Online discussion 2015 - Discussion Groups

Welcome to this week’s discussion group on the relationship, if any, between human health-related issues and socio-economic considerations.

Ms. Ranjini Warrier will be moderating this final topic of discussion. Comments may be posted until next Monday, 4 May, at 1:00pm GMT.

Please kindly be reminded that you will be invited to post additional comments and thoughts on any of the questions discussed over these past weeks at the end of this week’s discussion. The open discussion will last for three days. We therefore urge you to use this coming week to post your interventions regarding the topic at hand only. Thank you for your cooperation and understanding.

Kind regards,

Paola

POSTED ON BEHALF OF Ranjini Warrier, Moderator

Dear Participants

Welcome to this week’s discussion group on socio-economic considerations and the relationship, if any, with human health-related issues.

It is a pleasure for me to be a moderator for this session and thank you Paola for the introduction.

Possible effects of LMOs on human health are typically dealt with under food safety assessments. Articles 15 and 16 of the Protocol also allow for taking into account risks to human health. However, some human health-related aspects of socio-economic considerations may not be fully or adequately addressed during food safety assessments. These might be human health related aspects with a direct link to social or economic issues.

The aim of this session is to identify such aspects, if there are any, and to discuss their relationship with socio-economic considerations. 

As this topic has not been much deliberated in the previous forums and is of great relevance to the work of AHTEG, it is important to focus our discussion as close as possible to the following guiding questions.

1. Are there any possible human health-related issues with relevance for socio economic considerations?

2. Are they already dealt with under food safety assessments or the provisions of Articles 15 and 16 (Risk assessment and risk management) of the Protocol?

3. Are there any situations when they could they be dealt with under Art 26 of the Protocol?

With that I am looking forward to a fruitful and lively debate on different views on this issue and the arguments supporting the same.

Best Regards

Ranjini

Dear colleagues:

I believe that there is a non direct relationship between evaluation and risk management whit socio-economic considerations.
LMOs authorized under evaluation protocols accepted by a State obey to technical and scientific matters, which under any circumstances should obey socioeconomic considerations, these one must necessarily be treated separately. Article 26 from CP is clear.

They should be considered in any way the effects of LMOs to human health within Article 26; should be exclusively handled in accordance with Articles 15 and 16 of the Protocol.

The robust technical and scientific evidence accumulated over 15 years, says that per se LMOs are no riskier than their conventional counterparts; therefore carried out a proper risk assessment, there is no reason to pretend condition their authorization to socioeconomic considerations.

best regards.

Dear participants,

The objective of the CPB clear states that the adequate level of protection includes the assessment of  ´risks to human health´ and this dispositive is kept in the Art. 15 and Art. 16 through the statement ´taking also into account risks to human health´. On the contrary  the Art. 26 mention that SEC may take into account in reaching a decision under certain circunstances: value of biological diversity to indigenous and local communities. So the context of each article in the Protocol are clear and there is no human health-related issues fixed in the Article 26.

Also according to the Art. 2 the Parties are encouraged to take into account available work undertaken in international forums with competence in the area of risks to human health and that leads us to the Codex Alimentarius (and to the ´international obligations´ fixed in the Art. 26).  The objective of the Codex Alimentarius is to protect the health of consumers, to ensure fair practices in food trade and to promote coordination of all food standards work (including foods derived from biotechnology).

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

The language of the Purpose of the Protocol (Art 1) and of the Scope provision (Art 4) both include “taking also into account risks to human health.”  The standard rules of legal interpretation are clear: such overarching language colors and informs every one of the succeeding operative provisions. Health considerations are completely appropriate under Art. 26,  and was so understood by the negotiators.

Also, of course, health is a “social” consideration, as Ministries of Health around the world recognize in their myriad operations.

Philip L Bereano

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

Many public health issues are not covered by the currently used methods for the Assessment of health effects of GMOs of those we can mention:

- Food intolerance and auto-intoxication are food-induced morbid states that do not involve a specific immune system reaction
- Anti-nutrients
- Food allergy; Atopic individuals may overreact to an allergen with different clinical manifestations, both localized or systemic. This event can show different degrees of severity and can also be fatal as in the anaphylactic shock. Agricultural biotechnology implies the introduction of novel proteins into the modified foods, and proteins can be allergens. There are two situations that may occur: first, a known allergen may be transferred from a donor crop into a non-allergenic target crop. The second scenario is the creation of a novel allergen with a possible de novo sensitization of the population
- Concerns regarding possible adverse effects associated with gene transfer, should take into account the metabolic fate of DNA and RNA, and the content of rec-DNA with respect to the total amount ingested. the gene transfer issue in gut microflora, may be better perceived considering how common this event is in nature. Unlike eukaryotes, bacteria have obtained a significant proportion of their genetic diversity through the acquisition of sequences from distantly related organisms. Horizontal gene transfer produces extremely dynamic genomes and has, in turn, a great impact on bacterial population dynamics as well as on bacterial evolution and speciation
- Antibiotic resistance markers are routinely used for the selection oftransformed plant cells, concerns have been raised about whether the enzyme product of the DNA might be produced in transgenic plant cells. Although various processing procedures would inactivate the enzyme in processed foods, ingestion of fresh or raw transgenic organisms may result in intake of active enzymes. Such an occurrence may cause the inactivation of orally ingested antibiotics;

Researchers or public health should consider these and other related issues

O.A. El-Kawy

On the positive side, we could take as an example the situation in Asian countries (major consumers of rice). In these territories there is a vitamin A deficiency. Golden Rice is a way to reduce this deficit. This Golden Rice is genetically modified, enriched with vitamin A. This is a human health-related issue and also connected with socio-economic aspects, since it is a public health and social problem. From an economic point of view, these kind of products are important to avoid excessive costs for certain chronic disorders. In the future, some new LMOs may be part of the solution of some of these public health problems.  Golden Rice, genetically modified, is an example.

I cannot think in negative effects related to them, because any possible adverse health impacts [...] of LMOs are already covered by risk assessment. It would not pass this phase if there should be negative effects.

I totally agree with Mr. Ramirez (Mexico). Necessarily socioeconomic considerations must be treated separately and consecutively. Article 26 from Cartagena Protocol is clear. The SEC assessments are voluntary and a different process from risk assessments, so they must remain separate.

Best regards,
Vanesa Rincón Martín, Ministry of Agriculture-Spain

Dear colleagues,

In my understanding the Art.15 and Art 26 are very much interrelated in the aspect of human health considerations.

As the risk assessment is based on the scientific evidence, such issues as the allergicity, toxicity, immunologic reaction of the human organisms, hereditary consequences etc. should be considered as the human health risks with direct impact and should be assessed on the statistical and factorial scientific methodology.

At the same time, socio-economic evaluation should consider, for instance, of how much this direct impact will affect the population or different ages' groups of population, rural/urban population, how much the medical treatment/recovery measures will cost, how much cost the investments to enforce the specific health care capacities (healthcare monitoring, clinic and ambulatory care, etc).   Temporal or long term loss of ability of people to work, medical insurance costs, that may have negative influence to the economic deficiencies and financial losses as for people as well as for production/services/agriculture sectors of country's economy.  

In this context I am sure that the socio-economic considerations on the human health issues should be evaluated in close interrelation with the risk assessment results of the respective human health scientific evidence. 

Best regards,
Angela
MD

I agree with others that human health issues are relevant for Article 26. This is completely consistent with the objective and scope of the Cartagena Protocol as contained in its Articles 1 and 4, whereby the taking into account of risks to human health is explicitly included. Subsequent provisions of the Protocol, and their implementation, should conform to the objective and scope. Health is an inherently socio-economic issue, as exemplified by the social determinants of health.

The AHTEG, in its “Elements of a Framework for Conceptual Clarity on Socio-Economic Considerations” indicated that human health dimensions that are not addressed in the risk assessment should also be addressed when taking socio-economic considerations into account. There will be some human health-related issues that are not dealt with under food safety assessments or the provisions of Article 15 and 16.

For example, the health impacts of GM crop co-technologies (e.g. herbicides used with herbicide-resistant crops and their residues on GM food) may not be taken into account in the risk assessment process in some jurisdictions. However, in light of increasing evidence of the impacts of herbicide sprays used in conjunction with GM herbicide-resistant crops on the health and well-being of rural communities [1], and of unexpectedly high levels of herbicide residues on GM food [2] which could potentially affect human health, any omission of these considerations is a large gap. With the recent reclassification, by the WHO’s International Agency for Research on Cancer, of glyphosate – to which the majority of GM crops are engineered to be resistant to – as a “probable human carcinogen”, this has become even more urgent. 

kind regards
Lim Li Ching
Third World Network

Footnotes:
[1] See for example, Leguizamón, A. (2013). Modifying Argentina: GM soy and socio- environmental change. Geoforum 53: 149-160, http://dx.doi.org/10.1016/j.geoforum.2013.04.001

[2] See for example, Bøhn, T., Cuhra, M., Traavik, T., Sanden, M., Fagan, J. and Primicerio, R. (2014). Compositional differences in soybeans on the market: Glyphosate accumulates in Roundup Ready GM soybeans. Food Chemistry 153: 207-215.

Dear colleagues,

Health issues are one of the most relevance aspects to be consider in the context of the discussions of the Protocol.  The linkgages between agricultural system production that have in the center transgenic crops and the package related.
That is the case of glyhposate.  Several could comments that glyphosate has been used since 1973 and this is OK, but one of the main aspects is that the molecule has change its pattern of use since the implementation of transgenic soybean and No Tillage.  Health studies related with this chemical are coming from science and these and other coming studies must be taken in consideration.
Other aspect, that my colleague from Spain rise is related with golden rice.   Instead Golden Rice could be a way to reduce the deficit of Vitamin A, this is a high cost implementation process.  And this cost rise, when what is happening is a change of agronomical system production.  With an integration of a more rich and diverse diet, the problem can be solve under a sustainable and permanent way at a very low cost for farmers and countries.
Best regards

Walter Pengue
ARGENTINA

Dear Colleagues,

I would like to expand upon the comments of Dr. Lozan regarding what is included in a science-based risk assessment of human health and address some of the errors posed in the posting by Dr. Abdelkawy. Dr. Lozan identifies that “allergicity, toxicity, immunologic reaction” are thoroughly assessed in a science-based health risk assessment. Moving beyond a health assessment that includes these attributes moves the assessment into the realm of speculative impacts, thus putting such assessment in violation of the WTO’s SPS Agreement.

It matters not what the negotiators of the CPB intended, what matters is how a WTO Dispute Settlement Panel will interpret a regulation that includes a health risk assessment that has a SEC component that is not science-based and is trade distorting. The scientific experts that constitute a Dispute Settlement Panel rely solely on peer-reviewed, quantified evidence of harm, not speculation of harms. To imply that health is somehow a social issue that is capable of complying with the SPS Agreement is a nefarious suggestion that is designed to mislead policy-makers. Similar suggestions by the Third World Network that pesticide residues should be included in the regulation of GM crops is further unfounded as if this were to be the case, then the pesticide residues on organic food products would also be subject to regulation, as organic crops are sprayed with chemicals that are far more ecologically toxic than glyphosate. Cornell academic Joe Kovach identifies that the organic use of sulfur is 3 times more ecologically damaging https://dspace.library.cornell.edu/bitstream/1813/5203/1/FLS-139.pdf than glyphosate (45.5 vs. 15.3) (http://www.nysipm.cornell.edu/publications/eiq/files/EIQ_values_2012herb.pdf).

The WTO Dispute Settlement Panel’s ruling in the case against the EU established a precedent as to what information will be accepted by a Dispute Settlement Panel. It noted that reports and publications by environmental NGOs, (such as those posted last week by the Third World Network) would not be eligible to be included. The importance of this WTO precedent is vital for this discussion of SEC implications of health risk assessments. If policy-makers decide to include SECs as part of a risk assessment, they have to be scientifically compatible with the SPS Agreement’s definition of risk assessment. To suggest otherwise would be misleading.

Policy-makers considering the SEC impacts of health, will need to look no further than the ex post assessment by Kouser and Qaim (http://ac.els-cdn.com/S0921800911002400/1-s2.0-S0921800911002400-main.pdf?_tid=414ea596-ef59-11e4-99ea-00000aab0f02&acdnat=1430412915_b7cf7b640892cea43a4239e7b7498255) that quantify the reduction in annual cases of pesticide poisoning as being in the millions. The findings of this article confirm that incredible human health benefits from GM crops.

Sincerely,
Stuart

Dear Colleagues

Thank you for the stimulating discussion so far.

I must say that I struggle to see how the aforementioned human health issues are ‘socio-economic considerations arising from the impact of living modified organisms on the conservation and sustainable use of biological diversity’.

I feel defining a specific example may be beneficial for gaining conceptual clarity. Is anyone able to provide such an example, preferably one that has been considered within an existing framework?

For fear of straying off topic I think it worth mentioning, that the discussions above generally frame socioeconomic considerations as negatives. I think it is worth reminding the group that if we consider these considerations valid, we should also accept and consider positive socioeconomic considerations.

Many thanks,
Steve

I think we had a similar discussion in the AHTEG on risk assessment, and the conclusion was to leave the issue of human health considerations (including food safety assessment) out of the scope of the roadmap on risk assessment bearing in mind that health has social dimension. I believe that the work of the AHTEG on socioeconomic should be complementary to the work of the AHTEG on risk assessment otherwise we will miss lots of aspects of assessment because each group thought that the other group should deal with that subject while the other group in fact did not.

I do understand some people point of view. However for some parties, they have Environmental Risk Assessment and the issue of human health is left out of the scope of Environmental Risk Assessment. It is true that for other parties the risk assessment may include some aspects of human health and other aspects of human health are dealt under socioeconomic considerations and some additional aspects of human health are dealt under food assessment studies. But doing so you may risk of losing some important aspects just because it may not fit under any of those category or you thought that it is dealt under a different category while it was not. I would like to remind ourselves that issue of not considering the health effect of herbicide that is used in conjunction with the herbicide tolerant GMO happened because in environmental risk assessment we do not consider human health issues and this aspect of human health is neither considered under food safety assessments nor socioeconomic considerations.

I think that for decision making, all impacts whether environmental, social, health, economic.. etc need to be considered in a process leading to appropriate and informed decision. Sometimes there is no clear cutting point between the different categories and this is okay as long as you have a holistic overview and not to leave an important issue to be considered without looking at it. 

O.A.El-Kawy

I would not say that socio-economic considerations are voluntary

Article 7 CBD establishes the mandate, in particular for the purposes of Articles 8 - 10, to identify and monitor the effect of processes and categories of activities, (including modern biotechnology (article 8g)), which have or are likely to have significant adverse effects on the conservation and sustainable use of biological diversity. An indicative list, clearly including socio-economic aspects, of categories of components of biological diversity to be considered is set out in Annex I.

The list includes:
"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; "

The language of the article is non-voluntary "Party shall, as far as possible and as appropriate"

O.A.El-Kawy

Thank you Ossama for bringing to us very useful arguments from the CBD language in favor of the socio-economic assessment to be considered for impact assessment to biodiversity. The mentioned articles and the Annex 1 should be taken into account for the biosafety scopes.
I am also of the opinion that Art, 26 should not be considered as a voluntary task, but it should be one of the key elements for overall impact assessment in decision making, along  and together with the risk assessment , that include human health issues.

Best regards,
Angela

Dear All,

Again a fascinating exchange.

First this: in the on line discussion on Synthetic Biology the concern was raised that the number of simultaneous online discussions (e.g. SECs, Synthetic Biology, RA, databases), makes it difficult to follow them and contribute in a coherent fashion. Understanding that at this point in time there is not much room to spread the on-line discussions, I echo the Secretariat’s request that the contributions be as concise, direct and on topic as possible.

With that, hereby a brief reaction to some of the points made in response to the points raised by Ranjini, whom I thank for her willingness to moderate this session:

• As Ramirez and Martin said, it is essential for this debate not to confuse the option (not obligation) of taking SECs into account in decision making on import with risk assessment. As the CPB and SPS underline: such risk assessment must be scientifically sound.
• Likewise it is important not to confuse food safety assessment with the risk assessment under the CPB. 
• I concur with Corin that it is difficult to see how the examples given in this exchange are issues ‘arising from the impact of living modified organisms on the conservation and sustainable use of biological diversity’.

Piet

I believe that moving away from the objective and scope of the protocol should not be done in interpreting some articles under the protocol.

The protocol sates that “In accordance with the precautionary approach contained in Principle 15 of the Rio Declaration on Environment and Development, the objective of this Protocol is to contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and specifically focusing on transboundary movements.”

So the aim is to ensure the safety by conducting risk assessment, socioeconomic considerations assessment and risk to human health assessment prior to taking any decision. Bearing this in mind, Benefit assessment of human health considerations do not fit because we are talking about risks.

Regards,
O.A.El-Kawy

Dear Colleagues

This debate offers an opportunity to reflect about human-health related issues beyond questions of food safety and I think it would be useful to go into some details.  The following questions may provide a better understanding of the issue:

i. What are some variables or parameters that have an impact on socio-economic considerations but are not dealt under RARM or food safety assessments?

ii. What may be the relationship between biodiversity and variation in diets? Can this be addressed under Article 26?

iii. What are the ways that food, diets and nutrition have an impact on socio-economic considerations?

iv. How can we capture the impact of diets and nutrition on socio-economic considerations?

v. How can socio-economic considerations be scoped to address issues relating to health, nutrition beyond questions of safety and risk?

vi. How are the above issues addressed in the food derived from conventional agriculture?

It would be useful if some thoughts and experience are shared on the above issues.

Regards

Ranjini

Dear Dr. Warrier,

While the questions you pose are interesting, they are also a clear violation of risk assessment as defined in the SPS Agreement. Given that the Protocol has no means of resolving disputes, the Protocol's definition of risk assessment will have little to no impact when the WTO SPS Agreement is used by a Dispute Settlement Panel. Also, any trade dispute involving Argentina, Canada or the US will be based on the SPS Agreement as none of these nations are Parties to the Protocol.

Countries have the sovereign right to enact regulations that do disrupt trade in agricultural products, provided they have scientific evidence to verify this. A country can enact a barrier to an agricultural commodity if it anticipates harm may happen. However, this has to be direct impact related and cannot be based on speculation or multiple order impacts as some have tried to suggest. For example, Canada has had its exports of beef banned by some countries following detection of a case of mad-cow disease. Export countries banned Canadian beef for a short period of time until verification that none of the beef destined for that market would be unsafe, then the ban ended. If a country uses regulations to ban an agricultural product for health reasons, continual scientific research has to be done to verify the harm and if no harm is found, then the ban has to be removed. Once proof of no human health harm is verified, then the country imposing the ban is required to remove the ban and if it does not, then it knows that it is in violation of the WTO Agreement.

The WTO also stipulates that one type of product cannot be treated differently than a similar type of product. For this reason, the questions you pose, would have to be applied to every single agricultural product developed in a country to be compliant with the WTO. GM crops cannot be regulated differently than other types of crops, if there is no science to support the different regulatory requirements. These types of regulatory-based questions would then have to apply to every single conventional, organic and imported food product within a specific nation. To single out a specific product for separate regulatory oversight without scientific evidence to support such a move, would violate the country's commitment to its international obligations. 

I hope this helps to answer your questions and clarifies that including topics such as these in a regulatory framework for GM crops would be a clear violation of the SPS Agreement.

Sincerely,
Stuart

Colleagues--

Again, I must remind us that it is the Protocol, not the WTO, we are charged with implementing.

Dr Smyth could just as easily make frequent reference to the Codex Alimentarius (in which the US, Canada, and Argentina are members, along with most--if not all-- of the Protocol States).  Since the largest proportion of LMOs transferred internationally are foodstuffs, the Codex clearly is relevant.  Its provisions allow for extensive assessment including, of course, health --one of the two objectives of the Codex system.

See ftp://ftp.fao.org/codex/Publications/Booklets/Biotech/Biotech_2009e.pdf

Since in 1995 the WTO decided to follow all Codex guidelines in determining trade disputes involving foods (and this decision is subsequent to the SPS provisions), I think it is clear beyond a doubt that for food LMOs health assessments are immune from any attack under the WTO. For non-food LMOs, the principles of analogy and consistency could be used to assess them in the same way.

Now, back to the Protocol . . .

Philip L Bereano
Emeritus Professor
University of Washingrton

Dear Colleagues,

The importance of this dialogue process is to improve the conceptual clarity of SECs and the regulation of LMOs. Given that the Protocol has no ability to settle disputes, it is imperative that those policy-makers considering the role of SECs in relation to the regulation of LMOs in their own country have a clear understanding of the role the WTO and particularly the SPS Agreement will ultimately have on any domestic regulations. I apologize if the clarity of my posts has been lacking.

The recent literature highlights that Codex has in fact failed to be an agreement with any bearing on LMOs. In 1993, Codex was tasked with establishing standards for the labeling of food products derived from biotechnology. In 2012, Codex admitted that it had failed to respond to this task as it was unable to get any agreement or consensus on how to label such products. In the end, all Codex was able to provide was a principle on the risk analysis of food derived from biotechnology, with the generic statement that labeling is an effective strategy for managing risk.

It is regrettable that after nearly 20 years of effort, that Codex was unable to provide international standards that could usefully contribute to the context of this weeks discussion questions. With no standards regarding products derived from biotechnology, Codex is incapable of being an insightful reference for further clarity of how health-based SECs will be interpreted.

Sincerely,
Stuart

Colleagues--

I really wish we could stay focused on the Protocol and Art 26. 

The Codex labeling decision ( I participated in those meetings for the last ~7 years of their deliberations) was, in many regards, a "win" for those of us favoring the labeling of GMOs--but it is completely irrelevant to this discussion, so I need not explain it here.

And yes, the Protocol DOES have a dispute resolution mecahnism.  As a dependency of the CBD, the two annexes to that treaty provide ways of settling controversies between Parties to the Protocol. 

As to disputes with non-Parties, I  hope Dr Smythis trying to get Canada to participate in the Protocol; I have been working on the US for quite a while.

Philip L Bereano

It is not true that the CPB has no ability to settle disputes.
Article 27 of the CBD is on settlement of disputes between Contracting Parties concerning the interpretation or application of the CBD and its protocols. There is also Annex II with its two parts on Arbitration and Conciliation.

I wanted to higlight that:
Article 24 of the CPB states that "Transboundary movements of living modified organisms between Parties and non-Parties shall be consistent with the objective of this Protocol".
Article 22 of the CBD states that" The provisions of this Convention shall not affect the rights and obligations of any Contracting Party deriving from any existing international agreement, except where the exercise of those rights and obligations would cause a serious damage or threat to biological diversity."

O.A.El-kawy

QUESTION 5

There  are some possible human health related issues with relevance for socio economic considerations .
-  At the farmer level health impacts as a result of GMOs crops , refer to the decrease on the use of pesticide that influence field workers thanks to the lower exposure to toxic substance     Also , there are health affectations due to the extended of herbicide ,in particular glyphosate, as a consequence of the expansion on herbicide tolerant GM seeds.
- Health impacts derive from use of GMOs is one of the main  concerns of consumers because they could derive in socio economic repercusions. For example , risk related to health issues are concern effects of novel toxins; allergenic and immune system reactions.

Koffi Edinam DANTSEY

Dear Colleagues:

It is indeed true that the SEC assessments are voluntary, as was mentioned by Ms. Vanesa Rincon Martin. However, this doesn’t mean that the possible socio-economic effects must not be studied and analyzed. The outcome of ignoring the possible consequences of a technology does not eliminate its occurrence. But having knowledge of its effects can minimize the potential risks before they become irreversible. As Dr. Ossama Abdelkawy said “I think that for decision making, all impacts whether environmental, social, health, economic.. etc need to be considered in a process leading to appropriate and informed decision.”

I believe that there are relevant human health related issues to take into account for socio economic considerations. There is a relationship between the use of certain chemicals and health effects. These effects imply an occupational hazard for the employees but not only them are affected when you consider that these chemical substances reach the water bodies and are spread away. This situation makes certain workers to be more vulnerable, especially those who have to support their families with low wages. In addition to the increase in public health expenditures.

For decades there has been evidence of health impacts of glyphosate in rural communities of Paraguay, Argentina and Brazil. Scientific studies have raised concerns about glyphosate safety and effects on human health and have been recognized by the World Health Organization, as it was stated by Ms. Li Ching Lim, and Prof. Walter Pengue. Evidence on the health hazards of glyphosate does not appear in a short term, but there are health effects from long-term exposures.

If companies selling technological packages of GM seeds and related agrochemicals are so sure of their low risk, I wonder why they refuse to conduct laboratory testing for short, medium and long-term health effects. Such an important issue cannot be left to goodwill.

Warm regards,
Michelle

Dear Colleagues
The first question on possible human health-related issues with relevance for socio economic considerations – all health related issues which are the subject of risk assessment certainly have relevance for SECs. This could be either positive or negative.  SECs will look into such issues on the society at large. 
On the second question, are they already dealt with under food safety assessments or the provisions of Articles 15 and 16 of the Protocol? No.  Food safety assessments are different from SE impacts. These impacts are the total effect of health related risk (benefits) on the society. Societies are different within the country and among the countries in terms of access, income, choices etc etc
On the third question, are there any situations when they could they be dealt with under Art 26 of the Protocol? Art 26 is severely limiting the scope of SECs, in the sense, It looks into only ‘SEC   arising from the impact of LMOs on the conservation and sustainable use of biological diversity, especially with regard to the value of biological diversity to indigenous and local communities’.  Hence the above only could be dealt with Art 26.

Regarding the references to WTO SPS agreement and our current topic in  the earlier postings, I feel our discussion need not be constrained by WTO SPS agreement. This is a forum to represent all the possible views on this issue.  In the light of discussion if some substantive issues emerge and the countries /members want to change, this can be raised /negotiated in the next round of WTO negotiations itself.

Dear Colleagues

I am sorry for the late reply and very much appreciate informative and insightful inputs from participants.  It seems that we have moved a bit closer to the conceptual clarity on SEC of LMOs.

In Korea, the concern on the long-term dietary impact of LMO is recognised and addressed through 'Risk Assessment' process where all LMO events are subject to re-approval process every ten years.  
Scientific evidences would be used to evaluate the long-term health effect of a given LMO and hence its re-approval.

Many suggestions for human-health related SEC including those of Andrea's do shed lights on the concept of human-health related SEC and would certainly contribute to the discussions in the next AHTEG meeting. 

It would be better, however, that human-health related SEC should be dealt with separately with long-term dietary impact of LMO.  Risk Assessment mechanism should confine itself to the evaluation of the health-impact of LMO not health-related SECs.

Best wishes
Hong-Tak

Dear friends

This is an intervention to endorse my support to views expressed by my colleague  Prof  Ashok Krishna Radha from India. 

Thank you Piet for highlighting the difficulties in participating in parallel on-line discussions.  Extensive coordinating is required among several agencies   at the national level to ensure timely and  effective participation. This  is a huge exercise for the NFPs. 

Inspite of the difficulties, I think we have made some good progress.

Thank you friends

Ranjini

Dear colleagues,
First I need to apologize for my long absence from this forum. Unfortunately I was not able to participate during the past two weeks due to personal reasons.
Anyway, I read all the contributions with great interest and I believe that the AHTEG will greatly benefit from the contributions.

Before I give my opinion to the topic at hand, just a brief general statement, which I will probably elaborate a bit more on in the general discussion. I believe, and that has been said by several others before, that we should not focus too much on the processes and requirements of other agreements (sometimes I had the impression we are discussing the SPS agreement here). I think they are important, but our task is the implementation of the CPB, and we should stick to that as much as possible.

Regarding human health related aspects:
I agree with several of the other participants, that human health effects may have great social and economic impacts. Besides the obvious parameters like allergenicity or toxicity, which are dealt with in the risk assessment in many countries, there are others, and we have started to discuss those issues at the AHTEG, which are not assessed in the RA process. The examples mentioned in tose discussions are mainly linked with food security and wider nutritional effects. Just an example: The use of GMOs may lead to a change in diversity of crop plants and therefore a shift in diet or a shift in the availability of certain food. This may have positive (enhanced nutrients) or negative (malnutrition due to change in consumption habits) effects. Both will have socio economic impacts.

This is just an example, but I believe that we need to think along these lines. This will also help to avoid conflicts with risk assessment, in countries where this is necessary.

Regards

Andreas

Dear all,

The Cartagena Protocol on Biosafety in its objective (Art. 1), general provisions (Art. 2), scope (Art. 4) and other procedural articles (e.g. Art. 7, Art. 10, Art. 15, Art. 16, Art. 17), makes explicit the relevance of human health in relation to the conservation and sustainable use of biological diversity. Moreover, the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress also refers to human health. Accordingly, human health is a crosscutting aspect of the Cartagena Protocol, and relevant to ecological and socio-economic assessments.

Given the multi-dimensional nature of human health – particularly in relation to the conservation and sustainable use of biological diversity, and the ecosystems that sustain it (re-calling the CBD definitions) – human health inherently relates to:

- Ecological aspects, e.g. changes in biodiversity relevant to local food systems; changes in environmental chemical load; changes in the fertility of soils used to local food production, etc.

- Socio-economic considerations, e.g. access to innocuous food at biological, chemical and genetic levels; changes in occupational exposure to pesticides; changes in access to food; changes in job opportunities deriving from the agrobiodiversity management; etc.

- Others that, besides the previous, also involve cultural and ethical aspects, e.g. the respect to the value of biological diversity to indigenous and local communities for their livelihood, food, knowledge and spiritual systems, among others.

The examples listed above to certain extent provide insights to the important questions proposed by this discussion´s moderator (Dr. Ranjini Warrier in her post #6900), and also highlight the distinctive value of the Cartagena Protocol in relation to the intertwined issues around biodiversity / LMOs / human health.

From the previous analysis – together with the current and growing body of peer-review literature – it can be concluded that LMO ecological risk assessment and risk management (Art. 15 and 16), and LMO socio-economic considerations (Art. 26) are complementary. This is particularly true in the process of identification of changes relevant to human health deriving from: (i) the genetic construct inserted in the LMO, (ii) the expression of the LM genetic construct, and (iii) the intrinsic technological package (especially relevant in the case of LM crops, e.g. LM herbicide tolerant and LM insect resistant crops). Furthermore, all human health issues are fundamentally public health matters, meaning, have socio-economic relevance. Dr. Angela Lozan in her post #6871 provides specific examples of public health parameters relevant to LMO assessment.

Kind regards,

Georgina Catacora-Vargas

Hi folks

Sorry to have gone all quiet - I was in the Kalahari, a zillion miles from the nearest cell-phone tower.

We appear to be struggling to identify possible health impacts that are not covered by the Risk Assessment. I pick up on two example:

Angela Lozan (6781) suggests "allergicity, toxicity, immunologic reaction of the human organisms, hereditary consequences..." But the first three are considered under the RA, and the last is not clear.

Ossama Abdelkawy (6865) lists a few more: Food intolerance and auto-intoxication, Anti-nutrients, Food allergy, in part due to genotypic/phenotypic differences between individuals. These are covered by the RA process generally, and I don't think it is constructive to require testing on all possible atypical pheno-genotypes(I exaggerate: "eat food only under medical supervision!"). We would not want, I believe, to hold up GMOs to higher standards than other foodstuffs. There are better ways of managing this: In SA we have Health legislation requiring food to be labelled if it contains known allergens (this is general to all foods but is specifically also for GMOs), and - specifically in the case of GMOs - if the introduced trait changes the way food needs to be prepared (in addition to animal-derived genes in plants or visa versa). Thus far we have not had to invoke this legislation (and developers would be very unwise to use a trait known to be allergenic).

Ossama further lists gene transfer & antibiotic resistance. These have been the subject of much ongoing research, and the former is not specific to LMOs, and there are much more evident ways the latter is being caused (eg incompletion of antibiotic dosage; preventative application in livestock).

The general issue, then, appears to be a difficulty in identifying the "pathway to harm" of LMOs on human health BEYOND what is included in the RA. Until a specific pathway can be identified, we are still speculating, and this then -at least in my view- cannot be an ex-ante requirement for any specific LMO application. Rather it could be the object of further (state funded?) research. But I also agree (with Stuart, I think) that this is probably stretching things excessively if we are meant to be looking only at SECs arising from biodiversity impacts.

Ben

Dear Colleagues:
Thanks for the lively discussion.  I want to share with the forum my following views:
1. Human health issues  both positive and negative are  highly relevant for the SE considerations.  Besides the Articles 15 and 16, Articles, 1, 7, 10 and 23 Para a, also mention the risks to human health. 
2. I agree with the views of Prof. Georgina Catacora Vargas regarding the multi dimensional nature of human health. To strengthen the understanding on human health impact of LMOs, besides the health risk assessment done before the commercial release, I want to suggest that a system has to be in place to collect information from the communities-  like  in the case of the  pharmaceuticals where continuous assessment of the drug is done  through collecting information from a wider user population on the “ adverse drug reaction” after the drug release as well.  Renewal of commercial licenses for seed production of food related LMOs should be subject to the assessment of this ‘LMO reaction data after the release’.
3. Situations like health risks due to illegal transboundary movements of LMOs should also be dealt with under Art 26.
With warm regards
lalitha

In response to Dr Ranjini Warrier’s interesting questions I share the following:

First question on variables or parameters that have an impact on socio-economic considerations but are not dealt under RARM – For example if in RARM the concern is detection of toxicity and its health impact, in SE analysis the concerns include what is the cost to individuals due to such toxicity?, What is the benefit due to the LMO? If the cost outweighs the benefits?  who are the most vulnerable? Does it bound to make any impact on crop production practices? Biodiversity? What kind of institutions required for monitoring and long term impact etc

The relationship between biodiversity and variation in diets is very much indirect and  very difficult to make attribution, especially in a globalized world where food moves across borders with ease.

Yes, food, diets and nutrition have an impact on socio-economic considerations because they affect the overall health and hence the productivity of human resources.

One approach to capture the impact of diets and nutrition on socio-economic considerations is the disability-adjusted life year (DALY) , which is a measure of overall health condition, expressed as the number of years lost due to ill-health, disability or early death.

Beyond questions of safety and risk SE considerations include parameters like nutritional security, life expectancy, infant mortality, maternal mortality, malnutrition of children, underweight,  etc

These issues are also pertinent to conventional agriculture. The important question is how LMOs make a difference, either positively or negatively, on the above issues.

POSTED ON BEHALF OF Ranjini Warrier, Moderator

Dear Participants

Thank you very much for your active participation in the online discussion forum on socio-economic considerations and the relationship, if any, with human health-related issues. The trend of debate under question 5 was more or less predictable and followed a pattern similar to the earlier questions 3 and 4 with two views predominating the debate. One in favour of including human health related issues as part of socio-economic considerations under Article 26 and the other group is of the view that human health aspects have been adequately covered in the risk assessment of LMOS. 

Attempts have also been made to indicate health related parameters that could be part of SEC both as direct and indirect impacts.  Arguments of positive (golden rice) and negative SEC impacts (glyphosate) were also put forth by some participants.  The relevance of guidance under Codex in the context of human health safety assessment and WTO non-compliance on going beyond the definition of risk assessment under the SPS Agreement and their relevance to the present debate were also part of the arguments put forth.  Participants also highlighted provisions of CBD and CPB and their interpretation to indicate that socio-economic considerations goes beyond Article 26 whereas some participants expressed that scope of SEC under Article 26 is  limited to impacts arising from LMOs on conservation and sustainable use of biological diversity especially with regard to value of biological diversity to indigenous and local community.  

The AHTEG would greatly benefit from arguments provided by both groups and I leave further interpretation on the discussions to AHTEG.

Thank you once again for your valuable time and understanding.

Best wishes

Ranjini

Thank you all for your participation. Discussion on question 5 is now closed. We would like to thank our moderator this past week, Dr. Ranjini Warrier, for her guidance on this topic.

Best regards,

Paola