Online Forum March-April 2013

Some provisions of the Protocol to consider:

A Party to the Cartagena Protocol on Biosafety may take a decision on import of living modified organisms that are intended for: (i) intentional introduction into the environment (paragraphs 2(c) of Article 9, and Article 10 and 13); (ii) direct use as food or feed, or for processing (paragraphs 4 and 6, Article 11).

The Protocol also refers to, “right of a Party to subject all living modified organisms to risk assessment prior to the making of decisions on import” (Article 5), and “right of a Party to subject all living modified organisms to risk assessment prior to decisions on import and to set standards for contained use within its jurisdiction” (paragraph 2 of Article 6).

As regards import of living modified organisms for intentional introduction into the environment, the Party of import has the option to take decision according to: (i) its domestic regulatory framework, or (i) the procedure specified in Article 10 of the Protocol.

The domestic regulatory framework that may be used as a basis for taking a decision on import of living modified organisms, including those for direct use as food, feed or processing, is required to be consistent with: (i) the objective of the Protocol, according to paragraph 4 of Article 11; (ii) the Protocol, according to paragraph 3 of Article 9 of the Protocol.

According to paragraph 1 of Article 2, each Party is required to take necessary and appropriate legal, administrative and other measures to implement its obligations under the Protocol. It is also provided under paragraph 4 of the same Article that “nothing in the Protocol shall be interpreted as restricting the right of a Party to take action that is more protective of the conservation and sustainable use of biological diversity than that called for in this Protocol, provided that such action is consistent with the objective and provisions of this Protocol and is in accordance with that Party’s other obligations under international law”.

UNDER SOME SITUATIONS A PARTY CAN TAKE A DECISION ON IMPORT UNDER DOMESTIC MEASURES IMPLEMENTING THE PROTOCOL. PERU, AS CENTER OF ORIGIN OF AGRICULTURE, HAS CONSIDERED OF GREAT IMPORTANCE AND NEED FOR PROTECTING THEIR NATIVE BIODIVERSITY TO ESTABLISH A TEN (10) YEAR MORATORIUM LAW (LAW 29811) TO BLOCK THE ENTRY AND PRODUCTION IN THE NATIONAL TERRITORY OF LIVING MODIFIED ORGANISMS (LMO) FOR CULTIVATION OR BREEDING PURPOSES, INCLUDING AQUATIC ORGANISMS, TO BE RELEASED INTO THE ENVIRONMENT.

THIS MORATORIUM LAW AIMS AT NATIONAL CAPACITY BUILDING, INFRASTRUCTURE DEVELOPMENT, AND GENERATING BASELINE FOR NATIVE BIODIVERSITY TO ALLOW FOR APPROPRIATE ASSESSMENT OF LMOs RELEASE ACTIVITIES INTO THE ENVIRONMENT. ONE OF THE MOST IMPORTANT ISSUES IS TO DEVELOP CAPACITIES IN RISK ASSESSMENT.

SINCE THE APPROVAL OF THE LAW 29811'S RULE (SUPREME DECRETE 009-2012-MINAM), ON LAST NOVEMBER 2012, THE DIFFERENT INSTITUTIONS RESPONSIBLE FOR OVERSEEING AND IMPLEMENTING CONSERVATION POLICIES FOR CENTERS OF ORIGIN AND DIVERSIFICATION OF BIODIVERSITY, AS WELL AS CONTROLLING CROSS-BORDER TRADE, ARE FOCUSED IN ADJUST THEIR SECTORAL, REGIONAL, AND LOCAL RULES AND PROCEDURES.

BESIDES, LMOs EXCLUDED FROM THIS MORATORIUM (INTENDED TO BE USED IN CONFINED SPACES FOR RESEARCH PURPOSES, AS PHARMACEUTICALS AND VETERINARY PROODUCTS, AND/OF FOR DIRECT USE), SHALL BE SUBJECT TO RISK ANALYSES PREVIOUS TO THE GRANTING OF AUTHORIZATION FOR ITS USE AND THE APPLICATION OF MEASURES FOR RISK ASSESSMENT, MANAGEMENT, AND COMMUNICATION, PURSUANT TO THE CARTAGENA PROTOCOL ON BIOSAFETY, CODEX ALIMENTARIUS RELATED TO "FOOD DERIVED FROM MODERN BIOTECHNOLOGY", LAW 27104, LAW ON PREVENTION OF RISKS DERIVED FROM THE USE OF BIOTECHNOLOBY, ITS REGULATION, AND OTHER APPLICABLE SECTOR RULES.

Thank you to Paola for the coordination of this working group and for the question  putting before us.

The scope of "decision on import" should include both intentional introduction into the environment and  direct use as food or feed, or for processing, and also the importation of LMO for containdes use.  In all cases, socioeconomic considerations (set forth in Article 26 of the Protocol) should be one element in such process.

As stated in Article 4.2 of the Protocol, a country has the right to apply more protective of biodiversity than those referred to in the Protocol. This should not be restricted only to the protection of biodiversity, but also the health of the population.

I would like to recall that Article 23 of the Protocol also estabece that society has to be consulted in decisions regarding LMOs, which should include imports of LMOs.

Elizabeth Bravo

Dear colleagues
Thank you very much Paola for facilating this working group.
Niger republic has adopted precautionary approach taking into account socio-economic considerations in its biosafety project law.  We also adopt the 3N initiative, Nigeriens feed Nigeriiens ,the agricultural programm of the president of the republic to encourage farmers to produce more food through a decision on seeds import .Actually 8 African countries including Benin, Burkina Faso, Côte d 'Ivoire , Giunée Bissau, Mali; Niger Senegal and TOGO are elaborating a common legal framework on LMOS socio_economic considerations for the protection of regional biodiversity. In my view you should include intentionnel introduction of LMOs into the environment for direct use, food and feeding , all aspects resulting from LMOs decision on import that should have an impact in agricultural practices .
Best regards
Dr Gado

Greetings to All!


Let me start with my extending compliments to the Secretariat for starting this on line discussion with the key elements of article 26. 

One of those key elements is indeed “decision on import”, and the question indeed arises what the scope of that phrase is. The first conclusion we can draw is that this is about decision making, i.e. not about risk assessment, and the second conclusion is that is about import, i.e. not about export.

Question 1 then guides us to the next sub-question, i.e. what is covered by “decisions”. The text of the Protocol makes it clear that “decisions” can be decisions under the Protocol as well as decisions under its domestic measures implementing the Protocol.

Article 26 does not specify which decisions on import under the Protocol it refers to. As was also recognised in the IUCN Guide on the Protocol, the broad language of Article 26.1 implies that these decisions can be decisions on individual cases, such as those referred to in article 10 (AIA) and article 11 (FFP), as well as more generic decisions such as those referred to in articles 13 (simplified procedures), article 14 (bilateral agreements) and article 7.4 (exceptions).

Looking forward to the remainder of the discussion and hoping that we can have similar exchanges on other key elements of article 26 such as “consistent with their international obligations”, and “arising from the impact of living modified organisms on the conservation and sustainable use (etc)”

Regards to all,

Piet van der Meer

Dear All

Well done to the secretariat for getting this process underway!

Some background to the South African situation: The South African legislation gives scope for including socio-economic considerations, but leaves the application open to each specific case.  The regulations further require public notices to be posted in the national and/or regional press (depending if it is a general (commercial) release, or a field trial application). Such notices also provide the contact details of the registrar where comments can be made, and all such comments are included in the decision-making process.  In certain cases the regulators have actively sought industry perspective on particular applications.

This certainly gives some scope for considering socio-economic issues.  But further, the decision-making body (the so-called Executive Council) includes five national government departments (Environmental Affairs; Health; Agriculture, Forestry and Fisheries; Trade and Industry; and Science and Technology), each of which bring their relevant expertise and policy approach to the table.  This Executive Council is informed by a Scientific Advisory Committee comprising independent (publically-funded) scientists with expertise relevant to different aspects of biosafety.

The key approach is risk-benefit (rather than merely precautionary), so it specifically allows for the case to be made for socio-economic advantages.

The experience we have gained since the implementation of our GMO Act (1997) has clearly demonstrated the value of having an active approach to gaining civil society inputs to the decision making processes.  There are many other elements of the South African approach to biosafety which, for reasons of brevity, I have omitted.

Ben Durham

Dear colleagues!
First I want to join the other contributors in thanking the Secretariat for starting the online-discussion and their efforts in preparing the guiding questions.

To my understanding the “decision on import” is made pretty clear in Art 10 and the reference made to Art 15 (risk assessment) therein. However, as also has been mentioned already, the decision has to be seen in its context. The import of LMOs is always done with a special purpose (scope), i.e. cultivation, FFP or contained use, and therefore the decision needs to be linked to this scope. The decision if such an import permission is granted should be based - according to the protocol - on a risk assessment according to Art 15. Other factors like socio economic considerations may be taken into account (Art 26) by the Party of import. In many countries such a decision on imports of LMOs is referred to as “authorization” and usually processes have been installed on how to reach such a decision. In the European Union we have a quite strict system of authorizing such imports. Decisions need to be made on a case-by-case basis (with reference to the scope of the application) and have to be based on the outcomes of an extensive risk assessment. Though our legal framework provides for taking socio economic considerations (in the law they are called “other legitimate factors”) into account this has not been done so far.

The second point raised was if there is a difference if the decision is taken under Art. 10 of the Protocol or under domestic measures. In my opinion this is a legal question. The application for import is usually not filed by a Party but by a company or research institution. As the Cartagena Protocol on Biosafety is an agreement between Parties under international law, it is not directly applicable to private companies or other stakeholders. Therefore the applications for import need to refer to the national laws and regulations of the importing country and the decision by the authorities need to be based on their laws. However, Art. 10 as well as all other provisions have to be implemented by Parties, as laid down in Art 2 (1), and should therefore be reflected in national legislation. In summary: In my opinion any decision on imports needs to be taken under national law of the importing country, as the stakeholders (companies, research institutes, …) are not obliged to follow the Cartagena Protocol, unless there is a direct reference to the provisions of the Protocol in the national regulations.

Best regards
Andreas Heissenberger
Environment Agency Austria

<http://bch.cbd.int:80/onlineconferences/portal_art26/se_forum_discussiongro
ups.shtml?forumid=17288&threadid=4382#4393> RE: What is your understanding
of "a decision on import"? How do you understand its scope? Does it matter
whether a decision is taken under the Protocol (Article 10) or under
domestic measures implementing the Protocol? [#4393]



Thank you Paola for getting this underway.

I would like to support this reply that a decision on import must be subject
to domestic measures for implementing the protocol for such important
considerations as  protecting native biodiversity.



India is in a similar position. We have great genetic diversity in crops and
plants and are the centre of origin for rice and a centre of diversity for
many plants. For example, in the case of  brinjal (aubergine), India is the
centre of the world's biological diversity in brinjal with several wild
species. We currently have an open-ended moratorium (imposed in February
2010) by the Ministry of Environment and Forests (MoEF) on the
commercialisation of Bt brinjal because the Risk Assessment  Protocols were
not robust. This moratorium is conditional on further independent testing to
the satisfaction of both science and the public (in step with Article 23).



Therefore,  the focus for India must also be on its in-country protocols of
Risk Assessment (RA). The decision to import should be subject to these.
Drawing on the experience of Bt brinjal it must be the case that India must
enact the most rigorous protocols of RA guided by the spirit of the PP which
is also a Constitutional requirement. It is also a precedent in Indian Law.

Furthermore, I believe that India may already be an exporting country for
LMOs to its neighbours in Asia. This places a burden of responsibility on us
as an exporting country of LMOs to ensure rigorous standards of biosafety.

On the above basis then, it becomes necessary that any import of any LMO
whether for intentional release, as direct use as food and feed or for
processing, must be an 'approved' LMO for import; 'approved' by and subject
to such in-country RA protocols, which are formulated to the strictest
standards of regulation in the light of up-to-date scientific knowledge and
technology (Article 4.2).



Furthermore, the exporter-country regulatory standards and RA protocols
would not be appropriate for the added reason that in many countries, RA
protocols are weak and in the US we have virtual deregulation of LMOs/GMOs
and certainly no requirement for bio-safety testing which is voluntary.



Aruna Rodrigues

Sunray Harvesters,

Bungalow 69

Mhow - 453441

M.P. India

Dear colleagues

This is a reply to Drs A Heissenberger and Elizabeth Bravo. Thank you both
for  clarifying various points in relation to their relevance to specific
Articles of the Cartagena Protocol. This is very useful and speaking for
myself, facilitates the discussion.

In India, SEC (Article 26) is theoretically part of the process of
regulation ie appraising the cost-benefits of a particular  LMO to be
introduced. However, it remains largely theoretical at present.

Socio-Economic Considerations of an LMO for 'import' must represent  a
serious input especially given our predominantly agrarian society with about
65% of our population rural-based and therefore,  I agree with Dr Bravo that
SEC must form part of the process.  Furthermore, RA (Art 15) and SEC (Art.
26) must both be an integral part of a process of regulation that is applied
to a decision to 'import' across three applications (intentional
introduction, direct use as food and feed or for processing) which define
'scope'.

Best regards

Aruna Rodrigues

Sunray Harvesters,

Bungalow 69

Mhow - 453441

M.P. India

I think it is very important to consider that a moratorium is only useful when a program is defined and implemented to generate adequate answers to the regulatory questions a country can face to make sound decisions. The case of Mexico is quite illustrative, because a moratorium on the environmental release of GM corn was established. During this 11-year moratorium very litle scientific work was made but important advances in the legal framework (Biosafety law and bylaws) were introduced. This legal framework gave solid base for the decision-making process and permits for experimental releases of GM corn were granted. The set of questions were exactly the same as in 1998 and now we realize that the answers can only be generated when you work on the field under strict biosafety measures. The only way of generating sound information for decision making is conducting experimental work. Speculation can not be the base for the definiton of a country's strategy

Dear Paola,

Thank you for starting this very useful and important discussion. The scope of the "decision to import" should include for contained use and deliberate release. Under deliberate release it should ideally be divided into three categories: FFP, GM processed food derived from LMO and Processed food containing ingredients derived from LMO.

The decision to import should be in the respect to the domestic regulatory framework but keeping in mind Article 15 of the CPB. In the case of a it developing countries should also extend to Article 26 in the CPB which relates to a socio-economic assessment. Both of which become especially important if the import is meant for deliberate release.

Having said this it is important that all mechanisms for regulating LMOs should be in accordance with the CPB, if the country is a signatory.

Regards

Neha Saigal

Greenpeace, India

National laws and measures should be the framework for decision making for imports. The case of Mexico is special: the main part of Mexican trade of agricultural products is with USA and Canada. USA is not member of the Protocol and this implies the need to have specific measures to regulate imports of seed and grain coming from this country. The Protocol measures serve as guideline and accordingly a strict procedure of risk assessment is applied to authorize such imports. The use of the LMO as food or feed requires authorization of the Ministry of Health.

In reading the messages, I find that the greatest work needs to be done before importation – asking questions like is the proposed GMO introduction needed and why, what is the scientific basis for this, who profits from the introduction and who loses, what are the potential hazards. and will scientists have free unrestrained access to study the material once introduced. In the USA, most of these questions not been adequately addressed, especially access to study GMOs. The highly touted bio-security assessments are extremely difficult to do and are hampered by commercial restrictions on investigating GMOs.

If all of these issues can be satisfied in the affirmative, then the introduction process is a procedural matter.

Greetings from the Philippine Panel!

We take cognizance to the provision of Article 26, whereby socio-economic considerations are a vital element in the conservation and sustainability of biological diversity and its value to indigenous and local communities.

However, the socio-economic considerations should not be a mandatory requirement in conducting risk analysis. The "decision to import" LMOs, whether it is for contained use, intentional release to the environment, direct use as food or feed or processing is an integral part of the risk analysis process of the individual countries. Therefore it is important to take into account that individual member countries with existing Biosafety Regulatory Framework that provides the domestic measures implementing the protocol should take precedence over the general provisions of the Cartagena Protocol.

Dr. Solleiro's views are absolutely right in the sense that unless the field trials of GMOs are allowed, no tangible decisions can be taken by the regulators. While, there is no second opinion about the sole decision to import or release of GMOs by the concerned countries, approval of field trials would the right way to generate relevant information of a particular GMO/LMO. Science cannot work only based on presumptions or assumptions! The concerned parties should understand this fact and one should not go the way Indian anti-GMO group has taken. Again I strongly reiterate here that allowing experimental field trials would be the ideal situation to assess the effect of GMOs/LMOs.

Dr Jose,

I find the point you have mentioned in the forum very interesting about doing trade with countries that are not a member of the Protocol like you have stated in the example for Mexico and the USA.

Considering that the USA is not a member of the CPB it poses great danger to another country importing from them as their regulation will not be in accordance with the standardised guidelines of the CPB. And unless a country like Mexico does not have the institutional infrastructure to test these GMOs independently and I can say coming from India, that we do not, it is an important decision for a country like Mexico to make whether they want to continue trade with a country like USA in GMOs, that is not a member of the CPB.

Regards
Neha Saigal
Greenpeace, India

Dear all,

Firstly, I’d like to thank Paola Scarone for the guiding questions and the current forum.

Concerning the opening questions, the protocol gives the Parties the choice of deciding to import under the procedures of the Protocol (Article 10) or to use its own domestic regulations (article 14-4,) when consistent with the Protocol.  This is also reflected in the provisions of the protocol mentioned by the Secretariat.

This flexibility is important as parties with no regulatory frameworks as well as those with domestic regulations in place can make decisions following defined measures to ensure the safe transport of LMOs. It is however crucial to consider that domestic measures must be consistent with the aims of the protocol, must remain within its scope, as well as with other international agreements such as WTO and prevent unnecessary trade barriers.

It is crucial that socio-economic considerations are reflected as in Article 26-1:
“Parties, in reaching a decision on import under this Protocol or under its domestic measures implementing the Protocol,
may take into account, consistent with their international obligations, socio-economic considerations
arising from the impact of living modified organisms on the conservation and sustainable use of biological diversity, especially with regard to the value of biological diversity to indigenous and local communities.”
In other words, decision on import:
a) can be either under the protocol or parties’ domestic measures;
b) article 26 clearly states that it “may” take socio-economic considerations (and not should as written in the posting number #4394 , or must as written in posting number #4400)
c) is consistent with other international obligations
d) socio economic considerations scope are limited to those arising from the impact of living modified organisms (LMOs) on the conservation and sustainable use of biological diversity.

Best regards, Lúcia

Dear colleagues

Dr Gutierrez raises essential issues in the regulation of GM crops. As he
says (of the essential work that must be carried before a decision is made
to 'import'),  "most of these Qs have not been adequately addressed". This
is the case not just in the US but in India as well. His  key point - "if
all of these issues can be satisfied in the affirmative -" and this then is
the point, the issues he has raised of fundamental importance for SEC
(because they are the first steps in regulatory protocols in an ex ante
assessment), are quite simply not addressed.

In India, we have 1 commercialised crop that was introduced 10 years ago
from an initial 'import' from the USA. We are grappling today with many
consequences of that decision. Those consequences have become known through
feedback from farmers in different agri-climates and soil conditions, with
and without irrigation. To take a 'deadly' example: today, it is not
disputed within  government sources (after 10 years!) that Bt cotton has
contributed to farmer suicides in some parts of India where it was planted
in marginal and rain-fed soils. There are other equally serious impacts of
Bt cotton including the question of performance yield. I will not address
the content at this juncture but leave it more appropriately for later.

The issue I feel I must raise quite legitimately at this juncture  has to do
with  the other side of the coin of SEC. If there is an 'ex ante evaluation'
or predictive research and analyses of SEC, which must be carried out before
a decision to import is taken for environmental release and for food and
feed, then it is equally - if not more - important to gather data on socio
economic effects after commercialization of the LM crop.

These data and results of an "ex post evaluation" are a  critical input
because they are  based on empirical studies (actual experience) OVER TIME.
This provides  evidence of the impacts on various categories of users
including crucially  in farmers' fields. There might also be a link to Art.
16 (risk management) and to the issues arising from the Supplementary
Protocol on Liability and Redress.

Such ex post evaluations of a planted crop can lead to profound decisions
down the line for decision-making on other LMOs for import and it is
certainly possible that the earlier decision to import an LMO is reversed
based on feedback of adverse impacts.

Therefore ex post evaluations are arguably, even more  important than  ex
ante assessments and should be an integral part of the decision making
process.

Aruna Rodrigues

Sunray Harvesters,

Bungalow 69

Mhow - 453441

M.P. India

M/S Aruna Rodrigues elegantly fleshed out the issues I tried to raise in my brief message. I worked with the director of the film “Bitter Seeds” that dealt with the link between farmer suicides and the predictable disaster wrought by the introduction of Bt cotton to rain grown cotton areas in India (e.g., Maharastra State). This case study should be a bellwether cautionary tale for socio-economic, and I might add, ecological implications concerning the importation of GMO commercially before testing. The details may differ but the general implications hold for other crops and countries. The outbreak of secondary pests in Indian Bt cotton (and elsewhere) required pesticide use for control launching poor vulnerable farmers on both the pesticide and biotech treadmills. And then there are issues such as the effects on biodiversity.

The economic analysis should include more than estimates of gross national gains, as adverse consequences may be suffered by many, while the gains are accrued by a few. The biggest flaw in introducing GMOs is that scientists are unable to do independent research on these crops (organisms) either before or after introduction, and this makes discussions of economic, social and ecological assessments mute.

All - This has been an interesting discussion so far and I welcome the opportunity to share the abstract from the paper by Guillaume et al. (2008) that examined in detail the issue of farmer suicides and Bt cotton in India.  Rather than restate the authors findings, I have simply pasted the abstract below.
Regards,
Eric Sachs

Bt Cotton and farmer suicides in India
Reviewing the evidence . . .
http://www.ifpri.org/publication/bt-cotton-and-farmer-suicides-india

Suicides in general, including farmers’ suicides, are a sad and complex phenomenon. Hence, their underlying causes need to be addressed within an equally complex societal framework. Here, we provide a specific case study on the potential link between technological choices and farmer suicides in India. Although officially recognized for having increased production and farmers’ income, Bt cotton, genetically modified, insect-resistant cotton, remains highly controversial in India. Among other allegations, it is accused of being the main reason for a resurgence of farmer suicides in India.

In this paper, we provide a comprehensive review of evidence on Bt cotton and farmer suicides, taking into account information from published official and unofficial reports, peer-reviewed journal articles, published studies, media news clips, magazine articles, and radio broadcasts from India, Asia, and international sources from 2002 to 2007. The review is used to evaluate a set of hypotheses on whether or not there has been a resurgence of farmer suicides, and the potential relationship suicide may have with the use of Bt cotton.

We first show that there is no evidence in available data of a “resurgence” of farmer suicides in India in the last five years. Second, we find that Bt cotton technology has been very effective overall in India. However, the context in which Bt cotton was introduced has generated disappointing results in some particular districts and seasons. Third, our analysis clearly shows that Bt cotton is neither a necessary nor a sufficient condition for the occurrence of farmer suicides. In contrast, many other factors have likely played a prominent role. Nevertheless, in specific regions and years, where Bt cotton may have indirectly contributed to farmer indebtedness, leading to suicides, its failure was mainly the result of the context or environment in which it was planted. We close the paper by proposing a conceptual framework for empirical applications linking the different agricultural and institutional factors that could have contributed to farmer suicides in recent years in certain districts of Central and Southern India.

Author: Gruere, Guillaume
Mehta-Bhatt, Purvi
Sengupta, Debdatta .

Dear Paulo

New Zealand’s legislation pre-dates the Protocol by four years but is compliant with it. Our legislation requires that any GMO (= LMO) to be imported, that is a transboundary movement, must have an approval whether or not it is for contained use, for food, feed, or processing, or for a deliberate release into the environment. New Zealand makes a specific decision, based on a risk assessment, on the importation of an LMO. Where the LMO is to be used in containment the approval will impose controls to mitigate any risk identified in the risk assessment and the containment facility must be approved. Where an LMO is to be released into the environment there are two types of approval - one acknowledges that there may be some risks but that these can be mitigated by controls and as such the LMO continues to be regulated. The other type is where no risks can be identified and therefore not mitigating controls are required. In such a case the specific LMO would no longer be regulated and any future transboundary movements into New Zealand would not require an approval. Thus our domestic legislation is consistent with the Protocol.

Regards
Geoff Ridley, Environmental Protection Authority, New Zealand

Dear Participants

It is unclear to me why a moratorium [#4399] is required if the domestic legislation is consistent with the Protocol? The protocol requires a risk assessment. If the risk assessment is inadequate, and it is important that the decision makers clear articulate the deficiencies in the risk assessment, then the application to release could be declined. The applicant is then free to gather further information and make a new application to release. A moratorium seems a very blunt instrument.

Regards
Geoff Ridley, Environmental Protection Authority, New Zealand

This is in response to Dr Geoff Ridley from NZ on the question of a moratorium.

I would look at this in two ways: One is a moratorium on open air field trials till you have a institutional mechanism for a regulatory system that can asses GM crops satisfactorily. So far in India this is lacking and considering the risks that accompany GM crops, its very important to have the mechanism to assess the safety aspects and effect on socio-economic framework of this technology. While India is a signatory to the CPB, this may not necessarily reflect in the regulatory framework in practice.

The other thing I would like to point out is that India is a country which is the centre of origin and diversity for many crops and this is crucial for the food security of the country. Thus a GM crop of these kind of crops definitely need to be kept out and a moratorium makes sense, Brinjal will be an example of this.

Regards
Neha Saigal
Greenpeace, India

The issue of field trials of LMOs is  important and a distinction must be
made between environmental release in open field trials and 'contained use'.
The problem lies with the former in that  if the LMO in question is
untested, then the science-based decision must be to withhold open release
of an unsafe LMO. Anything other would of course be  "presumption or
assumption".

  Every 'Event' must require regulatory rigour and transparency in RA. There
are several  safety-tests in  RA protocols that must be carried out before
environmental release of the  LMO in question to ensure safe release. Indeed
even some EIA (environment impact assessment) studies can be initially
carried out in 'containment'. The safety issue lies with the sequencing of
studies in  RA Protocols to determine at which point in the RA protocols may
the LMO in question be released responsibly in open field trials because it
is judged safe?

With regard to conducting trials on rice and other crops for which  India is
a centre of origin or diversity, India should be emulating Peru by imposing
a domestic ban on these LMOs (CPB: recognizes  "the crucial importance to
humankind of centres of origin").

Aruna Rodrigues

Sunray Harvesters,

Bungalow 69

Mhow - 453441

M.P. India

Greetings to all! Thank you for the interesting discussions so far.

In taking “a decision on import” under the Protocol or under domestic measures implementing the Protocol, Parties may encounter a wide range of socio-economic considerations. Parties, as accorded by Article 26, have the right to take these socio-economic considerations into account. Parties can also take socio-economic considerations into account in decisions taken under national laws implementing the Protocol. This right is established by the Protocol, in providing Parties the option as to whether or not to take socio-economic considerations into account. So I do not see this as merely a ‘may’ issue; but it is important to reiterate that this is a right set up under international law and that can be exercised either via direct decision-making under the Protocol or under domestic measures.

Parties to the Protocol also have the right to take action that is more protective of the conservation and sustainable use of biological diversity than that called for in the Protocol as established by Article 2(4). This could be reflected in domestic measures implementing the Protocol. For example, this means that Parties could, if they wish, exercise the right to take socio-economic considerations into account in a mandatory manner e.g. for every LMO application for approval, and I am aware of some jurisdictions which do this. Likewise, in national laws or domestic measures, the scope is not necessarily limited to socio-economic conditions arising from the impact of LMOs on the conservation and sustainable use of biological diversity and could be broader. Again, I am aware of jurisdictions that have done this.

A decision on import under Article 10 would relate to the first transboundary movement of LMOs for intentional introduction into the environment. In addition, a decision on import under domestic measures implementing the Protocol can relate to LMOs for (i) intentional introduction into the environment, (ii) direct use as food or feed, or for processing (FFP), and (iii) LMOs destined for contained use, as set out by various articles of the Protocol. Underlying any decision on import is the implementation of the precautionary approach/principle as outlined in Articles 1, 10(6) and 1(8) as well as in paragraph 4 of Annex III.

Taking a decision on import is further related to many important biosafety aspects. According to the IUCN Explanatory Guide to the Protocol, because Article 26.1 has broad language, this implies that in taking a decision on import under the Protocol or under domestic measures implementing the Protocol, Parties have the right to take socio-economic considerations into account when implementing a number of provisions of the Protocol or domestic measures. These could be, inter alia, those dealing with import; procedures for LMO-FFPs; review of decisions on import; risk assessment and risk management; unintentional transboundary movements and emergency measures; handling, transport, packaging and identification; capacity building; public awareness and participation; liability and redress; transboundary movements of LMOs between Parties and non-Parties; and illegal transboundary movements.

A decision on import is also inherently related to risk assessment (Article 15) and Annex III of the Protocol as clearly stated in Article 10(1). Hence, social and economic issues can be taken into account in parallel, or even integrated, with the risk assessment, taking also into account risks to human health. Socio-economic impact assessment would assist Parties in decision-making.

kind regards
Lim Li Ching
Third World Network

Dear all,I find hard to believe that the sad problem of farmer suicides in India is simply to be blamed to Bt cotton and it could be easily solved without the access of this tool. For instance, it was already in the media that the southern state of Maharashtra began reporting a significant rise in farmers’ suicide in 1995. In other words, several years before the introduction of Bt cotton. How can it be that Bt cotton was the cause when it was not yet available?
As mentioned before, Guillaume et al. (2008) “Bt Cotton and farmer suicides in India - Reviewing the evidence” reached a very different conclusion and it states that the introduction of Bt cotton in India had actually been led to higher yields and decreasing pesticide usage by nearly 40%.
In addition to have a better understanding of the high suicide rate in India, I would like to suggest the reading of a paper in the medical journal Lancet (Patel et al 2012): Suicide mortality in India: a nationally representative survey
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2812%2960606-0/fulltext

Among the authors' observations: “Suicide death rates in India are among the highest in the world. Poisoning, mostly from pesticides (mainly organophosphates) used in agriculture, was the leading method of suicide but suicide deaths in unemployed individuals and individuals in professions other than agricultural work were, collectively, about three times greater than they were in agricultural workers,”
It seems that the suicide problem in India is complex and probably needs an array of measures to effective reduce the problem. Restricting access to pesticides might prevent more suicide deaths in India, than restricting access to Bt cotton that’d actually being well accepted among the farmers due to reduced number of needed pesticide spraying when using this technology.

Best regards, Lúcia

Greeting to all
This has been effectively an interesting and active discussions. I want to thank Dr Eric Sachs for sharing the abstract from the paper by Guillaume et al ( 2008 ). This is a great contribution for the discussions group . I support the view that the risk assessment is very important as required by the Protocol. I support the comments of Neha Saigal on the case of India.
Best wishes
Dr Gado

Dear all,
I totally agree with Drs.: Solleiro, Ridley, and Balachandra. Field trials are essential to gain the knowledge and experience needed to make valuable/effective decisions.  Field trials can be done safely; risk is minimal just by taking appropriate steps to reduce and control the exposure, etc (risk management measures). A moratorium might discourage research when it might be mostly needed and you consequently might miss opportunities to actually protect your environment.
Best regards, Lúcia

Interesting discussion!  Perhaps it would be useful to start trying to define "harm" or "benefit" in the context of socioeconomics? Perhaps this would be useful in starting to get to grips with socio-economic considerations?
Ben Durham

Dear all,

While the discussion is around socio-economic considerations, I would like to clarify a point made by Lucia on Bt Cotton. Bt cotton has not been the miracle crop that it is made out to be. In India we have Bt hybrids and not Bt varieties, showing that it is the hybrid that has caused the increase in yield. Also pesticide usage across the country has actually increased and not decreased except the state of Andhra Pradesh which has a large area under the Non-Pesticide Management (NPM). Also in India the decrease in pesticides is due to the Integrated Pesticide Management, the policy was adopted by the Government in 1985.

And while there are varying views on farmer suicides, it is important to understand that Bt cotton for Indian farmers is part of the input intensive cycle like pesticides. There has been recorded incidence of secondary pests, resistance in the case of Bt cotton which lead to increased cost of cultivation for the farmers and this is especially significant in the case of small and marginal farmers.

In India we have pockets that practice ecological farming, NPM, that do not use GM seeds and pesticides and you don't hear these farmers committing suicide. This is where socio-economic assessment becomes crucial to compare the best available farming practice to one with GM crops using the bench-mark of economic and socio-cultural implications and ethical considerations. 

Regards
Neha Saigal
Greenpeace, India

My name is José Falck-Zepeda. I am a Senior Research Fellow at the International Food Policy Research Institute. I have been working on the socioeconomic assessment of agricultural biotechnologies since 1997, starting with the assessment of the first introduction of Bt cotton in the USA in 1996.

I would like first to thank the CBD Secretariat, the funding countries, Paola and the rest of the team helping organize this dialogue. In particular, I am quite keen in hearing especially the voices of the Parties and Non-Parties in order to understand what issues and concerns they require more conceptual clarity. This is extremely critical for us in terms of designing capacity building/strengthening responses to such needs.

I believe that there is a need to gain conceptual clarity in terms of defining socioeconomic issues, assessment methods, decision making processes, decision making rules and standards, defining standards of quality and evidence or in fact help in addressing the most basic question for many countries which is whether to include socioeconomics in their decision making. Certainly defining the scope of whether this applies only to decisions on import or whether countries will use national measures that go beyond the Protocol are relevant in this dialogue. I guess the later may not be the purview of this specific dialogue.

Certainly Article 26 reaffirms the sovereign right of countries to include or not include socioeconomics in their decision making. I certainly know personally countries who have focused and are likely to continue focusing only on the risk assessment and who will not include socioeconomics in their decision making. The opposite approach is also true.

The decision to include socioeconomics is in practice a policy/political decision. As I have explained in quite a bit detail in a couple of articles (Falck Zepeda et al. 2012; Falck Zepeda and Zambrano 2011 I can send you copies of the article upon request) inclusion of socioeconomics has costs, benefits and in some risks, to countries making the decision. I hope that countries do take into consideration these issues, but also include the potential consequences and impact on innovation, technology delivery and availability, impact on the public sector research, and the need for alternative approach to address productivity and production constraints. Developing countries require more alternatives rather than less and I do come from Honduras, a country desperately in need of more technological tools to address these issues. 

We can add to this list, the practical implementation issues and the limitations from such approaches. Those of us who have been involved for many years in conducting socioeconomic assessments now the issues and the pitfalls from such assessments and their relationship to decision making. We are certainly willing to share readily this knowledge with parties and non-parties. 

Finally, after reading all the valuable contributions to this dialogue, I think we have to carefully separate two distinct issues. One is whether to include socioeconomic issues in the risk assessment and second whether to request a formal socioeconomic assessment as a requisite for approval apart from the risk assessment. These are two distinct issues in my mind. I propose that the risk assessment already considers many socioeconomic issues including impacts on biodiversity. Starting of course from the most basic decision to classify a target insect/organisms as a pest that needs control all the way to compliance with insect resistant management practices.

Thanks,
Jose Falck-Zepeda
j.falck-zepeda@cgiar.org


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

A paper by two IFPRI colleauges, Guillaume Gruere and Yan Sun, should provide a bit more data on the issue of the relative contribution of Bt cotton to the increase in cotton yields and production in India.


Gruere, G. and Y. Sun. Measuring the contribution of Bt cotton adoption to India’s cotton yields leap. IFPRI Discussion Paper 01170, International Food Policy Research Institute (IFPRI), Washington, DC. http://www.ifpri.org/sites/default/files/publications/ifpridp01170.pdf

While a number of empirical studies have demonstrated the role of Bt cotton adoption in increasing Indian cotton productivity at the farm level, there has been questioning around the overall contribution of Bt cotton to the average cotton yield increase observed these last ten years in India. This study examines the contribution of Bt cotton adoption to long- term average cotton yields in India using a panel data analysis of production variables in nine Indian cotton-producing states from 1975 to 2009. The results show that Bt cotton contributed 19 percent of total yield growth over time, or between 0.3 percent and 0.4 percent per percentage adoption every year since its introduction. Besides Bt cotton, the use of fertilizer and the increased adoption of hybrid seeds appear to have contributed to the yield increase over time. However, if official Bt cotton adoption contributed to increased yield after 2005, unofficial Bt cotton might also have been part of the observed increase of yields starting in 2002, the year of its official introduction in India.

I agree with the number of participants who have found the discussion interesting.  I think we are already going beyond the scope of the original question to getting into the more specific aspects of  what we mean by socio-economic analysis. 

Ben  Durham [#4431] suggests that "Perhaps it would be useful to start trying to define "harm" or "benefit" in the context of socioeconomics?"
I agree that this would be valuable especially since this will vary according to the legislation and also the social context of the different countries - it may help us to understand the different approaches currently adopted by different countries.

The New Zealand legislation requires consideration of five different areas - environmental considerations, human health considerations, Maori cultural and spiritual values, social and community considerations and economic considerations.  However, as Geoff Ridley has pointed out
-
"New Zealand makes a specific decision, based on a risk assessment, on the importation of an LMO. Where the LMO is to be used in containment the approval will impose controls to mitigate any risk identified in the risk assessment and the containment facility must be approved. Where an LMO is to be released into the environment there are two types of approval - one acknowledges that there may be some risks but that these can be mitigated by controls and as such the LMO continues to be regulated. The other type is where no risks can be identified and therefore not mitigating controls are required".

Following on from this clearly there is a difference between importation into containment and 'release' into the open environment.  We need to acknowledge and discuss these differences.  In the case of a field test/trial which is by nature contained (though the form of containment may differ) it is possible to use this to research the effects on the environment and possibly on human health, but I don't believe that field tests are useful in terms of undertaking research on or exploring socio-economic aspects.  It is incredibly difficult to (a) identify potential harms (risks) or benefits unless there is previous history of such releases, and (b) how do you assess them?  As an (ex) social scientist I am very much aware of the problems of measurement and also the fact that so few studies have been undertaken post 'event' to provide validation.

And I have't even touched on whether you look only at direct effects or to what degree you can consider indirect effects (such as farmer suicides).

regards
janet gough

Dear colleagues!
I really appreciate this so far very constructive discussion. It proves that this is an important issue for many Parties.

Let me first say that I agree with Lim Li Ching and Jose Falck-Zepeda, when they say that it is up to the Parties to decide whether or to take socio-economic assessments into account when making decisions on import of LMOs, and that this can also be an obligation if the country chooses to do so. We all know some examples of countries who have already implemented this in their national legislation. However, I guess we also know, that there is definitely a need for more clarity on how to handle the issue. This has been recognized by the Parties and that's why it has been included in the strategic plan and the decision of COP/MOP6. So it is not a question if Parties should base their decisions on import also on a socio economic assessment, but if they chose to do so, assist them by providing some conceptual clarity and ultimately some guidance.

The discussion so far has been quite interesting and many issues have already been brought up. However, as far as I recall there has been a strong wish by the parties in the discussions at COP/MOP6 but also at earlier meetings, that the discussions on socio-economic issues and risk assessment should be kept separate. Although I'm fully aware that this is sometimes difficult as there are direct and indirect links between the issues, I think we should stick to that wish of the Parties. First because there is currently a process with regard to the risk assessment documents going on, and second mixing up those two issues could jeopardize the success of this forum, as it might distract us from the main topic. However, I do acknowledge that the final assessment of socio economic impacts can run in parallel with or be an integral part of the risk assessment - but this is again up to the country to decide.

Separating the two issues is to some extent also necessary, as they use different assessment methods: While risk assessment (acc. to Art. 15) is usually based on clear scientific data, this is much more difficult in ex ante socio economic assessments. The latter often include modeling approaches, which are and need to be based on assumptions. This is unavoidable and needs to be recognized.

I would also like to comment one point raised by Aruna Rodrigues regarding the long term effects and the issue of ex-post evaluation. For risk assessment/risk management issues this has been implemented by several countries - called post market monitoring. I agree with her that for socio economic issues this is even more important, as our knowledge is limited and we need more data on  possible long term effects. So I guess this is an aspect we need to come back again to when we are discussing more on the scientific/technical aspects in questions 3 and 4.

Regards
Andreas Heissenberger
Environment Agency Austria

POSTED ON BEHALF OF Amparo C. Ampil

The decision to import is based on a country' regulations and covers intentional decision to import, that is,  it is based on procedures and a decision-making process. Under the Cartagena Prtocol and Philippine regulations,  it refers to intentional transboundary movement. The scope covers importation for contained use, field test and commercial propagation. Under Philippine regulations on biosafety, a decision to import covers tranboundary movement or trade between parties and non-parties to the Cartagena Protocol.  Non-parties have to comply with Philippines biosafety regulations, which have been formulated consistent with the Cartagena Protocol.

Amparo C. Ampil    
Philippines
Department of Agriculture

POSTED ON BEHALF OF Dr. Leonardo Gonzales, Philippines

We take cognizance to the provision of Article 26, whereby socio-economic consideration are a vital element in the conservation and sustainability of biological diversity and its value to indigenous and local communities.

However, the socio-economic considerations should not be a mandatory requirement in conducting risk analysis. The "decision to import" LMOs, whether it is for contained use, intentional release to the environment, direct use as food or feed or processing is integral part of the risk analysis process of the individual countries. Therefore it is important to take into account that individual member countries with Biosafety Regulatory Framework that provides the domestic measures implementing the protocol should take precedence over the general provisions of the Cartagena Protocol.

Dr. Leonardo Gonzales, Philippines

Dear colleagues,

I jump in this already warm discussion by first thanking the Secretariat for the launching of this important discussion on the issue of SEC, and for their trial to organize the discussion around some key questions with the aim of conceptual clarification of the meaning of Art. 26.1 of the Protocol.

Relatively to the 1st question proposed, I would first like to answer by raising some basic consideration.

The beginning of § 1 of Art. 26 which is : The Parties, in reaching a decision on import under this Protocol or under its domestic measures implementing the Protocol ....."  can also be read:
"The Parties, in reaching a decision ........
on import under the Protocol ........
or under its domestic measures implementing the Protocol ........."

This being said, the objective of the Protocol ( Art. 1 ) is to ensure an adequate level of protection in the field of safe transfer, handling, and use of LMOs.......... specifically focusing on transboundary movements.  Specifically does not mean exclusively. Moreover, the General Provisions ( Art. 2 ) demand the Parties to ensure that the development, handling, transport, use, transfer and release of LMOs are undertaken in a manner that prevents or reduces risks ( Art. 2.2 ). Logically, the development, use, and release of the LMOs do not occur during transboundary movements. In addition, Art. 4 gives the precision that the scope of the Protocol applies to transboundary movement, transit, handling and use of all LMOs . All this in order to say that one may understand that the Protocol more particularly develops tools to avoid risks during transboundary movements but that its objective applies also to the use of LMOs inside the countries; and thus that the decisions taken under domestic measures implementing the Protocol do not necessarily only apply to decisions on imports, but also to decisions on LMOs developed inside the Parties.

Saying that, I agree that domestic measures implementing the Protocol, if existing, apply at least to transboundary movements . ( If no domestic measures are existing for the import of LMOs, the Parties may ask - cf. Art. 9 - to candidate exporters to proceed accordingly to the procedure of the Protocol specified in Art. 10, for what is concerning the 1st TBM of a specific LMO to be released into the environment; and for the 1st import of a LMO intended for direct use as food or feed or processing, the Parties may ask to proceed accordingly to the procedure specified in Art. 11 § 6 ). And in any case, the decision on import should take into account a risk assessment carried out according to Art. 15

I also agree with the declarations of several participants saying in particular ( as reminded also by the Secretariat ) that " Nothing in this Protocol shall be interpreted as restricting the right of a Party to take action that is more protective of .... biological biodiversity than .... this Protocol ..., provided that such action is consistent with the objective and the provisions of this Protocol" ( Art. 2.4 ).
Taking this into account, and referring to Art. 4 and 5, differences that may exist, following my understanding,  between a decision on import taken under the Protocol and a decision on import taken under domestic measures implementing the Protocol could be among other that a decision taken under domestic measures could include LMOs for contained use and LMOs which are pharmaceuticals for humans, whereas this would not be true for decisions taken under the Protocol; these last would apply only to LMOs for direct use as food or feed or for intentional introduction into the environment.

So far for my present considerations on this 1st question.

Best regards.

Lucette Flandroy

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

It is very important to be practical and realistic in these matters. It's quite easy to say that a country should stop trade with another country (particularly USA) but real world is different. Our discussion in this group is on socioeconomic considerations and these should include the proper analysis of a typology of implications of a country's decisions including: employment, value chain, supply of products for consumers, exchange mechanisms for raw materials and produce, etc.
Biosafety regulations of both USA and Mexico follow risk assessment procedures aligned with the Protocol and the Codex Alimentarius as well. Just a few people are aware of the complex assessment conducted by three authorities in Mexico to grant permits and authorizations for import and use of LMOs as food or feed (Ministries of Agriculture, Environment and Health). There are also trinational working groups to deal with many different biosafety and risk assessment matters.
What I'm trying to express is that there is no need to fear that transboundary movements between Canada, USA and Mexico occur without any regulation and oversight mechanism.

Dear Colleagues

A few things need to be stated about farmer suicides  in India among Bt
cotton farmers. At the outset, it has always been clear that there are
multiple reasons for farmers committing suicides connected with the serious
agrarian crises in India. However it is quite another thing to completely
disassociate Bt cotton as an  aspect of the problem, as the Industry and
indeed the Regulators as well, have sought to do, , because it  has added to
it. For one thing, a significant proportion (nationally) of farmers who have
committed suicide are Bt cotton farmers.

However, let me cut to Vidharba, in Maharashtra, also called the 'killing
fields', because we know a great deal more about Vidharba and because there
is no question but that in this region, Bt cotton has been a significant
contributory factor to farmer suicides, though once again the Industry and
also the government unfortunately, have tried hard to obfuscate facts.
Virtually all farmers in Vidharba are Bt cotton farmers and it has the
highest suicide rate in India.

Socio-economics  is not a hard science where you sit with data
dispassionately and analyse it, particularly in life and death decisions as
we have in Vidharba. We have plenty of examples of such studies, including
some quoted in this forum.  This aspect of monitoring Bt cotton in Vidharba
over the last 6-7 years has been incredibly hard and it has been left to
civil society to undertake. Not  just in Vidharba, but across all dimensions
of the impacts of Bt cotton in India, there has been no post market
monitoring (PMM) of it since its introduction. There will be more on this in
later posts to this forum. I will mention very quickly a second impact, that
on India's ancient weaving industry which is the second largest employer of
labour after agriculture. This provides a hint of the magnitude of the
problem. The absence of PMM is a serious vacuum which must impact the import
of future LMOs and the planting of LMOs/GMOs under rigorous and transparent
national RA protocols.

We know the Vidharba experience of farmers from  the group of dedicated
people who have helped these farmers, agonised with them,  reported from
there year after year, and berated an unwilling government that refused to
listen; whose lives have been intertwined with farming families, suicide
notes, grieving widows and bereft children. No amount of fancy data can
substitute for the insider knowledge of these people, reporting death after
death, like a census, reaching into their pockets to try and provide a
scanty meal to a grieving widow left with a mountain of debt --- paltry
gestures in the face of utter catastrophe. Official recognition of the
farming crises here, the suicide belt in Maharashtra which has seen the
highest levels of suicides amongst Bt cotton farmers in India, took
agonisingly long, but eventually, 'even' the government were forced into the
admission that Bt cotton had a significant contributory role.   Higher input
costs, failed crops because this is a rain fed area, are the reasons and the
awful part, that the powers that be,  have always know that Bt cotton
hybrids are unsuited to rain-fed agriculture. This is a settled issue.

I provide the following statements to back what I have said. The links for
anyone wishing to read the detail are provided at the bottom.

(a) Two statements of the Government of Maharashtra: The first in April 2012
of the Minister of Agriculture, Radhakrishna Vikhe-Patil, State of
Maharashtra who said of the Bt cotton crises in Vidharba where  production
had fallen by 50% over the previous year:

"The cotton crop yield this year is 45 lakh bales. Last year, it was 85 lakh
bales," . "The primary reason for the shortfall in the cotton production is
delayed rains. The intermittent showers which were unseasonal further
aggravated the situation as it damaged the crop. In addition, the Bt cotton
cultivation is not working in Vidarbha region. It is causing more distress
to the farmers."  (emphasis mine)

The second in Dec 2012 with the Maharashtra government officially admitting
that cotton yield is likely to reduce by nearly 40%

(b) Reaping Gold though Bt cotton is a grim report of Monsanto's false
advertising and fraudulent claims aided by a willing national daily. P
Sainath, rural affairs editor of the Hindu  delved into this murky story to
provide the unvarnished truth.

And (c ) the Parliamentary Standing Committee for Agriculture, 31 MPs
cutting across Party lines delivered a unanimous report to Parliament dated
August 2012 on GM crops, had this to say:

"The Committee during their Study Visit in February - March, 2012
extensively travelled in rural areas of Vidharbha to have a first- hand
assessment of the worst agrarian crisis affecting the region. From what they
saw during the Study Visit, they are in concurrence with the findings of
IAASTD Report. They are also in agreement with the question raised in IAASTD
Report as to whether detected benefits of GMOs will extend to most agro
ecosystems or be sustained in the long run as resistances developed to
herbicides and insecticides. 5.46 A significant finding made in the Report
is about modern technology creating both costs and benefits, depending upon
the manner in which it has been incorporated into societies and eco systems
and whether there is the will to share benefits as well as

costs because sometimes benefits are at the expense of reducing biodiversity
or access to traditional foods. The Report has also  found that neither
costs nor benefits are currently perceived to be equally shared, with the
poor tending to receive more of the costs than the benefits. Extensive
interactions of the Committee during their above mentioned Study Visit to
Vidharbha proved that this

observation of experts in IAASTD Report has a sound basis. Due to initial
increase in production as a consequence of reduction in yield loss, the
simple farmers of the area went in a big way for cultivation of Bt. cotton.
However, because of very high input costs, yield loss due to development of
resistance in the targeted pests, the local agrarian economy has been
totally shattered within a few years with

great losses, mostly to the small and marginal farmers. There have been 7992
farmers suicides in the region during 2006 to 2011. In several of them,
caused due to agrarian reasons, the indebtedness and a multitude of other
problems caused by sowing of Bt. Cotton have been a contributory factor.
Furthermore, due to the craze for cultivating Bt. cotton because of its
perceived advantages, the

traditional local cotton varieties have been almost wiped out. Seeds of
traditional varieties are not available even to farmers desperate to return
to their old agricultural practices. The Committee during their Study Visit
to Vidharbha have seen with their own eyes that while the seed companies
have benefited from the transgenic Bt. cotton,the poor and hapless farmers
have received more of the costs than the benefits. The situation is grim
today inspite of the massive loan waiver scheme of the Government in 2009
and several other financial packages for the indebted farmers".



http://www.dnaindia.com/mumbai/report_more-trouble-for-debt-hit-vidarbha-far
mers_1679818

http://www.dnaindia.com/mumbai/report_bt-failure-to-hit-cotton-yield-by-40pc
t-govt_1769428


Reaping gold through cotton, and newsprint', The Hindu dated 10 may 2012 by
rural affairs editor P sainath

Aruna Rodrigues

Sunray Harvesters,

Bungalow 69

Mhow - 453441

M.P. India

Greetings to everyone from the United Kingdom, and thanks to the Secretariat for initiating discussions on what is already proving to be an interesting and complex discussion.

I'd like to start off by referring first of all to Article 1 of the Protocol which helpfully reminds us that the objective of this instrument is to "contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of living modified organisms...that may have adverse effects on the conservation and sustainable use of biological diversity." I've deliberately quoted from this article selectively - and there are two key elements here I'd like to highlight:

1) the use of the word "contribute" - which implies the Protocol is not the only tool here
2) the phrase "may have adverse effects"

The reason why I've isolated these aspects of article 1 in particular are because the fundamental bedrock for any and all decisions on import and use of LMOs should be a robust case-by-case scientific risk assessment as that it is the most effective way to protect the conservation and sustainable use of biological diversity. A fully effective risk assessment system ought to mean that "adverse effects" do not occur - although even if a risk assessment concludes that adverse effects are possible, those same systems should be smart enough to suggest mitigating measures to manage that risk (e.g. consent conditions limiting how, when and where an LMO should be used) so that decisions can be taken with regard to the evidence (i.e. risk management rather than simply hazard aversion). The Protocol should not be used as an alternative to effective risk assessment, but should be used in conjunction with it.

I agree with Andreas that as this discussion unfolds we should take great care to separate risk assessment from socio-economic considerations if we are to make meaningful progress. Any decision not to import following a risk assessment and/or a socio-economic assessment must be consistent with broader international obligations e.g. WTO rules. We must also remember that Article 26 of the Protocol only relates to "socio-economic considerations arising from the impact of living modified organisms on the conservation and sustainable use of biological diversity, especially with regard to the value of biological diversity to indigenous and local communities". If we are to be successful in realising our objective of providing conceptual clarity on this matter we must be disciplined in keeping to this strict definition of socio-economics in and not try to grapple with every conceivable socio-economic impact in its broadest sense.

One other general point that I fear is often missed, is that effective risk assessment and effective socio-economic assessment can also be used to ensure that the benefits offered by LMOs are both understood and realised. For example, when LMOs provide an alternative agricultural production method which either reduces or avoids the need for insecticides, pesticides or fungicides we must remember that that has the potential to deliver a positive impact on the conservation and sustainable use of biological diversity. So in highlighting any concerns regarding safety - we also have a duty to highlight the positive benefits which can be expected as well so that Parties can take fully informed decisions based upon all the evidence.

As far as this first question is concerned, if my understanding of legislation is correct, EU law fully transposes the Protocol, and our domestic UK legislation fully transposes EU law - so in taking a decision on import under domestic law we are in effect automatically compliant with both EU law and the Protocol simultaneously. Decisions taken to carry out field trials in the UK would not constitute a "decision on import" - unless of course it was a GMO exported from a third party. The EU system is designed to allow market access for products which have undergone a comprehensive, science-based, case-by-case risk assessment which should give predictably to EU member states, third party countries and commercial operators. It doesn't always operate as smoothly as it's designed to - but that's perhaps an issue for discussion on another day or in another forum!

Mike

Dear Amparo Ampil. Greetings and thanks for presenting the Philippines experience which has accumulated by know real experience conducting risk assessments for a growing set of crops and traits for FFPs, containment, confinement and for general release.

Just a clarification request. If a proponent develops an event within the country, and thus there is no decision on imports, does this mean that Article 26 does not apply in this specific situation?

I guess my question is really more a call to open a discussion on the differences between regulatory regimes that deal with trade and importation of events versus the research conducted in country and to which the Protocol may not apply. Seems that by not clearly differentiating between the two, we may be penalizing valuable research conducted in country, particularly that done by the public sector. Certainly domestic measures may include other processes, but this is a separate matter.

Jose Falck-Zepeda
IFPRI

Dear Colleagues,
I am hoping that we do not dissociate defining our understanding of "decisions on import" and scope in this discussion, from the implementation issues should a country decide to apply Article 26. By the way, the word "may" opens up the option where countries reaffirm their sovereign right so that that they may apply or may not apply inclusion of socioeconomic considerations in their decision making. Both options are equally valid and we have seen countries follow either paths.

It is my personal opinion that countries debating whether to include socioeconomics in their decision making, or those who have taken the decision and are looking forward for an implementation pathway, may take into consideration the following set of elements:

"Need to maintain biosafety (risk) assessment a science and evidence based process"

In as much as has been implemented in generally accepted practice, the process of conducting a biosafety (risk) assessment needs to follow elements of best practice, maintain scientific standards of excellence, and should be conducted by experienced assessors or under the supervision of such valuable human resource.

Inclusion of socioeconomics can have costs, benefits and risks -not clear whether there will be positive (net) benefit to society, thus need to weigh decision in the specific national context

Socioeconomic assessments can contribute new -and in some cases improved- knowledge. This may help separate those technologies that may be valuable from those who are not valuable to society. Yet, there are costs associated with the inclusion of socioeconomics in decision making. Costs include costs of implementation, potential of introducing uncertainty into the process and the possibility of developing an unworkable process. Inclusion of socioeconomics may increase the time of compliance a

"If a country has taken the decision to include socioeconomics in decision making, then it’s a matter of devising implementation"

Countries who have taken such decision need support in terms of designing a system that will be as much as possible transparent, feasible, cost and time efficient, fair and protective.

"Socioeconomic assessments and analysis need to adhere to standards of excellence, elements of best practice and reliance on well-qualified experts for implementation"

Regardless if the process will require de novo studies or whether it will rely on an qualitative assessments of socioeconomic issues, the assessment and analysis need to adhere to elements of best practice for implementation. This is the only way to ensure that multiple methodological issues -including own assessor biases- are properly addressed and to improve the accuracy and precision of the socioeconomic assessment.

"Prudent to explore the value of a sequential process where risk assessment is completed and then if and only if anything is identified as an issue, proceed with the socioeconomic assessment"

Exploring whether this option -as devised in the case of Brazil and perhaps Mexico- is prudent and valuable for implementation. This approach ensures that no resources are unnecessarily spent on a socioeconomic assessment, by conducting the biosafety(risk) assessment first and thus filtering those technologies that may not be deemed safe or in some cases ineffective. In addition this approach may help generate additional information and knowledge that may be used (prudently) in the implementation of the socioeconomic assessment and/or in conducting a socioeconomic evaluation study.

Dear participants,

While all postings in this session were very interesting to follow, some of them went somehow further, does it seem to me, than answering the precise question of the Secretariat, by presenting and discussing on precise cases rather than on generic considerations.

Anyway, they lead me to insist on one element already mentioned by some participants, which is to indeed take into account Art. 23 of the Protocol in the decision making process relative to authorization of LMOs. Still more than for environmental and health risk evaluation and management that should/could stay mainly in the hands of scrupulous experts, socio-economic considerations are concerns of everyone, of every part of and of the whole society, where different groups of the society may have experiences that should be listened to, and where the concerns of different groups can be different. This should be taken into account in the process of decision making.

Obviously, this does not make it easy to practically take this into account; but I guess that discussion on adequate methodologies could be discussed in another part of this forum ( whereas they occurred already in the online  forum on this issue between COP-MOP5 and COP-MOP6 ).

It makes it in any case worth wile to take into account concerns of various parts of the society in ex ante SEC, precisely to allow the development of eventual management/mitigation measures of socio-economic impacts ( ? can we consider that Art. 16 of the Protocol also applies to socio-economic "risks " ? ) that would be negative for some stakeholders when the global socio-economic impact of LMOs for the society would appear to be positive from this ex ante evaluation.

And obviously, like for the case of environmental and health risks, the uncertainties in the ex ante evaluations should be recognized  ( in SEC like in ERA ) and should lead to the development of monitoring plans that should take place among the ex post evaluations; in case the uncertainties rest on too important risks, the decision could also be to refuse the LMO, on the basis of the precautionary principle, the more that it would refer to SE impacts arising from impacts on biodiversity. All this should be clearly foreseen in the decision making process.

And actually, like recognized for the decisions based exclusively on the environmental and health risks evaluation, the socio-economic protection goals and limits of concerns that would influence the final decision on LMO authorization/import would be partly in the hands of each Party individually ( depending among other on the socio-economic situation and natural characteristics of the country ) , while respecting international obligations.

Best regards, and already nice end of week to all of you.


Lucette Flandroy

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

I want to make some contributions on the direction you are taking this discussion on socio economic consideracioens must be taken into account when making decisions on GMOs.
1. This should be a process based on caution, using the best scientific evidence, but should not be a "sciences & evidence driven process". We should not expect to have death people   before decisions when using caution can be avoided
2. Some of the participants mentioned that SEC shoul reflect what is beneficial to society, but I would like to ask, Who is society?. If we analyze from Political Ecology realize that society is heavily traversed by power relations, and that at the time of making decisions, prevailing the interest of the strogest . That's why, despite being reported suicides in India, which have won judgments in Argentina and that relacioann Paragauy the RR soy model with disease and death, they are still talking about the need for "evidence" as if the evidences of the victims are not valid.
3. I think the point that we must focus when dealing with SEC is not whether the technology is effective, but how we protect human communities, the family and peasant economy and food soverignity, how it is to protect the agricultural knowledge and use traditional seed health and general population.

Dear all,

First I would like to thank Paola for organizing this forum and all the colleagues for their interesting contributions.
After reading all the posts, and trying to answer the raised questions, I would try to express my point of view.
I think it is quite clear the meaning of “a decision on import” and here I would like to support everyone who understand it like is stated in article 10 of the Protocol (Pier van der Meer and others).
Moving to the meaning of the “scope” of this decision on import, I see it fits perfectly to all the uses we can give to a GMO, contained use, voluntary release or commercialization. The Protocol is wide enough here. But to make this decision we should take account art. 25 (risk assessment) and, only in a voluntary manner, art. 26 (SEC).
This two different approaches, give us the reason why we have to keep separated both, RA and SEC in this forum, though in practice they are mixed in the decision making process.
At this stage, I agree with those who understand the Protocol as a tool to guide their decision making process in case of lack of regulatory national framework. In case of existing this domestic laws, based in Protocol, seems logical to use it instead of the Protocol provisions.
Finally, in Spain, as Mike said before, we have developed national regulation, which develops European regulation, which is based on Protocol.
It means that, we include some SEC as they are defined in art. 26 “conservation and sustainable use of biological diversity” for example, but this is not a separated part of the process.

Best regards

Omar del Río

Dear Colleagues,

As a number of the submissions to date indicate, there are many aspects of the question of socio-economic concerns under the Protocol, and some of the discussion under this first question has moved into the topics of the subsequent questions.  Regarding the initial question of the scope of a 'decision on import', I found Dr. Ampil's very concise response (34396) to be very useful - the scope would include decisions on import for contained use, environmental release and for food feed and processing.  I believe that Dr. van der Meer expressed the same view (#4396). 

Dr. Luiza de Souza (in post #4418) provided a similarly clear statement about whether it matters if the decision is taken under the procedures of the Protocol (Article 10) or to use its own domestic regulations (article 14-4,) when consistent with the Protocol. As she notes, this flexibility is important as some Parties may have no regulatory frameworks while others have domestic regulations in place, and in either case Parties can make an approriate decision to import.  Of course, as a number of posters have pointed out, it is crucial that the domestic measures be consistent with the aims of the Protocol and that Parties' decisions are consistent with other international obligations related to trade. 

This input serves as a very good starting point for the two subsequent questions that we will be exploring as part of this on-line Forum. 

Like New Zealand (see post 4423), the United States' regulatory policy for LMOs predates the Protocol.  This rigorous multiagency framework evaluates LMOs using science-based risk evaluation with regards to human health, animal health and the environment, and applies to contained use, intentional release, and use for food, feed and processing and does not differentiate between foreign or domestic origin. 

Regarding the question of treating decisions on imports from Parties differently from decisions on imports from non-Parties, reference can be made to Article 24, which says  that imports from non-Parties should be ‘consistent with the objectives of the protocol.’ It is important to remember that the 'decision on import' is made by the importing country.  Regardless of the state of LMO regulations in the exporting country, the imported LMO must meet an importing countries’ requirements, and those requirements must be consistently applied and based on risk assessment, regardless of what country the LMO came from.  

Thanks to all for the comments thus far, and I look forward to the discussions on the two further questions that Ms. Scarone has crafted for us.

Greeting to all.

Maybe for some people it is not very clear the reason for a moratorium, since the protocol requires a risk assesment. There are some additional arguments (besides the fact that Peru, like other countries around the world, is recognized as a center of origin of biodiversity) that I will like to share with you. The first one is referred to the institutional conditios inside our country, that at this moment not allows us to guarantee an adequate risk assessment; precisely the moratorium law has as a main objective to strength/build the capacities we need. Another reason is that recent studies are demonstrating that through gene flow, native varietes could became mixed with OVM genes and since that moment it is impossible to stop that process. Finally, I agree with the argument indicated by Austria, about the necessity of Parties to establish thier domestic regulations since stakeholders, like private companies, are not obligated to follow the Cartagen Protocol.

Regards,

Dora Velasquez
MINAM-Perú

I appreciate the active participation and discussion on the Article A26. As always in the on-line forums under the Cartagena Protocol on Biosafety, I see that there is participation of diverse backgrounds with various views, but the Protocol is only one for a specific mission.
A26 states "socio-economic considerations arising from the impact of living modified organisms on the conservation and sustainable use of biological diversity, especially with regard to the value of biological diversity to indigenous and local communities". Thus, straight forward focus shall be made accordingly.
Also it is always cardinal to pay attention to the experience of different countries on the deliberate releases of LMOs and its association with A26 on the biological diversity, and especially with the value of the biological diversity to indigenous and local communities.
With the point, i) arbitrary discussion should be avoided and ii) case experience may be shared, iii) but it is up to the each territory / nation as so much of various social, cultural and other backgrounds exist, and iv) consideration on integration to make a rule should not be the achievement of this this discussion.

Going to Q1: What is your understanding of “a decision on import”? How do you understand its scope? Does it matter whether a decision is taken under the Protocol (Article 10) or under domestic measures implementing the Protocol?
To me, this goes beyond the context for the discussion for A26, “a decision on import” is totally national liberty of its territory on decision making as far as meeting with the scope of the protocol, while as SCBD pointed out each party can choose the Protocol or its own domestic measures.
[#4446] , as Dr. Jose Falck-Zepeda mentioned, we do not need debating to define “a decision on import”, yes, no need to discuss on each of national system to be defined and no need on a intention on unification into one.

Going to experience issues such at India, from where contradictory information flow to the world such on bt cotton, again this is not the discussion issue on the forum. But it can be only reference for caution for understanding on what is scientific fact, as many of the information is fraud interpretation in Agriculture practice with many of issues are dumped without logical separation of complex agriculture status of the country, not directly on the conservation on the biological diversity.
Starting with “a decision on import”, may not reach the substance on A26, and specific cases may be excercised as references as general elements on the socio-economic consideration.


Kind regards,


Kazuo Watanabe
Univ. of Tsukuba, Japan

Greetings Paola and participants,

Thank you for the interesting discussion. 

I am aware that much of the discussion has strayed from the question of the meaning of "decision on import".  However, this is understandable, as in seeking to answer this question, one would want to consider the purpose of taking into account socio-economic considerations.   What is it meant to accomplish, and therefore when and how should it be applied? I assume future questions will allow us to focus directly on this question of purpose (and some of the contributions here have begun this discussion).

Various interpretations of “may take into account” have been advocated or rejected, but given the context of this agreement (trade in LMOs), the key point was made by Lim Li Ching (#4427): the Protocol makes it clear that Parties have a right under the Protocol to take socio-economic considerations into account.  So the point is not that all Parties must do this, but, rather, if Parties decide to take socio-economic considerations into account, this decision, as a right, is protected against attempts to challenge it (e.g., in the WTO).

On the question of whether a “decision on import” includes importation for contained use, some appear to include open-air field trials in this category.  This seems to me to go against the definition provided in Art 3(b).  In any case, the many failures of confinement/containment of open-air field trials suggest it would be unwise not to treat such trials as a kind of environmental release.

With regard to whether the “decision on import” excludes pharmaceuticals, care must be taken here in the interpretation of “pharmaceutical”.  The language of the Protocol (“this Protocol shall not apply to the transboundary movement of living modified organisms which are pharmaceuticals for humans”) does not appear to take biopharm plants and animals (plants and animals that have been genetically engineered to produce pharmaceutical substances to be used in humans) into account.  As these LMOs, introduced into the environment deliberately or through failures of confinement/containment, clearly pose risks of “adverse effects on the conservation and sustainable use of biological diversity” and risks to human health, they must be included in the scope of “decision on import”.

Kind regards,
Joanna

Dear all,

The broad language of article 26 of the Protocol implies that, in making decisions on imports of LMOs, or under the its domestic measures implementing the Protocol, parties may take socioeconomic considerations into account when implementing a number of provisions of the Protocol including but not limited to:
Article 10 – Procedures for decisions on import;
Article 11 – procedures for LMOs intended for use as food or feed, or for processing;
Article 12 – review of decisions on import;
Article 13 – Simplified procedures for decisions on imports;
Article 15 and annex III – Risk assessment;
Article 16 – Risk management;
Article 18 – measures relating to handling, transport, packaging and identification;
Article 24 – measures with respect to transboundary movements of LMOs with non-parties;


Article 26 states the right of parties to take into account the socioeconomic considerations and hence, where introduction on LMOs under the Protocol affects biological diversity in such a way that social or economic conditions may be affected a party can use Article 26 to justify taking such impacts on its social or economic conditions into account for purpose of making decisions on imports of LMOs or in implementing domestic measures under the Protocol.

Regards,
O.A.El-Kawy

I agree with Andreas H. [#4398] and Ching in [#4423] and their interpretation of the scope. Taking a decision on import is related to many important biosafety aspects as indicated in the IUCN’s discussion on Art. 26, referenced by both first by Peet van der Meer in post [#4396] later by Ching [#4423], and the related articles to those aspects outlined more fully by Ossama in [#4467]. These are important considerations to establish for later discussions so good that it is clarified here.

Kind regards,

David Quist

Greetings to all

Whether a decision is taken under the Protocol (Article 10) or under domestic measures implementing the Protocol is not really an issue for parties. Article 26 of the CPB highlight the importance of socioeconomic considerations specially the value of biological diversity to indigenous and local communities. Which is fully in line with the article 8j of the parent CBD. Under the CBD parties have the obligation to identify, monitoring and protect components of biological diversity important for its conservation and sustainable use from all processes that may have an adverse effect on them such as the introduction of LMOs. The indicative list of those components is present at the annex 1 of the parent treaty and include :
1. Ecosystems and habitats: containing high diversity, large numbers of endemic or threatened species, or wilderness; required by migratory species; of social, economic, cultural or scientific importance; or, which are representative, unique or associated with key evolutionary or other biological processes;
2. Species and communities which are: threatened; wild relatives of domesticated or cultivated species; of medicinal, agricultural or other economic value; or social, scientific or cultural importance; or importance for research into the conservation and sustainable use of biological diversity, such as indicator species; and
3. Described genomes and genes of social, scientific or economic importance.

No need to mention that the CPB is a protocol to the CBD and a State that is a Party to an international treaty is bound by that treaty and must comply with its obligations under the treaty. For this purpose, it must ensure that activities carried out within areas under its jurisdiction or control are in accordance with the pertinent obligations. The Party may itself decide on the legal, institutional and other means through which to achieve implementation. The tools generally used by States for this purpose are a national legal framework setting out rights and obligations of persons (natural and legal) under its jurisdiction which aim at ensuring the implementation of the international instrument, and an institutional framework to apply and enforce the national legislation.

regards,
O.A.ElKawy

Dear all

I would just like to re-emphasize something that Lucette [#4439] has said, which is that under national law/domestic measures a Party can take into account socio-economic considerations not just for imports, but also for GMOs produced domestically. This is common in national laws all over the world that normally would not allow separate treatment of domestic or foreign products.

With regard to the discussion around ‘benefits’ – let me just stress that in many cases, these are so far CLAIMS of POTENTIAL benefits, which need to be assessed at face value (is what is being claimed really true?), as well as in the longer term as to whether this will remain the case.

Taking the example provided by Mike Rowe [#4444] (“For example, when LMOs provide an alternative agricultural production method which either reduces or avoids the need for insecticides, pesticides or fungicides we must remember that that has the potential to deliver a positive impact on the conservation and sustainable use of biological diversity”), we can also say that, failure to deliver a claimed benefit will likely result in net harm. For example, if a claimed potential benefit of a herbicide tolerant plant is reduced use of herbicides, but as an inseparable consequence of the use of the plant there is inevitable increased use of herbicide, the benefit was at best not sustainable. Moreover, if an inseparable consequence of using the plant is weed resistance to the herbicide, then the adverse effect is essentially irreversible.

So I think that if we were to go down the path of talking about potential benefits, it would be logical that decision-makers would need to validate the truth of the claims, verify whether the claims are actually realized and obligate the importer to assure the claimed benefits are sustainable.

kind regards
Lim Li Ching
Third World Network

I am a bit confused about the claim that there are no studies examining realized gains from LMO crops. I guess my confusion lies on how one defines “realized gains”. If we define studies examining realized gains as those that have conducted field measurements by conducting quantitative farm surveys and/or qualitative studies such as small group discussions, focus groups, expert opinions or semi-structured interviews with actual farmers adopting a technology; then there are plenty of examples. Obviously, we cannot interview each and every farmer adopting or not adopting a specific technology.

When a researcher presents results from the impact of adoption of a Bt maize in the Philippines (Yorobe and Smale 2012; Birol et al 2012), Bt maize in Honduras (Falck-Zepeda, et al 2012), Bt cotton in Colombia (Zambrano et al 2012) or herbicide tolerant soybeans in Bolivia (Smale et al. 2012) and Bt maize in South Africa (Gouse 2012). These studies are based on field work done in the countries mentioned. These studies have examined not only economic issues but also social issues such as labor use, gender, and institutional issues related to adoption.

These studies have many limitations which other authors and I have discussed in the papers themselves and which Smale (2012) has provided and excellent summary. Note that the purpose of most of these multi-year studies was to characterize impact of adoption. There are many issues raised in these papers which should inform decision makers in the countries studies and in other countries considering potential adoption of such crops.

A summary of both types of studies done before and after adoption is Smale et. al. 2009.  This summary for the first 10 years of measuring impacts focused on economic methods and other social issues considered in these studies. For broader meta-analysis summaries of impacts one can consult Areal, Riesgo and Rodriguez-Cerezo (2012) and for Bt cotton in Finger et al. 2011. Many of these studies can be found in our online database of peer reviewed literature called bECON. If you are interested in the literature we have a searchable dataset of peer reviewed literature on the economic studies focused on developing countries. We are in the process of expanding the database to consider other issues such as gender, public health and other related social issues.

You can find bECON here: http://ebrary.ifpri.org/cdm/landingpage/collection/p15738coll6

If one is looking at the impact on biodiversity to local and indigenous communities from the adoption of LMOs, there is a big gap in knowledge. There are many studies examining impacts on intra and inter specific agrobiodversity and more general biodiversity from the introduction of improved crops and animals, but none that I am aware of examining LMOs specifically. There are very good reasons for this.

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

Birol, E., M. Smale, & J.M. Yorobe, Jr. Bi-Modal Preferences for Bt Maize in the Philippines: A Latent Class Model. AgBioForum, 15(2), 175-190. Available on the World Wide Web: http://www.agbioforum.org.

Falck-Zepeda, J., A. Sanders, C. Rogelio Trabanino, & R. Batallas-Huacon. Caught Between Scylla and Charybdis: Impact Estimation Issues from the Early Adoption of GM Maize in Honduras. AgBioForum, 15(2), 138-151. Available on the World Wide Web: http://www.agbioforum.org.

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

Gouse, M. GM Maize as Subsistence Crop: The South African Smallholder Experience. AgBioForum, 15(2), 163-174. Available on the World Wide Web: http://www.agbioforum.org.
Smale, M.  Rough Terrain for Research: Studying Early Adopters of Biotech Crops. AgBioForum, 15(2), 114-124. Available on the World Wide Web: http://www.agbioforum.org.

Smale, M., P. Zambrano, R. Paz-Ybarnegaray, & W. Fernandez Montaño A Case of Resistance: Herbicide-tolerant Soybeans in Bolivia. AgBioForum, 15(2), 191-205. Available on the World Wide Web: http://www.agbioforum.org.

Smale, Melinda; Zambrano, Patricia; Gruère, Guillaume P.; Falck-Zepeda, Jose´ Benjamin; Matuschke, Ira; Horna, Daniela; Nagarajan, Latha; Yerramareddy, Indira; Jones, Hannah. Measuring the economic impacts of transgenic crops in developing agriculture during the first decade : Approaches, findings, and future directions. 2009. Food Policy Review 10. Washington, D.C. International Food Policy Research Institute (IFPRI). http://www.ifpri.org/sites/default/files/publications/pv10.pdf http://dx.doi.org/10.2499/0896295117FPRev10

Yorobe, Jr. J.M.  & M. Smale. Impacts of Bt Maize on Smallholder Income in the Philippines. AgBioForum, 15(2), 152-162. Available on the World Wide Web: http://www.agbioforum.org

Zambrano,P,  M. Smale, J.H. Maldonado, & S.L. Mendoza. Unweaving the Threads: The Experiences of Female Farmers with Biotech Cotton in Colombia. AgBioForum, 15(2), 125-137. Available on the World Wide Web: http://www.agbioforum.org.

I can see that this forum is getting really interesting.

I thanks Ching for her very useful comments.  Indeed, GE seed marchants made a lot of claims, and what happen when the crops fail?  While you talk of "potential benefits", which has hardly demostrated, you have to prouf, with no ambiguety damage, ignoring the precautionary principle.

Since cotton in Colombia has being mentioned, I would like to recall that the cotton producers had huge losses in 2009 (Please http://www.wradio.com.co/noticias/economia/algodoneros-denuncian-perdidas-por-venta-de-semillas-transgenicas/20090609/nota/826412.aspx)

Can you said that you import GMOs only when a country need them?  Of course no. Please remember FTA.  Those countries who has signed, it is force to buy some amounts of GE commodities every year (like cake or grain of corn or soy), even if it will affect its domestic production.

In other countries, once GE cotton seeds have being approved, conventional seed just disapair from the market, and nodoby know why, so cotton farmers do not  have any other choise.

A cotton farmer once told me:  "Growing cotton is the only think I know, and it is what my father teach me since I was a child.  If there is not conventional seeds in the market, I am forced to buy the GE seeds, whether I that like then, or not".

Note:In relation with GE corn production in South Africa, see http://digitaljournal.com/article/270101

The problem of non-gm seed disappearing from the market is a significant one and there are I am sure many examples around the world where this has occurred.  It is an economic issue since the cost of establishing dual processing chains can be  very high - while it is possible it is costly.  As a consequence seed merchants may not be prepared to go to the extent required to ensure that the seed that they provide can be certified as being non-gm.  Thus over time grower's choices are reduced.  While I am concerned about this matter , in my view this is an issue  that a country must make decisions on internally.  I am not sure that it is relevant to this discussion.
regards
janet gough

Dear All
While the discussion is riveting, are we not straying from the ultimate objectives : how countries, if they choose, can take socio-economics into consideration regarding LMO introductions?  I am of the view that we are not here to establish the absolute truth of claimed harms or benefits, but rather to recommend a minimal or "fit for purpose" set of questions (perhaps with some associated methodologies?) that will provide guidelines to regulators and to the introducers of LMO's, giving an opportunity for either (countries may vary in their approach as to whether the public or private sector should be gathering the evidence) to develop and present a CREDIBLE argument regarding relevant socioeconomic issues to government-appointed regulators.

Part of the solution may be to establish principles that decision-makers should include in their considerations (in my view, this would be included in defining "harm" and "benefit"), and part may be in determining risk management processes, following a decision, that would establish the veracity of the original argument (which could feed back to the regulators for either reconsideration of previous decisions, and/or for future considerations).

I do not see how we can determine the exact nature of socioeconomic benefits or harms - something I believe to be close to impossible because of differing interests, values and beliefs across communities and societies - but rather recommending an approach for sufficient evidence to be gathered for regulators/decision-makers to make their decisions (obviously where the country chooses to consider socio economics).
Ben Durham

I would like to respond to a statement that Dr. Goven made in her post #4466.  She states that Parties have the right, but not the obligation, to decide to take socio-economic considerations into account in making a decision on import.  I believe this is accurate.  However, she goes on to say, if I have understood correctly, that this right is immune from challenge, for example, a challenge under the WTO.  I do not see anything in the Protocol that would give this kind of immunity.  In fact, the language in Article 26 specifically qualifies the right - Parties may take socio-economic considerations into account 'consistent with their international obigations.'  Of course, not all Parties to the Protocol are also Members of the WTO, and the obligations under the WTO would not apply to non-Members.  There are other relevant international obligations, but I believe that there will be further discussion of this topic under the next questions.

Dear Ben Durham:
Thank you for your contribution as it is quite convergent with my first post in this forum. In fact, one of the issues that becomes quite clear from the contributions so far, is the need to weigh competing claims and the quality of evidence presented in peer reviewed publications by scholars and researchers, by the proponent and by pressure/interest groups of all kinds, that will allow making a sensible decision.

I am quite cognizant about the issues involved with the assessment of socioeconomic considerations and on the way they may be included in decision making.  Personally, along with other socioeconomists out there, think that trying to define socioeconomic issues -even more a standardized protocol to conduct socioeconomic assessments- in a meaningful way will be next to impossible due to multiplicity of issues and the different weights that members of society put on them.

One additional problem complicating this state of affairs is that due to the nature of the SEC assessments themselves, they can be manipulated by interest groups to show one position or another. As a colleague put it succinctly “such an inclusion may lead to rent seeking behavior.” We can try defining some elements of best practice, but those are almost one and the same with those conducting high quality science and research. There are some elements of best practice and guidelines out there such as the ones by the International Impact Assessment Association.

I concur with you that a potential way forward, is to define some elements in a process that may be useful for regulators and/or decision makers to make a sensible decision in those countries that have made the decision to include SEC in their decision making. Uptaking some of your comments/suggestions and assuming that a country makes the decision to include socioeconomic considerations in their decision making, this may look like this:

1) Define a decision making standard and a process for inclusion or assessment.
2) Define elements describing “benefits”, “costs” and “harm” and ways to weigh evidence between competing claims. This will have to be consistent with risk assessments procedure and probably the KL-NA supplementary protocol on L&R
3) Explore sequential processes such that applications for containment and confinement are not required to have a socioeconomic study. Applications for general release or FFPs undergo the risk assessment as defined elsewhere in the Protocol and Annexes. Then if and only if the event is defined as “safe” it may undergo a socioecomic assessment if an issue is raised about the application.
4) In addition, I believe it would be a bit of waste of time and resources to require a socioeconomic study for each event submitted to the regulatory agency. One may think about requiring one for class of events within a crop (e.g. insect resistant cotton, herbicide tolerant soybeans).

Like I indicated before, I am bit skeptical about the likelihood of being successful in defining such approach especially in a regulatory process that leads to a decision in the end.  We can always try.

Dear Colleagues,

Referring to the questions proposed by Paola, I would like to share some of my thoughts on these issues.

1. In my view the socio-economic consideration’s assessment should be applied for all types of imports of LMOs, such as for contained use, FFP and intended to release into environment.
2. The SEC should be done on case-by-case base for every type of LMO intended to be introduce in a country, as well as while LMOs is  internal produced and intended to be used inside of he country.
3. The SEC should be part of decision making process under the domestic law, if Party. The Protocol establishes general rules between Parties, at the same time the import of LMOs is undertaken by companies, institutions etc., so domestic laws have to be respected in priority, as they implement the Protocol and may have larger interpretation, specific to the country. In case of Party-NonParty, it should be respected Art. 24 of the Protocol, and specifically p.1 “Transboundary movements of living modified organisms between Parties and non-Parties shall be consistent with the objective of this Protocol. The Parties may enter into bilateral, regional and multilateral agreements and arrangements with non-Parties regarding such transboundary movements.
4. The Parties have the right to involve SEC assessment as part of decision-making process.
5. SEC may be component part of Risk assessment procedure, or might be as well as a separate procedure, this is as the individual Party considers in their domestic laws.
6. The Parties have the right to apply SEC in a larger way then it is formulated in the Protocol. The multiple aspects of SEC might be considered as macro and micro-economical possible impact, public perception of LMOs, assessment of possible public tension and manifestations, especially in countries with political instability, and many others.
7. As the Risk assessment document is a part of notification process and have to be done by producer/importer, and is based on scientific data, it is imposed that the SEC assessment should involve domestic experts aware with actual internal political, economic and social processes in the country.
8. The SEC should also involve the ethical aspects of Biosafety, including medical, religious, psychology and human traditions of the region.
9. The international and regional collaboration in SEC assessment is considered valuable and important to ensure safety in neighboring countries.  
10. There is a need to elaborate a guidance for SEC assessment, that will include the methodology, arching questions, scenarios and recommendations to help countries with limited experience in this specific assessment related to LMOs.
11. The SEC should be part of public information and public participation process via decision making.

Bes wishes,

Dr.Angela Lozan, Ministry of Environment, Moldova

It is important to remember that the CPB talks of “socio-economic considerations”, not “cost/benefit analysis”.  The two are not equivalent.  It is presumably understood by all participants here that distributional effects may matter more than aggregate ones and that not all significant socio-economic considerations can be translated into a cost/benefit analysis, at least not without great distortion.  “Socio-economic considerations” also include, for example, going beyond the question of immediate returns to farmers to the question of food security of vulnerable populations.

As noted by Elizabeth Bravo and others, widespread societal participation (and/or appropriately grounded social-scientific research) is necessary because local knowledge is essential to identifying what it is that needs to be considered and protected.   This is one reason it would be a mistake to attempt to produce a single model for taking socio-economic considerations into account.

While past experience in one context cannot be automatically be assumed to describe future experience in another, it is important to use past experience to derive questions to be asked of current applications.  For example:
• given past experience of significant differences between short-term and longer-term effects on, e.g., yield and pesticide use, and the socio-economic consequences of this, the decision-making process should always take dynamics over time into account;
• given past experience of loss of access to non-GM (and perhaps locally adapted and farmer-owned) seed, which as several participants noted has significant socio-economic effects, the decision-making process should recognise this problem and either effectively counteract it or, if that is not possible, be free to reject an application on such grounds;
• given past experience of deliberate constraints placed by owners on independent research on the effects of proprietary LMOs, as Dr Gutierrez has pointed out, the decision-making process should take into account the risks (socio-economic and to biodiversity) of permitting the importation of a LMO that has not been subjected to independent research and, more significantly for this discussion, would constrain the kind of post-importation monitoring and research that could be carried out;
• Given the past failure of many claimed benefits to materialise, the decision-making process should closely scrutinise claimed benefits, taking the points above into account. (An aside here: a previous poster was concerned of lack of consideration of potential benefits; this seems very unlikely, as applicants can be counted on to detail potential benefits).

On the question of immunity to WTO challenge raised by Mary Madell: it is difficult to see how a right can be meaningful if it can be violated in the very domain in which it is meant to apply.  The automatic supremacy of WTO over other international agreements has not, as far as I am aware (though I invite correction), been established in law, nor is it, in my view, justified.

Kind regards,
Joanna Goven

I thanks Joanna Groven [#4480] to clarifiy the pint that SEC is not related with cost/benefit analysis and inmediat retorns to the producers.  Please remember that Art. 26 refers to "local and indigenous communities". 

It is true, Art. 26 refers to the obligations of the States with other international obligations. I would like to point out that in most countires of the world the only international obligations that are above the Constitution are those related with human rights, which including the rigth to health, the right to food, to a healthy environment, and so on.

Regards from the Honduran panel.

My name is Maria Mercedes Roca and I am a member of the CTBio (Biosafety Technical Committee) of Honduras. I have been designated by my CTBio colleagues to represent the views of Honduras in this forum.  I am also a member of the newly formed ICABB, Iniciativa Centroamericana de Biotecnología y Bioseguridad – The Central American Initiative for Biotechnology and Biosafety. ICABB was officially constituted at a meeting in Costa Rica a few weeks ago, were designated regulators for  all Latin American countries participated, including the Andean countries. ICABB includes the 8 countries in Central America, from Guatemala to Panamá, and the Dominican Republic.  We are all very small countries with limited resources for biosafety but with an interest in complying with Protocol and accessing new technologies; thus we formed this official  association to share views, experiences,  and to collaborate on many issues on biosafety, including risk assessment. Our group is under the auspices of all the Central American Ministries of Environment, Agriculture and Health, and the Dominican Republic.  For more information, here is the official link.

“Centroamérica crea iniciativa regional de biotecnología y bioseguridad”: http://www.iica.int/Esp/prensa/paginas/comunicadoprensav1.aspx?cp=835

Members of ICABB have worked extensively in understanding the process of risk analysis and its practical applications. We make a clear distinction between risk assessment (measuring biological factors) and risk management, where socio-economic considerations are included to shape policy and ultimately take political decisions. 

The formal position of Honduras in complying with the Protocol is that we do not include socio-economic considerations in the risk assessment process. The risk assessment is done strictly by professionals with credentials in the relevant technical fields involved in each case-by case risk assessment. Risk management on the other hand is participatory and involves all stake holders. Ultimately the country’s decision-makers shape policy accordingly and make the final decision responding to national priorities and policies.  In the case of Honduras, the formal policy is to promote sustainable agricultural production, especially for food security crops relevant to the country.  We will not accept any recommendation that implies a change in the voluntary nature of the inclusion of socio-economics considerations as described in our national regulations.

Sharing a common language and to a large extend, a common culture, the official regulators of many Latin American countries  that met recently in Costa Rica, will continue to collaborate on many aspects of biosafety regulation. We are very fortunate in our region to have countries such as Brazil, Argentina, Mexico and Colombia with considerable experience in biosafety regulation to help guide the less experienced countries.

Best regards,

Dr. Maria Mercedes Roca, Zamorano University, Honduras

Joanna Govern has made a very important point, that cost-benefit analysis is not the same as socio-economic analysis.   It is often a component of socio-economic analysis.
Another important matter that we need to remember is that in many cases it is what you learn from the analysis that is important rather than any 'number' that might result at the end. This is of course also critical with risk analysis.

Dear Ben,
I fully agree with your points on Socio-econmic considerations but I think apart from evidence alone we also need to work on trust of society with scientific advancements.  As a society we must ensure that S&T advancements are inclusive, accessible and equalitarian in their focus but at the same time we also should allay all fears related to safety. In this context, due lessons may be drawn from the rich experiences of other countries like the Netherlands and others which have developed institutions for science and society interface with due diligence. They have evolved scientific methods to deal with complicated policy choices through relevant indicators, perception surveys and ethical frameworks.    The central question is not whether we approve GM crops or not. The question is ‘how, we as a nation, arrive on a decision of this nature’. And the question applies not only to GM crops but also to our approach on continuation and location of nuclear plants, use of nano-particles, applications of synthetic biology, funding of stem cell research and even building of social utilities like dams and highways. Public policy formulation process has to absorb multidisciplinary approaches for getting the essence of context within which decision is to be taken. This approach is possible when the system has the ability to deal with various streams of knowledge such as technical, economical, legal, ethical and social. This is easier said than done, particularly when even scientists have differing views on safety and social relevance. Several developed societies, with advanced innovation and S&T systems, are still struggling with such frameworks, but this does not mean that we should not try. Each country has specific context for need of technology and very different innovation trajectory. Accordingly, the systemic absorptive capacity also varies.

Dear colleagues,
Referring to the different aspects of question 1 proposed by Paola, I would like to share some of my thoughts:

1. In my view article 26 could be applied on: a) all LMO imported for contained use, intentional release to the environment, direct use as food or feed and processing, including use as fuel and fiber and vaccines (not for human consumption); b) socio-economic consideration assessment should be taken into account ex-ante, as well as ex-post, so there is the possibility to monitor long-term effects and even reverse a decision based on the gained experience (as already stated by Aruna Rodrigues and Lucette Flandroy previously).

2. It is important to have in mind the links between the different articles in the Protocol, as article 26 does not stand-alone. In that sense, SEC could be taken into account when implementing different provisions of the Protocol: decision procedures (art. 10), risk assessment and risk management (art. 15 and 16); liability and redress (art. 27), etc. This point has also been raised by Lim Li Ching, and it is also developed in Catacora (2012). SEC could be then taken into account in the decision-making process in parallel or even integrated with risk assessment, as already mentioned by Lim Li Ching and Andreas Heissenberger. In this sense, it is important to assist the Parties wanting to implement their right to apply art. 26 to effectively to do so.

3. If a country has adopted national biosafety regulations that include SEC, the national measures should be applied. Is it a right of the Parties to apply article 26, but nothing can prevent them to take additional more restrictive measures “provided that such action is consistent with the objective and provisions of this Protocol and is in accordance with that Party’s other obligations under international law”. This has already raised by different contributors.

4. It is important to highlight the need to promote public awareness and consultation (art. 23) in decision-making processes in order to identify needs to be targeted and protected, as well as to recognize uncertainties in the analysis. This has also been commented by Elizabeth Bravo, Ben David Durham, Joanna Goven or Lucette Flandroy among others.

Best regards,
Rosa Binimelis

Dear participants,

I appreciated the previous short posting of Dr. Ossama Abdelkawy who synthetized the various articles of the Protocol that should be taken into account when taking a decision under the Protocol.
Among these, he cited Art. 12 that relates to Review of decisions.

It is indeed very important that Parties willing to include SEC foresee clear procedures to review decisions, including based on SEC, in case ex post socio-economic analyses, including socio-economic monitoring of ex ante considerations, reveals data contradictory to ex ante SEC and/or that justify to review a previous authorization.

Generally speaking, I wonder if all the articles cited by Dr. Ossama Abdelkawy, and in particular those where reference is made to "risk assessment", can apply also to SEC. From my personal point of view, these articles could apply also to socio-economic risks, for the Parties that want to take SEC into account. But this could be a matter of discussion in itself, a question of clarification under this SEC forum, because I wonder if the term "risk" also applies automatically to SEC in the wording of the Protocol, where it is used only in reference to environmental and health risks, whereas only the word "considerations" is used for socio-economic.

I also want to make reference to a previous posting of Li Ching Lim who pronounced for the first time, if I am not wrong, the word "sustainability" in the context of this discussion.
Since, as repeated by Dr. Jose Falck-Zepeda, SEC would indeed add costs in the process of decision making relative to LMOs, it is important that SEC are made and decisions are taken on the basis of mid-and long-term impacts rather than short-term impacts; and that the reversibility/irreversibility of impacts would be taken into account in this context.

While this is, maybe, going further than the question 1 raised by the Secretariat, this is an opportunity to clarify that SEC could indeed include social benefits and risks, economic benefits and risks, ( this taking into account the distinct distribution of benefices and risks between various groups of the society ) and environmental benefices ( since environmental risks are taken into account in the ERA ) in particular compared to these announced in the submitted candidate authorization files.


That being said, I agree with Dr. Jose Falck-Zepeda, who has a long experience of such studies, that it surely not is an easy task to make such studies and to draw clear-cut conclusions and balanced decisions out of these. It is anyway worth wile to do it for Parties willing to do it because, in this period where new technological developments can spread products very fast all over the planet, it is a responsibility of politicians to foresee and balance costs/benefits for society of all these new developments that can affect irreversibility the evolution of the planet; in the case of LMOs that, till now, concern mainly the agricultural domain, one should admit that agriculture is a very important sector that influences worldwide environment and health ( including long-term food security ) directly and indirectly, also in economic terms. As already said before, main protection goals of each Party should help to prioritize their SEC, while they should take into account the wording of various parts of Art. 26.1.
Concerning this, I appreciated the last posting of Dr. Sachin Chaturvedi  from India.

While also going further, I think, than the subject of the present question raised by the Secretariat, I appreciated also the postings of Dr. Andrew Paul Gutierrez who gave some precisions about the truth that can be given in various methodologies, and those of Janet Gaugh who reminded that socio-economic analyse is not synonymous of costs/benefices analyse ( as said previously by Joana Govern ) ( and should not only include figures and in particular in monetary terms, as suggested, if I am not wrong, by Dr. Elizabeth Bravo ). Sorry if I forget other participants who suggested similar ideas.

Best regards, and nice end of week-end.

Lucette Flandroy




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

Dear participants,

One addition, that I forgot in my previous message:

Decisions should take into account, while having in mind the precaution principle, the realistic practicability and functionality and implications, at long term, of risk management/mitigation, and also monitoring measures, for environmental, health, as well as for socio-economic considerations.

Maybe going beyond the strict matter of this session, but linked to it: the concern expressed in the preceding § is a reason not to postpone all/most analyses in ex post analyses ( this is again true also for environmental and health considerations ), where, as said by Dr. J. Falck-Zepeda, it will sometimes be very difficult to draw cause-effects relationships. It is good to have an ex ante overview of all evidence-based and/or relevant considerations, even if not all proved by quantified measures, in order either to refuse LMOs on the basis of the precautionary principle or to follow, ex post, more rigorously in particular the evolution of concerned parameters in potential cause-effects relationships.

Best regards.

Lucette Flandroy

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

Greeting from New Delhi to all and special appreciation to CBD Secretariat for their efforts.

I have been following the week long debate with great interest.

The understanding of ‘a decision on import’ in the context of LMOs  needs to be seen in the context of the objective of the CPB which is to "contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of living modified organisms...that may have adverse effects on the conservation and sustainable use of biological diversity."

To assist Parties in meeting this objective, the Protocol provides for Rules and Procedures which places obligations on Parties of import (Article  2, 4, 5, 6, 7, 8,  9, 10, 11, 15 &16, 20) and the importer (Article 7, 8, 9 10 , 11, 18).

The decision of a Party to import LMOs also needs to be seen in the context of the scope of the instrument which provides for categorizing the LMOs on the basis of their intended use (intentional release, FFP and contained use).This is specifically important while taking decision on the basis of Risk Assessment and Risk Management in accordance with Article 15 and 16 and Annex III of the Protocol. Accordingly decisions need to be taken on a  case-by–case risk assessment.

The Protocol recognizes the sovereign right of a Party and therefore if a national law exists, decisions  under domestic law would prevail provided it is consistent with the objective of the CPB.  In the current online discussions, views have been expressed that the Sovereign right of a Party allows for more stringent norms under the domestic framework. While I fully agree and support these views, such decisions need to be consistent with other international obligations including WTO.  I would like to highlight that  the Protocol also provides for Parties to follow Simplified Procedure (Article 13) and trade with Non Parties (Article 24)  in accordance with their Sovereign right under their domestic law or through bilateral, regional and multilateral arrangements.

Views have also reflected the need for integration of socio-economic factors in the decision making process under CPB. Though this issue is outside the scope of discussion under question 1. I am of the view that for the purpose of understanding Article 26, socio-economic issues should be separated from the decision procedures under Article 15 and 16 pertaining to Risk assessment and management. 

Previous discussions on this issue (pre and during COP-MOP 6) also indicate that  understanding among some Parties is that socio-economic considerations though important for the country, is not mandatory in the decision making process in the context of CPB under Article 26. Parties have also called for further clarity in understanding the scope of Article 26 for which COP-MOP 6 has laid down certain procedures... the online discussion forum being the beginning of such initiative.

I hope the ensuing discussions will provide  more clarity on  intangible issues  such as ‘may take into account, consistent with their international obligations, ‘impact of living modified organisms on the conservation and sustainable use of biological diversity’, especially with regard to the ‘value of biological diversity to indigenous and local communities’ while addressing socio-economic impacts of LMOs.

I am keen to hear more on these issues.

Ranjini Warrier
India.

Dear all

I would like to thank Rosa Binimelis [#4487] for listing in a clear and concise manner her thoughts on the issue, which I found helpful. She mentions the paper by Catacora (2012) that points out the interrelationships of Article 26 with other provisions of the Protocol. For the benefit of all, I am attaching the paper here (see page 7), which was published as part of a special journal issue on biosafety and socio-economic considerations.

With regard to the relationship with the WTO as discussed by Joanna Goven [#4466, #4480] and Mary Madell [#4477] (which we will take up in more detail in next week's discussion), I would like to just reiterate here that the Protocol establishes the right of Parties to take into account socio-economic considerations. While that right exists as a sovereign right of countries in any case, it is now established in an international legally-binding agreement. The implementation of Article 26 of course has to be consistent with Parties' other international obligations, including under the WTO if they are also WTO members. The three preambular paragraphs in the Protocol provide some insights to this relationship, highlighting mutual supportiveness and in effect achieving a counterbalance. How this will work in practice will depend on specific disputes, the forum of arbitration, who are parties to what agreement, case law, etc. I believe it is then still an open question. I am looking forward to exploring these issues further next week.

kind regards
Lim Li Ching
Third World Network

Dear Sachin,

I agree a lot with your contribution. We certainly need to be prepared for other technologies in the R&D/innovation pipeline such as synthetic biology, nanotechnology or even multiple traits added to one crop or animal; which may be regulated in the future.

In our biosafety capacity development/strengthening program we hold dearly the principles of a functional biosafety system described by Greg Jaffe in a publication of some ago. These include comprehensive, adequate legal authority, clear safety standard, proportionate risk reviews,  protectiveness, transparent and understandable, post approval oversight, participatory, flexible and adaptable, and efficient/workable and fair. As part of the efficient I have annexed the qualification of being time and cost efficient.

Defining a process which renders multiple optional decision (approval, rejection, request for more information, tentative approval following post release monitoring and so on...) clearly is part of what describes a functional system, but as you have described is not the only component of such system and process. Part of our task in helping the Parties develop such functional process which will allow a technology have a fair shot of proving its worth to users and/or society or be discarded if it does not comply with the safety (in some cases performance) standard.

First, I’d like to thank all for this very interesting and wide-ranging discussion so far. My comments are directed at the central questions posed: what is a decision on import and how do you understand its scope.

Several commenters have very clearly and thoroughly answered these questions, so in the interest of space and time, let me just state my agreement with the contributions of Rosa Binimelis [#4487], Lucette Flandroy [#4439 and #4448], Ossama Abdelkawy [#4467 and #4469], Joanna Goven [#4466], Angela Lozan [#4479], and Lim Li Ching [#4427 and #4470].

These comments highlight the numerous articles under the protocol that have bearing on a decision on import, reflecting the need for a broad understanding of the scope that should be applied in an interpretation of Article 26. The comments also draw attention to the national decisionmaking process, emphasizing that many countries incorporate socioeconomic considerations in domestic regulatory measures, whether for domestically produced or imported LMOs.

Article 26 describes the decision taken under the Protocol, or under domestic measures implementing the protocol, but it must be emphasized that domestic decisionmaking on LMOs may and does go beyond the requirements of the Protocol. As Li Ching [#4427] points out, countries at the domestic level have the right to, and do, incorporate in decisionmaking about LMOs socioeconomic considerations beyond impacts on the conservation and sustainable use of biological diversity .

I very much welcomed the most recent point by Li Ching [#4491] that what is an already existing sovereign right of a country to take decisions on what might enter or leave its territory is now reaffirmed in an international legally binding agreement, including with regard to socio-economic considerations and LMOs.

I also very much agree with the most recent posts of Lucette Flandroy [#4488 and #4489] of the importance of highlighting mid- to long-term impacts, reversibility and irreversibility, and overall sustainability in the socioeconomic considerations relevant to decisionmaking.

Regards,

Doreen Stabinsky
College of the Atlantic

Dear Colleagues

I respond very briefly to several participants among them, Lucette Flandroy,
Ranjini Warrier, Dr jose Falck-Zepeda and Sachin Chaturvedi (4492, 4490,
4486,4488. 4487, 4492) Lim Li Ching.  Thank you for insights and
clarifications.

While the wording of  Art 26  'may',  leaves Parties with a choice, the link
of SEC to very many Articles of the Protocol suggests that we ought to pay
particular attention to it in our domestic legislation and do so thoroughly,
both ex ante and ex post, the latter  as part of post market monitoring of
LMOs.  If I may say so, if all Parties do so with the same commitment to
rigour and safety, keeping in mind the PP, this would generate trust and the
'decision to import' would get much easier!

There is clearly an  aspect of SEC that does not belong to the sphere of
hard, quantitative research techniques, as I said in an earlier post,  but
to qualitative techniques. It is therefore, really important that
governments work  closely with civil society ("local and indigenous
communities"). Such efforts ought to therefore,  be executed and decided by
independent agencies in fully participative decision-making with civil
society. The process must be transparent and  democratic if it is to work.
As Sachin puts it  the question is 'how, we as a nation, arrive at a
decision of this nature'.

Best regards

Aruna Rodrigues

Sunray Harvesters,

Bungalow 69

Mhow - 453441

M.P. India

Perhaps this is an appropriate time to clarify a common misconception that tends to propagate about socioeconomic assessments and that is that it is only about monetary costs and benefits. Nothing can be farther from the truth than this.

Certainly those of us involved in the development economics and policies’ arena use monetary costs and benefits as part of a quantitative framework but it is not the only issue explored. After all working for an institute like I do whose commitment is seeking “sustainable solutions to end hunger and poverty” we cannot base our assessments and analysis only on this narrow issue.

In fact we are quite interested, and have done extensive farm and household level research with data collected with farmers and households along with many colleagues in the field, in examining issues such as gender, labor and employment, public health, environmental impacts, poverty implications, agro-biodiversity and subsistence crop biodiversity, small and informal seed systems, distributional issues and have done some inroads in examining irreversibility (I can share our work with colleagues at Wageningen University assessing the potential introduction of a fungal resistant banana in Uganda such as Kikulwe et al. 2011), amongst other things.

We have used both quantitative and qualitative assessment methods and frameworks in these assessments. We have also used quite sophisticated econometric and economic simulation methods and are using even more sophisticated bio-physical models -which in my mind continue to be projections or estimations about potential gains regardless if one uses baseline data- and are looking at long term projections of the impact of innovation and climate change unless based on actual farm/household level adoption of an actual technology.

I would thus propose that focusing only on a qualitative framework would actually hamper the quality of the assessment. Quantitative techniques and methods can help untangle many issues especially those related to defining cause and effect. Qualitative and quantitative frameworks are complementary and should be applied in practice as such. It is my opinion, that a call for qualitative-only frameworks for the assessment of socioeconomic considerations is misguided and will lead to incomplete assessment framework. Our experience with socioeconomic assessments is quite clear that more and better quantitative and qualitative methods and assessments are needed rather than less (See Smale 2012 and Smale et al 2012)

If the decision by some Parties is to include socioeconomics in the decision for imports and perhaps broader considerations in their domestic measures, then the task at hand is how to define a process that will indeed lead to a functional system with such inclusion, and this implies defining the process and issues and consequences from such inclusion during implementation.

References
Kikulwe, E.M., E. Birol, J. Wesseler, J. Falck-Zepeda. 2010. A latent class approach to investigating demand for genetically modified banana in Uganda Agricultural Economics. 42(5):547-560. First published online 21 Jan 2011.  http://dx.doi.org/10.1111/j.1574-0862.2010.00529.x

Smale, M.  Rough Terrain for Research: Studying Early Adopters of Biotech Crops. AgBioForum, 15(2), 114-124. Available on the World Wide Web: http://www.agbioforum.org.
Smale, Melinda; Zambrano, Patricia; Gruère, Guillaume P.; Falck-Zepeda, Jose´ Benjamin; Matuschke, Ira; Horna, Daniela; Nagarajan, Latha; Yerramareddy, Indira; Jones, Hannah. Measuring the economic impacts of transgenic crops in developing agriculture during the first decade : Approaches, findings, and future directions. 2009. Food Policy Review 10. Washington, D.C. International Food Policy Research Institute (IFPRI). http://www.ifpri.org/sites/default/files/publications/pv10.pdf http://dx.doi.org/10.2499/0896295117FPRev10

Dear All,

First I would like to thank the CBD Secretariat and Ms. Paola Scarone, for coordinating this important working group

According to the text of Article 26.1 of the Protocol, Parties may include consideration of socioeconomic (SE) relating to LMOs in their biosecurity procedures. Therefore, the text "in reaching a decision on import" is indicative of "when" and the "modus operandi" of the implementation of Article

Regarding "when" implies that the country has decided to include aspects SE in biosafety framework, they must be considered when making a decision on whether to permit introduction or ban on LMOs; ie through an ex-ante (before the introduction). The ex-ante procedure is critical to the implementation of the precautionary approach governing the Protocol, and avoid negative impacts SE related to changes or adverse effects on the conservation and sustainable use of biological diversity.

Regarding the "modus operandi", Article 26.1 states that the consideration of aspects may be made by domestic regulations or where appropriate, using the procedures of the Protocol. Regarding the latter, the text "in reaching a decision on import" addresses the two articles on "decision making". These include Article 10 on decision-making procedure in case of LMOs intended for introduction into the environment, and Article 11. About Procedure for living modified organisms intended for direct use as food or feed or for processing. In turn, Article 10 and Article 11 are related to other provisions of the Protocol. For example, if it is an introduction to the environment, as provided by Article 10 is in the consideration SE of aspects in the implementation of Article 7 (prior informed Agreement), Article 8 (Notification), Art 15 and Article 16 (Assessment and Risk Management), Section 21 (Confidential Information), and after the decision on the transboundary movement of LMOs, with Art 12 (Review of Decisions) and Section 18 (Handling, transport, packaging and identification),other articles transverse and  such as Art. 20 (Information Exchange), Section 21 (awareness, education and public participation), Article 22 (generation capacity) and Art . 24 (non-party). If you follow the decision-making process relating to Section 11, then the procedure is related to Article 15 and 16, Article 12 and Articles 18 and transverse listed above, all developed in Catacora (2012).

The relevance of Article 26 (specifically the text "in reaching a decision on import") to Article 10 or with domestic measures, is related to the existence of national provisions for the consideration SE of issues relating to LMOs. In this regard, Article 2 states that "Nothing in this Protocol shall be construed as restricting the right of a Party to take action that is more protective of the conservation and sustainable use of biological diversity than those in the Protocol, provided that such measures are consistent with the objective and the provisions of this Protocol and in accordance with that Party's other obligations under international law. ", ie that the relevant national measures on considerations SE can be more detailed precautionary or strict defined by the Protocol, provided they are consistent with international law. In case any such party lacks domestic measures, then the provisions of the Protocol becomes more relevant as it would fill the gaps in national legislation on biosafety. The latter and the potential transboundary movement of LMOs justify the importance of joint work between the Parties to the Protocol, in the definition of conceptual clarity (and later methodological) economic considerations "in reaching a decision on import" a LMOs.

Best regards

Sorka Romero Copa
Multilateral Relations Division
Vice Ministry of Foreign Affairs
MINISTRY OF FOREIGN AFFAIRS
PLURINATIONAL STATE OF BOLIVIA

The clarifications by Dr. Falck-Zepeda are useful both at the conceptual and methodological levels. Many thanks.

Posted on behalf of Carlos Almendares

---

From: Carlos Almendares
Sent: March-15-13 5:57:58 PM (UTC-05:00) Eastern Time (US & Canada)

As there is the intention to export part of wanting to do a first movement of a product from or containing living modified organism, it must make a request and prior notification to the importing Party of such intention, this implies that there must be a decision, must comply with Article 15 of the Protocol (risk assessment). It is very important this decision based on Article 10 of the Protocol, especially if we take the number 7 of this article that asks the parties to find the procedures and mechanisms to "facilitate" decision-making by Parties of import, but we that the opposite is happening.

Posted on behalf of Dr G.P.Reddy
---
From: Parashuram Reddy
Sent: March-16-13 2:34:03 AM (UTC-05:00) Eastern Time (US & Canada)

I agree with most of the points raised by very senior people. Socio-economics is a science  but not ,where you sit with data dispassionately and analyse it,  Data scientifically analysed and decisions taken .The decision to import by a country is based on a country' regulations and covers intentional decision to import, that is, it is based on procedures and a decision-making process. Under the Cartagena Prtocol and India's regulations, it refers to intentional transboundary movement. The scope covers importation for contained use, field test and commercial propagation. Under Indian  regulations on biosafety, a decision to import covers transboundary movement or trade between parties and non-parties to the Cartagena Protocol.


Dr G.P.Reddy.  Principal Scientist& Head ABM
National Academy of Agricultural Research Management
Hyderabad,India

Posted onbehalf of Amparo Ampil
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From: amparo amparo
Sent: March-16-13 6:21:27 AM (UTC-05:00) Eastern Time (US & Canada)

Dear Dr. Zepeda:
Thank you for your query.
Per E.O. 541s. 2006 or the National Biosafety Framework (NBF),  the principle of socio-economic considerations shall apply in the implementation of the NBF. The NBF applies to development, adoption and implementation of all biosafety policies, measures and guidelines and in making decisions concerning the research, development, handling and use, transboundary movement, release into the environment and management of regulated articles.

But even without the NBF, socio-economic considerations is an inherent mandate of the competent authorities and the scope of socio-economic considerations is broader than article 26.

The public research institutions in the Philippines developing local LMOs undergo or are subject to the same risk assessment principles,  procedures and safety standards as private technology developers who apply for a permit to introduce into the environment,  an event developed elsewhere.

In the context of the NBF, Article 26 may be included in the broader definition of socio-economic considerations.

We look forward to these discussions as our National Committee on Biosafety which consists of competent authorities have yet to draft formal guidelines on socio-economic considerations. 

Amparo Ampil

Posted on behalf of Ranjini Warrier
---
From: warrier@nic.inOn Behalf OfWARRIER
Sent: March-17-13 3:15:42 AM (UTC-05:00) Eastern Time (US & Canada)

"Greeting from New Delhi to all and special appreciation to CBD Secretariat for their efforts.

I have been following the week long debate with great interest.

The understanding of ‘a decision on import’ in the context of LMOs  needs to be seen in the context of the objective of the CPB which is to "contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of living modified organisms...that may have adverse effects on the conservation and sustainable use of biological diversity."

To assist Parties in meeting this objective, the Protocol provides for Rules and Procedures which places obligations on Parties of import (Article  2, 4, 5, 6, 7, 8,  9, 10, 11, 15 &16, 20) and the importer (Article 7, 8, 9 10 , 11, 18).

The decision of a Party to import LMOs also needs to be seen in the context of the scope of the instrument which provides for categorizing the LMOs on the basis of their intended use ( intentional release, FFP and contained use).  This is specifically important while taking decision on the basis of Risk Assessment and Risk Management in accordance with Article 15 and 16 and Annex III of the Protocol. Accordingly decisions need to be taken on a  case-by–case risk assessment.

The Protocol recognizes the sovereign right of a Party and therefore if a national law exists, decisions  under domestic law would prevail provided it is consistent with the objective of the CPB.  In the current online discussions, views have been expressed that the Sovereign right of a Party allows for more stringent norms under the domestic framework. While I fully agree and support these views, such decisions need to be consistent with other international obligations including WTO.  I would like to highlight that  the Protocol also provides for Parties to follow Simplified Procedure (Article 13) and trade with Non Parties (Article 24)  in accordance with their Sovereign right under their domestic law or through bilateral, regional and multilateral arrangements.

Views have also reflected the need for integration of socio-economic factors in the decision making process under CPB. Though this issue is outside the scope of discussion under question 1. I am of the view that for the purpose of understanding Article 26, socio-economic issues should be separated from the decision procedures under Article 15 and 16 pertaining to Risk assessment and management. 

Previous discussions on this issue (pre and during COP-MOP 6) also indicate that  understanding among some Parties is that socio-economic considerations though important for the country, is not mandatory in the decision making process in the context of CPB under Article 26. Parties have also called for further clarity in understanding the scope of Article 26 for which COP-MOP 6 has laid down certain procedures... the online discussion forum being the beginning of such initiative.

I hope the ensuing discussions will provide  more clarity on  intangible issues  such as ‘may take into account, consistent with their international obligations, ‘impact of living modified organisms on the conservation and sustainable use of biological diversity’, especially with regard to the ‘value of biological diversity to indigenous and local communities’ while addressing socio-economic impacts of LMOs.

I am keen to hear more on these issues.

Ranjini Warrier

India.

Dr. R Warrier
Director
Ministry of Environment & Forests
Government of India
Paryavaran Bhawan
CGO Complex, Lodhi Road
New Delhi - 110 003
Tel : +91-11-24363964
email: warrier@nic.in

Posted on behalf of Brian Wynne
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From: Wynne, Brian
Sent: March-17-13 5:50:24 PM (UTC-05:00) Eastern Time (US & Canada)

Dear Colleagues,

I would like to register my support for the observations made Dr Binimelis, Norway, on this week's question concerning the scope and meaning of "A decision to import", and its implementation under the Protocol Art. 10, or under domestic measures implementing the Protocol. The reference which she makes to the concordance with the observations of Aruna Rodrigues and Lucette Flandroy, on monitoring, and pre- and post-hoc impact assessment, with Lim Li Ching and Georgina Catacora with respect to the multiple reinforcements between different formal legal provisions and measures, and with Andreas Heissenberger and Lim Li Ching on integration of SEC with risk assessment, are all also important points with which I express agreement. On this latter point I also have to express respectful disagreement with the observation of Dr Roca, Honduras.
The further points which  Dr Binimelis makes concerning the freedom of parties to adopt more restrictive measures than those of Art. 26, consistent with their other international obligations, should they wish to do so, should also be supported.
With thanks,
Professor Brian Wynne, for the European Network of Scientists for Social and Environmental Responsibility, ENSSER

Posted on behalf of Brian Wynne
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From: Wynne, Brian
Sent: March-17-13 5:59:04 PM (UTC-05:00) Eastern Time (US & Canada)

Dr Rocas states not only that SEC are not relevant to risk assessment but only to risk management, but also appears  to justify this decision on the part of her government. There is every reason in principle to include SEC in a risk or impact assessment process, alongside potential health or environmental harms. Evidence on SE impacts or potential impacts, and analysis of influences upon them, can be gathered, organised and analysed for its robustness, and is i many parts of the world a key component of policy assessment processes for proposed developments, especially where land-use questions (such as agriculture) exist. There is no logical reason to exclude such SE questions from assessment processes, and only include them in more overtly normative policy processes such as risk management. It can be accepted that in principle, SE dimensions are often more complicated to control for, less stable and less precisely measurable than biological risk factors. This does not deny their human nor policy importance however, thus underlining the rationality and justice of including them in assessment where legal articles allow this, even when not mandatory (which gets us closer to the Question 1 topic). Moreover, as a research specialist in the social dimensions of risk assessment, I can note the literature - and policy recognition - showing that environmental risks in particular are objectively influenced by independent social factors (such as agricultural system-factors, management practices, etc). Thus, with respect, to divorce SEC from risk assessment, and include them only in risk management, does not seem to be the best procedure. Recognising them in one such phase does not exclude the need for their recognition in others also.
My thanks and best wishes to Dr Roca and to other colleagues involved in this valuable exchange,
Professor Brian Wynne (for the European Network of Scientists for Social and Environmental Responsibility, ENSSER)