Forum discussions

The third guiding question for theme 4 is "How might these needs be addressed, taking into account the overall capacity-building framework for biosafety?"

Dear all,

The best way to meet these needs is to initiate training and develop courses on socio-economic methods and assessment. Moreover it will also be important to organise workshops and web based tools as online discussion for sharing actual experience on socio-economic approaches between different countries. It is also important to recognize that it takes time to build up such expertise and therefore it is important to have a system in place that secures the knowledge transfer in a country, ministry etc in the case of rotation of personnel.

Norway has established a biotechnology advisory board (see http://www.bion.no/english/) with a mandate that focuses on (amongst others) giving the Norwegian authorities advice on sustainability, societal utility and other ethical aspects. We believe this is a good approach to build up competence. The advisory board has a broad range of members, both with specific expertise on biotechnology, medicine, law and ethics, but also has members representing the general public that again raises an awareness of the social component by use of modern biotechnology.

I agree with Anne Myhr that it takes time to build the expertise and in some cases it is lost by disruption of programs or rotation of personnel. A permanent institution like the Norway biotechnology advisory board is a good proposal, but I seem to me it is not enough in some contexts.

Mexican Biotechnology Law establishes two institutions: The Scientific Advisory Board, and the Joint Advisory Council. The first composed by academics from different disciplines including social sciences and the second integrated representatives of associations, chambers and private sector companies, social and productive. The problem is that it is not a broad range of members and they lack coordination, so the result is more a roll of legitimization of the decisions instead of participation.

I think that a mechanism of include in the risk assessment of a potential liberation of a GMO, a socioeconomic ex-ante study would give the decision maker additional elements. I know, as Jose Falck- Zepeda mentioned, that Article 26 is not a mandatory, so the decision maker may take into account or not the social study, but at least he has the information at hand. Thus a way of strengthening socio-economic analysis and assessments is the development of these ex-ante studies.

Our paper (Falck Zepeda and Zambrano 2011) can be used as a decision making guideline starting from the discussion on whether to include socio-economic considerations and if the decision has been made, what are the multiple decisions to be made for implementation and governance.

We are indeed in the process of developing this paper into such document with some colleagues in two regional programs in Latin America and Southern Africa. The next step in our agenda is to improve on our current mapping of the issues to the methods and to the tradeoffs involved with their application.

The issues involved can be summarized as follows:
Practical structural and governance decisions for socio-economic inclusion in biosafety processes
We 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



Falck-Zepeda, J.B. and P. Zambrano. 2011. Socio-economic Considerations in Biosafety and Biotechnology Decision Making: The Cartagena Protocol and National Biosafety Frameworks. Review of Policy Research. 28(2): 171-195. http://dx.doi.org/10.1111/j.1541-1338.2011.00488.x

Just wanted to add to Michelle's contribution that Brazil and other countries have pursued a similar strategy of having a technical evaluation body and another decision making body who will give the final authorization for deliberate release into the environment for commercialization purposes.

Socio-economic considerations in the case of Brazil seem to be included only if an issue is raised during the biosafety assessment In the case of Argentina it is mandatory but with a defined scope on trade issues. Our colleagues from Argentina have duly noted that this approach is under review.

The whole point is to carefully assess and define whether to include the process and to defined all the steps in the process once the decision is made.

I think that it is critical to clearly define how socio-economic assessments will be used for decision making in order to avoid having incongruities and to allow transparency so that everybody is clear about what will be expected in such decision making process. This will allow developers to assess whether they want to enter a market or develop a product for a specific market and for consumers understanding the rationale behind the decision rendered by the competent authority. Clarity can only introduce confidence into the system and help all stakeholders trust such decisions.

I believe there is not enough good information about the role of  socio-economic considerations and socio-economic assessments in existing national biosafety regulatory systems and individual decisions on particular LMOs.  Therefore, I think it would be very valuable to document case studies in different countries on how they addressed these topics in actual authorization decisions.  Reports, studies or papers with this information would then be extremely valuable in courses, workshops and other capacity building activities mentioned by other commenters.

Also, it would be helpful to have a comparative analysis of the case studies and different ways that countries address socio-economic considerations.  As with biosafety regulation, there is no one correct way to address socio-economic considerations or conduct a socio-econominc assessment.  The best capacity building tool would be a comparative analysis of what has been done in different countries so countries addressing these issues can learn from what has been done in different places and choose the models and experiences that fit their national policies and goals.  Capacity building in this area should not "reinvent the wheel" but instead provide the full range of options out there and allow countries to learn and adopt what has been done by others.

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

In a joint special session between Univeristy of Saskatchewan, Wageningen and IFPRI/PPBS at the 2010 Congress of Environmental and Resource Economics (see http://www.webmeets.com/WCERE/2010/Prog/  where you can open Day 2 Parallel Session 8;45am for the full papers) we documented a set of cases where there may have been inclusion of socio-economic considerations in India, China and the U.S. Argentina stands on its own because economic assesments are mandatory but used to be focused only on trade.

Since there are so few case studies to study where socio-economics have been included formally or informally in a biosafety approval decisiona and so few publicly available information about the decisions,  we in the end had to revert to discussing for other countries how they have included socio-economic consideration in their laws and regualtions. Those identified were discussed in the papers by Carl Pray and Wesseler/Smyth and I.

In summary, there is very little practical experience which has been covered in biosafety practice. We could try and expand the search to other countries and/or other regualtory systems to see if we can gather some lessons.

In terms of capacity building, you are aware of those efforts that we have led within IFPRI/PBS which I have amply described in this forum.

Activities we have implemented (and are implementing) range from short to long term capacity building, as well as the experiences we have had with multiple audiences including regulators, national biosafety committees/authorities, scientists, evaluation practitioners, and other stakeholders.

Based on those experiences I quite agree that building capacity is no different than in any other capacity building areas. Its a matter of building the proper capacities to ensure competency in performing evaluation tasks and for the audience to understand the issues, limitations of such assessments.

I may add that there is a generalized mis-understanding about socio-economic assessments, in part due to the lack of knowledge about the process and the methods used and its limitations, in that some audiences seem to have the perception that everything is potentially assessable...there are no limits to what can be done with such assessments. Nothing can be farther from the truth.

This is why it is extremely important for regulators/decision makers to understand how the socio-economic assessments have been done and what the results of such assessments mean in order to empower a proper decision making process.

References

Biosafety – The Role of Socio-Economic Assessments (Special session)
THE ROLE OF SOCIO-ECONOMIC ASSESSMENT IN DECISIONS ABOUT THE APPROVAL OF GMOS IN INDIA AND CHINA Presenter(s): Carl Pray, Rutgers University Co-Author(s): None

THE CURRENT STATUS OF THE DEBATE ON SOCIO-ECONOMIC ASSESSMENTS AND BIOSAFETY HIGHLIGHTING DIFFERENT POSITIONS AND POLICIES IN CANADA AND THE US, THE EU AND DEVELOPING COUNTRIES Presenter(s): Jose Falck Zepeda, International Food Policy Research Institute (IFPRI) Co-Author(s): Justus Wesseler, Wageningen University and Stuart Smyth, Research Associate

Much of the discussion thus far has been devoid of any mention of cost. It’s great to be able to have philosophical discussions about grandiose schemes, all without contemplation of the cost. To engage in a comprehensive discussion on socio-economic considerations, some understanding of existing and potential future cost has to be included in the current discourse. I offer the following analysis as a means of providing some context.

Every technology has the co-called ‘valley of death’ which occurs in the development of a product and ultimately kills any further research or work on that product. Often this occurs in the Research Cost Phase, but can also occur in the Gestation Phase, where testing and registration costs accumulate. The diagram below illustrates the cost-benefit cycle of a commercialized product. The challenge is, how big can the orange section get, without killing the product.

Figure 1: 4 phases of crop development
- This figure will not copy over to this post. I've attached it to this post as a file.

Kalaitzandonakes et al., (2007) provide one of the few estimates on the cost of getting regulatory approval for new GM crops, in this case GM corn. Their study reveals that the cost, just for regulatory approval in 10 key markets, ranges between US$6 million and US$15 million. Jaffe (2005) has also shown that at this time, it took on average 13.6 months to get the approval to commercialize new GM varieties. This was an increase from 6 months 5 years earlier. For the sake of argument, let’s say that it cost US$1 million per month to get regulatory approval for new GM varieties. Let’s also assume for this discussion that the time frame doubles when socio-economic considerations are added to a regulatory framework, so it would now take 27 months.

Based on the above diagram, the size of the orange section has doubled. As I discussed in an earlier post, we’ve done research on cost and time delays in regulatory approval in Canada, based on data from GM canola approval. Doubling the cost of regulatory approval in our model reduced the benefits by 16%. In our GM canola model, we added a 2 year delay in approval and this reduced the benefits by 28%. Based on this, a 13 month delay would reduce the benefits by 15%.

In terms of cost and time, it is a double effect. The cost has doubled and the time delay results in a combined reduction in benefits of 31%. In the figure above, the orange section doubles and the two green sections are reduced by about one-third. Without redrawing the entire diagram above, I believe that the costs in the Research Phase would be virtually equal to the benefits in the Adoption and Knowledge Stock Phases. Essential costs are equal to benefits or to put it another way, the return on investment is close to zero. Certainly enough to trigger the ‘valley of death’ for products facing this situation.

The World Bank has reported that annual yield increase of 2% in cereal varieties are required to feed the world’s growing population. Presently, the yield increases are about 1.2%. When variety developers are faced with the increase in cost and time for socio-economic consideration, it is difficult to foresee how this research will move forward. The end result is that socio-economic considerations will move yield increase further away from the required 2%.

Feel free to debate my numbers, but in a situation where the cost and the time it takes to approve new crop varieties increases, it is going to cost money. Every investment, no matter what it is, personal or corporate, has to provide a return. No variety developer, be it public or private, is going to be willing to develop new varieties that will face this type of a regulatory environment.


References
Jaffe, G. Withering on the Vine: Will Agricultural Biotechnology's Promise Bear Fruit? Center for Science in the Public Interest, Washington DC, (2005). Available online at: http://www.cspinet.org/new/pdf/withering_on_the_vine.pdf

Nicholas Kalaitzandonakes, Julian M Alston & Kent J Bradford Nature Biotechnology 25, 509 - 511 (2007). Available online at: http://www.nature.com/nbt/journal/v25/n5/full/nbt0507-509.html.

Dear all,



We feel that when we are talking about SEC capacity building needs, there is
a rush on moving on methods. We believe that the first priority is – as
first pointed out by Dr. Heissenberger - to define the “what” to assess
(assessment endpoints/ parameters). After that, the discussion on methods of
assessment will be more useful.



In relation to how to address the capacity building needs on SEC, we think
it is important to:



-       Focus on generation of local knowledge instead of “knowledge
transfer”. Certainly exchange of experience gained will be useful, however,
since every context where LMOs might be introduced are different, contextual
issues for capacity building also need to be taken into account.



-       Apply differentiated methodologies to different target groups.



-       Analyze the intertwined nature of ecological and SE impacts.



-       Share experiences in capacity building on SEC in environmental
regulation in general and biosafety in specific.



-       Apply participatory approaches.



-       Build up mechanisms for public participation.



-       Foster inter and multidisciplinary dialogue, including different
sorts of knowledge and sources of information (not restricted to scientific
or academic only).



-       Develop material adapted to the local forms of communication and
processes of knowledge generation.



Kind regards,



Georgina C.V.

Stuart,
This is one issue that is clearly extremenly important for public policy in developing countries and those interested in investing in R&D that will be of value to developing countries. We have seen the investments done in multiple developing countries not only on GM techniques but other biotechnology areas and in different crops and organisms, as well as, plant and animal breeding, conservation and other multiple areas of science and technology.Many done by the public sector and/or national private sector organizations (see list of papers below).

In the Next Harvest project, we identified that by 2001-2002, there were 209 events in what could be considered advanced regulatory stage in 16 developing countries. Much of these are events of interest to developing countries.  In the paper done with Jikun Huang and colleagues from CCAP China, we documented that by 1999-2000 there were 51 cases approved for environmental release and 26 ready for commercialization approval.

Countries have invested in biotechnology and other sciences, yet we have observed only two countries with GM plants being approved for commercial release developed by the public sector, being India and China. Note: a colleague reminded me that Cuba has also made some releases, will have to check exact nature of those releases.

Because of this fact alone, we have to consider all the implication from introducing regulations, and that certainly includes the cost of compliance with biosafety regulations.

Unfeasible or unnecessarily rigid regulations will increase the cost of compliance and introduce a lot of uncertainty for developers especially those in the public sector, national private sector and even those activities financed by producers themselves. These groups are the ones that are most likely to invest in R&D in those crops and traits of interest to developing countries.  


Biotechnology and Plant Breeding Capacity
1. Huang, J., R. Hu, Q.Wang, J. Keely and J. B. Falck-Zepeda. “Agricultural Biotechnology Development Policy and Impact in China” 2002. Economic and Political Weekly. July 2002. Pp. 2756-2761.
2. Cohen, J., J. Komen, and J. Falck Zepeda. “National Agricultural Biotechnology Research Capacity in Developing Countries” 2004.  FAO ESA Working Paper No. 04-14. Contributing paper to FAO State of Food and Agriculture (SOFA) 2004.
3. Trigo, E. J. Falck-Zepeda, and C. Falconi. 2010. Biotecnología Agropecuaria  para el Desarrollo en América Latina: Oportunidades y Retos. Documento de Trabajo LAC/01/10, Programa de Cooperación, FAO/Banco Interamericano de Desarrollo, Servicio para América Latina y el Caribe, División del Centro de Inversiones.
4. Trigo, Eduardo; Falck-Zepeda, José; Falconi, César; Villarreal, Federico.Estado de la biotecnología agropecuaria en Argentina” 2007. Working Papers Series Washington, D.C. Inter-American Development Bank (IDB), Rural Development Unit, Sustainable Development Dept.
5. Trigo, Eduardo; Falck-Zepeda,José; Falconi, César; Villarreal, Federico. “Estado de la biotecnología agropecuaria en Chile.” 2007. Working Papers Series Washington, D.C. Inter-American Development Bank (IDB), Rural Development Unit, Sustainable Development Dept.
6. Trigo, Eduardo; Falck-Zepeda,José; Falconi, César; Villarreal, Federico. “Estado de la biotecnología agropecuaria en Uruguay.” 2007. Working Papers Series Washington, D.C. Inter-American Development Bank (IDB), Rural Development Unit, Sustainable Development Dept.

7. Falck-Zepeda, José; Zambrano, Patricia; Cohen, Joel I.; Borges, Orangel; Guimarães, Elcio P.; Hautea, Desiree; Kengue, Joseph; Songa, Josephine. “Plant genetic resources for agriculture, plant breeding, and biotechnology: Experiences from Cameroon, Kenya, the Philippines, and Venezuela.” 2008. IFPRI Discussion Paper 762. Washington, D.C. International Food Policy Research Institute (IFPRI). http://www.ifpri.org/pubs/dp/ifpridp00762.asp
8. Falck-Zepeda, Jose´ Benjamin; Falconi, Cesar; Sampaio-Amstalden, Maria José; Solleiro Rebolledo, José Luis; Trigo, Eduardo; Verástegui, Javier. La biotecnología agropecuaria en América Latina: Una visión cuantitativa. 2009. IFPRI Discussion Paper 860SP. Washington, D.C. International Food Policy Research Institute (IFPRI). http://www.ifpri.org/sites/default/files/publications/ifpridp00860sp.pdf
9. Atanassov, A., A. Bahieldin, J. Brink, M. Burachik, J. I. Cohen, V. Dhawan, R. V. Ebora, J. Falck-Zepeda, L. Herrera-Estrella, J. Komen, F. C. Low, E. Omaliko, B. Odhiambo, H. Quemada, Y. Peng, M. J. Sampaio, I. Sithole-Niang, A. Sittenfeld, M. Smale, Sutrisno, R. Valyasevi, Y. Zafar, and P. Zambrano. “To Reach The Poor: Results from the ISNAR-IFPRI Next Harvest Study on Genetically Modified Crops, Public Research, and Policy Implications.” 2004. EPTD Discussion Paper 116. Washington, D.C.: International Food Policy Research Institute

Stuart:
In the paper presented with colleagues from Indonesia and The Philippines we documented the cost for existing advanced events in those countries.

Interesting result was that the cost was not at the level documented by Nick Kalatzaidonakes and colleagues, quite a bit due to the fact that there is a lot of familiarity with these events and thus there is a lot of knowledge already generated for potential regulatory system' use in their assessments.

The other factor is the possible underestimation of the costs associated with conducting evaluation activities themselves. In a paper done by Carl Pray and Bharat Ramawami, Jikun Huang and other colleagues for India and China, they also point to the fact that the public sector may not do full costing of such procedures.

We reached similar conclusions in our paper (Bayer, Norton and Falck Zepeda, 2010) to yours in the sense that cost of compliance compared to the potential economic benefits is not as important as the impact of regulatory delays in terms of releasing a potential technology. Where cost becomes important is, as you have mentioned, on its impact on public sector and national firms investing in technology.

Certainly, from the standpoint of anybody that is considering investing in any technology, as you have already pointed out too, what becomes more important from the standpoint of this decision is the uncertainty introduced by a ill defined decision making process for the potential approval of such technologies. Of course as Wesseler and Ansik have reminded us in their papers, we do have to contrast this with the gains in information and in the decision to postpone release to get better/more information.

I would hope that countries make their decisions based on full information, including costs, opportunities lost and information gains.

References:

Bayer, J. C., G. W. Norton, and J. B. Falck-Zepeda. (2010). Cost of compliance with biotechnology regulation in the Philippines: Implications for developing countries. AgBioForum 13(1): 53-62.

Falck-Zepeda, Jose Benjamin, Yorobe Jr.  Jose, Manalo, A., Ramon, G.,Amirsuhin, B., Lokollo, E. M., Zambrano, P. 2007. The Cost of Compliance with Biosafety Regulations in Indonesia and The Philippines. Selected Paper 175075 presented at the American Agricultural Economics Association>2007 Annual Meeting, July 29-August 1, 2007, Portland, Oregon. http://purl.umn.edu/9947

Manalo, A.J., & Ramon, G.P. 2007. The cost of product development of Bt corn event MON810 in the Philippines. AgBioForum, 10(1), 19-32. Available on the World Wide Web: http://www.agbioforum.org.

Pray, C. E., P. Bengali and B. Ramaswami. 2005. The cost of regulation: the India experience. Quarterly Journal of International Agriculture 44 (3): 267-289

Pray, C. E., B. Ramaswami, J. Huang, R Hu, P Bengali, and H Zhang. 2006. Costs and enforcement of biosafety regulations in India and China. International Journal Technology and Globalization vol 2 (1/2): 137-157.

Jose,

You raise some very good points. The one cost that I did not raise, one that is quite crucial to this debate, the cost of foregone benefits. All of this discussion have been focused on using socio-economic considerations to further refine the risk analysis literature. There has been nary a word about the lost economic and environmental benefits from LMOs should a new technology be rejected due to SEC.

Take, for example, the loss of the ability to use GM potatoes. Potato farmers, organic ones too, use pesticides frequently throughout the growing season to keep potato beetle damage to a minimum. When there is a heavy summer rain, it is common to hear reports of fish kills in nearby watersheds due to the pesticide residues being washed off the plants into the water system. Much, if not all of this, could have been prevented through the use of GM potatoes. This is a very clear example of how social considerations are now responsible for increased environmental damage.

Any discussion regarding the inclusion of SEC into a regulatory system has to be balanced by an accurate assessment of the foregone economic and environmental benefits. If not, it has the appearance of being the 21st Century equivalent of a 'witch-hunt'.

Dear all,

I do not disagree that costs are an important factor for consideration and that Parties will have to weigh all these issues up. However, precisely because there are cost considerations, there also needs to be some ex-ante policy discussions on the socio-economic impacts of LMOs, because socio-economic considerations and the ensuing assessments can better inform these discussions. Otherwise, investments (both public and private) could be invested, without due consideration to the issues and problems from a socio-economic perspective, and research, funding etc. proceeds along a certain pathway which is then hampered at a later stage because these issues were not considered earlier.

So in this sense, I would view the inclusion of socio-economic considerations in biosafety decision-making, not as necessarily resulting in regulatory delays, but even if it does so, it would lead to better-informed and more cost effective decision making.

I am attaching a paper by Pavone et al. (2011) (From risk assessment to in-context trajectory evaluation - GMOs and their social implications) that elucidates more on some of these issues, and also on the importance of socio-economic context. By the way, I think the paper also provides some interesting methodological examples from the social sciences that are relevant to our discussions and points to the need for such approaches along the trajectory of a technology. 

It has also been mentioned in previous posts that socio-economic considerations are not consistent with WTO obligations. I’d like to reiterate several earlier postings made in the first round on the issue that disagree with this statement.

Regards,
Lim Li Ching
Third World Network

Dear colleagues, I can only agree to this message send by Gregory. With regard to the many studies on SEC to which the following messages point I would like to remind of my earlier postings on taking into account the context in which studies are written.

One author of the papers presented at the Congress of Environmental and Resource Economics states that "However, paternalistic governments throughout the world assume that they are better at choosing technology than farmers are, and so they require socio-economic conditions are part of the approval process to make sure that the technology does not harm farmers’ economic conditions." Readers might get the impression that the outcome of the study is quite predictable.

A second paper starts with the sentence "Economist get frustrated frequently as societies do not follow their advice and enact polices that are sound from an economics perspective. This is especially true for regulation of technologies, natural resources regulations and product and environmental safety polices." Readers might prefer authors to write studies who are not so frustrated.

While this is not the place to analyse scientific publications, it is the place to call for constructive studies and contributions that will feed into the SEC dicussions under the CBD. It would be useful in this context to also engage or read authors that are not be too deeply involved in technology promotion and GE crop introduction projects. And we should also have authors that made positive experiences with their advice to society (and governments).

Dear all,



In response to some comments, we would like to share the following
additional points to our previous posts, which apply to SEC in
decision-making and capacity building. This aiming at contributing to
decrease the possibilities of misinterpretation of the Cartagena Protocol on
Biosafety (CPB):



-       *The CPB is rooted in the precautionary approach and focused on
potential adverse effects*.



The main purpose of the CPB is contributing to ensure an adequate level of
protection from LMOs that may have adverse effects on the conservation and
sustainable use of biological diversity, taking also into account risks to
human health (Article 1 and Article 4). In light to Article 26, Parties also
may also take into account socioeconomic considerations (SEC) in their
biosafety regulation.  Accordingly, biosafety regulations that require
ecological and socioeconomic (SE) risk assessments putting special attention
to potential adverse effects, are simply complying with their commitments
under the CPB and other international agreements, in addition to their
domestic legislation and national protection goals.



-       *Proper biosafety regulation has as first objective to contribute to
the overall society´s welfare and not only to specific sectors of the
society*.



Using as example the Bolivian experience in GM soybean, when analyzing the
benefits from the introduction of this LMOs (in this case an LM crops) we
see that specific groups benefit at economic level, mainly in the short and
medium term. When we add to the economic analysis other critical questions  -
such as who benefit? How the benefits are distributed? Is the introduction
of this technology going to increase o decrease social equity particularly
in the rural area? Do the potential benefits to certain sectors imply a
potential harm to others? If yes, to which extent is this acceptable? Or can
be avoided by other technological alternatives? - then the picture of
“benefits” changes and becomes relative to the framing of the assessment and
the parameters used in the analysis. Based on the experience of neighboring
countries, we see that this not only happens in Bolivia.



The Plurinational State of Bolivia, without neglecting potential benefits
from LMOs, sees with concern the fact that concrete – seen on the ground –
SE adverse effects arising from the introduction of LMOs are not reported at
the same extent as potential benefits. To us this implies an imbalanced in
generation of information and points out that in the literature there are
important gaps of knowledge. We are trying to overcome this by being
precautionary and seeking for proper regulation that will benefit the
overall society. To us this is a cost-effective decision making approach
since it takes into account potential social cost, as well (social cost that
are not only measured in monetary terms).



Again, the consideration of potential adverse effects in biosafety
decision-making process is the responsibility of regulators and the
commitment of Parties towards the CPB.



-       *Biosafety decision-making and regulatory processes have the
responsibility to address SEC beyond commercial perspectives and interest*.



Following our previous point and the discussion under this thread, we see
that the argument of “delay in benefits” from regulatory processes is mostly
in line with a commercial perspective (which is just one issue among the
different issues that should be considered in biosafety regulation and
decision-making). Perhaps here it is important to remember that LMOs
intended for introduction in complex ecological and socioeconomic contexts
(such as LM crops, LM mosquitoes, LM trees, LM vaccines, etc.) require time
for adequate safety assessment. Under the regulatory perspective, this is
not seen as “delay in benefits” but a responsible approach to secure
welfare, or at least decrease in potential harm, to the natural ecosystems
and societies.



In relation to one of our previous points related to the analysis /
identification of potential benefits from LMOs relative to the framing of
the assessment and the parameters used in the analysis, we would like to
quote some findings of the International Assessment of Agricultural
Knowledge, Science and Technology for Development (IAASTD):



“Two framing perspectives on how best to put modern biotechnology to work
for achieving sustainability and development goals are contrasted in the
IAASTD. The first perspective argues that modern biotechnology is
over-regulated and this limits the pace and full extent of its benefits.
According to the argument, regulation of biotechnology may slow down the
distribution of products to the poor. The second perspective says that the
largely private control of modern biotechnology is creating both perverse
incentive systems, and is also eroding the public capacity to generate and
adopt AKST [agricultural knowledge, science and technology] that serves the
public good.” (IAASTD, ed., 2009, p. 43)



“The Assessment [IAASTD] also concluded that another, if not the major,
barrier to development [and benefit creation] was in the form of IPR
[Intellectual
Property Rights] frameworks. The critical test for this comes from the
realization that if all governments were to decide tomorrow to completely do
away with all regulatory review of GMOs, the industry would still guard its
IPR. The costs of licensing would still be in place; liability for being in
possession of a transgene without permission would still be a risk for
non-GM farmers.” (Heinemann, 2009, p. 116).



(NOTE: The IAASTD is the result of a World Bank / UN organizations
multi-year initiative where more that 400 experts from all around the world
participated. The IAASTD is officially recognized by almost 60 countries).



Hence, more than critics aiming at softening biosafety regulation, perhaps
what we should aim at is fostering technologies and systems that supports
them that are safe/ safer in ecological and socioeconomic terms.



A final point under this issue is related to the restricted - if any – role
of confidential business information (CBI) in SEC along biosafety regulation
and decision-making. Under the Bolivian view consideration of CBI in the
context of the CPB mostly applies to the disclosure of technical information
with potential commercial application. In our view, CBI basically does not
apply to SEC. With exception of – and this is arguable – sales and marketing
plans, it is hard to identify what kind of business information should be
kept confidential in the SE analysis relevant to biosafety regulation.



-       *SEC needs to be approached in a holistic manner*.



Previous participants make two very important statements: re: “Any
discussion regarding the inclusion of SEC into a regulatory system has to be
balanced” (S. Stuart) and countries should re: “make their decisions based
on full information, including costs, opportunities lost and information
gains” (J. Falck-Zepeda).



Under the Bolivian perspective, SEC balanced discussions imply the analysis
of potential SE benefits and potential harms with participation of different
sectors and experts with different background. Giving a strong focus to SE
analysis and capacity building needs to the “cost associated with evaluation
or regulatory activities” is not a balanced approach. In terms of costs,
other issues such as “how much is the costs of adverse effects in the
conservation and sustainable use of biological diversity, taking also into
account human health, when approval of technologies did not properly assess
those *relevant* potential adverse effects?” must be considered, too.
Unfortunately, we have limited access to information on environmental and
social costs resulting from adverse effects (either potential or real) from
LMOs because little research has been done in this field for different
reasons (including availability of funds for this sort of research).
Nevertheless, here is where the precautionary approaches become operative.



In relation to consideration of full information, including costs,
opportunities lost and information gains, this also should include, inter
alia, monetary and non-monetary social and environmental cost of adverse
effects, lost of opportunities when non-adopters of GMO technology are
negativelly impacted (the high demand of GM-free soybean and lost of GM-free
soybean market and premium prices due to genetic contamination is a clear
example in relation to LM crops), gaps of knowledge when research is focused
on particular issues and do not have an holistic approach.



We would like to stress on the need to be holistic and context-based using
the previous GM potato example. Mr. Stuart mentioned that the GM potato
example that he shared is a clear case of re: “how social considerations are
now responsible for increased environmental damage”. From our point of view,
this is generalization and conclusion very much restricted to: i) a narrow
analysis of social and environmental sustainability and ii) a specific
situations where farmers might not have production options different from
industrialized agriculture, where the ecological imbalance that it creates
is artificially compensated with high use of synthetic, toxic and residual
chemicals. Accordingly, the analysis and conclusions on social and
environmental impacts are seen only through “the eye” of a particular
technology (e.g. LMOs), ignoring other alternatives suitable to local
contexts (particularly in countries with high biological and cultural
diversity where SEC play a crucial role in innovation of sustainable
technologies). In the case of Bolivia, if SEC would not have been considered
in the request for approval of GM potato based on sound-science information
and also considering narratives from indigenous people, maybe now we would
be saying that the lack of consideration of SE issues in the introduction of
technologies are responsible of serious social problems such as weakening
food security/sovereignty in local and indigenous communities.



Finally in this point, holistic SEC assessments need to make a very
important consideration (mentioned by H. Meyer), which is re: to consider
the context (including sources of funds) in which the reports and literature
on impacts of LMOs are researched and written in relation.



-       *SEC are WTO-consistent*.



The Plurinational State of Bolivia fully disagrees with the statement that
incorporation of SEC into biosafety regulatory frameworks violates the WTO
Agreement. As mentioned by different participants in a previous discussion,
WTO Agreements also consider sustainable development, protection of the
environment, makes general exceptions for trade-restricting measures when
they are based on the need to protect the public morals, human, animal and
plant life and health. WTO-SPS Agreement and other international standards,
guidelines and recommendations recognized by WTO (e.g. OIE and IPPC), also
consider relevant socio-economic factors in decision-making.



Here we believe it is important to quoted again to Dr. Spoek (Assessing
Socio-Economic Impacts of GMOs. Issues to  Consider  for  Policy
Development published by the Austrian Federal Ministry of Health and
Federal Ministry for Agriculture, Forestry, Environment, and Water
Management, p. 9) and posted by Lim Li Ching:

"WTO legislation does not a priori exclude socioeconomic aspects as long as
they are verifiable, transparent, and non-discriminating. In developing
their line of argumentation, countries need to define socioeconomic aspects
as risk-, health- or trade-related to make them subject to any of the three
WTO Agreements. Since the WTO dispute, GMOs have been considered almost
exclusively in the context of the SPS Agreement as if no other possibilities
exist. In fact, both the TBT- and the GATT Agreement provide more scope for
addressing socioeconomic factors compared to the SPS Agreement. The recent
WTO dispute on GMOs concluded that it is possible to base measures on more
than one agreement. Overall, it seems to be possible to meet the key
requirements, i.e. a legitimate objective, based on scientific or other
evidence, not more trade-restrictive than necessary, and non-discrimination
when making a case for socioeconomic consideration."



Thanks,



Georgina Catacora-Vargas



References:



IAASTD (International Assessment of Agricultural Knowledge Science and
Technology for Development), ed. (2009a). Agriculture at Crossroad.
Synthesis Report (Washington D.C., Island Press), p. 94.

Heinemann, J.A. (2009a). Hope not Hype. The future of agriculture as guided
by the International Assessment of Agricultural Knowledge, Science and
Technology for Development (Penang, TWN), p. 160.

Dear all,



In response to some comments, we would like to share the following
additional points to our previous posts, which apply to SEC in
decision-making and capacity building. This aiming at contributing to
decrease the possibilities of misinterpretation of the Cartagena Protocol on
Biosafety (CPB):



-       *The CPB is rooted in the precautionary approach and focused on
potential adverse effects*.



The main purpose of the CPB is contributing to ensure an adequate level of
protection from LMOs that may have adverse effects on the conservation and
sustainable use of biological diversity, taking also into account risks to
human health (Article 1 and Article 4). In light to Article 26, Parties also
may also take into account socioeconomic considerations (SEC) in their
biosafety regulation.  Accordingly, biosafety regulations that require
ecological and socioeconomic (SE) risk assessments putting special attention
to potential adverse effects, are simply complying with their commitments
under the CPB and other international agreements, in addition to their
domestic legislation and national protection goals.



-       *Proper biosafety regulation has as first objective to contribute to
the overall society´s welfare and not only to specific sectors of the
society*.



Using as example the Bolivian experience in GM soybean, when analyzing the
benefits from the introduction of this LMOs (in this case an LM crops) we
see that specific groups benefit at economic level, mainly in the short and
medium term. When we add to the economic analysis other critical questions  -
such as who benefit? How the benefits are distributed? Is the introduction
of this technology going to increase o decrease social equity particularly
in the rural area? Do the potential benefits to certain sectors imply a
potential harm to others? If yes, to which extent is this acceptable? Or can
be avoided by other technological alternatives? - then the picture of
“benefits” changes and becomes relative to the framing of the assessment and
the parameters used in the analysis. Based on the experience of neighboring
countries, we see that this not only happens in Bolivia.



The Plurinational State of Bolivia, without neglecting potential benefits
from LMOs, sees with concern the fact that concrete – seen on the ground –
SE adverse effects arising from the introduction of LMOs are not reported at
the same extent as potential benefits. To us this implies an imbalanced in
generation of information and points out that in the literature there are
important gaps of knowledge. We are trying to overcome this by being
precautionary and seeking for proper regulation that will benefit the
overall society. To us this is a cost-effective decision making approach
since it takes into account potential social cost, as well (social cost that
are not only measured in monetary terms).



Again, the consideration of potential adverse effects in biosafety
decision-making process is the responsibility of regulators and the
commitment of Parties towards the CPB.



-       *Biosafety decision-making and regulatory processes have the
responsibility to address SEC beyond commercial perspectives and interest*.



Following our previous point and the discussion under this thread, we see
that the argument of “delay in benefits” from regulatory processes is mostly
in line with a commercial perspective (which is just one issue among the
different issues that should be considered in biosafety regulation and
decision-making). Perhaps here it is important to remember that LMOs
intended for introduction in complex ecological and socioeconomic contexts
(such as LM crops, LM mosquitoes, LM trees, LM vaccines, etc.) require time
for adequate safety assessment. Under the regulatory perspective, this is
not seen as “delay in benefits” but a responsible approach to secure
welfare, or at least decrease in potential harm, to the natural ecosystems
and societies.



In relation to one of our previous points related to the analysis /
identification of potential benefits from LMOs relative to the framing of
the assessment and the parameters used in the analysis, we would like to
quote some findings of the International Assessment of Agricultural
Knowledge, Science and Technology for Development (IAASTD):



“Two framing perspectives on how best to put modern biotechnology to work
for achieving sustainability and development goals are contrasted in the
IAASTD. The first perspective argues that modern biotechnology is
over-regulated and this limits the pace and full extent of its benefits.
According to the argument, regulation of biotechnology may slow down the
distribution of products to the poor. The second perspective says that the
largely private control of modern biotechnology is creating both perverse
incentive systems, and is also eroding the public capacity to generate and
adopt AKST [agricultural knowledge, science and technology] that serves the
public good.” (IAASTD, ed., 2009, p. 43)



“The Assessment [IAASTD] also concluded that another, if not the major,
barrier to development [and benefit creation] was in the form of IPR
[Intellectual
Property Rights] frameworks. The critical test for this comes from the
realization that if all governments were to decide tomorrow to completely do
away with all regulatory review of GMOs, the industry would still guard its
IPR. The costs of licensing would still be in place; liability for being in
possession of a transgene without permission would still be a risk for
non-GM farmers.” (Heinemann, 2009, p. 116).



(NOTE: The IAASTD is the result of a World Bank / UN organizations
multi-year initiative where more that 400 experts from all around the world
participated. The IAASTD is officially recognized by almost 60 countries).



Hence, more than critics aiming at softening biosafety regulation, perhaps
what we should aim at is fostering technologies and systems that supports
them that are safe/ safer in ecological and socioeconomic terms.



A final point under this issue is related to the restricted - if any – role
of confidential business information (CBI) in SEC along biosafety regulation
and decision-making. Under the Bolivian view consideration of CBI in the
context of the CPB mostly applies to the disclosure of technical information
with potential commercial application. In our view, CBI basically does not
apply to SEC. With exception of – and this is arguable – sales and marketing
plans, it is hard to identify what kind of business information should be
kept confidential in the SE analysis relevant to biosafety regulation.



-       *SEC needs to be approached in a holistic manner*.



Previous participants make two very important statements: re: “Any
discussion regarding the inclusion of SEC into a regulatory system has to be
balanced” (S. Stuart) and countries should re: “make their decisions based
on full information, including costs, opportunities lost and information
gains” (J. Falck-Zepeda).



Under the Bolivian perspective, SEC balanced discussions imply the analysis
of potential SE benefits and potential harms with participation of different
sectors and experts with different background. Giving a strong focus to SE
analysis and capacity building needs to the “cost associated with evaluation
or regulatory activities” is not a balanced approach. In terms of costs,
other issues such as “how much is the costs of adverse effects in the
conservation and sustainable use of biological diversity, taking also into
account human health, when approval of technologies did not properly assess
those *relevant* potential adverse effects?” must be considered, too.
Unfortunately, we have limited access to information on environmental and
social costs resulting from adverse effects (either potential or real) from
LMOs because little research has been done in this field for different
reasons (including availability of funds for this sort of research).
Nevertheless, here is where the precautionary approaches become operative.



In relation to consideration of full information, including costs,
opportunities lost and information gains, this also should include, inter
alia, monetary and non-monetary social and environmental cost of adverse
effects, lost of opportunities when non-adopters of GMO technology are
negativelly impacted (the high demand of GM-free soybean and lost of GM-free
soybean market and premium prices due to genetic contamination is a clear
example in relation to LM crops), gaps of knowledge when research is focused
on particular issues and do not have an holistic approach.



We would like to stress on the need to be holistic and context-based using
the previous GM potato example. Mr. Stuart mentioned that the GM potato
example that he shared is a clear case of re: “how social considerations are
now responsible for increased environmental damage”. From our point of view,
this is generalization and conclusion very much restricted to: i) a narrow
analysis of social and environmental sustainability and ii) a specific
situations where farmers might not have production options different from
industrialized agriculture, where the ecological imbalance that it creates
is artificially compensated with high use of synthetic, toxic and residual
chemicals. Accordingly, the analysis and conclusions on social and
environmental impacts are seen only through “the eye” of a particular
technology (e.g. LMOs), ignoring other alternatives suitable to local
contexts (particularly in countries with high biological and cultural
diversity where SEC play a crucial role in innovation of sustainable
technologies). In the case of Bolivia, if SEC would not have been considered
in the request for approval of GM potato based on sound-science information
and also considering narratives from indigenous people, maybe now we would
be saying that the lack of consideration of SE issues in the introduction of
technologies are responsible of serious social problems such as weakening
food security/sovereignty in local and indigenous communities.



Finally in this point, holistic SEC assessments need to make a very
important consideration (mentioned by H. Meyer), which is re: to consider
the context (including sources of funds) in which the reports and literature
on impacts of LMOs are researched and written in relation.



-       *SEC are WTO-consistent*.



The Plurinational State of Bolivia fully disagrees with the statement that
incorporation of SEC into biosafety regulatory frameworks violates the WTO
Agreement. As mentioned by different participants in a previous discussion,
WTO Agreements also consider sustainable development, protection of the
environment, makes general exceptions for trade-restricting measures when
they are based on the need to protect the public morals, human, animal and
plant life and health. WTO-SPS Agreement and other international standards,
guidelines and recommendations recognized by WTO (e.g. OIE and IPPC), also
consider relevant socio-economic factors in decision-making.



Here we believe it is important to quoted again to Dr. Spoek (Assessing
Socio-Economic Impacts of GMOs. Issues to  Consider  for  Policy
Development published by the Austrian Federal Ministry of Health and
Federal Ministry for Agriculture, Forestry, Environment, and Water
Management, p. 9) and posted by Lim Li Ching:

"WTO legislation does not a priori exclude socioeconomic aspects as long as
they are verifiable, transparent, and non-discriminating. In developing
their line of argumentation, countries need to define socioeconomic aspects
as risk-, health- or trade-related to make them subject to any of the three
WTO Agreements. Since the WTO dispute, GMOs have been considered almost
exclusively in the context of the SPS Agreement as if no other possibilities
exist. In fact, both the TBT- and the GATT Agreement provide more scope for
addressing socioeconomic factors compared to the SPS Agreement. The recent
WTO dispute on GMOs concluded that it is possible to base measures on more
than one agreement. Overall, it seems to be possible to meet the key
requirements, i.e. a legitimate objective, based on scientific or other
evidence, not more trade-restrictive than necessary, and non-discrimination
when making a case for socioeconomic consideration."



Thanks,



Georgina Catacora-Vargas



References:



IAASTD (International Assessment of Agricultural Knowledge Science and
Technology for Development), ed. (2009a). Agriculture at Crossroad.
Synthesis Report (Washington D.C., Island Press), p. 94.

Heinemann, J.A. (2009a). Hope not Hype. The future of agriculture as guided
by the International Assessment of Agricultural Knowledge, Science and
Technology for Development (Penang, TWN), p. 160.

In all fairness to Professor Carl Pray of Rutgers University who wrote the paper cited here,and who is a professional who has had a distinguished career and recognized track record of publications, and since I co-organize the session in which the paper was presented and was the one who referenced the paper in this forum, I think it would be important to read the whole paper out of which these quotations were extracted. The meaning of such comments need to interpreted within the context of the whole paper presented in a special session at a professional conference.

Although the context of my comments had to deal with the decisions that countries will make in terms of the options that they have with regard to the potential inclusion of socio-economic considerations, certainly the issue of full information applies in the context of decisions about technology. In all situations, the issue of determining how much and the quality of information applies in delimiting the decision in all cases.

In the end, society has to make decisions in terms of the tradeoffs related to regulatory design, as we do not have infinite resources to invest in biosafety or socio-economic assessments, we have limits in terms of what science processes can do, and we have the possibility of committing regulatory errors.

In a public policy setting the question is indeed a matter of investing scarce resources in technology research and development, regulatory processes, technology transfer, technology discovery, public knowledge conservation and many other options.