One year after Ljubljana meeting, I am still concerning the issue of co-existence. It is really confused to have a part of related issues but was indicated to be outside of the roadmap scope.

It is well known that the biosafety protocol is used to deal with transboundary move of LMOs. That meant that one should declare or label the LMOs when doing the transboundary movement and the protocol committed to co-existence at this point. In addition, co-existence is one part of consideration in decision-making process. Thus the issue of co-existence should stay inside the roadmap unless we have very strong reasons to have that very strange statement ‘Some members of the AHTEG considered some issues to be related to risk assessment and decision-making process but outside the scope of this Roadmap’. Obviously, co-existence and other issues are important components of the decision-making process.

For an independent country who has both GM and non-GM organisms and has requested to label the GM ones. That right should be respected during international activities and the willing to separate GM from Non-GM should not be aggrieved and contemned. Someone may not need the issue of co-existence, but that should be only limited inside their domain but not the whole world. Co-existence should be considered on all international movements of LMOs.

For a country that is intending to have a diverse agricultural system, co-existence is a crucial part. We should work hard to prevent the loss of genetic diversity that could block further innovation breeding and the loss can be caused by predominance of only a limited number of crop varieties in the farmlands. That kind of predominance will damage our goal of biodiversity conservation and sustainable development and should be avoided. Co-existence is certainly important for maintaining diversity and it is certainly affiliated to risk assessment and should be considered in conserving the natural world of mankind.

I strongly insist that co-existence should be considered in risk assessment and management and should be included inside the roadmap.

Dear all and Wei Wei:

It is true that our memory need to be refreshed. Going back to the principles of RA and the mission of the guidance document, simpler content would help the beginners. But relevant information may be amended as supplementary information. With that context, Wei Wei intervention could be complication to the beginners?

Kazuo

Dear all
Many thanks to WEI WEI for being the first to launch discussions . I agree with Kazuo to be carefull in adding relevant information  in view to have the easiest tool of exploitation of principles of RA  and guidance documents in the Roadmap for begineers and other stakenolders.
Gado

I agree that it was useful of Wei Wei to raise co-existence. However, I support the conclusion of others that it would be confusing to deal with this issue in the Roadmap for risk assessment. Coexistence is a separate consideration, which is not linked to the identification and characterisation of risk. Neither is it directed at risk management - its aim is to provide choice between different supply chains (thresholds for LMO presence are therefore largely political taking practicality into account to varying degrees). If risk management measures are required to address a risk to conservation and the sustainable use of biological diversity, these should be considered on a case by case basis in proportion to the risk. The use of a tool that was not designed for this purpose is not appropriate and adds confusion to those hoping to gain an insight into how to approach LMO RA and RM.

I am confused by these postings about co-existence.  Certainly in any risk analysis of an LMO, the possibilities of contaminating organic and conventional crops (either in the field or during processing)is a risk which must be analyzed.  If it occurs, it would--for example--have negative economic consequences (simultaneously, the Secretariat is faciliting an electronic dialog, such as this one, focused on "socio-economic" considerations--Art 26 of the Protocol--which I am involved in, so such a scenario is very much on my mind).

Perhaps one of our colleagues who was active in the AHTEG in the previous cycle can explain the discussion and decisions about "co-existence" (which I think is more accurately called "contamination").

POSTED ON BEHALF OF RENÉ GATO, INSTITUTE OF TROPICAL MEDICINE "PEDRO KOURÍ"

-----

No necessarily co-existence implies “contamination”. We must take it into account as a concept in order to some plants. But in another genetically modified organisms it can work different. And furthermore in animals without capability of reproducing, as those developed to implement Sterile Insect Technique.

As chair of the sub-working group that has drafted the Roadmap, I find it very inspiring that the discussion on the Roadmap has started right on the first day. I would like to thank Wei for opening the discussion, and Kazuo, Gado and Louise for picking up the thread.
I agree with Louise’s statement on coexistence. These were also more or less the considerations of members of the AHTEG who discussed the issue of coexistence: it is a separate issue from risk assessment. Therefore the issue is not to be discussed further in the context of the Roadmap on risk assessment, but we thought it was appropriate to mention the issue in the paragraph on related issues.
I agree that the sentence that Wei is referring to, ‘Some members of the AHTEG considered some issues to be related to risk assessment and decision-making process but outside the scope of this Roadmap’, is not very appropriate. It makes a procedural statement at a place in the document where one would not expect such a statement.
Probably the sentence can better be deleted from the text.

Hans Bergmans
Natl. Institute for Public Health and the Environment, the Netherlands

I agree to the suggestion of Hans to delete the confused sentence ‘Some members of the AHTEG considered some issues to be related to risk assessment and decision-making process but outside the scope of this Roadmap’ and keep the part of related issues.

While I was drafting my previous comment, Phil Bereano posted a contribution, thanks very much Phil!
I have the following comments to your posting.

The possibility of outcrossing from an LM crop to any other (crop) plant is an issue in environmental risk assessment. In fact, when the transgenic trait of the LM plant is transferred to another plant, for instance a wild relative, this would result in a new LMO. Potential adverse environmental effects of this LMO have to be taken into consideration in the risk assessment. As such outcrossing is mentioned in the Roadmap.

‘Coexistence’ is not synonymous to ‘contamination’. Coexistence has been coined as a phrase to describe a situation where different ‘forms’ of agriculture are existing side by side. If an LM crop is grown side by side with a non-LM crop this may lead to outcrossing from one of these crops to the other. This may be a cause of, as you say, 'contamination'.
The issue of the economic consequences of this kind of contamination indeed belongs to another dialog, which, to my mind, does not mean that it would be of less (or more) importance, it's just a different issue.

Hans Bergmans
Natl. Inst. of Public Health and the Environment, the Netherlands

Continuing the dialog with Hans' posting-- of course, I was being a little too concise--"co-existence" and "contamination" are not identical--but they are inextricably related.  The legal concept of "co-existence" (with all the discussions about the US EPA's notion of "refugia", etc) came into being due to the consequences of contamination.  In other words, co-existence measures (such as legally imposed minimum distances for GE and non-GE plantings) are policy responses to the risks of contamination.

Thus, we can avoid including "co-existence" if we wish to impose such a boundary on the work of AHTEG, but certainly "contamination" is a major risk which must be included in every assessment. 

The fact that a separate discussion is currently occurring on Art 26 (Socio-Economic Considerations) does not absolve us here from recognizing that risks are actually expressed in probabilities of economic loss or of social disruption.  The Protocol operates as a seamless web, and those of us in this particular dialog should not artificially constrain ourselves by pretending that potential policy responses will flow from the risks assessed.

CLARIFICATION

I apologize especially to colleagues whose first language is not English--the last sentence in my posting would be clearer perhaps if I say "potential policy responses will or will not flow from the risks assessed."

I hope this is helpful.

Many thanks for all the kindly comments from our colleagues. I should make a clarification that co-existence is not only related to contamination in supply chain but also to biodiversity. The GM crop having selective advantage to pests or deseases and would be favorited by farmers. However, the monocultivation of the only GM crop variety will cause the loss of landraces.

I remember there was a big project on co-existence--sustainable introduction of GM crops in Europe. I believe that our European colleagues shall have solid floor when speaking co-existence. Including the issue of co-existence is a good way to seperate between GM and non-GM.

Thanks!

Dear All, welcome
and thank you Wei Wei for opening the discussion. What has been said about the concept of co-existence is the European understanding - strictly agronomic and referring to outcrossing of approved events to the same crops under cultivation. Different from that is the biodiversity issue and outcrossing into relatives etc. These "contamination issues" are and should be addressed in the risk assessment and are an important issue of risk management. 
May be there is the need to address this differentiation more clearly.
best regards
Beatrix

Dear colleagues,

First I would like to thank Beatrix, for summarizing the discussion in a clear way.

The issue of ‘contamination’ has many ‘faces’, in terms of environmental risk assessment which is directly relevant to the Roadmap, and in terms of other discussions, such as the political and socio-economic implications, which are outside the remit of Annex III, and therefroe outside the remit of the Roadmap.
The Roadmap is solely concerned with risk assessment issues in accordance with Annex III of the CPB.

Taking all this into consideration I propose the following way forward for the discussion:

- Environmental risk assessment has to take into account the interactions of the LMO itself and the environment, under the conditions of use; this is already covered in the Roadmap, and will be further discussed in the online forum and in the AHTEG.
- The conditions of use may lead to unintended environmental releases of the LMO itself, e.g., by spillage. This could have consquences for the receiving environment that has to be taken into consideration: the LMO may not only end up in the expected receiving environment but may also be present elsewhere, possibly in a situation that we would call ‘contamination’. This could be made clearer in the text of the Roadmap.
- One aspect that deserves further discussion in the context of the Roadmap is the potential of the LMO to exchange genetic material with other (sexually) compatible organisms (this is tentative wording, meant to cover exchange between all types of organisms including micro-organisms). For (crop) plants this is the issue of outcrossing and introgression, that is mentioned in the Roadmap.
It should be clear that genetic exchange in general may result in the presence of a modification in another host than the host of the original LMO, i.e., it may result in a new LMO, that may be present in another receiving environment. This situation would require a new risk assessment for the new LMO in the new receiving environment. This may be made clearer in the Roadmap.
- This discussion in the Roadmap would deal with the issue of potential adverse effects on biodiversity as it covers introgression of new traits into compatible wild species, as well as the issue of 'contamination' in coexistence, as it covers genetic exchange/outcrossing from an LMO to organisms of the same species.

I propose that we ask the AHTEG to take these issues into account when they discuss a revised text of the Roadmap.

The discussion in the Roadmap will necessarily stay away from other related issues, like the political and socio-economic issues, that are not within the scope of Annex III. In order to bring these issues to the attention of the reader of the Roadmap, these issue may be mentioned as ‘related issues’, at the end of the text of the Roadmap.

Hans Bergmans
Chair of the AHTEG sub-working group on the Roadmap

Dear all,

I stongly approve Hans idea to ask the AHTEG to take these issues into account when they will be discussing a revised text of the Roadmap.

Dear Members,

The exchange of ideas has been very useful. I too agree that AHTEG should
clarify the issues raised in the next revision of the Roadmap, as suggested
by Hans.

Dear all, Estimados todos,

During the evaluation of the Road Map it has been noticed that the document goes faraway from the established on the Art 15 and the Anex III of the Protocol. It is important, as has been mention by Hans and other colleges, to keep focus on the RISK ASSESSMENT. In my opinion, not just coexistence, but all the list of RELATED ISSUES must be eliminated because there are many other aspects that could be considered for decision making, and they can not be listed all. These are not part of the risk assessment and to keep it on the road map can create confusion.
As the college from the University of Washington mention, there are other groups that are now working on other subjects that could be considered on the decision making as the Cartagena Protocol establish, then there is not need to keep them on this guide.

In a guide like this, the language must be neutral and Science based. The term “contamination” is not neutral. It is more adequate the use of “gene flow”, “migration” or “introgresión” depending on the case. About the language it is important also to keep the same one as in the Protocol.

Other aspect that create confusion on the Road map is the text:
“…some unintended effects may be predictable”
could be some examples for this? If not, could be better to eliminate it.

Estimados todos,

Durante el análisis que se ha hecho a la hoja de ruta se ha notado que el documento toca aspectos que van más allá de lo que establece el artículo 15 y el anexo III. Es importante, como ha sido mencionado por Hans y otros colegas, el mantenernos centrados en los componentes del análisis de riesgo. En mi opinión, no solo el tema de coexistencia, sino todo el listado que se hace de TEMAS RELACIONADOS debiera eliminarse, ya que son muchos otros los aspectos que pueden considerarse en la toma de decisiones y será muy difícil el listarlos todos, estos son particulares para cada país, y por otro lado, no forman parte del análisis de riesgo y el mantenerlos en esta guía solo creará confusión.
Como lo mencionó el colega de la Universidad de Washington, ya hay otros grupos de trabajo enfocados a otros aspectos que podrían ser considerados en la toma de decisiones como lo establece el Protocolo, por lo tanto no es necesario el mantenerlos en esta guía.

En una guía como esta es importante mantener un lenguaje neutro y con bases científicas. El término “contaminación” debe evitarse, ya que no es neutral y en su caso debe utilizarse flujo génico, migración o introgresión a manera de tener un uso adecuado de términos. También es importante mantener el mismo lenguaje que el Protocolo, por ejemplo en la traducción al español en el Protocolo se menciona “pueden” y en el documento lo traducen como “deben”.

El concepto de "efectos no previstos pueden ser predecibles" resulta contradictorio o al menos confuso. Se sugiere dar un ejemplo, quizá más adelante en el documento, de lo que sería un efecto no previsto, predecible, o bien eliminar el término.

Dear All,

I agree with the opinion of Dr. Adriana Otero-Arnaiz that there is need to focus
wholly on science-based risk assessment. Including a lot of issues outside of
risk assessment will only add confusion and will not help countries that are
trying to establish their system to implement the protocol.

Obviously, co-existence is part of science-based risk assessment. There are at least two evidences. Co-existence or not would affect the genetic diversity of landraces, another point is that the supply chain and human health could be impacted.

Dear wei wei:

This discussion is based on: With the view to improving the Guidance on Risk Assessment of LMOs, participants of the Open-ended Group and the AHTEG are invited to make proposals as to ways of revising the current version of the Guidance on the basis of the results of the scientific review process, ie. the comments received from the Parties, other governments and organizations.

My understanding is not rebuilt the guidance doc from the square one, but to examine whether the present doc can serve for the users. Drastic consideration would be a separate entity as it was discussed in the very beginning of AHTEG. RA and its supportive guidance doc, shall help the decision making for AIA, however, over stretching the present Guidance doc would make confusion and more focus should be made how the present guidance doc can serve.

Kazuo

Thanks,Kazuo,

The part of 'related issues' received a lowest 64% agreement during the review. There is a reason to improve this part and we have an opportunity to revise the map...

Wei

My name is Ossama El-Tayeb.  I am Egypt's NFP for CPB.  My apologies for not
participating in commenting on the Guidance document or attending Nagoya
(ill health) or interacting earlier with the Forum (deep involvement with
national events).

I think the weakest element in the guidance document is that it did not
settle some key issues because of their trade/political implications, more
so than technical uncertainty.  Two examples of "related issue" are
socio-economic considerations in decision making, and virus vaccines.
Although reaching consensus on universally accepted "guideline document" to
become a acceptable standard for, say, the WTO with a standing similar to,
say,  the Codex would be a huge achievement it is unlikely to settle trade
issues since the WTO is not favorable to the entire Protocol.  More
realistically, the guidelines will help lesser equipped developing countries
draft (copy?) the guidelines nationally.  This is not likely to be
attractive to many developing countries when the guidelines continue to be a
"compromise"  document.

I do not see an easy way out but we should try to broader choices that may
serve best the interests of as many developing countries as possible.

In environmental sciences, the word "contamination" means imparting an
unusual or foreign material to a natural environment previously free from
that material, hence it is not really incriminating.  In a RA context it is
quite neutral.  The fact that to the public it may be alarming is
unfortunate but quite truthful.  When an exotic gene is introduced through
lab work into a genome, it contaminates that genome.  May be one could put a
footnote note that "contamination may be beneficial such as when a human
insulin gene is deliberately introduced into bacteria in order to
manufacture human insulin in a factory for alleviating certain cases of
diabetes".

Dear Hans:
I absolutely agree with your suggestion of further asking the AHTEG to consider and develop on "the potential of the LMO to exchange genetic material with other (sexually) compatible organisms" and the consecuences of that for biodiversity.......... It is a sufficiently important issue to be further developed and thought of in depth.
On the other hand, I just want to ask a question for you. Some participants have posted that the roadmap must be kept simple as for "the easiness of use of beginners" and, while I couldn´t agree more in that the language must meet beginners needs, the depth not necessarily so. The end objective that the roadmap is after as long as I understand it is not to just be "a beginners manual on RA" but a "useful manual on decoding annex III of the Protocol for everybodies use".
Kind regards,
Francisca Acevedo

Dear participants,

I agree with Fransisca Acevedo and previous messages that " the
potential of a LMO to exchange genetic material with other compatible
organisms, and the consequences of that for biodiversity" is a
fundamental issue to consider. It should be handled at the level of
biosafety risk assessment, but taking into account the socio-economic
context. Indeed, the extent to which those exchanges could happen
through voluntary crossing with conventional or traditional varieties,
in the framework of the world market, could be part of the biodiversity
concern. Not only the specific transgenic trait potential diffusion has
to be considered but also that of the whole genome ( and potential
epigenetic and pleiotropic effects ) of the single original GM line
crossed at large scale.

With best regards.

Lucette Flandroy 



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

I fully agree with the views of Ms. Lucette Flandroy.
Ossama El-Tayeb
NFP, Egypt

Ossama El-Tayeb, NFP- Egypt

I entirely agree with the views expressed by Ms. Lucette Flandroy.

Dear esteemed colleagues,

I marvel at the clear divergent views of risk assessment. But to Philippine
regulators of GM crops,  risk assessment is all about safety of a product to the
environment and to humans and animals.  I agree with Paulo Paes de  Andrade of
Brazil that risk hypotheses should have scientific basis otherwise the risk
assessment process will never be completed since risk hypotheses could crop up
as many as the human mind can imagine.  I agree that the risk of hybridization
between the LMO and any compatible species should be evaluated in terms of
effect on biodiversity but to color this with socio-economic consideration
should be a matter of government policy on risk management and not in the
evaluation of the safety of a particular LMO. Market considerations are often
affected by politics and may have nothing to do with safety.

Dear forum participants,

I would like to reply to and comment more on the basis of last remarks
of Saturnina Halos from the Philippines, that were partially a reaction
on my previous message.

I totally agree that biosafety risk assessments, among which should be
considered the potential of hybridization between LMOs and compatible
species, should first of all be evaluated scientifically in terms of
effects on biodiversity, without influencing these scientific reflexion
by political or economical a priori.

But what I meant is that the effect on biodiversity can be different
following the market and the socio-economic context, and this may not be
neglected, for biosafety reasons but also taking into account Art. 26 of
the Protocol.

Indeed, the extent of the voluntary ( through commercial crossing with
locally adapted varieties ) or unvoluntary ( indirect effect of
voluntary presence of the LMO, through contamination, by unefficiency of
coexistence measures ) diffusion of a concerned LMO on the market has
implications on concerns for biodiversity.  
The largest the diffusion market of a LMO, the largest could be the
impact on the general biodiversity and in particular on the
intra-specific agro-biodiversity of that LMO species. ( This without
saying that even if the impact is rather local but concerns a center of
origin of a species or an endemic species, it could be very important ).

If potential local impacts on traditionnal varieties would concern a
socio-culturo-economic context where local populations depend a lot on
the traditional varieties for their daily subsistance, the
socio-economic impact of the potential effect on biodiversity would be
locally more important at shorter term than in socio-culturo-economic
contexts that do less depend on traditional varieties for their daily
subsistance. The same for local impacts in regions where tourism and
business is largely based on the specific caracteristics of local
varieties of animals or plants.
As posted and discussed in the parallel forum on socio-economic
considerations related to Art. 26, there can be socioeconomic dynamics,
traditional market dynamics, socio-culturo-economic conditions that
would favour contaminations more than in other socio-economic contexts.


In relation to these considerations, I greatly appreciate the message
posted by Janet Gough on 2011-04-03 at 23h47.
In particular, she reminded that some uncertainties cannot be resolved
by further information. The Protocol, based on the precautionary
principle, indeed explicitly foresees that decisions could be taken in
presence of uncertainties. Janet Gough adds that there should be
guidance to decide which uncertainties need to be analysed, and that
there should be better guidance on the context.
Indeed, as somehow explained above, similar absolute potential impacts
on biodiversity can have different direct or indirect impacts at short
or long term, depending on the socio-culturo-economic context where the
same LMO would be released/used.

This has to be taken into account, when thinking to the potential direct
or indirect impacts on biodiversity and on socio-economic concerns (
"impacts chains", as posted by a participant in the parallel forum ).
This means in particular that all potential impacts and uncertainties on
aspects relevant to the biosafety concerns should be mentionned in the
RA, even if not considered 
very important for biodiversity; because there could be, at least in
certain socio-culturo-economic impacts, important indirect
socio-economic impacts, and finally, maybe, impacts chains on
biodiversity itself . And this should be taken into account in the
guidance, asked by Janet Gough, for working out " what aspect of the
consequence matter "

With my best regards.

Lucette Flandroy








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

I would like to further discuss gene flow, hybridization and threats to biodiversity (either in a natural environment or in farmlands) in the context of the Cartagena Protocol and specially in the context of the present forum. As explained by our Secretary, the scope of this forum is to discuss the RA-RM AHTEG proposal. Some side issues in this proposal included socio-economic considerations, but since the aim of the Catagena Protocol is to protect biodiversity from threats represented by LMO trans-boundary movements, these considerations would be taken into account only if threats in biodiversity are expected. Indeed, art.26 reads: “The 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”. As it is written, Parties may, but are not obliged to, take into consideration the socio-economic aspects, and even so they should keep a focus on their international obligations. This is typically an issue that has to be decided internally. To bring this kind of consideration back to the Roadmap is, in my opinion, to interfere in the countries internal affairs.
Moreover, as for the effect on biodiversity, for a profitable scientific discussion we should divide it in two parts: a) effect on agrobiodiversity; b) effect on natural biodiversity (wild environment).
Let us take the first point in focus. As well documented, local landraces of many crops have been maintained for many years or even centuries in different countries. In the last 50 years the ever growing gene flow pressure from commercial crops has been somehow allegedly avoided by local communities and indigenous farmers, although the observed practices of seed production, seed purity criteria and seed segregation do not foretell this success. Indeed, in-situ maintenance of agrobiodiversity, without adequate agronomical practices, is not practical: free seed exchange in local seed fairs, seed selection from grains by the use of simple traits as color, shape or hardness and other similar practices tend to contaminate the local landraces with each other, with commercial germoplasms and, in the future, with GM varieties, irrespective of how stringent the co-existence rules for LMOs can be. In my opinion, the first step towards the preservation of agrobiodiverstiy in situ is the implementation of a sensible program for seed production among traditional farmers and the elimination of certain traditional practices such as uncontrolled grain exchanged, wrongly designated as seeds by most traditional farmers. Anyway, most countries do have facilities to keep germoplasm banks and, therefore, agrobiodiversity ex-situ. As happened in Brazil, the germoplasm bank can rescue varieties lost due to any problem (either gene flow or other) that may happen in the field. These considerations are not just theory; they mirror what do happen in our fields in Brazil. Local differences, however, may be relevant, specially in the centers of origin of certain crops.
As for contamination of landrace grains and seed with transgenes, this may have some impact on local communities and indigenous farmers, but is not a question of biodiversity, but an economic issue. Co-existence rules should be established by the local Ministry of Agriculture and strictly followed if market problems arise or are predicted. Co-existence rules can help the in-situ maintenance of agrobiodiversity but, as I stressed before, it is not enough, as bad agronomical practices can ruin all other efforts made by third parties (mostly commercial farmers), such as adherence to co-existence rules.
Now briefly let me comment on the second point, biodiversity of natural ecotones. Most crops do not readily outcross with native flora. If they do, the regular risk assessment takes it into account and it is fully included in the present Roadmap. This is indeed in complete agreement with the aims of the Cartagena Protocol.
As an ectopic but nevertheless important subject, I would like to comment that although the Protocol indeed explicitly foresees that decisions could be taken in presence of uncertainties on risk and damage, it also emphasizes that this is relevant if there are threats of serious or irreversible damage to the environment. Indeed, Rio Declaration, in its Principle 15, states:
"In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation."
This is definitely not the case of agrobiodiversity, if the proper measures are taken (as they should have been taken by now, 50 years after the wide adoption of commercial hybrids and varieties for many crops) by the local governments. To put this issue as a point to consider in the Roadmap because of the precautionary principle, does not seen reasonable for me.
In conclusion, I would like to stress that the point of view expressed here is certainly shared with many of my colleagues at the Brazilian Biosafety Clearing House and has been discussed in depth both within the BCH as well as among farmers and in other opportunities.

Dear Francisca,

You asked a question about the concept that the Roadmap must be kept simple so that it helps "the easiness of use of beginners".
The Roadmap is meant to further clarify the environmental risk assessment of LMOs, in accordance with Annex III of the CPB. It is meant to help all individuals who are concerned with applying Annex III in their own situation, and it should make clear what environmental risk assessment entails.
In order to meet the needs of beginners, it should be clear and transparant; in order to meet the needs of more exprienced people it should not stay away from the difficult and maybe even the controversial topics. I think you state it correctly that "it is not to just be 'a beginners manual on RA' but [also] a 'useful manual on decoding annex III of the Protocol for everybodies use'". (I particularly like your phrase "decoding".)

I think and expect, and I hope, that this issue will be taken into account in our discussions on background materials to the Guidance on risk assessment, that will start next week.

Kind regards,

Hans Bergmans
Chair of the Sub-working group on the Roadmap

Dear All.
I am not sure if the topic “Coexistence or not” is already closed, but I would like to clarify the opinion of the majority of members at the Brazilian Biosafety Clearing House on this subject. Firstly, the Brazilian concept of coexistence is, as commented by Beatrix for the European context - strictly agronomic and refers to outcrossing of approved events to the same crops under cultivation.  Many crops in Brazil do not have wild relatives and therefore the question of gene flow to wild flora, which is part of the risk analysis, is not usually an issue. Consequently, coexistence concerns solely the intra-specific gene flow and an eventual introgression of the transgene. This is not considered as an element of our risk analysis and, although presently regulated by the Brazilian BCH, surely could be better addressed by the Ministry of Agriculture. As for agrobiodiversity, it is important to note that (maize) local landraces have been maintained for more than half a century now in spite of the large gene flow of commercial alleles from large cultivated areas into these landrace genomes. It makes no difference to avoid commercial alleles or transgenes. Moreover, the in situ maintenance of landraces will always be a tricky issue and therefore Brazil keeps a large germoplasm bank encompassing hundreds of landrace assets which began to be built more than 40 years ago.
Therefore, from the Brazilian BCH point of view coexistence is not part of the risk analysis and should not be included as an AHTEG topic of discussion for ERA. I am quite sure this is also the Argentina BCH position.
Kindly
Paulo Andrade

Dear Colleague,

This is a wonderful discussion that has been going on. I quiet agreed with Kazuo that we should be more focus on the present guidance document to be able to achieve what is requested of us due to time limit. meanwhile Wei Wei opening has really refreshing us and he has said that it is an opportunity to revise the road map. That is true, but we must be time cautious.

Hajara

Dear participants,

The discussion on the place of issues like ‘coexistence’ and socio-economic aspects of the use of LMOs within the discussion on the Roadmap for risk assessment appears to be ongoing still. Therefore I would like to make once again my position clear.

Issues like ‘coexistence’ and the socio-economic aspects of the use of LMOs are by their very nature not part of the environmental risk assessment in accordance with Annex III. This has been pointed out by some of the participants in the discussion and I agree.
That does not mean that they are not part of the considerations in decision making on the use of LMOs for specific purposes like placing on the market, of course they can be part of that process. The way and the extent to which these issues may be taken into account in decision making procedures is topic of discussions elsewhere. They belong to those discussions, and it would be confusing and lead to lack of transparency if these discussions would be taken on board in the further development of the Roadmap.

At the same time, the results of an LMO risk assessment will have relevancy for the other topics. Without going into detail, the issue of ‘coexistence’ originates from the fact that contacts between LMOs and non-modified organisms may occur. If risk assessment shows that these contacts, or their expected consequences, will not occur, that will have consequences for the coexistence discussion. The other way around, issues in the coexistence discussion may take into account that specific conditions of use of an LMO occur, like planting of an LMO crop. The methodology of LMO risk assessment should show the way how such conditions of use are taken into account in the environmental risk assessment; the environmental risk assessment is however not the process where the conditions of use are approved. That approval is the result of the decision making process, that may take into account the results of a coexistence discussion.

The socio-economic discussion and the risk assessment discussion are related to each other in a similar way. Probably it’s also the conditions of use where we find the main interface between these two discussions. The conditions of use, particularly after an LMO has been placed on the market, will depend on all kinds of considerations, inter alia socio-economic considerations. The conditions of use are among the data that are fed into the environmental risk assessment. The risk assessment will discuss the effect of the conditions of use, but it should be clear that the outcome of an environmental risk assessment cannot be different because of socio-economic arguments.

This is the way I propose we will take these issues into account in the AHTEG discussion: as issues that affect the parameters of a risk assessment, but not as issues of the risk assessment discussion itself.

I would like to draw your attention to another posting that I will make, where I will ask for your consideration of the other points of discussion that were put forward by the SCBD, at the start of the discussion.

Hans Bergmans
Chair of the AHTEG Sub-working group on the Roadmap

Dear Hans,

I totally agree with you, Hans, and as clearly reminded by the recent
message of Mr. Hiroshi Yoshikura, that the risk assessment is not the
process where the approval or refusal of a LMO or of its conditions of
use should be made.

But that the risk assessment is well the process where:
a) the potential hazards to environment and human health should be
identified and characterized;
b) the potential exposure ( probability, likehood of the hazard ) of
environment and humans to the LMO and that hazard - which depend on
their conditions of use, on the plausible pathways leading to adverse
effects - have to be assessed; and
c) where the potential risks ( combination of hazard and probability of
occuring ) should be characterized.

As repeated by Mr. Hiroshi Yoshikura, the decision for autorization or
refusal of the LMO intended use, and the eventual risk management
measures useful to mitigate some risks, have to be taken in a separate
process, that should take into account all the information gathered
through the risk assessment and other relevant factors.

Best regards.

Lucette Flandroy




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

Dear colleagues,

I fully share Hans's views on how coexistence and socio-economic issues are inter-related.
However, in order to accomodate some views expressed by colleagues on this topic, one possible way to improve the text of the Roadmap could be to specifically refer to socio-economic considerations in the section "context and scoping of the risk assessment" (on page 5 + in the flowchart). Indeed, protection goals and assessment end-points will be defined at least partly according to societal or economical aspects. And this is on the basis of these protection goals and assessment end-points that relevant hypothesis should be formulated and tested in the frame of the risk assessment process.

dear collegues
I like to add to the discussion and support Didiers sugggestion to refer to socio-economic aspects in the section about scoping and framing. It is quite clear that protection goals and assessment endpoints will be informed by societal and economic thoughts, values and recommendations. How we value protection goals and which impact a society is willing to accept will depend on a common understanding and agreement. Part of this is which agricultural procedure and management we choose to compare impacts, how we select test-organisms etc. And these "decisions" are taken in the beginning of an assessment.
I like to attach two recent publications worked out in the framework of a research project commissioned by my Agency which deal partly with these questions
Best regards
Beatrix Tappeser

Dear participants,

I thank Didier and Beatrix and agree with their idea that a simple way
to take into account socio-economic considerations into the RA guidance
can indeed be to formulate, in the section Context and scoping of the
risk assessment, that the protection goals and assessment end-points of
each country will be among other guided by societal and economic
considerations in addition to pure environmental considerations. Maybe
to remind it again in step 5 of the RA ( in Points to consider related
to acceptability of risks ), and in the considerations of uncertainties.


Beside that, the fact that the socio-economic situation can impact on
the likehood and and on the consequences of a hazard is actually already
somehow taken into account by the points to consider in the present
version of the guidance ( for "likehood" of the hazard : to consider
"user habits, patterns and agronomic practices, .." ) .

Best regards.

Lucette Flandroy



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

Thanks Beatrix.
Clearly these matters are part of the country specific case-by-case assessment.  This also reainforces the (critical) importance of 'Establishing the Context' in the initial stages of the process.

Dear Participants,
I agree with all of you who stated that issues like ‘coexistence’ and the socio-economic aspects of the use of LMOs, though of possible interest for decision making, are by their very nature not part of the environmental risk assessment (RA) in accordance with Annex III. As RA is, inter alia, used by competent authorities to make informed decisions (annex III (2) - Use of risk assessment). The guidance should be a practical tool to assist conducting and reviewing RA (as in the annex III and according to article 15) more efficiently and contributing to the CPB´s objective (in article 1). Adding steps that are not part of RA, adds confusion and obstacles to ensure RA´s accuracy and the performance of parties‘ obligations (such as Article 11 (b)). Besides it is easier for different authorities to find and make use of existing information if  assessments of the possible different aspects for decision making are clearly singled out. The expertise and need for assessing, for instance, socio economic aspects are not the same as the necessary for identifying and evaluating the possible adverse effects of LMOs on the conservation and sustainable use of biological diversity of regions with similar receiving environment.
Looking at the submissions, there is a consensus that there are still a number of points to be improved to make the guidance a practical and effective tool. We should make sure not to lose focus on the objective of RA (annex III). It seems improvement could be done in basic, general and starting points, for instance:
- An important consideration to start with include the intended use, this is essential to be able to define the nature and level of detail of the information required. The guidance, for instance, is not clearly showing the differences on how to proceed when for field trials and commercial releases. The level and type of information needed, the different possible levels and strategies for contention/to limit exposure, and the correlation between both.
- Variations are not unusual and not all changes are relevant and a safety issue. Choosing the appropriate comparator is a very important step in the RA to help identifying differences of relevance to safety. Better explanation on the different possibilities and how to decide which the best choice is, would be interesting.
- There are a number of introduced aspects, steps, and examples of points to consider that only makes sense to specific cases, not always. This may lead to wasting resources pursuing aspects of no relevance and missing the important ones. It´s difficult to make a list that would suit to all possible different cases (different types/traits of LMOs, uses and receiving environment). Basically, introducing new terms, aspects and steps should be avoided in the guidance to make it easier to understand. It should be reviewed which and if the current introduced elements are efficiently assisting making a good RA. When steps/aspects add complexity but do not add safety they should be removed. Monitoring, for instance, might be entailed to fulfill the objective of the RA but as appropriate (annex III 8 and 8(f)). The way it is in the guidance could lead to the misunderstanding that monitoring is always needed, which is not necessarily true. Actually, if not well thought monitoring can lead to waste of resources gathering data that is not necessarily useful/meaningful.  If the introduced terms are useful to improve safety and assist making a good RA, such as problem formulation, they should be explained for better understanding.
Best regards,
Lúcia

With all due respect, my view is completely opposite to what our colleague Lucia de Souza is advocating.

Having taught risk assessment for many years, may i befiefly review some of the fundamentals. A risk assessment evaluates "risks". What is a "risk"? Most definitions say something like "the probability of damage."  So, we must ask, what is damage?

Damage is the harm to something we value.  That something may be biological, physical, economic, social, cultural, health-related, etc.  It is valued. How can we ignore 'economic' when the protocol negotiations were constantly touching on issues of "trade"--clearly a socio-economic concern, and one that was specifically in mind when the 3 contradictory sentences were added to the Preamble (other international obligations, etc).

So, whereas one could argue that the PRIMARY impact under the Protocol must be environmental or health related, certainly the economic (and other) higher order consequences may be the reasons we place value on these consequences and copnsider them "damages".

If we look at the thousands of Environmental Impact statements filed in the US since the 1970 legioslation requiring them, we will find almost all are winding up discussing economic, social, etc imapcts as well as species loss and the like.

So, we should understand a process under Annex III starts with the action we are assessing (say the possible introduction of an LMO)and that leads to a number of consequences.  And these consequences have additional impacts.  The risk assessment must trace out along these "impact chains" because a major consideration for policy decisions may be a second or higher-order impact of the LMO introduction.

Possible contamination is certainly a relevant impact.

Any other approach would seem to ignore 4 decades of experience (in many countries, although i cite the one which I am most familiar with).

By the way, many of the comments in this "thread' seem to be relevant to the other threads of this overall discussion.  I certainly hope that the AHTEG and the Secretariat and all other interested parties will read these postings in relationship to ALL of the topics being discussed, where they apply.  (For example, my intervention above could also be put in another thread--I certainly don't want to burden this process by filing multiple copies of the same remarks!!)

Dear Phil,
Although you are certainly entitled to your opinion, I have to respectfully disagree with your assertion and your analysis.  The Environmental Impact Statements you cite under the U.S. National Environmental Policy Act (NEPA) are not risk assessments, although they may contain risk assessments.  NEPA specifically requires discussion of alternative actions and the potential impact on the "human environment" which includes a suite of socioeconomic considerations. In other words, there will be many things in a NEPA Environmental Impact Statement that are not part of a risk assessment under Annex III of the Protocol. 

The Protocol does not require a risk assessment of any and all "impact chains" resulting from the introduction of an LMO.  It establishes that Parties must consider a risk assessment that looks at the potential adverse effects on the conservation and sustainable use of biodiversity when making decisions.  Although Article 26 allows Parties to consider socio-economic impacts in decision making if they wish, it is not a requirement and not part of the risk assessment as many others have already pointed out.  Arguably, the very existence of Article 26 suggests that the Parties agreed that socio-economic considerations were separate from risk assessment, which is addressed in Article 15 and Annex III.

The problem with the very broadly defined "contamination" that you keep insisting be considered is that it includes a great many things that have nothing to do with conservation and sustainable use of biodiversity.  While any Party or government is free to consider these issues if they choose to, it has no place in a guidance document that is supposed to discuss risk to conservation and sustainable use of biodiversity under Annex III.

Dear all:

I would like to present my agreement with the arguments of Paulo Paes de Andrade and Lucia de Souza. What they put forward is scientifically sound, and avoid unwarranted flights into the realm of imaginary risks.
That comes also from my experience at the Brazilian Biosafety Clearing House. I would add also that the precautions already set represent a powerful net able to catch minimum threats to the environment as we move on a case by case analysis. It is well known, considering the history of agriculture, that all plants in use by man have been extensively modified by selection and forced breeding, grafting and, in the past century, by the additional use of powerful mutagens of chemical or physical origin. So innumerable mutations and genetic changes have been introduced before the precautionary theory to "protect" the environment was formulated. The result was always sought with an eye in the phenotypic characteristics of the plant like, flavor, appearance, productivity, nutrition. Simple tests, unburdened by excessive regulation, were done to exclude mainly acute toxicity. The result has been glorious: all kinds of useful foods brought to our disposal. And gene flow ("contamination") always freely present and uncheked. By this kind of no-precaution, risky approach, no superweeds appeared, no loss of biodiversity, in fact more biodiversity was generated and mankind was fed. Preservation of biodiversity, as Paulo Paes noted, is a highly important and scientific oriented endeavour, in the hands of seed banks as far as crops are concerned and, for natural ecosystems, a measure of protection by creating sanctuaries for all kinds of living creatures. Another major discovery was the frailty of all plants that we domesticated. They are "vegatable pets" and cannot thrive without our continous support and protection. The characteristics that turn them into attractive foods make them easy prey to all kinds of pests and severely blunt their ability to spread their seed and compete in the wild. We also learned that traits like invasiveness involve multiple genes and single manipulations, like the surgical procedures of modern genetic engineering, targeted to other virtues, cannot bestow invasiveness on a plant. It is an easy exercise to raise as many "ifs" as possible in the name of precaution, without proper attention to biological science, the history of agriculture, the expanding knowledge of natural horizontal genetic exchanges and probability. The LMOs became targets for unwarranted worry because they can be detected with uncanny sensitivity by the tools of molecular genetics. Also because they were initially produced (one exception is virus resistant papaya) by large commercial businesses that successfully convinced the US government to create a complex regulatory system as if the plant was a medical drug, with little basis in the biology involved. This increased costs immensely for the producer and excluded universities and small companies from participating and improving agriculture for all, generating biological solutions for agricultural and environmental problems related to crops. GM is indispensable tool to generate new crops, improve organic agriculture, increase productivity, reduce topsoil loss and protect natural ecosystems from being destroyed by expanding crop acreage. On behalf of humanity and to protect the environment, we should exert precaution in raising risks that have insufficient foothold in biological reality.

F.G.Nobrega

This is a rather broad comment on the issues raised, with all due respect to views expressed by all colleagues.
Revision on the Guidance on RA of LMOs.
The comments made with respect to socio-economic considerations being an "internal" matter linked to decision making, security of agrobiodiversity  through ex-situ germplasm banks, guarding against certain risks by application of co-existence measures by ministries of agriculture and the limits of application of the precautionary measures are quite valid in many countries but may leave risks un-attended to in others.  I would not, at this time comment on first and fourth points above but, since the roadmap should provide helpful guidance to all Parties one needs to be careful where some (or many?) parties are, in fact, ill-equipped to rely on the measures applied by "ministries of agriculture" to ignore certain risks.  The Protocol is part of the CBD which is the international guardian instrument for biodiversity on the planet, whose objectives are not focused on agrobiodiversity and which places an obligation on Parties to cooperate in conserving biodiversity worldwide.  Here are other points for consideration by the Group:
1. The limits of the precautionary principle is an issue under debate in many environmental forums (including the CBD but extending to much broader areas on which our group is not necessarily focused) and it would not be useful to take one viewpoint of the matter in isolation of the debate, and apply it to the RA element of the Protocol.
2. Should the roadmap be focused on agrobiodiversity or will it in fact be applied to all genetic resources such as fish, forest trees, microorganisms, viral vaccines, "pharmaplants", synthetic genomes etc. ?  If it is, the roadmap needs to be sensitive to all such possible entities.
3. Socio-economic considerations are not only related to the economic and social impact of LMOs on biodiversity but also the impact of social patterns on the risks which LMOs may pose to biodiversity.  A very small example relates to social patterns which do not distinguish between a "grain" and a "seed",  which was referred to by Dr de Anderade, which are clearly distinguishable in developed countries such as Brazil and France but not so clear (or non-existent) in the social pattern of many Parties (and I suspect even in some locations within developed countries like Brazil where several years ago it was claimed that farmers grew LMOs without obtaining a license from the owner of the "grain".
In my opinion, the roadmap will not serve its purpose adequately if it addresses, say,  commercial agriculture but not subsistence one where no label will be available on a heap of grains and where in fact grains may not be even handled in sacs.  In order to be useful to all Parties the  roadmap to be applicable  it needs to realistically address all possible cases.  We should remember that one problem with Annex III is that it was a compromise between negotiators  who wanted a useful Protocol and ones who never intended to be party to it!  Now is the "hour of truth": the roadmap is to be written by all Parties!

Revision on the Guidance on RA of LMOs.
The comments made with respect to socio-economic considerations being an "internal" matter linked to decision making, security of agrobiodiversity  through ex-situ germplasm banks, guarding against certain risks by application of co-existence measures by ministries of agriculture and the limits of application of the precautionary measures are quite valid in many countries but may leave risks un-attended to in others.  I would not, at this time comment on first and fourth points above but, since the roadmap should provide helpful guidance to all Parties one needs to be careful where some (or many?) parties are, in fact, ill-equipped to rely on the measures applied by "ministries of agriculture" to ignore certain risks.  The Protocol is part of the CBD which is the international guardian instrument for biodiversity on the planet, whose objectives are not focused on agrobiodiversity and which places an obligation on Parties to cooperate in conserving biodiversity worldwide.  Here are other points for consideration by the Group:
1. The limits of the precautionary principle is an issue under debate in many environmental forums (including the CBD but extending to much broader areas on which our group is not necessarily focused) and it would not be useful to take one viewpoint of the matter in isolation of the debate, and apply it to the RA element of the Protocol.
2. Should the roadmap be focused on agrobiodiversity or will it in fact be applied to all genetic resources such as fish, forest trees, microorganisms, viral vaccines, "pharmaplants", synthetic genomes etc. ?  If it is, the roadmap needs to be sensitive to all such possible entities.
3. Socio-economic considerations are not only related to the economic and social impact of LMOs on biodiversity but also the impact of social patterns on the risks which LMOs may pose to biodiversity.  A very small example relates to social patterns which do not distinguish between a "grain" and a "seed",  which was referred to by Dr de Anderade, which are clearly distinguishable in developed countries such as Brazil and France but not so clear (or non-existent) in the social pattern of many Parties (and I suspect even in some locations within developed countries like Brazil where several years ago it was claimed that farmers grew LMOs without obtaining a license from the owner of the "grain".
In my opinion, the roadmap will not serve its purpose adequately if it addresses, say,  commercial agriculture but not subsistence one where no label will be available on a heap of grains and where in fact grains may not be even handled in sacs.  In order to be useful to all Parties the  roadmap to be applicable  it needs to realistically address all possible cases.  We should remember that one problem with Annex III is that it was a compromise between negotiators  who wanted a useful Protocol and ones who never intended to be party to it!  Now is the "hour of truth": the roadmap is to be written by all Parties!

My understanding on this round of the on-line forum, is to comment on the appropriateness of the guidance docs reported at  MOP-5 in terms of practicality and feasibility for beginners on RA. I see some deviation which is going back to the past discussion and touching again rather than moving ahead to try elaborating the guidance docs. Some issues have been well discussed in the previous on-line forums over past two years or at much larger extent at different forums/conferences with more number of specific experts. Encouragements shall be made to those who are new to review the past information and documents residing the website.
Obviously the debates are welcome but this discussion group shall recognize the mission and expectation given to this group: 
http://bch.cbd.int/onlineconferences/discussiongroups_ra.shtml#outcomes
Quote:  Objective and expected outcomes
The objective of the current online discussions is to advance the work of the Open-ended Online Group and the AHTEG towards achieving the expected outcomes as mandated by the COP-MOP in decision BS-V/12:

i. A revised version of the "Guidance on Risk Assessment of Living Modified Organisms";
ii. A mechanism, including criteria, for future updates of the lists of background materials;
iii. Further guidance on new specific topics of risk assessment, selected on the basis of the priorities and needs by the Parties and taking into account the topics identified in the previous intersessional period.

Each of these outcomes will be a topic of discussion taking place between 28 March and 17 April 2011. The first outcome will be addressed during the first two weeks of discussion, followed by the other two outcomes in the third week of discussions.
Quote end.


With the given tasks, the present RA on-line forum should be careful with deviating to individual philosophical thoughts and national policy issues which are not mandated. Yes some intervention dilutes focus, which may give diversion of the mission of the forum. However, things to discuss forward may be placed but jumping to one to another subjects as shotgun approach may not be proper at this stage of the on line forum. The present discussion basis may stay with FINAL REPORT OF THE AD HOC TECHNICAL EXPERT GROUP ON RISK ASSESSMENT AND RISK MANAGEMENT UNDER THE CARTAGENA PROTOCOL ON BIOSAFETY (UNEP/CBD/BS/COP-MOP/5/INF/15  3 August 2010) but further topics deviation from the doc shall be carefully reserved in order to effectively wrap up this session with the given time line to feed back to the present guidance doc and future RA AHTEG task settings.

I understand that many of the RA AHTEG members are rather keeping observation, reserved for giving more opportunities for open-discussion to those who have not participated in RA AHTEG or in the past on-line forums, and this may be a fair consideration for not giving biases to the fresh audience and new participants of the present discussion group on guidance docs which the RA AHTEG members proposed, and encouragement should be made to anybody other than RA AHTEG members to comment in a forward thinking how to elaborate including the points and questions made by parties, non-parties with substantial experiences on RA and other agencies. 

The statistics of the consent/dissatisfaction over the present guidance docs, does not tell us jumping to considering new subjects discussion and analytic approach should be made over the feedbacks/comments from governments. Especially, clarification of languages and technicality of the terms in the guidance docs, could be raised for further elaboration as in the comments from some parties. 


Kind regards,


Kazuo Watanabe

POSTED ON BEHALF OF HIROSHI YOSHIKURA

-----

This is comments to the message posted by Dr. Lucia de Souza on 2011-04-06.

I found the above message contains several important elements.

1.     "The guidance is not clearly showing the differences on how to proceed when for field trials and commercial releases."

I entirely agree with this passage. I note that the Annex III contains requirements that could be answered correctly only after open field trials: examples are paragraphs 8 and 9.

Though these paragraphs have qualifications in the introducing sentences, such as, "as appropriate" in paragraph 8 and "depending on the case" in paragraph 9,  the reality is that all the bullet points from (a) to (f) of paragraph 8 and bullet points (a) to (h) of paragraph 9 are requested to answer in all the cases including field trials.

As "the parties shall, in accordance with their respective laws and regulations, consult the public in the decision-making process regarding living modified organisms and shall make the results of such decisions available to the public" (Article 23 Public Awareness and Participation), if requested by "public", the researchers planning to conduct field trials have to answer all of the items. It is impossible for them to answer convincingly because without field trials they never get sufficient data to answer.  The situation is circular. Under this situation, the innovation using the living modified organisms in the environment is blocked once the researchers consider such applications.

OECD addressed this issue in 1993 in its publication "Safety considerations for Biotechnology: Scale-up of Crop Plants" proposing "operation of the concept of stepwise development and evaluation" using the concept of "familiarity", a concept quite equivalent to "comparative safety assessment using the conventional counterpart" in the Codex Alimentarius.

In this connection, I entirely agree to the statement that  "Choosing the appropriate comparator is a very important step in RA to help identifying differences to safety". Here, I should say, that the situation may be rather inverse, i.e., we should choose to produce LMOs that have appropriate comparators through history of long safe use. 

2.     I strongly agree to the statement that "there are a number of introduced aspects, steps, and examples of points to consider that only makes sense to specific cases, not always. This may lead to wasting resources pursuing aspects of no relevance and missing important ones". The present Annex III is, I repeat, already sufficiently prescriptive (and even over-prescriptive).

3.     As for "co-existence" and "socio-economic" issues, they should be treated in the whole context of CBD and Cartagena Protocol in a way as I already indicated in the previous message.

Best regards,
Hiroshi

Dear all

Co-existence or not

I participated in commenting on the guidance document but am apologize for not interacting earlier with the forum. I would like to thank Wei, Gado and Louise for opening the discussion and picking up the thread. Co-existence should be considered on all International movements of LMOs. Co-existence is very important for maintaining diversity and it is certainly affiliated to risk assessment and should be considered in conserving the natural world mankind. That’s why, I strongly insist hat Co-existence should be considered in risk assessment and should be included in roadmap. At the mean time, I have some other points that are deserve to be discussed within the coming 2 days that’s as important as the Co-existence.

Prof. Dr. gamal Gomaa Medani

Dear Gamal,
While looking at Wei Wei first email on co-existence, and some called it as contamination. This term itself is already confusing.
Secondly, as Kazuo rightly pointed out, adding to the roadmap may add no clarity to the roadmap.
This is best left to supplementary.

THIS MESSAGE WAS SUBMITTED SHORTLY AFTER THE CLOSING OF THIS DISCUSSION AND IS BEING POSTED ON BEHALF OF WEI WEI, CHINA

-----

Dear All,

I am sorry to see some of you intend to keep the social and economic issues out of the scope of roadmap. I strongly believe that those issues especially the issue of co-existence is related to risk assessement. I would not like to repeat how co-existence will affect agriculture and biodiversity. I want to emphasize both environment and health risks are those concerns that should be inluded inside risk assessment. The RA & RM road map is intended to be used for risk assessment and management, after reading all your message and opinions I do not understand why some of you agree to exclude co-existence from the sope of this roadmap. Even in a deleloping country like China, the risk assessment reports is designed to address what kind of crop exist around the released GM crop. Only in that way, the safety of agricultural diversity is deliberately maitained and health of the food chain is carefully insured.

Best wishes

Wei