capacity Building we experienced a fairly low participation which made it not easy to give a useful input for the following meeting. This has really changed meanwhile!

----------

Association of financial or professional conflict of interest to research outcomes on health risks or nutritional assessment studies of genetically modified products
Johan Diels, Mario Cunha, Célia Manaia, Bernardo Sabugosa-Madeira and Margarida Silva
Food Policy Volume 36, Issue 2, April 2011, Pages 197-203
<http://tinyurl.com/438y4go>

Scientists' perspectives on the deliberate release of GM crops
Valborg Kvakkestad, Froydis Gillund, Kamilla Anette Kjolberg, Arild Vatn
Environmental Values, Volume 16, Number 1, February 2007, Pages 79-104
<http://www.ingentaconnect.com/content/whp/ev/2007/00000016/00000001/art00007>

Dear all,

I shall start by reacting to one of the last messages I appreciated the
most: this of Alejandro Lopez Feldman, saying that inside a country, "
there will be winners and losers of adoption/release of LMOs". Indeed,
if a socio-economic assessment is taking into account enough concerned
aspects, the situation will probably not always be totally black or
totally white for everybody and the environment.
And indeed, the results could be different in different countries,
because the results that can generate a technology cannot be considered
in absolute theoretical terms out of the real context where that
technology would be used .( About that, for ex., implementation,
controls, monitoring, of a risky technology have always to take into
account the real human situation of the practicability of the controls,
the education and the number of the people in charge of those
activities) . Those socio-economic studies would precisely be useful to
inform on the real context and the real results that can be expected.  
And the results would logically not be simple, monolithic, linear. And,
I agree with Philip Bereano that it would be the duty of political
decidors to make a choice, taking into account, integrating, weighing
the different elements of that complexity reflecting real life; in
democratic countries, the choice should be based on public acceptance
for certain types of risks.

And, indeed, as proposed by Alejandro Lopez, the complex information
gathered could help eventually designing compensations for the "
loosers" .
But that "compensation" should precisely not be made at all costs; I
hope we all agree that new technologies, new methods, have to serve
human well-being and future of mankind, and not the reverse ( human
population has not to adapt at all costs to new technologies perceived
as having globally negative impacts by a clearly largest part of the
public ).

Innovations, changes, are not necessarily good at any cost just because
they are innovations and  changes.
And, because of the present rapidity of spreading over the world and of
deceptions in front of some innovations, a still bigger part of
reasoning public has the legitimate wish to ask for accountability and
responsibility before engaging widely in big societal changes.
So, article 26 of the Protocol is the result of a demand that has to be
respected, which, indeed, does not mean that it is easy to implement.

Anyway, even if not perfect and able to give 100 % sure previsions, ex
ante studies can be made, as recognized by several expert participants
in this forum. ( I, among many other people, doubt that companies do not
make ex ante socio-economic studies before developing a new
product.......And those studies probably take into account present
knowledge on human psychology with its easily changing opinion on some
matters and stubbornness on other ones) .

Indeed, the type of socio-economic studies usefull here are probably
different from most of those that were practised till now. But,
precisely, there is room for innovation....
As mentionned by Dr. Meyer, SEA involve socioeconomic assessments, but
rather for global policies, programmes and projects than for specific
products or organisms.
This brings me back to my previous message saying that socio-economical
assessments could be made at a generic level, and not necessarily case
by case for each LMO. ( Indeed, while they are scientific reasons to
assess different events of the same LMO - same species and same trait -
case by case for evaluation of biosafety risks, this logically is not
necessarily justified for socio-economical assessments. ); that would
avoid a heavy supplementary assessment on each LMO file.
Dr. Meyer develops the same idea saying that assessments on LMOs could
be made " to give guidance to policy makers or to assist companies or
public institutions  to make better informed decisions which
technologies or traits should be used in a specific societal setting
..... " . ( One should discuss further on which categories of LMOs
should be considered;  for ex.: combination of species and trait and
problem to solve; combination of species and use, ..... ) . That would
be closer to the concept of SEA. And if done at a generic level, it
would also more easily give the opportunity to make comparisons, for
various criteria, with various other technologies intended to lead to
similar results. 

I take this opportunity to confirm that biosafety risk assessments and
socio-economic risk assessments are not as different as some people tend
to depict it, concerning the confidence that one can put in their
respective results. I am expressing here through my experience as a
member of a consultative biosafety council and as a participant in
discussions about that matter at the EU level. Lack of consensus between
experts are not just on silly details ( or on the fact that some would
like zero risk ) but also on methodologies ( some of which, that should
be useful to implement correctly the legislations, have still to be
developed or improved ), on elements to take into account, on the fact
that lab. results could be suffisant or not to draw rather sure
conclusions without having to make field trials, etc......... This is
not a reason not to do any assessment and not to engage in improving or
developing the best methodologies possible. Debates are occuring
presently at the EU level to still improve the situation.

For what could be the threshold of impact acceptability, there are also
similarities between the biosafety risk assessments and the potential
socio-economic assessments.
Ecosystem and agro-ecosystem functionning knowledge are still very young
sciences, the object of the study is complex, scientifically acceptable
levels of modifications (in order not to bring major disturbances in the
ecosystem) are not yet known in many cases, and legislations determining
precise "limits of concern" in biodiversity impacts are still scarce.
They should be progressively developed in particular to implement
decisions of COPs of the CBD. Here also, political decisions have to be
taken in front of various forms of uncertainties, like foreseen by the
Cartagena Protocol. The way to present and even the fact to present some
uncertainties is also a matter of debate beween experts. The fact is
that political decidors would prefer to be confronted with simple
scientific data on the basis of which they could take decisions easily.


All these considerations on methodologies and their difficulties should
actually be dealt with in a next session of these online discussions,
and bring us far from the object of this session which was in particular
to discuss on the socio-economic considerations that Parties may take
into account in the context of Art. 26 of the Protocol .
In addition to these mentionned in the questionnaire of the SCBD,
complements and details on socio-economic aspects to take into account
have been mostly brought by
Mihaela Antofie, Rosa Binimelis Adell, Motlalepula Pholo, Mahaman Gado
Zaki, Antonio Turrent, and somehow Ms. Li Ching Lin and Gregory Jaffe in
the contextof WTO obligations.
It seems clear from the various interventions that when considering
conservation and sustainable use of biodiversity, especially taking into
account of biodiversity importance for indigenous and local populations,
what is meant, among other, is the preservation in situ and sustainable
use of the integrity ( no volunteer crossing or unvolunteer
"contamination" with LMOs ) of traditionally used species and varieties,
that can be useful for local food, medicines, construction material,
traditional festivities and ceremonies etc ....., but that can also be
useful for the whole mankind for ex. For food security to face the
challenges of climate changes. Ecosystem preservation with their
functions and services is also concerned, and thus their economic value.


To the socio-economic elements to take into account already mentioned, I
would add:
- global resource efficiency of the agro-ecosystem ( impact of changes
in water, energy, renewable or non-reneweble intrants as fertilizers and
pesticides, use of by-products, ... )
- economic impacts of changes in land use ( for the various stakeholders
concerned ) .
- socio-cultural impacts of changes in land use.
- touristical, aesthetical value of particular elements of biodiversity,
sites, landscapes and ecosystems.


I hope and suppose that the precise wording and meaning of elements
listed could be further discussed at a later stage ( it should be the
case in the list in the questionnaire of the SCBD in particular for "
Labour and Employement " , "Land tenure" , Farmers' Rights, .......... )
.


Concerning the examples I had asked relatively to the WTO : I know well
the controversy between the EU on one hand and USA, Canada and Argentina
on the other hand
relatively to GMOs. But what I was asking are rather examples relative
to other kind of products where countries would have justified
restriction in trade by "public morals" reasons, or by "conservation of
exhaustible natural resources", and how did these cases evolve ?

I would like to thank Dr.Meyer for his last message. 

With best regards.





  





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

Since this conversation is getting to be quite long, and full of interesting information and opinions, I will make these remarks short and concise:

(1) My references to the thousands of assessments in the USA using social and economic factors was specifically to Environmental Impact Statements (EIS)required under federal law (“NEPA” ) or state law (“SEPS”).  Any of these terms, if googled, should bring up a great many examples.

(2) There are essentially NO US examples of LMO assessments because the US government (except for a few EPA situations) does not do them—it relies solely on industry submissions, without any methodology for systematically checking these.  So much for the repeated, but false, claims of “scientific” evaluations.

(3) This is why there has been very public and contentious litigation in the US on 2 recent LMOs—alfalfa and sugar beets.  In each case, the courts have held that the government FAILED to fully assess the impacts—socio-economic as well as to the environment and human health—and required the agencies to do so.

(4) One example that I am aware of from Canada was the rejection of r-BGH by Health Canada, relying on adverse health effects on cows.  These are not only negative impacts on their own, but cost farmers money—ie, an economic concern.

(5) All LMOs have been subjected to a type of socio-economic analysis before even being proposed for commercialization.  That is, of course, by the company proposing them.  However, this evaluation is PARTIAL, since it only looks at effects on the company (and its profits), although any massive negative social impact that would hinder sales would also be taken into account.

(6) Many of the postings refer to MODELS rather than actual studies.  Models are merely analogies, and, as such, embody  differences as well as similarities compared to the real world. We know that  the failure of governments and the industry to fund research on the consequences of LMOs is the main reason for the continued uncertainty in this regard. Models based on such a paucity of real information are not very useful.

(7) We should not confuse the issues of HOW to do a socio-economic study with the question of WHY to do it (its end points or utility).  The latter is set by risk managers and the political system.  Smyth’s questions about these matters are posed in a vacuum—in the real world, the evaluators know precisely what the end points are, as the thousands of examples  referred to in #1 above clearly show (eg, for a corporate evaluation, “will this make us money, and if so, how much ?”). Most real world situations clearly call for investigation of possible mitigation of any adverse effects (see again #1 above)

(8) I agree completely with the suggestion in Flanderoy’s last posting---it is not only the EXISTENCE of consequences, but their DISTRIBUTION among the population and social groups that makes such studies important and sometime contentious.  We are NOT “all in this together”—certain groups get more benefits and others bear more risks and costs. This is the reason that all these studies are basically political, no matter how ‘scientific’ our methodological instruments are. So, for example, in the real world, poor farmers are often hurt badly by the switch to LMOs, economically and socially; there are numerous stories of such consequences on the internet (eg, the significant number of suicides of Indian farmers who cannot afford the debt payments imposed by LMO-usage and other industrial agricultural methods.

(9) The framework for doing assessments under the Protocol is given in Annex III.  Language there is sufficiently broad to permit countries to include SECs:
• Sec 1.   identify and evaluate the potential adverse effects
taking also into account risks to human health
• Sec 2.  can take into account expert advice of, and guidelines developed by, relevant international organizations.
• Sec 8c.    An evaluation of the consequences should these adverse effects be realized
• Sec 8d. estimation of the overall risk posed by the living modified organism based on the evaluation of the likelihood and consequences of the identified adverse effects being realized;
[8 c and d show that indirect, higher-order consequences should be taken into account]
• Sec 8e.    A recommendation as to whether or not the risks are acceptable or manageable

Posted on behalf of Carlos Almendares:

In my particular way of thinking, I will insist that the SEC issue should be handled by the decision of each government according to its internal rules, leaving out passions of any kind.


Carlos Almendares

Dear Carlos,

I completely support your statement as it is indeed your right and the right of your country to decide any approach you decide. This right has to be respected and supported regardless of what approach one country takes towards biosafety as long as it is compliant with its international obligations.

In fact, what I have provided up to now are the components for a decision making framework that hopefully will help countries decide what they want to do in terms of policies, laws and regulations.

As part of an international food policy research organizations (IFPRI) I have a duty and an obligation to not only address the issues at the CPB level but also at the regional and national levels.

I am one of those who thinks that law, policy and regulatory development cannot avoid thinking about implementation during the gestation phase where countries decide on their own approach. In the end, the endpoint of any international protocol (such as the CPB) are the national level decisions who have to self implement the minimum floor established by the international protocol.

It is my personal opinion that disassociating the CPB discussions from the potential discussions and decisions that can be made at the national level, may not take into account the capacity and abilities that countries may have (or may acquire in the near future) and those that will be needed by any law/policy/regulation that may be discussed at the international level. In fact may this may lead for some countries in a quite difficult position to implement regulations that may not be even feasible in practice or who may affect other policy relevant areas beyond biosafety.

Dear Ms. Lucette Flandroy:
   I would like to add comments concerning the introduction/release of LMO to countries. I will discuss two issues that I believe are central to this exercise.
Clearly, the stakeholders in an introduction/release of LMO in a country include government, crop biodiversity and associated technologies, LMO technology developers, adopting producers, non adopting producers, consumers, non-consumers vulnerable to damage, independent scientists, society as a whole and ecology.  I believe that in order to “help members of CPB in further structuring capacity building in SEC” as Hartmut Meyer reminds us, we must approach the issue with a balanced consideration of all stakeholders.  In our participation in this forum we have expressed views that are identifiably akin to some of the stakeholders. My hope is that we all continue to bear our responsibility with objectivity.

ISSUE 1
   I chose the polemics around contributions of classical plant breeding and of breeding through genetic engineering as a focal point of reflection. I propose that this issue is central to our discussions because it is the genesis of risk in LMO introduction/release. There are those who argue that the latter breeding method is a continuation of the former method but it is more precise. Hence, it offers improved safety for human consumption. Whatever our position on this issue is, it is clear to me that in classical plant breeding, no prediction on the total effect of an apparently favorable allele (natural variability) can be made. This is so because of unknown Pleiotropic, Epistatic and collateral effects. Consequently, the total allele effect can only be known a posteriori, i.e., there is uncertainty.  It cannot be predicted whether or not a superior wheat variety developed through classical plant breeding will be allergenic to a fraction of consumers. The same is the case of certain apple cultivars.  However, breeding through genetic engineering adds uncertainty to a superior phenotype developed through classical plant breeding. This is so because a) it builds on superior phenotypes developed through classical plant breeding, and b) it carries its own uncertainties: Epistatic, pleiotropic and collateral effects of the transgenic cassette (structural and marker genes plus constitutive promoter) cannot be predicted either. Some would argue and present evidence (Séralini et al., 2007) that the increased uncertainty could be highly significant due to the novelty of the transgenic trait to the species. Such total effect can only be known through ex post evaluation. This evaluation must respond to human safety in first place, but also to other sources of concern like crop biodiversity [native maize landraces in Mexico, Central and Southamerica, brinjal (eggplant) in India], the receiving environment, and other legitimate concerns of all stakeholders.

ISSUE 2
   An additional issue involves questions on what LMOs have to offer to all stakeholders: a) How effective and sustainable are the novel traits? b) How significant is the alleged LMO reduction of production cost on crop commodity price as compared to policy effects of big exporting countries? I do not believe that there are a priori definite answers to these questions.

   I will only deal with the first question. About 11 percent of the 1530 million hectares of the world´s farm land is managed with LMO technology that focuses on pest and weed control (mostly cotton, maize, soybeans and canola). The sheer size of it speaks for a high degree of acceptance by stakeholders. This technology offers operational advantages to producers over the reliance on synthetic pesticide or biological control. These operational advantages are akin mostly to the industrial agricultural model, largely characterized by economies of scale and by monocropping. (It would be nice to know  farm size frequencies of this operation). LMO technology depends heavily on postponing the inevitable development of resistance or adaptation of pests and weeds. Several strategies like “the refuge and transgene cassette stacking” are being pursued. There is evidence though, that the refuge strategy is more frequently complied by large scale farming units than by small farming units. The Vaalharts irrigation scheme in South Africa offers an example of how small farming (less than 25 hectares) failed to comply with the refuge strategy and how the stem borer (Busseola fusca) developed resistance to Bt maize 10 years after introduction/release of Bt maize (Kruger et al., 2009). The Argentinean case of Johnsongrass (Sorghum halepense) developing resistance to glyphosate is a case that involves large farming of roundup ready soybeans (Binimelis et al., in press; CONICET, 2009). 
    
  Ex ante and ex post evaluations of risk provide objective criteria for the decision of a sovereign government on introducing/releasing LMO technology or prohibiting it thereafter.  However, as Professor Bereano sustains and provides evidence of, there are conflicting interests when the developers of LMO technology provide the critical results for decision making. Their procedures are anything but transparent.  I agree with Gregory Jeff on the critical need for transparency in the whole process leading to the decision by government. I further believe that the necessary research leading to government decisions should be exclusively funded by the public sector, conducted by independent scientists and open to all stakeholders. Certainly, the developers of LMO technology need to conduct the necessary evaluations to reach their own commercial decisions.  
 
LITERATURE CONSULTED
Binimelis R., W. Pengue, and I. Monterroso. “Transgenic Treadmill”: response to the emergence and spread of glyphosate resistance of Jhonsongrass in Argentine. Geoforum. In press.

Consejo Nacional de Investigación Científica y Tecnológica (CONICET). 2009. Evaluación de la información científica vinculada al glifosato en su incidencia sobre la salud humana y el ambiente.  http://www.fundacion-campo.org/userfiles/prensa/glifosatoinfoconicet09.pdf (consultado el 2 de abril de 2011)

Kruger M., J.B.J. Van Rensburg, and J. Van den Gerg. 2009. Perspective on the development of stem borer resistance to Bt maize and refuge compliance at the Vaalharts irrigation scheme in South Africa. Crop Protection. 28(8): 684-689

Séralini G.E., D. Cellier, and J.S. de Vendomois. 2007. New analysis of a rat feeding study with a genetically modified maize reveals signs of hepatorenal toxicity. Arch. Environ. Contam. And Toxicol. 52(4):596-602.

Dear Ms. Lucette Flandroy:
   I would like to add comments concerning the introduction/release of LMO to countries. I will discuss two issues that I believe are central to this exercise.
Clearly, the stakeholders in an introduction/release of LMO in a country include government, crop biodiversity and associated technologies, LMO technology developers, adopting producers, non adopting producers, consumers, non-consumers vulnerable to damage, independent scientists, society as a whole and ecology.  I believe that in order to “help members of CPB in further structuring capacity building in SEC” as Hartmut Meyer reminds us, we must approach the issue with a balanced consideration of all stakeholders.  In our participation in this forum we have expressed views that are identifiably akin to some of the stakeholders. My hope is that we all continue to bear our responsibility with objectivity.

ISSUE 1
   I chose the polemics around contributions of classical plant breeding and of breeding through genetic engineering as a focal point of reflection. I propose that this issue is central to our discussions because it is the genesis of risk in LMO introduction/release. There are those who argue that the latter breeding method is a continuation of the former method but it is more precise. Hence, it offers improved safety for human consumption. Whatever our position on this issue is, it is clear to me that in classical plant breeding, no prediction on the total effect of an apparently favorable allele (natural variability) can be made. This is so because of unknown Pleiotropic, Epistatic and collateral effects. Consequently, the total allele effect can only be known a posteriori, i.e., there is uncertainty.  It cannot be predicted whether or not a superior wheat variety developed through classical plant breeding will be allergenic to a fraction of consumers. The same is the case of certain apple cultivars.  However, breeding through genetic engineering adds uncertainty to a superior phenotype developed through classical plant breeding. This is so because a) it builds on superior phenotypes developed through classical plant breeding, and b) it carries its own uncertainties: Epistatic, pleiotropic and collateral effects of the transgenic cassette (structural and marker genes plus constitutive promoter) cannot be predicted either. Some would argue and present evidence (Séralini et al., 2007) that the increased uncertainty could be highly significant due to the novelty of the transgenic trait to the species. Such total effect can only be known through ex post evaluation. This evaluation must respond to human safety in first place, but also to other sources of concern like crop biodiversity [native maize landraces in Mexico, Central and Southamerica, brinjal (eggplant) in India], the receiving environment, and other legitimate concerns of all stakeholders.

ISSUE 2
   An additional issue involves questions on what LMOs have to offer to all stakeholders: a) How effective and sustainable are the novel traits? b) How significant is the alleged LMO reduction of production cost on crop commodity price as compared to policy effects of big exporting countries? I do not believe that there are a priori definite answers to these questions.

   I will only deal with the first question. About 11 percent of the 1530 million hectares of the world´s farm land is managed with LMO technology that focuses on pest and weed control (mostly cotton, maize, soybeans and canola). The sheer size of it speaks for a high degree of acceptance by stakeholders. This technology offers operational advantages to producers over the reliance on synthetic pesticide or biological control. These operational advantages are akin mostly to the industrial agricultural model, largely characterized by economies of scale and by monocropping. (It would be nice to know  farm size frequencies of this operation). LMO technology depends heavily on postponing the inevitable development of resistance or adaptation of pests and weeds. Several strategies like “the refuge and transgene cassette stacking” are being pursued. There is evidence though, that the refuge strategy is more frequently complied by large scale farming units than by small farming units. The Vaalharts irrigation scheme in South Africa offers an example of how small farming (less than 25 hectares) failed to comply with the refuge strategy and how the stem borer (Busseola fusca) developed resistance to Bt maize 10 years after introduction/release of Bt maize (Kruger et al., 2009). The Argentinean case of Johnsongrass (Sorghum halepense) developing resistance to glyphosate is a case that involves large farming of roundup ready soybeans (Binimelis et al., in press; CONICET, 2009). 
    
  Ex ante and ex post evaluations of risk provide objective criteria for the decision of a sovereign government on introducing/releasing LMO technology or prohibiting it thereafter.  However, as Professor Bereano sustains and provides evidence of, there are conflicting interests when the developers of LMO technology provide the critical results for decision making. Their procedures are anything but transparent.  I agree with Gregory Jeff on the critical need for transparency in the whole process leading to the decision by government. I further believe that the necessary research leading to government decisions should be exclusively funded by the public sector, conducted by independent scientists and open to all stakeholders. Certainly, the developers of LMO technology need to conduct the necessary evaluations to reach their own commercial decisions.  
 
LITERATURE CONSULTED
Binimelis R., W. Pengue, and I. Monterroso. “Transgenic Treadmill”: response to the emergence and spread of glyphosate resistance of Jhonsongrass in Argentine. Geoforum. In press.

Consejo Nacional de Investigación Científica y Tecnológica (CONICET). 2009. Evaluación de la información científica vinculada al glifosato en su incidencia sobre la salud humana y el ambiente.  http://www.fundacion-campo.org/userfiles/prensa/glifosatoinfoconicet09.pdf (consultado el 2 de abril de 2011)

Kruger M., J.B.J. Van Rensburg, and J. Van den Gerg. 2009. Perspective on the development of stem borer resistance to Bt maize and refuge compliance at the Vaalharts irrigation scheme in South Africa. Crop Protection. 28(8): 684-689

Séralini G.E., D. Cellier, and J.S. de Vendomois. 2007. New analysis of a rat feeding study with a genetically modified maize reveals signs of hepatorenal toxicity. Arch. Environ. Contam. And Toxicol. 52(4):596-602.

With regard to the idea of 'generic socio-economic assessments' that would, in my opinion, also have utility (in addition to the case-by-case approach) it is worth highlighting here the IAASTD (International Assessment on Agricultural Knowledge, Science and Technology for Development) (http://www.agassessment.org). This is the largest and most comprehensive assessment of agriculture to date, sponsored by multiple UN agencies, carried out over several years and involving hundreds of authors.

The IAASTD took essentially a sustainable development (and hence, the three pillars - social, economic and environmental) approach to assessing agriculture's past and future prospects, and looked at the following key development challenges: 1. Hunger and Poverty; 2. Nutrition and Health; 3. Inequity and Rural Livelihoods; and 4. The Environment.

The IAASTD considered biotechnology as a cross-cutting issue and looked at the issue of genetic engineering/modern biotechnology in some detail. It could help provide broad policy guidance on the issue.

The book 'Hope not Hype' by one of the authors (Prof. Jack Heinemann of the University of Canterbury) of the Global Report and the biotechnology section, was published by TWN in 2009, focusing in particular on the biotechnology discussions at the IAASTD. The book is available at the CBD Secretariat's Biosafety Resource Information Centre at http://bch.cbd.int/database/record-v4.shtml?documentid=100891

Lim Li Ching
Third World Network

Dear all,



At the end of the discussion of Theme 1, we (together with the Bolivian
CBD/CPD focal point) also think that the discussion has been very enriching
at several levels. We would like to thank all for that. However, we also
feel that the original guiding question has been somehow “lost” along the
majority of the discussion. Due to the relevance in the upcoming discussions
on SEC capacity building (as mentioned by Dr. Meyer) we would like to go
back to the “WHAT are the SEC”. As well guided by the Secretariat, to us the
“WHAT” needs to be answer before the “HOW” and “WHEN to assess socioeconomic
issues”.



In order to make concise our final contribution to Theme 1, we would like to
mention that we agree with Dr. Ossama Abdel-kawy, Ms. Lucette Flandroy and
Dr. Nina Vick in relation to the SEC that Parties may take into account
during the decision-making related to LMOs. Some additional issues to
complement and emphasize on the issues raised by these participants and also
by us in our previous intervention, are:



-       The identification and assessment of relevant SEC need to be done in
light of sustainable development. As mentioned by Mrs. Lim Li Ching, we also
think that the IAASTD provides a comprehensive conceptual framework to
approach the impacts of knowledge and technology (e.g. LMOs) in light of the
development challenges.



-       We also would like to stress that SEC related to LMOs should not be
restricted to LM crops.



-       In our view, the relevant SEC need to be identified on a
case-by-case basis in relation of the environmental and socioeconomic
context where the LMOs are introduced. This in light of: 1) the uniqueness
of the local contexts of introduction  and 2) the constant advances in
research and knowledge.



-       We fully agree with the notion of not restricting SEC to “existance”
but also “distribution” of impacts (as stated by Prof. Bereano). To these,
we would like to add “persistence” of the impact. To us this is crucial to
put in context the potential socioeconomic impacts (both positive and
negative). For instance, under “existence of impact” probably we will
restrict to “what socioeconomic benefits or harms will be generated?” while
considering the “distribution” we will also assess “Who will be affected?
How?, and with “persistence” will complement with “For how long time?” (time
scale relevant to sustainable development).**

**

-       It is true that the inclusion of SEC into decision-making processes
might delay decision-taking, reduce economic benefits, increase in costs,
etc. However, this should be seen as part of the preventive measure (or in
the case of harm as the internalization) of the potential environmental and
social damage that might arise from LMOs in light of precautionary
approaches. If not, our analysis would be reduced to pure economic / market
parameters only. This preventive assessment not unique to LMOs. Cosmetics,
pharmaceutical, chemicals, different material - for instance - follow the
same procedure (then, why LMOs should be excluded? Particularly considering
that are “living” organisms entering to complex living systems).**

* *

-       SEC also need to be analyze in terms of the socioeconomic factors
that may affect the safety of the LMOs in question and, consequently,
increase its potential for adverse effects on the conservation and
sustainable use of biodiversity. Two questions / examples to illustrate this
point: 1) “WHAT is the socioeconomic dynamic in which the LMO is introduced
and might increase the potential for adverse effects on the conservation and
sustainable use of biodiversity?” e.g. traditional market dynamics that
might accelerate gene flow). 2) “WHAT are the socioeconomic factors that
might increase the possibility of failure of the safe handling and use of
the LMO?” e.g. Co-existence measures usually fail due to socioeconomic
factors (e.g. farmers not implementing appropriate buffer zones due to
managerial issues).



-       Finally, in the definition of the “WHAT” the public needs to have an
informed participation, not only to identify potential SE impacts based on
local knowledge but also to facilitate access to justice in the case of
harm.**

* *



Many thanks,**

* *

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<p>I believe the discussion to date has been very interesting.  I would like to add a few comments not directed to anyone in particular.<br>
<br>
First, if socio-economic considerations are part of the advanced informed agreement process, it is very important to have transparency in that process.  An applicant, the public , and the regulators must know what socio-economic considerations will be taken into account, who will conduct the socio-economic assessment (the applicant, the regulators, an outside party, etc...), and what methodoloy will be used.  The rules and procedures need to be spelled out in regulations, guidelines, or other documents which everyone has access to.  The Cartagena Protocol has a lot of information in its Annexes about scienfitic risk assessment of LMOs and similar documents should be provided if socio-economic considerations are to assessed.<br>
<br>
Second, any assessment of socio-economic considerations should apply not just to imported LMOs but also to domestically produced LMOs.  This is for fairness reasons as well as compliance with international laws and oblgations.  <br>
<br>
Finally, if there is a socio-economic assessment, it should be released to the public and there should be an opportunity for public comment on it before any decisions are made about releasing the LMO into the environment.<br>
<br>
I also want to reiterate a point I made at the beginning of the discussion last week.  I think countries need to think about which activities with LMOs trigger an socio-economic assessment.  Activities with LMOs range from work in  contained laboratories to confined field trials to release of commercial seeds that are planted by farmers and harvested to be eaten by humans and/or animals.  Not all these activities might trigger the need for a socio-economic assessment.  And those socio-economic assessments might have very different scopes and issues to analyze.  Any biosafety regulatory system needs to be proportionate and tailor its requirements to fit the specific situation it is analyzing.  Thus, this issue will be critical to the transparency identified above.<br>
<br>
Thanks, <br>
<br>
Gregory Jaffe<br>
Director, Biotechnology Project<br>
Center for Science in the Public Interest<br>
</body></html>

The breadth and depth of what is involved in socioeconomic considerations are quite overwhelming; bearing in mind that the society is a complex organism that has evolved in specific contexts where economic, political, social, cultural and ethical spheres constantly interrelate with each other in an intricate manner.

Some components of socio-economic considerations can be identified by using general headings representing the key issues of society and the specific areas in each issue that GMOs may have potential impacts on. And can be summarized as follows:

1.   Social considerations:

a. Impacts on farmers’ rights: (potential consequences of GMOs on the traditional practice of farmers in saving, reusing, sharing, exchanging, and selling farm-saved seeds to save seeds. The inherent right of farmers to seed saving and exchange is legally protected by the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) under the Food and Agriculture Organization (FAO). Governments are entrusted to protect farmers’ rights through national legislation, a task which has not been easy for many countries that have also committed to protect IPRs of seed companies under international trade agreements, such as the Agreement on Trade- Related Aspects of Intellectual Property Rights (TRIPS) of the WTO.
b. Impacts on women and gender role
c. Consumer concerns: (Price matters for most consumers, especially in developing countries, however it is not the only factor that determines consumer responses to new products introduced in the market. Consumer acceptance is highly influenced by cultural and ethical values, and perceptions on health and environmental safety of the product.)

2.  Economic considerations:
a. Trade: (the ability of developing countries to compete in the international market if they decide to venture into commercial production of GM crops. Although GM crops promise to address specific problems related to particular pests and diseases, the quality of the product largely depends on the conditions in which they are produced and the management practices under which they are grown.)
b. Markets: (the price of agricultural commodities is highly sensitive to and dictated by supply and demand, GMOs that promise yield improvements may affect market behavior. Particularly vulnerable are developing countries whose economies are highly dependent on the production and export of specific agricultural products.)
c. Income security: (Economic cost- benefit analysis taking into account the specific farming practices and conditions of farmers).
d. Rural labor: (The situation in industrial agriculture predominant in developed countries, where the cost and availability of labor is a major production cost, is vastly different from the situation in household-based farming that characterizes agriculture in many developing countries where labor is readily available, abundant and often cheap. For instance, the introduction of herbicide-resistant GM crops that eliminates the need for weeding or tilling of the soil during land preparation will potentially have grave long-term impacts on rural labor.)
e. Income and wealth distribution: (Companies that develop GMO products intend to recoup their investments on research and development, through the intellectual property rights (IPR) system and marketing schemes. In situations where the GM variety is more expensive than the non-GM, companies may adopt a targeted marketing scheme that primarily offers its GM to rich and middle-income farmers who can afford the higher cost of seeds. If the companies’ claims with regards to their products are real, those who will benefit from this promise are obviously those farmers who can afford the cost of seeds and who already have relatively high income to start with. This situation will expectedly aggravate the problem of income inequality and wealth distribution in the rural areas.
f. Control over tools and relation to production in the particular context where the technology is introduced, questions like will the dissemination of GM seeds provide opportunities for poor farmers to have some control over the tools of production, or will it further entrench control of particular segments of the community over farm inputs, processing and marketing?
g.  Food security: (With the cultivation of GM crops in the developing world, household food security may face the threat of conversion of land areas traditionally planted with food crops for the production of commodity crops for industrial use and export.)
h. Food aid: (Many poor countries are confronted by emergency situations that inhibit farmers from producing their own food, particularly in areas affected by war, widespread conflicts, natural calamities, drought, and famine. In those situation countries should be able to formulate its position in procuring food aid from sources that could assure GMO-free food supply, whenever possible and available.)
i. Co-existence and GMO contamination: (The risk of transfer of pollen is particularly high for cross-pollinating crops, such as corn and canola. Producers of non-GM crops risk having their crops contaminated by nearby GM crops whose pollen can travel long distances by wind or with the aid of insects. This situation is expected to be much more complicated in most developing countries where landholdings are much smaller and distances between farms are much shorter. In addition to this GMO contamination of conventional crops, and of wild and weedy relatives, poses serious threats to biodiversity and the genetic base for long-term food security.)
j. Organic agriculture: (organic agricultural products have increasingly become important to the economy of many developing countries in recent years. Organic certification standards generally do not allow GMO contents. Should contamination of organic crops occur, farmers would lose the organic certification status for those crops and the premium prices they command.)
k. Intellectual properties rights: (Concerns about the implications of IPRs for GMOs extend beyond the economic sphere. This includes impacts of IPRs on public access to knowledge and technological innovations.)

Dear all,

We wish to thank all fellow participants in the discussion forum for the interesting input to topic 1 that has been submitted so far. To introduce ourselves this submission from Norway represents a joint effort by Dr. Casper Linnestad of the Norwegian Ministry of the Environment, Dr. Anne I. Myhr from GenØk - Centre for Biosafety, Ms. Audrun Utskarpen from the secretariat of the Norwegian Biotechnology Advisory Board and myself Dr. Nina Vik of the Norwegian Directorate for Nature Management.

In Norway decisions regarding release of LMOs into the environment must include an assessment that not only includes risk to health and the environment but also benefit to society, sustainable development and ethical considerations. These three criteria are included in the Norwegian Gene Technology Act of 1993 and its corresponding Regulations on impact assessment according to the Act. The criteria in the Norwegian legislation are broader than the context of Article of the Protocol. Also in the EU Directive 2001/18/EC there is a certain opening to consider both ethical concerns (Article 29) and socio-economic concerns (Articles 7d and 31).

We aim here to highlight specific elements of the Norwegian criteria that we consider of relevance for topic 1 of the online discussion forum. We have submitted the Act and other material to the CBD secretariat for further reading.

From the Norwegian Act and Regulations on impact assessment and other relevant activities and publications in Norway on this topic (e.g. discussion paper by the Biotechnology Advisory Board, report to the Directorate for Nature Management by authors Rosendal and Myhr and results from ad hoc working groups) we have identified the following considerations that may be of relevance to Article 26:

-> Impacts on biodiversity and ecosystem functioning, which include issues such as:

      Gene-flow (horizontal and vertical) and subsequent effects
    
      Non-target effects (mammals, birds, invertebrates etc)

      Increase of secondary pests

      Change in agricultural practices leading to effects on         biodiversity and ecosystem services (e.g. pesticide use)


-> Impacts on ecological limits, which include impacts on the

      Efficiency and extent of energy use

      Efficiency of the use of other natural resources

      Proportions of the use of renewable and non-renewable resources

      Emissions of global and transboundary pollutants as well as greenhouse gas emissions

-> Impact on the distribution of benefits and burdens between generations

-> Is there a demand or need for the product. Moreover, will the product solve or help to solve a socialproblem (e.g. employment) and will the product tend to create problems for existing production that should be maintained

-> Possible adverse effects on local and indigenous peoples, people who live in highly traditional cultures, or weaker groups. Special account should be taken for the right to self-determination. This may be especially relevant in mega-diverse countries and countries that are part of centres of origin and genetic diversity.

In a report to the Norwegian Directorate for Nature Management by Rosendal and Myhr (2009) (http://www.dirnat.no/content/582/Societal-Utility-and-Sustainable-Development) it was identified that in the basis for the assessment, i.e. the documentation in LMO applications, information on sustainability and benefit to society (societal utility) is lacking.

With regards to the criteria sustainability, it was found that information provided by the applicants was of high relevance for questions with regards to impacts on biodiversity, ecosystem functioning and ecological limits required by the Norwegian impact assessment. However, these questions entail also much wider concerns such as effects on socio-ecological relationships by introduction of the LMOs (e.g. changes in livelihood and knowledge systems).

For other aspects the LMO applications gave very little or no information that could be used (e.g. effects on employment, distribution between generations, is the technology suited for small or large farming enterprises).

We acknowledge that issues and questions raised above may not be applicable to all LMOs and therefore need to be considered on a case-by-case basis. The documentation from the applicant is important, but should always be evaluated together with existing local or national knowledge, e.g. regarding the local agricultural system, existing monitoring programmes and the basic local knowledge about the crop in question and possible impacts on the environment.

Based on these considerations we would emphasize the need for inclusion of information relevant to socio-economics in biosafety decision-making processes. At present the available understanding is mostly related to investigation of economic effects, which is highly relevant, but too limited for taking the social component into account. Therefore, there is a need for new methods (both quantitative and qualitative) for research of relevant issues of socio-economic impacts in areas where LMOs have become part of the agricultural practice, as well as research on socio-economic considerations in assessment/decision making processes.

Thank you

Best regards