Online discussion 2015 - Discussion Groups

Welcome to this week’s discussion group on environment-related aspects of socio-economic considerations. 

The discussions this week will be moderated by Mr. Ben Durham. Comments may be posted until next Monday, 20 April, at 1:00pm GMT. 

We encourage you to continue to participate actively.

My comments related to the Question 3 are that: The issue of Socio-Economic considerations are addressed in the Article 26, is not linked to the environment, both are two issues that must be addressed independently, since as regards the issue of environment is covered at the time of the risk analysis that is performed prior to environmental release of a Genetically Modified Organisms (GMO). This, is sustained as mentioned by Ludlow1, which states that standard methodologies for risk assessment of environmental release of GMOs: "The risks and benefits of other concerns such as the Socio-Economic Considerations or market implications are excluded as well as the use of social factors in assessing human health or safety or environmental risks. "

My cooments to the question 3 are that:
The issue of Socio-Economic considerations are addressed in the Article 26, is not linked to the environment, both are two issues that must be addressed independently, since as regards the issue of environment is covered at the time of the risk analysis that is performed prior to environmental release of a Genetically Modified Organisms (GMO). This, is sustained as mentioned by Ludlow1, which states that standard methodologies for risk assessment of environmental release of GMOs: "The risks and benefits of other concerns such as the Socio-Economic Considerations or market implications are excluded as well as the use of social factors in assessing human health or safety or environmental risks. "

In regard to the comments by our two Mexican colleagues, I want to point out again that we must include second- and higher-order impacts, not just primary ones.  In other words, there may be indirect social and economic considerations, where the primary or first-order impacts are on biodiversity and/or human health that decision-makers take into account.

Examples have already been given by colleagues in the discussions of Q1 and 2.  The disruption of an ecosystem by an LMO can lead to important economic, social, cultural, or health impacts.  These all can be considered under Article 26.  This point was made repeatedly during the negotiations of the Protocol and Art 26 specifically.

Phil Bereano
Prof Emeritus

Colleagues,

On the question 3, I agree with Prof. Emeritus Bereano in terms of considerations not only direct (economic or "crematistic" specially) effects, and include in the discussion second and side effects that of course, could imply more relevant impacts.

I will draw the attention of this group on the AHTEG ad hoc group on these issues, that integrating experts, scientific sector, NGOs and policiy makers, proposed and integrate, holistic and complite analysis of the whole aspects, and no only a partial and limited approach.

In that document and in the bibliography of course, Multicriterial Analysis and Multidimensional Analysis cover a broad corpus of aspects, that are not include in a partial or limited approach.

In terms of the methodoligies suggested and included as a demand for these issues, the document suggests that could be include several of these:

Methodological approaches
A wide array of methodological approaches is available to address the complexity of socio-economic
considerations, which could include the following:
• Situational analysis and baseline information
• Scenario planning
• Ex-ante and/or Ex-post studies
• Quantitative and/or qualitative studies
• Public consultation and participation modalities
• Multi-criteria analysis
• Socio-economic impact assessments
• Valuation of biological diversity

See document at CBD: http://www.cbd.int/doc/meetings/bs/bs-ahteg-sec-01/official/bs-ahteg-sec-01-03-en.pdf

Some examples could be revised on the particular issue of not having taking in consideration an integrate approach for this discussion:

1) The case, dramatical case in this moment, for argentine agriculture, in terms of appearance of RESISTANCE AND TOLERANCE in WEEDS, as results of a implementation and releasing of transgenic soybean in south America, shows the effects, ECONOMIC AND ENVIRONAMENTAL EFFECTS, that produce a tremendous cost for farmers and peasants in that places.

2) The expansion of agricultural border, directly involved with the potential of transgenic soybean, in a technological package of NT + Transgenic Soybean + Glyphosote.  No tillage in an ecological ecorregions (Chaco) that is very sensitive to transformations implies a direct cost for farmers, peasants and INDIGENOUS PEOPLE.

3) The drastic change to an increasing consume of glyphosate with MORE COSTs for farmers.

4) New demands of more information, abouth health aspects to be consider with glyphosate and other herbicides.  Beyond the potential issues involves with the demand of new studies on glyphosate, this implies direct and of course, indirect new costs, that must be stimated at first, at a preliminar aspects, before releasing herbiides and new GMO, and not after. The costs are being paid by societies and policiy makers and researchers must to be these considerations at first, beyond markets only.

Best regards

Walter Pengue

I would like to support prof Walter comments’.  The four point he highlight we are living in Brazil either. We have super weeds and new diseases. Because of that we are approving now 2,4 resistant technologies. 2,4 d is a very toxic pesticide and is forbidden in many countries. Associate with that we are year after year increasing our glyphosate use. And we will have the same problem with 2,4d. Associate with this we have the impossibility of coexistence. Brazilian coexistence rule are not adequate for Brazilian reality, so many farmer (most of them families’) today have to deal with contaminations problems and some of them are losing their landraces and peasants seeds.

Really useful posts from Ms Martin (Spain) and Mr Sousa (Brazil), giving some practical insight into how the system works in countries that have adopted certain LMOs.

I agree at a certain level with these two postings, but would like to get greater clarity on the distinction between the risk assessment, and the SEC processes.

In SA it is the same body that considers both aspects, in order to reach a decision on import/release. Case specific, but following the evaluation of the risk assessment, the identified risks directly inform, and guide, the SEC. Depending on the context, the SE considerations may rarely then require a further study, not infrequently involve getting input from various stakeholders (the public input, if any, is always considered), but often are dealt with just by considering alignment with national policy, where appropriate.

Hence I would like to ask Mr Sousa whether the "SEC" body in Brazil uses the risk evaluation of the "risk assessment" body, to inform their considerations, or if these are completely separate?

Many thanks!
Ben

Thanks Mr. Durham for the opportunity to explain how this occurs in Brazil. As I explained, the processes occur separately.

In Brazil the risk assessment (aspects of environmental impacts and security of human/animal health) occur by a technical body (the National Biosafety Technical - CTNBio) and its decision only covers the biological aspects of GMOs. All processes have a period of public consultation for 30 days where society can manifest on that research/product /or guided theme for discussion.

Risk analysis (SECs) are considered by a high-level body of the Presidency (National Biosafety Council - CNBS) that has the ability to analyze the SECs for commercial products and competes him the FINAL DECISION to approve or not a product to market. In practical terms, if the technical body to approve a commercial product, the CNBS may or not approve it based on SECs. If the technical body rejecting a commercial product, the CNBS can not reverse this decision, as this would imply the safety of the product in the market.

Each favorable technical decision to trade, the CNBS is warned and has a period of 30 days to respond. CNBS can also be triggered by the national registration and supervisory bodies or by the CTNBio, but always only to evaluate aspects of SECs.

In 2007 and 2008, at which time the first genetically modified maize were approved, the CNBS was triggered by the registration and supervisory bodies to the considerations of SECs. In all three cases, the Council sustained commercial approval. Currently for each market approval, as determined by our law, the statement of approval is sent to the council that the lapse of 30 days informs of whether or not an appeal to the decision of CTNBio. A commercial product may only obtain registration in other administrative agence through the manifestation of CTNBio and CNBS.

A possible environment-related aspects of socio-economic considerations is where the introduction of LMOs affects biological diversity in such a way that social or economic conditions are or may be affected. Such social or economic impacts are generally referred to as secondary or higher order effects in technology assessment literature.

O.A.El-Kawy

A standard science-based risk assessment includes an assessment of environmental issues that would comply with risk assessment as defined by the SPS Agreement. Standard science-based risk assessments include topics like potential gene flow to weedy relatives, impacts on non-target organisms (birds, bees, butterflys, fish, etc.). Duplicating these assessments under Art. 26 would be an incredible inefficient use of scare resources in many food insecure nations.

Science-based regulations as provided for under the SPS Agreement will only allow for direct impact assessments as moving beyond the scope of direct impact assessments, brings politics into the risk assessment. To allow the return of politics into the regulation and trade of LMOs would be to return to they Byzantine era of international trade where trade barriers were routinely implemented to protect national industries. In fact, the very rational for establishing the GATT was to remove politics from international trade. Once again we witness the rise of protectionism and the justification for the implementation of trade barriers, under the guise of secondary impact effects.

The methodological challenge of ex ante studies is that they tend to over estimate the risks and under estimate the benefits. An example can be found in the commercialization of Bt corn in the USA. At the time of approval in 1996, there were several studies that estimated that Bt corn would only be profitable to farmers 3 or 4 years out of the 7 year cycle of corn borers. In 2010, Hutchinson et al (2010, Areawide suppression of European corn borer with Bt maize reaps savings to non-Bt maize growers. Science 330: 6001: 222-225) found that 75% of the benefits of Bt corn went to non-Bt corn farmers. The suppression of corn borers was so high from the Bt corn that other farmers benefitted substantially from the adoption of this technology. The highlights how potential market impact studies are fundamentally weak when it comes to predicting with any accuracy about the future benefits of a technology.

The ultimate arbitrator on regulations based on secondary effects will be the WTO, through the SPS Agreement. Any case heard by the WTO will be heard by scientific experts that will only consider direct impacts. To stray beyond this allowable parameter so clearly defined by the SPS Agreement is to knowingly violate Art. 26 where it states that member states must comply with existing international commitments.

Thank you.  But ex ante analysis, is relevant in terms of avoid, high costs for farmers and environment.  Appearance of resistance so in weeds or in insects, is one of the main factors that involve the whole GMO process, when this is consider in short/mid/terms. Just only we can review this during the last decada in terms of the appearance of resistance (herbicides) and insecticides.  In ecological terms, change of pattern in the utilization of a new GMO crop, resistant/tolerant to a new herbicide/insectice, produce a response of the system that can be show in all the bibliography.
Aditional to the issue of multicriterial and multidimensional analysis, to go though in terms of temporal scale (short/mid/long terms), could help us to a better understanding of the system and obtain information under the way of a more sustainable approach and holistic approach. 
My best regards
Walter Pengue

A regulator's perspective (a SA point of view)

Interesting discussion, but we need to remind ourselves the SECs are to assist in decision-making, and this is not an academic exercise.  While it may be of great interest to follow a possible set of links from biodiversity impacts to socio-economics for an academic, regulators need to be pragmatic.  Here in SA, the link (btween possible biodiversity impacts and SE's) must be relatively clearly defined, otherwise this becomes (as appropriate) a risk management issue: SA issues "general release permits", which could be withdrawn if monitoring (under risk management and/or legislative processes) indicates unintended biodiversity/SE impacts (we have a public entity that is charged with LMO monitoring and surveillance; and a centre of excellence on alien invasives (explicitly including possible LMOs)).

As indicated previously, both bt and herbicide tolerance traits are DESIGNED to have a limited biodiversity impact, but the obvious SE impact is positive.  Our Biodiversity and food safety laws (i.e. other than our GMO Act) speaks to environmental impacts and residue levels of herbicides, and these apply equally to LMO and non-LMO herbicides (and other sources of impacts).

I tend to agree with Dr Smyth that SEC's projections can be quite inconclusive, and - if not convincing to regulators,  the pragmatic approach could be to monitor such under risk management or other processes. Further, for any one set of SEC's arguing negative impacts, another grouping of stakeholders (eg. farmers - a significant subset of the African population) may well argue differently.  Regulators need to be pragmatic.

Ultimately, if a country is to introduce LMO's, there need to be the appropriate sets of checks and balances that give the public confidence in the 'system'.  Basing decisions on what may be weak and speculative links is not - I think - going to build confidence.  Rather, if the links are speculative, find the appropriate means to manage the system such that there is early detection and management.

Ben

The risk assessment evaluates the risk associated with LMOs like horizontal and vertical gene flows, impact on non-target organisms etc at the laboratory level or at field level. Basically most of these impacts are environment related impacts. There cannot be other environment related aspects specifically for socio-economic considerations. These impacts/aspects become socio-economic considerations when large scale adoption of LMOs takes place within the society, contrary to laboratory or field level experiment, causes impacts on the society, markets, profitability, changes in the biodiversity, species diversity, affect public preferences and  choices etc.

For example, In the case of Bt cotton, the field trial has shown that the insecticide consumption has reduced in the cultivation of cotton and it is an environment related issue.  When there was large scale adoption  (for eg in India more than 95 per cent), it affected the profitability of pesticide companies (cotton is the highest pesticide consuming crop), but increased the profitability of seed companies which sold GM seed. Consequent to this several mergers and acquisitions among pesticide and seed companies have taken place. These changes are the socio-economic aspects which are very different from risk assessment

Similarly large scale adoption of few GM cotton may reduce rich species diversity of cotton and it is an environment related issue. Decline in species diversity due to largescale adoption and its impact in the future is not a subject matter of risk assessment. Because the largescale adoption is determined by variety of socio-economic factors like farmers’ attitude, relative profitability of other crops, farmers education etc

There is also some clarity regarding the article 26 of the protocol itself. It says “….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”.  Here two aspects are important.

First, LMOs are developed from the rich biological diversity and hence conservation of biodiversity is essential for all such endeavors. But conservation of biological diversity is not caused by LMOs. Like in the case of Bt cotton, biodiversity of soil microbes enabled to develop GM cotton. So conservation of biological diversity is essential for development of LMOs and the causation could not be the other way round.

Second,  the impact of LMOs are important and relevant, as much as it is for the indigenous and local communities, for all sections of society and just focusing on its impact only on the indigenous and local communities would in fact amount to leaving a vast socioeconomic space.

A very useful posting by Prof Radha!
The question I have is, are LMO's treated differently than conventional hybrids in India when it comes to crop species biodiversity?  Surely (?) this is an agricultural issue rather than just a LMO issue?  I do think it is perhaps right to flag it as an LMO and SEC issue, but this needs to be in the context of conventional agriculture having had a dramatic (negative) impact on crop species diversity anyway.

I also support Prof Radha's final point (SECs are for all structures of society, i.e. not just indigenous and local communities), and this does raise again the point raised much earlier (by Jose Falck Zepeda, I think)  that  we are  talking both environmental AND agricultural biodiversity.

Ben

A very useful posting by Prof Radha!
The question I have is, are LMO's treated differently than conventional hybrids in India when it comes to crop species biodiversity?  Surely (?) this is an agricultural issue rather than just a LMO issue?  I do think it is perhaps right to flag it as an LMO and SEC issue, but this needs to be in the context of conventional agriculture having had a dramatic (negative) impact on crop species diversity anyway.

I also support Prof Radha's final point (SECs are for all structures of society, i.e. not just indigenous and local communities), and this does raise again the point raised much earlier (by Jose Falck Zepeda, I think)  that  we are  talking both environmental AND agricultural biodiversity.

Ben

Dr Ben
LMO's are not treated differently than conventional hybrids in India at least from the farmers’ point. I agree with you that its impact on crop species diversity is similar to any other crop improvement programme.  But when the efficiency of LMOs is very significant as in the case of Bt cotton (Yield increased by 30-40 per cent), there will be rapid large-scale adoption, replacing many conventional varieties.

Dear All,

Greetings!

As far as environment-related aspects of SECs that could arise from the use of LMOs is concerned, I think the following questions are needed to be answered in the context of Article 26 of the Protocol:

1. How technology influence use of agrochemicals? (Quantity of chemicals (active ingredients) used per acre, frequency of agrochemicals use)

2. How technology influences agri-biodiversity? (No. of varieties cultivated for individual crops, No. of wild varieties)

3. How technology affects soil and water quality? (Physical properties of soil, soil salinity and acidity)

4. Does technology result in change in pest and disease patterns? (Incidence of different pest and diseases and their severity)


Best regards,
Prof. Sachin Chaturvedi
DG, Research and Information System for Developing Countries (RIS),
New Delhi, India.

On this last comments and related to other questions to be respond, we could considerer, because  its direct effects related with SEC considerations:

+ Which is the influence of these new events on LUC (in terms of potential effects to open borders, release in the different ecorregiones, eg.).

+ Which the influence and trade-offs on soil biodiversity (in terms of the relevance of a health soil to sustain the productitive and good activitiy of soils, that is directly engage with food security and economic aspects of food production).

+ Which are the effects on other technologies (conventional, management practices, monoproduction, diversitification) and on indigenous technologies.

My best regards

Walter Pengue
UNGS - GEPAMA
Argentina

Comments to Question3

LMOs may be introduced into the biodiversity of a certain context and if the have negative impacts in the territories where the are introduced and on the livelihood of the people occupying such territories , this would fall within the scope of article 26. Furthermore , socioeconomic considerations arising from impacts on human health also need to be included.
Impacts of LMOs on biodiversity , the livelihood of local and indigenous and human health should include direct and indirect and long term impacts . It is possible for socioeconomic considerations to form the basis for measures that restrict or ban GM crops . So, there is need of inclusion of socioeconomic impacts in current risk assessment and risk management . We can not say that such impacts will not be evaluated in assessment when article 26 direct us towards them

Dear Koffi Dantsey

The wording of Article 26 is quite clear, and the socio-economic considerations are those that arise from impacts to the "conservation and sustainable use of biological diversity...".  So we are only considering environmental/biodiversity impacts and their link to SE, and how these are to be assessed.

Direct SE impacts are usually would fall within the scope of national legislation, and at least several countries do consider such direct impacts, and presumably these can "form the basis for measures that restrict or ban GM crops" as you say.  But this is not under Article 26.

For clarity and possible guidelines requested by MOP, we need to restrict our efforts to SE considerations arising from biodiversity impacts.

Hope this is useful/clear?
Ben

Colleagues--
There is nothing "academic" about the consideration of second- and higher-order impacts.  Indeed, in the real world these indirect consequences (which may be intended or not—it makes no difference) are often the factors that make evaluating LMOs necessary.

They may move groups and communities in the nation to take political action, for example, demonstrations, company mergers, suicides, press campaigns, introduction of legislation, sensitivities to the racism implicit in running roughshod over indigenous communities. These are actual SE factors that have accompanied the real world introduction of LMOs and their consideration (or not) has led to various policy outcomes.

As I have mentioned already, the concerns expressed in these discussions about SPS considerations is itself an SEC, and an indirect one at that. So is the non-regulation of LMOs in the United States (as evidenced by the internal opposition by government agency scientists in 1992 when an economic agency, the Vice-President’s “Council on Corporate Competiveness,” announced that there would be no oversight of LMO safety).

While the process of assessment may be non-political (and that itself is challenged in the literature), in the real world the context for every assessment is set by political considerations and the reception of every assessment is colored by political considerations.  To believe that the assessment itself in the real world is to be conducted without knowledge of such pressures seems naive and unhelpful to our task here.

The social and cultural impacts on indigenous communities from the introduction of an LMO would usually be unintended and indirect.  Thus, we cannot say a priori that such impact chains will not be evaluated in an assessment when Article 26 specifically directs our attention towards them.

Phil Bereano
University of Washington

Academic is in ecological science the consideration of an holistic and integrate approach, in particular, when mid and long terms issues should be considerer.  So on, indirect effects (ecological of course, and not only economic effects), should be considerer, if the research is really attending the goal of an integrate and sustainable approach.  By the way, partial approaches, will give us, only partial results.
Ecological approaches of course, integrate holistic analysis.  Best regards, Walter Pengue

Hi Ben,

I respectfully have to disagree with you on your opening sentence. After working in this area for over 15 years, I am of the opinion that SECs exist for two reasons: one, to prevent decision-making; and two, to prevent innovative technologies that benefit subsistence farmers from being commercialized. Let me explain why.

Science-based risk assessments have proven methodologies that quantify the level of risk. This risk is measured against existing risks in the marketplace for similar products. If the risk from a GM product is no different than that of an existing product, it is approved. That is how the Canadian and US regulatory systems function.

If SECs are allowed within an environment assessment, then they move away from direct impacts, having to consider second order and various other nebulous harms that could potentially exist. In my view, the problem is that assessments of this nature provide no information to regulators that facilitates decision-making. Arguments have been put forward in this debate that farmer profitability must be included in a SEC assessment. Every innovation has winners and losers, so the fact that someone who cannot or will not adopt a new innovation may be said to economically lose, cannot be quantified in any meaningful and informative method for regulators. Including this aspect in a SEC environment assessment would impede the decision-making process.

Last week saw a discussion of the GM eucalyptus commercialization and the speculation that this might affect Brazil's honey exports. If an environmental SEC were allowed to be applied to this case, the environmentalists would demand that commercialization of the new technology be banned as it might have a second market effect. Speculative harms are what SECs are designed to test for and doing so provides no clear, concise and valid information to regulators. SECs of this nature are disguised trade barriers, offering protectionist preferences for domestic production. The WTO exists predominantly to prevent protectionist behaviours.

I am not convinced that SECs are capable of contributing quantifiable information to regulators. Rather, they are an attempt to stall, delay or even worse, prevent the commercialization of beneficial agricultural technologies.

Respectfully,
Stuart

Dear Stuart (a SA perspective)

Your disagreement relates to my comment "...the SECs are to assist in decision-making...". I was paraphrasing Article 26, trying to emphasise the point that SECs SHOULD ASSIST in decision-making. It also relates to my comment that SECs should be pragmatic, not academic (using the definition of academic "Having little practical use or value, as by being overly detailed, unengaging, or theoretical").

Despite your concern, SA regulators do routinely consider SECs, and yet over 80% of our maize and soya, and all of our cotton, is GMO. The point is, we are truly focused on national socio-economic priorities, which (relevant to LMO's) includes food security, eradicating poverty, developing livelihoods, and improving quality of life (we also have other priorities about preserving our biodiversity heritage and so on). Like you,I find it quite remarkable that socio-economics justifications are used to prevent what is (often) a socio-economic benefit!

A final point I make is that SA will NOT (in my opinion as a regulator) release a LMO that is considered likely to have a negative biodiversity impact (beyond -mainly- pests that actually eat the insect resistant crop, or weeds in agriculturally-disturbed land). Our biodiversity is too important to take such a risk - both as a heritage issue and a livelihoods issue (discussed in theme/question2, but also including tourism). Given this approach, article 26 - for us - is moot.  We only consider direct SE impacts, because our LMO's are not considered likely to have a broader biodiversity impact.  And we have publically-funded institutions to monitor LMO's (plus require reporting by the permit holder for any unexpected developments) for any biodiversity-related impacts.

Hope this clarifies my perspective?
Ben

Hi Ben,

Thanks Ben, I appreciate your detailed explanation. Likewise, Canada would never release a crop variety that would negatively impact the biodiversity.

My concern is that many of the posts suggest that an environmental SEC will be applied in such a manner as to ensure the rejection of GM crops, thereby denying subsistence farmers of the benefits of this technology.

In Canada, we have grown GM crops for 20 years and the farmer benefits are enormous. The environmental benefits have been substantial as the environmental impact of the chemicals applied to GM canola has dropped by over 50%. Issues of herbicide tolerance in weeds were issues prior to the commercialization of GM crops and careful management of the technology is required to ensure that chemical resistance in weed populations doesn't increase. One can't say that herbicide resistance in weeds is strictly a GM crop issue, as some have suggested.

The crucial part of the SA process would be that only direct impacts are considered. Extending a SEC assessment beyond direct impacts is where the risk assessment process is opened up to political interference. Opponents to GM crops and biotechnology can offer an exhaustive list of hypothetical harms that might possible arise, thus being justification to reject the technology.

There has been a noticeable shift in how harm or risks are assessed in recent years. Environmental groups strongly advocate that the concept of zero risk is an achievable situation, when science articulates that nothing can ever be proven 100% safe, this is why there are agreed upon thresholds for international commodity trade and food processing. The environmental argument that new technologies, such as GM crops, should only be commercialized if there is zero risk and no one is adversely affected, is a distortion of market reality. If this zero risk concept had been applied to mechanized travel, we would still be riding horses as the chance that one single person could have been harmed in an auto, boat, train or plane accident would have prevented all of these technologies from being commercialized.

Opening a risk assessment to SECs that involve political interference and manipulation will, without a doubt, be a violation of a nation's commitments to their international obligations, particularly the WTO. The GATT and the WTO ensure that politics is, to the best of their ability, kept out of trade. Yet, the use of secondary effects and other nebulous market hypothetical scenarios clearly violates the integrity of the WTO, given their lack of scientific grounding. While it may be possible to use an ex ante assessment of a speculative harm and even be able to quantify it, the confidence interval in the results will be so low that it will be statistically invalid.

It would appear that opponents of biotechnology would support the inclusion of speculative harms within a zero risk framing in a SEC environmental assessment. Such inclusion would guarantee that subsistence farmers will continue to be subsistence farmers far into the future, if they are denied access to the much-proven and quantified benefits resulting from GM crops.

Sincerely,
Stuart

It is important to highlight that in order to integrate socioeconomic considerations into biosafety decision making two things need to be done:
First, you need to conduct social science research to clarify the issues relevant to biotechnology and biosafety in different national and local contexts and to generate information about the actual social and economic effects of the adoption of GMOs

Secondly, you need to implement and support appropriate regulatory processes so that socio-economic issues are properly considered and addressed

There are several currently applied research methodologies; those include
- Economic modeling: helps to predict the economic effects of various GMOs’ policy choices.
- Cost-benefit analysis: useful in determining the various opportunity costs and trade-offs of different approaches to biotechnology.
- Social impact assessment: the process of assessing or estimating, in advance, the social consequences that are likely to follow from specific policy actions or project development, particularly in the context of appropriate national environmental policy/ legislation.
- Sustainable livelihoods framework: relies on surveys, focus groups, key informant interviews, in depth household case studies, and secondary sources to generate data that is then used to analyze relationships between factors at the household, community, and regional levels to better understand causes of poverty and food insecurity.
- Systemic relevance assessment: applies the concept of ‘relevance’ to agricultural innovations such as new biotechnologies at two levels: the crop level (the innovation’s ability to overcome specific agricultural problems ) and the broader regional level, such as the innovation’s ability to meet farmer needs and fit within the general public’s goals.

However, it is important to note that all research methodologies have their limitations, and this should be recognized when carrying out studies on the socio-economic impacts of biotechnology. Research needs to approach this issue from a variety of angles; both quantitative and qualitative information is useful, and some types of studies may be more appropriate than others for assessing economic versus social or cultural issues. In addition, different methodologies will be appropriate in different cultural contexts, such that what is useful in one country may not be helpful to researchers and decision- makers in other countries.

O.A.El-Kawy

Given the lack of quantifiable methodologies, not to mention data, I think one thing that would be incredibly valuable to nations that have the misfortune to have SECs as part of their regulatory system, would be to have a socio-economic repository of peer-reviewed, quantified publications on the beneficial socio-economic impacts of GM crops. A repository of this nature would provide regulators with access to studies that quantify the reduction in chemical use, the reduction in pesticide poisonings, the yield increases from fewer weeds and the higher farmer incomes. A definite benefit of this would be a source of accurate information that would counter the baseless myths and accusations that have been so frequently esposed by individuals like Shiva, Benbrook and Seralinni.

In science-based regulatory systems, scientific studies are accepted by multiple federal regulatory agencies. For example, data on toxicity or allergenicity, would jointly be submitted in Canada, the USA, with EFSA and other national regulatory bodies. Similarily, there would be little need for each nation to undertake environmental SECs if relevant information exists that would meaningfully inform regulators. It is well proven that GM crops lower chemical use, so information of this nature would not require duplication by a nation having SEC requirements.

Having a source of factual, quantified socio-economic benefits would provide informative data for regulators grappling with the challenge of how to comply with an environmental SEC assessment. A definite benefit would be the consistency of the factual data, removing the problem of having to review speculative, hypothetical and manipulative unpublished reports released on the Internet. Biodiversity is equally important to each country, therefore quantified peer-reviewed publications that could be shared between nations will minimize the regulatory inefficiency of SECs.

There is no need to reinvent the wheel in regard to applying SECs. In cases where relevant and pertinent socio-economic benefit studies exist, they should form the basis for countries required to include environmental SEC assessments.

POSTED ON BEHALF OF Leonardo Gonzales, Philippines:

Hi Colleagues,
I've fervently followed the on line discussions  from the posting of Q1, Q2, and now Q3.
Unfortunately I was on an extended field work in the Philippines and was unable to find a suitable internet server. I sent my posting to respond to Q2, but I'm not sure if it was received by the Secretariat.

My take on Q3 is this: Science based risk assessment of LMO's impact on human and animal health and the environment such as gene flow and weediness, and impact to non target organisms is different from those envisioned under Article 26.

Socioeconomic effects are "transcendental effects" of LMO brought about by By the changes in the "socio-economic and policy environment" where the LMO has been released for commercial propagation. The use of socio economic characterization of local environment, baseline analysis and ex ante analysis, though they have their limitations, can be good starting point. These methods can be followed up with validation and ex post analysis overtime to be able to determine these effects.

Socio economic effects are primarily determined by the "forces of the market". Examples of these are volatility of input output prices faced by users of the LMO technology, that may affect the profitability of production. A worse scenario is total market failure because the demand of the specific product has declined continuously.

Regulators and policy makers should be able to develop socio economic indicators that they feel are central to their country's national development. They should also have consensus of the acceptable methodologies to qualify and quantify these socio economic indicators.
The Philippine regulators and policy makers have at  least identified the following SE indicators before and after the commercial approval of any LMO: productivity, cost efficiency,net farm income, ability to attain food security and alleviate poverty, return on investment, resource use efficiency, and global cost competitiveness.

Risk assessment and risk management are two distinct aspects of risk analysis. Socio economic considerations would be most necessary in recommending risk management measures to appropriately address special cases where consequences from the use of LMO are regarded marginal as compared to its benefits.

I think at this stage of the online discussions, it might be helpful for member countries to identify  SE indicators acceptable to them and standard methodologies to assess them.

Kindest Regards,
Leo Gonzales

Dear participants of the forum

It is true that the socio-economic assessment is different from risk assessment, but the risk assessment based on scientific approach, determines when and how we need to conduct a socio-economic assessment.

For example: if we have an LMO with a transgene that confers the capacity to produce an insecticide toxin, but in the risk assessment we determine that the toxin could affect one specie of a bee that live in the region where we pretend to liberate that LMO, surely we will identify the risk of damage to biodiversity due to the attack of that LMO to bee populations. In consequence, we need to determine what are the socio-economic impacts of introduce the LMO in the country, linking the ecosystem services that the bee represent to the country, for example the pollination service, and for example if we have knowledge of that bee is the pollinator of a specific plant that is economically important for the region, the SEC´s will be determine what is the impact in the economy of the country and the impact in the people who benefit of that crop between other aspects.

The important point here is, that is very important for us, delimitate when and how the SEC´s has to be done under the article 26 of the Protocol, and that is, when we determine damage to biodiversity that could affect the human health and other aspects like social and economic, if we decided to introduce an LMO into a Country.

But the SEC´s should be related only to the characteristic of the transgene, not to the other aspects like the use of pesticides that are a characteristic both a GM crop or a conventional hybrid.

The risk assessment and the SEC´s should always be related to the technology, because this is the central point to be pragmatic, impartial and scientifically correct when we judge if a LMO is susceptible to be introduced to a Country.

The other aspects proposed for SEC´s are 100% valid but, for all the production systems, this means, are valid for conventional hybrids, GMO products and even organic and alternatives forms of production systems.

Best regards

Carolina Villafañe, Colombia

Dear All,
Some very interesting and insightful contributions.

My contribution as a researcher struggling to understand the implications of Article 26 - The way I understand it, there are two ‘groups’ of socio-economic considerations of concern:

First group -Those resulting from a potential impact of LMO introduction on biodiversity (linked to direct impact of the LMO on biodiversity which is different to that of a conventional comparable crop), and

Second group - Those resulting from the commercial release / production of LMOs (not linked to the genetic makeup or functionality of the LMO or biodiversity, but linked to the way farmers and communities will likely produce or use the crop or commodity).

For the first, information on likely/probable biodiversity impacts should be pulled from the scientific environmental risk assessment and the potential socio-economic impact of these should be assessed. According to my understanding this is the ‘scope’ of the socio-economic assessment Article 26 refers to.

The question is however, if the environmental risk assessment flags likely detrimental environmental impacts  wider than just ‘direct impact of LMO on biodiversity’, should the socio-economic impact assessment then consider these as well? Environment does not necessarily equal biodiversity  - so do these fall into the second group?

Assessment of the second group of socio-economic considerations, I believe, falls outside of the scope of Article 26 and, though very important, might not be deemed acceptable when importation decisions are made strictly guided by the Protocol.

However, as an agricultural economist who has been doing impact assessments with small and large scale farmers in South Africa adopting mainly GM maize and cotton for the last 15 years, I believe doing socio-economic impact assessments are vital in order to identify socio-economic opportunities, limitations and threats and to develop mitigating as well as enabling strategies in line with national priorities. (In a sense government, innovation companies, farmers, trade companies and consumers, i.e. the market, do these studies on a continuous basis). But these assessments are especially important in developing countries where socio-economic opimising market forces are less effective.

While it is useful to have some ex ante high level ‘predictions’ of what is likely to happen in order to proactively establish an enabling and mitigating environment, the way markets and society shape technology adoption and the success thereof is not always clear cut, so ex post assessments, ideally following adoption from first release for the first couple of years after introduction is more useful. In this, not Protocol linked assessment, secondary and higher level negative and positive impacts can be assessed and compared / weighed.

Ideally these studies should be done as a collaboration between amongst others the technology innovator / importer, national Departments, farmer organisations, consumer organisations and academic institutions. This ‘second group’ study would this be for national interest and responsibility to maximise the socio-economic benefits of GM technologies while limiting the socio-economic negatives.

Best

Marnus Gouse

I apologize for not contributing in the two earlier questions and thanks to all for the important insights and contributions about the issues in discussion.
On the other hand, for the 3rd question I have some disagreements about appoitments that - I suppose - will be relevant to comment.
Really, there are diferente kinds of impacts, that we can discriminate :  first - second - and higher-order impacts. But these not justifications to postpone the social and economic considerations. They will not be only indirect results for health or environmental impacts, like some kind of collateral effect of the first. In reality, the subject of these tecnologies focus on economic results that wil be pursued by alterations that have  impacts in the biodiversity and/or human health as well as social-ecomic considerations. There are no reasons to establish artificial discriminations since the beginning of all motivations have socioeconomic reasons. And the consequences will be subjected to the same questions, for the beginnig, where not only the decision-makers linked to market motivations must be taken into account.
In effect, some of these impacts (in all the orders) have previous evaluations, for instance in laboratories, in field tests, in risk evaluations  and in econometric simulations.  But that is not the case of problems that are dependent of the largescale adoption. These condition affect all the kinds of impact and dont suppose any order of occurence. The massive use of Bt proteins or the abusive use of glyphosate  or both, in some place, for some years, imply benefits or damages for some soil and water communities, alter the seeds banks, stimulate the emergence of tolerances and resistances, the spread of trangenes by wind,  horizontal movements and pollinator that  affects the quality of water, the diversity of landscape conditions, the produtivity and the rentability for the soil and the cultures (GM or not). Damages to human health or biodiversity communities can arise in advance to economic problems, or not.

Consider for instance the destruction of tommatoes or apple trees near soybeans plantatios with ENLIST tecnology in the next Brazilian harvest season. And if the commercial products with 2,4-D active principle contains dioxin? The next generation will force the health public service to be confronted  to new and expensive  problems like the Vietnamese population. And what if this happens to populations in Uruguay, Argentina or Paraguay, where these technologies (sybeans tolerant to 2,4-D dont have autorization to be cultivated? Who should be concerned for that kind of socio-economic problems?
Finally, I strong agree to W.Pengue considerations and agree with another suggestion of metodology to compare technologies ensuring combinations of socio-economic, health and environmental indicatores. I refer to DEA (data Envelopment Analysis) instruments. They allow to combine qualitative and quantiative data, comparing results without contamination with subjectives perspectives. Naturally it will be necessary to establish the informations and the parameters to be taken into consideration. On this subject, in my point of view it is not sufficient to compare  GM technologies with the tradicional technologies. It will be necessary to include organic and agrocological perspectives.
The fact that most arguments ensuring inocuity of transgenics crops are collected in nutritions studies develop at short periods using  crops that were not cultived with the agrotoxics associated (tecnology for herbicides tolerance) illustrate this argument.
..
In reply to Prof. Ashok Krishan Radha, who makes strong statement for the large scale impacts, I can affirm that in Brazil de reduction of agrotoxics is not occurring with GM tecnologies. Considering Benbrook studies it is the same situation in the US. The reason is logic: the emergence of secondary pests,  tolerance and resistence and surplus utilization by the farmers expand the use of agrotoxics. This imposes increments for  all  kinds of risks, including socioeconomic impacts, and is aggravated by the move towards most toxic products (like 2,4-D in substitution to glyphosate).
The impacts will be affecting not only in the adopter’s group. It will be extended to indigenous populations, traditional  communities and organic farmes.  And the socioeconomical considerations, in this perspective, may account for biodiversity reductions, the availability of other seeds, the oligopolization of the markets and the alteration in the scale of minimal (economical) viability for the farms. W. Pengue has interesting studies on this subject indicating the deleterius dammages associated to the pressure imposed by these tecnologies to rural social tissues. In Brazil we have verified the same: the adoption´s expansion implies reductions of biodiversity and socio-ecomic plurality of farms, with strong implications for other rural activities and food security (not restricted to traditional and indigenous communities).
It is true that the “ LMOs are developed from the rich biological diversity and hence conservation of biodiversity is essential for all such endeavors”, but if it is released due to marked decisions, we will not have hope about the future of biological diversity conservation, and is is naïve to suppose that the damnages are not caused by LMOs.
Indeed, Prof. Ashok is correct in affirming that “the impact of LMOs are important and relevant, as much as it is for the indigenous and local communities, for all sectors of society and just focusing on its impact only on the indigenous and local communities would in fact amount to leaving a vast socioeconomic space”. I strongly support his statement, in this point.

Dear all (yet another SA perspective)

What is very apparent is the difference of views/perspectives on LMOs between participants and/or countries. Some have identified LMO problems - such as gene flow/coexistence; declining efficacy of herbicides & insect resistant technologies; the use of new, more potent herbicides - in their agricultural 'systems'. 

None of these issues, however are unique to LMOs - gene flow happens between conventional hybrids and more traditional land races; life (i.e.crops, pests, weeds) evolves/adapts to changing environments, hence herbicides for conventional and LMO varieties lose efficacy, and new herbicides need to be developed, pests gradually become resistant to pesticides (whether applied externally or a trait of the plant).

I'm not saying that we should not consider the socio-economics, but that seeking to solve general agricultural issues by focussing on the application of just one technology is inappropriate. The power of GM technology does warrant special care, but it needs to be proportionate and practical. The evidence that some countries have working regulatory systems (for LMOs and agriculture), and their citizens are able to benefit from the advancing technologies, should not be prejudiced because other countries (with respect) are unable/unwilling to manage their system and technologies. So what I am arguing for is a recognition of the sophistication required in coming up with clarity and eventually (?) guidelines. These must allow differing perspectives and differing approaches to be adopted.

So, to my mind, the SECs we develop must be constructive, and should not become merely an excuse to prevent adoption. As Dr Gouse has said (if I paraphrase correctly) ex ante studies should be at a higher level, and perhaps the more useful insight on SE will come through ex-post, in collaborations between technology innovators, govt departments, farmer and consumer associations (I would add civil society groupings), and academia.

Ben

Dear participants,

I think if there is a role for SEC, that is to assist in decision-making (and for sure not related  to risk assessment or risk management). Unfortenatelly these role is not as ´SHOULD´ be, maybe due to  little  experience of countries applying SECs, maybe due to  the absence of reliable methods,  or even maybe because of the broad amplitude of the aspects that can be considered without  having acurate measurement . And that leads do Dr. Stuart Smith´s commnent   that SECs `are an attempt to stall, delay or even worse, prevent the commercialization of beneficial agricultural technologies`. And that is the point where I perceive  the problem: SEC are presented by many people only as ´speculative harms´ (as used by Dr. Smith) or as issues that are not unique to LMOs (as commented by Dr. Durham) and I believe that SEC are about impacts, both positive and negative considered by a country IF they can be evaluated.

Taking as an example the eucalyptus approved in Brazil last week I can identify  two aspects: a science-based risk assessment that concludes there was no evidence of adverse effects for the environment and human/animal health and the potential benefits that could include:
- higher productivity per area
- higher competitivity of the brazilian florestal sector (FuturaGene responsible for the development of GM eucalyptus is a brazilian company)
- decrease of carbon emission due to smaller distance to transport the product
- reduction of insumes use
- decrease of land use for eucalyptus production due to higher productivity rates

Taking also into account another example: the GM beans expressing a resistance to virus submited to risk assessment and approved for comercialization in Brazil in 2011, we  can say that beans are a Braziian  stapple food , with  serious problem caused by Golden Mosaic Virus trasmitted by white fly. This can be cited as a good example of a GM product developed by a public research institution (Embrapa) in order  to solve a crop cultivated mainly by small farmers problem. We can identify   benefits  such as the increase in the yield; use of small amounts of inseticides to control the vector leading to a lower risk of pesticide intoxication and the environment contamination; use of more sustainable agricultural practices; possibility of using alternatives for resistance management; possibility to have higher incomes improving the life quality of these small farmers etc.

So in the scope of Art. 26 there are limitations in the scope to adopt SECs in the decision-making (be science-based according to international obligations; related to impacts of the LMO to the biological diversity; specifically related to indigenous and local communities) but if the countries decide to include SEC in this context they should consider both positive and negative impacts and that its implementation should not  prevent decision-making.

Best regards,
Luciana

Dear colleagues,

The socioeconomic considerations (SEC) contained in Article 26 are not linked to the environment. These issues should be dealt independently, because the environment is covered in the risk assessment that is performed before the deliberate release of Living Modified Organisms (LMO) into the environment. The process of risk assessment for the environment is already covered in the risk assessment process contained in Article 15 of the Protocol. A clear distinction should be made between the environmental risk as part of socioeconomic considerations and the environmental risk considered in the risk assessment process, where the precautionary principle is also included.

The SEC assessments are voluntary and a very different process from risk assessments, so SEC assessments must remain separate.

If environmental aspects of the SEC are incorporated in risks assessment procedure, they will become mandatory elements to consider when deciding to import LMOs. This would be inconsistent with Article 26.1 of the Cartagena Protocol and EU legislation. SECs should remain voluntary to ensure that there is no conflict with national level regulation, legislation or policy.
The SECs must be distinct from the factors considered as part of the risk assessment process.

Article 26.1 of the Protocol implies that, when decisions on LMOs are taken by the Parties, or when the Protocol is implemented by national measures, its provision, including those related to the assessment and risk management, must be taken into account.  Unlike the above, a socioeconomic analysis is not mandatory.

SECs should focus on the impact of the LMO on sustainable use and conservation of biological diversity (Article 26). This Article also identifies the different socio-economic considerations that Parties may take into account in decision-making on imports. The use of these considerations must be consistent with other international obligations of the Parties.

In summary, there should be a clear distinction between the risk assessment and SECs.  Risk assessment should focus on risks to environment and human health to determine if the LMO is safe to use. Where SEC analysis is used, it will be distinct from the risk assessment.

Best regards,

Dear Colegues

I strongly supoort the considerations from Ms Vanessa Rincon. The use of socioeconomic considerations not present any correlation with the biological safety of a genetically modified organism. The SECs should guide economic impact of decisions or social aspects, meaning a decision at the political level and the Protocol guarantees the independence of the parties to adopt them. At Brazil we have a government high-level body with this task (SECs) and another that analyzes the biosafety. This model has worked and are considered separately. The positive impacts for our whole production chain are considerable and I have already explained this in another manifestation. It is important to remember that any economic partner evaluation should be based on measurable facts and not unrealistic assumptions and necessarily include negative and positive impacts. A real example: the city of Catitu / MG was able to significantly increase the local economy with BT cotton adoption. This city is predominantly made up of a small local community of farmers who could no longer grow conventional cotton because of pests by the lack of appropriate agricultural management and the community was bankrupt. The generation of a local economy greatly benefited the quality of life of this community, increasing access to health goods and services. An unrealistic example: try to establish a link between the use of herbicides such as 2-4-D and the emergence of resistant plants in GM crops (it's important to remember that this technology is approved but is NOT available in the Brazilian market). This fact comes from errors in agricultural management, regardless of conventional or GM system. In Brazil, as the SECs and risk assessment occur at different stages, the environmental impact is considered when assessing risk, which is focused on whether there are differences in impact between GMO and conventional practices and whether these differences underlie an impact environmental science-based.

Resistance it is no a problem of "miss-management" of farmers alone.  Resistance must to be studied in an integrate and long-terms scenarios and for each particular situation and environment. No doing this, put the economy of farmers and of a country, under a dangerous line.  By the way, we have so strong experience as result of this, that including those promoters of the implementantion of new technology. Biosafaty at first is a key point to be in alert, facing a problem produce by the increasing of the utilization of a same herbicide, the change of patterns of using it and the appearance of "new biotypes" that present by one side "resistance" to a particular herbicide or "tolerance" generating a more ammount of herbicide to be apply to reach a moderate control.


On field studies and research needing “ex ante” analysis of the trade-offs of releasing a new event, is very useful to consider several results of the “herbicide-package” in countries like Argentina, where weed resistance now,  is a relevant consequence of practically 20 years of the implementation of the model NT+Herbicide Resistance Soybean + Glyphosate.
The alarm produce for this resistance put in a “late” alert, so governments, decision makers and companies and the result is a country, cover with resistance problems in its main agroproductive areas, increasingly dramatically the socio economic costs for farmers.
In this maps, those that have promoting the technology and argumenting in previous time that it is not going to resistance in weeds, are showing now, the results. 

MAPS:
http://www.aapresid.org.ar/rem/mapa-de-malezas-resistentes/
http://www.fyo.com/noticia/145187/rem-elaboro-mapa-malezas-tolerantes-10-provincias

ON THE COSTS:
http://horizonteadigital.com/el-costo-de-las-malezas-rem-aapresid/

ALERT FROM THE COMPANIES (PREVIOUSLY THE ARGUMENT WAS THAT THERE IS NO GOING TO BE RESISTANCE):
http://www.roundupreadyplus.com.ar/detector-de-malezas

In my book, Cultivos Transgénicos ¿Hacia dónde vamos?, UNESCO, 2000, we have there the arguments and scientific questions about why there was no to be “resistance” in weeds, particularly in Sorghum halepense.
http://www.unicamp.br/fea/ortega/energy/Walter%20Pengue.pdf

In Bioinvasiones and Bioeconomy: El caso del Sorgo de Alepo en la agricultura argentina, FLACSO, 2009,
http://www.produccion-animal.com.ar/produccion_y_manejo_pasturas/pasturas_combate_de_plagas_y_malezas/113-Bioinvasiones.pdf
Several of the agricultural countries shows rising economic costs “again” in control weeds, now as results of the implementation of transgenic technologies.  So on, “ex ante” analysis and holistic and integrate studies are the only way to find preliminarily this problem that could put several countries under danger conditions of production.

My best regards,

Walter Pengue
Argentina

Dear Colleagues,
In agreement with the points made by Ms. Ambrozevicius, Ms. Rincon, and Mr. Delfino, the United States wishes to particularly emphasize that SECs are voluntary, that Article 26.1 applies only to the decision to import, and that the scope is limited to socio-economic considerations (SECs) “arising from the impact of living modified organisms (LMOs) on the conservation and sustainable use of biological diversity.” Additionally, these SECs can be both positive or negative, as noted by Ms. Ambrozevicius in her comment above. We appreciate trying to keep the scope to that of the CPB itself, and not national regulatory frameworks that may go farther than the language of the CPB – something that is certainly within the prerogative of countries but outside the scope of these specific discussions.

Best Regards,
Marcella Szymanski
United States

Dear colleagues!
I was following the discussion over the last days, and I got the feeling that we are moving a little bit away from the question at hand.
I think that there is a strong link in Art 26 of the Protocol (which - by the way - was not introduced to prevent decision making or the introduction of LMOs) to environmental issues as there is an explicit link to biodiversity, which, and I guess we all agree on that, is an environmental issue.
The question here is, if there are environmental issues which are not covered by the risk assessment process, which might require an assessment in the context of SEC.
That Risk assessment as described in Art 15 is a distinct process with its own rules is very clear. Many countries have a long term experience in performing risk assessments of LMOs and the parameters some of which have been mentioned during the discussion are pretty much set, though there are differences in different countries. I agree that it would be a waste of time if those would be assessed again under a different umbrella. I guess that is reflected in the second part of question 3, as there was no doubt neither at the AHTEG meeting nor at the COP/MOP7 that a distinction between the two processes, especially when it comes to environmental effects, is necessary.
I believe that there are quite a number of environmental aspects which are not (always) covered by the risk assessment process and which might have an influence on biodiversity, possibly causing economic or social effects. Usually higher order effects, as has already been mentioned, are not covered in risk assessment. Many RA schemes do also not foresee an assessment of long term or indirect effects.
I want to close with an example, which has been already mentioned by our Colombian colleague, and that is the assessment of effects on ecosystem services, with pollination as the most prominent and easiest to understand. A negative impact on pollinators may have huge economic and social effects. This is clearly an aspect which is directly linked to biodiversity. Which is important, as honeybees – which are of course always mentioned in this context (and the tests performed during risk assessment) are only one, and in many cases definitely not the most important, pollinator. Usually effects on ecosystem services are not or only to a small extent assessed during risk assessment. Therefore it might be worthwhile to have a look at them during the assessment of SECs, focusing on economic and social aspects and not doing toxicity or other such tests.
In this context I also want to mention that some results from the risk assessment process might be a useful basis for an assessment of SECs.
I believe that this is a difficult issue, especially as we need to consider many national specificities as regards risk assessment and decision making processes. However I think that it is important, and that is the aim of the whole process, to assist Parties which want to take SECs into account when deciding on an import of LMOs (recognizing that an assessment of SECs is NOT obligatory under the Protocol).
Best regards
Andreas

Dear all,

As has been raised by many participants, according to CPB, a standard framework for risk assessment must be systematically applied to a GMOs on a case-by-case basis before being released. The Protocol provides (Annex III) the minimum required aspects to be examined in order to “identify and evaluate the possible adverse effects of living modified organisms on the conservation and sustainable use of biological diversity” (Article 15) on a scientifically sound basis by competent authorities. At the same time, the Protocol encouraged the use of other recognized risk assessment frameworks such as those developed by EPA, OIE and the Codex alimentarius (GMO food), etc. to have the most meaningful quantified risk assessment that takes into account known and anticipated adverse effects (direct and indirect) of the environment (ecology, animal and plant health) taking into account the human health. Most of these aspects have been largely debated in this forum, and hence I will not go back to it, but I agree with those who suggested RA covers all the possible quantifiable environment-related issues, and RA (by definition) is supposed to be continuously revised for further refinement and increased plausibility.

However, the question raised by Dr. Heissenberger: What other environmental aspects directly related to SEC that are not covered by the formal science-based risk assessment and which should be evaluated?
To me, this is a challenging question which constitutes the core of the present exercise, and is not only relevant to environment but also health issues:
1- If such aspects can be clearly defined (e.g. higher order effects), what would be the precise science-based framework to be adopted in order to address them adequately? Would it be a formal with systematic sequential steps like risk assessment (hazard identification, hazard characterization, exposure assessment and risk characterization), or another formal approach as yet to be developed? In the latter case, which is probably true, such approach should also be science-based (some how) and accepted by all Parties as leading to meaningful and reliable outcomes that can effectively assist decision-making to take SEC into account. Otherwise, "no permit" decisions may be regarded as economically and politically biased, and would give rise to trade disputes within the WTO.
2- The question may be more challenging when it comes to health issues raised by GMO foods and their relationship to SEC, since RA, as currently carried out, is rather a comparative study based on substantial equivalence than a RA per se. For the best, the GMO will be the closest possible to its conventional parent, and this would not discriminate between health effects on indigenous and local communities compared with "the general population" or "groups at risk", unless these communities are considered de facto as groups at risk, which will be highly questionable.

Therefore, I would agree to consider that RA as presently adopted (expected to keep being refined/revised as new scientific data are available, and which in some cases considers specific groups at risk) adequately addresses the “quantifiable” (when sufficient data are available) environmental issues related to GMO release/trade. 

On the other hand, I would suggest to focus on aspects such as the impact on:
• Cultural heritage of traditional knowledge,
• Nutritional habits,
• Change of agricultural practices leading to the change of the whole way of life on the long run;
o Increased dependence of small farmers in the developing countries on imported/expensive seeds (e.g., use of male sterile GMO seeds would eventually make them the only available seeds on the long rum)
o Complete and progressive substitution of traditional crops in a given area for GMO crops (economically more profitable on the short and medium run);
o Small farmers giving up farming (unable to afford increasing costs for farming) leading to rural exodus, etc.

Although, as was pointed out by Dr. Durham, even small farmers may take advantages of GMOs if adequately selected and properly used, and this should also be part of risk management of GMOs, which normally targets a balanced benefit/risk

Finally, when considering GMOs, it is unavoidable to raise the question of how deep will be the economic gap between industrialized and developing countries on the medium and long run with increased liberalisation of GMO trade, as the former are GMO producers (sellers) while the latters are mere users (buyers) and providing “experimental fields”?

Beyond the fact that GMOs are now a reality that we have to deal with in a way to protect each Party’s interest, I suppose that (1) Nagoya and (2) Nagoya – kuala lumpur supplementary Protocols partially address this specific point by: (1) advocating equitable benefit sharing with a clear emphasis on interests of developing countries, and indigenous and local communities, and (2) the liability and redress of any damage (intentional and non-intentional) caused by GMO usage and transboundary movements. (discussed previously in question 2)

Thanks

Noreddine Benkerroum

Dear all

I agree with Andreas’ observations. The AHTEG, in its “Elements of a Framework for Conceptual Clarity on Socio-Economic Considerations” clearly indicates that ecological (including environmental) dimensions that are not addressed in risk assessment may be addressed when taking socio-economic considerations into account.

So it is not a matter of repeating the environmental risk assessment, when taking socio-economic considerations into account, as some fear. This would clearly be redundant. They are distinct processes, but at the national level, should Parties exercise their right to take socio-economic considerations into account, they may be integrated and complementary to greater or lesser extents, and can usefully inform each other.

The question then is, what are the environmental-related aspects that may not be addressed in the risk assessment, that of relevance to socio-economic considerations? I believe, as mentioned by others, that these include higher order and indirect effects, as well as those of a longer-term nature.

For example, a question that could be asked of herbicide resistant crops is: Would changes in agricultural practice for weed management, in the event of development of weed resistance, affect biodiversity (terrestrial and aquatic), e.g. due to an increase in volume and toxicity of herbicide used? This is a socio-economic consideration with an environmental/ecological dimension, and there are social (e.g. health risks) and economic (e.g. increased costs of purchase of inputs) impacts. Such questions may not be asked directly in a risk assessment in some jurisdictions, but are important considerations for a decision-maker.

In addition, when we talk about sustainability, the environment is clearly one of the main pillars and as shown by the example above, there are mutual influences between the three pillars of environment, economy and society. We need to be able to address these different aspects in relation to LMOs.

kind regards
Lim Li Ching
Third World Network

In Brazil we only have LMO's that have received transgenes that will have no impact on improving productivity gains. Proteins like EPSPS, PAT, CRY, VIP and similar ones do not lead to productivity gains because they have no effect on the metabolisms involved with this. I am very surprised that it is different in other countries. I know that eventually, when a crop is confronted with a very large infestation of insects or weeds, these characteristics permit partially sustaining the potential productivity ... but this surely does not occur every time, everywhere,  because the infestation does not allow it. Surely, it is better in the absence of problems, when the potential productivity can be manifested without resistance. So where are the productivity GAINS coming from?  It is obvious that the reduction of insects in a given year will not be repeated each year... But yes, there are true management simplifications, which create benefits that are notably clear on large scale farms. This explains the adoption curve. Another reason is the oligopolization of seed markets and the absence of alternative seeds, at least in Brazil.
On the other hand, the massive use of the same toxins and herbicides year after year surely affect the trophic chains and consequently benefit some organisms (and damage others). Will this only have positive impacts on soil life? Perhaps...and considering the doubt, we need to examine these impacts on the life of the soil and its activities because this directly relates to food security and socioeconomic aspects of food production. How can we foresee this without evaluations? We have already seen that the excessive confidence in previous studies did not consider scale effects! This is not an academic question: the release of GMOs has effectively led to various policy outcomes and scientific publications that are at least contradictory. For example, consider this claim: “the statement concludes that the scarcity and contradictory nature of the scientific evidence published to date prevents conclusive claims of safety, or of lack of safety, of GMOs. Claims of consensus on the safety of GMOs are not supported by an objective analysis of the refered literature.” (Angelika Hilbeck, Rosa Binimelis, Nicolas Defarge, Ricarda Steinbrecher, András Székács, Fern Wickson, Michael Antoniou, Philip L Bereano, Ethel Ann Clark, Michael Hansen, Eva Novotny, Jack Heinemann, Hartmut Meyer,Vandana Shiva and Brian Wynne, 2015. No scientific consensus on GMO safety. Environmental Sciences Europe 2015, 27:4  ;  http://www.enveurope.com/content/27/1/4/abstract.)
Clearly, these concerns regarding LMO impacts on health and biodiversity do not exclude any future biotechnological contributions, but require attention in the present and allow affirming that favoring biotechnology that threatens future biodiversity resources is not justified.
If we discuss damages as problems to be expected this means that we know there will be implications; it is expected that similar events will occur. The problem is when and where we will have to confront them. And naturally there are other kinds of situation that we don’t know much about and so there are unexpected issues. For both cases we need to try to make projections about possible risks.
This is not a theoretical claim and does not suppose zero risk like some insist on repeating. There are occurrences that we need to consider before they cause real and significant damages in all kinds of risk dimensions.  It is true that we have publically funded institutions to monitor LMO's but it is not certain that their assignments would be properly done and with the accuracy that some analysts seem to idealize.
...
Lets return to the Brazilian case. Mr. Sousa says that “we have a high-level government body (The National Biosafety Council - CNBS) which has this task (SECs) and is responsible for making the FINAL DECISION to approve a product for market or not”.
“In practical terms, if the technical body to approves a commercial product, the CNBS may or may not approve it based on SECs. If the technical body rejecting a commercial product, the CNBS can not reverse this decision, as this would imply the safety of the product in the market.” And “In 2007 and 2008, at which time when the first genetically modified maize were was approved, the CNBS was triggered by the registration and supervisory bodies to the considerations of SECs. In all three cases, the Council sustained commercial approval.”
Unfortunately the CNBS made only these three examinations – concerning precisely the cases mentioned above. Most of the 70 LMOs have been liberated in Brazil without any socioeconomic evaluation (CTNBIo – the mencioned  “technical body” - does not do this and neither  does the CNBS). And what about post-release monitoring? The situation is almost the same: we don’t have information about the scale problems for the millions of acres cultivated in Brazil. Considering the large frontier with Uruguay, Argentina, Paraguay, Bolivia and Peru…, I believe we must carefully examine some risks considering the possible international consequences.
Another concern is the link between the use of herbicides such as 2-4-D and the emergence of resistant plants in GM crops (Mr. Sousa, observing that we do have tolerant weeds says “it's important to remember that this technology is approved but is NOT available in the Brazilian market”). This is true. We already have tolerant weeds. But we can observe that Dow’s expectation for Enlist technology is that it will account for almost 60% of the area cultivated with soybeans (that is 16 million hectares). This implies the application of millions of liters of 2,4-D. It is obvious that the selective pressure imposed on ecosystems will force the emergence and explosion of biotypes with resistance to this herbicide. In this case we can affirm that it will happen. It will happen in the soybean regions in the Central-west, Paraná and Rio Grande do Sul. When? The experience with glyphosate suggests that it will occur in four or five seasons. Which socioeconomic problems can be expected from this? Damage to soil communities, damage to neighboring areas due to drift, reduced economic results, health damages due to contamination of the water and so on. Can we affirm that those impacts are not conected to LMOs that promove the 2,4D use?
Leonardo Melgarejo

Dear all,

In my opinion there is not such a ´higher order effects´ to include SEC in the RA phase as commented by some participants. In the context of CPB there is an OBLIGATION to conduct risk assessment according to Annex III and there is the POSSIBILITY of a country to include SEC in the decision-making.

That means if the conclusion of RA is that the LMO is safe when compared to the conventional counterpart and estimated risks are acceptable or manageable the country COULD consider in reaching a decision on import socio-economic considerations specifically related with impacts in biological diversity in the indigenous and local communities.

So if we have a risk assessment based on the CORRECT RISKS HYPOTHESIS we will identify and evaluate the potential adverse effects of LMO in the conservation and sustainable use of biological diversity. That means  there is no reason to try to put the SEC in the context of Article 26 under the umbrella of RA just using other names for SECs like long term or indirect effects. 

Best regards,
Luciana P. Ambrozevicius

Dear All,

It is very encouraging to see such a lively debate and so many posts in this exchange.

While I agree with those who have expressed that some of the discussions are moving beyond the questions posed, but I believe that that is almost inevitable for several reasons, e.g.: there are different views about the objective of article 26 in general and of SECs in particular and there are different views of the scope of environmental risk assessment (ERA).

Let me quickly address these points:

Article 26 is about decision making and SECs that may in some cases help fine tune the decision making.  As Ranjini and many others said, ERA and SECs are two different processes having different mandates and objectives and therefore SEC cannot be part of the ERA.

As for SECs, I support what Magnus Gouse observations in relation to the two categories of SECs that he distinguished.

As for decision making, I agree with Ben Durham’s point that SECs are to assist in decision-making, and this is not an academic exercise, regulators need to be pragmatic. I also agree with Stuart Smyth’s observations that SEC's projections can go in many different directions, or just be inconclusive, depending on the assumptions made. It is in that context perhaps good to remind ourselves that unlike many articles of the CB article 26 does not talk about “potential effects” but about “impacts”.

As for the scope of ERA: I support the views expressed by Luciana Ambrozius

Best regards

Piet van der Meer

Dear Colleagues

I have been following the debate on question 3 with great interest.

In my opinion, as already stated by a number of participants,   Risk Assessment under article 15 and SEC under article 26 on the impact of LMOs on the conservation and sustainable use of biological diversity are two different processes having different mandates and objectives and therefore SEC cannot be part of the risk assessment under article 15. Further, risk assessment is a mandatory provision whereas SEC is a voluntary.

However, risk evaluation on the impacts of LMOs under article 15 is often qualitative and at times subjective based on the risk hypothesis. Often the impacts are ascertained as “ low”, “medium” and “high”.  It is at this stage SEC becomes an important tool for decision making. In this context, I support the views expressed by the participant from Colombia where as a case in example, SEC becomes important when the risk evaluation concludes that the LMO technology will have an impact on pollinator species and its economic importance in the region may be affected.  The reverse could also be true where release of insecticidal protein gene can have a beneficial impact due to reduced pesticide use.  

I also agree with Dr Lalitha, India that LMO's are not to be treated differently than conventional hybrids in the SEC as its impact on crop species diversity is similar to any other crop improvement program. 

The issue of resistance development is a management issue and not unique to LMOs and SEC in this context are to be considered in light of experiences gained from conventional practices.

Thank you.

Dear colleagues
I have been following the discussion for the last few days and I have seen this comment that some of the issues mentioned do not fall inside the scope of the article 26 of the protocol. However, article 26 of the protocol do not put any restriction on the scope of socio-economic considerations to be taken on board and if we carefully look at the language of the article we will just see that it highlights the importance of socioeconomic considerations arising from the impact of living modified organisms on the conservation and sustainable use of biological diversity, especially with regards to the value of biological diversity to indigenous and local communities. Nothing in the article says that you need only to consider them and nothing else.

I want also to highlight that for a better understanding of the protocol you need to carefully consider the context of the protocol and its relation with the mother convention.

The CBD recognizes the close interrelationship between biological diversity and indigenous and local communities, in particular their role in the conservation and sustainable use of biological diversity. This recognition is enshrined in the preamble of the Convention and in its provisions.

Aiming to reach its objectives, Articles 7 to 10 of the CBD establish clear and mandatory biosafety and socio-economic provisions for Parties:

• Article 7 establishes the mandate, in particular for the purposes of Articles 8 - 10, to establish a system for identification and monitoring of components of biological diversity that are important for its conservation and sustainable use. In addition, to identify and monitor the effect of processes and categories of activities, (which would include modern biotechnology), which have or are likely to have significant adverse effects on the conservation and sustainable use of biological diversity. An indicative list, clearly including socio-economic aspects, of categories of components of biological diversity to be considered is set out in Annex I.
• Article 8(g), together with Articles 19(3) and 19(4), relate to living modified organisms (LMOs), and gave origin to the Cartagena Protocol on Biosafety. It implies that Parties should establish or maintain means to regulate, manage or control the risks associated with the use and release of living modified organisms resulting from biotechnology and are likely to have adverse effects on the conservation and sustainable use of biological diversity, taking also into account the risks to human health.
• Article 8(j) provides that Parties need to put in place measures to: i) respect, preserve and maintain the knowledge, innovations and practices of indigenous and local communities relevant for the conservation of biological diversity; ii) promote their wider application under the approval and involvement of the corresponding knowledge holders; and iii) encourage equitable sharing of benefits arising from the use of biological diversity.
• Article 10 specifically provides for the sustainable use of the components of biological diversity. Both “sustainable” and “use” are intrinsically socio-economic issues in themselves (Catacora-Vargas 2012), captured by specific elements - such as protection and encouragement of customary use, consistency with traditional cultural practices – spelt out in the CBD´s Article 10.

The Cartagena Protocol on Biosafety linked to the Convention on Biological Diversity

In Article 19(3) of the CBD, the Convention’s Parties are called upon to consider the need for and modalities of a protocol for the safe transfer, handling and use of LMOs resulting from biotechnology that may have adverse effect on the conservation and sustainable use of biological diversity. In order to address this mandate, the Conference of the Parties (COP) to the CBD decided, at its second meeting, to develop a protocol on biosafety, specifically focusing on transboundary movement of LMOs. In 1996, the CBD’s COP established an Open-ended Ad Hoc Working Group on Biosafety to develop a draft protocol, which was adopted as the Cartagena Protocol on Biosafety (CPB) in January 2000 and entered into force on the 11th of September 2003.

The CPB, as any other protocol, is related to its parent treaty, the CBD, through substantive, procedural, and institutional links; accordingly, it must comply with the Convention’s provisions when implemented. Moreover, Parties to the Protocol have to also be Parties to the CBD (Article 32 of the CBD). Thus, the CPB cannot be read separately from the CBD, but in conjunction with each other since the Protocol implements the Convention.

Under the Protocol, according to its Articles 10, 11 and 15, Parties are required, in reaching decisions on LMOs, to take into account potential effects of the LMO concerned on the conservation and sustainable use of biological diversity, taking into account risks to human health.

Socio-economic considerations within the Protocol are not restricted to Article 26. One of the most important socio-economic issues addressed in the Protocol is explicitly stated in all the relevant provisions of the CPB, particularly its Article 1 (Objective) and Article 4 (Scope) which emphasize the need to take into account the risks to human health when considering the possible adverse effects of LMOs. The issue of public health in itself has a strong socio-economic dimension.

O.A.El-kawy

Dear e-forum participants,

As introduction to this post, it is important to mention that biosafety research and regulation, technology assessment (including risk assessment) and the precautionary approach relate to both ecological and socio-economic aspects, since both are intrinsically intertwined issues. This does not apply only to LMOs but to any technology, and human project, initiative or activity.  This is not new; along history and in current times there is an abundant body of examples on how ecological aspects influence socio-economic dynamics and vice versa. In the context of the Cartagena Protocol these issues may seem to be separated issues; yet, it is just because Art. 26 is a compromise text, both in content and degree of obligatoriness (given the strong contrasting positions of including or not socio-economic considerations). Yet, this does not exclude that in reality we are dealing with highly entangled aspects at normative and technical levels.

Following the mother treaty (the Convention on Biological Diversity), the Cartagena Protocol integrates ecological and socio-economic issues along its text, starting from the Protocol´s objective. Art. 1 makes explicit the Protocol´s alignment to Principle 15 of the Rio Declaration on Environment and Development; focuses on the safe transfer, handling and use of LMOs, all of them referring to socio-economic processes; and aims at the conservation and sustainable use of biological diversity taking into account the risks to human health. Art. 26 is not a stand alone provision; hence, it is ascribed to the Protocol´s objective, adding the relevance of the value of biological diversity to indigenous and local communities.

Possible ecological-related aspects of socio-economic considerations that could arise from LMOs and that are relevant in the context of Art. 26 are of first (direct) and second (indirect) order in the short, mid and long term in relation to the genetic modification, its expression and the associated technologies (e.g. technological packages in the case of LM crops). For example:

- Changes in the dynamic in the medium and long term of non-target organisms that influence crop´s productivity (e.g. pollinators) due to exposure to the toxins inserted in LM crops resistant to Lepidoptera insects.

- Changes in fitness of landrace varieties due to introgression of transgenes, potentially affecting landraces availability for production, consumption and cultural practices, among others.

- Emergence of herbicide-tolerant weeds to herbicides related to LM crops (e.g. glyphosate or glufosinate) resulting in changes in weeds management and production costs.

- Changes in the soil biota – in the medium and long term, due to the accumulation of toxins or pesticides related to the genetic modification (e.g. Cry proteins in the case of LM crops resistant to insects, or glyphosate in the case of LM crops tolerant to herbicides), and the corresponding effects on soil fertility and equilibrium of soil micro biota populations (e.g. changes in soil-borne diseases); resulting at the same time in effects on crop productivity, management costs and production stability.

- Bioaccumulation of the herbicides related to the management of LM crops tolerant to herbicides, and its potential effects on wild flora, wild and domesticated fauna, and human health.

These are examples on the direct and indirect relationship between the genetic modification, the conservation and sustainable use of biological diversity, and a socio-economic effects also considering human health.

Certainly these and many other socio-economic considerations should be approached in a practical but also responsible manner, since one of the main driving principles of decision making processes is the responsibility to promote and preserve common welfare, a multi-dimensional issue in itself and recognise as such in different pieces of national regulation, e.g. the Bolivian laws related to the Rights to Mother Earth.

Possible ecological-related aspects of socio-economic considerations could be distinguished from others covered in other Protocol´s processes by identifying the LMO effects on, inter alia:

- The conservation of biological diversity relevant to local livelihoods.

- The sustainable use of biological diversity and the ecosystems that sustain it (this in accordance to the biodiversity and ecosystem definitions of the Convention on Biological Diversity).

- The welfare and livelihoods of indigenous and local communities.

- Human health issues related to public and global health.

- Local knowledge relevant to the conservation and sustainable use of biological diversity, taking also into account human health.  

Kind regards,

Georgina Catacora-Vargas

Dear colleagues:
Unfortunately, I was not able to participate on the first two questions, nevertheless I have been following the discussion, so, my comments regarding to those 2 questions, could be read at the end of the discussion.
I totally agree with Dr. Heissenberger and by other participants: the socioeconomics considerations are related with the environment and biodiversity.
I have had the opportunity to participate on SEC’s online discussions on 2011 & 2013 and some of the aspects have been already discussed. However nowadays I think we need to provide to the AHTEG the proper elements to fulfill its mandate. Dr. Heissenberger also believed “that there are quite a number of environmental aspects which are not (always) covered by the risk assessment process and which might have an influence on biodiversity, possibly causing economic or social effects. Usually higher order effects, as has already been mentioned, are not covered in risk assessment” and the colleague from Philippines, Dr. Leonardo Gonzales, stated a series of indicators to be considered that is why the acknowledgment of SEC’s is a complement on the risk analysis. A real example –no an academic one- that happened on Mexico, it’s the utility of an ex-ante study of the economic and social effects prior the authorization of a LMO’s liberation permit.
Briefly, I will try to adapt the indicators presented by Dr. Leonardo Gonzales.

The EU in case C- 442 /09, determined to prohibit the sale of honey pollen containing unauthorized crop pollen, or at least to be tagged when containing more than 0.9% of pollen from GM crops authorized. In 2011, 42 tons of honey were detained at the EU because they contained pollen of transgenic soybean-- sown in Campeche, a honey producing region of the Yucatan Peninsula-- (Mena, 2012) .
             However on 2012, on Mexico the commercial sowing for 253 mil 500  hectares of soya GM was approved on seven states, three of which compose Yucatan Peninsula that is the region of production of organic honey for 21,000 beekeepers of which 85% are small producers mostly indigenous. Honey production is for being exported to the European market.
Upon this situation, there was a huge discontent of the producers and in general of all society. In March 2014, a judge rescinded the prearranged permit and prohibited the planting of soy beans at Campeche. In April 2014, the EU modified the rules and defined pollen as a natural component and not as a honey ingredient, which completely eliminates those cases that are reportable in food labeling the presence of GMOs.
Now, considering those indicators by the colleague from Philippines, we can realize:

• “Productivity, cost efficiency, net farm income and global cost competitiveness.” There are cost-benefit studies showing that de loses for the region are bigger if they stop the honey export than the income that they can obtain from planting transgenic soy. The coexistence of GM honey and soy, affected the honey’s free trade and Mexican competitiveness on honey’s world market.
• The other indicators: “ability to attain food security and alleviate poverty, return on investment, resource use efficiency.” The production of honey for small farmers is a supporting activity for their staple crops; the absence of this income turns their productive system even more vulnerable. The expansion of GM soy monoculture affects the biodiversity that bees use and threatens an export market for thousands of producers.
• Unlike Philippines, on Mexico there is not any kind of evaluations after the commercial planting has been approved.

With this example, I wanted to illustrate that, if the authorities had had an socioeconomically study, their decision maybe might have not been the same, for example giving the authorization on the other states that are not honey producers and not releasing the soy at Yucatan and Chiapas.
That might have saved to range a judge for defending the honey exportation market.  This case is a clear example of the importance of taking into account the SEC and ex ante studies for decision making. If the SEC’s are postponed for risk management, the odds of redirect the technology to a wide social benefit are limited.

Dear All

A SA perspective on key points:

1) We need to constantly remind ourselves that 'direct' SE impacts from LMOs are not in the scope of Article 26. Rather the article's scope is on those SE considerations which arise from biodiversity impacts. Although there is much passion about general SE impacts (which includes a variety of actual examples), the majority fall under the 'direct' SE impacts category, and -if we are to provide clarity to MOP on article 26- need to be excluded.  This is not at all dismissing the importance of them, but countries can choose to consider or manage such impacts under domestic legislation.

2) There have been a variety of contributions on environmental impacts, which has permitted the development of certain categories of possible impacts which could then form the basis of assessing a possible socio-economic impact. Some of these categories may well be detected in the normal risk assessment process (eg. non-target impacts), which could subsequently inform SE considerations. But certain of them may arise because we are looking for possible SE impacts arising from LMO-biodiversity affects (eg. Weed diversity, possibly as a result of resistance to existing herbicides; soil 'fertility' (if such results from soil microbe biodiversity affected as a possible result of bio-accumulation of the proteins derived from the introduced LMO trait; pest and disease impacts.)

However,

3) SECs need to take into account existing agricultural practices, so as not to hold LMOs to unreasonably high standards (with respect to biodiversity impacts) compared to conventional varieties).

4) Possible benefits of LMOs (to biological diversity, eg. reduced need for pesticides) need to be included in SECs such that it is more holistic and balanced.

5) SECs do NOT necessarily need to be based on studies. Regulators can merely (!) consider alignment to national policy/practices, or consult with affected stakeholders (although taking into account the debate under theme/question 1).

6) 'Higher order' impacts of biodiversity impacts on SE - if examined theoretically - may well be speculative.There need to be checks and balances in place to monitor, and as appropriate manage, SE impacts.  Such a system should be well integrated with 'normal' agricultural and societal systems.
Ben

Dear All

Many thanks to all the contributions and inputs we have had - a very lively debate. We have strayed, on a few occasions, off topic, but If we are to develop conceptual clarity, this can't be at the expense of not having heard the range of views.  This, then, is not a summary, but merely a statement of conclusion of this theme.

I think the AHTEG will benefit enormously from this rich discussion.

Well done & thanks!

Ben

Discussion on question 3 is now closed. Thank you for your comments. We also thank Mr. Ben Durham for moderating the discussions this week.

We look forward to your continued participation over the coming weeks.

Kind regards,

Paola