Online Forum March-April 2013

Some notes to consider:

Decisions taken with regard to the import of living modified organism for intentional introduction into the environment shall be in accordance with Article 15 of the Protocol (paragraph 1, Article 10 of the Protocol). Risk assessments undertaken pursuant to the Protocol shall be carried out in a scientifically sound manner. Such risk assessments shall be based on information provided by the notifier and other available scientific evidence in order to identify and evaluate the possible adverse effects of living modified organisms on the conservation and sustainable use of biological diversity (paragraph 1, Article 15 of the Protocol). The Conference of the Parties to the Convention on Biological Diversity (COP) has adopted guidelines on impact assessment. These include the “Guidelines for incorporating biodiversity-related issues into environmental impact assessment legislation and/or processes and in strategic environmental assessment” contained in the annex to decision COP-VI/7. According to these guidelines, the purpose of impact assessment is to predict and identify the likely environmental impacts of a proposed project or development taking into account inter-related consequences of the project proposal, and the socio-economic impacts. The other guidelines that COP has adopted are the “Voluntary guidelines on biodiversity-inclusive environmental impact assessment” contained in the annex to decision VIII/28. The guidelines focus on how to promote and facilitate a biodiversity-inclusive environmental impact assessment process.

Dear members of the Secretariat, dear participants,

Hello again in this new session of the SEC online forum !

While being surprised by this change in the order of the questions presented by the Secretariat, this allows me to come back to considerations that were raised by several participants during the discussions of last week, and in which I had to restrain myself not to intervene, which I tried to do since I found that these considerations should not mobilize too much space in this last session of the forum.

These considerations concern the relationship between the ERA process and the SEC process.

My impression is that during the former online discussions, during the spring 2011, on the ERA Roadmap on one side and on SEC on the other side, there was a wish of most participants in the ERA discussions not to mix both processes, whereas there was a  wish of most participants in the SEC discussions to mix both processes.
I believe this discrepancy is just coming from a difference between participants in the understanding of the wording “ mixing both processes”.

As well explained by Andreas Heissenberger in the preceding session ( posting n° 4436 ), there are obvious links between both processes ( and both processes should join somewhere ) but we should try to keep them separate during the present forum among other and mainly because they use different assessment methods and it could jeopardize the success of the present forum, where we have to define clear aspects relative to SEC, to call to mix them all the time.

However, it is obviously difficult to totally forget one process ( ERA ) when tackling the other one ( SEC ), the more that the wording of Art. 26.1 is asking to lean on “ socio-economic considerations arising from the impact of LMOs on the conservation and sustainable use of biological diversity ” . Relatively to this, I am very happy that Mr. Giovanni Ferraiolo from the Secretariat reminded us that under the CBD, from which the Protocol is dependent, the integration of biodiversity-related issues has already been discussed and even foreseen in guidelines; and, obviously, SEC are among these biodiversity-related issues under the Protocol.

To add some link to the CBD and SEC considerations, we should remind the TEEB initiative ( The Economy of Ecosystem Services ), which is one of the way to make a link between biodiversity and SEC. But we should know and remind that economic value is neither the only neither the most important value of biodiversity recognized under the CBD.

Now, I’ ll start to answer more precisely the specific question asked by the Secretariat in this session.

One 1st consideration about this: if Parties have indeed the sovereignty to take into account, in domestic measures, any kind of SEC, those covered by the Protocol are limited to” SEC arising from the impact of LMOs on ………. biological diversity” . These impacts could be direct or indirect.

By reading the wording of this part of Art. 26.1, one could consider that, during the process leading to a decision on a LMO authorization, the biosafety risk assessment should precede this phase of SEC, and that no SEC would be needed if no biosafety risk has been for sure recognized.

But, obviously, SEC could also be socio-economic benefits, and not just negative impacts, resulting from impacts of the LMO on the conservation and sustainable use of biological diversity.

On another side, the SEC analysis could anyway be useful, even if sure biosafety risks were not recognized, to evaluate the potential, eventually cumulative, costs and other socio-economic impacts in case uncertain identified biosafety risks would occur.

Moreover, many of the ERA processes till now are dedicated to short-term qualitative RA on focal species taken as representatives of functions in the ecosystems. Even when the legal frameworks foresee that long-term and indirect and cumulative risks on biodiversity should be looked at, it is still more recognized by scientists that this is very complex to do and that only modeling, subject to errors, can answer this requirements. Here also, the SEC analysis should evaluate the various ( maximal ) socio-economic potential negative impacts of LMOs resulting from impacts on biodiversity but also on cumulative and irreversible impacts on ecosystems functions and their services ( linked to impacts on biodiversity but sometimes indirectly and going further than impacts on biodiversity alone ), taking into account uncertainties linked to lack of knowledge due to the complexity of the system.

One additional uncertainty is the fact that the ERA is most of the time performed in some limited environments, and that generalizations to other environments are drawn from these ERA, whereas legislative frameworks require the ERA to be made in the environment where the LMO would be used.


In shorter words, SEC should consider the various socio-economic costs of inaction and other potential negative impacts ( thus, among other but not only in financial  terms ) that would be generated, in case the risks occur, by authorizing the LMOs in case of uncertainty of risk towards biodiversity, and considering broader and more indirect impacts on the ecosystem and the environment - including the limits of resources of the ecosystem of the planet - and the society than these generally considered in ERA processes.
But SEC could also obviously consider the costs and other negative socio-economic impacts resulting from the non-authorization of LMOs, proving that these LMOs would have generated positive impacts  on the conservation and sustainable use of biodiversity.


Obviously, one challenging element is the baseline to choose as comparator to make these SEC ( this is actually also true for the Environmental Risk Assessment ).

I stop here for my first message under this session, that could already, I think, appeal various complementary or reactive postings.

With best regards.

Lucette Flandroy




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Dear Lucette,

Interesting contribution. In the spirit of internal consistency, doesn't your contribution also mean that the inclusion of socioeconomics in decision making has to follow the standard of proof and procedures as in the rest of the Protocol? I am thinking of the standards and procedures required by the KL-NA supplemental annex on Liability and Redress, which although not ratified should set the standard for decision making. Meaning that one would require real evidence of harm -expanded in mind to include benefits and costs- perhaps compared to a baseline so as to avoid claims without proof. Standard is indeed higher.

Furthermore I would argue that we cannot limit the assessment to evidence of harm, but also that it is an imperative to consider also benefits -defined broadly beyond monetary gains of course- in order to ensure a better decision making by society. Whether such assessment requires new research/studies or whether this would me more of an assessment of available evidence remains to be determined.

Dear Dr. Falck-Zepeda,

Thanks for your fast reply to my first message.

Here some answer to feed the discussion.

I am convinced that the Parties that want to include SEC in their decision procedures relative to LMOs should establish a well defined procedure for that.

But, following my last message and these I posted in the preceding session, I do not think that all SEC taken on board should have standard of proof, as you say.
The Protocol clearly mentions socio-economic “considerations” and not socio-economic “ proven consequences” .

Some of these considerations could indeed be quantified and this in monetary terms; and they should, de facto, be quantified when they could, because it is generally easier to take decisions on the basis of precise figures. And they could , for ex., I guess, quantify in monetary terms some aspects of the socio-economic consequences of the worst scenario in case the uncertain risks linked to some LMO would indeed occur.
But, as already mentioned by several participants in the preceding session and in the preceding forum on this issue during the spring 2011, some socio-economic considerations are hard to tackle in quantified and especially in monetary terms ( and my opinion is that one should avoid to translate all values in monetary terms ), which does not mean that they are not important and not real. Most of them could be tackled by social and anthropological scientific tools, and using some kind of participatory process.

It would indeed be the responsibility of competent political decidors to take decisions on the basis of complex data.
But these political decidors should precisely be helped by a clear and transparent explanation ( foreseen in the procedure ) of the various socio-economic concerns and of their respective importance for various stakeholders of the society. In this explanation, the uncertainties should be clearly mentioned ( as they should for the biosafety ERA ), as well as the methodologies used for the assessment and the biases that they can bring ( for quantified as much as for unquantified data ), as well as the limits of information that each methodology can bring.

That being said, it is possible that not every political decidor likes to take complex decisions where he must make real choices and really engage his responsibility facing the complexity of the society. But isn’t it anyway the role of a political decider ?

That benefits should also be considered and not only harm, as you mention in your 2nd §, I recognized it also in my 1st posting.

With best regards, and looking forwards at the constructive participation of many dedicated people in this forum. ( I shall now be busy elsewhere this afternoon ).


Lucette Flandroy



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I agree with Dr. Falck-Zepeda. I also think tahat, in terms of socioeconomic considerations, a benefit-cost analysis should be the initial step for the assessment. It only makes sense to conduct an environmental risk assessment when the introduction of a specific LMO has significant potential POSITIVE impacts. If no positive impact is to expect, there is no need to conduct expensive trials to assess environmental risk.
In case that environmental risk is to be assessed, research shold be based upon scientifically supported hypothesis on the risk factors. This hypothesis will guide the experimental design and then the biosafety measures and considerations to be taken into account are already well documented after two decades of experience of field trials and regulatory work.

I think that Article 26 is about consequences as it speaks of the socioeconomic considerations arising from the impact on biodiversity from the introduction of an LMO. In fact, seems to me that the wording of the article actually points to a sequential approach where you actually determine an impact on biodiversity of importance to local and indigenous communities (at the risk assessment level?), and then determine the socioeconomic considerations relevant to that impact. In fact, the wording of the article seems to indicate that it is not only biodiversity per se, but rather the conservation and sustainable use of biodiversity. Article seems to lean towards a utilitarian view of nature where biodiversity draws innate value (broad terms) and value in use.

When I talk about a standard of proof, I do not necessary mean “proven consequences”. As long as an impact has a credible likelihood (or probability) of occurring, then it becomes relevant. This would of course mean an assessment to determine likelihood and potential impact and thus meet a standard of proof.

If there is no standard of proof, what would stop a stakeholder from making a spurious claim of biodiversity impact be it harm or benefit? Would it then be that anybody can stand up and claim such impact without any basis or credibility and that would be sufficient to motivate a regulatory/decision making response? Obviously, this is also connected to public participation and the fiduciary responsibility of regulators/decision makers to society (as Sachin Chatuverdi has pointed out in previous post). I am just thinking out loud focused on future implementation.

I would agree with Ms. Lucette Flandro (4510) that it can not only analyzed as "proven consequences", much less even only from the point of view of cost-benefit analysis.

There are very important tools, developed for example by ecological economics, as muticriterial analysis, which can help to assess the economic impacts aspects.

But there are other aspects that are incommensurable, such as those of cultural and ritual type, as is the effect on crops or sacred sites that are part of the calendar agrofestivo certain communities, which can easily be affected for releases into the environment of LMO.

Dear all,

A short evening reply to the last posting of Dr. J. Falck-Zepeda:

Indeed, Art. 26.1 is talking about socio-economic consequences arising from impacts on …….biodiversity, and not about causes of socio-economic considerations that could impact the probability of biosafety hazards, and thus the biosafety risks.

But this should include socio-economic consequences of potential, including uncertain impacts, and not only of sure impacts on ……. biodiversity. Otherwise, how to take this into account in the decisions on authorization of LMOs and in particular in authorizations before a  1st  transboundary movement ? This would mean that the harm or the benefit should have occurred before the entrance of the LMO in the country of import !?

I agree that there should be some relevancy in the claims of potential harms.
The relevancy to give attention to SEC could come a.o. from experience in other countries, analogy with similar situations, numerous repetition of similar claims from a group of stakeholders, peculiar professional expertise of some alert giver, …….

Nice evening, and waiting for coming contributions maybe to comment on the small points I put between “on “ and “ biodiversity” . ( the wording on biodiversity is indeed rather utilitarian in this part of the sentence; but with a sense of sustainable use; and value of biodiversity – to be discussed later - is not only monetarian. I just see the message of Dr. Elizabeth Bravo coming and commenting briefly about this …….  )

Kind regards.

Lucette Flandroy


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Dear all,

My short comment on this is that Article 26 is clearly talking about socio-economic considerations that could arise from the impact of LMOs on biodiversity and not the causes of socio-economic as stated by Lucette Flandroy. This also makes the SEC analysis much broader and does not limit the scope to biodiversity but expands it to livelihood etc. This requires the analysis to have a larger mandate beyond environmental risk assessment .

  This kind of an assessment become vital to countries that are a centre of origin or a centre of diversity, where there is a large proportion of indigenous and rural population and countries whose economic development depends on bio-diversity.  The 2 key factors that would be affected by a country who has a close relationship with biodiversity is food security and income of the agricultural population.

Keeping the 2 factors in mind a socio-economic assessment can be done parallel to a risk assessment (Art 15) as it is one thing to find a risk to biodiversity but at the same time it is important to assess the cost effectiveness to farmers of any technology.

Regards
Neha Saigal
Greenpeace, India

Dear colleagues
Many contributions are done in this round of discussions. I want to support the comments of Dr Falck Zepeda and Dr Jose Luis to say that we cannot llimit the assessment to evidence of harm but also benefits should be taken into account.
The article 25 effectively takes into consideration socio-economic considerations that could arise from the impact of LMOs on biodiversity.
Regards
Dr Gado

Dear colleagues!
I followed the discussion so far with great interest and I want to add a little of my thoughts on the issues discussed:

1) I agree with what has been said by Elisabeth Bravo, Neha Saigal, Lucette Flandroy and others (also in the first round) that we can and should not limit the assessment of socio economic considerations to an economical cost-benefit analysis. It has been pointed out that the wording of Art 26 (“arising from the use of LMOs” on “sustainable use of biodiversity”) requires a much broader assessment.

2) Regarding the discussion on proven evidence of harm and standard of proof, I’m a little bit afraid that we are again back to standards developed for risk assessment (environment and human health). I strongly believe that though any decision based on a socio economic assessment needs to be evidence based, it will be impossible to have any proof of harm in an ex-ante assessment. Unlike risk assessment studies (lab studies or field trials) usually no exact data can be generated for a socio economic assessment before it is used on a commercial scale. However, evidence of possible effects can be based on experience gained in other countries, modeling approaches, and so on, but these methods need to reflect the local circumstances. Socio-economic assessments can also not rely on field trials – as they have no relevance in the economic and social context. So I agree with what has been said by Jose Falck-Zepeda that if a possible effect has a certain likelihood to occur it is relevant. And if it is relevant it needs to be taken into account in decision making, if the Party decides include SECs in their decision making.
Just another point in this context: Evidence and likelihood should not only be a requirement for possible negative effects but also for claimed benefits, which in any case need be equally and thoroughly assessed.

Regarding the first point we have done a report on behalf of our ministry to develop a concept on assessing socio-economic effects (http://www.umweltbundesamt.at/aktuell/publikationen/publikationssuche/publikationsdetail/?pub_id=1941). Though this report focusses on possible risks (as this was what we were asked to do) it might be useful for our discussions. The basic concept was to frame socio-economic assessments around the concept of sustainability (social, economic and environmental impacts). Sustainability as an important topic was also mentioned in the discussion on question 1 last week by Lim Li Ching (#4427), Leonardo Gonzales (#4438), Doreen Stabinsky (#4493) and Lucette Flandroy (#4488). We think that this gives a broad enough basis to do a comprehensive assessment, while on the hand also allows to adapt the concept to national or regional circumstances.

Andreas Heissenberger
Environment Agency Austria

Dear All,

I thank the Secretariat for continuing the approach of discussing the key elements of article 26. The phrase “arising from the impact” is indeed another key element.

It is good to see converging understanding that SECs are discussed here in the context of decision making and that environmental risk assessment and decision making are two related but separate things.

It is also good to see converging understanding that “SECs” is an unqualified term and can include socio-economic benefits as well as risks.

Having said that, I also note in some interventions prescriptive terms as “should”, “must” etc.

Perhaps good to remind ourselves that article 26 does not institute an obligation for Parties - it talks about “Parties may”. In fact, it may be good to remind ourselves that article 26 did not establish anything new. Countries already had the right to, consistent with their international obligations, take certain SECs into account in decision making.  Article 26 merely recognises that, it does not change it.

Turning to the question posed by the Secretariat: “what does ‘arising from the impact’ mean?”:

Looking at the individual elements of that phrase, there is first the term “arising from”. As some participants underlined, this refers to a sequence of events, i.e. only after certain impacts have been established, can SECs come into the focus. I.e. we are not talking about SECs “per se”.

This too is consistent with international obligations such as SPS.

The next element of the phrase is “impacts”. Here we note a key difference between article 26 and many other articles of the CPB: while many other articles refer to “potential adverse effects”, article 26 uses the unqualified term “impacts”, which can mean both beneficial and adverse impacts.

In short, we have various possible combinations depending on whether we are looking at:
• Beneficial impacts on biodiversity and sustainable use.
• Adverse impacts on biodiversity and sustainable use
• Beneficial socio-economic results arising from these impacts
• Adverse socio-economic results arising from these impacts

In addition, there are various possible decisions, e.g.
• approvals (with or without conditions) vs denials,
• decisions in individual cases (e.g. arts 10 and 11) vs generic decisions (e.g. art 7.4, 13 and 14)
• etc.

Looking forward to the remainder of the debate

Piet

Posted on behalf of Brian Wynne
---
From: Wynne, Brian
Sent: March-19-13 8:35:31 AM (UTC-05:00) Eastern Time (US & Canada)

Dear Colleagues,

I'm grateful to all for their informative observations, and would just like to offer my own summary inputs to this important discussion in response to Question 2.

Firstly, as Joanna Goven, Lucette Flandroy, Andreas Heissenberger, Elixabeth Bravo, Neha Saigal, and Rosa Binimelis (and perhaps other I have missed) have already stated, "Socioeconomic considerations arising from the impact of LMOs on conservation and sustainable use of biodiversity"(Art. 26) can include important social impacts which an economic impact assessment does not include. Therefore economic assessment alone is inadequate, even if its framing (which excludes even some economic factors ab initio, which others might wish to include) is transparently done. Further social factors - possibly beneficial (as Pieter van der Meer says) as well as harmful - would need to be inclusively identified, evidence on them gathered from all relevant sources, analysed and assessed. I also agree with Heissenberger that if benefits are to be assessed like risk- or impacts-questions rather than simply presumed, their evidence-base, ex-ante as well as ex-post, requires scrutiny, including its relevance for the new situations for which it is proposed to be representative;

Secondly, in support of Andreas Heissenberger, Lucette Flandroy and others, there is no reason in principle why such SE impacts and impact-factors cannot be evidenced, and thus assessed in an evidence-based manner; but as Heissenberger notes also, socioeconomic factors are most likely - though this same point applies to conventional RA too, especially to Environmental RA - to require careful attention to local variabilities. These complexities and variations in local and regional conditions, of the utmost importance to those at the ground level, are something which especially economic assessments, in their anxiety to appear 'scientific' and universal (but forgetting that the science which they are trying to emulate often also denies this substantive variability), typically overlook.

Finally on the proposal which several colleagues have made, that SEC be defined in relation to sustainability principles (and I would emphasise the often-neglected obvious, that this introduces essentially long-term assessment criteria, even if salient evidence becomes less precise as a consequence), and which is included in double-emphasis in the Article 26 language ("conservation.." of biodiversity also means "sustainable", as well as "sustainable use of.."), I believe this to be a valuable step. in this respect, it could be proposed that all assessment processes relating to the CPB, not only socioeconomic but also (as already prevails for example in EU legislation and regulation for GMOs) for environmental and health regulation, be explicitly address long-term and not only short-term (or even unspecified) timescales. For example, reduction of microbial (soil), insect, plant, and germplasm or genetic biodiversity, including agricultural biodiversity, from projected hypothetical future or cumulative previous LMO imports may be an important impact on conservation or sustainable uses of biodiversity which is unlikely to be observable over the timescales typically used in existing socioeconomic impact (nor risk assessment) studies. While there is an irrefutable established logic for case-by-case assessment and decision, this kind of impact question, also salient to our Question 2, would require an additional larger (socioeconomic as well as natural-scientific) assessment framework.

Thanks to all,

Brian Wynne

I was hoping and continue to hope hearing more from the parties in terms of their thoughts and approaches with regard to Article 26. We have heard so far the formal positions from two (maybe three) parties.  Hope I have not left out anybody. We cannot deliberate about any party’s formal positions unless invited to do so by the party itself.

Yet, I think it is prudent for those countries who are still considering whether to exercise their right to apply or not socioeconomics in their decision making –to carefully weigh the issues related to such implementation, including the benefits, costs and risks in order to decide whether it really improves decision making. I am afraid the answer is not unequivocal, even in the case when the SEC assessments may have been properly done. If a country has made the informed choice to include socioeconomic considerations then the discussion becomes how they are going to do it-

From the standpoint of a well-seasoned expert, I know there are many pitfalls and issues related to the implementation of SEC assessments and that is why I like the challenge. As Andreas Heissenberger and Lucette Flandroy have pointed out, those SEC assessments done before the technology is released (ex ante) and done likely for approval purposes, are full of assumptions and data limitations. We have to take the results from even the most experienced expert with caution.

Parties will in fact have to weigh how much specificity they desire to gain knowledge about technology adoption with when to conduct such studies. Even those conducted after adoption (ex post ) done likely for monitoring purposes, are really tricky to assess and untangle cause and effects but may yield more and perhaps more precise information.  Projections made over the long run about impacts become even more diffuse over time. This is the reason why one cannot focus on qualitative but also quantitative approaches in such assessments.

The last point I wanted to make is that some contributors have already raised the issue of balancing and contrasting the SEC considerations derived from impacts on biodiversity resulting from LMO use with benefits derived from adoption including broader impacts such as food security. As Piet van der Meer has indicated, impacts on production, food security and sustainability can be positive or negative and thus we cannot focus on harm only. This implies also including the potential impact on innovation, technology release and thus on those potential benefits (and adverse effects) that may accrue to society in general. The later will include assessing the impacts of biosafety and other regulations on these issues.

To further elaborate on the issues, a relevant resource is the “Principles and Guidelines for Social Impact Assessment in the USA” IAPA (2003).

Some important issues highlighted in these guidelines include:
- Use of experienced experts in the field of impact assessment including economists, sociologists, anthropologists, geographers, and others to conduct such assessments especially for those done before the intervention
- Use of robust science based  research methods and concepts that are transparent and replicable
- Ensure quality control including formal peer review after scoping
- Focus on impacts deemed to be significant in terms of context and intensity. This implies a standard of proof and evidence.
- Consideration of not only impact but also mitigation approaches. Makes it consistent with environmental risk assessments

Worthwhile noting that the Social Impact Assessment (SIA) approaches are usually part of a broader assessment process. In the USA, it is known as the National Environmental Policy Act (NEPA) of 1970. The NEPA is a procedural stature – does not have the authority to stop an action- is used to inform about environmental consequences of projects by federal agencies in the USA.  Note also that the NEPA process is a graduated process that considers initial statements of “Categorical Exclusions”, Environmental Assessment (EA)/Finding of No Significant Impact (FONSI) and Environmental Impact Statement (EIS) and Record of Decision (ROD).

Reference
The Interorganizational Committee on Principles and Guidelines for Social Impact Assessment (2003). “Principles and guidelines for social impact assessment in the USA”, Impact Assessment and Project Appraisal, volume 21, number 3, September 2003, pages 231–250, Beech Tree Publishing, 10 Watford Close, Guildford, Surrey GU1 2EP, UK. http://www.iaia.org/publicdocuments/Pubs_Ref_Material/US-principles-final-IAPA-version.pdf

Dear Jose!
Just a brief remark on the issue of formal positions from Parties: Most of us, though representing our countries at CPB negotiations, are participating to this forum in our personal capacity. Therefore it is unlikely that there will be many official positions posted. To post an official position would require in many countries a formal consultation between authorities, and this will not be possible given the limited time we have to discuss the different issues.

Anyway there is an indication in the decisions of COP/MOP 5 (strategic plan) and COP/MOP6 in what the Parties want us to do.

I also think that it is not up to us to deliberate on the positions of Parties, but to discuss on a technical level the different issues framed by the Secretariat. In my opinion this has been quite fruitful so far and I’m looking forward to continue this exercise.

Best regards
Andreas Heissenberger
Environment Agency Austria

Dear all,
Firstly, I’d like to thank the secretariat for the continuation on this discussion.
Several interesting comments were made. I agree that impact can be either positive or negative, or even both depending on which aspects/perspectives are taken into consideration. Both positive/benefit and negative/harm are important to be considered. Including non-monetary and/or indirect effects considering the impact of LMOs on biodiversity… (art. 26.1) is also reasonable.
It’s also crucial to have a reasonable expectation on what can be achieved with SEC, as well as the costs of such an assessment and its limitations (I agree with Dr. Jose Falck-Zepeda #4532).  As it was pointed out by Dr. Jose Falck-Zepeda, Dr. Andreas Heissenberger (#4436), etc. there are a number of assumptions and other limitations on ex ante socio economic assessments. In addition, some aspects might not be very obvious especially before the technology is in use for some time. For instance, changes in tillage practices could be a SEC (an indirect impact), as it has an effect on soil erosion, etc. but would it have been foreseen for HT-crops before its use? Neither is necessarily the case in all regions where HT crops are adopted (e.g. more might be needed, such as awareness of different practices pros and cons). Other aspect that can be considered is, for instance, a modification in the amount of agrochemical compound used, this is an example of relevant change that is subject to selection bias or controversial conclusions, as one can in some cases be more effective choosing for instance the shift to less toxic agrochemical substances used. The decision on whether or not to opt for SEC, as well as, how it is done may delay, rather than promote the protection of biodiversity, … indigenous and local communities. There’ll be probably situations when SEC is a useful part of the decision process and others when not doing it, it is the best choice.
Best regards, Lúcia

Dear participants,

First I want to confirm the last posting of Andreas Heissenberger explaining that some of us, whereas being official negotiators of our governments in the COP-MOP of the Protocol, are not participating here as official representatives of a common political position of our country but rather as voluntary participants, considered as experts through our experience in the field of LMOs and related issues ( various of us being Ph.D. as back-ground ), in this brainstorming forum; this while being nominated as representatives of our country, but without exclusivity and without mandate.

I appreciated a previous posting ( n° 4533 ) of Dr. J. Falck-Zepeda that synthetized some elements of guidelines for SEC. It seems to me this is not exactly an issue of discussion in this session, but should rather be discussed in a debate on methods, but shall react briefly to it anyway. I copy here part of this posting

the “Principles and Guidelines for Social Impact Assessment in the USA” IAPA (2003).

Some important issues highlighted in these guidelines include:

- Use of experienced experts in the field of impact assessment including economists, sociologists, anthropologists, geographers, and others to conduct such assessments especially for those done before the intervention
- Use of robust science based  research methods and concepts that are transparent and replicable
- Ensure quality control including formal peer review after scoping
- Focus on impacts deemed to be significant in terms of context and intensity. This implies a standard of proof and evidence.
- Consideration of not only impact but also mitigation approaches. Makes it consistent with environmental risk assessments


I agree that as much as possible what are called scientific methods should be used to analyze the concerned SEC.
But this should indeed involve for ex. anthropologists, sociologists and historians of science politics, experts of cultural changes linked to development, historians and sociologists of agriculture  as much as economists, when one is talking about “SEC 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 the involved scientists should not neglect to listen to and to look for all kinds of relevant stakeholders.

Concerning the guideline: “Focus on impacts deemed to be significant in terms of context and intensity” .
I proposed myself earlier that “numerous repetition of similar claims from a group of stakeholders” could be one proof of evidence. This does not mean that only such numerous claims should be listened to.
First, the meaning of “intensity” can be very interpretative, and this is one example where subjective, sometimes political, choices can be made in so-called scientific methods.
Second, more maybe in pure science and biosafety issues than in SEC issues, the minority claimers are not automatically the wrong thinkers.
Finally, does it mean that minority groups would not deserve any attention for SEC ?

Concerning mitigation measures, I suggested it also in the previous session; but attention should be given to their practicability and sustainability and equitability.

I shall go on in a next message later on with considerations more directly linked to the question raised in this session.

Kind regards.

Lucette Flandroy


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Greetings again from the Honduran panel  and many thanks to all for thier valuable contributions.

I would like  to make for main points and the details will follow:

1. Sound decision making on the adoption of any technology requires analysis of both costs and benefits of the technology;
2. Socio-economic considerations (SEC)  are most appropriately addressed in the decision-making or risk management part of risk analysis;
3. The separation of risk assessment (identifying hazards and quantifying risks by estimating their likelihood and consequences) and risk management is a general paradigm of risk analysis and is embodied in the SPS Agreement of the WTO, CODEX, OIE (World Org. for Animal Health), and IS0 31000 Intl. Guidelines on risk management.
4. Is there a proposal in this group  to redefine the standard paradigms of risk analysis by including SEC  in the risk assessment process, instead of the risk management process?

The issues discussed here are of  great importance  for countries that  need and want  to preserve their biological diversity, but also  depend on agriculture for social and economic development. The safe inclusion of innovative and environmentally sound  technologies needs to be addressed carefully,   for their benefits as well as for  their potential negative impacts. I strongly support the statement by Dr. Jose Luis Solleiro from Mexico and Dr. Jose Falck-Zepeda from IFRPI,  who remind us that  as a firsts step, a cost-benefit analysis is  necessary and that  unless a new technology offers  benefits to society, it is pointless to even consider it.

I respectfully agree to disagree with Professor  Brian Waynne and maintain the position of Honduras  to include SEC in the risk  management process,  but NOT in the risk assessment process.  I also regret that he questions a carefully considered  technical decision taken by a party.  You state  that  my statement on behalf of Honduras  “appears  to justify this decision on the part of her government”. Honduras has exercised its sovereign right to follow national legislation and act accordingly. In Honduras,  the biosafety guidelines for use of biotechnology fall within the Phytosanitary Law.  There is no separate law for  LMOs  and it works well for the country, it’s priorities  and  policies.  We use the rigorous  and standard guidelines to conduct a risk assessment  as it  applies to pest, diseases and invasive species  to  evaluate the possible harm of  LMOs.  Indeed, our first training in risk analysis was done in the context of pest, diseases and weeds and this has served us well in understanding the required rigor and  nuances of conducting a risk assessment for LMOs. 

Maybe a reminder of  semantics and the  technical use of terminology in risk science would be useful at this point and may explain some discrepancies of opinion?   Language does matter – a great deal.

A basic  paradigm of the science and practice  of risk analysis is the separation of risk assessment and  risk management,  as stated by many messages in this forum and recently by Piet Van der Meer.  SEC, in this context,  belong to the  risk management  process and NOT to the risk assessment process  - a process that should only be  concerned with biosafety issues involving biological measurements by qualified professionals.  The next step, risk management,  must indeed  involve SEC to shape policy and ultimately for informed decision making. It’s a political and scientific decision while risk assessment is a scientific assessment of risk.   Both processes are interrelated,  but need two different sets of professionals with different backgrounds and training, asking different questions.

In everyday  lay language,  one would be forgiven for using words  like risk evaluation,  risk analysis, risk assessment, impact  study etc, interchangeably.  To mix and interchangeably  use these terms  in the context  of risk assessment   constitutes a technical  mistake. The Protocol language is very clear on the topic.  The distinction and correct  use of terminology  and thus procedure,  is a standard  feature of  the SPS Agreement of the WTO, CODEX, OIE (World Organization  for Animal Health), and IS0 31000 International Guidelines on risk management.

Is the intent of these  new proposals to redefine the  terminology and practice of the science of risk analysis by including socio-economic considerations where, historically and as a general paradigm, they don’t belong? This would be very confusing for new regulators trying to grapple with new terminology,  concepts and the practice  of risk analysis.  It would also make the process much more complex and expensive, overburdening  struggling biosafety programs in small developing countries, as it deviates from the norm in most international guidelines and what is taught in regulation courses that use standard risk analysis concepts.  In other words, countries that accept this would have one set of standards and guidelines for assessing pests and diseases following guidelines from SPS, Codex and other international  agreements and a  different set of paradigms  for risk assessment  of  LMOs issued by the Secretariat ? Would they not be contradicting or violating international  agreements such as the SPS Agreement?  That is for the lawyers to answer.

From a  capacity building or training point of view,  I  also anticipate  even greater  confusion when technical risk assessment and management documents are translated into other languages like Spanish by official translators, not by professional risk analysts.  Here,   mistakes or different semantic interpretations  in use of language could be  very easy to make. (eg. using the term assessment to mean analysis, or  harm to mean danger, etc.).

I apologize for the length and depth  of this message, but when questioned by Professor Waynne on the legitimacy of the decision taken by Honduras, a full  technical (and not political) explanation   was in order.

I look forward to continue to learn from all your important opinions.

Maria Mercedes Roca on behalf of the Honduran CTNBio and the ICABB for Central America

POSTED ON BEHALF OF Carlos Almendares, HONDURAS

Hello everyone,

Trying to understand BS-VI/13 decision, which relates with paragraph 1 of Article 26 of the Cartagena Protocol on Biosafety, first of all, we must recognize that it is not mandatory, however given the option to countries (part) they want, they can take into account the socioeconomic aspects before making a decision. To start this task, follow closely the decision itself, which indicates that must comply with its international obligations, further asks the Secretary-General that after all this work of gathering information, develop "conceptual clarity" in the context of paragraph 1 of Article 26.

Based on question No. 2, it seems that the idea is to start from "the knowledge of things by their causes", if this is so, leads us to speak of "an effect with the verification of facts" whether these positive or negative, for this, we must start by making all research work can demonstrate such effects, otherwise we would be reviewing and imaginary facts can hardly achieve the goal of developing "conceptual clarity".

I think this issue should be developed individually in each country of interest apply to imports socioeconomic aspects, foresee in their domestic law and the Secretariat could support them in capacity building activities. But it is difficult to claim that a mandate of the Protocol, all countries apply these aspects to their decisions. Similarly, this is an issue that goes completely detached pure risk assessment already provides in its format, the possible damage to the conservation and sustainable use of biological diversity and apparently wants to do double duty by pretending that the also include socioeconomic aspects, it seems that there is no clarity on what it want to do, we clarify the concepts of socioeconomic aspects and then under this concept work.

Carlos Almendares
FPP Coordinador del Comité Nacional de Biotecnologia y Bioseguridad de Honduras

Dear all again,

During surveys by the Secretariat in the preceding years and during the international online forum on SEC in the spring 2011, inputs were given by participants on what they considered as being relevant SEC to take into account in the context of the Protocol. I made a synthesis of these considerations that I present her without order of priority:


1)      Food security

2)      Impacts on knowledge and technics innovation

3)      Impact on preservation of traditional knowledge useful for the preservation of biodiversity and traditional medicines

4)      Impacts on food diversity and links with health

5)      Social, economic, cultural impacts of land use changes

6)      Impacts on farmer’ rights ( intellectual property )

7)      Impacts on traditional markets organization

8)      Impacts on access to market

9)      Impacts on land ownership

10)   Impacts on employment and work

11)   Impacts on farmers’ migration to the towns

12)   Impacts on change in pest(s) prevalence

13)   Global net benefices/costs ratio ( financial and yield benefices )

14)   Global resources efficiency of the agro-ecosystem ( use in water, energy, renewable and non renewable inputs )

15)   Macroeconomic impacts

16)   Impacts on global earth environment, biodiversity

17)   Coexistence. Contamination

While some are rather indirect, it seems to me that all these SEC are relevant among these potentially arising from the impact of LMOs on the conservation and sustainable use of biological diversity, especially with regard of the value of biological diversity to indigenous and local communities.

Once again, these impacts could be positive or negative following the case ( following the LMO and the context ), and several of these generic SEC could be defined differently with more precision in different countries or regions.

However, I agree with Dr. Bryan Wynne ( posting n° 4528 ) that “ While there is an irrefutable established logic for case-by-case assessment and decision” some kind of impact question, also salient to our Question 2, would require an additional larger (socioeconomic as well as natural-scientific) assessment framework. “

Good evening to all of you.

Lucette Flandroy

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

Dear All,

I would suggest reading the SIA guidelines themselves as it pays special attention to social protection, issues of environmental justice and protection of vulnerable communities including individuals or groups within a community.  The guidelines are also quite adamant about the assessment being conducted by multidisciplinary teams.

The issue of whether claims by individuals are sufficiently credible in themselves and to what degree they need to be addressed in the regulatory and/or decision making environment, is in the end a political/policy decision that Parties will have to decide upon. This of course will need to be weighted against the potential impacts from the technology adoption elsewhere in the country (apart from those communities claiming an impact) and with mitigation and management efforts which may be identified in the socioeconomic assessment supporting decision making.

I know that countries with ample regulatory experience around the world have incorporated many public participation mechanisms by which the public and interested stakeholders can voice their concerns and issues. The competent authority examine whether a claim has merit or not, and what type of response is needed.

Where I would raise a flag is if the process is not well-thought off, then pressure groups (for or against this and other technologies) can take advantage of this situation by introducing spurious claims and even shoddy evidence with improperly conducted studies/research. This would have a deleterious effect on the decision making process, and thus my call for robust assessments, a strong burden of proof and elements of best practice, including the highest standards for research.

A well conducted research study can take years and can be quite expensive, especially if done by a multidisciplinary team. Then I would urge the Parties, if they have already take the decision to conduct inclusion of socioeconomics,  to explore alternatives for implementation such as not requiring SEC assessments for containment/confinement as the likelihood that a technology will proceed is lower.

Alternatively, I urge the Parties, to focus SEC studies on more general categories of technologies such as insect resistance cotton or fungal resistant bananas, instead of requiring one for each event. In my opinion, the difference and issues between an event 55-1/63-1 (from Cornell University) and X17-2 (from U. of Florida) for ringspot virus resistant papayas are not likely to be that significant and the conclusions from an SEC assessment, especially resulting from a biodiversity impact, are not that large to merit separate assessments.

These approaches are likely to be more informative (and cost/time efficient) along with judicious literature reviews, secondary data and information from the experience in other countries.

Dear Colleagues,

I’d like to thank Andreas Heissenberger [#4525] for reference to a very useful and helpful Report on Socio-Economic Aspects in the Assessment of GMOS-Options for Action. This paper may be a good model for methodological approach and imput for how to better understand issues related the art. 26.

Referring to the Question 2 proposed by the Secretariat, in my understanding the wording of the phrase relates exclusively to the assessment of negative impact and consequences that might occur from from LMOs. It is very similar with the EIA concept and might be part of it at domestic level.

I strongly believe that Parties need to develop SEC as part of decision making process, and involve the broad sentence of it with multidisciplinary and multi-factorial components. The wording “sustainable use” imply to consider the biodiversity conservation in a large sense.

The existent experience of countries and organizations in providing SEC is very important and may be extremely helpful to elaborate the criteria and methodology to guiding countres-Parties during  decision-making. Some of the components of SEC should be determination of the status and quality of the biodiversity and the environment components before LMOs were released (state “0”),  assessment of volume and longevity of potential impact, monitoring of LMOs impact to the environment and biodiversity, preventive or redressing measures. Public hearings and ecological expertise should be part of the SEC.

Apart of the social and economical issues to be assessed, the ecological assessment (in a general sense) should be provided, that might include non-direct cost-driven impact, mostly social long-term effects.

I agree with the statement that in SEC should participate many various professionals, such as economists, sociologists, anthropologists, geographers, also ecologists, financial analytics, biologists and many others.

I would mention importance to elaborate the ecological criteria, as it was referred in the Report [#4525], along with economical and social criteria, that may involve:
“ - preservation of resources

- preservation of environmental quality

- preservation of biodiversity in cultivated areas

-preservation of biodiversity in uncultivated areas”.

Thank you Lucette for synthesizing the components of SEC. I would add some additions to it.
As regards to the social assessment part, I would mention importance to bearing in mind such moments as exposure and frequency of population to certain maladies, as ex. Hepatitis, child mortality, alergocity, thyroidism, low level of medical services etc.   

In general sense, I find reasonable to include the socio-economic benefit assessment of LMOs with the scope to give to the decision makers a full picture of the LMOs intended to import or release, along with the assessment of the socio-economic impact.

Best wishes,

Dr.Angela Lozan, Ministry of Environment, MD

I have been following the discussions closely and wanted to add to the rich discussion.  I very much appreciated the information posted by Lucette Flandroy (#4539).  I too have a list of considerations that various persons have identified as being relevant SEC for taking into account under Article 26 that looks much like the compilation from Lucette.  It is important that we examine such lists with a careful eye toward the language of Article 26.  It is clear from the many discussions on this topic and the continuing confusion as to what SEC are in scope that our discussion is important.

I include the language of Article 26.1 as background:

The Parties, in reaching a decision on import under this Protocol or under its domestic measures implementing the Protocol, may take into account, consistent with their international obligations, socio-economic considerations arising from the impact of living modified organisms on the conservation and sustainable use of biological diversity, especially with regard to the value of biological diversity to indigenous and local communities.

From this text, SEC may be taken into account by Parties in decision-making subject to two important requirements:  (1) only SEC arising from impacts on biodiversity and (2) only to the extent consistent with other international obligations.

The qualifying phrase “in reaching a decision” clarifies that SEC are relevant to decision-making, not risk assessment, as others have pointed out.

The phrase “arising from the impact of LMOs on the conservation and sustainable use of biological diversity” shows that the trigger for SEC is an impact on the conservation and sustainable use of biodiversity.

The unqualified use of the word “impact” allows for identification of both positive and negative SEC (compare with the terminology “adverse effects” used elsewhere in the Protocol).

In short, only SEC arising from the impact of LMOs on the conservation and sustainable use of biodiversity may be considered in decision-making under the Protocol. Other considerations must meet this limitation or be excluded as relevant under Article 26.

I offer below several examples of potential impacts on biodiversity, including potential adverse impacts on biodiversity, SEC arising from impacts on biodiversity, and SEC not arising from impacts on biodiversity.

Example 1 – The reduced use of pesticide(s) and the associated increase in number of beneficial predatory insects in the case of a pest resistant crop (e.g., Bt cotton).  In this situation, there are no potential adverse impacts on biodiversity or SEC arising from impacts on biodiversity.  There is however a number of SEC that arise but they are not from impacts on biodiversity.  These include: (1) Reduced exposure of workers to pesticides; (2) Reduced production costs for farmers due to reduced use of pesticides and fossil fuels; and (3) Reduced production costs for farmers due to reduced use of pesticides and fossil fuels.

Example 2 – As a pest resistant crop is grown over larger areas it has been demonstrated that target pest populations decrease, resulting in reduced pest pressure in adjacent fields, including conventional crops.  As in the previous case, there are no potential adverse impacts on biodiversity or SEC arising from impacts on biodiversity but there are SEC that do not arise from impacts on biodiversity, e.g., reduction of production costs and/or increased productivity for farmers in adjacent fields.

Example 3 – In the case where resistance emerges to a pest resistant crop (e.g., because functional refuges were not present), then the substitution of broad spectrum insecticides for microbial pesticides that are no longer effective due to resistance development could have localized impacts on biodiversity.  SEC in this case might arise as farmers may have increased production costs due to the need to use other pesticides in adjacent fields to manage resistance.  SEC not arising from impacts on biodiversity could include increased production costs in the pest resistant crop due to use of alternative pest management approaches.

There are other examples of SEC that do not arise from impacts on biodiversity, such as:
• Perceived ethical or spiritual issues or religious values;
• Micro-economic changes at the individual, household or community level;
• Changes in product availability/impacts on consumer choice;
• Economic loss if out-crossing of GM pollen results in noncompliance with thresholds; and
• Displacement of economic activity in case a GM product appears in high demand by farmers.

Under the Protocol, the potential effects of LMOs on the conservation and sustainable use of biodiversity will have been identified and evaluated in the risk assessment process.  Risk assessment may result in the conclusion that the potential impacts are not likely to materialize or, if negative, can be controlled through specific risk management measures.  In this case, there is nothing further to consider in the decision-making process since there is no impact on biodiversity that could give rise to SEC. 

Where the scientific risk assessment concludes that a potential impact is likely to materialize, a country may at its discretion decide that the related SEC could be considered in making a decision on applications in line with WTO obligations. 

Eric

Dear All
With due respect to Dr Lozan, I do not believe we are focussing on "preservation" of different environments/niches, but rather on conservation (ie. sustainable use).

Further, SEC's need to focus specifically on the GMO characteristics that differentiate them from conventional / traditional agriculture. The use of hybrids, for example, while having SE impacts (eg. increased yield (+ve) or affecting seed saving(-ve)), is not a GMO-specific consideration (although recognizing that GMO license agreements may compound the matter).

In practice, here in South Africa, decision-makers use government's policy perspectives, including National Environmental Management Act; National Development Plan; National Biotechnology Strategy (etc), which to some extent provide the definition of SEC's (albeit in a very text dense way!). Where a specific SE consideration is identified and the information is considered insufficient, a study may be required to further probe the matter.  It needs to be recognized, however, as Dr Falck-Zepeda has stated, that any SE study will have several assumptions.

The final stage is to consider permit conditions and environmental monitoring that will be able to test assumptions, and verify/disprove assumptions (either conducted by the permit applicant, or to be considered by our Biodiversity institute legislated to monitor GMO's, or a shorter term study where our Biosafety SA platform can commission some work.

I think, as several countries have done, it is useful to identify SEC's relevant to the nation (Lucette Flandroy has provided a useful list in her comment #4539), as done by several nations, including Norway.

Dear all

As always, this has been an interesting and rich discussion.

My first point is to reiterate that Parties have the sovereign right to have national laws that are stricter. So at the domestic level, a Party can 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.

In considering the “socio-economic considerations arising from the impact on the conservation and sustainable use of biological diversity”, I would like to draw from Catacora (2012) for insight: “the specification of socio-economic considerations “arising from the impact of LMOs in relation to the conservation and sustainable use of biodiversity” is broad in essence. It includes the direct, indirect, intentional, accidental, predicted and unforeseen effects on the different forms of life and their environments, and on their potential use in light of sustainability principles.”

The argument is that because biodiversity is a broad concept that embraces all forms of life and their environments (including living and non-living components) (drawing on the definitions of ‘biodiversity’ and ‘ecosystem’ in the CBD), thus impacts on biodiversity relate to a large spectrum of possible effects. As changes in biodiversity are complex and unpredictable, these may result in cumulative and combinatorial effects that can accelerate changes or lead to unintended adverse effects.

Moreover, conservation and particularly sustainable use of biodiversity have intrinsically socio-economic components as people play a part in managing and sustainably using biodiversity. Societies and socio-economic factors in which these individuals and groups are embedded play crucial roles in the long-term conservation and sustainable use of biodiversity while securing fulfillment of the needs of present and future generations.

It is not only the impact on biodiversity that is of importance to indigenous and local communities that should be considered, as seems to have been suggested by Dr. Falck-Zepeda [#4512]. The text “especially with regard to the value of biological diversity to indigenous and local communities” actually keeps the scope wide by pointing out that in addition to the broad array of implications on biodiversity and sustainable use in general, special considerations are needed relative to the livelihood, consuetudinary use (e.g. use of local biodiversity for food or income generation), culture, spirituality, etc. where biodiversity plays an important role for indigenous and local communities (Catacora, 2012). This also includes ethical/spiritual/religious values, because any impact on biodiversity could also impact these values. So I disagree with Eric Sachs [#4542] when he highlights these as not arising from impacts on biodiversity.

Since impacts on the conservation and sustainable use of biodiversity are wide-ranging, and since conservation and sustainable use also have socio-economic elements, it follows that the potential socio-economic impacts arising from these are also wide. Given the wide range of potential socio-economic impacts, it is clear that economic cost-benefit analysis, while useful, is not the only tool that should be used in the assessment.

While socio-economic impacts could be negative or positive, I believe that much more weight should be given to negative impacts, and that these actually are the impacts that should be taken into account in decision-making in the context of biosafety. This is because the objective of the Protocol is related to LMOs that “may have adverse effects” on the conservation and sustainable use of biological diversity, taking also into account risks to human health. “May have adverse effects” indicates the precautionary nature of the Protocol, as even LMOs that pose a threat of adverse effects are considered – even if such threats have not materialized. Moreover, all the provisions of the Protocol are geared toward “ensuring an adequate level of protection”, clearly setting the framing of the Protocol towards a precautionary approach in minimizing adverse effects and risks.

So we must also consider impacts that have not yet materialized, and ex-ante assessment is useful and while data availability is an issue, experiences from other countries would be instructive. One does not need to wait for an impact to arise and then only take socio-economic considerations into account. These processes must move in parallel.

Also as elaborated in my earlier post [#4470], claims of potential benefits in any case should be subjected to a process that assesses the veracity of those claims, including over the longer-term.

kind regards
Lim Li Ching
Third World Network

Dear All

While Lim Li Ching (#4544) makes some good points, I want to respectfully draw different conclusions from what she says. I appreciate her emphasizing the complexity of biodiversity, and the complexity of interactions of humans with that biodiversity.  She concludes that we should emphasize negative SE impacts. I think this is not appropriate in certain contexts/nations.

Take the example of drought tolerant (GM) crops.  A negative impact MAY be the expansion of subsistence/small scale agriculture into previously unused (possibly pristine?) land, with consequences for the traditional/cultural agricultural practices and biodiversity.  A positive impact MAY be increased food security for communities living on "marginal" land.

In my opinion, it is each nation - through their entrusted decision-makers - that needs to make the decision (based on policies, laws and strategies), whether, in this simplified example, communities food security outweighs biodiversity conservation (recognizing, of course, that food security is far more complex than described above).  But the positives need to be well defined too, in order for decision-makers to weigh up the issues and make a decision. (Not a brilliant example, admittedly, as a decision may well be taken on grounds of biodiversity impact alone).

While decision-makers need to be cautious and thorough, I do not think that absence of clear SE evidence should be used in preventing a positive decision, as "hard" evidence may well be impossible in an ex-ante study. I further think that SE considerations are potentially far more complex than environmental and health considerations, with one person/group/community reasonably having widely differing views from the next.  Which is why the wording in the Protocol is SE considerations "...arising from the impact of LMOs on conservation and sustainable use of biodiversity". A potential positive impact may never be realised if we require "hard evidence" in advance of a decision. But I would advocate again that there needs to be some form of monitoring to test assumptions / impacts, with feedback to the decision-makers. 

A final point at this stage: SEC's in advance of a decision, in my view, need to be as clear and simple as possible. I feel it is counter-productive to make SEC's so complex that potential permit applicants shy away from them.

Ben Durham

Dear all,

Various interesting reflections in this important forum have come again overnight !!

Whereas its is true that, as mentioned by Ben David Durham ( message n° 4543 ), the wording of the part of sentence of Art. 26.1 we are considering her  does not focus on preservation of different environments/niches, I agree with Angela Lozan  ( message 4541 ) when she says : “The wording “sustainable use” imply to consider the biodiversity conservation in a large sense.” Indeed, for the experts having some knowledge in environmental sciences, and as recognized in the CBD, no sustainable use of biodiversity will be possible if we do not preserve biodiversity in a broad sense. Indeed in the ecosystem function way of thinking, all elements of the biodiversity in the ecosystem are interrelated and at some point of disappearance of the elements of biodiversity the system is not resilient any more and some point later it will not function anymore. And the agricultural systems have to be incorporated in this way of thinking, taking into account the large place the agriculture takes, and still more, in the landscape and global ecosystem.
Among these elements of biodiversity, agricultural biodiversity itself has an important place, and in particular the in situ preservation of biodiversity, as recognized by the FAO, in order to allow adaptation of this biodiversity to the evoluting environment.


Good also that some examples have come in the discussion, to take stock on real cases to debate a bit and try to go to generic considerations and agreements in this forum.

As such, I come back to examples given by Eric Sachs in his posting n° 4542, and in particular to his example 3 :

Example 3 – In the case where resistance emerges to a pest resistant crop (e.g., because functional refuges were not present), then the substitution of broad spectrum insecticides for microbial pesticides that are no longer effective due to resistance development could have localized impacts on biodiversity.  SEC in this case might arise as farmers may have increased production costs due to the need to use other pesticides in adjacent fields to manage resistance.  SEC not arising from impacts on biodiversity could include increased production costs in the pest resistant crop due to use of alternative pest management approaches.

I do no agree with his last phrase: following me, the increased production costs due to development of pest resistance ( and it can also be the development of opportunistic pests replacing the killed pest ) is well arising from impacts of the Bt LMO on biodiversity, even if that impact is rather indirect.

Also, I do not agree that various of the other examples of SEC he cited do not arise from impacts on biodiversity:

“There are other examples of SEC that do not arise from impacts on biodiversity, such as:
• Perceived ethical or spiritual issues or religious values;
• Micro-economic changes at the individual, household or community level;
• Changes in product availability/impacts on consumer choice;
• Economic loss if out-crossing of GM pollen results in noncompliance with thresholds; and
• Displacement of economic activity in case a GM product appears in high demand by farmers.”

Taking into account the comments made by Li Ching Lin ( posting n° 4544 ) on the distinct values of biodiversity for various populations ( discussion that should actually come in a next session of this forum ), at least the points 1,3,4 in this preceding examples are rather directly linked to this value potentially given to biodiversity in some countries or by part of the population. Maybe some participants can even see links between impacts on biodiversity and SEC at the points 2 and 5 ?
The list I posted in message n° 4539, and which is the reflection of most generalized SECs expressed by participants in previous fora under the Protocol, could eventually be analyzed more carefully from that point of view.


I also agree with last posting of Ben David Durham saying that SEC's in advance of a decision should not necessarily always be complicated. If some SECs would need thorough scientific research to give some evidence of proof, other ones, I think, could be evidence-based by taking into account some adequate participatory process that could short cut long and costly studies. I am grateful to Dr. Zepeda to have also recognized this in a preceding posting. This does not mean again that this participatory processes are simple themselves to organize if they want to avoid various biases in data collecting and analyzing. ( I think India has some experience about this, that was exposed during the Workshop in New Dehli in November 2011 ), and they of course should be done with the involvement of a multidisciplinary team of experts in the participatory process.

One manner to avoid long and complex SEC ex ante analyses before each import could among other be, as proposed by Dr. Falck-Zepeda ( in his last posting n° 4540 ), and already proposed in preceding fora, would be to analyze SECs by categories of LMOs based on the species of the organism and the transgenic trait. But these categorized SECs should obviously each time be analyzed distinctly in different socio-economic and environmental situations.

Kind regards.

Lucette Flandroy







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

Dear international participants,

I would like to come back on questions raised by Dr. Maria Mercedes Roca from Honduras, in her posting n° 4537.

She concretely asked if we should change the paradigm of RA and include SEC in it.

Once again, whereas I agree with participants saying that we should separate ERA from SEC in the methodologies used and the precise concerns raised during each of these 2 assessments, both processes are linked; and they can be linked in both directions, not only through a cause-effect relationship between impacts on biodiversity and socio-economic impacts, but also through a cause-effect relationship between socio-economic context and impacts on biodiversity.  And moreover, the SEC causes and consequences of impacts on biodiversity are, in some cases at least, linked.
This was already discussed also during online discussions of spring 2011.

Indeed, while an absolute hazard ( absolute danger, absolute deleterious effect ) is defined by general ex situ scientific considerations, the risk, which is the probability of this hazard to occur, is obviously influenced by the type and the conditions of use  of the product, including the socio-economic-cultural context in which the product will be used.

This was illustrated, in previous online discussions in 2011, a.o. by participants of Latin America countries where the traditional market habits ( current exchange of seeds between farmers ) make it difficult if not impossible not to mix GM and non-GM seeds, and where consequently the introduction of GM seeds in this socio-economic-cultural context will either forbid the continuation of traditions that allowed a collaborative work among farmers for improving and adaptation/evolution of local agriculture to local conditions and habits ( thus, changes in the local economical practices to avoid mixing of GM seeds in local biodiversity ), either unavoidably lead to the introgression of GM traits and varieties - developed ex situ in laboratories – in local varieties, with potential socio-economic and biodiversity consequences ( the potential consequences being for ex. that the GM introgressed in the local varieties makes them less resistant to some local disease or less adapted to local soil and climate conditions, with socio-economic consequences for the local  farmers. ).

I thus see in the § here above a direct link between impacts on the conservation and sustainable use of biodiversity and “ micro-economic changes at the individual, household or community level”  for which Eric Sachs did not see any link in his posting n° 4542 .

Another example where the SE context can make a causal difference in the appearance of risks is the claimed and recognized fact ( including by the industry ) that the refugees zones around Bt fields ( risk management measure to avoid development of resistant pests ) or the amount of herbicide spread on herbicide-tolerant fields ( to avoid/limit the development of herbicide tolerant weeds ) are better respected ( in any case in initial steps ) when the farmers are well educated and/or informed ( and refugee zones will be more easily respected if the farmers have large fields where they can accept to dedicate part of their surface to this refugee zone ). By reverse, there will in these cases also be socio-economic consequences of the impacts on biodiversity of the more or less good information/education and of the  more or less good respect of the risk management measures.

Thus, logically, we should already take SEC into account when defining the context of the use of a LMO in order to calculate the biosafety risk and to develop adequate and realistic risk management measures.  But once again, taking relevant SEC into account should not mean necessarily to undertake in each case huge studies but could also rather just be a thorough logical implementation of Art. 23 on public awareness and participation coupled with generic complete studies.

And writing this, I come to be more convinced that the wording of Art. 26.1 does not impede to take into account also causal links of socio-economic context towards potential impacts on biodiversity, since Art. 26.1  tells about socio-economic considerations and not about socio-economic consequences.

Once again, these were examples to illustrate a more general reasoning. The SEC to take into account and impacts on biodiversity can be different case by case.

With kind regards.

Lucette Flandroy

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

Dear all,

Thank you for the very insightful discussion,

First I would like to agree with the Li Lim Ching's comments on a nation having the sovereign right to have national laws that are stricter and that biodiversity is a broad concept. The Art 26 of CPB states the SEC arising from the impact of living modified organisms on the conservation and sustainable use of biological diversity Contrary to Dr Sach's statement that the SEC considerations are not only arising from the impact on biodiversity but also the impact from the sustainable use of biodiversity, which is why livelihoods becomes an important aspect for consideration.

I would like to give the example of Bt cotton in India and based on the evidence from the ground as stated in this recent article, (http://www.thehindubusinessline.com/industry-and-economy/agri-biz/new-pests-begin-to-suck-bt-cotton-yields-in-punjab/article4526407.ece), the increase in sucking pests is  leading to an increase in pesticide usage after 2006 and decrease in cotton yield. This has led to an imbalance in the biodiversity due to increase in sucking pests  and thus the SEC arising from this situation like the increased cost of cultivation are very valid and should be considered during an assessment.

SEC become vital for a country where the food security and livelihoods are dependent on the sustainable use of biodiversity.

While I feel that a cost-benefit analysis is very crucial, it should also be important who is conducting this kind of an analysis and while we look at multidisciplinary teams, farmers should also be part of this group.

Regards
Neha Saigal
Greenpeace, India

While pondering the wording of Article 26, I cannot but conclude the following personal interpretations:

1) Parties who approved the text of Article 26 provided us with the line of causality and even the standard for the burden of proof for the implementation of the article.

The line of causality runs from considering the potential introduction of an LMO into a country, followed by introduction of an LMO into an environment which has a consequence or impact on biodiversity that is valuable to local and indigenous communities. The parties then ask us to focus on socio economic considerations arising from this line of causality.

In essence one has to identify a credible biodiversity impact before examining the socioeconomic considerations but not socioeconomic consequences. If Parties had decided on socioeconomic consequences it would have been included as socioeconomic consequences.

I guess this will modify slightly the risk assessment as the question during the technical assessment would then be: Will the introduction of this LMO have an impact on biodiversity of value to local and indigenous communities?

2) Impact cannot be understood in Article 26 only as damage, harm or adverse consequences. Otherwise the Parties negotiating the Protocol would have included the phrase adverse consequences in Article 26, as in the rest of the Protocol.

In fact this is one of the principles dear to all impact assessors.When one initiates an assessment, one cannot have a preconceived opinion about that specific technology. The option has to be to allow the technology to speak for itself and thus determine the benefits, costs and risks involved with a technology. By the way, all technologies will have benefits, costs and risk associated with them. Deciding factor is usually benefits outweighing the costs.

3) Note that the definition of biodiversity relevant for further study is quite specific in Article 26. I would even propose that it is not the broad biodiversity definition used in the Protocol. Here what is relevant is only that part of overall biodiversity which is of value to local indigenous communities in (sustainable) use or through its intrinsic value. This does relate to the discussion open by Ben Durham on the differential impact of this technology compared to other introductions such as hybrids or improved varieties through other means as decision makers will have to weigh this counterfactual in practice.

4) We can rescue also another list of socioeconomic issues that was developed in a meeting organized by the CBD Secretariat in Mexico DF back in 2008. The issue with this list and the list submitted by Lucette Flandroy is that they are lists of socioeconomic considerations. Now the task would be defining which of these are relevant to the focus of Article 26.

Ideally the mapping/identification of which SEC  considerations  are relevant to Article 26, would have been an exercise to be done at the country level, simply because trying to standardize in a meaningful way which ones are relevant so that they apply to all Parties to the Protocol will be next to impossible.  Maybe trying to define the lines of causality with specific/practical examples as initiated by Eric Sachs will be a useful exercise for this forum. May help define broad guidelines for the Parties to discuss and identify issues.

Finally, I cannot but think about the statement by Ben Durham (similar to statements by Maria Mercedes Roca, Jose Luis Solleiro, Lucia de Souza, and others) in one of his last paragraphs while he ponders about the added complexity proposed by some here and the impact on proponents. I would urge the Parties to consider this impact carefully. The cost of compliance and the impact of regulations in terms of time delays can be significant not only in terms of its impact of societal benefits but also in terms of those technologies available to farmers. With added cost, time delays and significant regulatory complexity there will be less technologies available to farmers especially in developing countries. Unless this is the explicit intention, farmers will be worse off with less choice in most cases.  This line of reasoning applies to LMO and to all other upcoming technologies.

As agriculture faces more and more complex challenges including climate change variability, we have to develop more options to these productivity challenges. As Shenggen Fan, our Director General at IFPRI has put it in one of his latest statement, we have to walk the talk and thus increase farmer’s productivity through increased investments in agricultural R&D with an intended focus of environmental protection. We do not have a choice anymore.

POSTED ON BEHALF OF  Amparo C. Ampil, Philippines   


Dear Participants:

Building on the contributions, I would like to express the following comments:

I agree with Dr. Piet van de Meer that Article 26 does not change the right of countries to invoke socio-economic considerations in decision making;
Impacts of LMOs on the conservation and sustainable use of biological diversity could be accounted for in an environmetnal risk assessment.
Socio-economic considerations cover a wide and broad range of issues and areas, but rightly so, there should be a link to the impact in the context of Article 26 , which i agree can be both positive and negative.
Lastly, the areas for agriculture cultivation have been expanded to areas which are vulnerable to changes in biological diversity, hence the significance of Article  26.

Amparo C. Ampil

POSTED ON BEHALF OF Brian Wynne

Dear Fellow-Participants,
Thanks again to all for their observations and arguments. Dr Roca poses the question (#4537, Question 4)),
"Is there a proposal in this group  to redefine the standard paradigms of risk analysis by including SEC  in the risk assessment process, instead of the risk management process? ", which I address below. First however, this is related to her explanation in her earlier post (#4438)
"Members of ICABB have worked extensively in understanding the process of risk analysis and its practical applications. We make a clear distinction between risk assessment (measuring biological factors) and risk management, where socio-economic considerations are included to shape policy and ultimately take political decisions".
The "standard paradigm" of risk analysis (or risk assessment), going right back to the 1983 US National Research Council (NRC) "Red Book" which first enunciated the standard classification: Risk Assessment (RA); Risk Management (RM); Risk Communication (RC), also gave them as sequential phases (first)RA; (then)RM; (then) RC. Dr Roca's helpful summary of the ICABB distinction between RA and RM is not explicit about the question of sequential phasing, but its phrasing  suggests that RM only follows RA, and does not occur either as part of RA, or as a prelude to RA. In fact the original paradigm-setting standard document, the US NRC "Red Book", did also however recognise that there are policy choices inevitably to be made, before and during scientific RA. A large research literature now exists, including a later US NRC report (1996) which shows that this is the case, and that such choices and commitments have often been made - are often made - without any explicit recognition of their policy, as well as socioeconomic, dimensions. The term, risk assessment policy, has been introduced to try to address such key questions, in a coherent policy way, and bodies such as the Joint Research Centre of the European Commission (IPTS, 2008) have compared such RA policies across many countries. As is recognised in this literature, socioeconomic conditions and assumptions made about them (assumptions which could be but typically are not tested by empirical observation in the areas of relevance) are a key part of RA processes, and shape their scientific outcomes. Evidence can be gathered which can test such assumptions, and in principle improve the RAs, as well as any ensuing decisions.
Whatever policy decisions might be made by parties (and for clarification let me assure Dr Roca that her fear that I may have been challenging the legitimacy of a sovereign state's chosen policy stance is unfounded. I was instead challenging the intellectual validity of the general stance which assumes that SEC are only salient to RM, and that such RM only follows RA. Of course, there are also SEC salient and essential to RM policy deliberation and commitment; but this does not mean that they can be excluded from the ex-ante phases, including the RA Policy processes which, recognised and quality-controlled or not, both frame and influence RA science.
I hope that by now I have answered Dr Roca's question 4. It is not a matter of challenging the political legitimacy of any sovereign body's policy decisions, but it is a responsibility which as an independent academic research specialist on risk I feel, to clarify how existing  policy arrangements may be founded in past scientific understandings which are always being up-dated and improved, as is normal for science - and as is true in this case.
To try to return to the Question for this week!
- SEC are significantly more than economic alone ('economic alone' anyway embodies social assumptions which need to be examined also);
- SEC are both normative (values-choices, in summary), AND descriptive-propositional, often mixed and unclear
- this mixing of normative and descriptive should as far as possible be clarified, also for scientific RA, and the descriptive-propositional claims including predictive claims, tested against evidence where possible, and subjected to quality control just as RA propositions should
- this SEC dimension is salient in both ex-ante and ex-post phases of assessment and decision or monitoring, or studies
- WTO's SPS can be left to next week I believe!
Respectful thanks to all,
Brian Wynne

To help identify the socioeconomic issues relevant to Article 26, I think it is important to define the terms “local and indigenous communities”. Here I ask the help of those involved with the Protocol negotiations and subsequent discussion in this task. It is my impression that the term “local and indigenous communities” have a specific definition, which probably explains the intention of the Parties.

In the case of local communities, I presume is does not refer to all the citizens of a country.  Term seems to refer to those communities close to the biodiversity resources whom draw value from the biodiversity or who at least have an explicit expression of value through conservation or sustainable use.

In the case of indigenous communities, there are several working definitions available including those by he UNPFII and the literature. In some cases these definitions follow ancestral laws and customs and/or in other cases follow formalized recognition by Government of existing rights and traditions.

For both definitions there seems to be a time and space dimension to them. So I am wondering, if the intention of the Parties was to refer to those biodiversity resources that are in reserves, protected and or pristine areas, and/or  adjacent/under care of formal indigenous and cultural domains/zones or those covered by recognized ancestral laws and traditions.  If this is correct then the list of socioeconomic considerations would refer to these specific communities.

Following the line of causality established in Article 26, to make a decision for import of an LMO, then one would have to assess the impact on biodiversity for the specific local and indigenous communities and the identify the socioeconomic considerations derived from such impact.

I would also add the question (and pardon my ignorance/naivety here), if the Parties' interpretation of socioeconomic considerations was so broad as the list of issues presented in this forum and those available elsewhere seems to suggest, why didn't the parties wrote it down explicitly?

Meaning, why focus only on biodiversity impacts in Article 26? Would it be, that the Parties felt that the Cartagena Protocol being an environmental/biodiversity treaty, that is was not proper to go beyond the mandate of the treaty itself? Why not just write "cover all/broad/complete or exhaustive list of socioeconomic considerations derived from the introduction of an LMO?

In essence, seems like the Parties were indicating that broader socioeconomic would be better left to national legislation/domestic measures and policies or for implementation under other treaties....

POSTED ON BEHALF OF Carlos Almendares, Honduras

We agree that states have the sovereign right to choose what suits them and are not subject to what the other parties disposal.
I want to emphasize that the mandate of the COP-MOP decision BS-VI/13 literally says, noting that, in accordance with paragraph 1 of Article 26 of the Cartagena Protocol on Biosafety, to decide on imports Parties may take into account, consistent with their international obligations, socio-economic considerations arising from the impact of LMOs on the conservation and sustainable use of biological diversity, especially in relation to the value of biodiversity has for indigenous and local communities, to reach a decision on import under this Protocol or any national measures to implement the Protocol and asked Executive Secretary to present its report at the seventh meeting of the Conference of the Parties so as to provide flexibility to take into account the specific situations of different countries. I do not see this command concepts of ethics, moral, spiritual, etc.. It is specifically related to the effects on the conservation and sustainable use of biological diversity.

Carlos Almendares
FPP of Honduras

I would like to contribute with some comment on the debate that is taking place.

1. The Article 26 says " especially in relation to the value of biodiversity has for indigenous and local communities". The word especially, opens a door for other aspects.

2. Has emerged a question about what is covered “biodiversity values” in relation with indigenous people and local communities. To answer this question, it is important to reflect  what kind of relationship of indigenous peoples to biodiversity?, To answer this question it should be noted that the term "biodiversity" is very broad.

It is primarily a construct that arises in the 80s of XX century. Most communities refer to "nature" and for many communities around the world, nature is part of its espiritualidad.Comodije before. sacred sites (which are ecosystems, seen from the point of view of biodiversity), may be at risk for importation of seeds trasngénicas.

Consider for example the Declaration of Copán Galel of indigenous and black women in Honduras:

“We understand that our ways of seeing and experiencing the world, the relationship with the land and natural wealth, spirituality, relationships with other people and with thought and creativity is different, and that difference is a former wealth and stored in memory especially for women, and is a great value for all of Honduras”.

3. The term "local community" is not limited to indigenous peoples, but is broader. For example group includes residents affected by their health-related air asperciones RR soybean crops, including rural communities, whose corn may be at risk from the introduction of GM corn. A rural community may also be affected by the release of mosquitoes trsngénicos, and this introduction may alter manejho forms of biodiversity of that community.

Finally remember that COP-MOP decision BS-VI/13 speaks of "flexibility," according to the needs of the countries.

Dear all,

I agree with what Lim Li Ching (#4544) and others have said about the broad scope of article 26 and SEC. I also agree, as many of you already have stated, that SEC should be far more than cost-benefit-analyses and economic considerations, and that various professions (anthropologists, other social scientists, ethicists etc.) should contribute to the assessments.

As you may know, the Norwegian Gene Technology Act requires that contribution to sustainable development, benefit to society and ethical considerations should be taken into account when evaluating an LMO. The Norwegian Biotechnology Advisory Board has worked with the operationalization of these criteria (http://www.bion.no/filarkiv/2010/07/2009_11_18_diskusjonsnotat_baerekraft_engelsk.pdf), and parts of this operationalization is taken into the regulations on impact assessment pursuant to the Gene Technology Act (http://www.regjeringen.no/en/doc/Laws/Acts/gene-technology-act.html?id=173031 and http://www.regjeringen.no/en/dep/md/documents-and-publications/acts-and-regulations/regulations/2005/regulations-relating-to-impact-assessmen.html?id=440455)

However, there is a need to further concretize these criteria. Thus, the Norwegian Biotechnology Advisory Board has worked on defining what should be required in order for herbicide resistant and insect resistant GM crops to contribute to sustainable development within the areas environment/ecology, economy and society. I will post some of our suggestions and recommendations.

Some general considerations:

A reason for assessing the contribution to sustainable development, benefit to society and ethics is to ensure that we will get the technology from which we will benefit the most while at the same time sustaining biodiversity and livelihoods in the long run.

For an LMO to be sustainable, advantages that show up in the first few years after starting to import and/or cultivate the new type of crop, such as HR crops, must also prevail in the long run, for instance more than 20 years time. If an advantage such as reduced herbicide use only applies for the first few years and then will be lost due to for instance increase in resistant weeds at a rate not seen for non-HR crops, the HR crop cultivation could not be regarded as sustainable.

Although every LMO is and should be assessed case-by-case, many socioeconomic impacts arise from the trait such as herbicide or insect resistance. This means that the same socioeconomic considerations will apply for many HR or IR crops.

HR crops come as a package where you have to apply the herbicide in order to obtain any of the promised benefits. The impacts of altered herbicide use result from the GMO having the herbicide resistance trait. Thus, the impact of the herbicide and the HR cropping system as a whole should be evaluated. When it comes to IR crops, altered crop practice including herbicide/pesticide use also results from the fact that the plants possess the specific IR trait, and should therefore be evaluated.

I would also like to emphasize that although methodology for assessing certain aspects currently is not developed, it does not mean that these aspects are not important and legitimate concerns.

The Norwegian Biotechnology Advisory Board has recommended that certain criteria be used, and has proposed specific questions that should be answered by the applicant seeking approval of an IR or HR LMO. We have also proposed certain questions that should be answered by the authorities when doing an overall evaluation.

I will come back to some of our proposed criteria and questions in another posting.

Kind regards,
Audrun Utskarpen
The Norwegian Biotechnology Advisory Board

Another valuable and interesting work where the concept of sustainable development and socio-economic considerations in agriculture and food production has been operationalized is the SAFA guidelines (Sustainability of Food and Agriculture Systems) developed by the FAO: http://www.fao.org/nr/sustainability/sustainability-assessments-safa/en/
A test version of the sustainability assessment guidelines is now available: http://www.fao.org/docrep/017/ap773e/ap773e.pdf
and is being piloted in several countries. The guidelines are made for application in different kinds of agriculture and food production and there are certainly many aspects that will be relevant when assessing socio-economic impacts also of LMOs.

This table is copied from the SAFA guidelines. More details can be found in the document.

Table 2: SAFA Sustainability Dimensions, Themes and Sub-themes

Dimension 1: GOOD GOVERNANCE
Themes Sub-Themes
G1 Governance structure Corporate ethics; Due diligence
G2 Accountability Holistic audits; Responsibility
G3 Participation Stakeholder dialogue; Grievance procedures; Conflict resolution
G4 Rule of law Commitment to fairness, legitimacy and transparency; Remedy, restoration and prevention; Co-responsibility; Resource appropriation
G5 Holistic management Sustainability in management; Certified production; Full-cost accounting

Dimension 2: ENVIRONMENTAL INTEGRITY
E1 Atmosphere Greenhouse gases; Air pollution
E2 Freshwater Water quantity; Water quality
E3 Land Organic matter; Physical structure; Chemical quality; Land degradation and de-sertification
E4 Biodiversity Habitat diversity; Ecosystem integrity; Wild biodiversity; Agricultural biodiver-sity; Threatened species
E5 Materials and energy Non-renewable resources; Energy supply; Eco-efficiency; Waste reduction and disposal
E6 Animal welfare Freedom from stress; Species-appropriate conditions

Dimension 3: ECONOMIC RESILIENCE
C1 Investment Internal investment; Community investment; Long-ranging investment
C2 Vulnerability Stability of supply; Stability of demand; Liquidity and insurance; Employment; Stability of production
C3 Product safety and quality Product information; Traceability; Food safety; Food quality
C4 Local economy Value creation; Local procurement

Dimension 4: SOCIAL WELL-BEING
S1 Decent livelihood Wage level; Fair trade practises; Capacity building
S2 Labour rights Employment; Forced labour; Child labour; Freedom of association and bargain-ing; Working hours
S3 Equity Non-discrimination; Gender equality; Support to vulnerable people
S4 Human health and safety Physical and psycho-social health; Health resources; Food security
S5 Cultural diversity Indigenous knowledge; Food sovereignty

Dear participants,

I would like to make some observations on the discussion of risk assessment in relation to this question.

1. On the relevance of risk assessment to this question:

Article 26 refers to “socio-economic considerations arising from the impact of living modified organisms on the conservation and sustainable use of biological diversity”, not “socio-economic considerations arising following a risk assessment of living modified organisms…”  In his introductory notes to this discussion, Mr Giovanni Ferraiolo referred to two sets of relevant guidelines adopted by the COP:  “Guidelines for incorporating biodiversity-related issues into environmental impact assessment legislation and/or processes and in strategic environmental assessment” contained in the annex to decision COP-VI/7and “Voluntary guidelines on biodiversity-inclusive environmental impact assessment” contained in the annex to decision VIII/28.  Both of these concern methods of assessing impact, and neither supports the narrow interpretation of SEC currently being argued by some participants.

According to these guidelines, an assessment of biodiversity-related impacts must consider all three of the CBD’s objectives: “The conservation of biological diversity (i.e. maintaining earth’s life support systems and maintaining future options for human development); The sustainable use of its components (i.e. providing livelihoods to people, without jeopardising future options); The fair and equitable sharing of benefits arising from the use of genetic resources.”

Taking into account the three objectives, “fundamental questions which need to be answered” in an impact assessment include (I quote here from “Voluntary guidelines on biodiversity-inclusive environmental impact assessment” contained in the annex to decision VIII/28.):
a. Would the intended activity affect the biophysical environment directly or indirectly in such a
manner or cause such biological changes that it will increase risks of extinction of genotypes, cultivars,
varieties, populations of species, or the chance of loss of habitats or ecosystems?
b. Would the intended activity surpass the maximum sustainable yield, the carrying capacity of a
habitat/ecosystem or the maximum allowable disturbance level of a resource, population, or ecosystem,
taking into account the full spectrum of values of that resource, population or ecosystem?
c. Would the intended activity result in changes to the access to, and/or rights over biological
resources?

If a risk assessment does not address these questions, then a risk assessment cannot satisfactorily determine the IMPACTS from which socio-economic considerations arise. 

2. On the nature of risk assessment:

During the discussion of Q1, I was disturbed by the tendency to split SE considerations from others on the grounds that these others were straightforward.  The problem with this thinking was made much more explicit in post #4537.   The characterisation of risk assessment/risk management in this post, while no doubt still espoused in some quarters, has been widely and effectively criticised. (For an overview, see E Millstone, “Science, risk and governance,” Research Policy 38 [2009]: 624–636.)  Risk assessment is not free of either values or politics.  To take the simplest example, who decides what constitutes a harm?  Distinguishing relevant harms (and benefits) from irrelevant considerations is a value-laden process.  The guidelines on assessing impacts recognise this when they emphasise wide participation in the scoping stage of an impact assessment in order “to identify which potential impacts are relevant to assess”.

Kind regards,
Joanna Goven

Dear all;

I would like to thank the secretariat for the continuation on this discussion.

Among valuable comments so far, I especially would like to appreciate Dr. Brian Wynne (#4552) for clarifying the difference between RA and SEC.
According to the following references, I understand RA is concerning on a particular agent, in contrast, EIA is concerning on an implementation of projects, programmes or policies;

“Risk assessment” is “a process intended to calculate or estimate the risk to a given target,
system, or (sub) population, ---, following exposure to a particular agent ---.”(IPCS Risk Assessment Terminology)
“An environmental impact assessment (EIA) is an analytical process that systematically examines the possible environmental consequences of the implementation of projects, programmes and policies.” (OECD)

In our context, a decision on import of LMO is based on the RA of LMO, which would be a particular agent.  In making such decision, Parties may take into account SEC based on EIA of the decision of import, which would be a policy.  Voluntary guidance on biodiversity-inclusive environmental impact  assessment is shown in UNEP/CBD/COP/DEC/VIII/28.

Best regards,

Isao Tojo
Ministry of Agriculture, Forestry and Fisheries of Japan

Dear All
I would like to thank the secretariat for the continuation on this discussion.

It is very important to differentiate between RA and SEA. Mixing up of the two has created several policy hcallanges.  There are three criteria which should be used for assessing LMOs: safety, efficacy and effectiveness. The criterion of effectiveness addresses how the LMO actually
works in different contexts and conditions and this is directly relevant to the assessment of
socio-economic impacts for which ex ante and ex post impact analyses may be undertaken. The RA should be addressed in the first instnace itslef.

Dear all

I would like to respectfully disagree with Dr. Jose Falck-Zapeda’s interpretation of Article 26 of the Protocol [#4549, #4553] when he surmises that “here what is relevant is only that part of overall biodiversity which is of value to local indigenous communities” or that “one would have to assess the impact on biodiversity for the specific local and indigenous communities” as the only issue.

The ordinary reading of Article 26 “socio-economic considerations arising from the impact of living modified organisms on the conservation and sustainable use of biological diversity, especially with regard to the value of biological diversity to indigenous and local communities” provides the understanding that the value of biological diversity to indigenous and local communities is especially important to be considered. However, this does not negate consideration of other socio-economic considerations arising from the impact of GMOs on the conservation and sustainable use of biodiversity. The Protocol merely identifies one particular socio-economic consideration that Parties may be expected to take into account.

On the issue of risk assessment that has been raised, I would just like to point out that the Roadmap produced by the AHTEG on Risk Assessment clearly outlines risk assessment as a process, not a discrete act, from which establishing the scope of the risk assessment “in line with the country’s policies and regulations, may involve an information-sharing and consultation process with risk assessors, decision-makers and various stakeholders prior to conducting the actual risk assessment, to identify protection goals, assessment endpoints and risk thresholds relevant to the assessment. It may also involve identifying questions to be asked that are relevant to the case being considered.”

The Flowchart from the Roadmap makes visually clear that “related issues” have a relationship to the risk assessment process, and these may be part of the decision-making process. They include:

“ * Risk Management (Article 16);
* Capacity-building (Article 22);
*  Public Awareness and Participation (Article 23);
* Socio-economic Considerations (Article 26);
* Liability and Redress (Article 27).
A number of other issues, which are not mentioned in the Protocol (e.g., co-existence, ethical issues), may also be taken into account...”

kind regards
Lim Li Ching
Third World Network

Dear Colleagues

This is indeed a debate that takes in the full arc of the swing of a
pendulum. I have read the posts with great interest and they are certainly
also revealing! Thank you.

At the outset, I would like to emphasise the difference between  the
position of Parties on the one hand and that Party which corresponds to
one's own country, because the prescriptive language will differ. I fully
agree with Andreas Heissenberger [#4534] when he says that it is " not up to
us to deliberate on the positions of Parties, but to discuss at a technical
level the different issues framed by the Secretariat". This is indeed our
opportunity!

While we respect the former positions even if we disagree, it is to National
action and legislation we must go and  focus on with determination, with
regard to what needs to be done in our own countries. This at present, is
the only window of opportunity that is available to civil society to
prevail, first within a Nation State and then within the CPB to the CBD.
Perhaps, herein, there is hope for evolution to a forum in the future,
within the C Protocol to the  CBD that will allow civil society
representation (according to laid down procedure), against a case of
environmental release of an LMO as a result of domestic legislation that is
so serious, because it is a case of  devastating consequences for the people
of a country. I can think of 2 potential specific cases, if it should come
to that: Bt brinjal in India, would clearly have been one if the Ministry of
Environment and Forests (MoEF) had not overturned the decision of the apex
Regulator to commercialise Bt brinjal and the potential case of Bt corn
being planted commercially in Mexico, against the recognition of the
Protocol (in its preamble) to centres of origin ("Recognizing also the
crucial importance to humankind of centres of origin and centres of genetic
diversity" CPB to the Convention on Biodiversity).

It has to be said in the latter case that we are consumed with anxiety. 

The fact is that the  decision-making process within India, of government
with its people of the impacts of LMOs on multiple dimensions, and
critically SECs arising out of these impacts, which are imbedded so clearly
within these impacts, is neither  inclusive nor democratic and this is true
of many countries, (Article 23, 2 Public Awareness and Participation and
Art. 22 capacity Building).

I now reply to some of the posts and provide my own insights and analyses to
a troubling issue of great importance, SECs being discussed under Q 2 in
this forum.  The language of the Protocol clearly alludes to and implies
that we are prioritising the impacts of LMOs on the receiving 'environment'
for any harm they may do (CPB: Recalling also decision II/5 of 17 November
1995 and Reaffirming the precautionary approach contained in Principle 15 of
the Rio Declaration on Environment and Development)

This emphasis though, does not mean that there may not be benefits. This is
the balance. Furthermore,  I find it difficult to find agreement with a view
point that gives priority to timelines in the face of the long term even
irreversible consequences of wrong decisions with regard to the impact of
LMOs. In fact, it is true that many socio-economic impacts will only be
visible after rigorous research and a process of close enquiry on multiple
fronts. Therefore, it is also true that such findings will probably have
become 'consequences' (ref Dr. Falck-Zepeda#4549), which I respectfully
suggest require even more serious consideration to mitigate harm (as far as
is possible) and links us  directly to the Protocol's 'Liability and
Redress' (Article 27), and reversing an earlier decision of import as I had
mentioned in the debate on Q 1 (Article 12 Review of decisions).

I thank and support Lim Li Ching ([#4544], Dr Joanna Goven [#4569). Dr Brian
Wynne ((#4552), and others for their well annunciated and argued position on
the legitimacy of taking the broadest  'scoping'  for "socio-economic
considerations arising from the impact of living modified organisms on the
conservation and sustainable use of biological diversity"? What is your
understanding of the wording "arising from the impact"? I'd like to
reiterate what I said in the Q 1 debate and I do so with some examples to
illustrate the point.

SECs under Q2 arise out of both ex ante evaluation as well as and ex post
evaluation under RA and beyond (to ethical questions).  Indeed,  I see that
SEC 'arising' out of impacts are  largely by definition visible ex post.
Others too have made this link.  In ex post evaluation, SECs are very much
'consequences' that become visible from monitoring or PMM (post market
monitoring),  which then must be grappled with after the horse has bolted.
It is probably inevitable that we will hit these serious hurdles of
consequences concerning  SECs, because ex ante evaluation in RA, may be
limited in its predictive power, but nevertheless remains critical to a
decision to release an LMO for commercial planting, as demonstrated in these
2 examples below from the RA of Bt brinjal (ex ante evaluation), which
underpinned the decision of the MoEF to override the approval by the
regulators to plant Bt brinjal commercially in India:

The safety dossier of Mahyco overlooked gene flow to wild relatives and land
races as also any IRM (Insect Resistant Management) strategy.  In his ERA,
'The scope and adequacy of the GEAC's risk assessment', Andow (David) drew
attention to both  gaps and concluded that contamination of brinjal
varieties was inevitable and that unless resistance strategies were put in
place, there would be brinjal crop failures in 4-12 years. Those most hit
would be small holder farmers.  His ERA, as well as the  RA undertaken by
other independent scientists, including the molecular analyses of the Event
(J Heinemann), underpinned the reasons for the moratorium declared on Bt
brinjal.

Similarly, ex post, India has many serious SECs to contend with, arising
from the  impacts on several dimensions of the release of Bt cotton and this
is now becoming visible after 10 years. They include:   flattening or a
levelling off of yield to levels that were prevalent in some States before
the introduction of Bt cotton; drastic reduction in the gene pool of cotton;
monopoly control of Bt cotton (90+%) in Mahyco-Monsanto's hands, which
translates to 90% of all cotton (non-Bt seeds being unavailable, a story
that is repeated everywhere including the US), a change from short and
medium Indian cotton varieties (47% in 2000)  to long staple American
cotton, G hirsutum 90% in 2007. The impact on weavers, spinners and a
culture of weaving over thousands of years in an Industry 2nd to only
agriculture in its employment potential has not been investigated
(Revolution in Indian Cotton, Directorate of cotton Development, Min of Ag,
GOI ).

This provides some idea of the importance of RA (both ex ante and ex post,
through PMM)  to  SECs (with ref to  Q2).

Finally, thank you to Lim Li Ching for pointing to the use of  The Roadmap
produced by the AHTEG, which outlines RA as a process, not a discrete act.
This is so right as the interplay and links to related issues, different
processes and policies are of singular importance to both the scope of the
RA as a precursor to it and the actual RA.

My apologies for a rather long post





Aruna Rodrigues

Sunray Harvesters,

Bungalow 69

Mhow - 453441

M.P. India

Dear all,
I would like to share some of my thoughts regarding different aspects of question 2.

1. In regard to the scope of the impacts that can be considered under article 26, I agree with the interpretation given in posts #4572, #4557 and  #4547, among others. The reading of the article brings attention to the considerations related to the value of diversity to indigenous and local communities, but it does not restrict its application to other SEC arising from the impact of GMOs on the conservation and sustainable use of diversity. Immediate, delayed, direct, indirect and long-term as well as combinatorial and cumulative effects along the production chain could be assessed, taking into account the different scales where they can take place, as well as the co-technology (#4567).

2. I think SEC could be assessed, in the decision-making process, in parallel or even integrated with risk assessment, as already mentioned by Lim Li Ching and Andreas Heissenberger in question 1 and Joanna Goven and Brian Wynne in the present discussion (#4569; #4552), so that SEC are not necessarily limited to the impacts raised in the risk assessment process. SEC may be taken into account ex-ante, as well as ex-post, so there is the possibility to monitor long-term effects and even reverse a decision based on the gained experience.

3. I would like also to deepen in the discussion on the baseline to be used for conducting the assessment of socio-economic considerations (which in fact it is also a critical issue regarding environmental risk assessment), taking into account that the usual comparator, conventional non-GM agriculture, may also create adverse effects. In that sense, additional sustainability criteria for agriculture and environment could be used, in order to protect development and protection goals defined by public interests and needs.

4. Regarding the use of appropriate methodologies, I agree with posts (#4544, #4567 and #4525, among others) on the need to go beyond simple economic evaluation (cost-benefit analysis, for instance) in order to: (a) be able to assess the multiple SEC that are incommensurable, and cannot be satisfactorily be expressed in monetary terms and/or quantitatively; (b) take into account that adequate cost and benefit analysis can be unfeasible due to restricted knowledge on both the potential benefits and adverse effects of GMOs in medium and long-term. In that sense, other tools allowing for the inclusion of long-term interdisciplinary perspectives and more systematic assessments in face of uncertainties could be used (e.g. deliberative multi-criteria approaches), which are also in line with Art. 23 (on the promotion of public awareness and consultation). I think it is also important to give sufficient consideration to regional particularities, taking into account the socio-cultural and institutional contexts (public and private) of introduction.

I would also like to emphasize an aspect raised by Audrun Utskarpen (#4567), who based on the experience of the Norwegian Biotechnology Advisory Board, explains that although appropriate methodologies for assessing certain SE aspects are not fully developed, it does not mean that these aspects are not important and legitimate concerns. This highlights the importance of understanding the SEC assessment as a learning process (which also applies for risk assessment). Moreover, I would also like to thank her for posting the SAFA guidelines (Sustainability of Food and Agriculture Systems) developed by the FAO (#4568) and Lucette Flandroy (#4539) for the synthesis of SEC proposed by previous participants, which I found very helpful.

Finally, I would like to thank all the participants for this intense and interesting exchange.
Best regards,
Rosa Binimelis

Dear international “ colleagues “,

Too bad that I am not paid only to participate in this forum and to have time to lean on all worth wile aspects of SECs now.

I anyway wanted since yesterday to rectify previous opinions of Dr. Falck-Zepeda, in the sense that was well made inbetween by Li Ching Lim and that has been approved already by other participants: Art. 26.1 is putting “ especially” but not “exclusively” a particular emphasis on the value of biodiversity for indigenous and local communities; thus impacts of LMOs on conservation and sustainable use and related SECs are indeed to envisage in a broad sense. And we focus too much on Q. 4, that would come later, if we stick to this part of the sentence right now.

I also want to thank particularly Joanna Goven ( message n° 4569 ) to have clearly explicited the wording and way for implementing the Guidelines adopted by the COP CBD for incorporating biodiversity-related issues into EIA and SEA ( and explained how this could be relevant in our present context of SEC.

I also find the examples given by Aruna Rodrigues interesting to illustrate the relationships between RA/RM/and SEC, after Bryan Wynne had made a brilliant presentation of theoretical considerations about this.

I also thank Audrun Utskarpen for his relevant information relative to SAFA guidelines and to have explained a bit how Norway is starting to concretize criteria to evaluate sustainability of LMOs, while recognizing that all methodologies for assessing certain aspects are not yet developed, which does not mean that these aspects are not important and legitimate concerns.  Good also to see concrete proposals from Austria.

Maybe it could be interesting ( at some point in this forum before COP-MOP7 ) to look back what are the common denominators between the various concrete SECs that are presented in this discussion and see what could be common denominators to consider as SECs under  Art. 26.1 of the Protocol.

Thanks a lot to all of you for very interesting participation.

Lucette Flandroy




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

After reading carefully all the contributions to question #2, I think there are some things we agree upon. As a personal note, I do echo Lucette Flandroy observation taking personal time to participate in this forum. This is an even more binding limitation especially for those experts, regulators, decision makers in developing countries who I wish hear more of their voices in this debate.

1) If we are talking about Article 26 and the scope of the Protocol on the issue of socioeconomics, then Article 26 describes a line of causality starting from making a decision on imports of LMOs, adoption of an LMO, impact on biodiversity and finally SEC arising from the impact on biodiversity. If a country decides to go beyond this line of causality, it is their sovereign right. In fact, taking into account socioeconomic considerations not arising from biodiversity impacts will have to be integrated into domestic measures due to the specific language of Article 26.

2) Decisions about which socioeconomic considerations to take into consideration for decision making will be done at the national level. This is due to the fact that implementation of Article 26 is voluntary and a reaffirmation of national sovereignty deciding to apply or not apply such Article, and if affirmative, a country will decide how to do so.

Some personal observations:

1) The negotiated language of Article 26 associates socioeconomics with considerations, and, biodiversity with impacts. It does not associate socioeconomic considerations with impacts directly. If the Parties desired to have socioeconomic impacts they would have explicitly indicated this process in the language of Article 26. I recognize that the text in Article 26 is the product of negotiations and thus this is the minimum text that would satisfy all the Parties. The fact that Article 26 leaves the door open for countries to implement whatever domestic measures they deem necessary – with the proviso on meeting their international obligations- only serves to emphasize the decisions at the national level which the Parties will have to take.

2) I recognize that the word “especially” does not infer “exclusively”. I now realize that any potential interpretation as such is an overreach. However, the fact that the word “especially” is in Article 26, still signals the Parties’ strong desire to focus on biodiversity impacts of value to local and indigenous communities. 

3) Every country will have a different set of socioeconomics and priorities for formulating policies. I believe our contribution in this forum should be to provide ideas and tools to facilitate Parties’ decision making in terms of whether they want to implement Article 26, and if so, what options, issues and consequences they will face from such decision. Furthermore, for those of us who are experts in performing - before and after release - impact assessments of such technologies, and who are involved with capacity building at the national level, we will have to contend with both implementation of Article 26 and domestic measures in our work in developing countries.

4)  Risk assessment is indeed a process. I hope I have not given the impression otherwise. Yet, most risk assessment processes that I am aware of, especially in those countries with actually proven and ample experience regulating LMOs, tend to have endpoints, timelines and decision making outcomes. In some cases, regulatory systems have chosen even to have the option of de-regulation. Certainly, most decisions have been made where the commercialization/general release permit is temporary pending post release monitoring.

Furthermore, in proposing that biodiversity impacts are identified during the risk assessment process and as part of the line of causality (a process in itself) this would make the process consistent with discussions in the AHTEG on risk assessment, which focuses on environmental impacts and thus on biodiversity.

The risk assessment studies biodiversity impact along with other issues such as food/feed safety and public health issues. Whether the initial risk assessment does not uncover a potential biodiversity impact in its initial assessment to draft a decision and/or recommendation, an impact which is later discovered in post release monitoring, this does not interfere with the line of causality described above which becomes part of the biosafety assessment process in itself. This is just the nature of things, and if the newly discovered impact has a socioeconomic relevance, then its up to the country to modify its original decision.

4) I would like to reiterate my observation that we need to abstain from commenting or debating a country’s formal position. Here I put on my hat as a Honduran citizen for this observation. As clearly indicated by Dr. Roca in post #4537, what she described was the formal position of the Government of Honduras on the matter of socioeconomics and the risk assessment. Dr. Roca clearly indicated that she had been designated by the competent authority in Honduras to speak on the formal position of the country to inform other Parties and the participants in this forum.

Whether one or a few papers in the literature effectively and widely criticizes this approach is debatable, especially when the formal risk assessment approach codified in Honduras Laws and regulations is quite similar to that to countries with ample experience in regulatory matters such as Argentina, Brazil, USA, Canada and Australia. We can certainly find articles and statements in support of the current risk assessment approach followed by functional regulatory systems globally.

I recognize that the biosafety system in Honduras has many limitations -notwithstanding the fact that all members of the Biosafety Committee in Honduras do these duties in their own time- but as of now the risk assessment process complies with its international obligations and with the Cartagena Protocol itself.

I believe it’s prudent, especially in this forum, that if we want to discuss the issues we do it in an abstract manner. This is OK. Internal issues related to a specific Party, are indeed internal, and only subject to discussion if invited to do by the Party itself. Qualifying an approach followed by a Party as wrong, is not welcome.

One more comment and please correct if I am wrong here. Voluntary guidelines and even the risk assessment guideline developed by the AHTEG on risk assessment (but not yet approved by the Parties) cannot be used to interpret the text of the Protocol as they provide potential options for countries to pursue. They are not binding in nature and thus just a recommendation. The fact that the Parties may have endorsed such documents is just an indication of their value as tools to help decision making.

A brief reply to the last posting of Dr. Falck-Zepeda:

OK that SEC is not synonymous of SE impacts, but it can include impacts.

I also do not totally agree with your 2nd § : as already expressed and explained also by other participants, the link between the SECs and the impact on biodiversity should not only be: adoption of a LMO • impact on biodiversity • SEC.

We should also note that the wording of Art. 26.1 relatively to the impacts is “ impact “ as a singular, and “LMOs” in the plural .
This suggests some generalization of the notion of “impact” and of that of “LMOs”, giving still more the impression that the concerned SECs should not be only SECs to consider ex post and only resulting from de facto impacts of LMOs on biodiversity.
This suggests a.o. that generic SECs relative to impacts common to all LMOs could also be taken into account by Parties, and not only case by case.

Kind regards to all of you, with hardly found air of spring coming from Belgium.

Lucette Flandroy

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

Dear all,
I think Ben David Durham (intervention #4545), made some very important, realistic and interesting points. Such as the introduction of a LMO can have both negative, as well as, positive impacts. Nothing is perfect. It’s a question of balancing what is more relevant. As well as, that it’s “counter-productive to make SEC's so complex that potential permit applicants shy away from them”. I totally agree with these observations.
In addition, I’d like to point out that SEC should not be considered regardless of actual demand or true need. That consideration is not because biodiversity, indigenous and local communities aren’t important and don’t deserve a special attention and care. Of course they are very important. But there is an obvious cost for doing these assessments and not always an obvious conclusion can be made. As resources are limited one should consider the most effective way they should be used to indeed protect biodiversity, people, etc. while fostering development (sustainable development). Parties can opt to protect their biodiversity, indigenous…in different ways, such as other domestic/national regulations, or a number of different efforts to either protect or effectively managing the risks associated with any activity. For instance, Brazilian law 11.460/2007 forbids the planting of LMOs in indigenous lands and areas of conservation. Thus the money that would be used for a SEC assessment covering what is forbidden anyway is probably better used for other activities, such as managing more effectively those protected areas that house these highly valued, species-rich zones, indigenous communities ….There are many options, combination of efforts, etc. depends on the case.
Best regards, Lúcia

Dear Lucia de Souza,

Thanks for bringing these issues to the discussion table. Even the simplest assessment of socioeconomics will have a cost and time consequence attached to them. Some participants in this forum may choose to disregard this cost, yet as a matter of public policy, we have to ensure that laws and regulations done as domestic measures are indeed feasible and cost/time efficient.

After all, as you rightly, point public budgets are not infinite and the resources are limited to dedicate to biosafety regulatory processes. This implies that (hard) choices will have to be made in terms of what would one wish to do and what is feasible doing. We simply cannot research everything under the sun.

Finding innovative ways to address these assessments is an imperative. Both Lucette Flandroy and I have proposed addressing SECs at the generic/class of LMO level as an alternative to the Parties.

Your call to consider internal (and external) consistency with other laws and regulations within a country is also an imperative. Particularly, as other laws and regulations may help define which issues to consider, and which can be discarded or set aside. Your example from Brazil is quite interesting as my home country Honduras followed a similar approach.

In the end what we all want is a functional biosafety system that is empowered to render decisions or recommendations for decision. If that is not the intention, then it seems a waste of resources by trying to define a system that will only yield a no or a yes as an outcome.

Thanks for your valuable clarifications. Yet, I would not put too much emphasis in the difference between "impact" and "impacts" and thus their weight in clarifying the intention of the Parties. After all, when we use the phrase "impact assessment" , it does not refer to one single impact, in spite of the word being in the singular. Impact assessment refers to a process why which multiple outcomes are identified, studied and potential solutions are proposed.

I think it is prudent that the wording in the report summarizing the discussions from this debate, will have to be quite clear that there are multiple interpretations on which socioeconomics that may be considered. It should also not endorse nor oppose such inclusion.

I also believe that it will be more practical and useful for the Parties, for this forum to delineate the elements of a road map (or guidelines?) that will help countries make their decision rather than trying to identify all the potential SEC that may arise from the actual or potential introduction of an LMO. After all, the list of SEC considerations is in essence infinite.

If we present such a list to the Parties, without any further guidance on how to choose from the all encompassing list which can be compiled, then we will introduce more confusion rather than facilitating conceptual clarity. Note that we still have not discussed implementation issues derived from the potential inclusion, but that is a discussion dependent on the identification of SECs.

Now, back to my job dealing with survey data analyzing adoption of LMOs in a group of countries.

I would like to help with some aspects of this discussion:

1. "Causality". One can not speak of "causality" when we are dealing with very complex problems. In tropical countries (as in the case of the Andean and Mesoamerican ones), we have very complex ecosystems and local communities (indigenous, peasant and other), which have a complex relationship with their environment. In these environments, interrelationships occurs with biological, socioeconomic and cultural factors that are synergistic, cumulative and long term. The negative impacts of the introduction of a GM crop can not be displayed mechanically, so the cause-effect analysis can not be applied. It would deny this complexity,an will be a reductionist methodology.

2. "International obligations". There is a tendency to associate "international obligations" of countries with trade agreements. There are treaties that are above all others, and are human rights agreements. Its implementation should be the main concern of a country. For example, in the American continent we have the San Salvador Protocol on Economic Social and Cultural Rights, highly relevant to the issue we are dealing here. This protocol includes the right to health, food and a healthy environment. These are issues that should be considered when making decisions on GMOs

3. You can not extrapolate the regulatory experiences of developed countries in countries with totally different socio economic realities, where there is often poor public health systems, which can not serve to communities exposed to fumigation associated with herbicide-resistant GM crops. With indigenous and peasant communities whose corn has been contaminated, where corn is part of its food sovereingnity and nutrition, and that is part of their ritual and spiritual life. That's the kind of socio-economic considerations that should be taken into account.

4. Finally I would ask. Does the fact that a country have regulatory experience, means that in these countries there is no socio-economic problems related to the release of GMOs?

The claims were reiterated of the supposed positive SEC outcomes of using Bt cotton and supposed negative effects of not using it. In a prior posting, I explained how ex post estimates of the economic benefits of Bt cotton introduction can be falsely attributed as the direct benefits of Bt cotton. I used a thought experiment based on knowledge of cotton in the Central Valley of California where secondary pest outbreaks were due to heavy pesticide use that had threatened to destroy the industry (Falcon et al. 1971, Evleens et al. 1974, van den Bosch 1978). Similar pest problems that occurred earlier in cotton in the Cañete Valley of Peru, Egypt, India, China, and Alabama and elsewhere were also related pesticide misuse (ecological disruption), but doing appropriate experiments to determine this were not done, and are now greatly hampered by industry IPR constraints. The question of need for a technology is paramount, and should to be demonstrated before the introduction of GMOs or any other proprietary technology is made, and SEC should be part of the basis for importation, though I would agree that countries have the right to make their own decision on such matters. To facilitate this, scientists should be free to investigate the SEC of GMO via independent field experiments (see prior post on complaint to the US EPA by 26 research entomologists on restrictions of research in corn in the USA).

The science of agroecosystem analysis has matured, and given the freedom to do the appropriate experiments could help resolve the issue of need and some of the SECs. Unfortunately, this opportunity is currently not available, and hence discussions of potential benefits of GMO introductions (or of SEC) are fatuous except ex post. To repeat, ex post analysis of economic panel data collected during the transition period from ecosystem disturbance to say Bt cotton introduction only enable us to tease out the contribution of factors in place, and begs the question of whether the technology was needed in the first place (e.g., India, Alabama, China or Central California). Such analyses have led to widely divergent claims of economic benefit (e.g., Qaim and Zilberman 2003). In constrast, early agroecosystem studies and modeling predicted the increased importance of plant bug and defoliators in Bt cotton as occurred in the SE USA (India) where the solution is to spray (see Gutierrez et al. 2006). In India and elsewhere, important SECs include the loss of local varieties and worse loss of farmer independence as they become trapped in the biotechnology treadmill with no apparent exit and in the pesticide treadmill as well because the GMOs do not control all pests.

The herbicide tolerance (HT) technology is more problematic than the Bt technology as this has proven to increase greatly herbicide use with many predictable SECs. Among the SEC issues of GMO in no particular order are:
• The 90-day-long tests are insufficient to evaluate chronic toxicity of GMOs, and the signs highlighted in the kidneys and livers could be the onset of chronic diseases (Séralini et al. (2011) http://www.enveurope.com/content/23/1/10).
• Union of Concerned Scientists (2012). Eight Ways Monsanto Fails at Sustainable Agriculture. http://www.ucsusa.org/food_and_agriculture/science_ and_impacts/impacts_genetic_engineering/lobbying-and-advertising.html
• GMO contamination of Mexican landraces of maize (Quist and Chapela 2001, 
See Piñeyro-Nelson et al. 2009)
• Research finds biotech corn not killing pests: http://www.stltoday.com/ business/local/article_48721bc6-38cb-5cf0-aae1-2b1a7e85cea5.html #ixzz1bYG9qz4p,
http://www.bloomberg.com/news/2011-12-01/monsanto-corn-may-be-failing-to-kill-rootworms-in-four-states-epa-says.html
• Hermaphroditic, demasculinized frogs after exposure to the herbicide atrazine at low ecologically relevant doses (Hayes et al. 2002).
• Glyphosate and its degradate aminomethylphosphonic acid in the atmosphere (Feng-Chih et al. 2011).
• Glyphosate in surface waters of agricultural basins (Coupe et al. 2011).
• Glyphosate is a chelating agent that binds essential plant micro-nutrients in the soil (talk by Professor Emeritus Don Huber, Purdue University at the American Phytopathology Society meetings in Honolulu, 2011).
• Rana pipiens tadpoles chronically exposed to environmentally relevant concentrations of POEA or glyphosate formulations containing POEA showed developmental abnormalities (Howe et al. 2004).
• Adverse herbicide effects on amphibian larvae (Cauble and Wagner 2005).
• Toxicity of Roundup Original MAX® to 13 species of larval amphibians (Relyea and Jones 2009).
• Resistance in weeds to glyphosate has developed (Nandula 2010).
• A biotech revolving door has developed between biotech corporation employees, USAID, FDA and other government agencies.
• US diplomats pushing GMOs worldwide -Wikileaks latest http://www.cablegatesearch.net/cable.php?id=08STATE129940


References
Cauble, K., and R. S. Wagner. 2005. Sublethal effects of the herbicide glyphosate on amphibian metamorphosis and development. Bull. Environ. Contam. Toxicol. 75:429–435

Coupe, R. H., S.J. Kalkhoff, P.D. Capel, and C. Gregoire. 2011. Fate and transport of glyphosate and aminomethylphosphonic acid in surface waters of agricultural basins.  Pest Management Sci.  68: 16-30.

Eveleens, K.G., R. van den Bosch, and L.E. Ehler. 1974.  Secondary outbreaks of beet armyworm by experimental insecticide application in cotton in California. Environ. Entomol. 2:497-503.

Falcon, L.A., R. van den Bosch, J. Gallagher, and A. Davidson. 1971. Investigation of the pest status of Lygus hesperus in cotton in central California. J. Econ. Entomol. 64: 56-61.

Feng-Chih, C., M.F. Simcik, and P.D. Capel (2011) Occurrence and fate of the herbicide glyphosate and it’s degradate aminomethylphosphonic acid in the atmosphere.
Environ. Tox. Chem. 30: 548-555. DOI: 10.1002/etc.431 

Gutierrez, A. P., J.J. Adamcyzk Jr., and S. Ponsard.  2006. A Physiologically based model of Bt cotton-pest interactions: II. Bollworm - defoliator-natural enemy interactions. Ecol. Modelling 191: 360-382.

Hayes, T.B., A. Collins, M. L., M. Mendoza, N. Noriega, A. A. Stuart, and A. Vonk. 2002. Hermaphroditic, demasculinized frogs after exposure to the herbicide atrazine at low ecologically relevant doses. Proc. Natl. Acad. Sci. U S A. 99(8): 5476–5480.

Howe, C.M., M. Berrill, B. D. Pauli, C.C. Helbing, K. Werry, and N. Veldhoen. 2004. Toxicity of glyphosate-based pesticides to four North American frog species Environ. Tox. Chem., 23: 1928–1938.

Nandula, V.K. (2010). Glyphosate resistance in crops and weeds: History, development and management. John Wiley and Sons, Hoboken, NJ, 321 pp.

Piñeyro-Nelson, A., J. Van Heerwaarden, H. R. Perales, J.A. Serratos-Hernández, A. Rangel, M.B. Hufford, P. Gepts, A. Garay-Arroyo, R. Rivera-Bustamante, and E.R. Álvarez-Buylla. 2009. Transgenes in Mexican maize: molecular evidence and methodological considerations for GMO detection in landrace populations.  Mol. Ecol. 18: 750–761.

Qaim, M. and D. Zilberman. 2003. Yield Effects of Genetically Modified Crops in Developing Countries, Science 299: 900-902.

Quist, D., and I. Chapela. 2001. Transgenic DNA introgressed into traditional maize landraces in Oaxaca, Mexico. Nature. 414:541–543.

Relyea, R.A., and D.K. Jones. 2009. The toxicity of Roundup Original MAX® to 13 species of larval amphibians. Environ. Tox. Chem. 28:2004-2008.

Séralini, G.E., R. Mesnage, E. Clair, S. Gress, J. Spiroux de Vendômois, and D.Cellier.  2011. Genetically modified crops safety assessments: present limits and possible improvements. Environ. Sci. Europe 23:10.

van den Bosch, R., 1978. The pesticide conspiracy. Anchor Press Doubleday, New York. 223p.

Some responses to your comments.

1) We cannot escape the fact that the Parties agreed to the wording of Article 26 which relates the decision on imports leading to the potential use of LMOs (‘the cause”) while directing us to identify socioeconomic considerations arising from the impacts on biodiversity (“the effects”). Like I have indicated before, if Parties decide to apply -or not apply- broader socioeconomic considerations and/or effects; that is their sovereign right.

Sure, biological and socioeconomic environments are complex, effects can be cumulative and long term. This complicates immensely the assessment. In fact, disentangling the impacts and identifying the complex links between components is where I spend a lot of my time lately. As I have learned, if we are not careful enough, one can be misled into the wrong conclusions.

If I had large budgets to spend on socioeconomic assessments and years to do, I guarantee you; I would love to pursue such path. But, that is not the reality of most developed and developing countries. Choices have to be made in terms of resources and time to be spent on this endeavor. The later decision needs to consider the impact on the delivery of potentially valuable technologies that may benefit farmers. The impact assessment community has documented several such examples.

2) Sure, there are more international agreements that may be relevant as part of Parties’ international obligations than those relate to trade. The response by many countries to other issues related to human rights and food security has been, amongst other ones, to ensure such rights are enforced and to invest in R&D, improve/revive extension services, and to invest in different producer support programs, in order to resolve the agricultural productivity issues still pending and which are probably going to get worse.

3) Why not? Surely many of the questions in developing countries and/or the focus of the assessments may be different. If developing countries cannot learn from the accumulated experience in developed and other developing countries, then the whole exercise of developing risk assessment guidelines in the AHTEG and capacity building/strengthening activities developed from such experience becomes pointless.

I believe there is some consensus that we cannot only focus on SEC harm/damage in the discussion but to also include benefits from the potential use of LMOs as has been documented in the literature. This is the only way to have a fair and transparent process.

4) My apologies, but seems like your statement does not follow. Countries with regulatory experience have chosen to address SECs in different ways. From having mandatory assessments on specific SEC issues to addressing SEC issues in the management protocols after release. This does not mean that there are no issues (benefits, costs and risks) in countries with regulatory experience, countries have chosen to different approaches.

Dr. Maria Mercedes Roca on behalf of the Honduras panel and the ICABB

I am very grateful for all the valuable contributions to this forum. In trying to make sense of sometimes opposing points of view, it may be useful to categorize where the different and very valid opinions are coming from and to try to reach a consensus in the near future:

I. The agricultural and food security perspective

I am very grateful  to Mr. Ben  Durham (4545) and  Dr. Jose Falck-Zepeda (4549) for bringing a very valuable appreciation of the balance needed to make appropriate decision-making about any technology that may or may not benefit society (and all its members).  Both Ben and José  looked at this from the point of view of farmers, increased agricultural productivity needed for the growing urban population (expected to be 80% of the total population by 2050) and ultimately, by addressing important challenges of climate change (for example increasing incidence of pest and diseases) and  food security. Poor rural populations (were yields are very low still by using ancestral technology) are often the most vulnerable in terms for food security. Honduras needs to import 50% of the corn it needs, for rural and urban populations. It is trying to become self-sufficient.

II. The ecological preservation perspective

Ms. Li Ching Lim from Third World Netwok and Ms. Elizabeth Bravo from Ecuador’s Ecological Action on the other hand, remind us of the sovereign rights of parties to adopt the Precautionary principle and   “ have national laws that are stricter. So at the domestic level, a Party can 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”. This view seems to be consistent with the perspective of groups working exclusively in protecting the environment and maybe small indigenous communities with different spiritual values to urban dwellers, where globalization, population increase and agricultural intensification of any kind, conventional or GM, may be seen as the biggest threat.  This perspective seems to be shared  Dr. Andrew Gutierrez from CASAS in California (4582). Many participants in this discussion seem to take for granted that GM technology is always going to cause  adverse effects.  In other discussions we could challenge this assumption with an equally long list of peered review studies  by reputable scientists that show a different perspective.

III. The national - policymaker perspective

For professionals and national decision-makers that need to consider the big picture and the wellbeing of all their country’s  citizens, the decision is  complex and not  clear cut. They need to consider protecting  the environment and small local and indigenous communities from very  real and tangible threats that are very quantifiable such as poor education, disease and malnutrition and not related to LMOs. They also  need to  promote agricultural policies for sustainable  economic growth and  providing adequate and healthy nutrition for the huge urban populations (like Mexico or Guatemala city to name a few). 

Dr. Falck-Zepeda also brings a very important dimension:  compliance with regulation.

He reminds us that “the cost of compliance and the impact of regulations in terms of time delays can be significant not only in terms of its impact of societal benefits but also in terms of those technologies available to farmers. With added cost, time delays and significant regulatory complexity there will be less technologies available to farmers especially in developing countries. Unless this is the explicit intention, farmers will be worse off with less choice in most cases. This line of reasoning applies to LMO and to all other upcoming technologies”

To finalize, is it difficult to answer  the question of which socio-economic issues need  to be consider in this discussion?  Categorizing the different perspectives from the different groups, may be useful. Recognizing that different countries have different  agendas, budgets and priorities  for biosafety issues may also help.

I respectfully send you all best wishes and continue to thank everyone for their valuable opinions

Maria Mercedes Roca

I will add a further perspective to my previous posting and to  to Dr. Falck’s  dimension:

The complexity of capacity building for  compliance and  how much it costs (in terms of time and money) for  already  struggling governments of  “ third world countries” (to use the term from Ms. Lim’s organization) to accommodate   ever growing demands for biosafety regulation.

Ms. Bravo from Ecuador stated that “you cannot extrapolate experiences from developed countries to those with different socio-economic realities”.  I totally agree. Industrialized and developing economies may have the luxury and required dedicated  human and financial resources to accommodate these growing demands.  Norway may be such a country with ample resources for biosafety issues. Governments of poor countries such as  those of Central American countries simply do not have the resources to deal with the ever growing demands of biosafety. This is becoming a problem.  Governements and their officials  have to choose whether to dedicate their very limited resources  to  for example  improve struggling education or health care systems,  or to  address demands in “improving” biosafety regulation" by adding more rigor. 

Just as an exercise, it would be interesting to calculate the cost in “man-hours” that it is costing to participate in this forum, instead of using this time on other  productive activities (in my case teaching and research).  Like some have stated already,  many regulators in developing countries do not get paid to work in biosafety regulation and do so out of civic duty to their societies or split their time between many jobs.

Dr. Falck’s wishes more people from parties from developing countries participated in this forum. They may  not  be doing so for 3 main reasons:

1. None of them work exclusively in biosafety and have very busy working agendas. To take time off to discuss these issues may not often be a priority in their busy  daily working lives

2. They may fnd the discussion a little dense,  especially when too much emphasis is put on Protocol language that they may not understand

3. It is difficult for non-native speakers to express themselves properly in English. This is a great limitation of this forum. It is intimidating to share your opinion in a foreign language.

Best regards, MMR

Dear participants,

I almost agree with Jose Falck-Zepeda(#4576), but one expression in #4576 that "biodiversity impacts are identified during the risk assessment process", I think, would be "biodiversity impacts are identified during the EIA process".

The following procedure would, I understand, supposed in the Protocol;
1. Notification of export of a LMO

2. RA of the LMO by the importing country
     Risk assessment is conducted according to Annex III of the Protocol.  (“Roadmap”, which is a guidance document developed by AHTEG, has been still under testing.)
     Potential “risks”, (they are not “impacts”), would be/ or not be identified.

3. (Optional) EIA of the decision of import or cultivation
     If the importing country would like to conduct EIA of the decision of the import or cultivation of the LMO in the country, the importing country may /or may not conduct EIA on the decision. 
     EIA can be conducted referring to “Voluntary Guidelines on Biodiversity-Inclusive Environmental Impact Assessment” (UNEP/CBD/COP/DEC/VIII/28), depending on the needs of EIA and the resources, such as time and budget.
     Potential “impacts” on the conservation and sustainable use of biological diversity would be identified.  “EIA is a process of evaluating the likely environmental impacts of a proposed project or development, taking into account inter-related socio-economic, cultural and human-health impacts, both beneficial and adverse.”(UNEP/CBD/COP/DEC/VIII/28)
     Also socio-economic considerations arising from such “impacts” would be identified, especially with regard to the value of biological diversity to indigenous and local communities. When making a decision, the import country may take into account the SEC, consistent with its international obligations.

4. Making decision

Best regards,

Isao TOJO
Ministry of Agriculture, Forestry and Ficsheries, Japan

Dear Dr Falck-Zepeda,

Are you saying that no one may comment on anything Dr Roca, or any other participant who has been designated to speak on the formal position of his/her country, may say? First, this would make for a very odd forum were there, as I believe you wish, a large number of such participants.   Second, the statements with which I and others took issue were not descriptions of Honduran government policy, rather they were general statements about the nature of risk assessment.  You have commented on them by agreeing with them. Moreover, as you and others have assigned such a large role to RA in this discussion, these general statements were highly pertinent to the general discussion.

This forum should explore the substance of claims and arguments.  You have not responded to the substance of the argument that RA is not value-free, you have simply said 1/ it is wrong to comment; and 2/ other people have a different opinion.  This does not seem to me to be the most useful way to proceed.

The following statement is a non sequitur: “Whether one or a few papers in the literature effectively and widely criticizes this approach is debatable, especially when the formal risk assessment approach codified in Honduras Laws and regulations is quite similar to that to countries with ample experience in regulatory matters such as Argentina, Brazil, USA, Canada and Australia.”  First, many such papers exist; this is not debatable.  Second, the papers were not said to criticise Honduran policy, they were said to criticise a particular approach to risk assessment; if this is Honduran policy, it is certainly not limited to Honduras, and in any case whose policy it is was not the point.  Third, whether or not countries such as Argentina, Brazil, USA, Canada, and Australia utilise the same approach demonstrates nothing about the existence of the papers or their quality. 

None of the above is intended as criticism of the specific policies of Honduras or any other Party.  They are responses to your comments, which I assume may be commented upon.

Respectfully,
Joanna Goven

Dear all,

I would like to thank Dr. Andrew Paul Gutierrez for bringing an important dimension to this discussion which is that of needs assessment, which is an important concept for sustainable development and must be part of the SEC. This has also been recommended by the scientific Technical Expert Committee (TEC) appointed by the Supreme Court of India. An assessment of the need the product/technology and whether there are alternatives in existence.
(http://indiagminfo.org/wp-content/uploads/2012/10/SC-TEC-interim-report-oct17th-2012-GMO-PIL.pdf)

I would like to respond to Mr Jose's post, most which I disagree with; his point on the budget of developed and developing countries to conduct SEC analysis. As it is seen in India that the applicant's take on the expenses to do risk assessments and so on, so should the onus be on the applicant to pay the expenses for SEC analysis. And unless a proper assessment which includes health, environment and socio-economic analysis, no one can come to the conclusion that is technology is going to benefit farmers.

I would like to revisit the provision in Art 26, para 2 which states  "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." One way of a SEC before environmental release of GMO is to study the experiences of other countries with the following, event, trait and crop. An example if is the experience of HT crops in the USA (http://news.cahnrs.wsu.edu/2012/10/01/pesticide-use-rises-as-herbicide-resistant-weeds-undermine-performance-of-major-ge-crops-new-wsu-study-shows/), which has increased herbicide use by 25% for farmers, parallels can be drawn by a diverse group of experts what would be the SEC impact for the Indian farmers.



Regards
Neha Saigal
Greenpeace, India

Colleagues, another interesting discussion.

I'm glad that there seems to be agreement that the wording of the Protocol is clear that socio-economic considerations ‘may’ be taken into account - this is not mandatory - and consensus also appears to have emerged on the need to include benefits in any consideration. How you balance risks and benefits seems to be at the heart of this debate which highlights the importance of having a comprehensive evidence base as a starting point. To add an extra, equally challenging dimension, it may also be relevant in some cases to undertake a risk/benefit analysis of not approving an LMO for release. The text of the Protocol is clear that this only relates to socio-economic impacts upon the conservation and sustainable use of biodiversity – and not every conceivable socio-economic impact arising from the release of LMOs.

In terms of answering the Secretariat's question - a starting point ought to be that a thorough scientific-risk assessment should alert decision makers if an LMO threatens to have adverse effects on the conservation and sustainable use of biodiversity. In many cases, if such a risk is identified the LMO may not be authorised in the first place, such is the general tendency to hazard aversion rather than risk management. Using crops as an example, if an LMO is approved which may have potential adverse effects on the conservation and sustainable use of biodiversity – there’s still no guarantee that socio-economic ‘costs’ will arise as that will depend on multiple factors, including the crop/trait, receiving environment / ecosystem and cropping system. And even then, the benefits expected from releasing the LMO may outweigh those costs – particularly when compared to the alternative non-GM crop. It’s also worth remembering that most, if not all, agricultural practices involve some degree of interference with the environment that is likely to have detrimental impacts. We must take care therefore to ensure we use a comparative assessment of GM versus conventional crops and practices in order to gain a true understanding of the risks/benefits of the technology so that evidence based decisions can be taken.

An independent Committee of Scientific Experts in the UK undertook a major analysis of this issue a few years ago which I’d recommend to participants: http://webarchive.nationalarchives.gov.uk/20080727101330/http:/http://www.defra.gov.uk/environment/acre/fsewiderissues/pdf/acre-wi-final.pdf.

The report made seven recommendations for how to approach this:

1. take account of benefits as well as risks,
2. be evidence based,
3. recognise that an opportunity will often be needed to assess the impact of novel crops and practices on a limited scale, before widespread use,
4. be based on comparative assessment with current crops and practices,
5. protect and nurture opportunities for innovation and therefore choice of comparator should take care to avoid the rejection of novel crops and practices while retaining more damaging established crops and practices,
6. be straightforward to apply,
7. be sensitive to the competitiveness of all sectors of [UK] agriculture.

The report proposed a matrix-based approach in the form of a Comparative Sustainability Assessment (CSA) that could be used to encourage a more objective and comprehensive approach towards agricultural and rural policy which contained ten criteria for assessing sustainability, benefits and risks. Not all of these will be directly relevant to the definition of socio-economic considerations in the Protocol, but most are. The independent experts used BT cotton as one of the case study examples (see pg 38) and concluded that: “compared to cotton sprayed with insecticides, Bt cotton has major benefits in terms of the environment, yield security and human health. The environmental disbenefits appear marginal in comparison.”

Since that report was published the evidence base has evolved considerably and now seems to suggest that the adoption of BT / HT crops can lead to positive environmental impacts which will have a beneficial impact on the conservation and sustainable use of biodiversity; for example: reduced pesticide use, reduced soil erosion and nutrient leeching, reduced levels of insecticide in soil and water, reduced greenhouse gas emissions – as well as providing yield increases, yield protection or agronomic convenience for growers (though these last three socio-economic impacts are arguably beyond the scope of the Protocol). There is also debate about whether or not use of herbicide has reduced – though the answer to that can depend on the metric used, volume is the simplest – but a more precise Environmental Impact Quotient can be helpful in assessing the risks/benefits of using a greater amount of a more benign active ingredient than a smaller amount of a more toxic herbicide. Monetising or quantifying all these benefits remains a challenge – but it might be sufficient to analyse this on the basis of a simple comparison with conventional crops by asking if the overall net environmental impact of the LMO and the socio-economic consequences of that net environmental impact is likely to be higher or lower than it’s conventional alternative.

I’m not saying that the benefits will be universal in every application of GM technology – as for risk assessment it will depend on multiple factors and a case-by-case approach will therefore be required. But where I think the attached Report may be helpful is that it sets out a suggested framework by which Parties could assure themselves that they’ve asked the right questions in order to be able to attempt to come to decisions which reflect their local, regional and national priorities / value systems – should they wish to.

Mike

Department of Environment, Food and Rural Affairs
United Kingdom

Hi All,

Risk assessment is complex enough despite the set of well defined protocols from the biological, environmental and natural sciences... More so if SEC is added as part of RA.

"Hard evidence" similar to the impact protocols established by the hard sciences on biodiversity will be difficult to provide for SEC. That's why I agree with Ben Durham  (4545) when he affirmed that the SEC should be a major responsibility of individual country decision-makers with reference to their existing laws, policies and programs, in contrast to Lim Li Ching's (4544) position on emphasis of the negative SEC impacts.

To weigh the merits of the impact of LMOs on biodiversity vis-a-vis SEC, (e.g. on food security or poverty alleviation) development goals should be a paramount framework in the decision-making process to be handled by individual country's major decision-makers... The decision-making process can be facilitated faster if there is a congruence of the individual country's NBF with existing policies e.g. Trade/GATT-WTO, which has implication on the transboundary movement of LMOs.

If SEC is an intrinsic part of RA, and hard evidence like those protocols provided by the biological, environmental and natural sciences are needed for commercial approval of an LMO, then commercial approvals will be very difficult unless it is evaluated within the overall context of a country's development goals... So again a well balanced decision-making process is needed in weighing the SEC of an LMO RA.

Dear all,

Again some reflections after the interesting messages posted since yesterday.

Dr. Andrew Paul Gutierrez has introduced the important notion of the “need” ( or has reinforced that notion already suggested before ) of the LMOs among the SECs to consider during a decision under the Protocol. I indeed believe that, if this notion is irrelevant in the RA process itself, it is totally relevant to take into account in the SECs and even useful in a period where we realize that we should avoid wasting of all kinds. I think that Norway has introduced this notion in its legislation.

Once again, the need should here be of course understood in the context of Art.26.1, thus as the need to import/utilize the concerned LMOs in order to insure the conservation and sustainable use of biodiversity, and to improve potential inked SECs.

At least 2 aspects of the “need” should be looked at:

-          the need of the LMO to solve a problem in the production of the non LMO counterpart

-          the need of the product itself for society.

( About this  aspect of need, I guess you are all aware that not everybody does agree on the need to raise food production 70 % by 2050. They are other ways to solve the issue of feeding a growing population ( like avoiding losses of production in garbage of industrialized populations and losses in storage in developing countries, reduction of meat consumption, …. ), and there is more need in improving present world food quality than quantity. )

By looking at the need to solve a problem, we should look, like is or should be done in medicine, at the cause, the origin, of the problem rather than just to try to mask the symptoms. Saying that, when looking at solutions for this problem, alternative solutions could indeed be looked at during that SEC evaluation, and look which is the most useful and sustainable solution.

This leads me to the issue of the comparators to use to look at benefices or risks ( whereas I agree that for some “values” the notion of comparator will have no of few meaning ). If in the RA process, it is just asked to the LMO not to have more risks than the ( conventional ) comparator, in the SEC process and in considering the “need” of the LMO  it would be logical to require that the LMO would do significantly better than the conventional counterpart in socio-economic but also in environmental point of view, since the LMOs are presented as being solutions to solve including environmental problems generated by conventional agriculture.

And, once again, these socio-economic benefits of LMOs, a.o. when concerning LM cultivated plants, should not be just for the farmers cultivating LMOs and/or for the GNP of the country but for the whole population of the country. And should be mainly at long term, to insure their sustainability over time. There is obviously something wrong in the functioning of our present society that has always to do everything fast, where we should look always to fast urgent new technics that have all the time to solve the problems generated by the preceding new technic……….., without taking the lessons of the past, without giving attention to the deep causes of the problems and without looking at more sustainable solutions.

Finally for now, I do not think, Dr. Falck-Zepeda, that many participants in this forum take for granted that GM technology is always going to cause adverse effects. But many want to show that if ex ante RA and SECs, that were expressed long ago by a part of the stakeholders including the scientific community, had been duly taken into account, one would have avoided real problems that have occurred or are occurring at least with some LMOs in some places and that could generate irreversible damages for environment, health, and socio-economic.

With kind regards.

Lucette Flandroy





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

Dear all,

First of all, I would like to join others in expressing thanks to the secretariat for the organization of this on-line discussion forum. Compliments are in place for the approach that has been chosen, using questions to guide the discussion on this complex and wide issue!
In response to the question of this week, I would like to make reference to two reports on this issue that were published in the Netherlands. While written mainly in the context of the discussion on socio-economic aspects in the EU, I believe they contain several elements that are also relevant for the discussion in this forum.

The first report was written by our advisory committee on gmo’s, COGEM.  It can be accessed here:
http://www.cogem.net/index.cfm/en/publications/publicatie/socio-economic-aspects-of-gmo-s

This report identifies several socio-economic aspects related to GMO’s and categorizes them in 9 main themes from the perspective of sustainability (in terms of people, planet and profit). The report further states that for a number of the aspects identified, indicators to measure them objectively are not readily available. Furthermore, when trying to determine socio-economic impacts, a lot depends on which frame of reference is used. Also, it can be difficult to determine whether the impacts are due to the gmo’s specifically, or due to wider agricultural circumstances.

The second report was drafted by Wageningen University in cooperation with CREM and Aidenvironment and can be found here:
http://edepot.wur.nl/166665.

This report describes three case studies in which the impact in terms of sustainability was determined for gmo’s imported to the Netherlands. Amongst other interesting findings, it concludes that sustainability of gmo’s varies between different crops and traits. It further concludes that the role of GMO’s is hard to disentangle from other drivers of change in agriculture.

In summary, both reports help get a clearer picture of what kind of socio-economic considerations could be related to sustainable use of biodiversity and identify opportunities and challenges that exist in addressing them. This week, the question put before us also concerns the understanding of the wording “arising from the impact”. The wording seems to clearly imply that any considerations taken into account should be specifically due to the impact of LMO’s. In this regard, it is relevant to note that from the reports mentioned it becomes clear that this can be very difficult to establish in practice.

I look forward to further interesting discussions on this issue!

Ruben Dekker
Ministry of Infrastructure and the Environment
The Netherlands

POSTED ON BEHALF OF Carlos Almendares, HONDURAS

In fact Dr. Falck, his observations are correct, you can not think of a range of factors because doing so would lead to one protocol inapplicable and therefore a trade barrier. Therefore, it seems that in order to progress this issue should be defined strictly related aspects as you noted.

Best Regards

Carlos Almendares
FPP-Honduras

Dear Lucette:

I am a bit hard pressed to understand or think about terms such as contamination, suicides, poisoning, or ecological genocides; as neutral. They convey a message of harm or damage. Moreover, it is debatable that some of the purported negative consequences presented in this forum are indeed real or verifiable. At the very least and as Dr. Roca has indicated, we can produce lists of peer reviewed studies disputing many of these claims, which in some situations relied on opinions and/or questionable research. I don’t think this is a proper forum to discuss these  issues.

What is really important is that the Parties will have to have a clear understanding of what they want and need in terms of socioeconomics, as they will need to define the scope, the when, the how, the decision making standards, and they will have to define a way to judge between competing claims, even those peer reviewed. Defining functional biosafety systems is the goal here, at least that is my understanding.

I agree that a socioeconomic study can help identify potential issues and their impact if done properly following the elements of best practice such as those delineated in the impact assessment association I submitted a day ago. I have conducted plenty of these studies myself and these are available upon request.

I also know that the introduction of socioeconomics into the regulatory process can also have other benefits, costs, risks and the possibility of introducing public policy distortions. The later arises due to interest groups “gaming” the system or what a colleague called “introducing rent seeking behavior”. Because of the potential issues affectign regulatory outcomes, and since this is not an academic exercise, the need exists to describe these issues to the parties, while providing them with the information and tools necessary to draft a decision.

Finally, speaking from the experience performing many socioeconomic research studies and assessments. We cannot study everything, otherwise becomes an unwieldy and prohibitively costly exercise. We need to identify and select which issues are more important in order to define the proper research methods and approaches that will yield a robust assessment whose outcome is scientifically credible and defensible. This is the reason why I insist on focusing our efforts in devising guidelines for the Parties in order to help them with this prioritization process. Hope the collection of issues does not become a wish list of all SEC things out there which in some cases may not be even relevant to a Party, without more guidance on how to choose and the issues derived form such choice. That would not be helpful.

I have some points I wanted to make about your post.

1) My original statement still stands. It is not proper to discuss the formal positions and/or the policies and domestic measures of any party, except for the citizens of that specific country. Such discussion is not appropriate for this forum as it is an internal matter, and thus avoiding such action respects the basic principle of national sovereignty(codified in Article 26 and elsewhere) and an inherent right we need to enforce. I wanted to make this statement a general statement and thus did not do a direct reply to you.

Dr. Roca post #4537 was an expanded explanation of the formal position and the current policy of the Republic of Honduras with regard to the risk assessment and socioeconomics, and a response to another post. Thus post #4537 is still a description of a formal position by a party. If you were not aware of this fact, or if your intention was not to make a judgment on the formal position and policy of Honduras, then my apologies. I am quite passionate about defending my country’s and any country’s national sovereignty,  especially the sovereignty of developing countries.

2) I perhaps should have separated the rest of my post from the previous statement as the later was indeed a direct response to you. I don’t think there is any discussion that a “best” regulatory system exists out there. Every single regulatory system responds to its national needs and capacities, and policy frameworks. At least they should do so. Although Dr. Roca has pointed out the recent development of increased pressures for more complex regulatory systems which do not seem to come from within.

As such, we know that there are plenty of values that intervene in the design and implementation of regulatory processes everywhere. There is no pure scientific or science based regulatory system out there. What risk assessors usually defend is the protocol and the approach based on many well accepted scientific procedures which have worked quite well in the past. Has this been a perfect approach? No, particularly since regulatory approaches are learning processes by nature.

Can we learn from these countries with ample experience? Sure we can. Even in some cases on how to adapt, simplify and pick those approaches that may be feasible for developing countries (I hear you Dr. Roca). Just in 2011 Canada has reviewed 229 submissions for 858 Confined Field Trials. The USDA in the USA has reviewed 16,900 applications for field trials (including releases and notifications). Surely, they must be doing something right and they have learned something during the many years they have been performing risk assessments.

Once again, my apologies if my re-statement of such basic principle as that of my country's sovereignty was misplaced.

Dear Mike Rowe,

Thank you very much of a quite sobering and excellent summary of the many converging positions and issues that seem to be arising from the discussion. I do want to thank you for the excellent resources you have submitted to the forum.

In my institute and project (IFPRI/PBS) we are collecting these tools for capacity building/strengthening purposes, so that they are available in our training courses on socioeconomics and decision making, on overall biosafety, and for those socioeconomics practitioners that are going to be undertaking studies and/or assessments in the near future in our Asian and African country partners.

Jose Falck-Zepeda

One caveat. The need exists to clearly differentiate the requirements for containment,  confinement and general release in drafting these regulations. We know that experiments are done in some crops or other organisms, not because there is a "need" but because it is expedient, accessible or feasible to do in order to demonstrate and proof of concept, while scientists define the protocol to pursue to transform the actual target organism. If  a requirement of "need" is imposed to all applications, I would suggest the need exist to clearly define at what stage and under what conditions.

Let me explain the argument of the cost of compliance with biosafety regulations and its impact on innovation. I have described these issues in much more detail in the article Falck-Zepeda et al. (2012).

The issue per se is not really who is paying the cost of conducting a socioeconomic study (and/or the environmental and food/feed safety studies). As an aside, one of the consequences of requiring the proponent to pay for all of these studies is that it does have a negative impact on public sector and smaller domestic private firms as they usually have more budget limitations than multi-national corporations. Whether public sector that is likely to develop those technologies of a public nature (e.g. tar spot complex fungal resistant corn, fungal/bacterial wilt resistant bananas, viral/drought tolerant cassava) will be able to comply with these additional costs is debatable.

The issue is really that including additional regulatory requirements such as requesting a socioeconomic study will unequivocally increase the cost of development. As I have shown with colleagues in a paper for four technologies in the Philippines (Bayer, Norton and Falck-Zepeda 2010), this is usually not a problem as the proponent may incorporate these cost and pass it over to farmers if feasible. If the cost is excessive, however, beyond the value of potential market for private firms or the value to society of the damage (i.e. from the pest or disease) then the proponent will not enter the market and thus farmers or society will lose a potentially valuable technology.

One can argue that protecting humans, animals of the environment does not have a price. this is quite true in the sense that we have difficulties determining their value. Yet, the public sector and even the private sector do not have unlimited budgets, and certainly at one point the public sector will indeed have to pay for assessing whether such studies are valuable or not. This includes the resources for the national biosafety committees, which even when voluntary as in the case of Honduras and others, these have a significant opportunity costs as these human resources may be better used in other places.

In as much the cost may be important; in reality the time delays are even more important. As shown in the same paper before (Bayer, Norton and Falck-Zepeda 2010) even small time delays (three years) can have significant impacts on the value of net benefits to society. A similar argument is made in the Ph.D. thesis of Kikulwe (2010) for the potential development of a fungal resistant banana by the public sector in Uganda considering irreversibility. Important noting, that both papers were ex ante projections of potential economic and societal benefits.

The decision to enter a market or for a public sector research organization to develop a public crop will be based on the feasibility and/or the net benefit from developing such product. If a regulatory system is not transparent, costly or where there is uncertainty about the timelines involved, this will have a deleterious effect on the development of technologies. This state of affairs affects both the public and private sector.

Your last point opens one item which is controversial. Who in the end is the best judge of value about these technologies? Is it a regulator, a decision maker, an impact assessor (like me) or farmers who vote with their purse and feet? Although I am confident that what I do in terms of socioeconomic assessments are state of the art in terms of methods, I am not so sure that it would have contributed to making better decisions on behalf of farmers.

After all, in spite of the existing ex ante socioeconomic assessments or lack thereof, farmers continue to purchase the seed year-after year in many countries of the world because they are convinced of the value of the seed or better yet the stream of seeds that will come in the future. Granted in many places there is very little choice about seed availability, but the response should be then to improve choice, not reduce it and let the better judges of the technology to make such choice.

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. http://www.agbioforum.org/v13n1/v13n1a04-norton.htm

Falck Zepeda, J., J. Yorobe, Jr., B. Amir Husin, A. Manalo, E. Lokollo, G. Ramon, P. Zambrano and Sutrisno "Estimates and Implications of the Costs of Compliance with Biosafety Regulations in Developing Countries: The case of the Philippines and Indonesia,".  GM Crops and Food: Biotechnology and Agriculture in the Food Chain. Volume 3, Issue 1   January/February/March 2012 http://www.landesbioscience.com/journals/gmcrops/article/18727/?nocache=668315680

Kikulwe, Enoch (2010) On the introduction of genetically modified bananas in Uganda: Social benefits, costs, and consumer preferences. PhD-Thesis. Wageningen University.

Dear all,
I would like to thank to Secretariat this new opportunity to debate about SEC.
I have read along the forum very interesting posts which clarify some aspects about “what are SEC”. From this perspective, I am agree with Lucette (#4507) and others when she says that we have to keep separated risk assessment process and SEC process. However I disagree about SEC is after RA (#4507), because as it is said by Jose Falck, if you do not foresee any beneficial impact, at any level (economical, social, biological, etc), the RA will not be necessary.
Taking account that we will find potential benefits in GMOs is when we have to look for risks, in order to orientate the decision making process. So, it takes us to the Pier van der Meer post (#4526) when he affirms that “SEC is an unqualified term and can include socioeconomics benefits as well as risk”.
Thereon, my understanding of SEC, in the context of question one, is similar than Mike wrote (#4590) i.e. we should not open it to the broad meaning of SEC but to limit it to the impact on conservation and sustainable use of biodiversity (art. 26).
Finally, I agree with Andreas (#4525) when he underline the importance of the local/regional  circumstances when we want to make a deep SEC analysis, combined with a case-by-case approach.

Best regards
Omar del Río
Ministry of Agriculture, Food and Environment
Spain

I would like to comment the following statement:

"is debatable that some of the purported negative consequences presented in this forum are indeed real or verifiable"

Looking what happen in Latin America are the impacts in the RR soy producing area, and the relationship between GE seed which are tolerant to herbicides and the actual spray of herbicides.  I was last year in a suit against a GE soy producer in Argentina as international observer in
the Court, and in what we could see was that in an area with a 169 cases of cancer and 14 cases of leukemia, in a population of 5.000 people. According with WHO you will expect one case of leukemia every 100.000 people in normal conditions, so there is something going on there. This
is the case of thousands of villages around the GE soy producing area in South America.

In relation with the costs of conducting SE evaluations I will said that since the objective of the CBD, under which we have the BSP, is conservation and sustainable use of biodiversity, and that most of the country have obligations under Human Right Convensions, if a country can not affort to conduct this assessments, so, they should not accept GMO in their national territory, as an application of the Precautionary Principle.

You can say it is  anecdotal, but when you see 150 millones Ha of  HR crops, then you have a case that should be taken very seriouly.

In relation with countries which can affort to conduct SE evaluations due to high costs, well, the safety of the people should be 1st, international trade later.  The precautionary principle should be applied in those cases

Dear all,

I would like to continue where I left in my previous posting (#4567 ) about the work The Norwegian Biotechnology Advisory Board is doing in order to further concretize how to evaluate a GMO's contribution to sustainable development. Contribution to sustainable development should be given considerable weight before making a decision on cultivation or import according to our Gene Technology Act. Also conditions in the country of cultivation should be taken into account when considering import of a GMO for food or feed.

We have suggested some questions that should be asked to the applicants and to the authorities when considering approval of herbicide and insect resistant GM plants within the areas environment, economy and society. Here I will present some of our suggestions for evaluating HR plants. As I mentioned in my previous posting: when assessing sustainability of an HR crop, the HR plant itself as well as the herbicide and its impacts must be assessed.

ENVIRONMENT/ECOLOGY:
Our proposed environmental/ecological criteria concern the characterization of the HR crop, the interaction between the plant and the environment, gene flow, and impacts on non-target organisms resulting from the plant itself and the herbicide. When evaluating the herbicide, the following should be considered: Characteristics of the herbicide including impacts on human health, impacts of altered spraying regime (frequency, concentration, amount, type of herbicide), and resistance to the herbicide among other plants. Impacts on soil, energy, water and climate should also be taken into account. These environmental aspects may also affect biodiversity and may have socioeconomic impacts.

ECONOMY & SOCIETY
Within the category economy/society we grouped our questions into certain areas that we wish to protect, such as food security, animal health, living conditions and profitability, biodiversity, and free choice of agricultural system in the future. The applicants should not just answer yes or no but give the reasoning and data behind their answers.

1. Food safety, food security and food quality

a. Does the HR plant contribute to reduced/increased input costs per production unit?
b. Does the yield per area unit increase/decrease?
c. What is the purpose of the HR plant; will it be used for food, feed or fuel?
d. Are the content and amount of herbicide residues (the active ingredients of the herbicide) in the food altered?
e. May products of the HR plant cause acute, chronic or long-term health impacts (toxic, immunologic, including allergenic, or anti-nutritional impacts)?
f. Does the HR plant contribute to better nutrition in regards to composition, amount in food and energy content?
g. Does the HR plant have properties that contribute to better preservation during storage?


2. Animal health and welfare

a. Does the product from the HR plant contribute to increased/reduced feed quality?
b. Same as 1.e.


3. Living conditions and profitability for the farmers cultivating the GMOs, including farmers' rights, duties, health and safety (short-term (less than 5 years) and long-term (more than 20 years) impacts)

a. Health/safety
i. Does altered use of herbicide(s) affect farmers'/farmworkers' health positively/negatively?
ii. Do the farmers/farmworkers get HSE-training and equipment needed related to the application of the herbicide(s) to be used with the HR plant?

b. Contracts/conditions
i. Are there limitations in the access to seeds, breach of contract, or information about the products to be used (seeds, spraying plans, herbicides/pesticides)

c. Cost and income development
i. Do the farmers' input costs increase/decrease?
ii. Does the HR plant alter the need for other short term and long term input such as production plan, spraying programme, deployment of labour, machines and equipment?
iii. Will future resistance problems reduce long-term profitability?

d. Agronomic conditions
i. What agronomic conditions is the HR plant developed for?

e. Right to seeds
i. Are farmers cultivating the HR crop allowed to save, exchange and sell seeds from their own harvest?


4. Living conditions and profitability in the production area (short-term (less than 5 years) and long-term (more than 20 years) impacts)

a. Health/safety
i. Does the use of herbicides change over time and is the population's health affected negatively/positively?

b. Other farmers' democratic rights and profitability
i. Is there a coexistence regulation, and are measures implemented?
ii. Is there a system for preventing spread of the HT crop to other, non-GM crops?
iii. Will other farmers be more/less affected by weeds?

c. Employment
i. Does cultivation of the HR plant create increased/reduced employment locally, regionally and nationally?
ii. Does cultivation of the HR plant create increased/reduced employment for women?

d. Land ownership
i. Does the cultivation of HR crops alter ownership related to land and seeds in the area?

e. Advantages for consumers
i. Does the cultivation of the HR plant create increased/reduced benefits for the consumer?

f. Surveillance/logistics
i. Does the HR plant increase/decrease the need for surveillance and logistics?


5. Conservation of biodiversity

a. What regulations does the cultivating country have for herbicide use and are these regulations implemented?
b. Is the HR plant cultivated in an area defined as centre of origin or centre of diversity for the corresponding non-GM plant?
c. Does the HR plant contribute to a greater expansion of monoculture?
d. Is the HR plant freely accessible to further plant breeding?
e. Is the economy in the cultivating country negatively affected by reduced biodiversity?


6. Free choice of future agricultural system

a. Does cultivation of the HR plant exclude a shift to other agricultural systems in the future, such as organic or non-GM agriculture?  

We also propose questions required for an overall evaluation that we believe should be the responsibility of our authorities rather than the applicants. The authorities should consider consumers' choice (Are there similar non-GM products on the Norwegian market? Is there a labelling regime so that consumers can choose to buy or not to buy GM products?), segregation costs of separating GMO and non-GMO, consistency with public opinion on GMOs, and the fulfilment of Norway's food, agricultural and north-south policy goals.

We also need to figure out how to weigh different criteria against each other. The answers to some of the questions would count against or in favour of an approval, but not be decisive, and not everything would count as equally important. What we consider the most serious are irreversible adverse effects. An example would be that you might no longer be able to freely choose your system of agriculture in the future. We also see the risk of increase in resistant weeds and subsequent increase in (more toxic) herbicide use as a serious concern.

Sustainable development being a holistic concept, to break it down into smaller parts using such a checklist of criteria could lead to a reductionist approach where it seems OK to approve several GMOs but where the sum of GMOs approved at some point might no longer be sustainable. The authorities would have to keep this in mind too.

I would also like to thank Ruben Dekker along with Andreas Heissenberger who linked to reports with overviews of socioeconomic aspects. Such systematic approaches are very useful and helpful as a step towards determining what considerations may be relevant also for other countries. Also thanks to Lucette Flandroy for synthesizing and posting the list of SEC.

Kind regards,
Audrun Utskarpen
The Norwegian Biotechnology Advisory Board

These are very interesting points. Dr. Roca makes a good summary of the issues to be considered. I would like to insist in the importance of elaborating well supported hypothesis on expected socioeconomic effects  as the base to design a proper assessment.
I mentioned the benefit-cost analysis as methodological approach precisely because it takes into account not only economic but intangible effects too.
What should be avoided is to conduct an analysis of SEC departing from speculations and the exclusive consideration of perceived negative effects.

Id like to return the discussion the inclusion of benefits.

I would agree with others that the focus here is appropriately risk issues, and not benefits. However, if benefits were to be captured in the SECs, an important criterion for accepting the inclusion of any particular claimed benefit would be that it has undergone a systematic appraisal to validate the claim, which is every bit as robust as a risk assessment process for determining risks.

Likewise, such an analysis may chose to follow a case by case approach, to analyze whether the claimed benefits are indeed real in the case at hand, and document the critical uncertainties in the analysis. Otherwise it becomes difficult to justify the inclusion of a claimed benefit with highly asymmetrical standards  of proof between risks and benefits.


Therefore:

Has the claimed benefit been subjected to a robust analytical process to validate the claim in the likely potential receiving environment under consideration?

Might be first order question for deciding which of the potential benefits to include.

Best,

David

Jose Falck-Zepeda asks a very interesting question - Who in the end is the best judge of value about these technologies? Is it a regulator, a decision maker, an impact assessor (like me) or farmers who vote with their purse and feet? In a world with complete information it would be the farmer for sure, but in the application and adoption of these technologies farmers often have the least information about the technology. And because of IPRs, getting complete information to the farmer is difficult – we are forced as applied ecologist to nibble at the edges of GMO problems, or become corporate extensions.

One might ask why did farmers over used pesticides in the past, was it because they had complete knowledge or because they didn’t understand the basis of the pest protection problem they faced. For example, if one were to divide the cotton growing season into ten part and ask what combination of pesticide applications was optimal (i.e., maximized profit), the number of combinations is 1024, and of course every year and location will likely be different. In California cotton, 8-10 applications of insecticide were common with disastrous effects on yield, and yet when the right experiments were done, unsprayed cotton was the best – it was the first documented case of market failure in pest control. Pesticide sales folk are unlikely to know what applications are optimal, and besides this would conflict with the bottom line – maximizing personal profit. It is not too different with GMOs – e.g. in several cases, farmers do not foresee the full implications of the technology – they are going on the advice of expert who may be wrong. I can’t imagine that poor farmers in India knew the consequences when that adopted Bt cotton, and that after the fact they had no avenue of returning to their saved seed traditions, and even if they did, their seed might become contaminated with GMO genes as has occurred in North America (and elsewhere), and of course the companies are vigilant to assure that the saved seed cannot used. As a non-lawyer, it is a strange world when seed companies prosecute hapless farmers who plant saved seed that through no fault of their own was contaminated by GMO's genes. This is indeed a strange legal twist indeed. In addition to those in my prior posting, these are SECs.

In medicine, people self-medicate at their own peril. This is why in the USA we have FDA monitoring the efficacy, risk and side effects of drugs prior (and after) they are put into the market, drugs that are prescribed only by doctors. If a patient suffers ill-effects of taking the drug, the patient can take legal recourse. In pest control, bad outcomes are largely viewed as Acts of God or the farmer is accused of using the product (technology) inappropriately, this despite the fact that the person making the recommendation may have been ill trained. Polluting the commons with pesticides/ herbicides or GMO genes appear not to be considered in risk analysis, and yet these effects are quite predictable. The advent of still newer GMO technologies (e.g., RNA manipulation) should give abundant reason for public concern.

I disagree that demonstrating need (or not) for a technology is difficult, but it requires that pest control researchers approach the problem from a dynamics perspective, and yet most are not trained to do this. The models for Bt cotton we have developed could be used to evaluate pest problems in say India, but it would require gathering additional easy to collect data – a year’s effort. Ex post analyses are useful but may be misleading. We need to demonstrate need before the technology unleashes its benefits (+,0,-).

So back to the question:  Government and its agencies must do the synthesis of data required to protect the public, and in the case of countries lacking this capacity the synthesis could provide useful guidelines – which of course could be ignored at the country’s peril. We cannot assume that industry will self-regulate in the public interest – there is little positive history to support this.

Dear all
I fully agree with Ching intervention (#4544).

I would like also to add that Article 26(1) of the Protocol identifies one particular socio-economic consideration that Parties may be expected to take into account. This consideration is the value of biological diversity to indigenous and local communities (ILCs), may also refer to the impact of introduction of LMOs on the ability of ILCs to make use of the biological diversity upon which their community’s survival and traditional livelihood depends. In the negotiating history of Article 26(1), this phrase replaced a reference to Article 8(j) of the CBD

These socioeconomic considerations may include, inter alia, the impact that decisions on imports or other domestic LMO regulatory measures may have on:
- The continued existence and range of diversity of the biological resources in the areas inhabited or used by ILCs;
- The loss of access to genetic and other natural resources, previously available to ILCs in their territories; or
- The loss of cultural traditions, knowledge, and practices in a particular ILCs as a result of the loss of biological diversity in their territory.

regards,
O.A.ElKawy

Greetings to all

Impacts on the conservation and sustainable use of biodiversity are wide-ranging. 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.)

warm regards,
O.A.ElKawy

Dear All,

I would like to thank the colleagues who shared with us  very useful and helpful experience, reports and overviews of environmental, economic and social assessment of Austria (Mr. Andreas Heissenberger), Netherlands (Mr. Ruben Dekker) and Norway (Dr. Audrun Utskarpen) that shurely may be very useful for other countries.

I would like to continue the list of questions and suggestions provided by Dr. Audrun Utskarpen in [#4607] with some other considerations, if you can find them relevant.

Environment/ecology:
I agree with the listed here suggestions and questions related assessment of aspects related possible impact assessment from LMOs to environment/ecology. Additionally to that, I would specify necessity of assessment and costs of possible limitation or lost of income from ecological services offered by people in local communities, as well as degradation or des-equilibration of natural ecosystems, effects to the natural process of reconstruction and succession of species, in forests, steppe, wetlands etc., which will have long-term effects.

Agriculture:
The countries that practice organic/ecological agriculture non-GMOs, or conventional agriculture, may have also an important financial loss and social impact related to loss of their traditional local market or exporting of agricultural products and food.

Animal health and welfare
Human health:

In my understanding it is very important to take into account the geographical specificity of the country where LMOs is intended to be imported or released into environment. I mean the presence of some microelements and derivates in excess in natural environment like Cuprum, Fluor or insufficiency of Iodine may be additional factor or predisposition to specific types of illness of population that can’t be ignore when assessing the adverse effects from LMOs to human health and accumulative effects. 

The possible penetration and residual concentration of dsRNA in animal  and human blood due to their stability in gastric circumstances may provide effects on animal and human health that may have medical treatment costs (see references). The dsRNA also may be determined via trophic chain as GM-plant – worms – insects- mammals in ecosystems.

References:
1. Jack A. Heinemann, Sarah Zanon Agapito-Tenfen, Judy A. Carman. A comparative evaluation of the regulation of GM crops or products containing dsRNA and suggested improvements to risk assessments. Environment International. Volume 55, May 2013, Pages 43–55
2. L. Zhang, D. Hou, X. Chen, D. Li, L. Zhu, Y. Zhang et al.
Exogenous plant MIR168a specifically targets mammalian LDLRAP1: evidence of cross-kingdom regulation by microRNA Cell Res, 22 (2012), pp. 107–126
3. Y. Zhang, E. Wiggins, C. Lawrence, J. Petrick, S. Ivashuta, G. Heck
Analysis of plant-derived miRNAs in animal small RNA datasets BMC Genomics, 13 (2012) 

Best regards,

Dr.Angela Lozan, Ministry of Environment, MD

Some comments on your post.

1) We have conducted state-of-the-art ex ante assessments with publicly available data in spite of IPR. I believe the issue of IPR has been overblown a bit especially in an ex ante situation, at least in the sphere I work on and to level of accuracy/precision needed. After all, ex ante projections (before any technology is available to and used by farmers) in spite of how sophisticated the model are still projections.

Even if there were no IPR data issues, there will still be a lot of uncertainties about assumptions. Regardless of the uncertainties about data points used as baseline, there are methods to address such limitations such as Monte Carlo simulations and real options models, to name two. Models are great and can give a nice prediction about the future if the assumptions are correct.

I have conducted several ex ante studies without using any of the proponent’s data except for that which is publicly available. I have supplemented gaps with expert opinion and the literature as needed. I have done so to avoid any perception that may cloud the results. I do not think that there is anything particularly wrong about using proponent data, the issue is in the end reaching an agreement about full access to data and freedom to publish, and contrasting to other available data. If this is the situation, then full transparency is the standard when presenting results from such research. I have also collected primary data from farmers in both ex ante and ex post situation.

2) Surely there are many issues with ex post data. We dedicated a special issue of AgBioForum to explore many of these. Yet, there are methodological ways to deal with many of these issues, much more remains to be developed. Ex post analysis remains the only way to know for sure, assuming perfect information about the situation on the ground. Surely, if not careful, results can be misleading, but I rather work with data than with models/projections and assumptions as the latter are based on real conditions.

3) I, nor anybody else that I know of, would advocate releasing a technology without undergoing a risk assessment and for the competent authority to deem it as “safe” by meeting the existing safety standard. My question, rhetorical as it may be, refers to the decision for releasing a technology based on an ex ante socioeconomic assessment which will likely be based on multiple assumptions and frankly where a specific study is probably wrong. In my opinion, we cannot have the level of accuracy and precision in ex ante assessments necessary to make such decision on behalf of farmers. I guess, in the end it boils down on how good an approximation of general trends we can come up with for enabling a decision.

We do know that most ex ante assessments are possibly wrong as there have been extensive comparison of ex ante versus ex post assessments, for example done by the World Bank (and others) for their investments projects, which have shown that both do not even remotely agree. These are the reasons why I am a skeptic as I never trust any specific study including my own, relying more on the state of knowledge accumulated through several studies.

4) The previous issue is compounded if one bases a decision on shoddy research and/or anecdotal evidence which has not been properly researched and verified. This is especially true when examining epidemiological or extensive survey data which can really seriously misled you if not careful in the analysis.

This is why I strongly support basing these assessments –if the decision has been made to do so- on robust assessments methods and a well-defined burden of proof and lines of causality which considers cause-effect relationships or at least strong correlations.

Please don’t get me wrong. I am fully supportive of qualitative methods for gathering data especially to help define hypotheses and to disentangle interpersonal linkages and relationships. Qualitative research needs to also meet the standard of robustness and high quality research. Otherwise, society may be led astray by increasing the likelihood of doing the wrong decisions.

5) I avoid using terms like “contamination” as I rather use “gene flow” as the former implies a value judgment about the impact of pollen/gene movement whereas the latter is a formal expression of the biological process that is happening. Same with other terms that have been used before.

6) Just a reality check on timeline for studies. If you are thinking of doing a good ex post assessment based on data collected with farmers/households/markets –and abstracting from it time delay consequences- ideally one should do at the very least two cropping seasons to capture the inter-temporal dynamics of the different variables involved. We are talking not only of pest-disease dynamics but the human, market, household, value chains and other dynamics. I would prefer to have at least three cropping seasons.

If we are talking about gathering socioeconomic baseline data for an ex ante analysis and do a projection/simulation you may get away with one to two cropping seasons, but barely. Most of the ex ante studies we have done have been with one cropping season supplemented with secondary data mostly due to budget limitations.

If we talk about size of the sample and depending on the size of the sector, one would need data on production practices from at least 100-150 producers. Otherwise doing a statistical/econometric analysis becomes difficult. The largest data set I have had the luxury of having as 457 producers in a survey in Uganda. Obviously the more time needed and the bigger the sample, the more expensive it will be to conduct such study or assessment.

7) Your portrayal of the global and local cotton situation seems to be a bit at odds with the many assessments that have been done around the world either as direct impacts measurements or through meta-analysis and reviews. We have summarized many of these experiences in our Food Policy Review (attached to this post). Fingers et al. and Areal, Riesgo and Rodriguez Cerezo, are two meta analysis that merit more reading.

We can certainly draw a long list of peer reviewed publications supporting the contributions to society by Bt cotton (I just listed a small sample of peer reviewed publications below). The point here is not who is right rather that there will be significant differences in the claims and judgement by experts in the matter, and thus finding ways to judge the evidence is paramount here.

Does this mean that I believe that everything is fine with Bt cotton and other LMOs? No, absolutely not. We have document in several papers, along with other colleagues many technical, economic and institutional issues which decision makers, technology developers, farmers and other stakeholders will need to address in order to ensure their long term contribution to society’s welfare. All technologies have issues, which is just the nature of technology itself.  Addressing the issues, in my opinion should include exploring the many complementarities with other technologies and carefully synchronizing farmer needs to technology itself. This process should be done before even developing technologies. Which brings us to the next question, who best supplies what farmers need?

8) Maybe we are having an issue here in translating between disciplines here. The example of rising secondary pests when the primary pest is managed by the target insect protected LMO, is a good one. In the case of cotton, people have argued that the appearance of secondary pests and the additional control disqualifies the introduction of the technology.

As Jikun Huang showed quite robustly in China, the later is an incomplete analysis. Certainly, one has to consider the additional cost of control (usually with less toxic chemistries and the possibility of control through IPM) and the potential reduction in yield derived from secondary pests. This has to be weighed against the other beneficial effects such as damage abatement due to primary pest control and/or pesticide reductions. In the case of China, even when taking into consideration all of these factors, cotton producers were ahead in capturing net benefits, way ahead. One cannot focus on just one parameter to make an assessment on a specific technology.

From the standpoint of a biologist the rise of secondary pests may be negative impact and may even lead to claims of being on a technology treadmill…but isn’t this the nature of evolution? We can strive to find sustainable solutions, but this cannot be by not considering all potential options. This is the rationale why we keep on insisting on investing on R&D so that we develop as a species, the ability to respond to new and upcoming biological challenges and constraints. One cannot dismiss one alternative until it has been proven that it cannot contribute to improve society welfare. I am an agronomist by training and simply cannot be but practical about these things. We try all options and if something does not work then we move on.

9) Which brings us back to the issue of competing claims. If there can be significant disagreement amongst one discipline (we economists are famous for that) about an assessment, even when based on the same data set, what is going to happen when we ask different disciplines?, in many cases with completely different paradigms and approaches to develop a unified assessment process. See some interesting narratives about these differences in the papers by Herring and Stone listed below.

Finding a way to examine competing claims and the strength of evidence is a major undertaking and should not be easily dismissed. In the end, Parties will need to clearly define how they will decide between competing claims so that the process is fair and transparent.

References
Areal, F. J., L. Riesgo, L, and E. Rodriguez-Cerezo. E (2012). “Economic and Agronomic Impact of Commercialized GM Crops: A Meta-analysis.” Journal of Agricultural Science. Available on CJO2012 doi:10.1017/S0021859612000111.

Falck-Zepeda JB, Traxler G, Nelson RG (2000a) Surplus Distribution from the Introduction of a Biotechnology Innovation. American Journal of Agricultural Economics 82(May 2000):360-369

Finger, R., N. El Benni , T. Kaphengst , C. Evans, S. Herbert , B. Lehmann, S. Morse and N. Stupak. 2011. “A Meta Analysis on Farm-Level Costs and Benefits of GM Crops.” Sustainability 3: 743-762. doi:10.3390/su3050743.

Herring, RJ,  N Chandrasekhara Rao. On the ‘Failure of Bt Cotton’ Analysing a Decade of Experience. SPECIAL ARTICLE Economic & Political Weekly, May 5, 2012 vol xlviI no 1.
Kouser, S. and M Qaim. (2011) Impact of Bt cotton on pesticide poisoning in smallholder agriculture: A panel data analysis. Ecological Economics 70: 2105-2113.

Qaim, M. (2009). “The Economics of Genetically Modified Crops.” Annual Review of Resource Economics 1: 665–694

Smale, M. and J. Falck-Zepeda (2012). Farmers and Researchers Discovering Biotech Crops: Experiences Measuring Economic Impacts among New Adopters. A Special issue AgBioForum, Melinda Smale and José Falck-Zepeda, Guest Editors, Vol 15, Num 2, 2012. http://www.agbioforum.org

Stone, G. D. Stone. Constructing Facts: Bt Cotton Narratives in India. September 22, 2012 vol xlviI no 38. Economic & Political Weekly.

There are serious issues with IPR constraints as indicated by the 2009 letter of complaint to the US-EPA by 26 leading mid-western entomologists who tried to understand the ecological bases of pest problems in GMO maize in the USA. My own research was been hampered by IPRs, which is why I stopped doing field research in cotton. But there are methodological issues between economist and field ecologists that are apparent, though I have published in both areas. Conducting state-of-the-art ex ante assessments with publicly available data in spite of IPR is an application of the similar methods as ex post assessments but with different inputs (albeit supplementing gaps with expert opinion (a form of grey literature) and the literature itself as needed). The opinion of experts is checkered as amply illustrated by Peter Kenmore’s analysis of the ecological bases of green revolution rice breeding against the rice brown plant hopper in SE Asia (see Kenmore et al. 1985), and I can give numerous examples in invasive species eradication/containment efforts. Furthermore, how does one determine the level of accuracy needed to know if the trends are biologically/ economically correct and apply to future time – surely it is more than a statistical issue?

Pest problems are first and foremost biological/ecological issues with economic-social-environmental factors (SECs) superimposed. Getting the biology right is the first step, and economic ex ante and ex post analyses just don’t do the trick. Weather is a very big component in the dynamics of crop-pest systems as it determines the geographic distribution, dynamics and abundance in the absence of disruptive inputs. Furthermore, while weather may change, the biology changes only in evolutionary time unless severe pressure selects for change (e.g., insecticides, Regev et al. 1983, or BT toxin, Gutierrez et al. 2006a). Developing physiologically based demographic models (PBDMs, Gutierrez et al. 1994) of the biology of the interacting species as forced by weather gets at this biology in a manner independent of time and place, and such models can be used as the production function in an economic model (e.g., Pemsl et al. 2007). It was the development of a PBDM for cotton that enabled sorting out the pest status of the different cotton pests (Gutierrez et al. 1974, 1991) and that explained prior field results, and provided guidance. Similar models accurately predicted the potential geographic distribution and relative abundance of important pests such as pink bollworm, Mediterranean fruit fly and other pests (Gutierrez et al. 2006b, Gutierrez and Ponti 2001) where hundreds of millions of dollars have been spent on questionable eradication efforts. Superimposing the effects of GMO technologies (e.g., Gutierrez et al. 2006a) on this biology requires that we have legal access to do the appropriate biological studies. IPRs currently constrain such work. Once we get the dynamics and biology right, we can assess need, and if warranted we can expand into the realm of prospective SECs. We need to include the biology of  systems we wish to modify if we are to be good stewards.

I apologize for the extensive self -reference, it was merely convenient in lieu of a literature search.

• Gutierrez, A. P., J.J. Adamcyzk Jr. and S. Ponsard.  2006a. A Physiologically based model of Bt cotton-pest interactions: II. bollworm-defoliator-natural enemy interactions. Ecological Modelling 191: 360-382.
• Gutierrez, A. P., L. A. Falcon, W. B. Loew, P. Leipzig and R. van den Bosch. 1974. An analysis of cotton production in California: A model for Acala cotton and the efficiency of defoliators on its yields. Env. Ent. 4(1): 125-136.
• Gutierrez, A. P., W. J. Dos Santos, M. A. Pizzamiglio, A. M. Villacorta, C. K. Ellis, C.A.P. Fernandes and I. Tutida. 1991. Modelling the interaction of cotton and the cotton boll weevil. II. Boll weevil (Anthonomus grandis) in Brazil. J. Appl. Ecol. 28: 398-418.
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• Kenmore, P. E., F. O. Carino, C. A. Perez, V. A. Dyck and A. P. Gutierrez. 1985. Population regulation of the rice brown plant hopper (Nilaparvata lugens Stal) within rice fields in the Philippines. J. Pl. Prot. Tropics 1(1): 19-37.
• Pemsl, D., Gutierrez, A.P., Waibel, H. (2007). The Economics of Biotechnology under Ecosystems Disruption. Ecological Economics. 66:177-183.
• Regev U., H. Shalit and A. P. Gutierrez. 1983. On the optimal allocation of pesticides with increasing resistance: the case of the alfalfa wee

Dear all

Thank you for an intense and interesting discussion.

Parties have a right, now protected by international law, to take socio-economic considerations into account. This does not mean they are required to do so. It does, however, require other Parties to respect this right.

Article 26 refers to socioeconomic considerations “arising from the impact of living modified organisms on the conservation and sustainable use of biological diversity”, therefore Parties (who are also Parties to the CBD) who opt to exercise their right to take socioeconomic considerations into account should look to the COP decisions on these issues, inter alia, the "Guidelines for incorporating biodiversity-related issues into environmental impact assessment legislation and/or processes and in strategic environmental assessment" contained in the annex to decision COP-VI/7 and the "Voluntary guidelines on biodiversity-inclusive environmental impact assessment" contained in the annex to decision VIII/28. The COP endorsed both these Guidelines.

The Guidelines, which should be a starting point for Parties, provide a clear understanding of the broad scope and meaning of "impacts on conservation and sustainable use of biodiversity", and provide guidance for the questions to ask. Pertinent questions from a biodiversity perspective (Decision VIII/28) are:

(a) Would the intended activity affect the biophysical environment directly or indirectly in such a manner or cause such biological changes that it will increase risks of extinction of genotypes, cultivars, varieties, populations of species, or the chance of loss of habitats or ecosystems?
(b) Would the intended activity surpass the maximum sustainable yield, the carrying capacity of a habitat/ecosystem or the maximum allowable disturbance level of a resource, population, or ecosystem, taking into account the full spectrum of values of that resource, population or ecosystem?
(c) Would the intended activity result in changes to the access to, and/or rights over biological resources?

Both Decision VI/7 and Decision VIII/28 consider the range of impacts from genetic, species and ecosystem diversity perspectives, in keeping with the CBD definition of biodiversity, while also taking into consideration conservation and sustainable use of biodiversity. Their elements are similar, and I have reproduced Table 1 from Decision VIII/28 below (as it is the later decision):

- Would the intended activity lead, either directly or indirectly, to serious damage or total loss of (an) ecosystem(s), or land-use type(s), thus leading to a loss of ecosystem services of scientific/ecological value, or of cultural value?
- Does the intended activity affect the sustainable human exploitation of (an) ecosystem(s) or land-use type(s) in such manner that the exploitation becomes destructive or non-sustainable (i.e. the loss of ecosystem services of social and/or economic value)?
- Would the intended activity cause a direct or indirect loss of a population of a species?
- Would the intended activity affect sustainable use of a population of a species?
- Would the intended activity result in extinction of a population of a localized endemic species of scientific, ecological, or cultural value?
- Does the intended activity cause a local loss of varieties/cultivars/breeds of cultivated plants and/or domesticated animals and their relatives, genes or genomes of social, scientific and economic importance?

I would also like to thank Dr Ossama for posting the very instructive list, which I was also going to re-produce, as he had already brought that up in the 2011 forum. I would add that in general terms and in addition to his points and the points above as contained in the Guidelines, socioeconomic considerations may arise from, inter alia:

1. Changes in biological diversity on which local livelihoods depend on for fulfilling nutritional, cultural or spiritual needs (the latter are particularly relevant in centers of origin and diversity)

2. Changes in biodiversity and the natural resources that sustain it (e.g. soils) that may result in the use of more toxic substances (in terms of volume and toxicity) and accordingly jeopardize sustainability

3. Impacts on human and public health from the genetic modification inserted in the GMO and its inherent technological package (e.g. use of herbicides with herbicide tolerant crops)

4. Changes in local organization (institutional, labor and income related, etc.).

kind regards
Lim Li Ching
Third World Network

I must draw on the richness of Dr Andrew Paul Gutierrez's (Dr AP G)  post
[#4615), to apply it to what is happening in India with regard to Bt cotton
and provide what I hope is some useful evidence for this forum on the
question of the risks vs benefits of GM technology. I am aware of the  lack
of legal access to relevant data and reference materials that impede
scientific research, but the implications brought out By Dr AP G are of the
greatest importance for us in the realisation that their  lack  makes it
impossible to conduct "appropriate biological studies".

I'd like to emphasise at the outset that the thrust of the Protocol, no
matter the few protestations,  is very clear. It is the adverse impacts and
risks which are being addressed as a matter of first concern (ref my post
[#4573]. This is the logical approach for the laboratory-based technology of
genetic engineering whose LMOs are being released into the receiving natural
environment with concerns about their socio-economic implications  on many
fronts, including health.

The benefits of GM technology as Dr Andrew G has annunciated so clearly,
require some solid and extended work before a benefit can be assigned. Part
of that must require  a thorough enquiry on whether the GM crop is required
in the first place. In the case of Bt cotton, this was not done. It was not
done for Bt brinjal either. Pest management in alternative agri systems vs
IRM in Bt crops is a core enquiry and focus in such work.

With regard to the sustainability of Bt crops technology, this is now in
serious doubt based on 2 important reports. The first  concerns the serious
and outstanding example of "unexpected" insect corn rootworm resistance to a
Bt toxin, which has caused severe rootworm injury to Bt maize and which was
recorded for the first time in Iowa in 2011 (Review of Reports of Unexpected
Cry3Bbl damage in Monsanto's 2009 corn Rootworm dated 22nd Nov 2011).  The
problem appears to be also emerging in other key maize producing States of
the US and becoming chronic. Admission of how serious the problem is comes
from 22 leading US academic corn experts in their  strong message of
caution, in a letter dated  March 5 2012 to the Environmental Protection
Agency telling regulators they are worried about long-term corn production
prospects because of the failure of the genetic modifications in corn aimed
at protection from rootworm.

The EPA warns that merely resorting to other GM maize varieties using
several Bt toxins may not provide a lasting solution. The reduction of the
recommended refuge from 50% to 20% is "likely the reason for the development
of resistance".



Of course, if Bt cotton requires  a 50% refuge it is 'dead' on the ground.
In India, given the predominance of small holder farming (over 80%) the
issue of refuges, even at much lower %s is a problem. India essentially has
no IRM policy for Bt cotton based on its most important strategy of
maintaining refuges.



The second is the recent study of an unintended effect in Bt cotton: 'Pest
tradeoffs in technology: reduced damage by caterpillars in Bt cotton
benefits aphids' by Steffen Hagenbucher Et al
(http://dx.doi.org/10.1098/rspb.2013.0042). It points to the possibility
that non-target herbivores develop into pests. In India, we have had massive
crop failures in several cotton-growing States because of 'other' pests of
cotton some never before seen in India. China too has experienced the same
problem and these were shrugged off, if shrugged of they could be (with
their massive SE impacts), as 'insect shifts'. But the underlying mechanisms
are not clearly understood. The study shows that because of effective
suppression of Bt-sensitive lepidopteran herbivores, Bt cotton contains
reduced levels of induced terpenoids. "Changes in the overall level of these
defensive secondary metabolites are associated with improved performance of
a Bt-insensitive herbivore, the cotton aphid".



The obvious questions are: which other non-target herbivores other than
aphids, may develop into pests? And, what else is in store for us if these
two reports have taken more than 25 years after Bt cotton was first
commercialised in the US?



Both reports raise serious doubts on the sustainability of Bt crops
especially in the light of the proven success of NPM (non-pesticidal
management) systems in South India among other alternative agri successes
elsewhere.  The complexity of getting to the right conclusions on pest
problems was raised by Andow in his ERA of Bt brinjal. It is also elegantly
demonstrated by Dr AP G. As he says, "Getting the biology right is the first
step, and economic ex ante and ex post analyses just don't do the trick."



The matter of great anxiety for us in India is that extraordinary benefits
(essentially, socio-economic) are being claimed based on  the experience  of
10 years of  Bt cotton as the basis to approve other Bt crops, principally
Bt food crops. The Bt brinjal bio-safety dossier demonstrates how serious
the problems are of measuring 'benefits'.  In the case of Bt cotton, given
that serious socio-economic adverse impacts  have emerged on several
dimensions (some indication of these was provided in earlier posts), and
that there has also been no PMM, the lack of a factual basis in science
about claimed benefits of Bt cotton and the void in reflecting societal
concerns with regard SECs, in the official position is extraordinary.

It must be added,  that it is entirely problematical, whether a conflicted
Ministry of Agriculture and a similarly conflicted Regulator can be
entrusted with the first step of enquiring into an issue of outstanding
importance, leave aside subsequent studies that must be carried out in a
rigorous RA that includes health and a PMM and the SEC emerging from these.


Aruna Rodrigues

Sunray Harvesters,

Bungalow 69

Mhow - 453441

M.P. India

Dear all!

A short comment to the last posting of Carlos Almendares (#4538):

I think the approach posted by Carlos Almendares reduces the scope of Article 26 living to each country the decision to apply or not SEC from the impact of living modified organisms on the conservation and sustainable use of biological diversity and the Secretariat supporting only capacity building activities. My point of view is that the Art. 26 goes further than that, and this is why this space for discussion has been created. Insofar consensus is generated -for example, that SEC is not just cost-benefit evaluation, but it includes other aspects-, the clarification of terms stated in question 2 and others will make Art. 26 understandable for all Parties, given its linkages with a series of Protocol dispositions, as stemming from the Explanatory Guide to the Cartagena Protocol on Biosafety, and that this article's purpose is to provide Parties with legal support in decision-making, just as explained in said Guide
Michelle Chauvet

Dear colleagues –

Thanks to all for very interesting and thought-provoking posts. 

I agree with Dr. Falk’s post (post #4599) that our discussion on socio-economic considerations can contribute the most by guiding Parties in focusing on the socio-economic considerations they may want to take into account, and also by providing approaches for doing this.  To me, the key factor in identifying the socio-economic considerations is whether or not they result from an impact that the LMO is likely to have on the conservation and sustainable use of biodiversity.  Article 26 explicitly links socio-economic considerations to the impact on the conservation and sustainable use of biodiversity.  Thus, the socio-economic considerations that may be taken into account are those resulting from some impact on conservation and sustainable use of biological diversity from an LMO that is the subject of a decision on import.  If the decision on import were likely to result in such an impact, either positive or negative, the Party could determine what the likely socio-economic effects of that impact on conservation and sustainable use would be, and then factor them into its decision. 

Ms. Flandroy (#4539) provided a list of possible areas where the impact of an LMO on sustainable use of biodiversity might be observed and could be evaluated as did Dr. Abdelkawy (#4612).  The challenging part is that there may be socio-economic effects in those areas that DO NOT arise from the impact on sustainable use.  In other words, there may be socio-economic effects from a decision to import that are not related to the impact on sustainable use.  Dr. Utskarpen (#4607) and Mr. Dekker (#4593) gave examples of assessment processes used in their countries to consider a range of possible impacts from LMOs.  I reviewed them quickly, and it appeared to me that many of the considerations were related to socio-economic considerations beyond the effects on biodiversity.  These domestic policies evaluate the possible effects on biodiversity, but analyzed the socio-economic impacts separately from these possible effects.  A useful thread of discussion in this Forum might be how to separate the socio-economic impacts that might arise independently from any impact on sustainable use. 

The risk assessment is useful in this regard.  Indirectly, Article 26 links socio-economic considerations to the risk assessment, because it is the function of the risk assessment to “identify and evaluate the potential adverse effects of LMOs on the conservation and sustainable use of biological diversity in the likely potential receiving environment…” (Annex III 1).  This implies, as some commenters have noted, a sequential process.  The risk assessment is completed first, and the information generated on potential adverse effects can be used to then identify and evaluate possible socio-economic considerations.  The risk assessment evaluates the likelihood of adverse effects being realized, and then evaluates the consequences on biodiversity should this happen.  Based on the information generated by the risk assessment, the socio-economic considerations of these consequences can be estimated. 

I would agree with those commenters who say that, if the risk assessment finds that no adverse effects are likely, there is little need to evaluate the socio-economic considerations.  The risk assessment may not be the best tool for identifying potential beneficial effects of LMOs.  Still, it may generate information that, along with that provided by the actors interested in importing the LMO in question, could indicate how the import could benefit biodiversity.  Mr. Rowe (post #4590) also suggested that previous experiences with LMOs can be helpful in looking at the potential benefits.  However, the consideration of benefits to sustainable use arising from an LMO does not, in my mind, translate into an obligation to show that there is a ‘need’ for the LMO to solve a problem related to the conventional variety or to provide some added benefit for society, an idea mentioned by Ms. Flandroy in post #4592.  If there is some demand for an LMO, and the risk assessment shows that it can be imported safely without negative impacts on sustainable use or negative socio-economic effects resulting from adverse effects on sustainable use, there is no provision of Article 26 that would require a demonstration of ‘need’.

I agree with those who see the risk assessment and the evaluation of socio-economic considerations as separate processes.  Socio-economic considerations could be quite relevant to the development of appropriate risk mitigation.  For example, local agronomic practices (such as farmers sharing seed) may make it harder to apply particular risk mitigations.  Although risk assessment and risk management are two separate processes, it can be quite beneficial to provide for dialogue between risk assessors and risk managers, to both improve the risk assessment and to develop better risk mitigations.  Thus, while they are separate processes and it is important not to take away from the objective scientific evaluation of potential risks, there are many opportunities for risk managers and risk assessors to benefit from one another’s knowledge and experience.

Dear all,

Socio-economic considerations (SEC) “arising from the impact of living modified organisms on the conservation and sustainable use of biological diversity” are those directly or indirectly related to the changes on biodiversity caused by the LMO in question and introduced in a specific ecological and socioeconomic context, together with its inherent production package or utilization approach.

For instance: Changes in the composition of the wild flora (a biodiversity change) taking place in LM crops tolerant to herbicides (the source of the impact) may result in the need of using more herbicides (in terms of volume and toxicity) resulting in social and economic impacts, such as increased exposure to herbicides and increased investment in weed control, respectively. In this line, other examples of impacts are changes in the agricultural landscape due to “homogenization” of the agrobiodiversity” due to the massive adoption of specific LM crops that, among others, may result in the reduction or loss of local and traditional crops relevant to the local food systems. Potential changes in the insect populations resulting from the introduction of LM mosquitoes that may raise new public health concerns are also SEC.

Based on these examples, the scope of the Protocol and that “biodiversity” is a broad concept (according to the CBD definition which also includes the abiotic components of ecosystems”), “impacts arising from” refers to SEC directly and indirectly related to the potential adverse effects of LMOs on the conservation and sustainable use of biological diversity. This in relation to what was expressed in the previous paragraph, “arising from the impact of living modified organisms on the conservation and sustainable use of biological diversity” refers to SEC that result from changes or potential adverse effects in the “life zones” and components of Mother Earth.

In light of this notion, it is important to consider that: i) Potential adverse effects on biological diversity do not take place in a linear or isolated manner, but through complex processes from which cumulative and combinatorial, intentional and accidental, as well as predicted and unforeseen effects may result; ii) According to the CBD definition on “biological diversity” in relation to the relevance of abiotic ecological components that sustain it, SEC also may arise from the technological package and utilization approach of LMOs since they directly relate to the establishment of “man-made” ecosystems (e.g. agricultural fields) that are part and also affect biological diversity; iii) “Conservation” and “sustainable use of biodiversity” are inherently defined and affected by socio-economic factors and processes; iv) Since Art. 26 as the rest of the provisions of the Protocol need to be implemented in accordance to Art. 1 (objective) and Art. 4 (scope) of the Protocol, accordingly human health issues expressed as public health impacts are relevant aspects of SEC; v) Based on all above, potential socio-economic and ecological aspects and impacts of LMOs are closely interrelated.

Regards to all,

Sorka Copa Romero

Dear all!
This was a very interesting round of discussion and I followed it with great interest. Though there are quite diverging views I think that it will prove to be good starting point for the discussion in the future.

I want to thank especially those colleagues who have provided useful background material, like Ruben Dekker, Audrun Utskarpen, Mike Rowe, Jose Falck-Zepeda and all the others. It really shows that there is a great interest in this topic, and though we still have no clear overview what else is out there, it proves that there are already a number of concepts and ideas available from which our work can profit.

I just want to add a few thoughts to the discussion:
First I want to react to some interventions on how broad or narrow the term SEC is defined in the Protocol. I guess we had both extremes from very broad (basically including all social, cultural, economic aspects) to very narrow (focusing  - at least for a start - on cost /benefit analysis). The latter approach was mainly argued with the fact that we need a slim decision making system which should not have negative impacts on trade. Though I understand the point of this position, I tend to agree with Lim Li Ching, Lucette Flandroy, Angela Lozan and others, who are in favor of a comprehensive assessment of socio-economic impacts for two reasons: It has been stated by David Quist and others that the precautionary approach is a central one of the Protocol and this alone already justifies a broad view on the issue, and another point is that the text of the Art. 26 needs to be seen as  the starting point when the Protocol was adopted in January 2000, but that we must not neglect the developments since then.

This brings me to a second observation: It has been asked, why the Parties did not specify more clearly what the wanted when they were drafting Art 26. First we have to bear in mind that the Protocol is a consensus text and is written in diplomatic language. So many things remain up for interpretation (I just remind you of all the negotiations we had with Art. 18(2)a, or on Liability and Redress). In interpreting the text of the Protocol it helps to look at the decisions taken at the various COP/MOPs and the various reports approved by the Parties. In the context of socio-economics especially important are the survey and the report of the Delhi workshop, which both have been carried out under the topic of capacity building and to which several colleagues already referred to. In my point of view the outcomes of both activities (which have been approved by the Parties) also clearly show, that we need to discuss socio economic impacts in a broad sense. This is in my opnion also the only way to tackle the enourmous complexity of the issue,

Finally I want to support the intervention by David Quist, which is in line with an earlier posting I have made and also one posting by Lim Li Ching, regarding the focus on benefits or negative impacts. In my point of view this brings us back to Art 1 of the Protocol. The precautionary approach is clearly focusing on protecting the environment and humans from possible adverse effects. This is the goal of the Protocol and that's where we should also put special emphasis on when discussing SECs. However, if we decide to also discuss the assessment of benefits (which are assessed anyway by the developers of LMOs) than we need to apply the same strict criteria as we do for assessing adverse effects.

Andreas Heissenberger
Environment Agency Austria

Dear Colleagues,
I would just like here to respond to Mary Lisa Madell's recent interesting posting (#4619), making several linked observations concerning the scope of SEC in relation to Risk Assessment (RA), and in relation to the language of Art 26, about impact on conservation and sustainable use of biodiversity. Like some other colleagues, she wishes to restrict the SEC which would qualify to be included in a decision on import, to those which are identified by risk assessment - (in her words): "...if the risk assessment finds that no adverse effects are likely, there is little need to evaluate the socio-economic considerations."
Quite apart from the longer-term risks to health and environment (which include, or should include, more than only biological factors) which RA does not cover, and which "conservation and sustainable use.." surely logically includes as a requirement, scientific risk assessments themselves are always necessarily limited to those factors which have been defined as 'relevant', and excludes those which have not been so defined. Would that an open deliberative process of the kind we are involved in here for SEC, were to be initiated also for RA, even if now retrospectively, where it is also needed for a genuinely robust and public interest science. These selective processes are buried within RA procedures as if they were themselves scientific, so only revealing nature's meaning, when they are - perhaps with the best will in the world, "protection" - actually inserting meaning, by defining what is relevant and what is not. As Ms Sorka Jannet Copa Romero of Bolivia (#4620) has pertinently and powerfully expressed the point, impacts on biodiversity, including agricultural biodiversity, (and not only in important biodiversity-rich regions as in Bolivia, but elsewhere for example Europe) reach far beyond the extremely limited scope of RA, and may centre upon both direct and indirect SE impacts , and where impacts on biodiversity are also at the same time, impacts on many human lives as SEC. When we also include sustainability as Art 26 does, this general point that SEC cannot be restricted to the scope of RA, is even stronger. I express my full agreement with Ms Romero's observations, and those corresponding ones of others such as Li Ching Lim (#4616), Joanna Goven, Aruna Rodrigues (#4617), Rosa Binimelis, and Mr Abdelkawy of Egypt (#4612), and therefore respectfully disagree with Mary Lisa Madell's restrictive framing of the scope of SEC, should a Party decide to exercise its right to assess these for import decisions.

With reference to the linked point raised by for example Dr Gutierrez (#4615), about the limitations on RA and SE assessments created by IPR arrangements, and bearing in mind his own direct experience of this along with his appropriate reference to the letter of complaint to US EPA from 26 independent US academic research scientists in 2009, (also published in Science), colleagues may find interesting the recent publication on the unnecessary and often unduly exaggerated restrictions on risk-related data in applicants' dossiers submitted for regulatory approval, which claims for "confidential business information" status create in the 'independent' assessment process. This is published by a scientific member of the European Food Safety Authority GM expert panel, in PLoS Biology:
http://www.plosbiology.org/article/info%3Adoi%2F10.1371%2Fjournal.pbio.1001499;jsessionid=6CC6CD75FF933E6E5A66B1EEE3498DF0

With thanks to all for a rich and informative discussion
Brian Wynne

Dear all,

Before the end of this interesting session, I had liked to place in annex to this message a study made by Belgian academicians some years ago on demand of my Ministry Department ( Belgian federal Ministry of Environment ). It is related to the evaluation of potential agro-and – socio-economic impacts of LM transgenic plants on the agro-food channel. It presents a methodology for analyzing case by case the relevancy of LMOs in comparison of other methods to solve the same agronomic problem. It also analyzes the socio-economic reasons why some peculiar solution is often chosen even when it is not necessarily the best one in terms of sustainability. While the biggest part of this study is in French, it contains tables with criteria in English ( p. 99 – 102 ) and suggestions in English for integration of systematic relevance assessment in regulatory procedures and in research policy from p. 103 on.

Concerning my posting n° 4539, it seems to me), in contrast to remarks made by some participants, that most of the SECs mentioned in this summarized list can be linked to impacts, even if indirect, on conservation and sustainable use of biological diversity ( too long to explain in detail her and now ).

Beside that, I understand and agree with the main conclusions of the studies evoked by Rubben Dekkers, that it will sometimes be difficult to distinguish between ex post impacts due to LMOs or to other drivers. As I said in a previous message ( I think already last week ), this is one more reason for the importance of ex ante SECs, where relevant concerns can be clearly expressed before they would occur, and adequate decisions can be taken on the basis of these concerns ( refusal of the concerned LMO or risk management/mitigation measures put in place at right time to avoid negative impacts ex post ) .

In any case, one should agree ( and have already agreed, I think ), like repeated by some participants, that what has to be assessed is not only the LMO per se but the whole ( agricultural ) system in which it is used, and not only short term and direct impacts but also indirect, cumulated and long term impacts on biodiversity . And whereas this is foreseen in RA processes, this is not always done in view of the complexity of the ecosystems. ( cf. my posting n° 4508 ).

In addition, as I said in my posting n° 4592, in terms of SECs, we could require that the LMOs should do better, and not just the same or not worse, than the technics they are supposed to replace, on defined aspects of sustainability ( in relation to impacts on conservation and sustainable use of biodiversity and linked SECs ). And about that, I agree with the last posting of Andreas Heissenberger that I see just coming, that “ if we decide to also discuss the assessment of benefits …..,  than we need to apply the same strict criteria as we do for assessing adverse effects.”
So, it definitively seems to me that even when some RA process is coming to the conclusion that a particular LMO does not pose an obvious big risk for biodiversity or health, this is not a reason to conclude that there is no SEC to take into account following the wording of the Protocol.

One last comment concerning SEC analyzes related to the wording of the Protocol: one should not forget to take into account, just in pure economic valuation of ecosystems, the sustainable gratis nature of the services of ecosystems ( and of the recognized importance of biodiversity in the functioning of these ecosystems ) that should have to be replaced, in case of destruction, by more costly unsustainable man-made technics.


With best regards, from still snowing Belgium under this 24 March.

Lucette Flandroy



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

Dear all,

Following Andreas, H, this has been a very interesting round of discussions indeed!

Just a few comments to follow up on specific points of the discussion, which were prepared in conjunction with some of my colleagues from the SEED (Society, Ecology and Ethics Department) at my institution,  GenØk – Centre for Biosafety.

The insights provided by Lucette Flandroy (#4539), Andreas Heissenberger [#4525], Audrun Utskarpen (#4607), Ossama Elkawy [#4611; #4612], Angela Lozan [#4613], Lim Li Ching [#4616] give important and concrete guidance for defining the different parameters to respond to (in practical terms), “what SECs are”. In relation to these concrete suggestions and for an effective implementation of the Protocol, it is important to re-emphasize a few comments so far.

As stated by Angela Lozan [#4541] the scope of the Cartagena Protocol has as main focus the potential adverse effects arising from LMOs. In light of this Protocol provision, our members of our team have investigated such issues in the past (see Catacora-Vargas, 2011) http://www.genok.no/filarkiv/File/Publications/GENOK_GMO-SD-FINAL.pdf  

The long-term perspective, as stated by Audrun Utskarpen [#4567], is crucial for an appropriate assessment of SEC arising from LMOs. As we know, conceptually “long-term” is central to the sustainability approach and methodologically it is highly relevant in relation to the dynamic nature of the socio-economic and ecological systems. Cumulative and/or combinatorial effects (intended or unforeseen) of LMOs taking place in complex systems (both natural and man-made) can be adequately assessed only from a long-term perspective, and – as complemented by Angela Lozan [#4541] by appraising the “multidisciplinary and multi-factorial components [that] might include non-direct cost-driven impact”. According to this, and based on the aforementioned Catacora-Vargas (2011) report, the analysis of potential effects along the life cycle of LMOs (from R&D to disposal, when applicable), can help obtain a more comprehesive view on the the actual impacts on sustainability.

Conservation and sustainable use of biological diversity are, as mentioned by others, broad concepts in their own right, and inherently related to the local social, economic, institutional and ecological factors where LMOs are introduced. Here our group has also done some research, as mentioned by Lim Li Ching (#4544) in the report by Catacora-Vargas (2012) http://www.genok.no/filarkiv/File/Catacora-12-SEC_context_CPB-RIS_ABDR-Nov12.pdf.

In line of the scope and objective of the Protocol, the consideration of human health issues is also central, both arising from the genetic modification introduced in the LMO, its expression, and the related technological package of the LMO in question. These may have effects on the conversation and sustainable use of biological diversity resulting in SEC, including human health (from the public health point of view).

Finally, we should perhaps look further at the relationship of SEC with broader ethical and cultural issues. Here it is important to recall that ethical considerations are inherent in how we define sustainability, and cultural and spiritual dimensions play a role in the implementation of the Protocol with respect to a complementary focus on local and indigenous communities as stated in Art. 26. These often take particular importance  in centers of origin and genetic diversity, as mentioned in other Protocol discussion fora.

Kind regards,

David

Dear all!!

Dr. Roca's insight (#4537) is important, clarifying the distinct competences of Risk Assessment (RA) and Risk Management (RM), and it is complemented by Brian Wynne's comment that they are thought of as different points in a sequential phase. In fact, Dr. Roca mentions that after RA the next step is RM, including SEC. The question that arises is if, in his opinion, taking SEC into account would be a monitoring ex-post exercise, and in such case, what would be the point for decision-makers, if the decision is already made.

As Lucette Flandroy (#4508) and Piet van der Meer (#4526) have mentioned before, RA and SEC are related, even if they are different issues. If decision-makers have, alongside RA, information on the positive or negative SECs of releasing LMOs into the environment or of not doing so, their decision would be more solid, and might inside in mitigating adverse effects and directing technology towards social inclusion, or not to adopt it given social exclusion implications. If SEC are postponed to RM, possibilities to redirect technology towards wider social benefits are limited.
Warm regards,
Michelle Chauvet

Dear Colleagues

The post of Dr. Audrun Utskarpen of Norway [#4607] provides the right
perspective on Article 26 as it derives its authority from the intent and
the clarity given to that intent,  in the Protocol itself (The CPB to the
CBD). His post on Norway's legislation also represents the best in
regulation, although I have a feeling that this is not exactly the same
'best' regulation that  Dr. Jose Falck-Zepeda was alluding to in his post!

The CBD definition of biodiversity (below) provides full scope to SEC, which
includes health impacts, "arising from the impact of living modified
organisms on the conservation and sustainable use of biological diversity" .
Therefore, I do disagree with the narrow definition that some in this forum
are arguing for under Q 2.

"Biodiversity" refers to "the variability among living organisms from all
sources including, inter alia, terrestrial, marine and other aquatic
ecosystems and the ecological complexes of which they are part: this
includes diversity within species, between species and of ecosystems"; while
"ecosystem" is described as: "dynamic complex of plant, animal and
micro-organism communities and their non-living environment interacting as a
functional unit" (Secretariat of the CBD 1992:3).

Impacts on biodiversity relate to a large spectrum of possible effects.
There is widespread and well-documented recognition that any impact on
biodiversity or ecosystems does not take place in a linear or necessarily
scale-dependent manner. On the contrary, changes in biodiversity are complex
and unpredictable, which may result in cumulative and combinatorial effects
that can accelerate changes or lead to unintended adverse effects (Cardinale
et al. 2012; Stabinsky 2001).  Conservation and particularly sustainable use
of biodiversity have an intrinsic socio-economic component. On one hand, the
"use" of biodiversity is defined by social, cultural and economic factors.
Moreover, the biological and socio-cultural components of life that define
consuetudinary practice (established custom) are inseparable, particularly
among indigenous communities (Prilgrim and Pretty 2010; Maffi 2010;
Cardinale et al. 2012). On the other hand, the use of biodiversity in a
"sustainable manner" entails its management by individuals and groups. Thus,
societies and socio-economic factors in which these individuals and groups
are embedded play crucial roles in the long-term preservation of
biodiversity while securing fulfilment of the needs of present and future
generations (Borrini-Feyerabend et al. 2004). (ref: Asian Biotechnology and
Development Review, Vol. 14 No.3, pp 1-17, 2012, Research and Information
System for Developing Countries (RIS)).

Implementation of SEC: There is little reason to block the evaluation of
socio-economic considerations as many government including the US have
sponsored and instituted EIS (Environmental Impact Assessments), and a large
body of professional literature has grown up around this practice.  In order
to improve the quality of its decision-making, the US Congress for example
enacted The Technology Assessment Act of 1972 (Public Law 92-484). Sec 2 (d)
of the law states that "it is necessary for the Congress to - 1. equip
itself with new and effective means for securing competent, unbiased
information concerning the physical, biological, economic, social, and
political effects of such applications [of technologies]."

Assessing these impacts is also well-understood by international agencies;
see for example, FAO's Environmental Impact Assessment: Guidelines for FAO
Field Projects. (http://www.fao.org/docrep/014/am862e/am862e00.pdf). This
document notes that "Environmental impact assessment cannot be divorced from
social impact of the project, hence the latter is considered as a key
dimension of the EIA process" (p. 7).

The existence of such a huge body of socio-economic evaluations proves that
there are well-established methodologies as well as procedures for
integrating the studies into governmental decision-making. The
inter-dependence of the Protocol's articles, for example, Arts 26 and 23, is
illustrated by a US observation linking the importance of public
participation to the evaluation of SEC: "Citizens often have valuable
information about places and resources that they value and the potential
environmental, social, and economic effects that proposed federal actions
may have on those places and resources."(
http://ceq.hss.doe.gov/nepa/Citizens_Guide_Dec07.pdf) Numerous other
countries have adopted similar activities, performing assessments
incorporating technical, environmental, social, health, and economic
considerations. Hundreds of reports are archived online by the Office of
Technology Assessment ( http://www.fas.org/ota/otareports). One of the most
relevant among them is Perspectives on the Role of Science and Technology in
Sustainable Development, September 1994. (
http://www.fas.org/ota/reports/9422.pdf

Source:Philip L Bereano, Washingon Biotechnolgy Council:



And finally, with regard to public participation it is well to note that on
ethical questions about social and environmental impacts of the use of
technologies we should be listening not to scientists but to experts on
social justice, human rights, animal welfare and third world development -
the very experts that have been systematically ignored by the government and
big business.

Aruna Rodrigues

Sunray Harvesters,

Bungalow 69

Mhow - 453441

M.P. India

Dear Colleagues,
I concur fully with Andreas Heissenberger's post (4621) mainly on the scope of SEC, but also on the final point concerning whether, and if so how, benefits should be included in SEC. I would like to add a further observation in the latter issue, of benefits. Regulatory decision-making as it developed in the late-20th century concerning innovations such as we are considering here, has always followed the taken-for-granted conventional political philosophy of liberal free-market democracy - that public or social benefit equals the sum of all individual private benefits, or self-interests. On this basis, if any individual (or legal individual like a corporation) wishes to promote for regulatory approval a product for which they see a market, it has been assumed until only recently, but is still established practice, that by definition there is a social benefit. I mention this here because it does provide us with some perspective as to why society at large has been primitive (Norway apart! as Audrun Udkartsen explained and elaborated upon for us #4567) in its assessment of benefits of LMOs as well as almost everything else up for decision. We are at the earliest phases of a developing learning process here, as she also reminded us very appropriately. However another point follows, if as several colleagues have argued, we should address benefits here, as well as risks and other SEC. If we are to assess benefits, or social needs (for the proposed import, or innovation) this also implies logically that alternatives to that proposed decision-object should also be identified and assessed. Ordinary publics if given the chance or put in such a situation, tend to be asking this kind of question already. A rigorous scientific focus on risk or harm would also  lead to the same conclusions about the value of asking what - sustainable - alternatives are or could be available?
Thanks and best wishes,
Brian Wynne

Dear All,
I am grateful to Dr Chauvet for her reference (#4627) to an earlier observation of mine concerning the relations between RA and RM. Contrary to the meaning which she gives to me however, I explained the point recognized even by the US NRC originators of the RA-RM (and RC, risk communication) distinction as a pragmatic one, that there are policy choices to be made before RA science can even begin (and actually, during that scientific RA too), and which have been recognized by international bodies such as the EU's Joint Research Centre, and FAO. Indeed in its 2007 report on this, the FAO was quite explicit, at para 14:
"Risk assessment policy should be established by risk managers in advance of risk assessment, in consultation with risk assessors and all other interested parties. This procedure aims at ensuring that the risk assessment is systematic, complete, unbiased and transparent"
http://www.fao.org/docrep/007/y5817e/y5817e04.htm
A clear implication is that if the RA policy is not established in consultation with risk assessors and all other interested parties, then the scientific risk assessment will fail to be systematic, complete, unbiased, and transparent. In any case, it is clearly accepted by FAO that RM does not simply follow RA, and that it proceeds, as an inclusive matter with all interested parties, both before, and iteratively with RA. RA policy includes the definition of what is relevant to the scientific risk assessment process, what protection goals are to be achieved, what comparators are chosen as normal baseline for defining harm, what criteria of evidence and burden of proof apply, how precautionary should the RA science be, bearing in mind uncertainties and unknowns, and the need for assumptions.
This point having been established with reference to the UN FAO, and EU JRC, I do not wish it to be understood that I believe that, as Dr Chauvet seems to represent me, "after RA the next step is RM, including SEC". Contrary to this, as many other posts including my own have affirmed with reference to CPB and official Guidance text, SEC arising from impacts of LMOs on conservation and sustainable use of biodiversity exist and can arise substantially beyond the artificially restricted scope of this formulation favoured by Dr Chauvet. SEC should not therefore be further restricted to only those factors which (already restricted) RA can identify. Indded as the FAO's text on RA policy suggests, SEC if conducted and framed with appropriate inclusive breadth, and at the earliest possible phases, could inform scientific RA and its questions, and render it more robust.
Thanks again to all for these rich discussions, and best wishes,
Brian Wynne

Dear All:

I completely agree with Lucette's last comment (#4623) regarding the importance of ex ante studies, which has also been mentioned by other participants such as Angela Lozan (#4541) and Andreas Heissenberger (#4512), amongst others. As José Falck Zepeda (#4512) mentioned: “As long as an impact has a credible likelihood (or probability) of occurring, then it becomes relevant. This would of course mean an assessment to determine likelihood and potential impact ...”. In last week's discussion I said that in the case of the introduction of GM soya in the honey-producing region no SEC evaluation was carried out, and that has put honey exports to Europe for thousands of small apiarists at risk.

Taking SEC into account is useful not only to highlight adverse features, but also to point out its potential benefits, as some participants have posited, such as Dr. Gado (#4524) and Dr. Falck Zepeda (#4509). In Mexico, the Sociology Department of the Universidad Autónoma Metropolitana (UAM), where I work within the research area of social impacts of biotechnology, carried out an ex ante SEC study about the introduction of a genetically engineered Papaya ringspot virus (PRSV) seed, an innovation of the public research centre CINVESTAV-I. The results of the study showed that its cultivation would be beneficial for small papaya producers, whom would see their virus-related losses diminished. However, the project never reached its commercial phase, due not to bio-security problems, but for economic reasons, given that the big papaya exporters opposed its development. This is a case that shows the SEC of not introducing a LMO.

More information on the matter can be consulted in the book Chauvet M. et al. (2012) Efectos sociales de la papaya transgénica: una evaluación ex ante. Ed. UAM-A; and in the article: Laura Silva-Rosales, Diego González-de-León, Salvador Guzmán-González, Michelle Chauvet (2010) Why there is no Transgenic Papaya in Mexico. In: Tennant P(Ed) TRANSGENIC PAPAYA. Transgenic Plant Journal 4 (Special Issue 1), 45 – 51.

Kind regards,
Michelle Chauvet