Online discussion 2015 - Discussion Groups

Welcome to this week’s discussion group on the relationship, if any, between risk assessment and socio-economic considerations.
Discussions on this question will be held between 20 – 27 April 2015.

Ms. Angela Lozan has kindly accepted to moderate this week’s discussion. Comments may be posted until next Monday, 27 April, at 1:00pm GMT. 

Some posts last week have already touched on issues that may be relevant to this week’s discussion. We encourage you to continue to participate actively.

Dear Participants of the online discussions on socio-economic considerations,
Welcome to the fourth round of discussions of the online discussion.
Thank you Paola, for the introduction made to the 4th week of the on-line discussion.  As mentioned in the information presented by the Secretariat, the fourth round of our discussion will focus on the Question 4: Is there any relationship between risk assessment and the assessment of possible socio-economic effects? Are there any concrete examples of links between those assessment areas?
The risk assessment process in accordance with Article 15 of the Protocol is intended to evaluate all possible adverse effects of LMOs on the likely potential receiving environment. However, some environment-related aspects of socio-economic considerations may not be fully or adequately addressed during an environmental risk assessment.

This section of the discussion is aimed at collecting different views on this issue and the arguments substantiating those.

I believe that it is important to continue the discussion but to focus  more on the practical aspects and provide more detailed information.

With that I am looking forward to a fruitful discussion!

Best Regards,

Angela

Dear Colleagues,

I'd like to thank Ben for giving up some leeway with last week's discussion.

In opening this week's discussion, I think a solid starting point is to draw upon the WTO's Panel Ruling in the Measures Affecting the Approval and Marketing of Biotech Products Case filed by (and decided in favour of) Argentina, Canada and the USA against the EU over the EU's member states prohibiting or restricting markets for GM foods and crops.

The EU argued that the reasons why some of its member countries imposed bans on GM products were not inconsistent with the SPS Agreement as some of the reasons guiding those decisions fell outside of the scope of the SPS Agreement, including loss of biodiversity, protection of native crops, impacts on farms and farming systems and long-term ecological impacts. Many of these same arguments were made last week by various contributors.

The Panel ruled that identification of a potential economic impact is necessary but not sufficient for imposing a SPS measure. Measures have to be based on well-defined scientific risk assessments in order to be consistent with Article 5.1 of the SPS Agreement. Documents supporting measures must be consistent with identified risk assessment procedures themselves.

The Dispute Settlement Panel report indicated that in every instance the EU arguments had been rejected, as the EU member states had not met their obligation of basing their measures on a scientific risk assessment. The EU argued that Article 5.7 of the SPS Agreement, which authorizes measures to protect human, animal or plant life or health from imported products, provided the appropriate authority for its member states to ban and set pre-marketing approval restrictions. The Panel rejected this argument indicating that EU member state measures did not meet the procedural requirements under Article 5.7. Measures under 5.7 are subject to the other provisions of the SPS Agreement, including the requirement in Article 5.1 that the trade restricting measure be based on a scientific risk assessment.

The Panel further ruled that the EU could not rely on either non-expert civil society (i.e. environmental non-governmental organizations or eNGOs) reports or on general scientific studies, even those appearing in peer-reviewed journals, which did not otherwise provide an assessment of specific context-based health or environmental risks pursuant to specifically defined scientific protocols. Indeed, in the Panel’s view, these sources did not constitute ‘adequate’ risk assessment because, they did not look to or take into account risk assessment techniques (protocols) developed by the relevant international organizations. 

Given the conclusions of the WTO Panel on regulations restricting the trade of GM products, I think the above provides strong bearing on this week's question. If a risk assessment is not able to be scientifically quantified, the WTO has already ruled that this will be viewed as a trade barrier. More importantly, the WTO ruling that there has to be rigorous academic quality to all peer-reviewed evidence established a precedence that simple publication by a random online journal does not constitute scientific evidence, reinforces just how important it is to scientifically quantify the direct impact that any SEC assessment would attempt to capture.

I hope that this framing from the WTO sets the stage for another week of interesting dialogue.

Sincerely,
Stuart Smyth

Dear All

I think Stuart uses the case study to make a good point about the need for robust, objective, and science-based evidence IF countries are to use SECs justifications.  We have - in this online forum - seen that higher order ex ante SE impacts MAY necessarily be theoretical and/or speculative.  My contribution develops from this:

As previously mentioned, the decision-making body in SA considers the risk assessment, any public comment, and also considers 'alignment' to national policy (which obviously includes SE issues), in its decision making (i.e. concurrently).  Because SA does not deliberately introduce LMOs that have biodiversity impacts (beyond intended pest/weed impacts - I have previously described this), the SE considerations are what I have termed 'direct' SE impacts (i.e. not under the scope of Article 26).

For the higher order (Leo Gonzale's 'transcendental’:)) and specifically the UNANTICIPATED SE effects (i.e. those that arise from biodiversity impacts), SA therefore relies on - if the LMO is approved - monitoring and surveillance (by our public entities appointed to this task); industry (it is a permit condition); farmers (they WILL complain if something affects their ‘socio-economics’); the various universities (academic research); NGO;s and the public to notify the authorities of any impact.

Again, as previously mentioned, SE considerations of Article 26 is a moot point in SA because we do not approve LMOs for release if they are considered likely to have a broader biodiversity impact.  Case specific, but the reasons for rejecting a LMO are based on the risk assessment, and/or potential direct SE impacts (with robust evidence). 

The decision-making body can impose a specific monitoring requirement ex post (i.e. on the release of a LMO) on the applicant, can initiate a government-funded study, and more, to verify the assumptions of any risk assessment.  Hence unanticipated SE impact COULD be determined in a manner which more easily provides robust evidence  to convince regulators to revoke a permit (not yet happened in SA), and comply with the standards of the Cartagena Protocol.

Ben

Dear All,
Thank you Ben in clearly describing the decision making process of SA on risk assessment and its relationship with SECs.
We have basically a similar decision making process in the case of the Philippines. The risk assessment is the basic criterion for the approval of the commercial propagation of LMOs. The ex ante socio economic analysis,although a part of the decision making process, does not provide the basis for the decision of approval/disapproval of the propagation of LMOs. However, ex post analyses and continued monitoring of the LMO are done when the LMO is already traded in the market place.
These decision making processes of course imply the use of robust and science-based(Stuart) analytical procedures. If SECs become a compulsory requirement for commercial approval in the commercial propagation of LMOs, the danger is that the ex ante analysis is not robust and very limited for the simple reason that the LMO has not yet been tested by actual forces of the market.
That is  why there is wisdom in making Article 26 of the Protocol voluntary..It leaves room for flexibility among members!
Kind Regards,
Leo Gonzales

Dear All,
Let me post a quick note of appreciation to Dr Michelle Chauvet of Universidad Autonoma for bringing into fore Mexico's export of organic honey to EU and the commercial propagation of LMO soybeans.
The Mexican case simply illustrates the need for due diligence in conducting science based researches prior to LMO introduction(ex ante), and after commercial approval(ex post). I think this science culture be it in RA, ERA, and Social research(SECs) should be an integral part of the decision making process of individual member countries of the Cartagena Protocol.
My query to Dr Michelle at this point is:If your ex post analyses of the three States of Yucatan Peninsula indicate negative transcendental effects, using the indicators we have used in the Philippines, does your Regulatory System have the power to withdraw the commercial use of
GM soy in these three States? or on a wider application, are there member countries of the Protocol where  LMOs which have been commercialized for sometime were withdrawn because of negative transcendental effects?
I honestly believe that the more we present and understand specific country cases  in this forum on socio economic considerations, the better help  AHTEG on SECs in defining with conceptual reality Article 26 of the Protocol. In this regard, my warm appreciation to Dr Michelle for presenting the Mexican case.

Kind Regards,
Leo

Dear Participants,

Some answers to question 4 makes it very clear that it is impossible to associate a risk assessment and the assessment of the possible socio-economic effects, considering the case, as already mentioned in my answer to question 3, totally different scenarios.
This is because the risk assessment of LMOs sticks solely to SCIENTIFIC aspects of the product developed, at which the developer seeks to demonstrate the absence of any adverse effect (risk) of your product, either for human and animal health, is to the environment, without which the developer will not get the desired approval.
Hence the correctness of the opinion externalized by Dr. Leonardo Gonzales, Philippines, which harmonizes completely with my point of view, to the extent that any commercial approval based on ex ante socioeconomic analysis is not able to provide the basis for any decision. We must consider the limits inherent in the nature of this type of analysis, “for the simple reason that the LMO has not yet been tested by actual forces of the market”.
Although, as also the example given by Dr. Ben David Durham, South Africa, his country has adopted similar process to the Philippines in making their decisions, there is no possibility that the SE issues are considered, since the possible impacts are “direct”, with solid evidence, so, on biodiversity, it is not under the scope, however, in Article 26. Any consideration of potential impacts SE ex ante, outside that context, could actually be only theoretical and / or speculative.
Again, therefore, reaffirm the wisdom of their own art. 26, to accommodate an optional clause on the subject, leaving a healthy "room for flexibility among members," in the words of Dr. Leonardo, Philippines.
Despite the possibility that the SEC are made ex ante in Brazil, this procedure is not under for the group of experts from the National Biosafety Technical Commission (CTNBio), which only analyses the risk assessment and approves the commercial release of LMO. Is under a Board of Ministers of the Federal Government the power to assess, with regard to SE, such approval prior to marketing the product, without, however, any mandatory.
Anyhow, Brazil has adopted the ex post commercial release monitoring, with the sole purpose of assess possible adverse effects to the environment or to human or animal health, not identified in the risk assessment of an LMO.
Best regards

My answer to Dr. Leonardo Gonzales from Philippines is that in Mexico ex post analysis is not carried out by any authority. Once cleared for commercial planting, the Regulatory System does not perform monitoring the environmental or social impacts.  For this case and by court order, sowing was suspended in the Yucatan Peninsula region.

Universities are the institutions where ex ante and ex post studies have been conducted. Despite the ban in 2013, in the case of the honey, there was presence of soybean pollen. In 2014, there was no evidence of this pollen. The changes in the European standards keep-out the labeling that contain less than 0.9% tg genes, however, for organic certification it is required zero presence of them.

Regarding the question this week, I think that it is a very reductionist perspective only to consider  the economic cost-benefit, direct effects, and its commercial implications. As other participants have stated, such as the Indian colleagues Prof. Lalitha Ashok Narayanan and Prof. Radha Krishan, assessments should be comprehensive and consider the direct and indirect consequences, and also include the short, medium and long term effects.

               In the honey case, an environmental aspect is closely related to socioeconomic considerations. The herbicide used for the RR-soybean has been seeped to the groundwater in the region that are connected by underground streams due to the calcareous rock that characterizes the soil. This situation affects the flora, fauna, and all the indigenous communities of Yucatan. Their cultural and social worldview are closely related to their environment, and not only to commercial aspects.
Warm regards,
Michelle

QUESTION 4

The possible adverse effects of LMOs as mentioned in article 15 of Protocol that are to be identified and evaluated , are those that affect biological diversity , taking also into account risk to human health. Based on the wording of that and the methodology for risk assessment set in annexe III, it appears that evaluation of each  possible adverse effect are  to be identified  then includes assessment of the likelyhood of that adverse effect and of its consequences.
Possible effects to be considerate include both short-term and long-term effects as well as direct and indirect effects. Primary effects on human health or on environment wich are result of the LMOs itself and indirect effects occuring through a causal chain of events , through mechanisms such as interactions with other organisms, tranfe rof genetic material, or changes in use of management. Therefore , it clear that socio economic impacts are inherent part of methodology introduction and adoption. This point out the need of including socio economic considerations in  biosefaty decision making related to GMOs.

Proper socio economic assessment require going beyong the common practice  of economic assessments , but aiming towards sustainable development . In order to carry out these socio economic assessment relevant to precautionary principe and sustainability assessment are  needed, completed with regular monitoring ( ex post).

We totally agree with Ben when he mentioned that :
- The reasons for rejecting a LMO are based on the risk assessment and / or potantial direct socio economic impacts.
- The decision-making body can impose a specific monitoring requirement ex post
- government can initiate study to verify the assumptions of any risk assessment . Hence , SE impacts could be determined in a manner wich more easly provide evidence to convince regulators to revoke a permit .

thank you

Dear Forum Participants,

I would like to thank Stuart, Ben, Leo and Koffi Edinam for your interesting and very useful input and opinions into the online discussion on the Question 4.

I encourage other participants to also make their contributions to this forum during the remaining time of the round.

You may wish to bring the experience of your countries/regions/organizations that have practicing the evaluation of risks and socio-economic consideration related to LMOs.

The forum is looking for provide better understanding of possible correlation between the Art.15 and Art 26 of the Protocol, that may involve an analysis of similarity of each type of assessments – risk assessment and socio-economic, as well as to identify the specificity and distinguish characters, their role in overall assessment for decision making.

As the colleagues have mentioned, the possible effects to be considerate include both short-term and long-term effects as well as direct and indirect effects.

An existent experience in combining both assessments under other international conventions and agreements would also be helpful and useful. 

Wish you further fruitful and interesting discussion!

Sincerely,

Angela

MD

Dear Colleagues:
Greetings. I agree and emphasize that SECs should be an integral part of the decision making process regarding LMOs and for this ex ante and ex post analyses done with sound methodologies would serve the purpose.  Point H in Annex III mentions that risk assessment should take in to account the characteristics regarding, “receiving environment. Information on the location, geographical, climatic and ecological characteristics, including relevant information on biological diversity and centres of origin of the likely potential receiving environment”.  Particularly on the point on relevant information on biological diversity, it should be emphasized by the countries contemplating on a particular locality for release of LMO, efforts should be made to  completely document the biodiversity of the specific locality. This diversity documentation (DD) would serve very many purposes for both exante and expost studies. In case of agriculture, DD will provide the list of crops, varieties, seed sources, trends in yield and yield disturbances if any in a particular  geographical area. Thus, DD will provide evidence on the community’s dependence on local resources. Using the field trial data of the LMO and the data from the DD, an a apriori analysis could be attempted to assess the possible impact on bio diversity. In the case of ex post analysis, the DD could serve as a baseline info to assess the after impact.  In India, under  the auspices of the National Biodiversity Board, some of the states have already taken the initiative to document the biodiversity-known as people’s biodiversity register. This exercise can very well be used to assess the risks of LMOs.
With regards
Lalitha

I think it is crucial to clarify two points raised in this comment. That being long-term and indirect effects.

Virtually all of the countries that have adopted the CPB are also party to the WTO. In cases where international trade is affected by a country's regulations, the WTO, and particularly the SPS Agreement, will be the arbiter.

The risk assessment process as defined by the SPS Agreement examines human and animal food/feed safety as well as environmental impacts. Any country that considers deviating from this globally agreed upon method for risk assessment, must have quantifiable scientific evidence to justify this move. Assessing long-term impacts would be a clear violation of a nation's obligations to the SPS Agreement. The same applies to moving beyond direct impact assessments.

Including long-term impacts and indirect impacts in a regulatory framework for LMOs establishes an incredibly dangerous precedent that would be wide open to manipulation by environmental organizations opposed to GM crops. These opponents could argue that 5 years of long-term impacts are required, then 10 years, 20 even, as well as assessing the impacts of fifth and sixth orders removed. All of these actions would needlessly delay the benefits of adopting GM crops to subsistence farmers in terms of profitability and improved health, as well as contributing to improving food security.

As I stated at the start of this round, the WTO Panel clearly established that politics will not be allowed to impede international trade. Including long-term and indirect effects is driven solely by political agendas of those opposed to GM crops, there is no scientific evidence to support assessments such as these.

I believe that policy-makers in countries that are a party to the CPB need to be fully informed about including long-term and indirect impacts into biosafety regulations. Based on the WTO Dispute Panel's ruling in the Canada, Argentina and US case against the EU, any such regulations will be a clear and evident violation of the SPS Agreement and will be required to be removed by the WTO.

This Expert Consultation is about the Cartagena Protocol, not the WTO agreements.  In the negotiations, it was left purposefully vague how the two agreements might mesh, so Dr Smyth’s comment that “In cases where international trade is affected by a country's regulations, the WTO, and particularly the SPS Agreement, will be the arbiter” is factually unsupportable.  I understand that he might not have been a part of the Cartagena negotiations, but there are records of what was discussed and decided.  This is not the forum to re-open those debates.

Smyth goes on to elaborate on “risk assessment process as defined by the SPS Agreement.”  This is quite beside the point here.  We are to discuss the the risk assessment process as defined by the Cartagena Protocol on Biosafety!

All risk assessments start with a defining action and seek to identify the first order (direct) impacts of that event (here the possible importation of an LMO).  But these impacts in turn have consequences (second-and-higher-order-effects) which may be of great importance.  The decisions as to how to “bound” the assessment and where to end the “tracing of an impact chain” are political ones, since the decisions affect different groups in a society differentially. That is to say, different groups benefit, bear the risks, pay the costs. Higher order impacts may actually be more important than direct ones. These notions are completely fundamental to the notions of assessment and there is a whole literature on these subjects.

Over 750 real-world examples can be found, for instance, in the output of the US Office of Technology Assessment which existed from 1972-1995; while the quality may vary, of course, there are numerous discussions of bounding and of tracing impact chains.  http://ota.fas.org/technology_assessment_and_congress/  An electronic archive can be accessed at http://www.princeton.edu/~ota/ .

In addition, and as well illustrated by OTA assessments, rigorous exploration of impacts sometimes cannot be quantified and this aspect does not diminish their importance. Science is indicative and exploratory, as well as sometimes being mathematical.

A simple illustration: Last summer was the 100th anniversary of the assassination of Archduke Ferdinand and his wife Sophie. Direct effect--bereavement among a handful of the nobility. Indirect effects: World War 1, the dissolution of 3 empires, the emergence of new (or re-emergence of old) nation states in Europe, the drawing of artificial borders to create nations in the Middle-East (still lots of higher order effects going on today), the Bolshevik Revolution, and some would include the rise of Nazism. These are a bit more significant, I would say than the direct tears of the Hapsburgs.  And to begin to understand all of this, quantification is not necessary.

SECs are an integral part of the risk assessment under the Protocol (else why would we assess?  Because of the impacts to important interests).  So Durham’s intervention shows how SECs are in fact being used as a major factors in risk assessment under the Protocol: in South Africa “we do not approve LMOs for release if they are considered likely to have a broader biodiversity impact” and the government “considers 'alignment' to national policy (which obviously includes SE issues), in its decision making (i.e. concurrently).”

In other words, I submit the “answer” to Question 4 (“the relationship, if any, between risk assessment and socio-economic considerations”) is straightforward and simple: SECs are a part of any adequate assessment under the Protocol.

Given that Dr. Bereano is emeritus faculty it is understandable that he won't be up on the current literature, so it is quite important to correct an error he made in the above posting. It appears that Dr. Bereano has forgotten about the part of Art. 26 that requires parties to be consistent with their international obligations. It is important for these discussions that this inaccuracy be rectified.

There is nothing remaining to "mesh" between the CPB and the WTO. All of the parties to the CPB are members of the WTO and have acknowledged that the WTO will be the international agreement to resolve trade disputes. Given that Argentina, Canada and the United States are not members to the CPB and are three of the four largest GM crop exporting nations, any trade barriers created by the implementation of SECs affecting trade of these three countries, will be dealt with by the WTO as was evidenced by their case against the EU.

Dr. Bereano could not be more inaccurate with his implication that there is somehow going to be something forthcoming that will absolve CPB parties to violate the WTO as they consider implementing SECs. The WTO panel ruling has established the international precedence for dealing with trade disputes that are not scientifically validatable. The Dispute Panel was explicitely clear in defining what constitutes proof and what does not. The intent of this case was to esablish international predence for countries considering further implementation of SECs that negatively affect trade. Recent literature has been very clear in clarifying this this ruling.

A country has the sovereign right to undertake any risk assessment it wants to. However, as in accordance with the wording of Art. 26, any RA has to be consistent with their international obligations, thus meaning that any RA based on socio-economic issues has to be compliant with the SPS Agreement's definition of risk assessment.

It is vitally important to participants of this dialogue event, that this error be corrected and properly validated.

Sincerely,
Stuart Smyth

Since this is the heart of the matter, I will reply--but only briefly.

There is no decision, of the WTO or any other body,  as to whether an assessment is TOO BROAD, by the inclusion of SECs or for any other reason. The  decision Dr Smyth  references was one where  The Dispute Resolution Panel found there was either NO ASSESSMENT AT ALL (the Member State bans) or an INADEQUATE one (the EU Commission).  This is not a precedent concerning a State using SECs as part of its decision-making .

And whether it is one-step (as  apparently, in South Africa, according to Dunham) or two (as in Brazil)  before the decision-making is a mere formality.  The issue is can SECs be taken into account in the decision, and the answer is yes--both in terms of the Protocol text and in terms of the actual practice of actual States.

Anyway, the WTO Dispute Resolution Body is not the final word as to whether the WTO trumps the Protocol. The answer to that question has been left ambiguous by the nations of the world. And since  WTO decisions are often not fully followed by the WTO losing Parties, it is a stretch to say they are very authoritative about anything  (eg, the US leveled tariffs on EU goods because the EU would not/could not follow through and implement the decision ).

"Emeritus" need not imply senescence.

Phil Bereano

Dear Angela, Dear all
There is a very strong relation between risk assessment and socio-economic considerations.

Annex 1 of the CBD identifies components of biological diversity important for its conservation and sustainable use. Those components are to be monitored (article 7 of the CBD) and protected against adverse effects that might be caused by any process or human activity that may impact them such as the introduction of LMOs in the environment.

In the following example, I will try to clarify how this relates to socioeconomic considerations and risk assessment:

If a country identifies in its policy that a given species needs to be protected.

The species may be important for being threatened; wild relatives of domesticated or cultivated species; of medicinal, agricultural or other economic value; or social, scientific or cultural importance; or importance for research into the conservation and sustainable use of biological diversity, such as indicator species.

In the problem formulation step of risk assessment, the scenarios need to be built in a way that makes sure that this particular species is not harmed by the introduction of the LMO

The same not only applies to species but to also to Ecosystems and habitats: containing high diversity, large numbers of endemic or threatened species, or wilderness; required by migratory species; of social, economic, cultural or scientific importance; or, which are representative, unique or associated with key evolutionary or other biological processes

What needs to be protected can be only identified by the country itself; also it is important to highlight that sometimes risk assessment conducted elsewhere may not take into consideration the protection goals of a country and that is why the protocol highlights the importance of taking into account the potential receiving environment

Regards,
O.A.El-Kawy

Dear all;
I would like to share our comments according our regulation on the issue of GMOs:

In Mexico according to the Law on Biosafety of Genetically Modified Organisms and regulations there are three stages to the environmental release of genetically modified organism: release in experimental stage pilot program and commercial release, each stage has different aims:
Experimental stage: studies of potential risks that the release of GMOs could generate the environment and biodiversity, as well as animal, plant and aquatic health.
Pilot program: The main objective is to perform cost-benefit assessments, but sometimes can make assessments of risk to the environment that magnitude of the experimental stage could not be performed.
Commercial stage: During this stage, reports results of previous (experimental and pilot program) and derived from the results discussion, the relevance of a commercial release is defined at this stage that this information is requested monitoring possible effects.
Due to the above, considering that there is a relationship between risk assessment and evaluation of the potential socio-economic impacts in terms of having elements for commercial approval of an event in Mexico but they are handled separately, because the risk assessment is performed previous to the authorization of the experimental stage and it is only from the environmental point of view. Assessments of the socio-economic aspects are important according to Mexican law, but only are considered as additional elements to decide on the experimental release into the environment, and next releases as a pilot program and commercial stages, and are considered as an aspect of decision, although made supported by scientific and technical evidence, not closely related to Risk Assessment (ER).

Information about the Mexican regulation can be found at the following links:
•Law of Biosafety of Genetically Modified Organisms (LBOGM)]: http://www.diputados.gob.mx/LeyesBiblio/pdf/LBOGM.pdf

•Rules of the LBOGM: http://www.diputados.gob.mx/LeyesBiblio/regley/Reg_LBOGM.pdf

Dear all;
I would like to share our comments according our regulation on the issue of GMOs:

In Mexico according to the Law on Biosafety of Genetically Modified Organisms and regulations there are three stages to the environmental release of genetically modified organism: release in experimental stage pilot program and commercial release, each stage has different aims:
Experimental stage: studies of potential risks that the release of GMOs could generate the environment and biodiversity, as well as animal, plant and aquatic health.
Pilot program: The main objective is to perform cost-benefit assessments, but sometimes can make assessments of risk to the environment that magnitude of the experimental stage could not be performed.
Commercial stage: During this stage, reports results of previous (experimental and pilot program) and derived from the results discussion, the relevance of a commercial release is defined at this stage that this information is requested monitoring possible effects.
Due to the above, considering that there is a relationship between risk assessment and evaluation of the potential socio-economic impacts in terms of having elements for commercial approval of an event in Mexico but they are handled separately, because the risk assessment is performed previous to the authorization of the experimental stage and it is only from the environmental point of view. Assessments of the socio-economic aspects are important according to Mexican law, but only are considered as additional elements to decide on the experimental release into the environment, and next releases as a pilot program and commercial stages, and are considered as an aspect of decision, although made supported by scientific and technical evidence, not closely related to Risk Assessment (ER).

Information about the Mexican regulation can be found at the following links:
•Law of Biosafety of Genetically Modified Organisms (LBOGM)]: http://www.diputados.gob.mx/LeyesBiblio/pdf/LBOGM.pdf

•Rules of the LBOGM: http://www.diputados.gob.mx/LeyesBiblio/regley/Reg_LBOGM.pdf

The fourth round of discussion on the relationship between risk assessment and the assessment of possible socio-economic effects is very useful and interesting.

Stuart says “Including long-term impacts and indirect impacts in a regulatory framework for LMOs establishes an incredibly dangerous precedent that would be wide open to manipulation by environmental organizations opposed to GM crops’. One could argue that the contrary is also true.  The intention is not to oppose the LMOs, but if, “robust and science-based analytical procedures’ as he puts it, establishes such long-term and indirect impacts, should we not consider them?

It is interesting to note Dr Bereano’s expression of first order (direct) impacts and the second-and-higher-order-effects. I think this is precisely the answer to the question on the relationship between risk assessment and socio-economic effects, the former is concerned with first order impacts while the later on the high order effects.

For me, when we talk about ‘second-and-higher-order-effects’ it really means SECs.  The very nature of social science research is on the behavior of the society, which is not like writing a chemical equation or writing a law on physics.  It may not be a ‘science-based analytical procedure’ as Dr Stuart puts, but there is well established scientific methodologies for social science research to analyze such impacts.

If we limit our concerns with first order effects only, not considering the second-and-higher-order-effects, it would be just like science for the sake of science. More important is how science impacts society.

Dear participants,

I understand the CPB clearly states that the Art. 15 is an obrigatory step based on available scientific evidence, comparative approach and carried out on a case-by-case basis while Art. 26 is a facultative step that describes the possibility of countries to take into account SEC under very specific conditions – impacts of LMO in the biological diversity to indigenous and local communities and respecting the international obligations. So if a country decide to consider SEC into account in reaching a decision on import should be in this context.

In my oppinion the text of the Protocol was wisely writen and put the two steps (RA to analyse safety aspects of LMO and the possibility to take SEC into account for decision making only in very restrict context) to avoid the use of SEC as trade barriers based on speculative risks. So if a country decide not to import a LMO based on a specific socio-economic consideration it has to be proven that decision was reached based on a robust assessment using the adequate protocols and scientific evidence.  

In Brazil we have three different steps for a LMO approval: an obrigatory RISK ASSESSMENT based on five main principles – stepwise approach, science-driven, case-by-case, comparative assessment and a interactive process; a OPTIONAL consideration of socio-economic aspects for the final decision making (SEC technicaly fundamented) and an obrigatory presentation and adoption of a plan for case-specific monitoring or general surveillance.

Best regards,
Dr. Luciana Ambrozevicius / Ministry of Agriculture - Brasil

Dear All,

The questions in this thread are:

1) Is there any relationship between risk assessment and the assessment of possible socio-economic effects?
2) Are there any concrete examples of links between those assessment areas?

Before addressing these questions, I must first express concern that these and earlier guiding questions go in part well beyond article 26, and that it seems inevitable that the responses and discussions go every now and then in well beyond article 26 and in various directions.

For example, the first part of the question talks about “the assessment of possible socio-economic effects”.  As the contributions of Leo, Stuart, Ben and others have shown, ex ante assessments can be very theoretical and speculative, and result in any possible conclusion about causes and effects, a bit similar to suggesting that the assassination of Archduke Ferdinand actually caused World War 1, rather than the boiling geopolitical situation of the time.

If decision making on imports could be based on ‘possible socio-economic effects’, then arbitrary decisions and protectionist measures could easily be the result.

As the preamble of the Protocol says: “trade and environment agreements should be mutually supportive with a view to achieving sustainable development”. This was the guiding principle in the negotiations around article 26, which resulted in some key elements of article 26:
a) in order to be consistent with the WTO/SPS, which requires that measures have to be based on well-defined scientific risk assessments, the trigger of being able to use socio-economic considerations in decision making under article 26 is an “impact of LMOs on conservation … (et cetera)”. As Ben correctly underlined, this must be based on robust, objective, and science-based evidence
b) article 26 refers explicitly to “consistent with international obligations,
c) article 26 refers to “socio-economic, considerations arising from the impact of LMOs on the conservation and sustainable use .. (et cetera)”, rather than to “does not refer to ‘possible socio-economic effects’.  The terms “arising from” and “impacts” are the result of long negotiations and imply something far more tangible than ‘possible effects’.

To get useful results from these online discussions we need to keep in mind the two step sequence that Luciana summarised very elegantly:
1) assessment of the safety aspects of the LMO, and
2) if the risk assessment indicates an impact on the conservation and sustainable use (et cetera), then it is possible for countries to take in the decision making socio-economic considerations into account arising from that impact.


Returning to the questions posed:
1) Is there any relationship between risk assessment and the assessment of possible socio-economic effects?
Yes, in the sense of the two steps described above, but not in the sense that an assessment of socio-economic effects is suggested to be an integral part of the risk assessment.

NB: The fact that certain socio-economic factors, such as the intended use, can be taken into account when conducting a risk assessment should not be confused with assessing for socio-economic effects.

Likewise, the fact that in the risk assessment we can take into account indirect effects such as effects on certain non-target organisms, or trophic effects, should not be confused with indirect socio-economic effects.

Finally, we should also realise that in the stage of field trials there is very little to nothing one can about socio-economic considerations, and that it would be very regrettable if important field testing research could not proceed because of speculation of what might happen if the tested plants will in the future be placed on the market.

Best regards to all

Piet

Dear all,

There is a relationship between risk assessment and assessment of possible socio-economic effects of LMOs in the context of the Cartagena Protocol, according to:

- The objective of the Protocol that refers to “safe transfer, handling and use of LMOs”, “sustainable use of biological diversity” and “taking into account human health”. All of them interrelated ecological and socio-economic aspects subject of the corresponding ecological and socio-economic assessments.

- This recognition is also indicated in the Guidance on Risk Assessment of LMO that explicitly mentions that risk assessment and decision-making process are also linked to socio-economic considerations (Art. 26), among other Protocol´s articles.

- According to Art. 26, if a Party decides to take into consideration socio-economic issues at the time of making a decision of import, such decision triggers different articles that lead to Art. 15 and Art. 16 on risk assessment and risk management a.i. Art. 10 on Decision Procedure, Art. 11 on Procedures related to LMO intended for direct use as FFP, Art. 17 on Unintentional transboundary movements and emergency measures, and Art. 25 on Illegal transboundary movements, depending on the LMO in question and the type of transboundary movement. A more detailed explanation on these relationships is available in the attached article.

There are multiple examples of these relationships. For instance the emergence of herbicide-tolerant weeds to herbicides related to LM crops (a change related to ecological risk assessment), which results in changes in weeds management and production costs (changes related to socio-economic assessment), and exposure to complementary herbicides to manage the tolerant weeds (another change linked to socio-economic assessment from the public health point of view).

Kind regards,

I think that it is clear that there is a relationship between risk assessment and the assessment of possible socio-economic effects. This is evidenced already in the objective of the Cartagena Protocol – to contribute to ensuring an adequate level of protection, and the reference to the conservation and sustainable use of biological diversity, taking also into account risk to human health – all of which point to the need for LMO assessment that also considers the socio-economic dimension, if we are to truly meet the objective.

Of course, the Protocol establishes, in Article 26, the right of Parties to take socio-economic considerations into account, and for Parties who choose to exercise this right at the national level, the risk assessment and the assessment of possible socio-economic effects may be integrated and complementary to greater or lesser extents, and can usefully inform each other. Some jurisdictions consider the two arenas to be fully integrated processes, others as distinct but complementary – this is a sovereign Party’s right to decide.

One example of links between the two assessment areas is to be found in the WTO’s SPS Agreement itself, where risk assessment involves a mix of scientific and socio-economic considerations. When assessing risks to animals and plants, WTO Members are to take into account relevant economic factors (SPS Article 5.3) – the potential damage in terms of loss of production or sales in the event of the entry, establishment or spread of a pest or disease; the costs of control or eradication in the territory of the importing Member; and the relative cost-effectiveness of alternative approaches to limiting risks.

Furthermore, WTO Members shall base their sanitary or phytosanitary measures on international standards, guidelines or recommendations (SPS Article 3.1) and the specific bodies mentioned in Annex A.3 are the Codex Alimentarius Commission, the International Plant Protection Convention and the OIE (now the World Organization on Animal Health). Please see the analysis contained in the Third World Network publication, ‘Socio-economic considerations in GMO decision-making: International agreements in context’ (http://www.biosafety-info.net/file_dir/100460222543b716ea9409.pdf) for more detailed discussion of the incorporation (and extent thereof) of socio-economic considerations into their risk assessment processes.

kind regards
Lim Li Ching
Third World Network

POSTED ON BEHALF OF Angela Lozan, Moderator

Dear all,

I would like to thank the participants for interesting discussion under the Question 4: Is there any relationship between risk assessment and the assessment of possible socio-economic effects? Are there any concrete examples of links between those assessment areas?

Here is a short summary of the discussion.

We have controversial opinions of the participants.

Some of participants are of the opinion that:

- It is impossible to associate a risk assessment and the assessment of the possible socio-economic effects.

-“If a risk assessment is not able to be scientifically quantified, the WTO has already ruled that this will be viewed as a trade barrier. Some of the reasons guiding those decisions fell outside of the scope of the SPS Agreement, including loss of biodiversity, protection of native crops, impacts on farms and farming systems and long-term ecological impacts”.

-The risk assessment is the basic criterion for the approval of the commercial propagation of LMOs. The ex ante socio economic analysis, although a part of the decision making process, does not provide the basis for the decision of approval/disapproval of the propagation of LMOs.  

On the other side, other participants give arguments in favor that the SECs are a part of any adequate assessment under the Protocol:

-“Primary effects on human health or on environment which are result of the LMOs itself and indirect effects occurring through a causal chain of events , through mechanisms such as interactions with other organisms, transfer of genetic material, or changes in use of management. Therefore, it clear that socio economic impacts are inherent part of methodology introduction and adoption. This point out the need of including socio economic considerations in biosefaty decision making related to GMOs.”

- Some participants are agree and emphasize ” that SECs should be an integral part of the decision making process regarding LMOs and for this ex ante and ex post analyses done with sound methodologies would serve the purpose.  Point H in Annex III mentions that risk assessment should take in to account the characteristics regarding, “receiving environment.  Information on the location, geographical, climatic and ecological characteristics, including relevant information on biological diversity and centres of origin of the likely potential receiving environment”.

-“All risk assessments start with a defining action and seeks to identify the first order (direct) impacts of that event (here the possible importation of an LMO).  But these impacts in turn have consequences (second-and-higher-order-effects) which may be of great importance.    Higher order impacts may actually be more important than direct ones.”

Participants made also reference to the Annex 1 of the CBD which identifies components of biological diversity important for its conservation and sustainable use that are to be monitored (article 7 of the CBD) and protected against adverse effects that might be caused by any process or human activity that may impact them such as the introduction of LMOs in the environment.

A number of participants concluded that there is a very strong relation between risk assessment and socio-economic considerations. The assessment under  the Protocol “not only applies to species but to also to Ecosystems and habitats: containing high diversity, large numbers of endemic or threatened species, or wilderness; required by migratory species; of social, economic, cultural or scientific importance; or, which are representative, unique or associated with key evolutionary or other biological processes”.

Thank you for bringing to us your countries’ experience and existent rules for considering risk assessment and socio-economic evaluation in the domestic legislation as part of decision making and monitoring process. 

Thank you again for interesting and useful discussion!

Best regards,

Angela

Discussion on question 4 is now closed. Thank you all for your contribution. We would also like to thank Ms. Angela Lozan for moderating the discussions this week.

We encourage all participants to continue this lively exchange as we turn to our final topic.

Regards,

Paola