Online Real-time Conference on Socio-economic Considerations in Decision-making concerning Living Modified Organisms: Western Europe and Others Group and Central and Eastern Europe (English)
Automatic translations by Google: French | Spanish
Thank you, Secretariat.
Distinguished colleagues,
Good day and welcome to the real-time online conference for Western Europe and Others and Central and Eastern Europe. It is an honour for me to chair this conference.
This series of regional online conferences was requested by the Parties in decision BS-V/3 adopted at their fifth meeting. The conference is intended to:
(i) facilitate the exchange of views, information and experiences on socio-economic considerations on a regional basis; and
(ii) identify possible issues for further consideration
Our discussions today will focus on the following three areas:
- National experiences with socio-economic considerations in biosafety decision-making;
- Considerations driving inclusion of socio-economic issues in biosafety decision-making; and
- Other issues for further consideration. |
The outcomes of this online conference and those from the other regions will serve as inputs for the workshop on socio-economic considerations, which is tentatively scheduled for November 2011. Furthermore, the Parties also requested the Executive Secretary to synthesize the outcomes of the online conferences and workshop and submit a report to the sixth meeting of the Parties for consideration of further steps.
The real-time conferences are, therefore, an opportunity to provide information and views from your perspective, learn from the views of others and consider possible ways forward.
The importance of active participation and open sharing of information to make this conference a success cannot be stressed enough.
On this note, I declare the conference open!
We will now move to Item 2. Organizational Matters; sub-item 2.1 Adoption of the agenda. |
I invite you to turn to the provisional agenda contained in document UNEP/CBD/BS/REGCONF-SEC/1/1, which was prepared by the Secretariat and reflects the objectives of our meeting.
Unless you have amendments or objections to any of the items, I propose that we adopt the agenda of the meeting as contained in document UNEP/CBD/BS/REGCONF-SEC/1/1. |
I see no requests for the floor.
The provisional agenda as before us is adopted.
Let us now turn to agenda Item 2.2, Organization of work. |
Our conference is scheduled to last for approximately four hours. Due to the large number of participants, we may need to stay a little longer than planned. I hope I can count on your understanding and cooperation on this matter.
I also propose that we have a break of 15 minutes half-way through the conference or as needed.
I trust that you have prepared your interventions on the basis of the questions contained in the annotations to the provisional agenda that was made available by the Secretariat as document UNEP/CBD/BS/REGCONF-SEC/1/1/Add.1.
I propose that we make use of these questions to assist our deliberations today on each substantive item on our agenda.
I also propose that we take up the items on the agenda sequentially and, as Chair, I will endeavour to keep the discussions moving through the different agenda items in a timely manner. I encourage you to participate in the discussions in a prompt, direct and open manner.
Is there any objection to this organization of work? |
I see no objection. The proposed organization of work is adopted.
Before we start with the substantive issues on our agenda I have two remarks:
1) Given the quite a high number of participants and the time limit, I would kindly ask all of you to stick to the guiding questions the Secretariat drafted in preparation of the conference and not to repeat the discussion we had in the online forum.
2) I also would like to remind you that we need to follow the rules of procedure for meetings of subsidiary bodies. This means that the order of speakers is as follows: Parties, non-Parties, observers.
Having said this, I now invite you to turn to item 3 on the agenda.
ITEM 3. SUBSTANTIVE ISSUES |
The first substantive issue for us to consider is:
ITEM 3.1. NATIONAL EXPERIENCES WITH SOCIO-ECONOMIC CONSIDERATIONS IN BIOSAFETY DECISION-MAKING
This item is intended to respond to the first objective for the conference. I propose that we spend approximately one hour and a half on this item.
We will use the questions from the annotated agenda (document UNEP/CBD/BS/ REGCONF-SEC/1/1/Add.1) to structure the discussions. |
I will now open the floor on the first guiding question:
(a) Has your country included provisions on socio-economic considerations in its national biosafety framework, biosafety policy, legislation and/or regulations? If yes, briefly describe the relevant provisions.
The floor is open for your comments. |
| Is there anyone who wants to take the floor? Who is going to break the ice? |
Dear Andreas, dear participants,
First of all, thanks again to the secretariat to have organized the previous online discussions and this online conference.
Belgium did not include till now such provisions.
However, the issue has already been discussed, in particular in a meeting ( Spring of the Environment, 2008 ) attended by various stakeholders.
In case such provisions would be included, the idea of most stakeholders favorable to include it was at that time that a socio-economic committee would base its work on scientifically sounded studies to present to political authorities, without trying to necessarily present a consensual advice but rather clearly the different positions if existing, different aspects of the issue with their objective basis.
We have anyway a little experience in using such considerations, that I shall mention later on.
The European legislation allows, in some articles and preambles of regulations and directive , to take into account other legitimate aspects than biosafety, when relevant, in decisions on GMOs authorizations. But, practically, this has not been done officially till now, whereas the question is presently in debate in the EU in o |
| Dear all! The interventions are limited to 1200 char. Lucette, yours was cut off. Maybe you want to take the floor again to finish your intervention? |
Thank you, Mr. Chair, for giving me the floor
As this is my first intervention, I want to thank the Secretariat for preparing this setting for the CEE regional online conference.
This is an unique experience for me and it is an great opportunity to discuss this issue.
On this topic, the Spanish GMO legislation is based on technical risk assessment and if with the actual state of knowledge and after the results of the Risk Assessment with the prevention measures recommended by the Competent Authorities, authorization are provided.
Basically, this means that if the results of the Risk Assessment prove that GMO organism is as safe as its counterpart then is authorized. So Spain has not included this provisons.
At present there is an open discussion in order to modify the EU directive for intentional realease of GMOs in to environment in order to include other aspects besides the technical one in order to add other aspects in order to restrict or prohibit GMO cultivation |
| It was not lon anymore.
I type again the last §
The European legislation allows, in some articles and preambles of regulations and directive , to take into account other legitimate aspects than biosafety, when relevant, in decisions on GMOs authorizations. But, practically, this has not been done officially till now, whereas the question is presently in debate in the EU in order to maybe implement this openly after having reached a better consensual view on the issue between Member States. |
| Dear All
Let me start to thank the secretariat for hosting this real time online conference.
The Austrian GMO law includes a provision allowing decision makers to ban the marketing of products which are considered ‘socially unsustainable’ (‘sozial unverträglich’) - referring to social, economic, and ethical aspects. The meaning of this provision has never been clarified; it has been discussed to be potentially in conflict with EU legislation. In no case, explicit reference was made to this provision – which could therefore be considered as void. In case of an EU policy change, e.g. allowing for national assessments of socioeconomic impacts of GMOs, this provision could become an interesting reference. |
| Any comments on this first interventions? Is there anyone who wants to add something to this first question? |
| A interesting question is whether we should also consider coexistence frameworks. |
| If there any comments to this topic, they are more than welcome. |
Good morning/evening/night everybody!!
I thank the CB Secretariat for hosting the online conferences and the current online discussion.
Is it correct to state then, that there has not been any country within the EU who has included assessment studies of socio-economic considerations in their decision making to date, right? In fact only countries in the world, that I am aware of who have included socio-economic assessments are Argentina, Brazil, China, Mexico and India. Except for the case of Argentina and perhaps Mexico/Brazil, it is unclear how these considerations have been used for decision making. |
| Maybe we have a participant from the EU who wants to answer Jose's question? |
| I noticed that Norway and France are on the list of participants. It would be helpful if we can have a brief intro from them as they - to my knowledge are the only EU/EEA country explicitly considering socioeconomic impacts. |
| Good afternoon
I'd like to point out that until now the decisions for placing in the market (import or cultivation) ar not taken at EU member state level but at EU level. Policy is being revised but currently thi sis the situation. |
| Concerning coexistence: yes, Belgium has developed coexistence rules. This has been done separately at the level of the Regions ( Flemish and Walloon Region ) that are mostly competent for agricultural matters. Distance separation between GM and non-GM maize fields are for ex. very different between both regions. They are presently trying to develop "border"coexistence agreements.
If I remember well, there are 12 out of the 27 Memeber States of the EU that did not develop till now coexistence rules. |
| Dear all
I would also like to thank the secretariat for hosting this conference. Norway has included socioeconomic effects, i.e. sustainable development and benefits to society and ethical considerations, as criteria in the Norwegian Gene Technology Act. Norway has also developed some more detailed criteria for these issues. However, it has been difficult to get producers to answer the questions that we have put forward and therefore difficult to make good assessments. |
| Thank you for your interventions. If there are no more requests for the floorto this first questions I think we move on. |
In the environmental release authorizations, Spain includes the coexistence measure in a case by case analysis as a condition for the release authorization. This is done taking into account the crop, the ecosystem and the economical activities.
The EU Commission approved last year guidelines for coexistence and it was expected originally a regulation on the topic. |
| I noticed that Martin Remondet might have difficulties with his connection. So let me briefly refer to France:
In France, the High Council on Biotechnology (HBC) was established following a recent change in GMO policy. One of the two HCB Committees (CEES) provides advice to the government on economic, ethical, and social aspects of GMOs including in the course of routine evaluations of Directive 2001/18/EC and Regulation1829/2003 dossiers. Based on the limited experience gained so far, CEES perceives its main challenges to be the lack of relevant information in the dossiers and the lack of guidance for criteria, methods, data, and assessments. CEES practice apparently includes providing advice to the formal decision makers based on a weighing-up of health and environmental risks on the one hand, and socioeconomic concerns and benefits on the other hand. |
Good day to all. I also appreciate the opportunity to participate in this online discussion.
I have a related question to that posed by Jose? Based on the experience to date in the EU, would you say whether there have been socio-economic impacts – positive or negative – confirmed in the EU? |
| Does anyone wants to respond to Eric's question? |
| The EU experience is limited to Bt maize, and the scientific studies give similar results than those found in other areas of the world (i.e. incresed yield due to reduced pest attacks, higher gross margin for adopters, etc) |
I don't have any further requests for the floor.
Thank you for your interventions. Let us now please turn to the next question:
(b) What experience does your country have with implementing socio-economic considerations in biosafety decision-making? (For example, has your country taken socio-economic considerations into account in making a decision on a specific LMO or conducted a general technology assessment?)
The floor is now open. |
| I would first like to briefly answer Eric Sachs question.
The EU experience reflects what was said during the online discussions for the international level: the results based on strong quantitative dat refer mainly to in-farm level results of farm cultivating GMOs, at rather short term, and come to the same conclusions as what is reflected in other similar international studies. |
Socio-economic considerations were taken into account for national approvals for 2 field trials of GM trees in Belgium.
One for apple trees, before 2004. The Minister for public health and environment established a provisional committee, giving an opinion based on ethical and socio-economic considerations, in addition to the usual biosafety concerns considered by the Biosafety Belgian Advisory Council. The opinion of that committee was unfavorable, and so was the final decision for the field trial.
More recently, the federal Ministers for health and environment took a negative decision for field trials of poplar trees, after a positive advice submitted to risk management conditions of the Biosafety Belgian Advisory Committee. The negative decision was based a.o. on public concerns and on doubts about the societal benefit and therefore the sustainability of the GM poplars ( developed for biofuels to be used in transportation ). The applicant went to the administrative Court. The State Council gave reason to the applicant, considering that the arguments for a negative decision were not justified enough and should have been based according to the legislation derived from EU law only on risk concerns, especially for a field trial level of dissemination in the environment. |
| For the EU/EEA context explicit reference to socioeconomic considerations for market authorisation has so far been limited to Norway which is not an EU Member State. I wonder if we could have more views on field trials. |
| Hello to all participants!
In my understanding, coexistence rules are a typical part of SEC, or more exactly economic considerations. Until now, coexistence rules do not play a role in the EU approval procedure but can be used by EU Member States to regulate the actual GM crop planting. You find a first overview on the EU member states at:
http://www.gmo-safety.eu/coexistence/449.european-patchwork.html
and on the German rules at:
http://www.bvl.bund.de/DE/06_Gentechnik/01_Aufgaben/02_ZustaendigkeitenEinzelneBereiche/06_Koexistenz/gentechnik_koexistenz_node.html
I am not aware of a collection of the national regulations and rules in English language. In Germany there is a federal sub-law regulation (Rules on Good Agricultural Practise amended by the "Gentechnik-Pflanzenerzeugungs-Verordnung" of April 2008) that sets up the framework for coexistence rules with regard to GM-Maize cultivation (eg. 150m distance to conventional maize, 300m distance to organic maize). As a federal country, Germany gives some autonomy to its States in matters of agriculture and environment, which some of them have used to set up additional coexistence rules based on the federal framework.
I am not aware of any SEC applied to field releases in Germany |
| As present, Spain has no experience since no provision has been included in the Biosafety Legislation. The only analysis done is in determining the coexistence measures in field trials and releases which are set by a technical committee and set by crop, region and regional economical activities |
| IS there any request for the floor. If not we will move on. |
| In Austria coexistence legislation was established by each of the nine Federal Provinces (Bundesländer) and do forsee a number of additional requirements for cultivating GM crops (can be accessed at http://www.bmg.gv.at/home/Schwerpunkte/Gentechnik/Rechtsvorschriften_in_Oesterreich/Gentechnik_Vorsorgegesetze_der_Laender (German language only). |
| The reason I was asking my previous question, is that as a socio-economic assessment practitioner there are two issues in our mind that are of critical importance.
First, we as practitioners, need to know that issues are important for society to understand so that we can design a reasonable and feasible assessment in the field as we simply cannot assess everything in a time and resource limited environment.
Second,, we need to know how will socio-economic assessments will be integrated or contrasted with other risk assessments (food/feed and environmental) so that the assessment contribute to a coherent and systematic decision making process. |
| A new Commission Recommendation of July 2010 on co-existence of GM crops with conventional and/or organic crops gives more flexibility for Member States to define technical co-existence measures to avoid unintended presence of GMOs in conventional crops (to reduce the economic risks of technology adoption). The Recommendation confirms the role of the European Commission JRC-based European Co-existence Bureau (ECoB) to develop together with Member States best agricultural practices for co-existence as well as provider of technical guidelines on related issues. The EcoB produced with experts of EU member states the first EU level consensus on best agricultural practices for coexistence in maize production. The document is not legally binding, though. ( http://ecob.jrc.ec.europa.eu/). |
Thank you for your interventions.
As the experience among the participating Parties is obviously quite limited the contributions with regard to the next questions may provide some information why this is the case.
Let us now, therefore, please turn to the third question under this item:
(c) What have been the main challenges and obstacles to taking socio-economic considerations into account in decision-making? How have these been addressed?
The floor is now open. |
| Let me first respond to the last intervention by Jose ( I am typing quite slowly):
The second point mentioned be Jose was on my agenda too.
There is not always a clear-cut distinction between socioeconomic impacts and health and environmental risk assessment. For instance, the scope of environmental risks in the EU has been widened over time to include impacts which are partly targeting socioeconomic effects, e.g. resistance management strategies aiming at avoiding pests to become resistance against Bt. |
Good afternoon, all Participants,
Lithuanian government before two years initiate first study to evaluate socioeconomic impact of GMO.
The difficulties were to clarify concept social, because the economical impact was more clear. So, we limited our study only on the impact on various groups of consumers and their available information about such products. |
| The last remark of Armin Spoek is true, and maybe actually good to know to implement Art. 26.1 while respecting WTO rules. |
| In fact there are a number of comparative studies out there which show different framings for environmental risk assessments and changes over time in EU Member States. These framings have partly been influence by socioeconomci considerations. |
| One question to Lithuania: have the studies you refer to been published, or are they available on the web? |
| Regarding question about the impact of insect resistance management strategies...
Resistance is possible to any pest managment approach. How is resistance or strategies to mitigate resistance considered as a socio-economic impact? |
| Lithuanian study was published as an information publication, but I guess only in Lithuanian. |
| I also would like to respond to José's question: When we talk about coexistence rules in the EU, I think that we do not talk about "assessments" so much any longer. Based on some research projects and the request by many stakeholders to limit or prevent comingling in agricultural commodities, EU member states have adopted (binding) rules how to organise the GM crop planting. Coexistence considerations are included in the national regulations on GE crop planting. Our former Minister of Agriculture once stated that he does not regard GM canola as "fit for coexistence" especially in German medium-scale agriculture and would oppose its planting - but he was never in the situation to make such a decision.
I think that the main limitation in the EU is the fact that SEC were not included in the EU decision making framework as a binding element until now - so almost no member state has applied them. If the EU and its member states decide to go for SEC this will be a pretty new task for the assessors and regulators. I see a large lack of experience amongst those experts dealing with GMOs - but I also see some experience in other fields of environmental decision making. |
I am now answering question the 3rd question.
The main obstacle in Belgium is that, till now, there is no total consensus in Belgium, between different political opinions and between different regions, if and how socio-economic considerations should be taken into account in decisions concerning LMOs.
Moreover, such decision at the national level would depend on decisions at the European level. Neither at the European level is there till now a consensual view on that issue, whereas various elements in the EU GMO regulations allow to take into account other factors than biosafety, among other socio-economic, in decisions regarding GMOs.
A report from the European Commission based on comments from the different Member States on that issue was published recently; it focused actually mainly on socio-economic considerations linked to cultivation of GM plants inside the EU. I let Emilio Rodriguez give some details on the Commission report. |
I cannot speak on the EU experience and thus cannot speak of co-existence issues, but it has been our experience at IFPRI working in developing countries that the following are some of the issues related to the potential inclusion of socio-economics considerations in decision making:
1) Unclear decision making process that lead to the inclusion of socio-economics into laws/policies/regulations. Countries have to be able to clearly define why they want include socio-economic assessments in their decision making and to define whether society will be better off by including such considerations into decision making. In other words, will society’s biosafety decisions be better off considering all factors (all opportunity social costs and benefits) after the inclusion of socio-economic considerations.
2) Lack of (in some cases incomplete or misguided) understanding of capacities, limitations, scope and feasibility of socio-economic assessments
3) Human and financial resources to undertake socio-economic assessments and to evaluate
4) Difficulties with implementation regulations in practice, especially those that do not define or are unclear about issues, scope, timing, mandatory vs, voluntary, sequence, time to completion, integration with other aspects decision making
5) Unclear or un-existent laws, policies and implement regulations which do not define biosafety processed overall.
6) Biosafety capacity in general.
7) Defining what are socio-economic issues in general |
| Good morning/good afternoon,
I think this conversation has been confusing because it seems to be blending the policy envelope which sets protection goals and endpoints, which may be derived from socioeconomic considerations, the risk assessment process, which is scientific and analytical, and decision-making, which will consider the risk assessment and other associated considerations.
I think we need to be clear where in the process we are considering socioeconomics. |
| First I want to clarify that coexistence rules in EU countries apply to crops already auhtorised (i.e. they are not part of the authorisation process for the moment)
As mentioned by Belgium, in 2011, the Commission published a report on the socio-economic impacts of GMO cultivation in Europe . The conclusions are that quality, independent scientific data on impacts in Europe is limited and that EU institutions, member States and stakeholders should benefit from defining a science-based set of indicators for impact assessment. The European Commision JRC has in-house experience research and data on socio-economic impacts of GM crop cultivation and is reflecting together with DG SANCO on how JRC could be involved in providing assistance to member states when defining indicators and methodologies to measure socio-economic impacts. |
| The report is available at
http://ec.europa.eu/food/food/biotechnology/reports_studies/docs/socio_economic_report_GMO_en.pdf |
| Just a brief answer to Luis: I guess that there is general answer to that, as this needs to regulated by the Parrties in their respective legislation which also sets the scene for the procedure on how to take SEC into considerations. |
| Thanks for the clarification. It may be useful in the discussion to refer to the steps in the process where we feel socioeconomic considerations could be taken into account. |
| As there currently no requests for the floor let me ask again, also to the new participants to the conference (Welcome!): What have been the main challenges and obstacles to taking socio-economic considerations into account in decision-making? |
I would like to address Luis Barnola point a bit, as it has to do a lot with one of my many concerns which include understanding the overall assessment and decision making process that lead to a biosafety regulatory decision (approve, not approve, require more information).
When we talk about a socio-economic assessment as a companion to the scientific/conventional risk assessments, then we have to consider not only the risks, but also potentially the social/public and private benefits and the costs derived from technology adoption and use.
This is clearly different than the policy/law/regulatory framework which may be informed by socio-economic assessments. |
Thank you. I invite you to move to the final question under this agenda item:
(d) Does your country have experience with socio-economic considerations in other sectors besides biosafety? (For example, have socio-economic considerations been included in decision-making processes for other products such as pharmaceuticals or in planning and decision-making for development projects using methodologies such as social impact assessments or strategic environmental assessment?)
This question is intended to identify relevant experience and information on socio-economic considerations in other fields besides biosafety.
The floor is open for your interventions. |
| Still responding to Q 3.1.c.: for the EU context we can summarise that the EU regulatory and political context does - at present - not allow/encourage Member States to EXPLICITLY refer to socioeconomic considerations in the decision making procedure on individual EU market approvals. Would participants agree to that summary
The workaround was and still seems to be (i) to consider socioeconomic aspects when designing national coexistence framework and/or to (ii) implicitly consider them in the discussions about health and environmental risks. |
Good morning / afternoon
The french « High council for biotechnologies » is producing socio-economic considerations for every single case that is evaluated. These considerations are sometimes difficult to take into account as they are the result of both an analysis of the (few) socio-economic avalaible data and of a debate between stakeholders (with different opinions).Thus, considerations usually do not point at one single answer, but try to explicit important / relevant points for the political decision. Nevertheless, French authorities consider inputs from stakeholders as a crucial part of such an evaluation. |
| Adding to Jose's immediate points above responding to Luis' question, efforts to use socio-economic assessments in the policy/law/regulatory environment are subject to the issues related to the potential inclusion of socio-economics considerations in decision making Jose has articulated above. |
| Point of clarification for France: At what point would socioeconomic considerations be taken into account? Would it be part of the risk assessment, risk management, or decision-making process? Would guidance be available to proponents? How will you ensure consistency? |
Continuing with Luis Barnola point on differentiating regulatory design and assessment implementation. This one is related more to the socio-economic assessment inclusion framework.
Countries have many choices in terms of how they can implement the inclusion of socio-economic considerations into decision-making. We can consider the following decision-making nodes for regulatory design including type of inclusion, scope, approach, assessment trigger, when, how,
In most countries, decisions related to the options presented here may be better and more flexibly addressed in implementing regulations rather than in laws or policies. This will ensure that changes can be made readily if the regulatory system considers potential alternatives to comply with inclusion of socio-economic considerations into decision-making.
I discuss many of these choices in the following article:
Falck-Zepeda, J.B. and P. Zambrano. 2011. Socio-economic Considerations in Biosafety and Biotechnology Decision Making: The Cartagena Protocol and National Biosafety Frameworks. Review of Policy Research. 28(2): 171-195. http://dx.doi.org/10.1111/j.1541-1338.2011.00488.x
and my blog http://socioeconomicbiosafety.wordpress.com/ |
To Luis Barnola :
Socioeconomic considerations are part of every step in the current French system of evaluation of GMOs, according to a law passed in 2008. Guidance is available to proponents (on different topics : GOM importation , GMO cultivation, experimental field trials). We try to ensure consistency by making public guidelines and questions we plan to address. |
Thank you.
May I invite you again, to turn to the last question under this agenda item?
(d) Does your country have experience with socio-economic considerations in other sectors besides biosafety? (For example, have socio-economic considerations been included in decision-making processes for other products such as pharmaceuticals or in planning and decision-making for development projects using methodologies such as social impact assessments or strategic environmental assessment?)
This question is intended to identify relevant experience and information on socio-economic considerations in other fields besides biosafety.
The floor is open. |
| One related field in which economic factors play a role in a governmental approval process is the German seed variety registration. Apart from the usual criteria based on the UPOV convention, the German law also requires that a new seed variety offers a larger economic benefit to farmers than the existing ones - if the new trait itself is not a unique trait and a benefit in itself. According to the preliminary data gathered through official field tests in the late 1990s this "fourth criteria" would have been a major challenge for the planned approval of herbicide-tolerant canola varieties. Although the respective GE canola had a biosafety approval, its economic benefits compared with the existing practices could not be sufficiently proven in these trials - a variety approval could have been problematic. But the authority was never in the situation to consider approval because the EU GMO moratorium stopped the GM canola approvals. |
| Hartmut, are there any guidelines or is there any legislation on how to assess this economic benefit of new seed varieties? |
| Dear chairperson, dear colleagues
Sorry for my late entrance as I was not able to participate the first hour.
As Audrun has previously mentioned Norway has implemented criteria for assessment of SEC both in our Gene Technology Act + in specific Regulations. So these principles are firmly established in our legislation on LMOs and there is a clear decision in Norway that SEC are independent assessment criteria when taking a national decision on LMOs. There is also a broad framework on what may/should be considered in annex 4 of Norways Regulations on Impact Assessment.
Regarding challanges I will mention some that spring to mind: 1) There is a need for more imformation on SEC, both from those that apply for release of LMOs - but also other sources should/needs to be investigated; 2) There is a need for further work on the framework and guidance. SEC consists of both qualitative and quantitative data and there is still a need to consider and to evolve methods for how to do this.
With regards to point nr 2 we work continously to evolve the criteria we have in our regulations and that includes looking at SEC in other areas. For example there is a long experience in SEC connected to spatial planning and they have developed methods for assessing both qualitative and quantitave data and monetary/non-monetary values. There may be lessons learnt there that may be of use. |
The experience in developing countries on socio-economic assessements is similar to other countries. . In 2008, IFPRI conducted a literature review of 137 publications. We selected only those publications with an identifiable peer review process and a stated economic assessment method as a requisite for publication. We classified studies according to the unit of assessment studied, including measuring impacts on farmers/households, trade, industry/national, and consumers. A number of these studies conducted by IFPRI and partners.
Conclusions:
• Bt cotton is the most-studied crop and trait combination
• Most studies were conducted in China, India, and South Africa
• On average, the adoption of Genetically Modified crops was profitable—but averages mask variability by agro-climate, host cultivar, and farmer
• This collection of studies concluded that too few traits have been studied and there are too few cases/authors implementing such studies. Taking this into consideration, generalization about all GM crops should not be drawn yet.
• Assessment methods need improvement, especially those dealing with household decision-making processes, risk and uncertainty, different types of selection bias, and endogeneity
• More time is needed to describe adoption and better methods to describe adoption in an ex ante setting.
Reference is Smale et al. 2009. |
| Again I have no currently no requests for the floor on my speaking list.
I would like to encourage the participants to express their views, as this will be a very important input for the process leading to COP/MOP6 and the conference tentatively scheduled for November this year. |
I would like to answer in several parts to question 4 because too long answer for 1 shot:
Belgium has some experience in taking socio-economic considerations into account in other sectors than biosafety, in particular :
For chemical products, for the implementation of the European rule REACH ( Registration, Evaluation and Authorization of Chemicals ) :
A European socio-economic committee has been established, in parallel to a risk evaluation committee.
The socio-economic committee includes representatives of the European Commission + 2 representatives of each Member States ( of Belgium, one from federal ministry of environment, one from federal ministry of economy) + various stakeholders + 5 co-opted members.
This committee proposed very recently its first opinion ( not yet published ).
For this first experience, the Committee has analyzed all data provided from all sources. ( Following some members of the committee, it seems it was difficult, in this first experience, to get complete and balanced information, good quantitative data; a lot was based on assumptions. )
The conclusion of the analysis of the socio-economic committee is transmitted to decidors as an opinion accompanied by background documents arguing the opinion. It would have as much importance in the final decision as the risk evaluation ( Art. 70-72 of REACH ): the ECHA ( European Chemical Agency ) must propose an advice based on opinions of both committees. |
Belgium has experience in other sectors:
For pharmaceuticals:
The European legislation for pharmaceuticals registration asks to consider the added value of a new pharmaceutical, in addition to looking to the benefit/risk relationship in a defined target population, or the effectiveness/safeness relationship under conditions of use.
Moreover, whereas not yet being constraining, the cost/effectiveness relationship and the comparative effectiveness is still more considered in the marketing authorization processes. |
| Thank you Lucette. Could you let us know when you post the last part of your intervention? |
Belgiumhas experience in other sectors:
In SEA ( Strategic Environmental Assessment ) and parallel assessments for global plans and programs:
At the federal level, Belgium has established a SEA committee assessing global environmental impacts of wide plans and programs (law of 13/02/2006 transposing the European directive 2001/42/EC).
The SEA committee is composed of members of federal ministries of Environment, Health, Sustainable Development, Mobility, Economy ( in particular, Energy Department ), Foreign Affairs.
The author of a plan must submit to the committee a first report on environmental assessment from the first redaction of the plan on, accompanied by proposals for reasonable alternatives. On the basis of comments of the SEA committee, the author must complete the environmental assessment.
The environmental assessment is part of a more complete sustainability assessment, including socio-economic aspects,
that is submitted to public consultation, regional governments, CFDD ( federal council of sustainable development, composed of various social groups: NGOs active in environment, development cooperation, protection of consumers and workers and employers, energy producers, scientists ), in addition to the SEA committee.
Plans for nuclear wastes management and prospective studies for electricity supplying from different sources have been submitted to SEA at the federal level in our country.
Regions have also transposed the European directive |
And the last small tenatives of Belgium:
Concerning Ecosystems, the Belgium Ecosystem Services cluster, part of the Belgian Biodiversity Platform ( acting as a common platform between scientists, policy makers and other stakeholders ), aims to deliver an overview of the issues at stake, including methodologies, from an environmental, economical and sociological point of view, and to advice on priority research and policy actions needed to come to policy-relevant strategy for ecosystem services in Belgium.
In the framing of political objectives linked to Climate change, socio-economical aspects ( especially impacts on employment ) are also taken into account.
Thanks for patience ! |
| Thanks Lucette for mentioning the REACH example. Here, it seems that socioeconomic aspects can be explicilty considered for EU market authorisation by a dedicated body and without being challened under WTO (so far). Any ideas about this? |
| SEC considerations are included in other processes in the Spanish legislation as Infrastructure planning and others but they are studied in a case by case, depending on the SE impacts (positive and negative) and subject to Public interest and included in the Environmental Risk Assessment. |
| In Canada, we have a variety registration process that considers merit for the introduction of a new variety. Clearly this is a consideration of benefits. We have heard a great deal of discussion of risk and avoiding risk, but not much discussion on the consideration of benefits. Would this be part of the Norwegian (and other Parties) approach that already consider SEC? |
| A note of clarification as there is sometimes a misunderstanding about "economic" studies from the standpoint of field assessments.
Although many of the studies conducted by IFPRI and partners and other authors in the literature are classified as “economic” and have a strong economic/quantitative method and emphasis, we have examined issues such as labor use, gender and generational, household decision making processes, institutional issues (credit, access to information/extension), seed dissemination networks, informal and formal seed markets, participatory innovation platforms, stakeholder analysis and others.
We have used different approaches beyond economics including qualitative methods and more structured approaches such as the Sustainable Livelihoods Approach in the past. So, there is a significant blurring in the assessment of social and economic issues and the approaches to conduct such assessments. We are operating beyond conventional “economic” studies for technology assessments.
The question then becomes how to integrate these methods and approaches to the decsion making process, to innovation and technology development policies, poverty alleviation and food security efforts, and to the overall/broader economic/development goals that a country may have for decision making. |
| In answer to Luis: yes, both positive and negative impacts are part of the assessment when we consider soicio-economic impacts |
| You can find more information on the German seed variety registration procedures (test on Distinctness, Uniformity and Stability test (DUS-test) and on Value for Cultivation and Use (VCU-test) at:
http://www.bundessortenamt.de/internet30/index.php?id=28&L=1
the examination guidelines for DUS- and VCU-testing are available at:
http://www.bundessortenamt.de/internet30/index.php?id=9&L=1 |
| A question to Nina..
How are positive and negative impacts evaluated and weighed in order to reach a recommendation or decision? |
in answer to Luis :
As the French HCB method for producing advices tot the government is based on debate between stakeholders, both risks and benefits are taken into account. Stakeholders such as the seed industry, some agriculture trade-unions, agro-industry representatives, … underline potential benefits and make them part of the information the committee is working on |
I thank all of you for the lively discussion on national experiences. I propose that we now move to the next item on the agenda:
3.2 CONSIDERATIONS DRIVING INCLUSION OF SOCIO-ECONOMIC ISSUES IN BIOSAFETY DECISION-MAKING
This agenda item is also intended to respond to the first objective for the conference. I propose that we spend approximately one hour on this item.
As outlined in the annotated agenda, paragraph 1 of Article 26 of the Biosafety Protocol allows Parties to take socio-economic considerations into account in their decision-making on living modified organisms but it does not require Parties to do so. Countries that decide to include socio-economic considerations in their decision-making will do so for specific reasons or in order to achieve certain goals or objectives.
I suggest that we again use the questions from the annotated agenda to structure the discussions. |
I will now open the floor on the first guiding question:
(a) What goals does your country wish to achieve by taking socio-economic considerations into account in decision-making on LMOs?
The floor is now open. |
The creation of the HCB with a socioeconomic committee was an answer to the strong request made by the working group on GMOs which gathered during the “Grenelle de l'environnement” ( anationwide reflexion on sustainable development) at the fall of 2007. This working group concludes that the societal interests of cultivation, importation and consumption of GMOs should be evaluated as the risks are. The idea was to establish an evaluation body whom criteria of evaluation were those of sustainable development : environmental, societal and economical criteria. A better implication of socioeconomical stakeholders and civil society was also requested.
One of the basis of the new french law regarding GMOs is the creation of the right to produce and consume with or without GMOs. This raises several questions of coexistence between productions, information and transparency for the citizens. Socio-economic evaluation is a mean to answer these goals. It offers the possibility to balance the benefits of those productions with the constrains and costs they could produce, by creating the need of coexistence rules, controls and information for example. The respect of this right to consume and produce with or without GMOs needs a specific analysis that an evaluation of environmental or health impact can't provide. In fact the absence of this kind of impact cannot prejudge of the absence of economical impact on the non GM productions. |
| Perhaps I should clarify my question to Nina and extend the question to Martin...
It is clear that both positive and negative impacts are considered but what are the methodologies that are used to arrive at a clear and robust decision based on a foundation of science? |
As said previously, there is no consensus at the Belgian or European level concerning the taking into account of socio-economic considerations in decision-making on LMOs.
Among the politicians and stakeholders who would like to take this into account in BE, reasons are a.o.:
To add elements to weigh, to balance, when having to take decisions in case of scientific uncertainty relative to some biosafety risk(s).
To take into account environmental protection goals, land planning decisions, that would not be taken into account (enough) in the biosafety risk assessment. To take into account socio-economic and agriculture development plans of regions, that could be perturbed by the culture of LMOs.
To develop and import products that have a real plus-value for the common wealth, and more than at short term. This is particularly important in agriculture and food products, essential for survival.
To look for the sustainability of the method and product proposed in comparison with other existing methods/products aimed at solving the same problem; in other words, to make widely understood comparative costs/benefits evaluations.
To foresee potential negative impacts for certain stakeholders, take decisions being informed about these negative impacts, and foresee managements to avoid or compensate some negative impacts if the global impact is considered positive.
To take into account not only international environmental but also public rights and related agreements. |
| Is there somebody who wants to contribute to this specific question? If not, I guess we move to the next one. |
| As far as I am aware Austria is rather in favour of including SEC. It would allow for a broader picture and to consider the very specific agricultural and topographical context (alpine region, highest proportion of organic farming etc.). |
| Chairperson - I know you have moved on but will give Eric a short answer (which can be elaborated at a later stage)
Thank you Eric for your question. Short version now since the chair has moved on. There are several "layers" in the decision making process. Norway has an Biotechnology Advisory Board consisting of a broad group of members. They are one of the "tools" that consider and weigh these issues. Another "step" is the considerations made by all involved ministries - where you then get all the sector considerations. But this is just a short overview and some of the steps. With consideration of the time issue today we can consider these issues further during the process under the Cartagena Protocol. |
I cannot speak of the EU experience, but many developing countries have stated such goals as economic development, sustainable development, food security, poverty alleviation, promoting sustainability, conserving biodiversity, promoting agricultural biodiversity, as the overall goals for the biotechnology and biosafety policies in general.
Furthermore, I have had many difficulties in many developing countries, identifying a clear explanation on their views of how specifically the inclusion of socio-economic issues and assessments into a biosafety decision making process will contribute (positively and/or negatively) to such goals.
In addition, I am having trouble identifying in a number of developing countries themselves have assessed and clearly examined the many trade-offs resulting from such policy and regulatory outcome.
There is a lot of unclarity...out there... |
| An answer to Eric question (I know we have moved on but i would like to answer briefly) :
The High Council for biotech SE committe goal is to make explicit to the government what are the stakes of cultivation (or import) of a specific GMO. It thus gathers information on both positive and negative impacts through stakeholers, and try to weigh them with scientific data when it is possible. It is then the french government task to take a decision, on the basis of the information and analysis provided by the HCB |
| Would the chair consider a coffee break after we are done with the present issue and before moving on to the next agenda item? |
| The coffee break was scheduled a little later, but I guess people are in need of some coffein and/or refreshments. We break now for 15 min.
The meeting is adjourned until 15:15 (GMT). |
Distinguished delegates,
Welcome back to our conference. I trust you are refreshed and ready to continue.
We continue our discussion and I hand over the floor to Nina. |
| What goals does Norway wish to acheive.
I think that Norway's intentions as to why SEC is included in the decision making process, in addition to the assessment of risk to health and the environment, is expressed fairly well in § 1 of the Gene Technology Act: "... to ensure that production and use of GMOs and the production of cloned animals take place in an ethically justifyable and socially acceptable manner, in accordance with the principle of sustainable development and without adverse effects on health and the environment". These are the "broad goals" if you see what I mean.
Further deliberations on the intentions/goals that were considered when the Gene Technology Act was in preparation in Norway is something I can investigate more closely and share with you at a later stage if this is of interest. |
| Andreas - thank you for the opportunity to wrap up the last exchange. I do not plan to extend this discussion.
Thank you Nina and Martin for your responses. It would appear that there is a process for decision-making in some countries but it is not clear what the actual process is that leads to a particular decision outcome. The inclusion of scientific data when possible is good but what happens when scientific data are not available or the scientific or other data conflict or are ambiguous? What happens when the study methodologies are lacking an appropriate scientific foundation, missing the appropriate controls, or subject to spurious outcomes? How are conclusions of the researchers considered appropriately when the methods or data are limited?
The process of weighing potential positive and negative outcomes appears to be more subjective than objective but I am sure we can discuss this point for hours. I do appreciate your responses. As Jose said, there is a lot of uncertainty out there.
Time for a cup of coffee! |
I invite you to turn to the next item on our agenda,
and move to the second question:
(b) What socio-economic factors would need to be assessed to achieve the goals identified?
Anyway if there is still the need to elaborate on question a) "What goals does your country wish to achieve by taking socio-economic considerations into account in decision-making on LMOs?" you are invited to elaborate also on this.
The floor is open. |
Several issues could be assessed and obviously it will depend very much on the goals to reach but in a first thought, some issues could be the following:
-Social:
a)Impact on farmers traditional practices and loss of traditional varieties (saving seeds)
-Economical issues:
a) Coexistence and contamination by GMO.
b) Organic farming
c) GMO Technology value
d) Crop managing and labour cost
e) Reduction of economical risk due to pest control |
| Thank you Rodrigo. Does anyone want to add some additional factors to be assessed or anyone who wants to comment? |
| This is a difficult question to answer as the goals can be (and in many cases are) quite broad and may be even divergent in terms of actions and outcomes. For example, if a stated goal in a country is to maximize food security and food production, the issues to assess may be different if the stated goal is to preserve agricultural or overall biodiversity.
The key is then to identify and map the issues to the specific goals a country may have, which by the way, since countries may have multiple goals, there may be the need to examine the trade-offs necessary to accomplish those goals and thus the feasiblity of accomplishing goals. Once issues are defined then practitioners and decision makers can settle upon methods and approaches. |
Question b) can on Norway's part be answered by looking, amongst others, at the Regulations on Impact Assessment annex 4. There we have formulated guiding questions that we consider central for SEC. Some of these are (we published this list also in the on-line forum):
• Impacts on biodiversity and ecosystem functioning
o Gene-flow (horizontal and vertical) and subsequent effects
o Non-target effects (mammals, birds, invertebrates)
o Increase of secondary pests
o Change in agricultural practices leading to effects on biodiversity and ecosystem services
• Impact on the efficiency and extent of energy use and the use of other natural resources
• Impact on the proportions of renewable and non-renewable resources used
• Impact on emissions of global and transboundary pollutants
• Any particular impact on greenhouse gas emissions
• Impact on the distribution of benefits and burdens between generations
• Is there a demand or a need for the product. Will the product will solve or help to solve a social problem (e.g employment)
• Will the product tend to create problems for existing production that should be maintained
• Possible adverse impact on indigenous peoples, people who live in highly traditional cultures, or weaker groups. Special account should be taken of the need of these groups to be able to control their own processes of social change. |
The main factors the HCB is currently considering are : impact on agricultural practices (especially the use of pest control products, …), on cultivated biodiversity, impact on farms size, labor, on organic and non-GM productions, interest for the consumer …
We have guidelines detailing all those factors for different types of dossier : cultivation, import and field tests of GMOs, gene therapy, … Sadly, they are only available in french yet, but you can contact me if you want them. |
| I have a question for Nina. As far as I know, this guiding questions are not only taking into account for Norway but also for the producing country in case of imports, is this right? |
| Rosa: yes, that is correct. In that regard it is important to note that the Norwegian Act is broader in scope that Article 26 of the CP and also (probably) broader in scope than socioeconomic considerations. But it is correct - the Norwegian criteria apply not only to cultivation in Norway but also for import. |
| The precise criteria to take into account as well as the methodologies to study and integrate them have not yet been defined in Belgium, the more as there is no national consensus on the goals to pursue.
This brings me to comment a little bit on José Falck and Eric Sachs remarks. There can indeed be some uncertainty in the results and subjectivity in the considerations of what is good or not. But there are also uncertainties in scientific risk assessment results, and they have to be treated taking into account the precautionary principle, and on the basis of protection goals that are actually also partly defined by oriented political backgrounds.
I just read the question asked to Nina by Martin Rémondet. Is it in conformity with WTO rules to take into account, in decisions of import, situations in the country of export, would it be related to environmental, health or socio-economic considerations ? |
| We need to stay focussed on the goals of the Protocol, which allows for the consideration of SEs in the context of the sustainable use of biological diversity.
In addition, we would regard considerations such as effects on non-targets, gene flow, increase of secondary pests (etc.) to be integral to the environmental risk assessment rather than SECs. Hence, there is a need to clearly define what we mean by SECs. |
| The participations so far in my mind serve to highlight the importance of identifying what are the issues relevant to a specific country or community, as very quickly the list can become a never ending story.
As practitioners, we do have limitations in terms of time human/financial resouces to conduct such assessments and thus have to frame our research projects into a manageable approach that responds to state-of-the-art methods and thus respond to elements of best practice that will be defendable in a peer-review environment.
One approach, we continue using, for our reserach projects at IFPRI is conducting focus groups and other participatory consultations in prospective study area(s) as a preliminary step in order to identify issues relevant to the community and then focus in those identified issues in our quantitative in conjunction with advanced qualitative methods. We are still in the process of validating this sequential/coordianted approach. |
| To Rosa : this precise point raised a very prolific debate within the French SE committee. Our guidelines (for import dossier) finally states that the HCB considers SE conditions in the producing country when "fundamental values" are at stake (human rights, safety of the populations, work conditions, ...) |
Responding to Q 3.2 b:
In Austria the multifunctional role of agriculture has been highlighted for quite some time - well beyond the pure productivity function and might therefore be considered when drafting assessment criteria:
- Production function, supply of services
o food, feed, fibre, biomass, energy carriers
o tourism, secondary activities, community services, waste management, recycling
o food security, animal welfare
- Spatial function, viability of rural economies
o rural infrastructure, street network, provision of land, open landscape
o direct and indirect employment, rural value added, direct sales, buffer function on labour
market, support system for rural dwelling
- Ecological and landscape esthetical functions, viability of rural environment
o landscape stewardship, landscape management, provision of cultural landscapes
o maintenance of natural resources, biodiversity, deer feeding, genetic resources
- Protection function and regeneration of natural resources
o groundwater recharge, maintenance of surface water courses
o protection of the environment, protection against natural hazards
- Socio-cultural function, cultural role of farmers
o rural life style, maintenance of historical objects and local traditions |
| Are there any requests for the floor on this question? If not, we move on to the last question on this agenda item. |
| Hello to everybody.
I would mention the regulation on Environmental impact assessment which consider variouse socio-economic possible mpacts over the environment, biodiversity that provide general framework for socio-economic assessment. As regard to the biosafety, the national procedures for permission involved along with the scientific risk assessment to assess a potential socio-economic effects of the GMOs over ecological goods and services, farmers, communities, internatl and trade and export of agricultural products and food staff, tourism, rural development, protected areas, recreation, organic agriculture etc. Regularly, the procedures for decision making and permissions requires an general assessment of socio-economic factors and protection goals. Unfortunately, there is limited technical capacities and lack of guiding document of how to proceed in detals with the socio-economic risk assessment specifically to the LMOs and taking into account the traditional agricultural practicies and trade condition of the country. |
Thank you once again for your input. I think that the final question under this agenda item is very much linked to the other two, and your contribution will be an important input to the conference on SEC later this year. So, lets turn to question c:
(c) What capacity-building does your country require to meet the goals identified?
The floor is open for your comments. |
| To me it appears to be extremely difficult to proceed to capacity building without have a clearer idea about scope, impact dimensions, criteria, and normative baselines in SEC. There is an urgent need to systematically map the entire area of SEC and identify common grounds in the extremely broad area of SEC. |
- Capacity building/strengthening has to be a response to a careful evaluation/inventory of human, financial and technical capacities in country. See McLean et al (2003) for a conceptual framework for biosafety capacity building which is quite useful for this type of evaluation in a biosafety regulatory setting.
- Developing capacity building/strengthening activities that will develop functional capacity have to be carefully based on the current status and level of experience that the country has at that particular stage.
For example, there is very little sense in developing capacity for conducting socio-economic studies in a specific country, when the country is only able to implement confined field trials, a regulatory step which is not likely to require socio-economic assessments. Once the country is ready to move on to the next stage of commercialization then it obviously makes sense to develop/strengthen such capacity as it may be required by the competent authority.
- The necessary capacity for implementation of socio-economic assessments has to respond to the policy and political decision of what will be required for the assessment. Different capacities will be required in a country that only requires a relatively narrow economic assessment such as impacts on trade or financial impact incurred by farmers, when compared to another country that will require broader social and economic assessments. |
- Our experience at the International Food Policy Research Institute (IFPRI) and the Program for Biosafety Systems (PBS) as a capacity building/strengthening program that introducing regulatory issues prematurely before countries have been exposed to all the potential issues and consequences from a proposed regulatory structure introduces a lot of confusion. This is usually connected to a pending application in country. If country is ready to deal with an issue (e.g. socio-economics) then it should handle the issue in a systematic manner once it becomes a need, usually when there is an application pending at the competent authority. Creating capacity prematurely, may lead to resources’ waste when there is no demand for such services.
- Providing an integrated and systematic approach to capacity building/strengthening usually works best. This implies a sustained and medium to long term effort to build assessment capacity if required.
- Finally, socio-economic assessments when required for decision making in a regulatory setting, will likely follow the path observed for most regulatory systems in human history, that is, there will a learning curve involved which will have its own set of implications in terms of cost and resources. |
| Angela,
You mentioned in your previous intervention some lack of capacities and guidance. Do you want to elaborate a little more on this? |
| It also is relevant to point out that the investment in capacity building to evaluate the impacts of new approaches to improve agricultural productivity and environmental sustainability is at the expense of investment in the development of the same new techologies to be assessed. |
My latter statements translates into developing/strengthening capacity of
• Policy and decision makers
• Regulators
• Practitioners
• Developers/operators especially those in the public sector
• General public
The explicit capacity building efforts will be different for each of these groups. For example, a deep understanding of methods will be required for practitioners to deal with the particularities of LMOs, but for policy/decision makers the issue is more of developing capacity to understand what results from a socio-economic assessment mean and what are the limitations of such studies. |
| Hello to all.
I would tend to agree with Armin. Before the need for capacity-builing can be difined, it is important to have a clearer idea about scope, impact dimensions etc. |
| As there doesn't seem to be an urgent need for capacity building among most of the participants, may I ask if somebody of you - especially the Parties to the Protocol - have experience with capacity building initatives on taking into account SEC in decision making? |
| In summary and reflecting several comments of other participants, in order to take socio-economic considerations into account in decision-making on LMOs and whatever would be the goals, Belgium would especially need available human and financial resources, methodologies to integrate various data on various criteria ( and the political will and consensus to accomplish this ... ). |
| As I have already mentioned in the previous SEC online forum and as it has been mentioned today as well, SEC are integral part of several governmental decision making procedures in the EU (and other countries), for example the Environmental Impact Assessments or the Strategic Environmental Assessments, based on EU regulation, and also described in CBD and OECD recommendations.
Instead of limiting our discussion to biosafety expertise only - that has indeed limited experience how to apply SEC in our regulative context - I would like to suggest that the National Biosafety Focal Points/Competent Authorities and the SCBD try to involve those national authorities in the discussion which actually have experiences in SEC. In most countries, those experts will be "close" colleagues of the biosafety officers. This would also help us with all the questions on which methodologies are applied, which criteria can be chosen, which decision making procedures exits. We should look at the existent practices to learn for our biosafety discussions.
And I would also recommend that this existing expertise is also included in the SEC workshop in November to be able to inform the biosafety discussion on SEC.
This will certainly help us in shaping the ideas what SEC in biosafety could be and how it could be done - based on this we can talk about capacity building needs. |
| From a vey pragmatic point of view, what we (the french HCB) currently lack in order to strenghten our SE evaluations is :
- Knowledge in the agronomy and agro-economy fields : there are researchers, but expertise is not that well structured yet
- Studies that are not limited to the farm scale, but that take into account whole sectors of production
- Support for international comparisons of the SE impact of GMO cultivation
- International exchanges on methods and criteria of evaluation |
On capacity building, due to the lack of studies and scientific data on the GMO impacts in Europe, it would be important to provide assistance in developing and defining methodologies and indicators for a proper SE assessment and also in defining rules in data collection
Also, it is important to define criteria for inclusion in the SE Assessment.
Finally, the capacity building should not only focus in the ex ante but also in the ex post analysis.
Unfortunately, no experience on capacity building initiatives on SEC. |
| The countries of CEE in my view have needs to capacity building for ensuring socio-economic in consideration to biosafey and require strenthening the political and regulatory framework with specification of biosafety in the decision making. A consolidation of human resources, researchers and personnel training would be important. A development of specific guidelines would be necessary. A system of exchange of information and access of public and civil society to provide and participate at the socio-economic assessment would be extremily useful. A large regional and subregional cooperation in he socio-economic assessment issues has to give more success in this issue. |
| First of all I agree with Jose that there are several "groups" that need capacity building and that their needs are different.
In comment to your last question Mr. Chairperson I would not say that our countries do not have a need for capacity building. I think - in the same way as for health and environmental risk assessments - there is a need for continous research and gathering of data. This is also the case for SEC - the need for further knowledge - and here we still have a need for increased capacity. |
| Eric: From a regulators point of view it is essential to evaluate the impact of the new technologies to ensure that the newly developed technologies do in fact make contibutions towards the intended goal. |
Thank you once again. I invite you now to turn to the third and final substantive item on our agenda:
ITEM 3.3. OTHER ISSUES FOR FURTHER CONSIDERATION.
As I indicated at the beginning of the conference, one of the objectives for the conference is to identify possible issues for further consideration. These issues will help to inform the organization of the workshop on socio-economic considerations scheduled to take place later this year. The issues will also be included in the synthesis of the online conference that will be submitted to the sixth meeting of the Conference of the Parties serving as the meeting of the Parties on the Biosafety Protocol (COP-MOP 6) for its consideration.
We may again use the questions from the annotated agenda as the starting point for our discussions under this item.
I propose that we spend most of our remaining time on this agenda item. |
I will now open the floor for your comments on the first guiding question:
(a) How should operational objective 1.7 of the Strategic Plan for the Cartagena Protocol on Biosafety for the Period 2011-2020 be implemented? The operational objective is “to, on the basis of research and information exchange, provide relevant guidance on socio-economic considerations that may be taken into account in reaching decisions on the import of living modified organisms”.
The floor is open. |
| One last thing on the previous point: We are seeing from this discussion that perhaps before we decide to embark on capacity building, as was stated by Jose, we need to think carefully about what we mean by SEC and at which step we are putting this into the process. |
| We at IFPRI/PBS have conducted workshops, conferences, one-on-one training and are developing other mechanisms for building capacity for the assessment of socio-economic issues in developing countries including Indonesia, Philippines, Kenya, Uganda and many others.
We have conducted activities leading to building awareness of all the potential options for inclusion of socio-economics into a decision making process and in many cases inform them about the trade-offs in terms of cost, benefits, time implications and opportuntiies lost or delayed, gains in knowledge, etc, but since this is in the end an issue of national sovereignty we have to fall shy of making an actual recommendation for a final process, unless explicitly asked to do so by the countries themselves. |
| (Answer to previous question on capacity building)
In terms of capacity building, we are currently running different experts groups (researchers + professional organisations) on topics dealing with GMO SE impact at the farm scale, at the industry scale and from a national economic competitivity point of view.
Both the mandate and the compostion of the groups were elaborated with the input of stakeholers from our commitee, in order to ensure neutrality and representativity of the experts.
We thus try to build a network of experts that we can mobilize on different occasions and topics. |
| 1. Guidelines on SEC on ecosystems goods and services
2. Guidelines on criteria and indicators for SEC
3. SEC on trade, benefits and risks. |
| Thank you. Are there any other suggestions or ideas on how the practical implementation of operational objective 1.7 of theStrategic Plan could be facilitated? We would greatly appreciate some views of the participants. |
| I believe that the process that we now have embarked on is a good starting point. The online forum, online regional conferences and the workshop are good starting points to "flush out" relevant issues and considerations. But this is a starting point that needs further work and considerations.
As I stated in an intervention in the online foum a month or so ago it is my belief that we need to consider the topic stepwise. There has been (to my knowledge) no joint efforts yet in "translating" Article 26 of the CP - that is what we have embarked on now.
In that process we need to consider further just what might be included in the context of Article 26 - that is the starting point: "what are we talking about".
After that we must move on to a series of other questions, e.g. how these issues can be evaluated. This is a step that will help develop guidance for those countries who choose to include SEC in national decisions. |
| It would be good to spend some thoughts about procedures which would allow to move forward with these issues. One section of the November workshop could for instance identify and discuss such procedures. We need to define a clear starting point and scope for any further discussion. |
| I would again ask to lay down my comments in several steps.
As discussed again during the online discussions from 21 March to 8 May, the wording of Art. 26 § 2 “ encourages Parties to cooperate on research and exchange on any socio-economic impacts, especially on indigenous and local communities” , whereas Art.26 § 1 allows Parties, in reaching a decision on import under the Protocol, to take into account more limited socio-economic considerations , these “ arising from the impacts of LMOs on the conservation and sustainable use of biological diversity, especially with regard to the value of biological diversity to indigenous and local communities” . Moreover, the decision should be consistent with international obligations of the Party. |
| During the online discussions, it was pointed that one main international obligation Parties should respect is presently WTO rules. GATT, SPS and TBT agreements foresee conditions, a.o. linked to socio-economic considerations, that allow Parties to take measures that limit freedom of international trade. And it was pinpointed, during the online discussion, that socio-economic considerations covered by Art. 26 § 1 are among those that are the more likely to be in conformity with WTO rules. |
Thus, the capacity-building around this issue starting in the workshop foreseen in Norway should, on the basis of socio-economic preoccupations evoked in various documents listed in Annex of document UNEP/CBD/BS/REGCONF-SEC/1/1/Add.1 consider to:
1) look at or give guidance to look at the preoccupations that can indeed be taken into account to be in conformity with WTO and Art. 26 § 1;
2) maybe group the various preoccupations under some headings to facilitate the discussions and considerations about them. |
3) help to ( guidelines ) frame the potential problems that Parties want to consider and the related assessment endpoints, criteria, to be considered in socio-economic analyses so that they reflect the preoccupations of the Parties while being in conformity with WTO and Art. 26 § 1. The framing should anyway not be too precise, in order not to be too limitative and to let freedom of interpretation depending on specific socio-economic and environmental situations of each Party;
4) look to existing methodologies, in the various disciplines ( sociology, economy, anthropology, comparative agronomy, …… ) that can be concerned, that allow to apprehend the concerned situations in a relevant way; encourage the development or adaptation of relevant methodologies; afterwards, suggest useful and relevant methodologies; at the same time, defining good practices. |
5) look at or develop methodologies ( including methodologies for multidisciplinary transparent participation ) that help to integrate the results of studies and analyses made thanks to point 3), so that a complete balanced socio-economic picture could be presented to decidors;
6) while performing steps 2 to 5, look at and take advantage of existing studies as examples and experiences that work well or not, in the field of biosafety and in other fields.
Easy to say, more difficult to do ! ........ |
| The BCH system might be extremely useful to provide with the SEC informationa exchenge options for parties, as well as giving opportunity to e familiar with good practices of countries in this context.
A working group of experts in domain might develop the criteria and common approach and methodologies as a guidelines for SEC and to be useful for developing countries and countries with economy in transition. |
| Again, from the online forum of experts, it is apparent that our national sovereignty, regional interests, and conflicting stakeholder opinions will make designing any kind of guidelines a complicated process. Not until we have a common understading of SECs, could we realistically think of drafting guidance. Who will be involved, how to weigh the factors, when in the process is it going to occur, but most importantly, it needs to respect the objectives of the Protocol.
We have already heard that this has an implied cost either though resources or actual financial costs and this needs to be clear as we proceed. |
| After the workshop and the conclusions of the process opened by decision BS V/3, it will be clearer what will be the next steps to be taken in order to implement objective 1.7. At present, it is necessary to have additional inputs in order to have a common understanding of SEC. |
| Sorry, one final point on capacity building. We IFPRI along with the University of Saskatchewan-Canada, Technische Universität München_Germany, and Tor Vergata University-Italy will be conducting a policy roundtable on Article 26 of Cartagena Protocol on Biosafety titled “Socio-Economic Considerations, Biosafety, Biotechnology and Decision- Making”, June 27, 2011.
This policy roundtable will be held at the International Consortium on Applied Bioeconomy Research (ICABR) 2011 Conference, Rome, Italy, (June 26-29, 2011) where we will engage multiple internationally recognized experts in the assesement field as well as other stakeholders, that will help draw some of these issues, limitations, methods and approaches for assessments and decision making. For more info you can visit http://www.economia.uniroma2.it/icabr-conference/sarea.php?p=12&sa=142 or contact me.
I think the process implies identification of:
1) Country goals and objectives
2) Issues contributing to goals and objectives
3) Identification of existing national capacities (human and financial resources, laws/regulations)
4) Mapping of methods to issues to goals/objectives
5) Practical implementation issues
Which in turn may be very country-specific. |
| After being flooded with postings - I am not sure if I do repeat comments: countries and analysts diverge on the interpretation of the scope of Article 26 - therefore, I feel the need to clarify how we possibly could proceed though the starting point is not yet clarified. |
Thank you very much. Let us please move to the second question under Item 3.3.:
(b) What are some key issues for your region that should be discussed during the workshop on socio-economic considerations?
The floor is open for your views. |
| Are there any special issues which you think are relevant for the WEOG and CEE regions, which should be discussed during the workshop? Your contributions are most welcome in order to allow for a thorough preparation of this event. We definetly would appreciate some input. |
| 1. What are the criteria for SEC?
2. who can provide SEC assessment?
3. Should SEC provide as well as the benefit assessment and the impact to economy and socila life? |
| I do agree with Armin quite a bit, especially seem we have a two+ level set of legal frameworks. On one level, we have the Protocol which is quite narrow in its scope, but one which leaves countries the freedom to countries to implement what they want in terms of inclusion of socio-economic issues.
On another, we have the natioanl/regional level frameworks themselves which may quite narrow or broad in their scope and application. If we add the relationship to other treaties such as WTO or CODEX, then defining a single guidelines becomes quite difficult.
By the way, I am still not completely convinced by arguments presented in the online forum that socio-economic considerations will be allowed under WTO rules unless within the scope of trade issues. This is a bit of a development that will need more expertise and perhaps a ruling. |
| A possible way forward would be good to categorise impact dimensions /criteria as
- potentially generic for all parties
- potentially specific
and then start to discuss in more detail generic /specific criteria |
| Some possible topics :
* Definition (and international comparison) of socio-economic criterias
* The production of SE considerations : which role for experts ? stakeholders ?
* The juridic status of SE considerations within the different existing regulatory frameworks |
Thank you for sharing your views.
I invite you to consider a further question:
What are some key issues for your region that should be discussed at COP-MOP 6 in the context of socio-economic considerations?
The floor is open. |
| Just one more remark on the next steps: An interesting issue for the Nov workshop or similar contexts would also be to draw some parallels between GMO risk assessment and SEC - and what we could possibly learn from any similarities and differences.
See also our report http://www.bmg.gv.at/cms/home/attachments/5/0/0/CH1050/CMS1291038713992/assessing_socio-economic_impacts_of_gmos,_band_2_20101.pdf |
| Another possibility would be to define a set of characteristics of a functional biosafety system that incorporates socio-economic considerations. Potential attributes or characteristics include:
- Feasibility
- Protectiveness
- Cost and time effectiveness
- Contribution to national goals/objectives
-Internal/external law and regulatory consistency
-Transparency
- Directly related to risk
Quite similart to those proposed by Greg Jaffe in one of his publications. Reaching a consensus on this, will help evaluate options at the national/regional level.
Once this is done, then proceeding to the two level approch suggested by Armin (although I focus it a bit different)
1) General = relevant to the strict interpretation of Article 26.1.
2) Specific = relevant to those at the national/regional laws/regulations |
| Coexistence between GM and non-GM crops, from a SE point of view, appears as a crucial topic : who will pay for coxistence costs? which spatial organisation ? which legal framework ? I would really appreciate an international / comparative perspective on such a point |
| For CEE a specific topic for discussion is the strenthening the capacity buildings forr SEC in frame of the Art 26 of the Protocol and item 7.1 of the Strategic plan. |
| I'm completely aware that the COP/MOP6 seems to be quite far away, but as you know and as we have been informed yesterday in a notification from the SCBD, SEC are on the agenda of the MOP. So this would be now an opportunity to provide some input already in helping the SCBD to prepare the discussions. Any contributions especially on this? |
| At this stage, probably it is difficult to defining the next steps that the COP MOP 6 should be taken without the conclusions of the workshop. |
Thank you for the points you have raised.
I invite you now to raise any other issues for further consideration that have not already been identified.
The floor is now open. |
| I am not sure that I can think of region specific topics. In generel I would say that this work we are now doing on SEC in the context of Article 26 is probably interesting to all Parties - simply because this has not been elaborated yet. I would also say that we will probably have a better idea after the workshop and that considering/giving suggestions to COP/MOP 6 is certainly something that should be included in the workshop - or after if the WS is pressed on time. |
| On the previous point, we would agree with Spain that we are still missing a lot of clarity and that the outcomes of the November workshop would be critical to informing SEC issues for the SCBD. |
| At some point we need to think about possible impacts of introducing SEC requirements - this might help to inform our further discussions. This should be openly addressed. |
Thank you very much for all your comments and your active participation. I am confident that the deliberations under this regional conference have provided an important opportunity for us to exchange information on socio-economic considerations at the regional level.
The conference has also provided valuable input to the workshop on socio-economic considerations and the deliberations on this matter that will take place at COP-MOP 6. |
This concludes our consideration of the substantive items under agenda item 3.
We will now move to:
ITEM 4. OTHER MATTERS
I will open the floor for a few minutes for any suggestions, comments, etc. that you may wish to make that are relevant to the mandate of this conference.
The floor is now open. |
Speaking based on our experience in developing countries, including some who have already have had multiple approvals for commercialization.
There is a lot of uncertainty in many countries on how to include socio-economic consideration, especially in those countries that have introduced a mandate, in many cases, without a complete discussion on all the potential consequences of such regulatory development.
Potential impacts include
a) Increased regulatory compliance costs.
b) Gains in knowledge about the potential technology in the hands of farmers.
c) Reduction in the number and type of technologies available for release if a cost increase is binding to developer’s budget. This is of special interest to the public research sector.
d) Potential for selecting the best technologies (and to compare with other potential alternatives) and to weed out those technologies that are not safe or may have a negative impact on biodiversity and other socio-economic issues.
Many of these issues/implications will be have to de assessed at the national level. |
| Sorry, I had to leave for a while.
A topic to maybe still consider in the workshop : relationship of the concerned SEC with other precise domains where political decisions, requirements, engagements have in any case to be respected ( health, agriculture, environment, culture, .... ) |
As there are no more requests for the floor we may now move to the final item on our agenda for today:
ITEM 5. CLOSURE OF THE CONFERENCE
As we approach the end of our conference, I would like to invite the Secretariat to make some final remarks.
Secretariat, you have the floor. |
We would like to thank all the participants for taking part in today’s real-time conference. A special thanks goes to Dr. Andreas Heissenberger for his work in chairing the conference.
The Secretariat’s experience with real-time conferences over the past few years has demonstrated that they are a good means of sharing information and building common ground prior to face-to-face meetings. We are confident that the outcomes from today’s conference and those that are to follow in other regions will similarly set the stage for the workshop on socio-economic considerations that is to be held later this year.
The full transcript of this conference will be available on this web page a few minutes after the closure of the conference. We encourage you to read the outcomes from the other real-time conferences that will take place in the coming days and weeks.
Thank you all and enjoy the rest of your day! |
| Many thanks to Kathryn and Andreas for hosting and charing this meeting. |
Thank you, Secretariat, especially Kathryn and Erie, both for your remarks and for your assistance in preparing and organizing this conference.
I would like also to thank all the participants and guests for their contributions and active participation and all of you who have contributed in making today’s conference a success. It was a very interseting experience for me and I think we can all look forward to following the next steps on this challenging issue under the Cartagena Protocol on Biosafety.
With that, I declare the Western Europe and Others and Central and Eastern Europe Real-time Online Conference on Socio-Economic Considerations, closed.
Thank you! |
List of Participants
| Chair Person |
# |
|
Andreas Heissenberger
Umweltbundesamt - Federal Environment Agency, Austria
|
49 |
| Party |
# |
|
Armin Spoek
Austria
|
20 |
|
Lucette Flandroy
Belgium
|
20 |
|
Martin Rémondet
France
|
11 |
|
Audrone Kozlovskaja
Lithuania
|
- |
|
Daiva Skuciene
Lithuania
|
2 |
|
Audrun Utskarpen
Norway
|
1 |
|
Bjarte Heide
Norway
|
2 |
|
Nina Vik
Norway
|
9 |
|
Angela Lozan
Republic of Moldova
|
6 |
|
Rodrigo Diaz
Spain
|
8 |
| Non-Party |
# |
|
Luis Barnola
Canada
|
8 |
|
Fan-Li Chou
United States of America
|
- |
| Observers |
# |
|
Dale Jiajun Wen
International Forum on Globalization
|
- |
|
Emilio Rodriguez Cerezo
European Commission-Joint Research Centre-Institute for Prospective Technological Studies
|
5 |
|
Eric Sachs
Monsanto/Global Industry Coalition
|
7 |
|
Gregory Jaffe
Center for Science in the Public Interest
|
- |
|
Hartmut Meyer
Deutsche Gesellschaft fuer Internationale Zusammenarbeit (GIZ)
|
5 |
|
Jose Falck Zepeda
International Food Policy Research Institute (IFPRI)
|
18 |
|
Masakuni Ueta
SCBD
|
- |
|
Rosa Binimelis Adell
European Network of Scientists for Social and Environmental Responsibility
|
1 |
|
Sarah Lukie
CropLife International
|
- |
| Guests |
# |
|
Anna Buccio
CBD
|
- |
|
Jock Langford
Environment Canada
|
- |
|
Luis Benavides
Autoridad Panameña de Seguridad de Alimentos
|
- |
|
Mahaman Gado Zaki
Direction Générale de l' Environnement et des Eaux et Forêts
|
- |
| Secretariat |
# |
|
Charles Gbedemah
UNEP/SCBD/Biosafety
|
- |
|
Erie Tamale
UNEP/SCBD/Biosafety
|
- |
|
Giovanni Ferraiolo
UNEP/SCBD/Biosafety
|
- |
|
Kathryn Garforth
UNEP/SCBD/Biosafety
|
1 |
|
Paola Scarone
SCBD Biosafety
|
- |
|
Stéphane Bilodeau
UNEP/SCBD/Biosafety
|
- |
|
Ulrika Nilsson
UNEP/SCBD/Biosafety
|
- |
|
