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Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4151]
POSTED ON BEHALF OF FRANCISCA ACEVEDO
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Dear Participants of the Open-Ended Online Forum:

Welcome to the Third round of discussions of the Open-Ended Online Forum on Risk Assessment and Risk Management!

As mentioned in the email sent out by the Secretariat earlier, this forum discussion invites participants to “Consider the development of guidance on new topics of risk assessment and risk management, selected on the basis of the Parties’ needs and their experiences and knowledge concerning risk assessment.” as outlined in paragraph 1(c) of the annex to decision BS-VI/12.

The objective of this round of discussions is to review the need of Parties for the development of new guidance on risk assessment and risk management and, if so, discuss which topics should be considered based on these needs.

Please find below some further guiding questions to help focus the discussion:

1.Do Parties to the Protocol have a need for guidance on new topics of risk assessment and risk management to be developed?

2.If such a need exists, which topics should be considered based on your experience and knowledge concerning risk assessment?

I am looking forward to a vibrant discussion!

Best regards,
Francisca Acevedo
posted on 2013-02-17 23:36 UTC by Dina Abdelhakim, SCBD
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4152]
POSTED ON BEHALF OF RYOSUKE FUDOU
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Dear all.

I would like to make a brief comments at the beginning of the third session.

In my view, the first priority of our forum is to structure and focusing the process of testing the guidance(TERMS OF REFERENCE, Methodology~).
Therefore,  it is not a appropriate timing to start the discussion on a new topic of risk assessment at this time.  The guidance is still to be tested. In order to avoid the confusion of the discussion, we should, for the moment, concentrate our attentions to testing of the current guidelines.
With more experiences and knowledge which could be obtained from testing, we could have fruitful discussions on further topics of guidance. “When things are done hastily, they are not done thoroughly.”

Furthermore, it is probably appropriate to note the Paragraph 3(c) to the annex to their decision BS-VI/12 which shows the expected outcomes for online forum and AHTEG with respect to a new topic of the guidance is to provide:  “a recommendation on how to proceed with respect to the development of further guidance on specific topics of risk assessment,,,”.
We are not expected to consider the contents of new topics of guidance, but the procedure or steps by which we are going to take in the forthcoming discussion on the new topics.

Ryosuke Fudou
Japan Bioindustry Association(JBA)
posted on 2013-02-18 11:28 UTC by Dina Abdelhakim, SCBD
Responses to contribution #4152 [#4208]
Dear Participants

I would like to reiterate the point made by Ryosuke Fudo [#4152]. The quest of many Parties in Hyderabad was to have the road map tested and I have made this point in the previous two forums. Once the road map is tested and any changes made to it then the next task will be to look at the material already provided as guidance e.g. GM trees. Although we need to understand why the road map is not sufficient and why extra guidance is required.

Regards
Geoff Ridley, New Zealand Environmental Protection Authority
posted on 2013-02-24 19:54 UTC by Dr. Geoff Ridley, Environmental Protection Authority
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4153]
Dear All,

I just come back from the traditional Chinese New Year Festival! I will you all a happy snake year in 2013.

This tradition came for many years in China, it brings happy feeling to everyone but also troublesome in traveling etc. We want to change but cannot resist the tradition. We burned fireworks and exacerbated air pollution. We have many recommendations and guidelines to avoid pollution, but we are afraid that too many guidelines would prevent the happiness that we enjoyed when we saw the fireworks.

Actually, from a scientific view, it is not necessary to fear of any new guideline, provided that they are suitable. The new guidance may bring safety to our happiness; there is no reason to refuse.

With the fast development of biotechnology, we necessarily need new guidance to ensure the biosafety of the environment and the health of human being. I strongly support to develop further Guidance in new topics that identified by parties as important and urgent.

We have had a list of recommendations in the past AHTEG meetings on the topics needing to develop guidance. Among them I would emphasized two: 1) Risk assessment of living modified microorganisms and viruses. Human history is the history fighting with viruses; we should take care when we try to give advantages to the enemy. 2) Risk assessment of living modified organisms produced through synthetic biology. This topic had been discussed within COP11 and very urgent regarding of the fast development of this technology.

In addition, I would propose additional ones:
1) Risk assessment for GM organisms created through use of dsRNA techniques;
2) Guidance on integrating human health into the environmental risk assessment;
3) Risk assessment of nutritionally altered, pharma and industrial compound-producing GM plants.

I look forward to more comments and fruitful discussions.

Best wishes

Wei
posted on 2013-02-18 11:41 UTC by Mr. Wei Wei, China
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4168]
Dear All
I agree with some colleagues for testing the guidance. For developping countries the need of further developpement of guidelines is also a priority. I want to suggest the following topics to be included :
Guidance on integrating human health into the environmental risk assessment
Risk assessment of nutritionally altered pharma and industrial compound producing GM plants
Best regards
Gado
posted on 2013-02-19 08:46 UTC by Mr. Mahaman Gado Zaki, Niger
Comments on #4153 [#4210]
Dear Participants
Wei Wei [#4153] that there is no reason to refuse new guidance and that there are topics that need guidance developed, some of it urgently e.g. synthetic biology, and he provides a list of five topics. To be candid I would expect to see some justification why these topics are being suggested. For instance what is the concern with dsRNA techniques that cannot be handled with the road map?

I am also concerned that we do not expand beyond what the Cartagena Protocol was established for and that is “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.”

It concerns me that some participants forget that Cartagena is not there to regulate all aspects of LMOs but only those that are relevant to biodiversity issues, account risks to human health, and specifically focusing on transboundary movements.

We need to make sure we do not step beyond our mandate.

Regards
Geoff Ridley, New Zealand Environmental Protection Authority
posted on 2013-02-24 21:51 UTC by Dr. Geoff Ridley, Environmental Protection Authority
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4154]
Dear Colleagues.
I fully agree with RYOSUKE FUDOU. The establishment of new topics was well behind the testing of the guide, which is the obvious thing to do. That was clear during the last COP-MOP.
Moreover, the present topics are far from being clear and useful for the beginner on risk assessment and the main reason is that the approach is always case by case. A general text on, let us say, GM insects, can only compile a list of different worries, without a logical connection to the product itself (no pathway to damage) and painting a dreadful portrait of the technology, with is certainly not the case.
Certainly a lot of new product will be on the pipeline for contained release in the next years, including algae, animals and perennial plants, and using new transformation and gene expression technologies, but what is the use to discuss these new topics if we still do not know if the guidance is useful at all?
I strongly suggest we should suspend this discussion until the Parties agree that the guidance is useful, by exhaustively testing it in real life risk assessments.

Paulo Andrade
Department of Genetics, Federal University of Pernambuco, Brazil
posted on 2013-02-18 12:23 UTC by Mr. Paulo Paes de Andrade, Brazil
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4155]
Dear Colleagues,

Among other colleagues, I am looking for further development of guidelines. I suggest the following topics to be included in the list:

1. Risk assessment for GM organisms created through use of dsRNA techniques, including dsRNA direct injection into cells or organelles and other in vitro techniques;
2. Guidance on integrating human health into the environmental risk assessment
3. Risk assessment of nutritionally altered, pharma and industrial compound-producing GM plants, including effects on both vertebrate and invertebrate pests.

Best wishes,

Angela
posted on 2013-02-18 13:55 UTC by Angela Lozan
Comment on #4154 [#4211]
Dear Participants
I fully agree with Paulo Andrade [#4154] guidance can only be written from experience. In some of the suggested topics there is no specific experience. In those cases the jurisdiction undertaking the first risk assessment will be provide the beginning of a guidance for all those jurisdiction that are faced with it in the future. The road map, if it is worth its salt, should provide what is needed to start the risk assessment process. As problems are identified by the risk assessors they can then go further afield to acquire experts to help them with the problems that they have encountered. Guidance can then be developed and updated from real examples as they happen.
Regards
Geoff Ridley, New Zealand Environmental Protection Authority
posted on 2013-02-24 22:58 UTC by Dr. Geoff Ridley, Environmental Protection Authority
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4156]
Dear Colleagues.

I do not want to stir discussions on eventual new topics, since I am convinced this is not the moment to propose new topics, but would like to comment on some of the first suggestions, as I think they are fully covered by the guidelines or by previous international experience.

1. Risk assessment for GM organisms created through use of dsRNA techniques, including dsRNA direct injection into cells or organelles and other in vitro techniques

RNAi was, indeed, one of the first biological mechanisms of resistance exploited in the development of GM plants. There is nothing new on it and GMOs based on RNAi have proved to be very reliable. The methodology used for transformation is, in itself, irrelevant: the final product is the subject for risk assessment. I really don’t see the point to have specific guidelines or a meticulous discussion on this subject.


2. Guidance on integrating human health into the environmental risk assessment (ERA)

Although human health and the environment are very much connected, risk assessment is internationally developed taking into account food safety (mainly concerned with human health) and the possible impacts on the environment. As all of you know, food safety is a universal question (it does not make difference if the product will be eaten by Chinese or Brazilian people) and also includes questions related to allergy (which is sometimes an environmental issue). On the other hand, ERA also takes into account eventual negative impacts of a GMO on humans, if pollen, leaves or whatever other part of a GMO can harm human health. Operationally, it is logical and efficient to separate both issues and the risk assessor already considers the integration suggested here as a normal step in his (or her) evaluation. 

3. Risk assessment of nutritionally altered, pharma and industrial compound-producing GM plants, including effects on both vertebrate and invertebrate pests.

The adoption of pharma-GMOs in the World points to a general solution concerning environment impacts: the plants are kept in confinement. Moreover, the risk assessment of these plants is essentially identical to the many other GM plants already extensively studied, evaluated and monitored in the last 15 years.

As I stated before, the international experience of the many risk analysts around the World has produced a considerable knowledge and expertise in most of the risk assessment topics that may be dealt by newcomers to the field. It is this experience, and not guidelines on new topics, hastily produced as a response to a low Parties priority, that will help risk assessors everywhere.
posted on 2013-02-18 14:44 UTC by Mr. Paulo Paes de Andrade, Brazil
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4157]
I agree with Ryosuke Fudou saying that it is not a appropriate timing to start the discussion on a new topic of risk assessment.

I also think that the guiding questions raised by the Secretariat is not appropriate, or even misleading, in light of the MOP6 decision. What we are being asked is to "Consider the development of guidance on new topics of risk assessment and risk management, selected on the basis of the Parties’ needs and their experiences and knowledge concerning risk assessment", but not the consideration of the Parties needs only.

In my opinion, the presence of enough experiences and knowledge is an absolute prerequisite to develop a guidance which is scientifically sound. If a guidance is to be developed on a topic on which we don't have enough experiences and knowledge, and the development is only driven by precautionary "fear", the resulting guidance will be far from practical and far from scientifically sound.

If we need to pick up this subject now, we need to consider the experiences and knowledge as well.

Nobuyuki Fujita
posted on 2013-02-18 14:45 UTC by Mr. Nobuyuki Fujita, Japan
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4167]
POSTED ON BEHALF OF MARIA MERCEDES ROCA
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Dear colleagues,

I congratulate Wei-Wei from China  for talking about guidelines bringing safety to our happiness. I think it is also  good for this group  to acknowledge that we are all on the same boat: we want  a better world for our young people and our children  and we want to use science to answer the great challenges faced by hour planet in the XXI century.  Wei-Wei also talks about “the enemy” – indeed we have many:  disease, hunger and malnutrition in our countries, great losses in agriculture due to pests and diseases and to biodiversity through  low productivity from poor seed and practices when there is good technology available,  contamination from actual  toxic chemicals that cause real and not imagined damage, climate change mainly caused by big economies burning fossil fuels. 

The list goes on and on… I honestly don’t think that LMO’s are in the class of the big, nasty  enemies  mentioned above.   And  don’t  even think that all  viruses are even all that evil  -  but forgive the bias, I am a virologist. Understanding viruses and how they work has opened  many doors in modern biological sciences including our current knowledge of RNAi or dsRNA and how we are able to silence genes that cause disease.  To delay the potential that science could bring to solve  many challenges through cumbersome regulation,  would be foolish indeed,  as we contemplate the greater evils we are facing. Of course we need caution, but we don’t need overt precaution that fills us with fear and  stops us from moving ahead.  We all know that science is moving much faster than regulation, so we need to strike a coherent  balance, based on critical thinking and not on fear.

I agree with Ryosuke Fedou and Paulo Paes in saying that to re-open the discussion  on new topics when we have not even done the testing of the guidance is premature and will confuse  regulators from  inexperienced parties, who first need to grapple with the basics of already tested technologies.   At least in the countries where I work (Central America) this fear and confusion on how to move forward  with their biosafety systems  is translated into  inaction.  And please note that there has been no shortage of capacity building and training and no shortages of published literature on how to conduct a sound Environmental Risk Assessment.

I look forward to hearing the many interesting opinions from this group. I learn a lot from you, especially in my role of teacher to agriculture and environmental science  students and  trainer for regulators of biosafety  in  my region.

Best regards,

Maria Mercedes Roca
Department of Environmental Engineering  and Development
Zamorano University
Honduras
posted on 2013-02-18 18:50 UTC by Dina Abdelhakim, SCBD
Comments on #4167 [#4212]
Dear Participants

Maria Mercedes Roca [#4167] has made a very valuable contribution in directing us to the real enemies and the problems to be solved. There is a real problem in that many people are identifying all LMOs as enemies based on unfounded concerns that are never translated into real risks. For instance I would draw your attention to the risk assessment and risk management paper UNEP/CBD/BS/COP-MOP/6/13 discussed at Hyderabad in which the secretariat reports on its call for Parties to provide with scientific information that may assist in the identification of living modified organisms or specific traits that may have or that are not likely to have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health. No Party has yet done so.

This would suggest that LMOs, so far, have not been the problem that those with concerns would have us believe. That does not mean that we should not do risk assessment but it does suggest that the road map should be sufficient to allow jurisdiction to do so.

This brings us back to the point, that we should be testing the road map to ensure that it is up to the task. If it is not then we should be identifying where it needs to be modified.

Regards
Geoff Ridley, New Zealand Environmental Protection Authority
posted on 2013-02-24 23:37 UTC by Dr. Geoff Ridley, Environmental Protection Authority
RE: Comments on #4167 [#4214]
Dear All

With respect to interventions #4211 and #4212, I would like to make the following responses.

Geoff says that “In some of the suggested topics there is no specific experience. In those cases the jurisdiction undertaking the first risk assessment will be provide the beginning of a guidance for all those jurisdiction that are faced with it in the future…Guidance can then be developed and updated from real examples as they happen.”

First, this seems to me to be precisely the rationale for developing guidance for which the Parties have expressed a need having identified a lack of existing capacity to undertake the risk assessment. Some countries might be comfortable with being in the lottery to be the first to receive a developer’s application on a trait or LMO for which neither they nor anyone else in the world has prior experience. Other countries may not be comfortable being in this position. These countries might appreciate if some guidance had been developed. Developers in those countries might also appreciate if some guidance had been provided otherwise they most likely face long delays or certain ‘no approval’ from their regulator if the regulator lacks capacity to make an assessment.

Second, it is either the AHTEG - with all the help of online forums, reviews by the Parties and testing - that first considers these cases, or it is a lone regulator in a single country under the pressure of legislative deadlines. Why leave it to chance who does the first assessment, and when this is done, in order to make guidance? Why should one regulator be better at providing an assessment that forms the basis of guidance, than the collective contribution of Parties, non-Parties and observers in the AHTEG, with the assistance of the online forum and testing?

The Parties have gone to a great deal of trouble to establish a program of intense guidance development and review with testing. This is a high standard and a priori no less rigorous than guidance developed from a single pioneer regulator on a new kind of LMO or trait.

Finally, I don’t know how the observation that so far no Parties have been able to provide “scientific information that may assist in the identification of living modified organisms or specific traits that…are not likely to have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health” can become evidence that “LMOs, so far, have not been the problem that those with concerns would have us believe.”

Moreover, while the Secretariat reported that no additional submissions by Parties on “the identification of living modified organisms or specific traits that may have adverse effects has been submitted to the Biosafety Clearing-House or the Secretariat”, that was for the time period since MOP5. MOP-05-12 does report receiving submissions making such identifications. UNEP/CBD/BS/COP-MOP/5/INF/11 describes submissions of various sorts from several Parties.

Kind regards
Jack
posted on 2013-02-25 02:05 UTC by Mr. Jack Heinemann, University of Canterbury
RE: Comments on #4167 [#4224]
Dear Participants

In response to Jack’s comments [#4169] is simply mean that in learning to drive a car I would rather take guidance from someone who has driven a car then from someone who hasn’t. Similarly I would rather wait and take guidance from some one that has tried to do a risk assessment then from someone who has only done it in theory.

Regards
Geoff Ridley, New Zealand Environmental Protection Authority
posted on 2013-02-25 06:57 UTC by Dr. Geoff Ridley, Environmental Protection Authority
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4218]
Dear all,

The following comments relate to the last post from Geoff Ridley (#4211 / #4212), in which it is mentioned that “guidance can only be written from experience”, that there is a trend of “identifying all LMOs as enemies based on unfounded concerns that are never translated into real risks”, and that no Party has identified an LMO that may have adverse effects (referring the document UNEP/CBD/BS/COP-MOP/6/13).

First of all, thanks for this comments because they allow to expand more on the Bolivian position that more guidance documents on risk assessment and risk management (RA&RM) are needed, and the current Guidance and Roadmap are really useful.

In relation to the first issue, it is true that the process of writing new RA&RM guidance documents will benefit from experience. However, the current limitation that we see is that the claimed experience is concentrated in specific countries, each one with different ecological and socioeconomic contexts in relation to other countries who do not have enough RA&RM experience. So that accumulated experience might not be fully transferable. Certainly, to improve the RA&RM process we need experience, but the experience can be built upon proper guidance documents and capacity building since the former will not take place spontaneously. Moreover, there are several LMOs introduced in the environment and more in the pipeline, of which we know very little. Our conclusion, then, is that we need more RA&RM guidance documents than the existing ones in order to expand and strengthen the current experience and benefit more countries.

Concerning the other two comments, it is important to note that the document mentioned (UNEP/CBD/BS/COP-MOP/6/13) clearly states that a country (Colombia) has banned a LMO because the benefits of its introduction would not be higher than the potential risks, among other reasons. Of course this is one single example; however, it shows that there are records on the BCH of countries identifying potential adverse effects from LMOs. Furthermore, it is also important to consider that the lack of records in the BCH on banning of LMOs does not mean that their prohibition or identification of LMOs that may have adverse effects did “never translated into real risks”. We have several examples of LMOs banned and not reported for different circumstances. For instance, in the case of Bolivia, LM potato (2000) and LM maize (2005) were forbidden for the risk of their introduction in our country, center of origin and genetic diversity of potato and maize, respectively.

Additionally, it is very possible that several countries did not submit their RA documents in the BHC because at the time when they were done, no potential adverse effect was identified, and later those hypothetical risks materialized. Again, Bolivia is as example. The RA of LM glyphosate tolerant soybean – on which its approval was based, mentioned that it was very unlikely the occurrence of glyphosate resistant weeds, and even less likely that LM soybean would become a weed. Now, we have three induced glyphosate resistant weeds spreading quickly and volunteer LM soybean (which is a problem in up to 40% of the soybean fields in some soybean producing communities). To us, these examples prove that we need to improve the current approach and methods applied on RA&RM of LMOs. For this purpose, we need more RA&RM guidance documents because the current accumulated knowledge and information is not the most appropriate for effectively identifying potential adverse effects of LMOs on the conservation and sustainable use of biodiversity, also taking into account human health.

Finally, as a country, we recognize that not all the Parties to the Protocol consider that they need more guidance and capacity building on RA&RM for different reasons. We respect that. However, our request – in line to the objective and scope of the Protocol, is that in this process it is not ignored the recognized need of some countries (as Bolivia and many others) for more RA&RM guidance under the Protocol. Isolated bilateral or inter-institutional cooperation will not be enough to convey in the new guidance documents the wide range of expertise needed and to revise them multiple times as the current RA&RM Guidance and Roadmap have been (and this is fact, regardless the level of acceptance that the current RA&RM documents have among different countries an even AHTEG member).

Thanks again and regards,

Georgina Catacora-Vargas
posted on 2013-02-25 03:02 UTC by Sra. Georgina M. Catacora-Vargas, Bolivia (Plurinational State of)
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4223]
Dear Participants

With respect to Georgina Catacora-Vargas comment [#4218] can I ask why “in the case of Bolivia, LM potato (2000) and LM maize (2005) were forbidden for the risk of their introduction in our country, center of origin and genetic diversity of potato and maize, respectively.”

“Concerning the other two comments, it is important to note that the document mentioned (UNEP/CBD/BS/COP-MOP/6/13) clearly states that a country (Colombia) has banned a LMO because the benefits of its introduction would not be higher than the potential risks, among other reasons.” I don’t think that this was the case at all. No benefits where identified and no risks were identified.

The induced glyphosate resistant is a result of the farming practice not of the LMO. Glyphosate resistance occurs where ever there is heavy use of glyphosate. To ban an LMO because of poor farming techniques is short sighted.

Finally, I do not object to the development of guidance were a need is identified. So far only a desire for more guidance has been made and no need has been justified. I am simply asking for you to justify the claimed need.

Regards
Geoff Ridley, New Zealand Environmental Protection Authority
posted on 2013-02-25 06:49 UTC by Dr. Geoff Ridley, Environmental Protection Authority
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4225]
Dear Francisca, Secretariat and members of the forum

This is my first intervention so I want to take a moment and thank Francisca and the Secretariat for their hard work, and members of the forum for their engagement.

There are a number of recent interventions that I would like to follow on from.

At least two members of the forum have suggested that it is the obligation of Parties expressing their need for guidance to provide extended justifications [e.g. #4120, #4205, #4223]. The Decision does not imply the need for this any more than it requires those not wanting further specific guidance to tell us why. I trust the Parties to know for themselves whether they want further guidance. The justifications were the reasons that COPMOPs have been issuing decisions that include the development of further guidance, and I see no obligation of Parties to reiterate their reasons here and asking them to provide this would be prescriptive. I take their reasons as given.

At least two members [e.g. #4205, #4191] have said that specific guidance should be restricted to LMOs or traits that are not covered by the Roadmap. I understand that this was a criterion adopted for operational reasons by the previous AHTEG, but I am not aware of this being a criterion specified by the COPMOP6 or previous COPMOPs. The Parties may have different legitimate reasons to want specific guidance on particular LMOs or traits even if there is redundancy between Part II and Part I of the Guidance. So while the list of topics for additional guidance may be prioritized by the AHTEG using this criterion, the criterion itself is not a construct of the COPMOP and not necessarily what should limit the entries on the list.

Finally, participation is a challenge for all [#4210], no less for those of us who volunteer to participate in the process and receive no recognition for that in our remuneration packages or degree work. It is my understanding that the Secretariat has neither set the pace for discussions nor the timeline.  Rather, these are the result of the Secretariat trying to meet its obligations as set forth by the Parties in COPMOP6.

With best wishes and interest in the ongoing discussion.
Dorien Coray
posted on 2013-02-25 09:06 UTC by Dr Dorien Coray, University of Canterbury
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4230]
Dear all,
Thanks Francisca for undertaking this moderation.

I just want to make a small comment to Georgina Catacora-Vargas [#4218] who mentioned document UNEP/CBD/BS/COP-MOP/6/13. Georgina says “.. Colombia has banned a LMO because the benefits of its introduction would not be higher than the potential risks, among other reasons.”
If you read carefully the official resolution (RESOLUCION No. 000879 - 25 MARZO 2008, available at http://www.ica.gov.co, it clearly states that after several studies (I am copying the most relevant paragraphs) the product is considered safe, but, as Diabrotica is not a pest of economic importance in the corn zones in Colombia, the recommendation is not to authorize the import of seeds of the corn MON- 88017-3 (CCR) to the country. Therefore, this is a technical and economic recommendation, even the CTNBio considered it safe.
This is an example of how important the case by case evaluation is, and that no matter how good and safe a product can be, its use is not universal.
Here we evidence the requirements of knowledge of the specific conditions for a given crop in particular zones.

Some of the paragraphs:
“Que los modos y sitios de actividad biológica son significativamente diferentes entre Cry3Bb1 y CP4 EPSPS, no se conoce ni se concibe un mecanismo de interacción entre estas proteínas, el cual pudiera generar efectos nocivos para la salud de los animales o del hombre;….
Basándose en la anterior evidencia, se puede confirmar la seguridad del producto;”
….”Que en Colombia en el cultivo de maíz los insectos de mayor importancia económica se encuentran los gusanos barrenadores (Diatraea saccharalis, D. indigenella, D. busckella, D. rosa, D. grandiosella, D. muellerella y D. lineolata), el gusano cogollero (Spodoptera frugiperda), el gusano soldado (Spodoptera exigua) y el complejo de gusanos belloteros (Heliothis virescens (Fabricius) y Helicoverpa zea Boddie). El gusano cogollero causa pérdidas en el cultivo de maíz que van desde 13 hasta el 60%; los barrenadores del tallo ocasionan pérdidas que van del 10 al 20%. El control de estos insectos es causante de un aumento significativo en los costos de producción de los agricultores, disminuye la rentabilidad del cultivo y afecta de manera negativa la calidad final del producto;  
….”Que el Diabrotica no es plaga de importancia económica en las zonas maiceras en Colombia;…… se concluyó que se debe recomendar al ICA NO autorizar la importación de semillas de maíz MON- 88017-3 (CCR) al país,

Un gran abrazo desde Colombia
posted on 2013-02-25 15:37 UTC by Professor Elizabeth Hodson, Colombia
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4231]
Dear Francisca, dear colleagues,

first of all I would like to thank you Francisca for moderating this round of online-discussion and guiding us in a very able manner through these important discussions.

I think it is very appropriate and timely to address the questions you posed at the outset of this online discussion forum and I do not see a conflict at all with the other tasks listed in the terms of reference of the open-ended online forum and AHTEG. It is true that para 1c) of the terms of reference gives the consideration concerning the development of guidance on new topics less priority than the testing (para 1a)) and the development of a package that aligns the guidance with the training manual (para 1b)). However, if we look at the expected outcomes we see in para 3c) that the open-ended online forum and AHTEG has to develop "a recommendation on how to proceed with respect to the development of further guidance on specific topics of risk assessment ….”. We all know how fast time passes and it is therefore very important that we start thinking at an early stage on how to accomplish this task. I think it would be very productive if we use this expected outcome as a reference point for our discussions.

I will try to answer Francisca`s very useful questions one after the other:

Question 1: Do Parties to the Protocol have a need for guidance on new topics?

I think the answers have been diverse but very clear and we do not need to start from zero. The Canada/Norway Workshop and rounds of discussion during the previous AHTEG and online forum have provided a clear signal concerning the need by some experts from Parties. Others do not see the development of new Guidance as a priority. The advantage of Guidance is that it is not prescriptive – those who see a need and do want to use can do so while others may decide not to do so. What may be improved is the supply of arguments why certain type of Guidance is needed.

In this context Francisa`s question provided in her second intervention (4192) of 22 February provides a very good basis:

What are the documents on new topics intended to accomplish?

The way I see it that new Guidance should complement Annex III of the Protocol and the Roadmap (tested and further improved if needed in the future), and already established additional Guidance on specific LMOs and traits (also tested and improved if needed in the future). The topics depend on new and emerging types of LMOs and applications where developers and risk assessors see the need for further guidance to be able to accomplish their task. By the way, I am not of the opinion that general guidance on certain topics of risk assessment is not necessary as we always have to follow a case-by-case approach. On the contrary, the case-by-case approach needs solid guidance on a general level as a basis!

Question 2: If such need exits, which topics should be considered?

Here again I think we do not have to repeat discussions we already had and start from zero. The Canada/Norway Workshop, the previous AHTEG and online forum have developed a list of topics based on a structured approach, which can be retrieved from the reports of the previous AHTEG. Some of the topics were taken up by the previous AHTEG and guidance has been developed, which will be now further tested and if needed improved in the future. Other topics are still on the list and wait for further work to be done on them. We can always review this list and modify it - in fact we should do that. And we can and in fact should discuss working methods to improve the structured approach to proceed with respect to the development of further guidance. In fact this is our task and the expected outcome. Here again Francisca`s additional question is very useful:

What process should be followed in creating them?

I think that we should allow experts to identify their 3 priority topics (if they have any) and ask them for a concise argumentation why they see the need for Guidance on these topics. Based on this and in a second round I think it will be quite straightforward to come up with a very good recommendation on how to proceed which should be taken up by the new AHTEG in its possible face-to-face meeting.

Thank you for this opportunity to provide my thoughts and I am looking forward to the continuation of this debate. Best wishes

Helmut Gaugitsch, Environment Agency Austria
posted on 2013-02-25 16:22 UTC by Mr. Helmut Gaugitsch, Austria
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4169]
Dear Francisca, Dear Participants

Thank you Francisca for agreeing to moderate the forum and for your introduction to the purpose of the forum. I would like to address both of your questions.

1.Do Parties to the Protocol have a need for guidance on new topics of risk assessment and risk management to be developed?

The answer to this question is yes, for some Parties, and no, or not right now, for some others. That is apparent already from the first few postings to this forum. Thus it seems to me that if the next AHTEG has the will and means it could legitimately consider developing new guidance for those Parties that have stated a need for it.

2.If such a need exists, which topics should be considered based on your experience and knowledge concerning risk assessment?

Several Parties have expressed an interest in particular topics. This list may continue to grow. I think the list of 5 topics presented by Wei [#4153], which includes the list of priorities from Angela and Gado, already provides a nice diversity from which the AHTEG might choose.

That Parties feel that they may benefit from specific guidance on certain issues does not have to be seen as an expression of fear; regulation of products is not an a priori dismissal of those products (if it were, we would not have e.g., air travel, automobiles, pubs, or light bulbs) and the Protocol itself is clear on this message: “The Protocol thus creates an enabling environment for the environmentally sound application of biotechnology, making it possible to derive maximum benefit from the potential that biotechnology has to offer, while minimizing the possible risks to the environment and to human health.”

Countries have a right to apply risk assessment on these products and I respect their rights and reasons for seeking specific guidance just as I respect the conclusions of other countries to not seek it. Because the guidance is not binding the latter can ignore it while the former makes use of it.

I believe that Paragraph 1(c) allows the AHTEG to develop additional specific guidance on topics in which Parties have an interest if the AHTEG finds that it is possible and desirable to do so in the next term. And I do not think this activity is incompatible with Paragraph 3(c) of the annex to decision BS-VI/12. The AHTEG can both develop new guidance and make recommendations as to further guidance that may be developed in future sessions.

After all, Paragraph 3(c) goes on to say: “with the view of moving toward the operational objectives 1.3 and 1.4 of the Strategic Plan and its outcomes.” Those outcomes are, inter alia:
•  "Guidance on risk assessment and risk management including guidance on new developments in modern biotechnology"
• "Parties enabled to identify, assess, and monitor LMOs or specific traits that may have adverse effects"
These operational objectives and outcomes are entirely consistent with the interpretation that the AHTEG may consider developing new guidance as well as producing a list of further guidance to be developed by future AHTEGs or sessions of the next AHTEG.

With best wishes
Jack
posted on 2013-02-20 01:25 UTC by Mr. Jack Heinemann, University of Canterbury
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4170]
Dear participants
Initially I would like to thank Francisca for moderating this Forum.
Trying not to repeat the few posts already shared, I would say that I agree with those, like Paulo, who think that the the establishment of new topics should come after a period of testing the guide.
If we see the situation like Jack posted recently – some parties “need” and others don´t – why to go further on general discussions if not all are asking for it? Are we, as experts indicated by the Parties, deciding for the Parties? Our position here is to participate in a science-driven discussion about items the Parties requested for.
So, respecting the positions from those participants who have expressed an interest in particular topics, I would discuss if these topics are really a necessity for all the participants, if some of the participants have good experience on these topics and could share their experiences with the Forum, and or if we agree it is not time to go further with discussions on hypothesis or “needs” not clearly stated by the Parties.

Regards

Deise Capalbo
Embrapa Environment
Brazil
posted on 2013-02-20 09:22 UTC by Dr. Deise Maria Fontana Capalbo, Brazil
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4179]
Dear Dr. Paulo Paes de Andrade, dear forum participants,


My apologies for not attaching to my prior message the actual report that I referenced, the “Report of the Canada-Norway Expert Workshop on Risk Assessment for Emerging Applications of Living Modified Organisms” for your information.

This report is the outcome of a scientific workshop of 68 experts from the scientific community and risk assessors from government agencies that looked into these issues already prior to my suggestion for further RA and RM guidance on transgenic fish and transgenic viruses (and LM pharma plants as well).

In the report is you will see that these 68 experts from the scientific community and risk assessors from government agencies that looked into these issues already concluded, inter alia:

• There is insufficient guidance on how to perform risk assessment for GM fish and viruses.

• There may be a need to develop specific methodologies and specific protocols for generating data necessary to conduct risk assessments for the future applications of modern biotechnology, especially for transgenic fish, trees and viruses.

• All risk assessments of living modified organisms should be conducted on a case-by-case basis as the impacts depend upon the trait inserted, the recipient organism and the environment into which it is released.

• There is a need for additional data on several elements necessary to conduct risk assessments for all four types of transgenic organisms (fish, trees, viruses and pharmaplants). Further research is recommended to fill the knowledge gaps, inter alia the specific gaps identified during the workshop.

Further details can be found in the report, which is attached.


Kind regards,

David Quist
posted on 2013-02-20 19:38 UTC by David Quist
Coments on #4170, #4179 and #4171 [#4213]
Dear Participants

I think that Deise Capalbo [#4170] comments on that the “need” for guidance should be by all Parties if we are to advance it to the AHTEG. I think that David Quist’s [#4179] and [#4171] example of GM salmon is a great example of guidance needed by only a few jurisdictions. Salmon are introduced to New Zealand and not native to this region. I quick assessment of what I might need to know (this is only hypothetical) for a Cartagena risk assessment for a GM salmon introduction into New Zealand is:

• Do GM salmon have any more of an adverse effect on biodiversity than non-GM salmon e.g. are they super predators compared with non-GM salmon?
• Do GM salmon adversely affect their predators (e.g. fish eating birds) especially native predators?
• Are GM salmon benefit non-native predators?
• Do GM salmon behave differently from non-GM salmon that causing an adverse environmental effect (e.g. feeding behaviour increases turbidity)?
• Given that GM salmon would be introduced for fish farming have they been approved for
human consumption by the food approval authority?

Other than the economic benefits we would not need to know anything else. As I believe that this is true for most of the Parties in the tropics and Southern Hemisphere the need for guidance is very much a temperate Northern Hemisphere need.

However the above would be a test for the road map in that did it help me identify these questions and did it identify anything else?

Regards
Geoff Ridley, New Zealand Environmental Protection Authority
posted on 2013-02-25 01:57 UTC by Dr. Geoff Ridley, Environmental Protection Authority
RE: Coments on #4213 [#4222]
Dear Colleagues,

A quick response to Geoff Ridley’s comment of certain types of guidance being only needed by some jurisdictions in in post [#4213] – citing LM salmon as an example. His point would be valid if LM salmon were the only type of LM fish that was, or could possibly be, developed.

A quick Internet search is that that is needed to reveal that this is not the case. Other types of LM fish under development – LM tilapia for example – would be of relevance in tropical environments (but not so much to temperate ones).

Certainly, as some specific types of LM plants will not be likely receiving environments to all terrestrial environments, and the same will be true for LM fish – which is precisely why the discussion concerns LM fish as a class of organisms and not a singular type of LM fish.

With this in mind, one could reasonably expect that any jurisdiction with an aquatic environment with fish may be a potential receiving environment for a LM fish. 

In the same post Geoff Ridely provides a useful list of potential hazard-ID questions for LM fish (salmon). Many of these the risk assessor may be interested in (and there may be others), but not be aware of. This may be the case if the assessor is an expert in plants (which is often the case), and hence may be unfamiliar with fish ecology and biology of fish and the unique hazard questions that may be important in relation to desired protection goals.

It is here where specific guidance becomes useful to the inexperienced risk assessor or those lacking the resources to develop such scientific information on their own.

Kind regards,

David Quist
posted on 2013-02-25 05:55 UTC by David Quist
RE: Coments on #4222 [#4226]
I agree completely with David Quist [#4222].  

If countries have experience with LMOs it is almost entirely with LM plants.  Indeed, not only have several countries told this forum that they need further guidance on certain LMOs, but several of the LMOs they have named are non-plant species, such as fish and viruses.  Moreover, if a country has had experience with LM plants, it is usually with LM plants that are designed to produce a protein that confers resistance to insects or herbicides, as these are by far the most common LM plants that have come into commercial production to date. Therefore, these countries may have little experience with other types of LM plants, such as plants designed to generate pharmaceutical or industrial products, plants with altered nutrition, or plants incorporating dsRNA technology.  And  these are the very LM plants that participants from some countries have stated they want further guidance on.

Finally, I am concerned that there seems to be an interrogating and demanding tone developing from some countries that I find unfortunate and simply not constructive to the discussion.
posted on 2013-02-25 11:38 UTC by Dr Judy Carman, Institute of Health and Environmental Research
RE: Coments on #4226 [#4236]
Dear Participants

Judy Carman [#4226] said “Finally, I am concerned that there seems to be an interrogating and demanding tone developing from some countries that I find unfortunate and simply not constructive to the discussion.”

I assume that this is directed at me and I apologise if I have offended anyone. However, this is a technical forum that will lead to the setting of a work programme. As a technical forum I think that I can ask that statements be supported by evidence. And given the limited resource available we need to justify and prioritise any work we suggest for the work programme. This is all simple good science and good business practice.

The other comment Judy made was that most countries only had experience with LM plants which is fair enough. However there was no guidance to start with and it was built up through a reiterative process as I described earlier. It was also based on the experience of doing risk assessment on non-LM plants. We have the same experience to draw on for all the groups of proposed LMOs. I would rather see guidance developed through experience then an academic exercise.

Regards
Geoff Ridley, New Zealand Environmental Protection Authority
posted on 2013-02-25 19:20 UTC by Dr. Geoff Ridley, Environmental Protection Authority
RE: Coments on #4222 [#4237]
Dear Participants

Dave Quist [#4222] commented on my post on GM salmon which I agree with. However I think he misses the point on the reiterative process. I would rather see Norway and Canada produce guidance on dealing with GM salmon from their real experience. Then if New Zealand, as a hypothetical example, where asked to consider the release of GM carp as a biological control of a pest species we could look to that guidance for any helpful experiences and add our own of our experience. Thus the guidance would grow in the species dealt with and the situations in which LMOs are to be used. In the end we have real experience and real guidance and not just an academic exercise.

Regards
Geoff Ridley, New Zealand Environmental Protection Authority
posted on 2013-02-25 19:36 UTC by Dr. Geoff Ridley, Environmental Protection Authority
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4171]
Dear Francisca and forum members,

First of all I wish to extend a thanks to Francisca for moderating this discussion, and providing us with two useful, appropriate and timely questions for consideration in this discussion. I think these fit nicely with our aim to produce outcomes in support of Strategic Objectives 1.3 and 1.4 as stated Paragraph 3(c) of the annex to decision BS-VI/12.

Ill take both questions in turn.

1.Do Parties to the Protocol have a need for guidance on new topics of risk assessment and risk management to be developed?

For Norway, the answer is yes.

We can appreciate that some Parties may find a need for additional specific guidance and other observers and Parties do not. Obviously there will be uneven priorities with regards to this issue by the different Parties. The main aim of our efforts is to develop guidance for RA and RM in accordance with the Protocol for those most in need of such guidance, not the least. From either a political or scientific standpoint, I would not presume to know what another Party does or does not need within their particular context.

Recognizing and respecting these different needs means that not all will find utility in each of the guidance documents equally. Given that these guidance documents are non-binding, those among us that do not find particular information or guidance necessary for our own context can simply chose not to use it, but we should not stand in the way of others who want and need specific information to be developed in order to carry their own RA and RM activities.


2.If such a need exists, which topics should be considered based on your experience and knowledge concerning risk assessment?

Ill refer you to the original AHTEG terms of reference in Decision BS-IV/11 for which the AHTEGs work is to be “primarily” based upon – the report of the Canada-Norway Workshop on Risk Assessment for Emerging Applications of Living Modified Organisms (UNEP/CBD/BS/COP-MOP/4/INF/13), which  ”addressed available guidance on risk assessment for emerging applications of modern biotechnology, identification of gaps in information or science that could impact on appropriate risk assessments and appropriateness of current models for risk assessment applied to emerging applications.”

One conclusion of this scientific workshop: “There is insufficient guidance on how to perform risk assessment for GM fish and viruses.”

We believe these topics of LM fish/animals and LM viruses are urgent need of specific guidance given their biologies and life strategies that present unique assessment challenges. Further, their current or impending regulatory approval use means that applications for transboundary movement with these classes of organisms will in likelihood be landing on the desks of the competent authorities in the near future.

A number for other topics have bee proposed during this discussion that may be quite useful.

Wei Wei first introduced suggestions for:

- Risk assessment for GM organisms created through use of dsRNA techniques;

and

- Guidance on integrating human health into the environmental risk assessment

In events involving dsRNA, in our own risk analyses in Norway we have faced particular challenges for arriving an evidence-based conclusion given the lack of information and critique appropriate methodologies. Further, we find that the getting serious about integrating human health issues into the environmental risk assessment requires more specific guidance on appropriate methods for accounting for sub-chronic effects, investigating pathways of exposure, and leveraging new risk assessment methodologies particularly targeting RA and RM to human health issues.  So we find both of these topics particularly useful as subjects a specific guidance.

Lastly, with regards to timing of the development of new guidance, we would expect that procedurally it will become necessary to conduct other related guidance activities, such as testing, in parallel with the development of new guidance. We don’t find it an impediment, but rather another potential source relevant information if the new guidance is developed earlier rather than later so it also can contribute to any suggested improvements to the existing guidance, along with any testing activities.

Kind regards,

David Quist
posted on 2013-02-20 12:39 UTC by David Quist
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4178]
Dear Dr. Quist, dear all.

Again I would like to point to the futility of producing new texts on specific issues in risk assessment: after all, we have now texts of doubtful quality that have not yet been tested and that only shed doubts in the minds of the less experienced risk analysts.

Do you want a clear example? The text on risk assessment of transgenic mosquitoes, which brings to the reader a large set of speculative issues, without scientific foundation, making the risk assessment an erratic and meaningless adventure.

Few of us have enough experience with the issues that are coming to the table, such as transgenic fish. Let the scientific community and risk assessors from government agencies look into these issues before requesting the AHTEG colleagues to do the same, thereby avoinding further embarrassment.
posted on 2013-02-20 18:29 UTC by Mr. Paulo Paes de Andrade, Brazil
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4182]
I regret to see that our Brazilian colleague had such a view on the text on risk assessment of transgenic mosquitoes. I dont believe that this document has no scientific bases as it went through several rounds of discussion.

I think we should take every effort to go for seeking those guidances that we need to secure our world and human health. This procedure should not be blocked by the reason that some of us have no such experiences. We can seek scientific consultations from scientific community that we need. I appreciate the expert report that David had posted, which provided scientific advices on issues of risk assessment. For developing new guidances for the parties, we still need a scientific approache as I mentioned before and should also follow a scientific manner other than personal feeling.
posted on 2013-02-21 03:47 UTC by Mr. Wei Wei, China
Comments on #4178 and #4182 [#4215]
Dear Participants
I have read the comments of Paulo Paes de Andrade [#4178] and Wei Wei [#4182] and based on experience I am of the opinion that it is a reiterative process – the road map informs the first risk assessment, which informs the first edition of guidance, which informs the next risk assessment, which intern informs the next edition of the guidance etc. In the case of the GM salmon the Canadians and the Norwegians should invest in doing a risk assessment drawing on the expertise that is available to ensure the assessment is as robust as our current knowledge allows. The Canadians and the Norwegians can then develop guidance based on their experience. The guidance can then be used by the next jurisdiction to conduct a risk assessment which in turn can inform the further development of the guidance.
This would produce a real and useful document rather than an academic document.
Regards
Geoff Ridley, New Zealand Environmental Protection Authority
posted on 2013-02-25 02:13 UTC by Dr. Geoff Ridley, Environmental Protection Authority
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4172]
Dear Colleagues,

I agree with those of you who suggest now is not the right time to consider this question. The Decision states that the open-ended on-line forum and AHTEG should work “on the following issues in the given order of priority.” It was clear from the outcome of discussions at COPMOP6 that the issue of new guidance should be considered only if the first two tasks had been successfully completed. It is important to focus efforts on testing the guidance, which is the most important task. It will only be possible to determine whether guidance on new topics is necessary when the existing guidance has been tested.

If it is effective, the roadmap should provide sufficient guidance for the risk assessment and risk management of any LMO. The same questions will apply and the same framework can be used. It should not be necessary to develop guidance for each new LMO. Attempting to do so is to set a never ending task, and this is not best use of the limited resources available for this work. The absence of guidance on a specific type of LMO should not be seen as a barrier as in all cases the roadmap can be used.

In my opinion the current guidance on specific types of LMOs and traits is not useful. As Paulo Andrade has said it simply provides a list of potential worries without a link to a product. This is not useful and is in fact potentially damaging. In addition, at present there are limited opportunities to test these sections of the guidance in real cases of risk assessment. In this context it is not necessary or appropriate to continue developing guidance on new topics.

Best regards,
Kath
posted on 2013-02-20 13:04 UTC by Dr Katherine Bainbridge, Department for the Environment, Food and Rural Affairs
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4176]
First, I would like to thank Francisca for moderating this discussion. As well as to thank for all thoughtful inputs made to this discussion.
I agree with the several colleagues that posted that now it is not appropriate to start considering new topics for specific guidance. I believe that priority and focus should be on good quality and usefulness.  For that end, I agree that we need to thoroughly test the present guidance and focus on areas that need improvement, e.g. identify and eliminate points that might lead to error. In other words, we should ensure that the guidance is practical, mostly relevant, reflect real-life situations and gained experience, etc.  It's important that it is carefully reviewed by people  who are knowledgeable, experienced and with understanding  of the relevant topics. As well as, to evaluate the success of  those inexperienced people (for whom the guidance is mostly needed) in understanding, learning, etc.  from the guidance.
A well written general guidance should enable to transfer the learned knowledge, skills, etc. to other cases. Only once the guidance is successfully accomplished/tested we can better identify and effective prioritize which are the topics that need further specific guidance. In addition, it is confusing and even potentially damaging if we end up with a large number of unfinished,  inadequate, ineffective, and/or unreliable guidances due to unmet quality and needs.
Best regards, Lúcia
posted on 2013-02-20 16:15 UTC by Ph.D. Lúcia de Souza, PRRI - Public Research and Regulation Initiative/ANBio (Associação Nacional de Biossegurança - Brazilian Biosafety Association)
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4177]
First, I would like to thank Francisca for moderating this discussion. As well as to thank for all thoughtful inputs made to this discussion.
I agree with the several colleagues that posted that now it is not appropriate to start considering new topics for specific guidance. I believe that priority and focus should be on good quality and usefulness.  For that end, I agree that we need to thoroughly test the present guidance and focus on areas that need improvement, e.g. identify and eliminate points that might lead to error. In other words, we should ensure that the guidance is practical, mostly relevant, reflect real-life situations and gained experience, etc.  It's important that it is carefully reviewed by people  who are knowledgeable, experienced and with understanding  of the relevant topics. As well as, to evaluate the success of  those inexperienced people (for whom the guidance is mostly needed) in understanding, learning, etc.  from the guidance.
A well written general guidance should enable to transfer the learned knowledge, skills, etc. to other cases. Only once the guidance is successfully accomplished/tested we can better identify and effective prioritize which are the topics that need further specific guidance. In addition, it is confusing and even potentially damaging if we end up with a large number of unfinished,  inadequate, ineffective, and/or unreliable guidances due to unmet quality and needs.
Best regards, Lúcia
posted on 2013-02-20 16:15 UTC by Ph.D. Lúcia de Souza, PRRI - Public Research and Regulation Initiative/ANBio (Associação Nacional de Biossegurança - Brazilian Biosafety Association)
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4181]
Dear All,
Since this is my first intervention to this particular online forum, I will take the opportunity to thank the Secretariat for hosting and Francisca for agreeing to serve as the moderator.  I think the last two online forums have demonstrated that you need to be a brave soul to take on the responsibility of moderating such a lively group, so I congratulate you and wish you the best in your difficult task.

Francisca has asked us to answer two simple and logical questions- do Parties have a need for additional guidance, and if so, guidance on what topics?  I hate to take simple questions and make them more complex, but I think we first have to understand what we mean by “guidance.”  In my opinion, this has not been satisfactorily addressed by the AHTEG or the online forums over the past four years.  Even in this current forum, there is some confusion about the need for guidance, compared to the need for data and the need for valid methodologies.  Although these are related, they are not the same thing.  It seems clear now that the process would have been much improved by the development of a concrete description of what any produced guidance would look like, along with a clear description of the process that would be used to produce such guidance.  As has been pointed out by others, the group was (understandably) so eager to make progress that we simply started working on guidance documents without adequately defining the task.  Even if we were to agree that there was a need, we would face the same challenges in producing something useful that have plagued the current guidance documents. Therefore, I think that before the AHTEG starts to proliferate guidance we would be well served to spend the necessary time and energy to develop a consensus on what these documents are intended to accomplish, what they should look like and what process we will follow in creating them.  For example, if we want to continue to develop “specific” guidance I think it would be of great benefit to establish a process for engaging, not just the interested risk assessment community, but subject matter experts who can provide a solid scientific grounding for the document. 

In light of this, I agree with those who are suggesting that the appropriate time for further consideration of additional guidance will come after the testing and further development of the roadmap.  Looking at the original terms of reference for the AHTEG contained in Decisions BSIV-11, the roadmap has always been the first priority, and it seems like now is the time to focus our energies there.  While some have suggested there is no reason the AHTEG cannot do everything at once, I think the work of the group over the last four years illustrates perfectly that there is not an infinite amount of time and resources available for the conduct of our work.  If anything, we have been overly ambitious, and this has hampered our ability to accomplish our task.  I think it would be a mistake to once again simply start making documents without a better understanding of what we are trying to do.

Best Regards,
Andrew
posted on 2013-02-20 20:29 UTC by Mr. Andrew Roberts, International Life Sciences Institute Research Foundation
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4183]
Dear all

Thank you for the interesting discussions so far.

I am a little confused by recent posts suggesting that the existing Guidance has not been tested and therefore it would be premature to consider the development of new/further guidance on specific topics of risk assessment. In the first place, the Guidance has been previously tested (by Parties, other Governments and relevant organizations) and revised accordingly. The testing as mandated by COPMOP6 is for ‘further improvement’ in actual cases of risk assessment and in the context of the Cartagena Protocol on Biosafety. Secondly, it seems to me that testing of the existing Guidance package (to improve it) is not a barrier to the development of new guidance on specific topics, as these can be reiterative processes such that the latter can benefit from the former, and vice versa.

It is clear that some Parties support the development of further guidance on specific topics of risk assessment, while others do not see the need. This does not necessarily lead to an impasse, as any guidance would be precisely that and would not be prescriptive nor pose obligations, yet would be available to help Parties who choose to use it, developing country Parties especially, some of which had already expressed the need for further guidance.

The development of guidance on risk assessment and risk management, including guidance on new developments in modern biotechnology, is also integral to the Strategic Plan of the Protocol (2011-2020), and the expected outcome of our work, as highlighted by Jack. The Strategic Plan was developed (and adopted at COPMOP5) on the basis of submissions from Parties, the analysis of the first national reports, the successive decisions taken by the Conference of the Parties serving as the meeting of the Parties to the Protocol at its last four meetings, and through general discussions and comments received from Parties, other Governments and stakeholders. It is fairly safe to assume then that Parties have identified the need for such guidance as an element that will progress their implementation of their obligations under Articles 15 and 16.

So, in relation to the 1st question posed by our Moderator, the answer is yes, some Parties at least have a need for guidance on new topics of risk assessment and risk management to be developed. Thus, as such a need exists, we should focus our discussions on the 2nd question as to which topics should be considered and this must be selected based on the needs and priorities of Parties.

kind regards
Lim Li Ching
TWN
posted on 2013-02-21 03:55 UTC by Ms. Li Ching Lim, Third World Network
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4184]
Thank you Francisca for moderating the forum. Greetings to all participants.

This forum is again proving to be a stimulating and I have been following it with great interest. 

I am grateful for David Quist's [#4171] and Jack Heinemann's [#4169] clarification of one of the key issues here: the guidance is voluntary and non-binding.  It is there to assist developing countries, and only if they chose to have that that assistance.  The guidance is not being forced upon anyone or any country.

David Quist [#4171] has also suggested that the existing guidance could be tested at the same time as new guidance documents are developed.  In my view, waiting until the existing guidance has been tested before developing any new guidance documents could unfairly affect those countries that are clearly looking for more specific guidance on specific types of LMOs.  Already, we have heard from Wei Wei in China [#4153], Angela Lozan from Moldova [#4155] and Mahaman Gado Zaki in Niger [#4168] that they want more guidance documents developed for specific types of LMOs.  There is therefore a clear need for further guidance documents to be developed.  Some specific guidance documents have even been suggested.  For example, Wei Wei [#4153] has suggested more specific guidance for LMOs involving dsRNA, for integrating human health in environmental risk assessments and for nutritionally altered, pharma and industrial compounds-producing LMOs. 

Furthermore, David Quist [#4179] has provided evidence from the Canada-Norway Expert Workshop of 68 scientific experts and risk assessors, that there is insufficient guidance on how to perform risk assessments for GM fish and viruses.  Also from that workshop: “There may be a  need to develop specific methodologies and specific protocols for generating data necessary to conduct risk assessments for the future applications of modern biotechnology, especially for transgenic fish, trees and viruses.”

To me, based on the discussion in this forum, there is therefore a clear and expressed need for more specific guidance documents to be developed, and soon, that cover at least the following categories of LMOs:
LMOs created through use of dsRNA techniques, including dsRNA direct injection into cells or organelles and other in vitro techniques
LMO fish
LMO trees
LMO viruses
LMOs with altered nutrition
LMOs designed to produce pharmaceutical or industrial products, including effects on both vertebrate and invertebrate pests
For integrating human health into environmental risk assessments

Moreover, Jack Heinemann [#4169] has stated that the AGTEG has the ability to develop additional specific guidance documents on topics.  So, not only has there been an expressed need in this forum for further guidance, but a clear way has been presented as to how that could occur. Furthermore, as far as I could see, there was no requirement in Decision BS-VI/12 for all of the Parties to agree, or even a majority assent by the Parties to occur, before AHTEG could act. The Decision simply asked if there was a need to act. If there was a need, then it was delegated to the AHTEG to determine if the time and other resources were available to meet this need. To me, that need has been clearly expressed by a number of Party representatives participating in this forum and thus, in my view, the question has indeed been answered.

I also note that both Paulo Paes de Andrade and Lúcia de Souza [#4176] have returned to the theme of testing the guidance. However, I think it is worth remembering that the existing guidance is not in fact ‘untested’, but rather, the guidance has benefited from rounds of testing as acknowledged by the Parties in MOP6, and as stated by Li Ching Lim [#4183]. One task set by the Parties in MOP6 is the issue of further testing. Since others have used this forum to again suggest what form that testing should take [#4176], I would like to take this opportunity to attach to this post (below) my suggestions for consideration as well, based on my considerable experience in designing surveys.


With kindest regards

Judy


1.  Please provide your name.

2.  Please list your qualifications.

3.  Please provide the name of any government or organisation that you represent, and your position in it. 

4.  Which of the following roles do you associate with most closely?
(Circle as many as apply) national regulator / citizen / civil society / LMO developer

5.  Please provide the name of the country in which you live or work.

6.  Please describe any previous positions you have held, roles you have had, or experience you have obtained in risk assessments of LMOs.  For example, please describe any experience as a risk assessor in a government regulatory body, with a non-Government organisation or as an academic, and which government, NGO or university you worked for.   

7.  Please describe the type of LMOs you have previously assessed, if any.

8.  Are you conducting this test of the Guidance in one or more actual cases of risk assessment and in the context of the Cartagena Protocol on Biosafety?
(Circle one) Yes / No / Uncertain.
If yes, or uncertain, please briefly describe the living modified organism (LMO) you are assessing

9.  Please describe any intended receiving environments of the LMO.

10.  Is this an application for a small-scale environmental release or a large-scale release?

11. Are you conducting the testing of a Guidance document that is written in English or another language? 
If the Guidance is written in another language, please describe which language.
Please provide a copy of the translation that was used.

12.  Did you use all or only part of the Guidance in your testing?

If only part of the Guidance was used, which part(s) were used?

13.  With respect to Annex III section 8(a) of the Cartagena Protocol on Biosafety:
Did the Guidance and its associated bibliography help you to identify any novel genotypic and phenotypic characteristics associated with the living modified organism that may have adverse effects on biological diversity in likely potential receiving environments?  Please note that this includes risks to human health.

14.  With respect to Annex III section 8(b) of the Cartagena Protocol on Biosafety:
Did the Guidance and its associated bibliography assist you in evaluating the likelihood of any of these adverse effects being realised?  Please take into account the level and kind of exposure in the likely receiving environment(s).

15.  With respect to Annex III section 8(c) of the Cartagena Protocol on Biosafety:
Did the Guidance and its associated bibliography assist you in evaluating the consequences, if any, if these adverse effects are realised?

16.  With respect to Annex III section 8(d) of the Cartagena Protocol on Biosafety:
Did the Guidance and its associated bibliography assist you to estimate the overall risk posed by the LMO?  Please note that the overall risk is a combination of the likelihood of any adverse events occurring and the consequences if those adverse events did occur.

17.  With respect to Annex III section 8(e) of the Cartagena Protocol on Biosafety:
Did the Guidance and its associated bibliography assist you in coming to a recommendation as to whether or not any risks are acceptable or manageable, including, where necessary, identifying any strategies to manage those risks?

18.  With respect to Annex III section 8(f) of the Cartagena Protocol on Biosafety:
Did the Guidance and its associated bibliography assist you to identify any uncertainty about the level of risk and/or clarify how any risk may be addressed by, for example:
(1) Requesting further information about any concerns.
(2) Implementing appropriate risk management strategies
(3) Monitoring the LMO in the receiving environment(s)?

19.  Keeping to the references that were relevant to the actual case(s) used for testing the Guidance, did you find the background documents to the Guidance sufficient for your needs?

20.  Do you wish to recommend any additional documents that could be used?
If yes, what documents do you recommend?

21.  Are you aware that there is a procedure for recommending additional documents through the Biosafety Clearinghouse?

22.  Do you have any additional comments for possible improvements to the Guidance?  These comments will be included in the report for consideration by the Conference of the Parties serving as the meeting of the Parties to the Protocol at its seventh meeting.
posted on 2013-02-21 07:25 UTC by Dr Judy Carman, Institute of Health and Environmental Research
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4185]
Dear Participants,
I believe that the Guidance first of all is dedicated to the countries with developing RA system. So it is very good that it is not a mandatory document and provides flexibility in the risk assessment for the Parties but it is still needs improving with regard to its practical utility for risk assessment and management, as we discussed on the last Webinar. But I do not understand why the Guidance testing work can not be done in parallel with the development of the Guidance on new topics for private risk assessment. Existing Guidance testing and improving for making its really practical for novice in risk assessment and management should and could be done in parallel with the development of Guidance on new topics of risk assessment. They are two sides of the same problem that require attraction the knowledge of experienced scientists in risk assessment and their willingness to carry out such work. So I agree with the point of view that if some Parties need for Guidance on new topics of risk assessment (for example such important questions like risk assessment of GM fish and viruses pointed above) it should be done.

Galina Mozgova,
The National Coordination Biosafety Centre of the Republic of Belarus
(edited on 2013-02-21 08:51 UTC by Galina Mozgova)
posted on 2013-02-21 08:47 UTC by Dr. Galina Mozgova, Belarus
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4189]
It seems discussion go back to square one like a time machine to 2008 without looking back what have been done:

1) RA&RM for AIA:  There have been four-year discussions by RA AHTEG and also on-line forums on whether and how new topics on specific types of LMOs could be considered. It was reported to COPMOP-5 and with BS-V decision followed by BS-VI: this clearly indicated its not priority mandate. It may be discussed only after the immediate task of the testing Guidance and analyzing feedback of the usefulness to help the countered need to implement the RA and RM based on AIA. On line forum and the former RA AHTEG sound like self-propagating unintentionally its mission without initial intention of the on-line forums and RA AHTEG. Reminding that all are for helping AIA procedures and if a specific LMO is for the subject of AIA at immediate needs, there would be discussion. But the proposed subjects on this present on-line forum do not look like for the immediate needs. 
2) Focus on mandates: One may claim the evolution of the changes of the needs on specific LMOs, however so far attending at the COPMOPs as a GoJ government delegation member. I do not recall the points made by some of interventions in this forum: there is a more than diversity of interpretation of BS decisions, its rather over-reading.
3) Former RA AHTEG members shall be reserved: The potential users do not have much of inputs of this on-line discussion, while former AHTEG members make the same rounds of interventions, and I feel those who were at the previous RA AHTEG shall not repeat or come back the same issues.
4) Language may be a barrier: Those of NFPs at the countries as potential users shall be further encouraged and also submission of their original languages can be accepted as often yet English uses would be hurdle for busy officers in many countries. SCBD shall promote and encourage the participation of the government representatives and support message submission to the on-line forums.
5) With my understanding on the mission of forums, the discussion shall be oriented to make a support document for the beginners where no concrete AIA and RA&RM system available. Thus, it should not be a discussion on the needs of a country with fair development shall not be the subjects, but for LDCs. It is dangerous to incline to a pseudo-MOP negotiation on this forum neither at a AHTEG.
6) Followed up form the previous discussion earlier this year, discussion was more consolidated to the present Guidance document and how to use it with proper collaborations with the existing efforts under the Protocol. Overall I do not see the reasons on extension of on-line forum missions beyond the COPMOP instructions.

Kind regards,


Kazuo Watanabe
posted on 2013-02-22 00:10 UTC by Dr. Kazuo Watanabe, University of Tsukuba
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4190]
I would like to begin by thanking Francesca for moderating this session.
A number of participants in the forum have said similar things; I am only commenting on a few of the interventions that I consider to be reasonably representative.  As Ms Li Ching Lim [#4183] states “It is clear that some Parties support the development of further guidance on specific topics of risk assessment, while others do not see the need.” However, I am not convinced by her view that continuing with testing of the Guidance and developing further guidance on specific topics in parallel is appropriate as in my view this would mean that already scare resources would be diluted even more.
I concur with Dr Katherine Bainbridge [#4172] that it is not the right time to start developing new specific topics (for all of the reasons stated in her intervention).
Dr. Andrew Roberts [#4181] suggests that “we would be well served to spend the necessary time and energy to develop a consensus on what these documents [the guidance] are intended to accomplish, what they should look like and what process we will follow in creating them.”  While this might in some ways appear to be revisiting the subject matter of the previous forum I believe that Andrew is correct in suggesting that we should look at the purpose of the guidance carefully and consider the criteria that should be applied to the selection of any further topics for specific guidance as well as the form and substance of such guidance (with a view to applying a ‘yardstick’ for consistency of approach and quality control). 
Dr Judy Carmen [#4184] states that in her view “waiting until the existing guidance has been tested before developing any new guidance documents could unfairly affect those countries that are clearly looking for more specific guidance on specific types of LMOs.”  But I am not sure that there is any clear evidence of the ‘need’ – it is really more than a ‘want’?.  If we proceed along that line we need to be very clear and transparent about how we decide which areas need specific guidance documents, and in which order they should be developed?

In summary, I would urge caution before diverting scarce resources towards developing specific guidance documents without the results of the proposed testing to determine the scope and format of the existing specific topic guidance documents is useful and robust, and without a proper frame of reference for determining which topic areas these additional guidance documents should address.
posted on 2013-02-22 02:46 UTC by Janet Gough, Environmental Protection Authority
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4191]
Dear participants,
I also want to thank Francisca Acevedo for moderating this session of the forum.
I want to mention that I agree with many of the participants who say that it is not appropriate timing to start the discussion on new topics of risk assessment. Paolo Andrade makes a good point with his question: what is the use to discuss these new topics if we still do not know if the guidance is useful? If it turns out after the testing that the roadmap, as it intends, applies to all kinds of LMOS then we do not need specific guidance for other LMOs. If the roadmap is not useful for providing guidance for risk assessment, then the first issue to deal with is how to improve it (that is what the COP-MOP mandated). So I think that we should proceed first with making sure that the developed guidance is useful (and actually is used by those who need it) and not on developing new topics for additional guidance documents.
In particular I think that the first posting by Ryosuke Fudou is very appropriate, in reminding us what the COP-MOP decided on the expected outcome in relation to considering the development of guidance on new topics  : “A recommendation on how to proceed with respect to the development of further guidance on specific topics of risk assessment”.
I think that this recommendation on how to proceed should include transparent criteria for defining when is more guidance actually needed. I include the following as a starting point:
1) Is there a need for guidance?
Some of the criteria for deciding whether there is a need for more guidance could be the following:
   • What is missing in the Roadmap that is not “allowing” the risk assessment of the LMO?, or why isn’t the roadmap providing clear guidance for the specific topic?
   • Is there already guidance available elsewhere? Is it available in different languages?  Has it been used by others?
   • What are the time frames for when LMOs in the research and development pipeline are likely to reach the regulatory stage?
2) Is there enough experience and knowledge for elaborating the needed guidance?
(This is following what Nobuyuki Fujita pointed out, “enough experiences and knowledge is an absolute prerequisite to develop a guidance which is scientifically sound.” This is in the decision of the Cop-MOP)
Some of the criteria for deciding that there is enough experience and knowledge for developing scientific guidance could be:
   • Is there enough knowledge on the specific topic of risk assessment?
   • Are there available experts to develop the guidance? Are these experts within AHTEG?
   • Do the experts have enough experience to develop a good guidance? (imagine someone developing guidance on how to do brain surgery if the guidance author had not done many such surgeries).
3) Is there a proper mechanism in place to develop the needed guidance?
  • Here we may identify criteria related with financial resources, communication mechanisms, etc.

Maybe some of the colleagues who are asking for more guidance could explain what their reasons to do so are, and these could be discussed as possible additional criteria for the recommendation on how to proceed.

I think these could be some of the issues we could be discussing for a recommendation on how to proceed with respect to the development of further guidance on specific topics of risk assessment. This approach will contribute in a transparent manner to a clear recommendation on whether there is a need for more guidance, why, and if this is feasible for a particular topic.

Finally I will like to support Janet´s recent posting. I share all her points particularly what she is highlighting from Andrew Roberts posting.
Kind regards
(edited on 2013-02-22 03:29 UTC by Sol Ortiz García)
posted on 2013-02-22 03:24 UTC by Ms. Sol Ortiz García, Mexico
Comment on [#4185 [#4217]
Dear Participants

I note that Galina Mozgova [#4185] supports the development of guidance. So I will ask the question that I proposed above – why do they need further guidance. I checked the BCH and, as far as I can tell, Belarus has not conducted a risk assessment. Is this due to the lack of capacity or the lack of guidance to do so? Or is it the lack of an application to import an LMO? Given the limited resources available we need to be sure that we do not produce outputs that are not going to lead to a desired outcome.

Regards
Geoff Ridley, New Zealand Environmental Protection Authority
posted on 2013-02-25 02:56 UTC by Dr. Geoff Ridley, Environmental Protection Authority
RE: Comment on [#4185 [#4227]
This year Belarus intend to conduct field trials of LMO and RA. So, of course, we need good clear and practical valuable Guidance for conducting RA and for RM. For all the merits of this manual I think (and last Webinar confirms it) it can be improved and checked for practical value (instruments have been proposed in the last Webinar). I see a two-way process (Guidance checking and development of its new chapters that the Parties are needed) with the view that it will become the Guidance for new valuable topics of RA and, second, will help to reveal the flaws in the Road MAP and allow her to make more clear and efficient for RA.
We don’t demand or interrogate to develop the Guidance [#4226]. Of course, now we are developing our own documents on RA in compliance with our legislation, and there are lot of information on scientific based RA in different world databases to make such documents valuable and effective for us, but our country –is the Party to the Cartagena Protocol and we want to conduct the risk assessment in accordance with its developed documents and the documents become more clear for all the participants involved in this process.
My best wishes,
Galina Mozgova.
posted on 2013-02-25 14:06 UTC by Dr. Galina Mozgova, Belarus
RE: Response to 4227 [#4241]
Dear Participants

Excuse my ignorance, I live on an island that is 2,250 km from its nearest neighbour, but I would have thought that Belarus and any of the other European country lacking capacity could draw on the experience of those European countries that have both significant capacity and experience in risk assessment of LMOs? I note that the distance from Minsk to Berlin is 954 km and this is less than the distance from Auckland to Dunedin in New Zealand. With such a concentrated experience in such a small area I struggle to understand why any European country has to wait for guidance from this process.

Regards
Geoff Ridley, New Zealand Environmental Protection Authority
posted on 2013-02-26 00:10 UTC by Dr. Geoff Ridley, Environmental Protection Authority
RE: Comment on [#4185 [#4285]
Dear Galina,

It just now caught my eye that you noted Belarus intends to conduct field trials with a LMO.  You state "we need good clear and practical valuable Guidance for conduction RA and for RM".  If the LMO is a plant, it may be helpful to have good guidance on conducting a confined field trial.  I am sharing a link to very good guidance developed by scientists as the Donald Danforth Plant Sciences Center:

http://www.danforthcenter.org/science/programs/international_programs/pbs/docs/ICS%20complete%20corrected%20version%20Mar%2008.pdf

This is an excellent manual, which combined with many other guidance documents already available on RA (some, but not all, of which are cited in the roadmap) should help you and your colleagues off on solid footing. 

I'm afraid if Belarus is waiting for for this process to provide good guidance reflecting the experiences of regulators that have completed risk assessments that have led to decisions coming, it will be quite some time.

Good luck,
Tom
posted on 2013-02-27 23:09 UTC by Mr. Thomas Nickson, Consultant
Comment on #4183 [#4216]
Dear Participants

Lim Li Ching’s posting [#4183] demonstrates one of the major problems with the Cartagena Protocol process in that it is focussed on outputs and not outcomes. We have participants telling us they need more guidance but they don’t tell us why they need guidance? Have they had application for LMOs that they have rejected because they did not have the capacity to assess? Or did they allow entry of an LMO because they could not access it? It would be interesting to know why these participants feel this need for these guidance documents (not knowing how to do it is not a reason if you have not been required to do one).

I note that Maria Roco [#4167] said “… please note that there has been no shortage of capacity building and training and no shortages of published literature on how to conduct a sound Environmental Risk Assessment.” I voiced this same concern in Hyderabad – that there has been plenty of training sessions (an output) and document (another output) but this has not translated into increased capacity (an outcome). That is the conclusion that I have inferred from the number of Parties still requesting basic capacity building. I do not see that guidance documents will be any different – guidance will be produced and no one will use it.

Given that we already have outputs in the form of guidance we know need to see an outcome, a risk assessment conducted and a decision made, using this guidance to validate the investment made in it. Not just the production of more and more guidance documents.

Regards
Geoff Ridley, New Zealand Environmental Protection Authority
posted on 2013-02-25 02:37 UTC by Dr. Geoff Ridley, Environmental Protection Authority
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4192]
Nighttime in Mexico City……………………

Dear participants to the forum:
I am very greatful to be helping (¿???) out as a moderator to this forum……….if not brave, at least naïve enough to have accepted the task. Seriously, it has been up to now interesting and a difficult task to keep up with all your comments!!!
First of all, I would like to share what the Secretariat answered me before the forum started about the timing for new guidance to be developed (if and only if a need had been identified by the forum participants), and the answer was:
“The issue of setting a timeframe for the development of new guidance, if that is the case, will be up to the COP-MOP 7 to decide. The forum is mandated to consider the development of new guidance and subsequently make a recommendation to the COP-MOP based on their discussions and the consensus amongst Parties’ needs.”

I have been following the discussions and I have the impression that some participants are trying to convince others of the reasons of why to develop or not further guidance...I am not sure this should be our main goal. As I pointed out at the beginning of the online forum starting this past Monday, the aim of this particular online forum focuses on to main Q´s:

1.-need for further guidance on new topics of risk assessment and risk management,
2.-if the need is identified, then in what topics

I found quite useful what Andrew Roberts posted:

... “ I think that before the AHTEG starts to proliferate guidance we would be well served to spend the necessary time and energy to develop a consensus on what these documents are intended to accomplish, what they should look like and what process we will follow in creating them.”....

Taking his suggestion into account, regardless if you believe further guidance is or not the way to go, I would like to invite you to a round of discussion on:

1.- what the documents (i.e. guidance on new topics of RA&RM) are intended to accomplish,
2.- what process should be followed in creating them.

I strongly believe that there are many ways forward, and sharing our thoughts on these two issues could help amongst the different views (regardless of timing to undertake developing such further guidance).

Finally, I would like to invite other participants to share their views  in the forum so as to have a wider spectrum.

Un abrazo desde México!!!!!
Francisca
posted on 2013-02-22 04:50 UTC by Ms. Francisca Acevedo, Mexico
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4193]
Thank you Francisca for navigating us to a more constructive way, and wish you a good sleep.

1.- what the documents (i.e. guidance on new topics of RA&RM) are intended to accomplish,

This is clear to me. Any new guidance should serve to complement the roadmap (and thus to complement the annex III).

2.- what process should be followed in creating them.

What we should know first is the practicality, usefulness and utility of the current guidance (especially the roadmap) in actual cases of risk assessment. If any shortage is identified in its coverage through the testing process, then we may either consider to revise the roadmap to include missing elements, or consider to develop a complementary guidance to cover the subject which is difficult to be coherently integrated into the roadmap.

Best regards,

Nobuyuki Fujita
National Institute of Technology and Evaluation (NITE), Japan
posted on 2013-02-22 08:43 UTC by Mr. Nobuyuki Fujita, Japan
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4196]
Dear Francisca, Secretariat and members of the Forum

I would appreciate clarification from the Secretariat on the statement “The issue of setting a timeframe for the development of new guidance, if that is the case, will be up to the COP-MOP 7 to decide. The forum is mandated to consider the development of new guidance and subsequently make a recommendation to the COP-MOP based on their discussions and the consensus amongst Parties’ needs.”

A number of Parties and observers have taken a different interpretation of the latitude afforded the next AHTEG. My personal interpretation of "consider the development of new guidance" is that the Decision did not bind the AHTEG to the development of new specific guidance, but it did not exclude this from the work agenda if the AHTEG found it had the time and will to complete the task. I believe that linking the decision to Operational Objectives provides particular clarity on this point. Could the Secretariat please comment on this?

The questions conceived at the start of the forum were specific to the Decision. And the answers have been clear.

Various Parties have said yes, they have a need, and yes they have in mind various topics as priorities. There is no ‘forward’ to move on to; we have reached the objective of determining whether Parties think that there is a need. The Decision did not require Parties to agree that they had no need because other Parties told them they did not, or set a threshold of 100% agreement on needs.

The new questions are more appropriate to considerations of testing.

What is the guidance intended to accomplish? We should have this in mind when we test the guidance but this forum is about the need for new guidance and what topics do Parties need guidance on, rather than what Parties will accomplish with guidance. What they accomplish with guidance is dependent on country-specific legislation and goals.

What process should be followed? Again, either this question is about testing or we already know the answer. The COPMOP6 instructed the Secretariat to conduct online forums and convene an AHTEG to determine if there was a need and, if there was, to identify topics.

Ossama A.ElKawy’s post [#4195] is in my mind on target for this forum and draws us back to the Decision.

with kind regards
Jack
posted on 2013-02-22 19:38 UTC by Mr. Jack Heinemann, University of Canterbury
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4197]
Dear Francisca, Dear Participants

Thank you Francisca for agreeing to moderate the forum and thank you members of the forum for such a lively discussion. I would like to respond to Francisca’s kind invitation for new voices by addressing some of the previous comments that I found interesting.

Paulo (post #4178) mentioned “[…]the futility of producing new texts on specific issues in risk assessment: after all, we have now texts of doubtful quality that have not yet been tested and that only shed doubts in the minds of the less experienced risk analysts.” Lúcia (#4176) mentioned “I believe that priority and focus should be on good quality and usefulness. For that end, I agree that we need to thoroughly test the present guidance[…]”.

As remembered by Ching (post#4183) “the Guidance has been previously tested (by Parties, other Governments and relevant organizations) and revised accordingly”. In addition, I have already alerted some of our colleagues about the conclusions of the previous testing in regards to less experienced risk analysts/countries. Questionnaire results from the previous testing shows that less experienced countries did think that the guidance was useful and user-friendly. So it is not correct to say that the existing Guidance is untested.

In regards to the need for guidance on new topics of RA and RM and taking into consideration my experience in following the GM approvals in Brazil, I would like to agree with some of our colleagues Wei Wei (post #4153), Angela (post #4155), Judy (post #4184), Galina (#4185) and Ossama (post #4195) in regards to:

-LMOs created through use of dsRNA techniques, including dsRNA direct injection into cells or organelles and other in vitro techniques
-LMO fish
-LMO trees
-LMO viruses
-LMOs with altered nutrition
-LMOs designed to produce pharmaceutical or industrial products, including effects on both vertebrate and invertebrate pests
-For integrating human health into environmental risk assessments
-“Co-existence” between LMOs and non-LMOs in the context of small scale farming
-Socio-economic considerations in the context of environmental risk assessment

Finally, I am confused by the new topics suggested by Francisca. I fully agree with Jack (post #4196) that: “The Decision did not require Parties to agree that they had no need because other Parties told them they did not, or set a threshold of 100% agreement on needs.”
And that: “The new questions are more appropriate to considerations of testing.”

Best wishes,

Sarah Agapito
posted on 2013-02-22 20:12 UTC by Dr. Sarah Agapito-Tenfen, GenØk Centre for Biosafety
Comments on #4197 - links to previous testing of the guidance [#4219]
Dear Participants

Sarah Agapito [#4197] tells us that Lim Li Ching (post#4183) “the Guidance has been previously tested (by Parties, other Governments and relevant organizations) and revised accordingly”. It has been mentioned before that testing has occurred. It would be useful to those of us not involved in the previous forum and AHTEG to provide a link to the testing methodology, testing results and how this was accommodated in the guidance.

Regards
Geoff Ridley, New Zealand Environmental Protection Authority
posted on 2013-02-25 03:09 UTC by Dr. Geoff Ridley, Environmental Protection Authority
RE: Comments on #4197 - links to previous testing of the guidance [#4220]
Dear all

Please see the link which documents the testing process conducted so far on the Guidance:

http://bch.cbd.int/onlineconferences/ra_guidance/testing.shtml

According to UNEP/CBD/BS/COP-MOP/6/13/Rev.1, the open-ended online forum and AHTEG worked together in a collaborative process comprising the following step-wise activities, inter alia: "Testing of the Guidance by Parties, other Governments and relevant organizations, including during capacity-building activities, with a total of 28 submissions made (23 from Parties, one from another Government and four from organizations)"

Hope this helps our colleagues who are asking about the previous testing processes which led to revision of the Guidance.

Kind regards
Lim Li Ching
TWN
posted on 2013-02-25 03:39 UTC by Ms. Li Ching Lim, Third World Network
RE: Comments on #4220 - previous testing [#4240]
Dear Participants

I like to thank Lim Li Ching [#4220] for providing the link to the previous ‘testing’ of the roadmap/ guidance. The nature of testing and our expectation of what might constitute testing was discussed in the first forum in this series. The previous ‘testing’ falls short of what we would consider testing in this later discussion. The ‘testing’ is really a review process based on a questionnaire and I did not get any sense that anything was actually tested. I also not of those who responded only a few gave any in-depth comments and most simply gave yes or no answers. I think to claim that the guidance has been tested based on this survey is pushing the bounds of what to test means.

Regards
Geoff Ridley, New Zealand Environmental Protection Authority
posted on 2013-02-25 23:43 UTC by Dr. Geoff Ridley, Environmental Protection Authority
RE: Comments on #4197 - links to previous testing of the guidance [#4265]
Testing the guidance

As indicated by Lim Li Ching, I visited the BCH site http://bch.cbd.int/onlineconferences/ra_guidance/testing.shtml and checked the results of the Parties evaluations. Testing was mostly a theoretical exercise, as it seems that no one really used it guide the risk assessmento Fo a requesto for any GMO relase. And the results were very contradictory. For example, Bolivia said the guidance was very good. Brazil, on the other hand, considered it poor ando f very limited use.  Cuba said it is great, Germany thought it was poor. Denmark, Spain, Egypt and France agreed it was good or great. Great Britain said it was poor, as well as Honduras. Japan said the roadmap does not provide useful information, as well as Mexico and the Netherlands.  The opinions on the specific examples were also conflicting. And so on and so forth.

This is not the kind of evaluation we were talking about. The guidance must be used in real cases, not in an imaginary scenario. Significantly, those countries with more experience in R.A. regarded the guidance as poorly applicable.

Kindly
Paulo Andrade
posted on 2013-02-27 01:41 UTC by Mr. Paulo Paes de Andrade, Brazil
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4199]
Let me start by thanking Francisca for taking on the challenge of moderating this session of the post-MOP6 online forum.  Thanks also for both starting the discussion and your valuable and timely clarification. 

I believe the post-MOP6 online fora got off to a rocky start because of procedural issues that have created confusion.  As such, I support Jack’s request [#4196] for clarification from the Secretariat, but from the broader perspective of interpreting BS VI/12 in whole.  As others have pointed out, it is illogical to have a discussion on the last priority issue before (any) substantial progress is made on the higher priority elements of the decision.  

Some commentators have noted their approval of working “in parallel”.  I believe we should heed the caution of Francisca and others, which is that we still don’t agree what these documents are intended to accomplish.  As such, we are not and will not be working in parallel, but following trajectories that are independent and likely non-intersecting.  Until the roadmap is tested, modified and “fit for purpose” by the COP/MOP, there will be no coherence and interdependence in this activity; intersection would only occur by accident.  Capacity in less-developed or early-developed regulatory systems is best built with a roadmap that is “fit for purpose”.  Having a solid foundation will help later in both a needs assessment and addressing those needs in an efficient and effective manner.

I appreciate and support focusing on Francisca’s two new guiding questions.  First, what are these guidance documents intended to accomplish?  I would hope that they would be enabling tools to help developers provide risk assessors with relevant and appropriate information, and help risk assessors support timely decision-making.  

Second, what process should be followed in creating them?  The process should ensure the guidance is constructed using information and knowledge from those who have done risk assessment.  Furthermore, relevance to Annex III can be ensured by pointing to where and how existing risk assessments are consistent with the Protocol.  The guidance should clearly point out risk assessments that have led to decisions, which would require a process of collecting existing information and knowledge from functioning regulatory systems.   Furthermore, producing guidance requires an existing body of knowledge and experience.  We should not produce thought documents describing unprecedented methodologies and theories. 

Finally, is there a need for further guidance on new topics in risk assessment?  No.  It was very clear at MOP6 that many experienced and less-experience Parties see this exercise as unnecessary at this time.  As such, the negotiated outcome was that work on additional guidance would be the lowest priority. 

Thanks,
Tom
posted on 2013-02-22 22:13 UTC by Mr. Thomas Nickson, Consultant
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4200]
Dear all,

Para 1.c of decision BS-VI/12 allows the new AHTEG to develop additional specific guidance on topics in which Parties have an interest in the next term. And I believe it should do so specially that the first AHTEG had not covered all parties’ identified needs expressed in point 1.d.ii of the annex to decision BS-IV/11 quoted here “… the identified need for further guidance on specific aspects of risk assessment, including particular types of (i) living modified organisms (for example, fish, invertebrates, trees, pharmaplants and algae)…”. In addition, several experts from parties in this forum highlighted the need for the development of guidance on new topics of RA.

Regards,
O.A.ElKawy
posted on 2013-02-23 00:56 UTC by Mr. Ossama Abdelkawy, Syrian Arab Republic
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4194]
Dear Colleagues,

As many of you have already posted in the forum, I think that this is not the best moment to develop new topics of risk assessment and risk management.
I think that it would be better to finish the testing of the current guidance, only by this way we could decide if there is more need for guidance. In fact, some of the topics proposed for their development have been already addressed, and by testing the guidance we would see if in an appropriate way, useful for all the potential users.
Regarding if the debate about if different parties need different guidance, I think that our task is to provide all the parties the full formation to address the assessment. It does not matter for this discussion if they have already this knowledge or not, the guidance provided must be comprehensive.
So, in my opinion the question should be if this is the moment to develop new guidance, or if by testing the current one we would be able to solve some of the deficiencies or shortages that some parties could find now.
Best regards,
Victoria Colombo
posted on 2013-02-22 13:11 UTC by Dra Victoria Colombo Rodríguez, Spain
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4195]
Dear all
I strongly support the development of further guidance materials in new risk assessment topics that are identified by parties as important. I believe there is an urgent need for guidance documents on risk assessment as reflected in many COP-MOP decisions and I think we should not wait for the already produced guidance document to be tested since the 2 processes can go in parallel.

With regards to the topics that need to be considered, I propose the followings:
- Risk assessment of living modified microorganisms and viruses;
- Risk assessment of living modified animals, including fish;
- Risk assessment of living modified pharmaplants;
- “Co-existence” between LMOs and non-LMOs in the context of small scale farming;
- Socio-economic considerations in the context of environmental risk assessment.
-  Guidance on integrating human health into the environmental risk assessment

Regards,
O.A.ElKawy
posted on 2013-02-22 13:38 UTC by Mr. Ossama Abdelkawy, Syrian Arab Republic
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4198]
POSTED ON BEHALF OF PATRICIA GADALETA
-------------------------------------------------

Greeting to all participant and thanks for give us the opportunity to contribute to this forum.

We agree with some of you that it should first tackle the task of designing the tools (questionnaire, actual cases, etc.) to testing the usefulness and utility of the current guidance (especially the roadmap) that has been discussed in the previous forum. But following the mandate to consider the development of new guidance and subsequently make a recommendation to the COP-MOP as Francisca has pointed out, we want to give some suggestion resulting of a survey done between our regulators to answer the questions posed in this forum.

1.-need for further guidance on new topics of risk assessment and risk management,

We have not a real need in this moment but may be some new technologies and developments and new issues about them that are coming in the near future, so always is welcome to have guidance to deal with.

2.-if the need is identified, then in what topics

We agree with some topics referred by other participant will be useful to develop guidance documents, for example: GM trees, GM fish and pharm plants, and we think that these topics should be developed in guidance documents not only in regard to risk assessment but also risk management particularly to the confined release of the two last.

Best regards,
Dr. Patricia Gadaleta
Biotechnology Directorate
Ministry of Agriculture, Livestock, and Fisheries.
Argentina.
posted on 2013-02-22 21:01 UTC by Dina Abdelhakim, SCBD
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4201]
Dear Francisca, dear All,

I strongly believe that we have to continue the process of development of new guidelines on RA and RM. Many countries have expressed their needs to have guidelines on new topics. It would be  not appropriate to ignore their aspiration and requests to have these tools available and useful to involve them in their national decision making practices. 

In my view the guidelines as non-legally binding tools might be useful not only for developers and risk assessors from producer’s countries, and also for risk assessors and decision makers from importing or potential importing countries. This instrument is critically need to help countries to build their capacities in preventing possible impact resulted from the LMOs to the environment, health and economical development.

As Lim Li reminded us, the Strategic Plan for 2011-2020 expressed stipulates “Parties have identified the need for such guidance as an element that will progress their implementation of their obligations under Articles 15 and 16”.  This is also an argument of why we could not stop the process of further development of the new guidelines. 

The list of topics for specific guidelines has not fully realized by the First AHTEG.  During the on line forum many other new topics were proposed as needs of countries and we could suppose that the list will be in continue development.  I believe it is critical not to interrupt the development of new guidelines on the specific topics. My country expresses its strong convictions that the new AHTEG should be mandated not only for testing of existent guidelines, but also to continue work on development of new guidelines for new topics.

It would be very helpful at this stage to involve the valuable experience in providing RA/RM on many specific issues of LMOs gained by many scientific centers, universities, companies, countries.  I may mention here, as ex. GENOK, and also many-many other scientific centers with huge scientific experience in this field. These valorous knowledge and experimental results and practices are extremely helpful to bring them together and make it accessible and available for Parties. That means that the process of development of new guidelines should be continued.

I support  comments by Jack  Heinemann,  Galina Mozgova,  David Quist, Ossama El-Kawy,  Lim Li Ching and many others who expressed their convinction that the mandate of a new AHTEG should involve, along with the task of testing of existent guidelines, as well the task of further development of new specific topics.

Best wishes,

Angela Lozan
Moldova
(edited on 2013-02-23 08:38 UTC by Angela Lozan)
posted on 2013-02-23 08:19 UTC by Angela Lozan
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4203]
Dear Francisca and All
I support   comments by Jack  Heinemann,  Galina Mozgova,  Ossama El-Kawy,  Lim Li Ching , Angelaand many others who expressed their opinion on  the mandate of a new AHTEG to elabore and test  existent guidelines, the further development of new specific topics.

Best regards
Gado
posted on 2013-02-23 17:03 UTC by Mr. Mahaman Gado Zaki, Niger
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4202]
POSTED ON BEHALF OF GEORGINA CATACORA-VARGAS
-------------------------------------------------------------------

Dear Francisca and all,

Since this is my first intervention in this round of discussions, I would like to congratulate Francisca for assuming the role and challenge of being the moderator.

In relation to the questions posted, the last comment from Jack Heinemann (#4196) is absolutely useful to avoid losing track on the aim of the current round of discussions. Although relevant, the last questions suggested by Francisca, are - as stated by Jack Heinemann, related to the testing of the guidance and are not in line with the MOP6 decisions. Accordingly, the following restricts to the first two questions posted at the beginning of this discussion round:

1. Do Parties to the Protocol have a need for guidance on new topics of risk assessment and risk management to be developed?

For Bolivia, the answer is yes. Although under the CPB, we have available some guidance documents, the number of LMOs that they deal with (in terms of organisms and traits) is still very restricted, particularly when compared with the LMOs already introduced into the environment for commercial or field trial purposes (e.g. LM fish, LMO tress, LM microorganisms, etc.), not to mention the ones in the pipeline.

The gaps of knowledge on how to assess the risks of various LMOs recognized back in 2008 (according to the document shared by David Quist (#4179) on the Canada-Norway expert workshop on risk assessment, RA) still remain for various LMOs (e.g. again LM tress, LM fish and veterinary products). In other words, we have not addressed the RA needs yet of important LMOs. This together with the fact that not all countries are dealing with the same LMOs, plus the wide variety of interactions that they may trigger in the environment where introduced, is just a piece of the array of reasons for the need to develop further LMO-RA guidance documents.

Moreover, also in response to some of the previous interventions, it is important to point out that:

- As stated by David Quist (#4171) it is important not to assume what a country needs or does not need. It is also important not to assume that the expertise accumulated by some countries is applicable to others or fully transferable, as suggested by some.

- Following the previous point and Wei Wei´s intervention (#4182), the existence of certain level of experience and expertise in some countries is not a reason to stop searching for better ways of doing things, such as risk assessment and risk management (RA&RM). It is important to improve the current RA&RM framing, methods and approaches in light of the new scientific findings (including the acknowledgement of the things that we still do not know or understand). This is important to avoid underestimating potential adverse effects that – in certain points in time, seem very unlikely to happen and that actually end up taking place. The appearance of herbicide resistant weeds is a clear example (considered in the first RA as a very unlikely event, now as we know, it is an environmental problem in several countries). Preventing us from having more and better RA&RM guidance is a bigger source of embarrassment than having a minimally enough set of RA guidance documents that still need some tuning because they are newly developed.

- Developing more and better guidance documents for having a robust precautionary approach is not synonymous of fear. It is important to overcome the old school of thinking that precautionary science is for fearful countries and prevent development. On the contrary, precautionary-based research helps us to have a wiser approach toward R&D of safer technology and products. Better levels of welfare in other words.

- As mentioned by Galina Mozgova (#4185), the development of new guidance can be done absolutely in parallel to the testing of the currently existing ones. Actually, this approach will result in a much richer and beneficial process since the findings of one could provide useful insights to the other, almost in real-time fashion.

- Finally, as Judy Carman (#4184) and Lim Li Ching (#4183) mentioned, the current guidance were tested and the outcomes of that trial tests fed the corresponding discussions of the AHTEG.


2.If such a need exists, which topics should be considered based on your experience and knowledge concerning risk assessment?

Based on the mentioned above and also in agreement with Wei (#4153), Agnela Lozan (4155), Mahaman Gado Zaki [#4168] Judy Carman (#4184), Ossama A.ElKawy (#4195) and Sarah Agapito-Tenfen (#4197), it will be highly useful and timely if the new guidance documents deal with (at least some of) the following topics (in order of relevance to Bolivia):

1) LMOs introduced in centers of origin and genetic diversity
2) LM Tress
3)  Nutritionally altered LM plants
4)  Pharma and industrial compound-producing LM plants
5) “Co-existence” between LMOs and non-LMOs in large and small-scales
6) LM microorganisms and viruses
7) LM fish
8) LM organisms produced through synthetic biology
9) LMOs created through use of dsRNA techniques

Finally, the following should be crosscutting issues on the new guidance documents to be developed, or new guidance documents by themselves:

-Integration of human health and socioeconomic consideration on risk assessment in the context of the Cartagena Protocol
-Risk management of the potential risks identified

Regards,

Georgina Catacora-Vargas
posted on 2013-02-23 13:53 UTC by Dina Abdelhakim, SCBD
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4204]
Risk assessment and guidance application examples

Dear Colleagues

I would like to reinforce my point of view, which is shared by many experienced risk assessors from countries that have to deal both with GMO risk assessment and with the follow up of the commercial releases (monitoring): new examples are not the Parties priority neither should they follow the systematic under which they were build up.

The guide on  risk assessment prepared by AHTEG is in line with many other recent guides published by government agencies or international agencies or by scientists with experience in this area. After several revisions, the AHTEG guidance reached its maturity, and if corrections are needed, will be just a few ones. However, only its use by the Parties can demonstrate its usefulness, which has not happened yet.

However, the examples of application of the AHTEG roadmap do not the obvious applicability of the guidance and the reason is very simple: a risk assessment is done on a case-by-case basis and makes no sense to group hazards, damage and risk estimates for distinct groups of events, such as all GM mosquitoes or all GM trees. Evidently, each transgenic event has its own characteristics and examples should follow this logic. Thus, instead of quibble over all real and imaginary dangers involved in the use of a transgenic mosquito, the example should concentrate on evaluate an specific event, for example, A. aegypti in the Caribbean transformed with a specific gene construction. Likewise, instead of speculating about all possible risks of a transgenic tree, it would be far more clear and educative to focus the reader attention on only one case, for example, a eucalyptus tree with lower lignin contents, planted in Latin America.

The grouping into a single example of many different events, including different species and different genetic constructs, and the development of a risk assessment of potential hazards without defining geographic area or intended use, an error common to all examples of AHTEG, creates a huge confusion in the neophyte assessors´ minds, precisely those who most need our help. What the examples are now supplying the reader with is a bunch of imaginary dangers, most of them completely fictitious, with no scientifically plausible route that could lead to the proposed damage to some protection goal.

Let me give an example, which has no defined event (neither species nor genetic construct) nor the likely release site or its extension and does not mention the protection goals. The example was  taken directly  from the AHTEG risk assessment of living modified mosquitoes.

“Unintended effects on biological diversity (species, habitats, ecosystems, and ecosystem function and services)  (See “Step 2” and “Step 3” in the Roadmap)
Rationale: The role of mosquitoes in natural ecosystems should be assessed, as the release of LM mosquitoes may have unintended effects on the target vector and pathogen and other non-target species which may lead to adverse effects. Potential unintended effects will vary from case to case and may include:
a) New or more vigorous pests, especially those that have adverse effects on human health:  (four paragraphs follow with arguments)”

Clearly, what is the scientific link between the new genetic trait and the pathogen? Which gene is under scrutiny? Which mosquito species was transformed and which parasite, virus or bacterium does it transmit?  The risk hypothesis advanced in (a) should be supported by scientific data showing that this may happen, either because the new gene is working as expected or because it fails to produce the expected effects. But not a single bit of science-based arguments is given. If, as suggested, these are unintended effects, why then say that they vary case-by-case?

What is the use of a risk assessment example that is not case specific, does not follow the steps defined in the AHTEG guidance and is indeed a compilation of fears and hypothetical hazards without a scientific basis? I am sure all of you that were already involved in the real job of a risk assessment can understand that such the AHTEG approach to write the examples does not help at all a newcomer on risk assessment. Other examples on how to do R.A. for fish, algae or whatever other GMO, if written in the same systematic as displayed in the present examples,  will not shed light on R.A., but will just stay there as a compilation of irrational fears, presenting the GMOS as definitely dangerous organisms that can disrupt the environment and threaten the human health in a million different ways.
posted on 2013-02-24 00:28 UTC by Mr. Paulo Paes de Andrade, Brazil
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4209]
Dear collegues:

I would like to comment the message sent to the forum by Paulo Paes de Andrade. He talks about “imaginary damages” that have been incorporated in the guides.

In connection with that, I would draw attention to the Cartagena Protocol includes the precautionary principle. This principle was incorporated into international environmental law to avoid damage to the environment and human health, so we cannot speak about “imaginary damage” if we want to deal seriously with the precaution principle. Remember also that the risk assessment works with "scenarios". In these scenarios we need to consider the various types of damage that could occur, just to avoid them. That's the idea of precaution, and motivation why negotiators included this principle in the Cartagena Protocol.

Paulo also talks about “fears and hypothetical hazards without a scientific basis”.
The idea of the precautionary principle and risk assessment is to apply when there is no scientific basis, because if the damage has already been tested and do not need assess the risk, but measures for that damage does not go on.


If we treat the specific case of transgenic mosquitoes, their release have so little time we do not know "scientifically" what will be the damage sustained in the medium and long term, generated negative synergies with other environmental and social factors and effects cumulative. The same is true of GM trees.

Yes, we know very little "scientifically" about the environmental and social impacts that will occur for all new GMOs are being released into the environment. But they continue to approve new GM events. It is urgent to do something about it. Our route should be precaution, and based on the best available scientific information.  In order to get this information, new guids can be an important tool.

Sincerely

Elizabeth Bravo
posted on 2013-02-24 21:37 UTC by Dr. Elizabeth Bravo, Acción Ecológica, Ecuador
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4245]
Following my last proposal on the topics that should be included in the list for developing further guidance, I totally agree to include the topic of 'LMOs introduced in centers of origin and genetic diversity' as proposed by our colleague from Bolivia (#4202). This topic is also the most concerned one in China and I appreciate this suggestion. We should take step to protect the genetic resources and it is very important to avoid any contamination and not block their utilization in crop improvement. This topic was list as a point to consider in the roadmap and we should elaborate in details to implement this issue during risk assessment to prevent from any loss.
posted on 2013-02-26 03:54 UTC by Mr. Wei Wei, China
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4252]
Dear Francisca, Secretariat and members of the Forum
Thank you for the opportunity to contribute to this Forum. From the questions you pose there seems to be a marked division in the responses between those who see value in developing additional guidance documents and those who don’t. Part of the difficulty would seem to be a lack of direct evidence for either viewpoint. For example, there is the claim by David Quist that Norway requires additional guidance. The basis of this argument is unclear as Norway already provides extensive worldwide training on risk assessment of LMOs. Therefore it seems somewhat at odds that it wishes to receive more guidance in areas that it is claiming major expertise. Furthermore, is there any evidence that Norway is likely to receive applications for any type of LMO in the near future?
One simple and cheap solution to gain the necessary evidence could be a short survey submitted to National Focal Points from Parties. It could ask each Party
1. What types of LMO have required risk assessment by the national competent authority in the last year?
2. What types of LMO are expected to be received by the national competent authority for risk assessment in the next 2 years?
3. Will the Roadmap and other available guidance documents be used for these risk assessments?
4. Would additional risk assessment guidance material be considered useful to conduct these risk assessments?
5. If so, what topics would be most useful?
Regards
Paul Keese
posted on 2013-02-26 08:02 UTC by Paul Keese, Australia
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4254]
Dear All,

Interesting discussion so far!

A quick response to Paul Keese [#4252] – Indeed here Norway we are fortunate to have extensive expertise and experience with risk assessment (Norway actively participates in the EU regulatory processes through EFSA as an EEA country), and in parallel we have our own scientific authority on the matter. We currently have 3 types of LMOs under consideration for regulatory approval. Further, my home institute in Norway has coordinated biosafety training activities, including risk assessment training over the last 10 years, with over 560 participants from 115 different developing countries during that time.

And it is precisely this experience that has been insighful for understanding that despite our expertise and progress in risk assessement and the risk appraisal process, we do not know everything, and can not (as pointed out by Hans Bergmans [#4253], ongoing technological developments  will often require reflection on informational needs). In some cases, these needs warrant the development of further guidance on particular aspects of types of LMOs in order to conduct a scientifically robust assessment of risks. And the feedback we have gotten over the years from other actors within this field from these 115 developing countries reinforces that there is indeed a need, as we have already heard from others in this forum.

The next step is to start the task of prioritizing topics to inform future processes as invited in Helmut Gaugitsch’s timely intervention [#4232]. So I will take the opportunity to follow his suggestion to “identify their 3 priority topics (if they have any) and ask them for a concise argumentation why they see the need for Guidance on these topics”.

1. LM animals, particularly LM fish - see Canada/Norway workshop report (see post #4179)

2. LM microorganisms, particularly LM viruses – see Canada/Norway workshop report (see post #4179)

3. Human health issues – because there is a lack of guidance in the Protocol (including in Annex III), despite its specific identification as primary aim and protection goal, and because recent scientific evidence suggest that current internationally accepted approaches/experience may be inadequate for accounting for long-term human health effects.

I look forward to reading others prioritized lists.

Best,
David Quist
posted on 2013-02-26 12:51 UTC by David Quist
Response [#4253] and [#4254] [#4259]
Dear Participants

Dear Participants
Having read Hans Bergmans’s [#4253] and David Quist’s [#4254] postings I find myself questioning my understanding of the word guidance. I thought it meant that it was the experience and advice of someone who had been there before and this seems to be consistent with Hans’s use. But David uses in the sense of advice of experts who have not been there before and are speculating on their other experiences. In this case it is the contrast of writing advice before a risk assessment experience is had and writing advice after it is had. I am firmly of the belief that the experience has to be had first before guidance can be given.

I am also concerned about the unsubstantiated comments which create an impression that there is something to be worried about. In this case it is David’s point 3 on human health i.e. “recent scientific evidence suggest that current internationally accepted approaches/experience may be inadequate for accounting for long-term human health effects”. What does this mean? I think many of us would appreciate a little more information to explain this statement.

Regards
Geoff Ridley, New Zealand Environmental Protection Authority
posted on 2013-02-26 22:06 UTC by Dr. Geoff Ridley, Environmental Protection Authority
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4258]
Dear Participants

I would like to congratulate Paul Keese [#4252] for being far more eloquent then I was. He has quite clearly explained the difference between the desires of participants for further guidance documents and there need for such documents. He has also provided an excellent tool for us to determine our actual need for guidance. The only question I would be wary of is 5 as I believe it is answered by question 2 and 4.

Regards
Geoff Ridley, New Zealand Environmental Protection Authority
posted on 2013-02-26 20:36 UTC by Dr. Geoff Ridley, Environmental Protection Authority
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4205]
Hi  Francesca,

Good to see you involved again and thanks for taking on the role as moderator.

My compliments for splitting the issue in two consecutive questions, i.e. 1) is there a need for additional guidance on new topics?, 2) which of that new guidance should be developed by the on line Forum /AHTEG process?

In response to your first question several topics have been mentioned of which the contributors suggest that additional guidance is needed.

Given that many of the suggested topics are quite general and broad (e.g. ‘LMOs with altered nutrition’), it would for this online exchange be very important to get a better idea for which specific aspects of those broad topics additional guidance is felt missing.

For this purpose actual cases need to be used to test to what extent the roadmap gives adequate guidance and for which specific points it does not.

For the latter category, it then needs to be established whether for those points the roadmap needs to be improved and for which of those points guidance should and be developed by the on line Forum/AHTEG process.  Given that resources are limited, this needs be a well motivated choice for which we need clear criteria, as Janet Gough, Sol Ortiz and others have suggested.

In this context, I fully agree with Paulo Andrade, Kathrine Bainbridge and all the others who have stated that selecting topics for which the on line Forum /AHTEG process should develop additional guidance without proper testing, would go against the instructions of the MOP and would be illogical.

The instructions of the MOP are clear and make perfect sense: the existing guidance should be tested first before proposing further guidance to developed. Key in the instruction of the MOP, and indeed in the previous on line discussions, is that such testing is done on the basis of actual cases.

In summary, testing on actual cases serves several purposes, such as:
• Assessing to what extent the roadmap and specific documents provide useful guidance and for which specific points it does not.
• Evaluating whether those specific points are best addressed by revising the roadmap and for which points additional guidance documents would be appropriate
• Establishing which of such additional guidance is best developed by the on line Forum /AHTEG process.

In response to the suggestion that testing has already been done: it is indeed true that some forms of testing have been done. I know of quite a number of people who have read the roadmap and the specific guidance documents, and who came to the conclusion that the guidance is unclear and not very helpful (see the comments of Paulo Andrade and others for examples). No doubt others have -  after a similar exercise - come to another conclusion.

Yet, we have to move beyond general perusal of the documents and start testing as outlined in the MOP instruction, i.e. on the basis of actual cases. Whoever has done such testing on actual cases, please share details.

Looking forward to the rest of this debate

Piet
posted on 2013-02-24 09:16 UTC by Mr. Piet van der Meer, Ghent University, Belgium
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4206]
Francisca:

Thank you for moderating a very lively discussion!

I would like to add my support to those who have pointed to objectives 1.3 and 1.4 of the Strategic Plan and focused us again on the content of decision VI/12 as showing our way forward here.

A number of Parties have already indicated in this forum that there is a need for further guidance on new topics. Although I do not represent a Party, I concur with their views and support them. Guidance is guidance -- and not mandatory -- and it is meant to specifically help developing country Parties. Such guidance should be developed to support those Parties that indicate need.

On the list of topics for which the development of further guidance should be considered, I would include:

1. LMOs released in centers of origin and diversity
2. LM trees
3. LM fish
4. LMOs expressing pharmaceuticals
5. LM algae, bacteria, viruses

I would agree with those participants who have pointed out that prioritization does not imply a particular sequencing, but rather the amount of time and/or energy that might be put towards a particular effort. All the elements of the TOR in the decision are part of the work to be undertaken before COP-MOPVII, including on paras. 1(c) and 3(c) of the TOR.

I would reiterate comments made by others that the testing of the guidance is with the end of further improvement. As pointed out by Lim Li Ching "testing of the existing Guidance package (to improve it) is not a barrier to the development of new guidance on specific topics."

I would also encourage participants to accept that there are scientifically valid differences of opinion between the participants on this forum, and to refrain from attacking different views using such pejorative phrases as "irrational fears." The participants on this forum are all very intelligent individuals, most of whom possess advanced degrees of some sort or another. Just because some conclusions differ from your own does not mean that they are not also based on sophisticated, scientifically defensible understandings of LMOs, risk assessment, and risk management. I hope we can retain a degree of mutual respect as we continue debate in this forum.

Regards,

Doreen Stabinsky
posted on 2013-02-24 17:13 UTC by Dr Doreen Stabinsky, College of the Atlantic
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4207]
Dear Participants

This is my first contribution to this forum and I apologise for starting on a negative note. However this is the third forum in three months. All three forums have straddled the Christmas/New Year holidays, the summer holiday period in the Southern Hemisphere, and Chinese New Year celebrations to name a few. I am concerned at the speed at which these forums have been arranged, the quick succession of the forums, and the poor time all of which has led to what I fear is poor participation. I have tried to participate as often as I can but this is only part of my job and finding the time has been difficult. The reason I point this out is that New Zealand is a country that has developed capacity – if we are struggling to keep up how are those that are under resourced to contribute at the fast pace that these forums are taking place.

Regards
Geoff Ridley, New Zealand Environmental Protection Authority
posted on 2013-02-24 19:42 UTC by Dr. Geoff Ridley, Environmental Protection Authority
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4221]
Good night from México to all!
First of all I would like to greet all participants, and thank you for all your interventions, suggestions, and ideas.
I am just hoping in to make a very small intervention in order to try to clarify my past intervention where I added to new questions to the forum guiding questions originally posted.
It was not my intention to confuse or to lead in any way to believe that you should not discuss the main two questions related to the needs for guidance and for what particular topics until it was clear what the guidance documents are meant to accomplish and how to proceed in creating them.
The reason I added them to the forum was to learn a bit more on the views in relation to “what a guidance document should be aiming at” (in general term or generically speaking, not in relation to any guidance document already developed), meaning…”what are the principal aspects that, under your personal view, should be included in such a document”, and regarding the second question, what/who/how would these de developed.
Although it is true that my questions do not follow the original main questions posted, I believe that discussing them might help shed light and leave aside the discussions on “why guidance should be developed or not” (which I personally believe is not the main issue to be discussed in the forum, but really if need is present or not by Parties to develop further guidance, and by  prioritizing, what the topics to be undertaken would be in accordance with Parties needs).
Remember that risk assessment is an iterative process and that it is done on a “case x case” basis. This points out to the fact that:
1.- even though we might not know much about a topic in relation to risk assessment, that does not in any way prevent us from starting and feeding the process trough time…..
2.- what is known elsewhere might be useful but will certainly not be enough (or precise enough) to a particular case under analysis.
Un abrazo,
Francisca
posted on 2013-02-25 04:55 UTC by Ms. Francisca Acevedo, Mexico
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4234]
I would like to thank Francisca [4221] for the additional clarification that she has provided.  I agree that the additional questions she has posed are important for the discussions since it seems to be that there is a considerable divergence in opinion between the current participants in the forum as to the purpose of the guidance

I remain of the view that it is premature to consider developing additional specific guidance 'document' documents until the testing of the existing guidance has been completed, and I disagree that has already been done to an adequate and comprehensive level.  Ms Li Ching Lim,  [#4220] refers to the earlier 'testing' process - "Testing of the Guidance by Parties, other Governments and relevant organizations, including during capacity-building activities, with a total of 28 submissions made (23 from Parties, one from another Government and four from organizations)".  However, having been involved in this process I am very much aware of the limitations and lack of 'real time' testing involved - this is the reason why we are looking at 'new' approaches to testing.

Geoff Ridley [4208]  states that "Once the road map is tested and any changes made to it then the next task will be to look at the material already provided as guidance e.g. GM trees. Although we need to understand why the road map is not sufficient and why extra guidance is required."  I believe that this i very important as I have not seen any evidence to date suggesting that the Roadmap is not adequate for case-by-case assessment.

I also agree with Geoff [4211] and Paulo Andrade [#4154] that "guidance can only be written from experience. In some of the suggested topics there is no specific experience. In those cases the jurisdiction undertaking the first risk assessment will be provide the beginning of a guidance for all those jurisdiction that are faced with it in the future. The road map, if it is worth its salt, should provide what is needed to start the risk assessment process. As problems are identified by the risk assessors they can then go further afield to acquire experts to help them with the problems that they have encountered. Guidance can then be developed and updated from real examples as they happen."

In summary I remain of the view that before we look at developing new specific guidance 'documents' we should we sure that the existing guidance is adequate and in a suitable form for use by parties that do not have specific expertise.  Also, once we get to the point of starting to identify new guidance 'topics' we should have agreed criteria for prioritising their development.

regards
janet gough
posted on 2013-02-25 19:02 UTC by Janet Gough, Environmental Protection Authority
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4228]
POSTED ON BEHALF OF DR. MARIA MERCEDES ROCA, ZAMORANO UNIVERSITY AND DR. CARLOS ALMENDARES FROM THE NATIONAL COMMITTEE OF BIOSAFETY AND BIOTECHNOLOGY
------------------------------------------------------------------------------------------------

Dear all,

I join others in thanking and congratulating Francisca on her valiant efforts in moderating this lively discussion.

I will attempt to answer the two questions:

1. Need for further guidance on new topics of RA and RM.
The position of Honduras is NO.  The reason is that  the AHTEG has not been able to agree on what the documents are intended to accomplish. If they are meant to be useful guidance, mainly for inexperienced risk assessors (many of whom don’t speak English) then the task  has not been  accomplished at all.  I also concurr with Li-Lim in feeling confussed about the perception  that the  guidance has not  been tested yet. It was  - at least the Roadmap,  in a first round. A group  of regulators from the Honduran CTBio  tested the documents sent in 2012 and found the text dense and  very difficult to understand. We invested a lot of time and effort in this exercise and  would hesitate to do it again and find  the same result. Our time and resources are very limited and we have to prioritize our time. Please don’t  make the task  for parties with few resources even bigger.

As many have pointed out, there are many good, well written documents  on risk assessment and risk management already  available in several languages.  As a  regulator for Honduras and an instructor for the region,  I need to point out again and again, that guidance documents (or indeed any “teaching documents”) need to be in the language of  the people who will use them.  Translating a guidance with technical terms used in one language to  another language is a HUGE and diffciult task! Ask anyone who is trying to do it.  Professional translators  not familiar with Risk Science cannot  do this properly without creating a very confussing text. I am speaking from experience, as I am editing a translation from a Spanish ERA guide we developed for Latin America. Some of the original text was in Portuguese, so  to job was even bigger.

I congratulate our colleague Georgina  for her flawless English, but ask if inexperienced regulators in Bolivia will be able to understand a dense, tecnnically complex text in English on Risk Assessment. The answer   for Central America  is NO.

However, on the positive side,  there is a regional training workshop on Risk Assessment  for capacity building for Central and South American regulators taking place in Costa Rica next week. The instructors have  been busy preparing the Risk Asessment  material in Spanish from excellent already available  material . The instructors are experienced risk assessors from North and South America with hands-on experience on what they are teaching. Learning  “from a book” (or a document) is not the best way to learn anything. The “learning by doing”  is the best way.  We might be able to discuss the AHTEG guidance documents and may be able to comment on the usefulness,  as a regional group,  next week.    Also, we will be fortunate to have a field visit to the GM salmon facility in Panamá and  make up our own minds about  many  safety issues. 

2. Developing further guidance on other topics seems premature and a big investment in time and effort, before the usefulness of the guide is established. If you go ahead,  be prepared to translate it into other languages for it to be useful with the help of experienced risk assessors and not just official translators. Does the Secretariat has all these resources? How much more time can we invest on this?  Assuming that most developing countries will find these guidance  useful is premature.

Best regards and Carlos and I  join Francisca in saying in Spanish, un gran saludo desde Honduras.
posted on 2013-02-25 14:46 UTC by Dina Abdelhakim, SCBD
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4229]
Let me comment on some of the topics so far suggested in this forum. I would like to know why these topics are being suggested. Is there a specific need of risk assessment to be done on these topics in the near future? If yes, on what specific LMO or specific trait?

1. Risk assessment of living modified microorganisms and viruses

First of all, it may not be wise to consider a guidance which covers all the different segments of microorganisms, i.e., viruses, bacteria/archaea, fungi, and microalgae, because they are quite different in their biology, in their interaction with potential hosts, in their interaction with potential environments, and more importantly in the experties required for the risk assessment. It seems to me that many of the participants who are calling for a guidance on LM microorganisms are specifically referring to LM viruses but not to other types of LM microorganisms. If so, it would be much more productive to concentrate our discussion on LM viruses.

In Japan, we are assessing risks of hundreds of LM bacteria (Escherichia coli, Bacillus subtilis, etc) and LM fungi (yeasts, aspergilli, etc.) every year, but all of them are for contained use. We also assess risks of some LM baculoviruses, but again they are used under strict physical and biological containments. On the other hand, we have no experience of risk assessment of LM microorganisms for environmental use, and no product is even on the pipeline (maybe except some LM viruses for medical and veterinary use?). Even in such countries as US, as far as I know, only a few LM bacteria/fungi have so far been assessed, for their experimental release under strictly confined conditions. We still have a lot to be learned from laboratory works on, for example, how inserted genes will be propagated in the environment and how such propagation may or may not pose a risk to biological diversity. I would therefore say that there is no urgent need for a guidance for environmental risk assessment of LM microorganisms, especially in developing countries who are unlikely to be the initial targets of experimental release, and also say that we are still at an immature stage to formulate our experiences and knowledge into a science-based guidance.

2. Risk assessment of living modified organisms produced through synthetic biology.

"Synthetic biology" is quite a conceptual term, like other terms as "systems biology". Scientist often invent such conceptual term to gain advantage in getting research funds :-) From technological viewpoint, or from a viewpoint of product-based risk assessment, there is nothing new in synthetic biology compared with conventional LMO. Craig Venter's synthetic bug? It is nothing more or nothing less than a Mycoplasma judging from its final genetic makeup. Is synthetic DNA technology the key to synthetic biology? Obviously NO. Synthetic DNA technology is now routinely used in the construction of various types of LMOs to bypass cumbersome cloning steps, to overcome codon usage biases, and so on. There is no reason to believe that such synthetic DNA segments are more harmful or less harmful than DNA segments obtained by conventional cloning or recombination method.

According to the definition of LMO in the protocol, any organism that contain "novel" combination of genetic material obtained through the use of modern biotechnology should be regarded as a LMO. Novel combination here means any combination that overcome natural physiological reproductive or recombination barriers. Again, there is no reason to believe that so-claimed "synthetic organism" with novel combination of genetic materials can be exempted from the regulation, or to believe that "synthetic organism" needs special and additional consideration in its risk assessment, although risk assessment will become tougher and tougher as the
extent of foreign genetic elements, either synthesized or cloned, increase.

Nobuyuki Fujita
National Institute of Technology and Evaluation (NITE), Japan
posted on 2013-02-25 14:49 UTC by Mr. Nobuyuki Fujita, Japan
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4232]
Dear Francisca, dear colleagues,

first of all I would like to thank you Francisca for moderating this round of online-discussion and guiding us in a very able manner through these important discussions.

I think it is very appropriate and timely to address the questions you posed at the outset of this online discussion forum and I do not see a conflict at all with the other tasks listed in the terms of reference of the open-ended online forum and AHTEG. It is true that para 1c) of the terms of reference gives the consideration concerning the development of guidance on new topics less priority than the testing (para 1a)) and the development of a package that aligns the guidance with the training manual (para 1b)). However, if we look at the expected outcomes we see in para 3c) that the open-ended online forum and AHTEG has to develop "a recommendation on how to proceed with respect to the development of further guidance on specific topics of risk assessment ….”. We all know how fast time passes and it is therefore very important that we start thinking at an early stage on how to accomplish this task. I think it would be very productive if we use this expected outcome as a reference point for our discussions

I will try to answer Francisca`s very useful questions one after the other:

Question 1: Do Parties to the Protocol have a need for guidance on new topics?
I think the answers have been diverse but very clear and we do not need to start from zero. The Canada/Norway Workshop and rounds of discussion during the previous AHTEG and online forum have provided a clear signal concerning the need by some experts from Parties. Others do not see the development of new Guidance as a priority. The advantage of Guidance is that it is not prescriptive – those who see a need and do want to use can do so while others may decide not to do so. What may be improved is the supply of arguments why certain type of Guidance is needed. In this context Francisa`s question provided in her second intervention (4192) of 22 February provides a very good basis:

What are the documents on new topics intended to accomplish?

The way I see it that new Guidance should complement Annex III of the Protocol and the Roadmap (tested and further improved if needed in the future), and already established additional Guidance on specific LMOs and traits (also tested and improved if needed in the future). The topics depend on new and emerging types of LMOs and applications where developers and risk assessors see the need for further guidance to be able to accomplish their task. By the way, I am not of the opinion that general guidance on certain topics of risk assessment is not necessary as we always have to follow a case-by-case approach. On the contrary, the case-by-case approach needs solid guidance on a general level as a basis!

Question 2: If such need exits, which topics should be considered?

Here again I think we do not have to repeat discussions we already had and start from zero. The Canada/Norway Workshop, the previous AHTEG and online forum have developed a list of topics based on a structured approach, which can be retrieved from the reports of the previous AHTEG. Some of the topics were taken up by the previous AHTEG and guidance has been developed, which will be now further tested and if needed improved in the future. Other topics are still on the list and wait for further work to be done on them. We can always review this list and modify it - in fact we should do that. And we can and in fact should discuss working methods to improve the structured approach to proceed with respect to the development of further guidance. In fact this is our task and the expected outcome. Here again Francisca`s additional question is very useful:

What process should be followed in creating them?
I think that we should allow experts to identify their 3 priority topics (if they have any) and ask them for a concise argumentation why they see the need for Guidance on these topics. Based on this and in a second round I think it will be quite straightforward to come up with a very good recommendation on how to proceed which should be taken up by the new AHTEG in its possible face-to-face meeting.

Thank you for this opportunity to provide my thoughts and I am looking forward to the continuation of this debate. Best wishes

Helmut Gaugitsch, Environment Agency Austria
posted on 2013-02-25 16:26 UTC by Mr. Helmut Gaugitsch, Austria
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4233]
POSTED ON BEHALF OF DR. MARIA MERCEDES ROCA, NATIONAL BIOSAFETY COMMISSION, HONDURAS
----------------------------------------------------------------------------------------------

Dear all,

I would like to support the statement by Professor Hodson from Colombia in  clarifying that agronomic  technical considerations are very different from  biosafety consideration.  Our mandate as regulators and risk assessors is to assess the potential for  harm of  a GM  product, not it’s agronomic efficacy. The risk managers, with the help of experienced agronomists and entomologist will decide on agronomic issues and the final decision (this is the realm of socio-economic considerations). A case-by case approach is essential.

Colombia was very right in deciding they did not need a GM variety that controlled Diabrotica if this was not a bad problem (at the time) for Colombian farmers.  On the other hand, we in Honduras, have a big problem with this particular pest and are finishing confined evaluations to see if this particular Bt technology would be useful for our farmers. The safety of this product was established a long time ago and is being  used in many other  countries We may well decide soon that yes, the technology is safe, it is very useful for farmers and we may adopt it.    Again, these are socio-economic considerations that belong to risk management. They are not  risk assessment issues.

We went through the same process in Honduras when  deciding if  the other Bt toxins managed our other  bad maize pests (Eg Spodoptera fugiperda) . They did control our pests  – very well. Since adopting Bt maize, our farmers (big, medium and small)  have stopped using a lot of pesticides that used to harm their health, the environment and cost a lot of money to buy. So we have seen many benefit for our farmers, the economy, the environment and human health. Yields have trebled or quadrupled if farmers also use the right agronomic practices. Everybody wins!  We by the way, are documenting this through a very detailed study in collaboration with IFPRI in Washington and the University of California Davis.

Excessively onerous regulation in neighboring countries were this technology is forbidden, has resulted in farmers smuggling seed from Honduras to also get the benefits Honduran farmers enjoy.

Another clarification that  some our non-agricultural  colleagues may find  useful,  relates to the concern  that  weeds  may acquiring resistance to herbicides. This is a common occurrence in conventional agricultural, but it is a problem for the farmer and indeed for the industry that produces the agrochemical as their sales will drop if the product is no longer useful to farmers. It has always bewildered  me why our environmentalist  colleagues  will worry about this. A weed that is resistant  to a herbicide (and is not killed)  is wonderful news  for the weed itself and for the  many insects that may feed on it, so it is good for the ecosystem.  In this case, biodiversity wins, agriculture loses.

I would also like to   ask my dear colleagues  to explain to me what it is meant by “LMO viruses”  and why  they are concern to our group. Is this the same as RNAi technology?  Or  is it a technology  now  used in medicine and veterinary uses?  If the latter is the case,  it should not be our mandate to discuss this any more than we don’t discuss insulin made through genetic engineering or indeed stem cell research.

I want to thank the group again for their valuable input. I am learning a lot.

Best regards,

Maria Mercedes
posted on 2013-02-25 16:26 UTC by Dina Abdelhakim, SCBD
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4235]
Dear all,

I see many new suggestions for new topics coming from participants of the forum. What I can say, these topics reflect a country’s need, and usually they are point of interest not for only one country. Thank you colleagues for formulating them. I fully agree with the arguments involved by Jack Heinmann, David Quist, Georgina Catacora-Vargas, Sarah Agapito, Ossama ElKawy, Lim Li Ching to show us that the development of new guidelines on request of Parties is not excluded. As Jack Heinemann [#4169] stated, “Countries have a right to apply risk assessment on these products and I respect their rights and reasons for seeking specific guidance…The AHTEG can both develop new guidance and make recommendations as to further guidance that may be developed in future sessions.”


From my prospective, I would propose a compromised approach in the further actions and specifically to go on in parallel with the testing of the Roadmap and also to develop in next timeline at least of 2-3 new specific guidelines on agreed by all priorities. This would be a really good compromise and will bring together all opinions to meeting the goals of the Protocol.

Allow me repeatedly listing the identified topics as proposed by several participants:
-  LMOs introduced in centers of origin and genetic diversity
-  LM Tress
-  Nutritionally altered LM plants
- “Co-existence” between LMOs and non-LMOs in large and small-scales
-  LM microorganisms and viruses
-  LM fish
-  LM organisms produced through synthetic biology
-  LMOs created through use of dsRNA techniques
-  Integration of human health and socioeconomic consideration on risk assessment in the context of the Cartagena Protocol
-  Risk management of the potential risks identified
-  Socio-economic considerations in the context of environmental risk assessment
-  Guidance on integrating human health into the environmental risk assessment
-  LMOs designed to produce pharmaceutical or industrial products, including effects on both vertebrate and invertebrate pests.

I would very much support proposal made by Georgina Catacora-Vargas [#4202] related the specific guidance on LMOs introduced in centers of origin and genetic diversity. It is one of the key concerns of people on the glob to preserve the centers of origin and, no doubts, is a common understanding of all countries. I would like to suggest this topic to be a priority nr.1 in the list. According to N.I.Vavilov (1926, 1935), the eight centers of origin of crops are classified:
http://agriinfo.in/default.aspx?page=topic&superid=3&topicid=2099 .
As Georgina pointed out in relation of Bolivia,“we need experience, but the experience can be built upon proper guidance documents and capacity building since the former will not take place spontaneously”.

The guidance could not be developed just on base of experience of one country. My understanding is that the guidance should involve the experience of counties who practices the RA on that specific topic, and also academic approach and hypotetical questions. The guidance might and should be improved and completed with the new knowledge and scientific information as it is become available.

I would like to ask Dr.Geoff Ridley, why he consider that New Zeland have enough capacities in RA? If we check BCH, no one record on RA published by now.http://bch.cbd.int/about/countryprofile.shtml?country=nz
I am very surprised to see when someone believe that everything is done and no place for progress and perfection.

As a reply to Dr.Piet van der Meer [#4205] “I know of quite a number of people who have read the roadmap and the specific guidance documents, and who came to the conclusion that the guidance is unclear and not very helpful”, as the participant to the first AHTEG, he contributed a lot for the quality of the document, and I am surprised to see his uncertainty in the quality of the document. From my side, I discussed the roadmap with my colleagues in my country, they stated that it is a very good guidance, have a logic and clear structure and consistency and is very useful for evaluators and decision makers.

Wish you continuation of interesting discussion and getting consensus.

Best regards,

Angela Lozan
posted on 2013-02-25 19:13 UTC by Angela Lozan
Response to #4235 [#4243]
Dear Participants

Angel Lozan posted “I would like to ask Dr.Geoff Ridley, why he consider that New Zeland have enough capacities in RA? If we check BCH, no one record on RA published by now.http://bch.cbd.int/about/countryprofile.shtml?country=nz I am very surprised to see when someone believe that everything is done and no place for progress and perfection.”

New Zealand’s legislation, the Hazardous Substances and New Organisms Act 1996, deals with all intentional introduction of new organism, which is roughly equivalent to any species not already in New Zealand and all GMOs. As a result we do risk assessment on organisms ranging from viruses to elephants to Wollemi pine and all GMOs. We do not have the luxury to wait for guidance to be developed as we have statutory timelines in which we must complete our assessments. Thus we seek the experts and the information to help us complete them. Each time we assess a different type of organism we learn something new to add to our body of knowledge on conducting a risk assessment.

I do not believe that everything is done, nor do I believe that we should not strive for progress and perfection. What I am not convinced of is that the development of guidance through this process is going to contribute to this progress. I also cannot understand is why so many countries seem to be sitting on their hands waiting for other to develop the guidance they need.

Regards
Geoff Ridley, New Zealand Environmental Protection Authority
posted on 2013-02-26 00:33 UTC by Dr. Geoff Ridley, Environmental Protection Authority
RE: Response to #4235 [#4246]
I strongly feel that Dr. Geoff Ridley is trying to encourage the developing of guidance by individual parties other than developing an internationally agreed one within Biosafety Protocol. That is a way that distracts our current direction. Of course New Zealand is now in a position in developed world and has many advanced regulation systems. However, this is definitely not a constructive way to contribute to our current work but a risk to destroy any progress that the parties, especially the developing countries, struggled to achieve. Please remember that we are sitting together to discuss under one same Protocol as parties.
posted on 2013-02-26 04:36 UTC by Mr. Wei Wei, China
RE: Response to #4235 [#4247]
Dear Participants

New Zealand is a small country of 4 million people and agricultural dependent nation, and we have nowhere near the resource that China has so I think it is a little unfair to say that we are in the position of a developed world and has many advanced regulator systems. Rather we try to focus on what is import and spend our resources wisely. As I have said many times the focus here should be the testing of the road map that was we said at Hyderabad. If the road map does what we want it to do then we can consider testing the specific guidance topics developed so far to see if they do what we want. After that we can turn our attention to further guidance.

However, in the meantime I have outlined a reiterative process that would allow the scientific based development of guidance that all could contribute to overtime. A living, working guidance based in reality rather than a cookbook approach. I would also point out that any guidance developed here will not be an internationally agreed one it will be one agreed to by the Parties to the Protocol to which some significant countries are not a party to.

Regards
Geoff Ridley, New Zealand Environmental Protection Authority
posted on 2013-02-26 05:04 UTC by Dr. Geoff Ridley, Environmental Protection Authority
RE: Response to #4235 [#4249]
I beg to disagree with Geoff's statement that "I would also point out that any guidance developed here will not be an internationally agreed one it will be one agreed to by the Parties to the Protocol to which some significant countries are not a party to."

Any country can choose to use the guidance whether a Party or not. We cannot assume we know the actions of non-Party countries.
Non-Party governments are part of the history of the Protocol, and very much a part of the history of the AHTEG and this guidance.
All countries not a Party to the Protocol are significant.

All the best for continuing discussion.
Jack
posted on 2013-02-26 06:13 UTC by Mr. Jack Heinemann, University of Canterbury
RE: Response to #4235 [#4250]
Dear Dr. Geoff Ridley and all,

Sorry for the incorrect impression I got from your interventions. But Developed or not is not my question. My concern is the development of guidance on specific topics we need. The documents we developed are of course within the Protocol as I already mentioned in my last post. I agree to you that the agreed guidance doc did not necessarily need to be agreed by non-parties.

As we have to conduct risk assessment case by case taking into consideration of special environment in each country. The guidance documents are nonbinding and provide us guidelines with sound sciences to prevent us from forgetting some necessary points and leading to mistakes during assessment. Each party may choose to conduct their own assessment and thus I do not see any reason that any party will be against for developing further guidance.

Best regards

Wei
posted on 2013-02-26 07:07 UTC by Mr. Wei Wei, China
Response to #4250 [#4256]
Dear Participants

I thank Dr Wei Wei [#4250] for his clarification. I would also like to re-emphasise my point – I am not opposed to further guidance being developed. What I am challenging is how this guidance is to be developed. As Janet Gough [#4248] has said guidance need to be developed from case-by-case risk assessment. My experience of guidance produced before the fact is that it end up being of little use and then we spend a great deal of time justifying why we do not use it.

As an example China has a decade’s experience of LM poplars. Why does China not take the lead in developing guidance for LM trees based on its poplar experience? Then one day New Zealand might be able to use that guidance in an assessment of GM pines, should we ever receive such an application, and then we to could contribute to the guidance from our experience.

Regards
Geoff Ridley, New Zealand Environmental Protection Authority
posted on 2013-02-26 19:53 UTC by Dr. Geoff Ridley, Environmental Protection Authority
RE: Response to #4250 [#4261]
Dear Colleagues,

In light of the discussion that has ensued since my one intervention, I would like to offer a brief clarification and final thought.

First, on the question of whether additional guidance is needed, my answer is "not now given the current circumstances".  I don't want to leave the impression that my answer is an emphatic “No and Never”.  For me circumstances must change.  Most importantly, we have to first present a roadmap to MOP7 that meets their approval.

Second, I want to come back to the basic question that has been raised by a few, which is what purpose shall the guidance serve.  I believe the opinions concerning the objective of guidance under the Protocol as expressed by experts in this forum are widely divergent and probably irreconcilable.  It is good that it is not this forum that has the responsibility to set strategy. However, Parties should answer this question prior to reviewing the roadmap in Korea for without knowing your course you cannot know your way. 

Finally, as I have mentioned in many postings before, the developer sector hopes that guidance is an enabling tool; assisting regulators and other authorities to make timely and appropriate decisions.  The guidance, like the Protocol, should serve to enable the deployment of appropriate LMOs that will serve sovereign societies and their views on objectives of the CBD.  I would be concerned if the purpose of guidance became in essence a mechanism to delay, disable or cripple this specific technology without some valid basis, which the weight of evidence to date shows does not exist.  I am convinced that all experts in this forum have some objective they wish to achieve through the guidance under development.  My objective is very transparent.  However, Parties will ultimately have to decide whether the Protocol becomes an enabling tool.  And the question at hand relevant to this matter is what form will the roadmap take and what, if any, further guidance will be developed based on the roadmap?

Thanks to all for your many ideas.

Tom
posted on 2013-02-26 22:58 UTC by Mr. Thomas Nickson, Consultant
RE: Response to #4235 [#4248]
In Response to Dr Wei Wei
May I beg to disagree (and Geoff please correct me if I am wrong).

In my view Geoff is trying to direct us towards ensuring that the existing guidance is robust and useful before we try to extend further.

Risk assessment can only be conducted on a case-by-case basis - that is the intrinsic nature of risk assessment.  The Guidance provided in the Roadmap is of a generic nature intended to assist parties in ensuring that the process they use for their risk assessment is sounds.  The science they use is up to them.

regards
janet
posted on 2013-02-26 05:06 UTC by Janet Gough, Environmental Protection Authority
RE: Response to #4235 [#4255]
POSTED ON BEHALF OF MARIA MERCEDES ROCA
-------------------------------------------------------------
Dear colleagues,

I read with interest and I must admit, some bewilderment too, the growing list that some parties suggest we add to an already long, complex, expensive and time consuming process. Maybe I am too new  to this group, but does the Secretariat or some  kind of  benefactor has and endless supply of resouces and people have endless time to dedicate to this?

I suggest we take one step at a time and finish one task well, before we tackle the next.

I was also a little surprised by Wei-wei´s use of non-technical   terminology in a forum of this nature.  To suggest that the possible introgression of a gene (whether it comes from rDNA technology or not) is  ¨contamination¨ is a very allien concept in plant breeding and indeed in an evolutionary biological process.

Honduras is a center for diversification for maize and the government approved GM maize cultivation 10 years ago. The creolle varietis (or local landraces) continued to be used by poor farmers, continue to yeield very low productivity and they are mostly stored in seed banks for future plant breeding if required. So far, all the post- realease monitoring evaluations have showed no adverse effect to these varieties.

So, I must put your mind to rest Wei-Wei, that so far, we have not seen any disasters from ¨contamination¨. We do see  however, plenty of disasters with real, natural insect pests, viral, bacterial and fungal pathogens that attack our crops and threaten our food security every day. This has becme much worse with climate change.

Risk analyisis also exists for pest and diseases but none of our poor countries has the resources to engage in these to find mitigating actions. For example our coffee production is severly threatened by coffee rust - a fungal pathogen that came from other countries and is threatening the economy of Central America. We have to be pragmatic when it comes to thinking about ¨the  real enemy¨and where to put our resources.

Best regards to all from Costa Rica (at a regional risk assessment workshop in Spanish)

Maria Mercedes Roca
posted on 2013-02-26 12:52 UTC by Dina Abdelhakim, SCBD
Response to #4255 [#4260]
Dear Participants

I would endorse Maria Roca’s [#4255] comment that we “we take one step at a time and finish one task well, before we tackle the next.” I also agree with Maria that we need to identify what the real risks are and not be concerned with hypothetical risks that no one seems to provide any supporting evidence of their existence.

At the risk of being repetitious we need to focus on the road map.

Regards
Geoff Ridley, New Zealand Environmental Protection Authority
posted on 2013-02-26 22:19 UTC by Dr. Geoff Ridley, Environmental Protection Authority
RE: Response to #4255 [#4262]
Dear collegues:

I'm confused with the direction you are taking this discussion. We talk about hypothetical risks and probable risks. The essence of risk is uncertainty. That is why the risk evalaution works with risk scenarios and makes an analysis of likely damage occurs.

Given that genetic modification is changing the essence of life, and although many people say that all the risks have already been identified, and of course, we know how to handle them, the field evidence shows otherwise. The GM crops are totally unexpected impacts generated both by effect of the genetic modification as per the applied technological package.

Now proposes new GM, for example transgenic mosquitoes, of which we really know very little, and is an obligation of regulators trying to identify most of "hypothetical risk" for these mosquitoes have been released no damage on human health and biodiversity.

On the other hand it says that "Need to be Developed guidance from case-by-case risk assessment". If that's the case, they are not guides, are individual risk assessments.

Sincerely

Elizabeth Bravo
posted on 2013-02-26 23:01 UTC by Dr. Elizabeth Bravo, Acción Ecológica, Ecuador
Response to #4262 [#4264]
Dear Participants

I should apologise to Elizabeth Bravo [#4262] for introducing the unnecessary term “hypothetical risk”. What I was alluding to were statements like LMO cause “long-term human health effects” and no evidence is cited but if it is said often enough people begin to believe it. Too often a claim for a risk is made without proof. I must also note that Elizabeth does this as well in the statement “Given that genetic modification is changing the essence of life, and although many people say that all the risks have already been identified, and of course, we know how to handle them, the field evidence shows otherwise. The GM crops are totally unexpected impacts generated both by effect of the genetic modification as per the applied technological package.” Please elaborate as to what these totally unexpected impacts are and how they differ from any other new plant?

I also think that we over-think the risks. I previously listed of questions for GM salmon that we would ask in New Zealand. Questions you might ask for mosquitoes
• Do GM mosquitoes have any more of an adverse effect on biodiversity than non-GM mosquitoes e.g. do they feed on a wider range of organisms than non-GM mosquitoes?
• Does the collapse of the target mosquito population from the introduction of GM mosquitoes have an adverse effect on biodiversity? E.g. an adverse effect on their predators such as mosquitoes eating fish?
• Do GM mosquitoes behave differently from non-GM mosquitoes that causing an adverse environmental effect (e.g. major host switch)?
• Are humans adversely affected by being bitten by GM mosquitoes that is different from being bitten by non-GM mosquitoes?
• If an adverse effect can be established how does this compare with the use of an insecticide or the human health issue if nothing is done?

After that I really struggle to see what else is relevant. If you can answer these questions I think you have completed the bulk of an environmental risk assessment (obviously it still needs the socio-economic assessment).

Regards
Geoff Ridley, New Zealand Environmental Protection Authority
posted on 2013-02-27 00:54 UTC by Dr. Geoff Ridley, Environmental Protection Authority
RE: Response to #4262 [#4267]
Dear participants

I am concerned that Geoff Ridley [#4264] may be going off-track.  A discussion as to whether there may or may not be human health effects from LMOs, and the evidence for and against positions on this issue, is, to my understanding, not a discussion for this forum.  However, as a result of what Geoff Ridley has written, I have been led to believe that Geoff Ridley may be suggesting that he sees no need for further guidance for integrating human health into the environmental risk assessment.  Is this correct?

I also believe the Geoff Ridley has gone off-track for suggesting actual questions that could be included into a risk assessment for mosquitoes [#4264] (as he did before with salmon).  Surely, any such questions are not only beyond the scope of this forum, but should be developed in conjunction with a team of experts who have many years of experience in mosquito biology, mosquito habitats and diseases carried by mosquitoes, such as dengue and malaria.  I am not aware that Geoff Ridley has this expertise.  Surely, this provides a sound reason as to why a specific guidance document is required for LM mosquitoes.  Developing such a document would allow world experts in these areas to be consulted so that the guidance is sound.  And it would prevent numerous countries  having to scramble to find experts themselves to determine how they could fit LM mosquitoes into the existing guidance.  Surely it is worth doing this once instead of many times over in separate countries? 

As we have found out numerous times, mosquitoes tend not to stay-put in one country.  I am aware, for example, of a new species of mosquito being imported into a country with a shipment of tyres (“tires” in the US), because there were small puddles of water in the tyres and the mosquitoes bred in them all the way across the ocean to their new home.  International experts, rather than home-grown ones, are more likely to be aware of such circumstances and the potential effects of any importation of a LM mosquito on their own countries.

Can I  also ask for clarification as to what Geoff Ridley meant by “we over-think the risks”?  For example, who is the “we” he is referring-to and what does he mean by “over-thinking”?

Kind regards to all

Judy
posted on 2013-02-27 06:29 UTC by Dr Judy Carman, Institute of Health and Environmental Research
RE: Response to #4262 [#4268]
Dear all.

Dr. Geoff Ridley is not off-track in relation to his arguments on the long term impact of LMOs in human health, as suggested by Dr. Judy Carman. The main issue is, obviously, the lack of any scientific support on Dr. Quist´s plea that LMO´s do have such impact. It is simply not correct to present LMOs as powerful disruptors of the environment or true threats of human and animal. Neither there is evidence for that not are they genetically prone to be such dangerous living beings. Dr. Ridley´s concern is also my concern, because
a) a couple of posts in this forum do say that LMOs are far more than dangerous that we know they are;
b) the specific examples in the guidance also follow the same track: GM trees and GM mosquitoes, for example, are clearly presented as far more threatening than crops.
If new specific guidance comes again with such Armageddon flavor, I am sure that it will be of very, very limited used for any risk assessor.

To finish this post, I would like to argue against two points of view expressed in this online forum and in the specific AHTEG guidance;
a) Generalizations on risk assessment are dangerous, as the evaluation follows a case-by-case methodology. Let us take, for example, Dr. Carman´s statement that “as we have found out numerous times, mosquitoes tend not to stay-put in one country”. It is true for some mosquito species (specially Aedes aegypti) but is not true for the GM mosquitoes under evaluation in Brazil and that have been studied in the Cayman Islands. These mosquitoes die after a few days and their spread, either by flying (usually no more than a few hundred meters) or by any human-aided method, is irrelevant. Such generalizations are spread over the specific guidance texts. As another example, GM trees, being perennial, are assumed to be far more dangerous than GM crops. This is far from being true in the case of eucalyptus in areas where there are no native plants able to hybridize with eucalyptus. Indeed, eucalyptus has many characteristics that make of it a very safe GM tree. The demonization of all GM trees, grouped together, is not scientifically sound. In conclusion, general texts on large groups of LMOs are of limited use. Much more useful are the previous risk assessments made by many countries around the world, which can be found in the site of the ICGEB (http://www.icgeb.org).
b) Lack of appropriate knowledge is frequently presented as an argument to produce new specific guidance or simply to prevent the adoption of the technology. This is not true for most of the LMOs currently in the market and for those being assessed by the national authorities. Take as an example the RIDL GM Aedes aegypti. The biology of this vector is very much studied, including its relations to the environment and to the viruses it transmits. All relevant questions for the risk assessment can be plainly answered with the present knowledge. The same is true for many perennial plants and microorganisms. Before stating that there is lack of knowledge, we should be aware of what the relevant questions for R.A. are.

Kindly
Paulo Andrade
posted on 2013-02-27 12:12 UTC by Mr. Paulo Paes de Andrade, Brazil
Response to #4262 [#4277]
Dear Participants

My apology to Judy Carman [#4267] for not being clear and for confusing her.
I support the development of guidance that is a living document and based on real experience and have said this repeatedly in this forum. However I question what is being called guidance here is in fact guidance. There appears to me to be many jurisdictions that have been scared by those who claim monsters under the bed but never provide proof of their existence. One of the monsters mentioned in this forum was GM mosquitoes so I went away and had a bit of a look. I looked at the draft guidance framework at WHO http://www.who.int/tdr/news/2012/GMM_Guidance_2012.pdf and if this was my first exposure to do a risk assessment on these LMO I would panic – it is a turgid and dense document. So I then asked myself what would I need to know to start fleshing out a risk assessment – and those where the questions I posted. Suddenly the whole process was less daunting. My point here is that much of the a priori guidance does not facilitate risk assessment.

I also thank Judy for pointing out my lack of expertise. By looking at the list of participants you will see my details. I am a principle scientist and I work as part of a team to do risk assessment. When I am in doubt here I go and talk to my colleagues before posting. I work for the risk assessing government agency of a Party, I am a National Focal Point for the BCH, and I am a biologist.

I thank Judy for pointing out the information on the inadvertent transboundary movement of mosquitoes. I live 10 km from such an inadvertent establishment of an exotic mosquito species and the on-going attempt to eradicate it so I am quite aware of this problem. For countries with contiguous borders with other countries some risk assessment will indeed need to be regional rather than country specific however that does not change the basic question that need to be asked.

By ‘over think’ I mean documents like the one I have provided the link to. It is so over the top that it scares people and as a result impedes risk assessment. Again the point I was making by posting my mosquito questions was to show that the questions we need to address are often simple, but I do agree that getting the appropriate data often is not easy. Guidance should be clear and simple and I do not believe that the process here will deliver such a product. The ‘we’ – I hope that I am not part of the ‘we’ by not supporting the development of this type of a priori guidance.

Regards
Geoff Ridley, New Zealand Environmental Protection Authority
(edited on 2013-02-27 20:42 UTC by Geoff Ridley)
posted on 2013-02-27 20:40 UTC by Dr. Geoff Ridley, Environmental Protection Authority
RE: Response to #4262 [#4296]
I have read with interest some of the comments regarding GM mosquitoes (#4255 and #4262), and I would like to offer to the forum the following perspective:

The guidance and roadmap should be suitable for all LMO's, although has been developed predominantly on the experiences of risk assessment gained with GM crops.  Therefore I believe there is a gap that has been potentially overlooked : the recipient crop is not in itself intrinsically harmful, it is generally regarded as safe whereas a  recipient mosquito (and potentially viruses and bacteria on a case by case basis) either are already harmful or have the potential to be harmful.  Genetic changes are being developed in mosquitoes to make them less harmful by either reduction in vector numbers or modifying the mosquito to a less harmful form.   Consequently the risk assessment should take into consideration that a mosquito ( or virus or bacteria ) " should do no more harm " than the existing insect, which is a recommendation in the WHO draft Guidance document  mentioned by Mark Benedict as well as other guidances on GM insects.  

Additionally as a risk management tool there should be consideration of the alternatives - either no-action or continue with existing actions - in the case of GM mosquitoes a" no-action" ( not allowing the release of the mosquito (or equally applicable to a less harmful form of virus or bacteria) could result in a more harmful outcome to the human population than the release of the GM version and the continued use of residual insecticides could result in more harm to the environment than the use of the GM mosquito.  It is therefore this context that should be considered in the Roadmap and future Guidance documents which also supports Maria Mercedes Roca's point (#4167) - disease, hunger, malnutrition and devastating crop losses from pests etc are the real challenges for many developing countries.

I would also remind the forum that a Guidance document has already been developed for GM mosquitoes in AHTEG and may require review as suggested by Paulo Paes Andrade,  but it is not a new topic for further Guidance

thank you for the lively debate so far
Camilla Beech ( Oxitec Ltd)
posted on 2013-02-28 11:18 UTC by MS Camilla Beech, Oxitec Ltd
RE: Response to #4262 [#4273]
Dear Participants,
I would like to offer one bit of information because there has been some discussion of transgenic mosquitoes.

I direct you to an effort led by the WHO and the Foundation for the National Institutes of Health (USA) described as:

“…a draft guidance framework to provide quality standards for assessing the safety and efficacy of genetically modified (GM) mosquitoes for malaria and dengue control.”


The draft document can be found here (http://www.who.int/tdr/news/2012/GMM_Guidance_2012.pdf).

Revisions based on public comments are now underway. You might find this helpful to your discussions.

It is evident that there is not a long history of experience assessing the risk of mosquito control using LM mosquitoes. There is however a large body of work applying methods that have achieved similar goals of the LM mosquitoes that are being tested (population suppression) and the reduction in disease transmission that is hoped for. I believe that these experiences contribute, in part, a foundation to assessing this novel technology until a larger body of direct experience from limited trials accumulates.

Mark Q. Benedict
University of Perugia
posted on 2013-02-27 15:41 UTC by Mr. Mark Benedict, Centers for Disease Control and Prevention
Response to #4273 [#4279]
Dear Participants

Having posted my comments on the WHO guidance framework I then saw Mark Benedict [#4273]. While I have described this document as ‘turgid and dense’ that does not mean that it is not useful as a resource document, however I am just not sure I would call it a guidance document for conducting a risk assessment. There are many documents that I repeatedly use that are not riveting reading (sorry Mark).

Regards
Geoff Ridley, New Zealand Environmental Protection Authority
posted on 2013-02-27 21:08 UTC by Dr. Geoff Ridley, Environmental Protection Authority
Consideration of the development of further Guidance on new topics [#4281]
Dear all,



I would like to share that Bolivia has determined that development of
additional guidance on a number of issues is a relevant tasks for our
country. As a centre of origin and genetic diversity of many species, we
agree with Wei Wei (#4245) on identifying good guiding RA&RM questions for
consideration in centers of origin and genetic diversity. We consider this
highly relevant to assist in meeting the objective of the Protocol to
effectively contribute to the conservation and sustainable use of
biological diversity.



Regards,



Georgina Catacora-Vargas
posted on 2013-02-27 21:35 UTC by Sra. Georgina M. Catacora-Vargas, Bolivia (Plurinational State of)
RE: Response to #4235 [#4286]
Dear Wei,

Concerning your post #4246, I respectfully disagree.  I feel that the criticisms your characterize as distracting and not constructive are exactly the opposite.  To achieve the goal of and internationally recognized guidance, it must stand up to the critical examination of experts.  This is fundamental to the scientific process. 

Thanks,
Tom
posted on 2013-02-27 23:13 UTC by Mr. Thomas Nickson, Consultant
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4238]
POSTED ON BEHALF OF THE SECRETARIAT
---------------------------------------------------

Dear Participants of the Open-Ended Online Forum on Risk Assessment and Risk Management,

We would like to thank everyone for the vibrant discussion in the current forum being moderated by Ms. Francisca Acevedo of Mexico. Several interventions requested clarification from the Secretariat as to the expected outcome from this discussion.

The discussion in the current Forum is ultimately aimed at contributing to realizing the expected outcome as stated in paragraph 3(c) of the annex to Decision BS-VI/12:

" A recommendation on how to proceed with respect to the development of further guidance on specific topics of risk assessment, selected on the basis of the priorities and needs indicated by the Parties with the view of moving toward the operational objectives 1.3 and 1.4 of the Strategic Plan and its outcomes". 

The outcome of the deliberations by the Open-ended Online Forum and AHTEG is to provide input to the above recommendation to COP-MOP7 for its consideration.

There is no mandate to develop any new guidance during this intersessional period.

We hope that this clarifies the concerns and views shared by participants of the Open-Ended Online Forum.

We look forward to your continued participation in the discussions and active exchange of ideas and solutions.

Best regards,
The Secretariat
posted on 2013-02-25 21:19 UTC by Dina Abdelhakim, SCBD
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4239]
Thanks to SCBD on clarification of BS-VI/12 especially on no mandate to develop any new guidance during this intersessional period.

The present discussion, then should be focused whether topics given by some participants are touching any hurdle with AIA procedures? Are they intended to deliberate release to the environment at a close occasion? Is it likely taken place as such an use at an environment? Some would be unlikely and it is on the subject of contained use, which is out of scope of AIA.



I would like to support two comments:
[#4229] Dr. Fujita:  The reason should be given on why the topics is listed and those who had proposed are encouraged to provide explanations associated with facilitating for RA (and RM) for AIA.



[#4237]DR. Ridley:
The process should be scientific-sound approach and hypothetical approach shall be avoided.  If Norway and Canada have experiences  trials on the LMO salmon, then those examples should be provided with the evidence.


Kazuo Watanabe
posted on 2013-02-25 23:35 UTC by Dr. Kazuo Watanabe, University of Tsukuba
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4242]
Dear Francisca, Secretariat and members of the Forum

Thank you to the Secretariat for the above intervention. It is useful to be reminded that the topics may be selected on priorities of the Parties to avoid extended discussions between what constitutes need and want.

This is truly an engaging and interesting discussion.
Jack
posted on 2013-02-26 00:24 UTC by Mr. Jack Heinemann, University of Canterbury
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4244]
Thank you to the Secretariat for the clarification on the aim of this open forum, so now, we can the more focus in the discussion.

In the last meeting of the AHTEG in Montreal last June, we already had a list of new issues that need to be developed, including:
Risk assessment of living modified microorganisms and viruses;
• Risk assessment of living modified animals, including fish;
• Risk assessment of living modified organisms produced through synthetic biology;
• Risk assessment of living modified algae;
• Risk assessment of living modified pharmaplants;
• Risk assessment of living modified plants for biofuels;
• Risk assessment living modified organisms for production of pharmaceutical and industrial
products;
• Risk assessment and management of LMOs intended for introduction into unmanaged
ecosystems;
• Interface between risk assessment and risk management;
• “Co-existence” between LMOs and non-LMOs in the context of small scale farming;
• Socio-economic considerations in the context of environmental risk assessment.

I thinkit can be used as a basis for a report to the next MOP
posted on 2013-02-26 03:04 UTC by Dr. Elizabeth Bravo, Acción Ecológica, Ecuador
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4251]
Dear participants, secretariat and moderator of this online forum,
It is a privilege to participate in this lively discussion.

Irrespective of the need for any new guidance for new categories of new LMO’s as expressed by several participants of the forum, it seems worthwhile to consider that there is already a strong framework which can be considered as a basis for risk assessment of all LMO’s (the Roadmap). In my opinion, the Roadmap –although written for LM plants- is meant to be a guidance which lays down the basic steps and principles of the case-by-case environmental risk assessment of LMO’s and as such the Roadmap should in principle be applicable to all kind of LMO’s. Testing (and adjusting) of the Roadmap could therefore also include testing of other LMO’s than plants to see in which extent the Roadmap will be applicable also for these groups.
The principles of risk assessment will be the same for each LMO, however for specific groups of LMO’s (e.g. trees, microorganism) it could be envisioned that there are specific aspects that need more attention or that a different approach to answer specific questions in the ERA may be necessary. For example trees have a longer lifespan than crops and more emphasis should be put on this aspect in the risk assessment.
If for each new category of LMO a new guidance will be developed, there is a possibility that the consistency between the guidance documents will deviate and we end up with a lot documents that may not be very useful and this could be counter productive. Therefore, my message is to be careful with developing guidances for new LMO’s from scratch and test the guidance we have already available, to see in how far this guidance is applicable to these new LMO’s or not.  In cases where it is not applicable, it can be indicated which aspects are different for the ERA of this specific group of LMO’s and those would be the aspects that need further study. Experts can then be invited to deal with these latter issues. In this way we keep a more consistent approach in the ERA for all LMO’s.

Boet Glandorf, GMO Office, NL
posted on 2013-02-26 07:53 UTC by Ms. Boet Glandorf, Netherlands
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4253]
Dear Francisca,

I want to thank you very much for the opportunity to join this discussion, that has been very lively, partly because it has touched upon a number of issues that may not be the primary issues of the discussion but that appear to be very much on people’s mind.

My comments may also go a little bit beyond the questions that we are being asked, but I think this necessary to understand our position in the Netherlands, and how we consider the need for new guidance.
In the Netherlands we don’t have a need for new guidance documents at this moment. That may sound arrogant, and some have rightly pointed out that, as technical developments will keep going on, there will always be a need for new reflection by risk assessors.
But, does that mean that we will continuously be in need for new guidance?
That would imply that we as risk assessors cannot think on our own. And that is obviously not true.

In the Netherlands we are discussing about many new developments in genetic modification, and what they mean for risk assessment. For this, we need to be able to ask the right questions to the experts in the various fields where the developments are ongoing. They are the ones that should provide us with the technical guidance that we need. As an example: we are at this moment discussing how to deal with ‘novel’ genes that are being ‘picked up’ on the basis of genomics research, and used in genetic modifications and how these developments will continue in synthetic biology. The crucial point that we are discussing here is: what questions do we need to ask about these genes and their applications, and how do we interpret the answers we get in terms of risk assessment.

In a similar way the guidance that we develop under the Protocol should help people to conduct such a process by themselves, not just provide the answers. Only in this way can we become capable of dealing with issues ourselves, and develop our own guidance, or even: become capable of helping others with guidance.

The Roadmap has tried to do this: to explain how you should ask questions so that a risk assessment can be done. I agree very much with Boet Glandorf that we should keep this in mind, and that further guidance should be written as a complement to the Roadmap.
The Roadmap in principle covers all LMOs, but has been written with crop plants providing the main examples. COPMOP has asked us to reflect on the Roadmap and on the other guidance documents to see if there are flaws in these documents that should be straightened out. This process will help to use the Roadmap, and it will also help to write new guidance that will complement the Roadmap.
So, when we consider the need for new guidance, we should think along the following lines: does the Roadmap already prompt the relevant questions that should be asked about a new group of LMOs, a new group of traits or some other new development? And if it does not, how do we arrive at the correct, complementary questions or should we help point the way?

In that way I do agree that it will probably be good to work on guidance on:
1. Cellular microorganisms – because there are scientific issues in environmental microbiology that are very different from crop plants and that merit a separate treatment.
2. Viruses, because also for viruses there are scientific issues that are very different from crop plants; the focus could be on viral applications as mentioned in the Canada-Norway workshop.
3. Animals, in particular fish – also here preparatory work has been done in the Canada-Norway workshop.

Best regards,

Hans Bergmans
Senior risk assessor
GMO Office, Natl. Inst. Public Health and the Environment
The Netherlands
posted on 2013-02-26 11:15 UTC by Mr. Hans Bergmans, PRRI
Response to #4251 [#4257]
Dear Participants

I would like to support Boet Glandorf’s [#4251] wise words. I would also suggest that the road map should be robust enough to deal with any LMO not just LM plants - this is why we argued in Hyderabad for testing to see if it was robust. If the road map is not able to deal with the variety of LMOs that have been proposed for new guidance in this forum then it is the road map that requires further development.

Regards
Geoff Ridley, New Zealand Environmental Protection Authority
posted on 2013-02-26 20:11 UTC by Dr. Geoff Ridley, Environmental Protection Authority
RE: Response to #4251 [#4263]
Dear all participants

I would like to support both [#4251]Boet Glandorf and [#4257]Geoff Ridley.
Also being at the initial negotiation processes of the Cartagena Protocol, I recall that ANNEX III of the Protocol is a condensation of all components with some compromises of all stakeholders over years with many of professionals on RA, and yet robust enough for any LMOs including the future possibilities at the time (of the negotiation processes) of different type of LMOs which now some of participants at this on-line forum are proposing. Furthermore, the roadmap of the guidance doc is expected to cover general processes and wide enough to take care of different type of LMOs.
Another point is that RA should be based on case-by-case experience with scientific information, and it should not be hypothetical nor imaginary.

Kind regards,

Kazuo Watanabe
posted on 2013-02-26 23:35 UTC by Dr. Kazuo Watanabe, University of Tsukuba
RE: Response to #4251 [#4266]
Dear all.

I would like to support Boet Glandorf, Geoff Ridley and Kazuo Watanabe´s latest posts. The roadmap could be applied to support risk assessments of different GMOs, including new organisms with novel traits. Again, it is my opinion that new examples, especially if they follow the present trend of putting in the same bucket different organisms, different constructions and different release areas, will be of very little help and may even create useless fears.

Kindly
Paulo Andrade
posted on 2013-02-27 01:52 UTC by Mr. Paulo Paes de Andrade, Brazil
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4269]
As always, the discussion on the forum has been both active and interesting.  I'm sure I speak for many of the other participants when I express my regret that my "day job" has kept me from participating more fully.

I'd like to thank the Secretariat for this clarification of what we are hoping to accomplish with this online forum [#4238].  This reassures me of two things.  First, that the AHTEG and members of this forum are not expected to prematurely begin development of additional specific guidance based on the suggestions received in this discussion - the topics will instead be suggested to the Parties at the next MOP for their consideration.  Second, I am heartened by the fact that we should have the opportunity to revisit this topic after engaging in testing of the Roadmap.  Once we have some experience in that regard I think we will have a better idea of what recommendations for further work would be useful as well as a better understanding of the best way to pursue that work.

In this vein, I would like to express very ardent support of the suggestion of Paul Keese [#4252].  I think this gets to the heart of what we can usefully do to advance our cause, which I hope we can agree is to provide assistance to those Parties that wish to undertake risk assessments but for whatever reason are unable to do so.  I think a survey that asks Parties what types of risk assessments they are currently undertaking and expect to be undertaking in the near future will be far more informative than simply asking this group to identify “needs.”  In hindsight, this probably should have been the first course of action when the last AHTEG was formed following MOP 4.

I’d also like to offer some thoughts on the discussions as they are playing out.  At the risk of repeating my earlier post, it seems ever more obvious that there is no shared understanding of what we mean when we say “guidance.”  This is more than simply a case of divergent perspectives on scientific issues.  This is fundamental to the work that we have been asked to do.  If we are developing and testing guidance without a definition of what guidance is, how could we be surprised when people don’t agree on the need for or the adequacy of the resulting work?  Further, we don’t have an established process for reconciling these differences and moving forward.  I would like to thank Angela Lozan [#4235] for compiling a list of suggested topics for guidance that have been put forward.  While I don’t agree that work should be started on any of these, I think it’s very helpful to have the list in a single place.  Considering these topics, I see several that have nothing whatsoever to do with environmental risk assessment (Coexistence, socio-economic considerations).  While these are clearly important topics which can be informed by science, they are not appropriate subjects for the development of guidance by a group that has been asked to provide technical input on risk assessment.  Other topics on the list, in my opinion, would not benefit from guidance elaborated by this body or the AHTEG.  I would be open, however, to reconsidering these topics in the context of a definition of “guidance” and a framework for how such guidance would be developed. 

So, with apologies for the lengthy post, I would like to once again emphasize that our first priority must be the testing of the Roadmap as instructed by the Parties and as eloquently explained by Piet van der Meer, Kazuo Watanabe and many others.  I think the Roadmap has a clear and understood purpose – to provide procedural and process guidance on risk assessment in all cases- and our mission now is to ensure that it does this with high quality. Using the knowledge gained in the testing process,  I think our next step would be to seriously consider the questions Francisca has posed in [#4192] and clarified in [#4221] with the aim of producing a framework for the development (if necessary) of guidance on specific types of LMOs.  If we don’t do this, we will continue to have the same discussions that we are having now and any resulting work on specific guidance will likely be received by this group, and by the next MOP, with the same reaction as the existing specific guidance received in Hyderabad.  As has been pointed out in this forum as well as previous ones (and put very nicely by Maria Roca [#4255]), our desire to move quickly should not lead us down avenues that will be unproductive.

Best,
Andrew
posted on 2013-02-27 13:25 UTC by Mr. Andrew Roberts, International Life Sciences Institute Research Foundation
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4326]
Dear Participants and Francisca
I want to acknowledge this clarification from the Secretariat.
I sometimes get confused with what the mandate of the MOP was after all the ideas and visions shared, we can have different interpretations, this clarification is unambiguous:
“The outcome of the deliberations by the Open-ended Online Forum and AHTEG is to provide input to the above recommendation to COP-MOP7 for its consideration.
There is no mandate to develop any new guidance during this intersessional period.”
If there is not a mandate to develop new guidance during this intersessional period, there will be a better use of our time if we built on the criteria to identify “needs of the Parties" and clarify how this is related to "experience and knowledge” in order to present a well structured recommendation to the COP-MOP7.
Kind regards
posted on 2013-03-01 14:46 UTC by Ms. Sol Ortiz García, Mexico
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4328]
I have been following the discussions closely with a keen interest. This gridlock I believe requires guidance from the Secretariat so that our deliberations remain focused, relevant and productive.

Thanks to all for wonderful experiences.

Abisai Mafa
Zimbabwe
posted on 2013-03-01 15:17 UTC by Abisai Mafa
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4270]
Dear Francisca, dear All
Thanks to Francisca moderating this very lively debate.
I join this debate quite late and very important aspects have been raised.
I would underline three aspects:
as mentioned by others and clarified by the secreteriat the online forum and the AHTEG have the mandate to deal with the topic if and which further/new guidance is needed and provide a proposal to the next COP/MOP on this issue. As the testing on usefulness and practicality should be done in this interim period  further guidance can build on the outcome.
we ( as former AHTEG members) have characterised the Road Map and the additional guidance documents on stacked genes, abiotic stress resistent plants, GM trees, GM mosquitoes and monitoring all as living documents. This means that we were aware of the fact of a constantly evolving field and the possible need of adapting and improving the current documents.
Guidance can be developed and be helpful (without being prescriptive) in fields where there is experience with a number of cases ( as with GM crop plants) to sum up the experience in a generic or more general form ( based on the legal framework and recommendations etc.) - that is what the Road Map aims for -  and it can be complementing, helpful and supportive in more nascent developments or special cases - that is what the additional guidance is meant for.

A number of parties expressed their needs and provided  topics.
the biology of viruses and microorganisms as one proposal and GM fish or animals as other proposals are very different from that of GM plants and out of my perspective could benefit from additional guidance.
And I like to underline Hans statement that the different guidance documents are not meant to provide ready made answers but give guidance to ask the right questions and enable  to develop the own guidance ( if needed).

best regards
Beatrix
posted on 2013-02-27 14:08 UTC by Beatrix Tappeser, Federal Agency for Nature Conservation
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4271]
POSTED ON BEHALF OF LUCETTE FLANDROY
---------------------------------------------------------

Dear international colleagues,

I wished to participate in this lively forum since days, but just found hardly the time to follow the postings without time to answer.

So now, first, I want to thank the Secretariat for organizing this interesting discussion, Francisca Acevedo to have accepted the hard task to moderate it, and all the participants who take time to try to make a useful process of this.

Intervening late, I shall somewhat confirm interventions of preceding participants – trying to avoid repeating all their arguments -, of whom I shall not list all the names, but they will recognize their opinions. I hope anyway to add some personal useful ideas, on the various issues that were tackled during the discussion ( sometimes a little bit out of the questions initially asked, but interesting to discuss anyway, as long as they do not lay unuseful obstacles in our task ).

What is the purpose of such guidance, ask some participants ?
I thought it was clear that it is aimed at detailing the RA to be undertaken by Parties following Annex III of the Protocol, to help risk evaluators ( these who make the practical RA ) and the risk assessors ( these who decide if the risk evaluation is complete enough and if its conclusions are science-based, and who can on that basis give advice to the decidors on the acceptability or refusal of the concerned LMOs ) to make a scientific sound RA taking into account all potential risks. It is logical that the Parties to the Protocol develop this harmonized guidance at the international level because, having ratified this Protocol, instrument depending on the CBD, we should all ~ agree on the scientific rational of what and how it is important to look at to avoid potential risks of the LMOs on biodiversity and health, because we all live on the same planet where the natural environment, the biodiversity does not recognize the political borders of our countries, even if the protection goals and the limits of concern can vary somehow inside the countries.
Would some Parties consider they have a perfect national RA process, it would in any case be important to develop this common guidance to help less developed Parties that need it ( we should not forget that a basic aspect of the Protocol is capacity building ) and to insure that common understanding of what is needed in a RA process to respect the specific objectives of the Protocol. 

Is the guidance useful ? I think enough Parties, experts from Parties, have answered that, yes, it is useful for them.

This does not mean that it cannot, must not, be tested to improve especially its practicability. About this, as well new practitioners as experienced ones have useful comments to bring. And here can a wise ( but still to be discussed more process ) combination of the Manual written by the Secretariat and of the Guidance be useful, because the Manual gives more practical examples that can help new practitioners to understand and use the sometimes scientific maybe too unconcrete proposals for neophytes made in the Guidance. And experienced practitioners can comment on practical and theoretical aspects to add, to ? delete ? to present in another order, …….

Should such guidances be written by experienced people ?
Experienced in what ??? In hazards that already occurred ? I hope we all agree that such guidance have to be elaborated to avoid hazards before they happen and not after they have occurred ! …... As such, we indeed need to involve very good experts in the biology of the corresponding non modified organisms ( in mosquitoes, in trees, in viruses, ……. ) to participate in the development of such guidance, in order to foresee as many as possible of the potential hazards that could result from a perturbation of the biology of these organisms and of their relationships in the ecosystems; and for this, theoretical hypothesis have to be made.
About this, one of the conclusions of the Canada-Norway workshop of 2007, already evoked in this forum, had been that there are obvious gaps in the basic knowledge of the biology of some types of  organisms that should be filled by the study of non- modified organisms before releasing the corresponding modified organisms into the environment. Not seeing any GM virus or mosquito becoming fluorescent or causing short term epidemic of emergent diseases does not mean that they could not be slow, invisible, potential hazard under development !
LMOs should indeed not be considered automatically as monsters, but they are man-made biological products without life history, resulting still further from natural processes than the  selected breedings operated by man for agriculture and animal raising, they can interact with the rest of the biological world, and are rapidly dispersed ( more rapidly than ever occured with other types of seeds, for what is concerning GM plants ) all over the world once they are on the market; as such, we are responsible for their release in the environment that they will unavoidably influence by some way ( not necessarily in a bad way, indeed, but possibly in some different way than their non-GM counterpart ) ; we should avoid repeating errors of the past, and “ jouer à l’ autruche” is surely not the best way to give confidence in any GMO to the public. The Parties to the Protocol have agreed directly or implicitly on all this ( look to the preamble ), and other countries are welcome to join the Protocol.

Do we need new guidance on new topics ?
I think enough experts representative of Parties have answered “yes” , mostly for the same topics, and the decision of COP-MOP6 indeed did not require that 100 % of Parties agree on this to consider that there are needs. ( Once again, one prominent aspect of the Protocol is Capacity-building, so that all Parties would be able to implement this Protocol correctly )
Are these “wishes” instead of needs ?
I think the different topics on which needs have been evoked are on LMOs that are in the pipeline, that could come on the market in a short time for some of them that are already under trials released in the environment ( or reveal concerns from experts of the Parties that they consider are not treated enough through the present Guidance ); it is thus a legitimate wish to have guidance for ad hoc RA before these LMOs knock at the door of the countries. And, yes, we need a general science-sound framework to make the RA even if the answers will be different case by case and if some questions suggested in the guidance will not be relevant in each case.

This being said, the general Roadmap is indeed intended to be applicable to all kinds of LMOs. But, as recognized by Hans Bergmans himself, it has, for obvious reasons, been designed mainly with the LM plants in mind. So, indeed, it should be analyzed, during the testing phase, if this Roadmap is indeed applicable to all kinds of LMOs or if some parts should be modified with this goal. One problem is that, maybe, not all kinds of potential LMOs are already in a phase where such RA is relevant.

In any case, even if/when the general Roadmap is applicable to all LMOs, the peculiar biology of some of the corresponding phyla/sub-phyla would require to insist on some details of the RA process or to really complement the general roadmap by specific guidance. Again, preceding reflections and precise recommendations were already done on this for trees, fishes, viruses and pharma-plants during the Canada-Norway workshop. 

Should this elaboration of complementary guidance be started during the testing of the general guidance/roadmap or after ?
Following my understanding and as confirmed by the Secretariat, the wording of decision BS-VI/12 suggest to consider if and how to develop new guidance and to make recommendation about this at COP-MOP7, but not to start the development of such guidance now. 

How to proceed with respect to this development ?
I think this should still be discussed in a next round of this forum. But, indeed, as already suggested, prioritize, with arguments, on the worth wile topics that have been mentioned.

I would precisely prioritize on the basis of the stage of development ( LMOs ready to come on the market ), of the peculiar biology of the organisms very different from plants, and of the probability that they would be released in the environment and not developed in confined use ( or that they could escape in the environment ), and of the lack of existing or coming adequate guidance.

As such, and if it is decided to prioritize on 3 categories ( more could indeed be much for a next round of work of the AHTEG ), I would focus on:

1)      LM viruses,
2)      LM animals and in particular fishes, 
3)      LM bacteria if they should be considered separately from viruses ( even if one can somehow both range them in the world of “microorganisms”, they have quite different peculiar biological characteristics ), and can include other close monocellular microorganisms. 

I could repeat precise reasons for this prioritization , but they can be found among other in the report of the Canada-Norway workshop of June 2007. In summary, anyway, some characteristics:

1)       GM viruses are in development in particular for vaccines ; there are many gaps in knowledge about recombination/collaboration between viruses, about their host specificities, the mechanisms of coevolution between virus and hosts, and the abiotic influences. No RA guidance except for clinical aspects.
2)       GM fishes : several species of GM fishes in development, some almost on the market. Aquatic environment has a vast and complex trophic chain hardly reproducible in laboratoria ; lack of knowledge of the biology of many fishes in their natural environment ( their sensibility to climatic factors, presence of preys or predators, diseases ) ; great importance of the containment efficacity and of easy traceability in case of escape.
3)       GM pro-karyotes ( biology different from eukaryotes, with potential exchanges of genes through conjugation, invisible, and some pathogenic )  , if they include microalgae ( cyanobacteria, that could be used as biofuels ) and other bacteria developed for bioremediation purposes, for ex. , and could be released into the environment.

Actually, I confess I am flexible on the 3rd priority,  in case some other relevant topic is considered  more urgent. I have some opinion on the relevancy and importance of each of the other topics cited, but
I shall stop here for now, and let other participants bring arguments for other topics they would favor.

Hoping useful outcomes from this forum, I send my best regards to all of you.


Lucette Flandroy
posted on 2013-02-27 14:49 UTC by Dina Abdelhakim, SCBD
Response to #4271 [#4280]
Dear Participants

I want comment on one part of Lucette Flandroy’s [#4271] contribution and that is ‘Should such guidances be written by experienced people ? Experienced in what ??? In hazards that already occurred ? I hope we all agree that such guidance have to be elaborated to avoid hazards before they happen and not after they have occurred !”

I find this further convinces me that we have multiple ideas in this forum as to what guidance is. I have reread Lucette’s comment several times and it appears to me that she is asking for an a priori risk assessment and not a guidance document.

Regards
Geoff Ridley, New Zealand Environmental Protection Authority
posted on 2013-02-27 21:30 UTC by Dr. Geoff Ridley, Environmental Protection Authority
Response to #4329 [#4333]
Dear Participants

I note Lucette Flandroy [#4329]. I did think that this was to be a discussion group where ideas were to be kicked around and pulled apart with the idea we would come up with something robust and useful. I have tried to have such a discussion and please forgive me if I misunderstood.

I do not have a “CLEAR” pathway forward or synthesis of what to do and again I thought that this is what ‘discussion’ was for? However I have suggest that I robust and meaningful guidance could not be developed a priori. A list of beginning questions for risk assessment of new types of LMOs should be developed as this would flag to risk assessors what questions need to be addressed and flag to researchers what data and analysis is required. Once the first risk assessment is done this would indicated what was useful, what was not, and any new questions that were discovered. This would be the first guidance. The next jurisdiction to do a risk assessment could then use this guidance, do their risk assessment and add their experience to a second edition of the guidance. Such a document would be real guidance forged through experience. Such guidance should and could be housed and developed through the BCH as its function is to share experience. I do not support the development of further guidance as been done in the past as I think it only creates shelf fillers to gather dust.

Regards
Geoff Ridley, New Zealand Environmental Protection Authority
posted on 2013-03-01 20:00 UTC by Dr. Geoff Ridley, Environmental Protection Authority
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4272]
POSTED ON BEHALF OF GAMAL MEDANI
--------------------------------------------------

Dear Colleagues,
Basically, road map should deal with any LMO not just LM plants. If the road map is not able to deal with the variety of LMOs that have been proposed for new guidance in this forum then it is the road map that requires further development.

I am supporting Boet Glandorf, Geoff Ridley and Kazuo Watanabe´s latest posts. The roadmap could be applied to support risk assessments of different GMOs, including new organisms with novel traits.

I would like to stress upon an issue which is vital from my point of view , the basic question that has been raised by a few, is what purpose shall the guidance serve.  I believe the opinions concerning the objective of guidance under the Protocol as expressed by experts in this forum are widely divergent.  It is good that it is not this forum that has the responsibility to set strategy.

Actually, I am not keen to further guidance being developed. What I am challenging is how this guidance is to be developed. As Janet Gough [#4248] has said guidance need to be developed from case-by-case risk assessment.

With all my best wishes.

Gamal medani
UAE
posted on 2013-02-27 14:55 UTC by Dina Abdelhakim, SCBD
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4275]
Dear all,

I would like to share that Bolivia has determined that development of additional guidance on a number of issues is a relevant tasks for our country. As a centre of origin and genetic diversity of many species, we agree with Wei Wei (#4245) on identifying good guiding RA&RM questions for consideration in centers of origin and genetic diversity. We consider this highly relevant to assist in meeting the objective of the Protocol to effectively contribute to the conservation and sustainable use of biological diversity.

Regards,

Georgina Catacora-Vargas
posted on 2013-02-27 19:39 UTC by Sra. Georgina M. Catacora-Vargas, Bolivia (Plurinational State of)
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4276]
Dear Francisca and all,

Following the comments from Galina Mozgova (#4227) and Wei Wei (#4246), for Bolivia one important reason to develop new specific guidance documents under the Cartagena Protocol (complementary to the existing ones) is to jointly comply with its mandate (ratified by 166 countries as per Feb. 2013).

There are some other specific reasons that add to the list of justifications for undertaking the development of new guidance documents under the Protocol:

- LMOs may be subject of transboundary movement. As we know, this is a core element in the Protocol. Our regulations are implemented within strict geographical borders; however, the dynamic and possible movement of LMOs goes beyond them. Therefore, as Parties of the Protocol having as core motivation the protection of global biodiversity, it is important to have a common understanding on how to assess risks and potential adverse effects arising from LMOs. In this regard, in response to Geoff Ridley (#4223) on the inclusion of herbicides as weed management practices of LM HT crops and its implications in the RA, it is important to mention that this particular subject is part of existing RA frameworks. It is also included in current Guidance among points to consider in Steps 1 and 3 of the Roadmap, e.g. Step 3 states that “The evaluation of consequences may also consider the adverse effects associated with the existing practices or with practices that will be introduced along with the LMO (such as various agronomic practices, for example, for pest or weed management)”. As additional note, even assessments focusing on the benefits of LM HT crops also consider the inherent herbicide (to the HT crop in question) as part of the LM HT crop assessment. Accordingly, in our view, both the biology of the LMO and the associated human activity and co-products must be considered in the RA&RM, especially because LMOs that may be subject of transboundary movement.

- Developing jointly RA&RM guidance under the Protocol will help us to have more elements for identifying timely unforeseen adverse effects. The discussions among experts from a diversity of backgrounds brings into the table wide knowledge that can help us to identify issues that we may not foresee when relying only on few national or regional experts and expertise.

- The language. In full agreement with our colleague from Honduras (Mercedes Roca) in her intervention (#4228) that the language is a big limitation in so many processes, the development of new guidance documents under the Cartagena Protocol creates the opportunity to translate this forthcoming material into the six official UN languages. To us this is a great possibility for accessing information discussed by experts from a diversity of backgrounds, and that otherwise will remain in English, only.

Finally, we would like to join the concern expressed by Judy Carman (#4226). We believe that this difficult but needed process will benefit from constructive criticisms on the topics discussed.

Sincerely,

Georgina Catacora-Vargas
posted on 2013-02-27 19:43 UTC by Sra. Georgina M. Catacora-Vargas, Bolivia (Plurinational State of)
Response to #4276 [#4282]
Dear Participants

I would like to comment on Georgina Catacora-Vargas [#4276] posting.
In her first dash point in the case of countries with contiguous border with other countries their decisions are made within their political border and not geographic borders. This is why I said earlier that such countries need to take a regional/ geographic approach to risk assessment. Any risk assessor knows this and guidance is not required.

In the same dash point comment is made that “on the inclusion of herbicides as weed management practices of LM HT crops and its implications in the RA, it is important to mention that this particular subject is part of existing RA frameworks”. As it should be but this is not specific to LMOs as I would also expect to see it in conventionally bred herbicide resistant crops, or in the risk assessment of new species that is tolerant to herbicide. All of these would result in herbicide resistant weeds and that is the role of risk management to ensure that farming practices take this into account. It is about farming practices not specifically about LMOs.

The second dash point seems while a noble idea is unlikely to happen given limited resources available for the development of guidance. The comment also suggests that this guidance will be a final product and as no risk assessment will have been done it is difficult to see how this could be the case.

Finally, and yet again, we need to test the road map and we need to encourage countries to contribute to the development of guidance based on experience.

Regards
Geoff Ridley, New Zealand Environmental Protection Authority
posted on 2013-02-27 22:35 UTC by Dr. Geoff Ridley, Environmental Protection Authority
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4287]
I am confused by the reason given by Georgina in #4276 that "for Bolivia one important reason to develop new specific guidance documents under the Cartagena Protocol (complementary to the existing ones) is to jointly comply with its mandate".

What specific "mandate" requires guidance.  While compliance with the Protocol in general is not as it should be, there are hundreds records of AIA's in the BCH (including 2 from Honduras), all of which have been produced in the absence of these guidance documents.  In the absence of guidance, risk assessments have been completed in compliance with Annex III.  Perhaps the more efficient approach would be consulting within the region.  As it has been pointed out, Brazil, Honduras, Colombia, Mexico and other Latin American countries could be a great resource for regional collaboration. 

I remain unconvinced that there is a compelling reason for Parties to commit the Secretariat's valuable time to this exercise.

Thanks,
Tom
posted on 2013-02-27 23:24 UTC by Mr. Thomas Nickson, Consultant
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4288]
Dear colleagues

I want to express my full support to all the colleagues that expressed their countries’ needs for additional guidance documents and provided topics.

I would also like to highlight the following:
- Pursuant to article 15.1 and 15.2 of the protocol, parties are mandated to ensure that scientifically sound risk assessments are carried out for decision taken.
- Para 3 of annex 3 of the Protocol emphasizes the importance of taking into account risk assessment (RA) guidelines developed by relevant international organizations while conducting RA.
- Bearing in mind that RA guidance documents assist countries to identify and evaluate the potential adverse effects of living modified organisms on the conservation and sustainable use of biological diversity in the likely potential receiving environment, taking also into account risks to human health. And that RA is, inter alia, used by competent authorities to make informed decisions regarding living modified organisms. Guidance documents would assist countries to better comply with the objectives of the Protocol.

Regards,
O.A.ElKawy
posted on 2013-02-28 00:31 UTC by Mr. Ossama Abdelkawy, Syrian Arab Republic
Response to #4288 [#4289]
Dear Participants

I have read Dr ElKawy [#4288] comments that he wished highlight and note the comment “RA guidance documents assist countries to identify and evaluate the potential adverse effect.” This is the same comment that Lucette Flandroy’s [#4271] made in that guidance should be an a priori risk assessment. If that is the case should we stop calling it guidance and start calling it an a priori risk assessment?

Regards
Geoff Ridley, New Zealand Environmental Protection Authority
posted on 2013-02-28 00:59 UTC by Dr. Geoff Ridley, Environmental Protection Authority
RE: Response to #4288 [#4293]
Dear colleagues,

I do not consider this is the time to start discussion on recalling or renaming  the guidance. The guidance is the wording of the text of the Protocol. This is understandable for people as essence to advise evaluators and decision makers in RA. The guidance might be prescriptive, as in case of WTO, or non-prescriptive as it is considered within the Protocol.

Regards,

Angela Lozan, Ministry of Environment, MD
posted on 2013-02-28 08:08 UTC by Angela Lozan
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4290]
I am a bit puzzled by the message posted by Dr Ossama Abdelkawy [4288]
stating that "Bearing in mind that RA guidance documents assist countries to identify and evaluate the potential adverse effects of living modified organisms on the conservation and sustainable use of biological diversity in the likely potential receiving environment, taking also into account risks to human health. And that RA is, inter alia, used by competent authorities to make informed decisions regarding living modified organisms. Guidance documents would assist countries to better comply with the objectives of the Protocol."
I am starting to wonder people mean by 'guidance'.  I would like to reiterate two things.   (a) risk assessment by nature case-by-case, and (b) the receiving environments will differ significantly from country to country (and some countries are more inclusive than others in terms of what constitutes the receiving environment.
So what further guidance is needed than the Roadmap? (and the plethora of other international documents that have been already described in this forum).

regards
janet
posted on 2013-02-28 02:08 UTC by Janet Gough, Environmental Protection Authority
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4295]
Dear all,

it is good suggestion of Tomas [#4287] to consulting issues related RA within the region and promote regional collaboration in this regards. This would be very helpful and efficient, but just after having the internationally agreed guidances involving international experience and opinion of Parties. The geographical, biogeographical and regional aspects and specific should be taken in consideration, as well as eventual cooperation and collaboration in providing RA would be efficient.

Best regards,

Angela Lozan, Ministry of Environment, MD
posted on 2013-02-28 08:56 UTC by Angela Lozan
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4278]
POSTED ON BEHALF OF MARIA MERCEDES ROCA
---------------------------------------------------------------

Dear all,

The idea from our colleague   Georgina  Catacora   that each region concentrates on specific guidelines (case by case) to develop guidelines for  LMOs introduced into their centers of origin or diversification makes sense. In this regards, it would make a lot of sense for Mexico and Central America  to concentrate on maize  and the many other crops that originated in this region and  for Bolivia to concentrate on potatoes.  To this effect, please note that the  recently published Spanish  ERA Guide for Latin America very specifically deals with the possible  gene flow issues  from maize to teosintle and to local landraces, as this applies very specifically to our region. There is a specific example of an ERA for  GM maize in a center of origin. I hope risk assessors from our region find this useful.

Honduras took this subject very seriously when GM maize was introduced in 2003 and we incorporated this subject into our process or Risk Analysis and consulted world experts on the matter. We widely  discussed the likelihood of exposure of GM pollen and most importantly, the biological consequence of the unlikely, but possible introgression of the transgene to the local landraces.  So far, in 10 years of commercial release, we have seen no adverse effects to the land races. The local landraces continue to be very susceptible to the pests and the herbicide and  sadly, continue to yield very poorly. Our small farmers,  who cannot afford better seed, continue to use them widely through the country. 

If anyone is interested in this important  subject of gene flow, please consult our local experts Drs. Ariel Alvarez and Sol Ortiz from Mexico. May also be of interest to consult   the following link for an abstract  on research showing rather slow introgression of genes from hybrids into landraces compared gene stock from landraces (1950 seed bank samples) with yr 200?  landrace collection  ( not statistically sig different). The rate of  introgression from transgenes should not be different from genes from hybrid varieties.

http://ec.europa.eu/research/biosociety/pdf/rt_papa_abstract.pdf


Best reagrds to all,

Maria Mercedes
posted on 2013-02-27 20:53 UTC by Dina Abdelhakim, SCBD
Response to #4278 [#4284]
Dear Participants

It was with interest I read Maria Roca’s [#4278] posting. Here is a country that has real experience of a risk assessment and release. What they have learnt of 10 years is what needs to be captured in guidance for future risk assessment. This is would be a prime example of the reiterative process they I have been talking about.

Regards
Geoff Ridley, New Zealand Environmental Protection Authority
(edited on 2013-02-27 22:41 UTC by Geoff Ridley)
posted on 2013-02-27 22:41 UTC by Dr. Geoff Ridley, Environmental Protection Authority
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4291]
The genetically modified crops are different from tranditionally breeded varieties as they carried genes from animal, microoganism and human being etc. These genes can be called foreign transgenes. The gene flow from GM crops is different from the one from conventional varieties as the GM crops carried foreign transgenes. The consequence of presence of foreign transgenes in landraces, wild relatives and other varieties is thus different though there is perhaps a similar rate of gene flow. On that point we assume this consequence as a 'contamination', which is unwanted and not intended for, and probably harmful to human people and the environment. Having similar rate of gene flow is not a reason of safety. Of course, you can choose not use 'contamination', but this does not change this fact of gene flow. Risk assessment of gene flow is definitely one aspect of the safety concerns of GMOs (we called LMOs in the protocol).
posted on 2013-02-28 02:25 UTC by Mr. Wei Wei, China
Risk Assessment and Risk Management Consideration of thedevelopment of further Guidance on new topics - A new message has beenposted to the forum [#4283]
Dear international colleagues,

I wished to participate in this lively forum since days, but just found hardly the time to follow the postings without time to answer.

So now, first, I want to thank the Secretariat for organizing this interesting discussion, Francisca Acevedo to have accepted the hard task to moderate it, and all the participants who take time to try to make a useful process of this.

Intervening late, I shall somewhat confirm interventions of preceding participants - trying to avoid repeating all their arguments -, of whom I shall not list all the names, but they will recognize their opinions. I hope anyway to add some personal useful ideas, on the various issues that were tackled during the discussion ( sometimes a little bit out of the questions initially asked, but interesting to discuss anyway, as long as they do not lay unuseful obstacles in our task ).

What is the purpose of such guidance, ask some participants ?
I thought it was clear that it is aimed at detailing the RA to be undertaken by Parties following Annex III of the Protocol, to help risk evaluators ( these who make the practical RA ) and the risk assessors ( these who decide if the risk evaluation is complete enough and if its conclusions are science-based, and who can on that basis give advice to the decidors on the acceptability or refusal of the concerned LMOs ) to make a scientific sound RA taking into account all potential risks. It is logical that the Parties to the Protocol develop this harmonized guidance at the international level because, having ratified this Protocol, instrument depending on the CBD, we should all ~ agree on the scientific rational of what and how it is important to look at to avoid potential risks of the LMOs on biodiversity and health, because we all live on the same planet where the natural environment, the biodiversity does not recognize the political borders of our countries, even if the protection goals and the limits of concern can vary somehow inside the countries.
Would some Parties consider they have a perfect national RA process, it would in any case be important to develop this common guidance to help less developed Parties that need it ( we should not forget that a basic aspect of the Protocol is capacity building ) and to insure that common understanding of what is needed in a RA process to respect the specific objectives of the Protocol.

Is the guidance useful ? I think enough Parties, experts from Parties, have answered that, yes, it is useful for them.

This does not mean that it cannot, must not, be tested to improve especially its practicability. About this, as well new practitioners as experienced ones have useful comments to bring. And here can a wise ( but still to be discussed more process ) combination of the Manual written by the Secretariat and of the Guidance be useful, because the Manual gives more practical examples that can help new practitioners to understand and use the sometimes scientific maybe too unconcrete proposals for neophytes made in the Guidance. And experienced practitioners can comment on practical and theoretical aspects to add, to ? delete ? to present in another order, .......

Should such guidances be written by experienced people ?
Experienced in what ??? In hazards that already occurred ? I hope we all agree that such guidance have to be elaborated to avoid hazards before they happen and not after they have occurred ! ...... As such, we indeed need to involve very good experts in the biology of the corresponding non modified organisms ( in mosquitoes, in trees, in viruses, ....... ) to participate in the development of such guidance, in order to foresee as many as possible of the potential hazards that could result from a perturbation of the biology of these organisms and of their relationships in the ecosystems; and for this, theoretical hypothesis have to be made.
About this, one of the conclusions of the Canada-Norway workshop of 2007, already evoked in this forum, had been that there are obvious gaps in the basic knowledge of the biology of some types of  organisms that should be filled by the study of non- modified organisms before releasing the corresponding modified organisms into the environment. Not seeing any GM virus or mosquito becoming fluorescent or causing short term epidemic of emergent diseases does not mean that they could not be slow, invisible, potential hazard under development !
LMOs should indeed not be considered automatically as monsters, but they are man-made biological products without life history, resulting still further from natural processes than the  selected breedings operated by man for agriculture and animal raising, they can interact with the rest of the biological world, and are rapidly dispersed ( more rapidly than ever occured with other types of seeds, for what is concerning GM plants ) all over the world once they are on the market; as such, we are responsible for their release in the environment that they will unavoidably influence by some way ( not necessarily in a bad way, indeed, but possibly in some different way than their non-GM counterpart ) ; we should avoid repeating errors of the past, and " jouer à l' autruche" is surely not the best way to give confidence in any GMO to the public. The Parties to the Protocol have agreed directly or implicitly on all this ( look to the preamble ), and other countries are welcome to join the Protocol.

Do we need new guidance on new topics ?
I think enough experts representative of Parties have answered "yes" , mostly for the same topics, and the decision of COP-MOP6 indeed did not require that 100 % of Parties agree on this to consider that there are needs. ( Once again, one prominent aspect of the Protocol is Capacity-building, so that all Parties would be able to implement this Protocol correctly )
Are these "wishes" instead of needs ?
I think the different topics on which needs have been evoked are on LMOs that are in the pipeline, that could come on the market in a short time for some of them that are already under trials released in the environment ( or reveal concerns from experts of the Parties that they consider are not treated enough through the present Guidance ); it is thus a legitimate wish to have guidance for ad hoc RA before these LMOs knock at the door of the countries. And, yes, we need a general science-sound framework to make the RA even if the answers will be different case by case and if some questions suggested in the guidance will not be relevant in each case.

This being said, the general Roadmap is indeed intended to be applicable to all kinds of LMOs. But, as recognized by Hans Bergmans himself, it has, for obvious reasons, been designed mainly with the LM plants in mind. So, indeed, it should be analyzed, during the testing phase, if this Roadmap is indeed applicable to all kinds of LMOs or if some parts should be modified with this goal. One problem is that, maybe, not all kinds of potential LMOs are already in a phase where such RA is relevant.

In any case, even if/when the general Roadmap is applicable to all LMOs, the peculiar biology of some of the corresponding phyla/sub-phyla would require to insist on some details of the RA process or to really complement the general roadmap by specific guidance. Again, preceding reflections and precise recommendations were already done on this for trees, fishes, viruses and pharma-plants during the Canada-Norway workshop.

Should this elaboration of complementary guidance be started during the testing of the general guidance/roadmap or after ?
Following my understanding and as confirmed by the Secretariat, the wording of decision BS-VI/12 suggest to consider if and how to develop new guidance and to make recommendation about this at COP-MOP7, but not to start the development of such guidance now.

How to proceed with respect to this development ?
I think this should still be discussed in a next round of this forum. But, indeed, as already suggested, prioritize, with arguments, on the worth wile topics that have been mentioned.

I would precisely prioritize on the basis of the stage of development ( LMOs ready to come on the market ), of the peculiar biology of the organisms very different from plants, and of the probability that they would be released in the environment and not developed in confined use ( or that they could escape in the environment ), and of the lack of existing or coming adequate guidance.

As such, and if it is decided to prioritize on 3 categories ( more could indeed be much for a next round of work of the AHTEG ), I would focus on:


1)      LM viruses,

2)      LM animals and in particular fishes,

3)      LM bacteria if they should be considered separately from viruses ( even if one can somehow both range them in the world of "microorganisms", they have quite different peculiar biological characteristics ), and can include other close monocellular microorganisms.


I could repeat precise reasons for this prioritization , but they can be found among other in the report of the Canada-Norway workshop of June 2007. In summary, anyway, some characteristics:


1)       GM viruses are in development in particular for vaccines ; there are many gaps in knowledge about recombination/collaboration between viruses, about their host specificities, the mechanisms of coevolution between virus and hosts, and the abiotic influences. No RA guidance except for clinical aspects.

2)       GM fishes : several species of GM fishes in development, some almost on the market. Aquatic environment has a vast and complex trophic chain hardly reproducible in laboratoria ; lack of knowledge of the biology of many fishes in their natural environment ( their sensibility to climatic factors, presence of preys or predators, diseases ) ; great importance of the containment efficacity and of easy traceability in case of escape.

3)       GM pro-karyotes ( biology different from eukaryotes, with potential exchanges of genes through conjugation, invisible, and some pathogenic )  , if they include microalgae ( cyanobacteria, that could be used as biofuels ) and other bacteria developed for bioremediation purposes, for ex. , and could be released into the environment.

Actually, I confess I am flexible on the 3rd priority,  in case some other relevant topic is considered  more urgent. I have some opinion on the relevancy and importance of each of the other topics cited, but
I shall stop here for now, and let other participants bring arguments for other topics they would favor.

Hoping useful outcomes from this forum, I send my best regards to all of you.


Lucette Flandroy













Disclaimer : http://www.health.belgium.be/eportal/disclaimer/
posted on 2013-02-27 22:40 UTC by Ms. Lucette Flandroy, Belgium
RE: Risk Assessment and Risk Management Consideration of thedevelopment of further Guidance on new topics - A new message has beenposted to the forum [#4294]
Dear all,

I would like to support the comments and arguments made by Lucette Flandroy. I want just to point your attention that three important topics for guidances were agreed in 2007 at the Canada-Norwey workshop, so six years ago. I think it is too much time is lost and now we continue to debate if it is the or not to continue with development of new specific guidances.


Best regards,

Angela Lozan, Ministry of Environment, MD
posted on 2013-02-28 08:43 UTC by Angela Lozan
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4292]
Dear Participants
Hello to everybody, this has been a fruitful and intense discussion! As I haven’t been able to participate before and this is my first intervention, I would like to thank Fran for moderating the forum and the Secretariat for organizing it.
Concerning the initial two questions, in my personal view, actual efforts should be mainly directed to test the usefulness of the guidance (in particular the Roadmap) and to design a comprehensive way to  gather and analyze the testing results so that they become useful  to give feedback to the “live” roadmap, (keeping in mind that the guidance is voluntary and non-binding).
If guides are to be developed, the topic concerning introduction of LMOs in centers of origin and genetic diversity, that has been already mentioned by different participants as Georgina Catacora-Vargas, Wei Wei and supported by others, has a particular importance for us in Mexico.  The likely potential receiving environment is a fundamental factor in the  “case by case” equation. Countries where the crop‘s wild relatives are present, and local crop landraces are being used and managed with traditional farming practices, that include seed exchange, will need  to consider different risk scenarios than countries that  are not in this situation. For the former countries, it would be useful not only to  gather specific information, but also to discuss about  the aspects involved and possible approaches to the subject matter.  This could lead to the development of either a specific guideline on LMOs in centers of origin and genetic diversity, or a specific section of the actual guideline.
In other words, the topic deserves attention because it brings into consideration certain aspects that might be very particular to specific regions of the globe  (centers of origin and genetic diversity), but that are very relevant  because it is in those regions where most of the genetic diversity of a crop is present. These aspects are relevant in discussions taking place actually in Mexico, but we believe that wider discussion and analysis is necessary, as crop genetic diversity should be a matter of global concern. 

Kind Regards,

Caroline Burgeff, CONABIO Mexico
posted on 2013-02-28 04:07 UTC by Ms. Caroline Burgeff, Mexico
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4297]
dear All
I like to stress that I support the proposal of developing guidance how centers of origin and diversity should be "handled" in a risk assessment. As our Mexican collegue and a number of others pointed out centres of origin and diversity are of great importance for those living in these areas and working with their biological diversity but also for all of us, for humanity. There is some reference to centers of origin and diversity in the road map and and the GM tree additional guidance when dealing with the receiving environment. But these points to consider raise only the "if" and not the "how". 
best regards
Beatrix
posted on 2013-02-28 13:06 UTC by Beatrix Tappeser, Federal Agency for Nature Conservation
Centre of origin [#4307]
Dear Participants

I have been reading the concern for guidance on the centre of origin topic. It strikes me that this topic is unique amongst the topics suggested so far. It differs in only being one aspect of a risk assessment, i.e. you cannot do a risk assessment on centre of origin. The questions that might need to be addressed around gene flow into the non-LMO population and this will be very case specific as the impacts are different. For instance in New Zealand our concern about gene flow, in the case of maize for instance, is total focused on product labelling. We do not have any landraces, wild population or any closely related species so genes can only flow between commercially plants fields. The degree of gene flow is going to be very dependent on the size of area planted in the crop and the location, size and flowering phenology of the non-LMO population. If a novel gene becomes established in the non-LMO population will it have a beneficial effect or a negative effect on those feeding directly or indirectly on the plants, and does this have a beneficial or detrimental effect on biodiversity or human health. Also does the gene have a beneficial or negative effect on non-LMO populations.

This is a fascinating area for research and I would propose that as risk assessors we should be drawing up a list of research topics that we think need answering to allow risk assessment to be conducted. But I do not see that we are in a position to right guidance on risk assessment for centre of origin.

Regards
Geoff Ridley, New Zealand Environmental Protection Authority
posted on 2013-02-28 23:03 UTC by Dr. Geoff Ridley, Environmental Protection Authority
RE: Centre of origin [#4317]
Dear all,
The clear conclusion of all the discussion is that in each of our countries we have to strengthen our knowledge of the biology, ecology and possible interactions in a case by case analysis. The guidance, as good as it can be is just that: a GUIDANCE which cannot solve all our specific challenges or problems. We cannot blame the road map (guidance) for our own failures or lack of knowledge or understanding our specific conditions.
RA is performed in a comparative basis (behavior and risks of the conventional, non-transformed organism and possible behavior and risks of the GM organism) Therefore, the cornerstone of a RA is the scientific knowledge (scientific robust criteria), and solid quality information you have as a basis, including understanding the biology, the ecology, possible interactions of the organism (both the non transformed and the GM), the environment and specific conditions of the release (potential receiving environment), where experiences with organisms with the same or similar characteristics –genotypic or phenotypic- should be considered (history of use of the non-modified recipient).
Additionally each country –individually- has to have absolutely clear what is the issue that they intend to protect (protection goals), and the assessment end point, as well as risk thresholds and management strategies. Consequently, the clue is: which are the questions that should be addressed in order focus on our specific goals and concerns.
The evident conclusion is that, in each of our countries, we must strengthen our knowledge and understanding of our specific conditions and experiences in order to perform a sound, scientific based RA, and we should use the guidelines as the very valuable orientation they are, but the road map cannot solve or answer our concerns, our task is to respond to them with all our skills and scientific knowledge.
Kind regards,
Elizabeth Hodson
posted on 2013-03-01 02:50 UTC by Professor Elizabeth Hodson, Colombia
RE: Centre of origin [#4321]
May I express my strong support for the position stated by Professor Elizabeth Hodson [#4317].  It is particularly important to remember that risk assessment is not a scientific method, but that risk assessment uses (sound) science to establish the nature and level of risk; in that sense is is a decision support tool.
regards
janet gough
posted on 2013-03-01 03:10 UTC by Janet Gough, Environmental Protection Authority
Response to #4296 [#4306]
Dear Participants

I would like to support Camilla Beech’s [#4296] posting. The comment that she has made is the point that I was trying to make with my set of questions. The questions we need to ask are often very simple but it is the experimental design to gather data that can be very difficult.

Regards
Geoff Ridley, New Zealand Environmental Protection Authority
posted on 2013-02-28 22:19 UTC by Dr. Geoff Ridley, Environmental Protection Authority
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4298]
POSTED ON BEHALF OF LUCIANA P. AMBROZEVICIUS
----------------------------------------------------------------------

Dear participants,

Being far from the forum in the last week was hard to read all the messages but I’d like to agree and emphasize two main points already commented by many (Dr.
Fudou, Dr. Fujita, Dr. Watanabe, Paulo Paes, Deise, Paul keese, Geoff Ridley, Maria Roca, Piet van der Meer, Janet Gough, Sol Ortiz etc):
- Concentrate our attentions and efforts to test the RoadMap on actual cases
- After the testing, if the necessity of further guidance was identified, the reason why that topic was choosen need to be transparent

It seems also that there is already discussions about further guidance (Real Time On line Conference held on April/2012; Discussions held from 28 March to 18
April/2011 at the on line forum) so I understand that  we should accomplish the first task of testing the RoadMap and than, if necessary and based on the result of previous discussions of topics,we should  prioritize a topic for further guidance and present concrete arguments for the choice.

Kind regards,
Luciana P. Ambrozevicius
posted on 2013-02-28 14:32 UTC by Dina Abdelhakim, SCBD
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4299]
POSTED ON BEHALF OF HIROSHI YOSHIKURA
---------------------------------------------------------

This is my first intervention to this round of the on line forum.

I basically agree with the comment, “actual efforts should be mainly directed to test the usefulness of the guidance (in particular the Roadmap) and to design a comprehensive way to gather and analyze the testing results so that they become useful to give feedback to the “live” roadmap, (Caroline Burgeff, CONABIO Mexico).

Having said, I find Dr. Hans Bergmans’ proposal is interesting to see if the current Guidelines as such are actually applicable to;
1. Cellular microorganisms – because there are scientific issues in environmental microbiology that are very different from crop plants and that merit a separate treatment.
2. Viruses, - because also for viruses there are scientific issues that are very different from crop plants.

I do have a problem, for example, in identifying “centers of origin” of E. coli (Annex III, paragraph 9 (a), (h)). The notion of “centers of origin” was first coined by Vavilov for crop plants if my memory is correct. I do not know if it is applicable to all the living organisms.

The horizontal gene transfer is rather rule than exception in prokaryotes (Guideline Document on Horizontal Gene Transfer between Bacteria, OECD Consensus document No. 50, 2010). There are problems associated with taxonomy of bacteria (Guidance Document on the Use of Taxonomy in Risk Assessment of Microorganisms: Bacteria OECD Consensus document No. 29).
Probably, the current Guidance under test should have paid more attention to qualifications carefully added to several paragraphs in Annex III, such as, “as appropriate” in the first line of paragraph 8, and “depending on the case” at the beginning of paragraph 9. With these qualifications, Annex III may be applicable to LMOs in general.
Test of the guidance through actual testing will reveal potential problems (depending upon how to use it) associated with the present guidelines under test.

Best regards,
Hiroshi
posted on 2013-02-28 15:11 UTC by Dina Abdelhakim, SCBD
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4300]
Dear Francisca and participants of the Forum,

Angela Lozan (#4235) and Lucette Flandroy (#4271) made very useful overviews of the topics suggested for new RA&RM guidance. The approach proposed by David Quist (#4254) on setting a prioritized list for future guidance development might be a compromise approach, and allow to accomplish the decision BS-VI/12 that “allows the new AHTEG to develop additional specific guidance on topics in which Parties have an interest in the next term” as mentioned by Ossama A. ElKawy (#4200).

Hence, we agree with the prioritized list proposed by David Quist, we just would add RA&RM of LMOs created through use of dsRNA techniques. This because the existing RA guidance makes reference to identification of gene products (which should include dsRNA e.g. Step 1 of the Roadmap); however, there is no specific international guidance on the best way to identify them or their potential adverse effects.

Finally, in response to a previous comment:

- When it was mentioned to jointly comply with the “mandate” of the Protocol, it referred to the mandate of “contributing to the conservation and sustainable use of biological diversity, also taking into account human health”. For accomplishing this mandate we require agreed procedures and tools (e.g. RA&RM guidance).

- Our proposal for considering the particular risks and adverse effects that LMOs imply in centers of origin and genetic diversity is far from what was stated by Mercedes Roca (#4278): “that each region concentrates on specific guidelines (case by case) to develop guidelines for LMOs introduced into their centers of origin or diversification”. That is a complete misinterpretation of the proposal and real concerns from Bolivia. On the contrary, as mentioned in previous posts, we believe that the development of further guidance should be a joint effort under the Cartagena Protocol, and in support of what was expressed by Wei Wei in his last intervention related to the risk of gene flow, further work is needed for avoiding/preventing LMOs release in centers of origin and genetic diversity. Just as reference, our current legislation expressly forbids the introduction of LM species (specifically crops) of which we are center or origin and genetic diversity. 

Sincerely,

Georgina Catacora-Vargas
posted on 2013-02-28 16:16 UTC by Sra. Georgina M. Catacora-Vargas, Bolivia (Plurinational State of)
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4301]
I appreciate Wei's [#4291] and Georgina's [#4300] responses because they indicate to me the some members of the forum are concerned about "differences" and national policies.  Wei stated that GM crops are "different from traditionally bred varieties".  I agree with this statement as a statement of fact.  It is also a statement of fact that one individual plant is different from another individual plant of the same species.  This does not require the development of guidance to sort out what is scientifically obvious.  I believe that the issue is whether that difference is harmful.  Since there are no international standards defining harm with regard to differences between varieties of the same species (harm is determined nationally), international guidance is of no utility. 

Georgina concludes her posting with:  "further work is needed for avoiding/preventing LMOs release in centers of origin and genetic diversity. Just as reference, our current legislation expressly forbids the introduction of LM species (specifically crops) of which we are center or origin and genetic diversity."  To me, the policy in Bolivia is quite clear.  As a developer, it is clear that one can not bring potatoes improved through GM technololgy to Bolivia.  What then is there need for further guidance? 

It would be innappropriate for experts to use this forum in an attempt to develop policies for Parties and call it guidance.

Thanks,
Tom
posted on 2013-02-28 17:13 UTC by Mr. Thomas Nickson, Consultant
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4303]
Dear colleagues,

I am following this online discussion with interest and would like to provide a few additional thoughts and reflections before this round is soon brought to a close.

This round refers to paras 1c) and 3c) of the Annex of decision BS-VI/12 concerning the development of new guidance, so I will refrain to comment on other issues which have been repeatedly brought forward by colleagues, such as testing the existing guidance etc. I think COPMOP6 has given us a clear task here and I would like to thank the Secretariat for clarifying this task in their recent posting.

As a non-English native speaker I am not sure if I can follow all the arguments concerning the correct terminology among the different possible terms (guidance, a priori risk assessment etc.). But I would strongly suggest that we continue to use the established term guidance and, if necessary, clarify its meaning. From my point of view, I understand the concept of “Guidance” as we have used it from the beginning in our discussions of the previous AHTEG and online expert forum. And that is a document that provides in certain area of LMO risk assessment the following elements:

- points to consider, relevant for the risk assessment
- rationale for the points to consider and
- link to relevant literature

These three corner stones of a guidance document, especially the link to relevant literature ensure that the Guidance fullfills its purpose, being non-prescriptive but trying to assist the target audience, by guiding it also to the relevant literature available in the various fora.
In this context I also fail to see why some experts characterize existing or future guidance as creating fears, listing only dangerous aspects etc. The aim of a guidance is to list “point to consider” and provide the rationale why a certain point to consider is relevant. The previous AHTEG and expert forum tried to develop the now existing guidance documents along these lines, supported by the results from previous testing, and future testing will show if there are needs for improvement.

On the topic of this specific online forum I re-iterate my procedural suggestion that experts should be invited to identify their three priority topics and argue in a concise manner why guidance is needed on these topics. From my point of view I would like to support those who have suggested that guidance should be developed on how centres of origin and diversity should be "handled" in a risk assessment. The main argument is that this item is of global relevance concerning the protection of biodiversity, regardless of the specific region, and that the issue is mentioned in but not covered by the roadmap in an operational manner.

Best wishes

Helmut Gaugitsch, Environment Agency Austria
posted on 2013-02-28 17:22 UTC by Mr. Helmut Gaugitsch, Austria
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4304]
Dear all,

As Helmut Gaugitsch [#4303] suggested again to be concise and identify three priority topics, we support the topics as the main interest and urgency, argumented by many participants to the forum (David Quist (#4254), Georgina Catacora-Vargas, [#4300]  Wei Wei and many others), that are:

1. Risk assessment of LMOs in centres of origin and genetic diversity;
2. Risk assessment for GM organisms created through use of dsRNA techniques, including dsRNA direct injection into cells or organelles and other in vitro techniques;
3. LM migroorganisms / viruses (Canada-Norway workshop).

It was quite difficult to do this selection from the number of very important topics discussed here and I expect we will be able to return to them in not very far time perspective.

Best wishes,

Angela Lozan,
Ministry of Environemnt, MD
posted on 2013-02-28 18:22 UTC by Angela Lozan
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4302]
Dear all,

I would like to share with you that I am participating in a very interesting workshop in Costa Rica. A very representative group of biosafety regulators   from 19 countries,  including Central and South America, Mexico and Spanish speaking Caribbean countries (Cuba and Dominican Republic) are participating in this week long work shop on  Environmental Risk  Analysis  and Low Level Presence (LLP). The workshop includes technical presentations on Risk Analysis, with emphasis  on technical aspects  of risk assessment  and field trips to see LMOs. We have also consolidated a regional   (Central America) biosafety group known as the  “Iniciativa  Centro Americana de Biotecnología y Bioseguridad”  (ICABB) that advices our regional Ministries of Environment, Agriculture and Health on key topics. Risk Analysis is one of them.

The workshop is being organized by IICA and the UNDP-GEF biosafety project for Costa Rica. For those interested to learn more, here is the link about  our newly formed group, ICABB. Apologies to those who don’t speak Spanish.

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

Lively and constructive discussions regarding various aspects of conducting an ERA  have been central to our agenda this week.  The questions proposed by Paul Keese [#4252]  were  put out to the group today and questions about the usefulness of the Secretariat’s guidance. When I have the chance to analyze  the answers, I will send this information to the Secretariat and post it on the BCH on behalf of the newly formed ICABB.
 
More general points of consensus (discussed today in a face-to face meeting)  from our group of Latin American regulators include the following:

1. Our countries need biotechnology and need to strengthen capacity on risk analysis to support robust and scientifically defensible decision making.   These is the mandate from our Ministers and  is especially true for Central American and some Caribbean  and Andean countries.  There are many resources already available to help risk assessors in the region. The guide being developed by the Secretariat is just one more in the list, but unless it is in Spanish and with the right technical terminology used by experienced Spanish speaking risk assessors, it won’t be useful to our region. All countries present agreed on that.  The group also agreed that a very useful resource currently available  is the ERA guide  in Spanish  recently published  by  Latin American regulators with experience in conducting ERAs in their countries.

2. There is a growing concern about the cost and investment in time and other resources that the ever  growing biosafety processes demand.  Overworked regulators in Central America  don’t have the luxury of just dealing with biosafety issues.  They also need to concentrate on other  very real and pressing issues that threaten us,  among other things:  a). our agriculture (pest and diseases exacerbated by climate change); b). our  environment (loss of habitats and consequent loss of biodiversity);  c).  human health (the growing incidence of dengue for example currently managed by pesticides).  Risk analysis in general must be commensurate  with the potential negative effects and balanced with very real known risks such as the ones mentioned above. With very limited resources available in our countries, this is especially important to consider. We question the usefulness of developing even more guidance  documents, when plenty already exist.

3. Colleagues from many countries, especially Andean countries, well represented in this workshop,  have pointed out their concern that there is divergence of opinion (lack of consensus)  from country delegates officially representing their biosafety committees of their country (CTNBios) and those opinions  presented by individuals in international discussions, such as this on-line fora. In the spirit of being transparent,  we should understand that opinions presented in this forum by experts are very often personal opinions and often don't accurately represent the consensus in a country or even a biosafet committe.  This has been apparent by listening to different  official country representatives.


4. It is the general feeling that  the smaller countries of Latin America, feel very blessed to have “older brothers” such as Brazil, Argentina, Mexico and Colombia, guiding us with their experience.  We are all learning from each other experiences and would be happy to share them with other countries outside the region too.

We wish you all very productive discussions and look forward to learning more from this group too.

Maria Mercedes Roca, Zamorano University
posted on 2013-02-28 17:19 UTC by Dr. Maria Mercedes Roca, CIBIOGEM, Mexico
Response to #4300 [#4308]
Dear Participants

I am constantly amazed by the use and acceptance in this discussion of unsubstantiated statements. I would challenge Georgina Catacora-Vargas [#4300] comment “further work is needed for avoiding/preventing LMOs release in centers of origin and genetic diversity”. Where is the consensus that this can never happen and on what scientific evidence is it based? This is what risk assessment is for to look at each release on a case-by-case basis and determine whether or not a release should be made.

Regards
Geoff Ridley, New Zealand Environmental Protection Authority
posted on 2013-02-28 23:14 UTC by Dr. Geoff Ridley, Environmental Protection Authority
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4305]
Good afternoon to all from Mexico!!!! Again, thanks to all for your effort, your time, your interventions!!!!!!
I just want to share some of my impressions related to the discussions up to now (and I apologize that I am making this statement till today, almost at the end of the two week forum).  The discussions has been a bit polarized, and although in some cases it is clear you are “listening to each other”, there are other cases in which it seems to me that this is not occurring.
Drawing from what I have seen, I highly recommend that a forum session is set particularly to discuss the purpose of guidance, including what it should accomplish, what it should look like as well as how/who/when it should be done. These points deserve more thought and exchange of views.
I firmly believe in the need for collaborative effort in “biosafety” (the “safe and responsible” use of modern biotechnology) matters. Part of this process includes learning, understanding and building upon common grounds that the Cartagena Protocol already set forth. We must all pay more attention to the voices set forward in order to build upon them, and make this a more constructive process.
I finally want to draw your attention to the strategic objectives 1.3 and 1.4.  These constitute the umbrella under which the Parties should act under the strategic plan in relation to risk assessment and risk management. The challenge is to strive for and achieve common understanding on the way forward towards the strategic objectives, and how best the AHTEG can start to contribute towards the objectives.
posted on 2013-02-28 20:32 UTC by Ms. Francisca Acevedo, Mexico
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4309]
Dear Francisca

Thank you for your posting as it reminds us why we are here. If we go to the decision document and specifically what it is we are discussing it is:

“Consider the development of guidance on new topics of risk assessment and risk management, selected on the basis of the Parties’ needs and their experiences and knowledge concerning risk assessment.”

Consider the development selected on needs. That is exactly what we have been discussing and as yet I have not seen anyone justify a need for guidance. Many have expressed a desire for guidance but not a need. I would have thought strategically we need to be doing what is critically needed and not a long list of resource demanding desires.

Regards
Geoff Ridley, New Zealand Environmental Protection Authority
posted on 2013-02-28 23:44 UTC by Dr. Geoff Ridley, Environmental Protection Authority
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4310]
Hello Francisca,

Thank you for all your efforts as moderator to set these forum discussions on a productive path.  The discussions have indeed been far ranging, and your reflections in these final hours of the forum give us much to consider even after the forum closes.

I regret that I have not been able to post prior to now, but I appreciate the opportunity to add some comments now before the forum closes.  I also appreciate the energy that the participants have brought to the forum discussions

It has been very interesting to see the responses that others have provided to your two questions that set this forum in motion, namely (1) do Parties to the Protocol have a need for guidance on new topics of risk assessment and risk management to be developed, and (2) if such a need exists, which topics should be considered based on your experience and knowledge concerning risk assessment? 

The discussions in this forum should be required reading for anyone considering the testing of the Roadmap/Guidance document.  To me, the many comments that provided long lists of desired guidance on new topics is an indication that the Guidance document produced by the AHTEG over the past four years is seen as inadequate, at least by those who see need for new topics.  This does seem reinforce the decision of the Parties at MOP6 to call for real testing of the Guidance document to see if it is both faithful to Annex III of the Protocol and reflects the experience gained over many years in practical systems to inform decision making by governments.

In the interest of time and patience, I will keep my comments brief.

Rather than answering yes or no to new topics for guidance, it is more useful to try to agree on criteria that would be used to decide the need and whether there is sufficient experience gained upon which to develop guidance.  Guidance is based on many real-life examples, and it is from these examples that general practices can be gleaned.  A number of commenters ask for guidance on LM viruses, yet they do not cite the many LM virus reviews that have been done in countries using LM viruses in the environment (e.g., pseudorabies vaccine, and the many vaccines to protect poultry and livestock).  Likewise there have been many reviews done for plants with altered nutritional characteristics.  I urge people to review these before setting off to develop separate guidance documents. 

I wonder if people are taking advantage of the information that countries have posted online for the reviews for LMOs, including LM fish, trees, viruses, etc.

If the online forum and AHTEG can distill criteria for choosing topics for additional guidance, it will be necessary to have a more adequate account of existing guidance, reviews to date, and the expertise and time of the people who are to produce such guidance.  On this last point, I recognize that that the AHTEG process has numerous drawbacks.

This calls again for the topic of this forum to be considered in light of the testing of the Guidance that has been produced by the AHTEG that just finished its work.  I agree with the points raised by others that it is illogical to embark on consideration of additional guidance topics prior to the appropriate testing of the Guidance, and that such testing reflect actual experience to date. 

Thanks for allowing me to participate.

David Heron , USDA-APHIS, Biotechnology Regulatory Services
posted on 2013-03-01 00:15 UTC by David Heron, United States of America
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4312]
Dear All,

This is a response to post [#4309] with my respective attitute. Dr. Geoff Ridley still questioned that nobody justified a need for guidance for selected topic if I understand correctly. I would give an example on the topic of centres of origin and diversity. There are various inputs that provided the reason including mine of the guidance need regarding of centres of origin and diversity. I really appreciate the point provided by Helmut [#4303] that indicated the important relation of this topics to CBD and its significant contribution to biological diversity.

In case of the  regions for centres of origin and diversity, even no related LM crops are permitted, there is an need. China is one centres of origin and diversity of the wild soybean, GM soybean were not permitted to grow commercially. However, we import every year plenty from US, Brazil and Argentina, the origin of GM soybean. There is possibility of leaking during transportation like the case happened with GM canola volunteer in Japan and in US. In addition, Chinese scientists are developing some GM lines currently. That means we have a need and I believe that other parties may also need this guidance dealing with centres of origin and diversity.

Even in a country that does not permit the import and release of GM crop in the centres of origin and diversity, there is also a need when one day imports may necessarily happen upon some kinds of stress. And also the possible unintended dispersal could happen from neigbours.

Thank you!

Wei
(edited on 2013-03-01 01:57 UTC by Wei Wei)
posted on 2013-03-01 01:49 UTC by Mr. Wei Wei, China
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4315]
In response to Dr Wei Wei, I am a little puzzled as I understood that we were looking at transboundary movements of GMOs.
Dr Wei Wei states that "Even in a country that do not permit the import and release of GM crop in the centres of origin and diversity, there is also a need when one day imports may necessarily happen upon some kinds of stress. And also the possible untended dispersal could happen from neigbours."
I am at a loss to understand how the Guidance is necessarily able to assist with accidental introduction except that it might be useful for countries (at times) to explore possible impacts (but this might not necessarily be risk assessment but simply consequence assessment) in the case of inadvertent introduction.
But this is not the purpose of the Guidance which supports Annex III.  Please correct me if I am wrong.

regards
janet gough
posted on 2013-03-01 02:23 UTC by Janet Gough, Environmental Protection Authority
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4316]
Dear Janet Gough,

I have to respond because I am afraid that you may assume that I think you are correct. As a non-native speaker of English, it is a pity that sometimes what I talked in English can cause misunderstanding. Import is of course an official tranboundary movement. This topics we talked about is difinitely related to the conservation of biodiversity. We as the people living in the importor country will not be too worried once we have the guidance in hand.

As we are approaching the end of the forum, if no time permits my further explanation to any further question that does not necessarily mean that I think my point is incorrect.

Thanks for your question that gives me an opportunity to clarify somehow.

Best regards
Wei
(edited on 2013-03-01 02:49 UTC by Wei Wei)
posted on 2013-03-01 02:48 UTC by Mr. Wei Wei, China
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4314]
Dear Francisca and members of the Forum

Perhaps I am naïve to the workings of intergovernmental interactions, but I would have thought that the place to establish and justify the need for guidance, priority of topics etc was during the COPMOP. This forum, which is far less formal, was to instead deliver on the task specified. That task, as has so often been repeated, is for countries to declare a need if it exists and to prioritise those needs.

Countries have done so. I am increasingly of the opinion that some Parties are attempting to re-negotiate the COPMOP Decision and include post hoc an expected outcome that requires countries to provide details on their internal processes for determining how they came to identify their needs and priorities. Like so very many other internal policies, choices and decisions that are made by different countries that explicitly or implicitly shape the views expressed in the forum, also this information is not required by 3(c) of the Terms of Reference.

Nevertheless, some countries have provided more extended explanations (e.g., [#4312] but also others). Thus, they have expressed and justified their needs.

The three forums have been specific to the three tasks set by the COPMOP6. This third and last forum follows from, as the Secretariat kindly reminded us (3c): " A recommendation on how to proceed with respect to the development of further guidance on specific topics of risk assessment, selected on the basis of the priorities and needs indicated by the Parties with the view of moving toward the operational objectives 1.3 and 1.4 of the Strategic Plan and its outcomes".

In response to Geoff [#4309], I think it is quite clear that the topics can be selected on the basis of the priorities and needs of the Party. Country representatives in the forum have a right and have exercised their rights to list topics for further guidance based on their internal processes for determining priorities and needs. The COPMOP6 did not appoint particular countries or observers to serve as arbiters over differences in perceptions on what constitutes needs, wants or priorities.

In response to Francisca’s interesting recommendation [#4221]: “I highly recommend that a forum session is set particularly to discuss the purpose of guidance, including what it should accomplish, what it should look like as well as how/who/when it should be done. These points deserve more thought and exchange of views” I have mixed feelings. Such a philosophical discussion would surely be of interest to this academic! But again I do not see the forum or the AHTEG as being in a position to prescribe to Parties what the purpose of guidance is, or to determine for them what it should accomplish. Beyond the irregularity of another forum outside the specified list of expected outcomes set by COPMOP6 - and the tremendous costs associated with participation in these forums (as noted in particular by Geoff in [#4207]) - these considerations were either implicit in the list of historical Decisions mandating an AHTEG on RA&RM or should instead be generated in response to a request from the COPMOP in the form of an expected outcome.

Well Francisca (and also Hans and Helmut), I am glad for your patience with and dedication to this process and even more glad to not have to bear your work as moderators!

Best wishes
Jack
posted on 2013-03-01 02:11 UTC by Mr. Jack Heinemann, University of Canterbury
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4323]
I would like to agree with Jack Heinemann statement.  I think this forum has gone far beyong the initial objective and mandate from MOPCOP.
posted on 2013-03-01 04:45 UTC by Dr. Elizabeth Bravo, Acción Ecológica, Ecuador
Response to #4314 [#4334]
Dear Participants

JackHeinemann [#4314] has concerns that some parties are trying to renegotiate the COPMOP decision. In Hyderabad we spent somewhere around 12 hours discussing the risk assessment document. This was no way near enough and many did not get to voice their thoughts or to discuss them. I would have thought that the setting up of a discussion group at the COPMOP was in fact to allow this to happen. I would have also thought that as a discussion group we could come to the conclusion that the COPMOP got it wrong and to make a recommendation to that effect.

Regards
Geoff Ridley, New Zealand Environmental Protection Authority
posted on 2013-03-01 20:14 UTC by Dr. Geoff Ridley, Environmental Protection Authority
RE: Response to #4314 [#4335]
Dear All;
The discussions are quite interesting.
The directives of COP-MOP6 are very clear on this matter. The guidance marerials are to assist Parties particularly those who do not have enough capacity on risk assessment and not prescriptive. The more guidance materials the better. Those who emphysis the cost of developing more guidance materials must note that it will cost more if the wrong approach to risk assessmnet that is not in conformiting with  international best practices is taken and the global biodiversity and human health are compromised . More over the more guidance materials there are the more information available to regulators as well as more confidence to take informed decision. While parties are advised to test the already developed guidance, AHTEG should develop more guidance.
The guidance materials are not meant for advanced parties but for parties that need then. Let us give opportunity to  parties to be at the same page in the adoption of  modern biotechnology safety  . Modern biotechnology has come to stay. Africa needs the technology in a sfe manner and more African countries are embracing it. The guidance Materials prescribed by Beatrix and Gado are very important.

Rufus Ebegba,
National Biosafety Office,
Federal Ministry of Environment,
Abuja, Nigeria
posted on 2013-03-01 21:41 UTC by Dr. Rufus Eseoghene Ebegba, Nigeria
Response to #4335 [#4338]
Dear Participants

Rufus Ebegba [#4335] makes a good point that “guidance marerials are to assist Parties particularly those who do not have enough capacity on risk assessment”. Much of the discussion in this forum has been whether or not the process used to develop the existing guidance actually produce guidance that “assist Parties particularly those who do not have enough capacity on risk assessment”. Many are not yet convinced that it does and wish to see the road map and guidance tested for this reason. If we are convinced that it does then I for one will be more than willing to see further guidance developed. If it does not we need to signal this to the COPMOP and Secretariat that there is a need to go back to first principles and consider again how guidance id developed.

Regards
Geoff Ridley, New Zealand Environmental Protection Authority
posted on 2013-03-01 22:23 UTC by Dr. Geoff Ridley, Environmental Protection Authority
RE: Response to #4335 [#4341]
AHTEG was set up to elaborate on Annex 3 of the CPB to make it more user friendly and comprehensive. The Road map and the guidance materials cannnot be said to be in- adequate for now until feed backs are received from parties who have testsed them. However they are said to be living documents which could be improved upon as new finding emerge. While we test the existing  guidance documents new ones could be developed along the same line to save time and to give opportunity to receive feed backs from those partie that need them.
Rufus
posted on 2013-03-01 22:41 UTC by Dr. Rufus Eseoghene Ebegba, Nigeria
RE: Response to #4335 [#4342]
I wonder what he would do to harm Dr. Geoff Ridley that other countries feel they need more guidance, have them, especially those who do not have the same experience that apparently has its country. On the example of brain operation I would say two things 1) I would not let a surgeon operate is beginning to be tried out, practice has not, not even an internship in brain surgery before. 2) I find it experimental method, ie applying the evaluations go as experience is gained. Is that why trasngénicos crops have generated negative impacts both in places where they have been adopted?

Elizabeth Bravo
posted on 2013-03-01 22:43 UTC by Dr. Elizabeth Bravo, Acción Ecológica, Ecuador
RE: Response to #4335 [#4345]
Those parties that have enough knowledge to conduct risk assessment should provide more information that would assist the developement of more guidance. Africa is fast adopting modern biotechnology. We need more guidance to enble us benefit from the technology just like other advanced parties to enhance our economy.

Rufus
posted on 2013-03-01 23:03 UTC by Dr. Rufus Eseoghene Ebegba, Nigeria
Response to #4345 [#4347]
Dear Participants

In response to Rufus Ebegba [#4345] I desperately want to give to those countries with insufficient capacity to do what they need to do the tools. However I don’t want to give them untested documents that could result in bad decisions for those countries. That is why I have repeatedly said we need to test and it is why I have outlined how I think good guidance could be developed.

Regards
Geoff Ridley, New Zealand Environmental Protection Authority
(edited on 2013-03-01 23:27 UTC by Geoff Ridley)
posted on 2013-03-01 23:26 UTC by Dr. Geoff Ridley, Environmental Protection Authority
Response to #4342 [#4346]
Dear Participants

In response to Elizabeth Bravo [#4342] New Zealand does not have any experience of experience of the release of an LMO into the environment. However, we are always on the watch for development overseas and looking at guidance documents from jurisdictions doing risk assessment. When the time comes for us to conduct a risk assessment we will be going directly to those jurisdictions for guidance.

I have no objection to countries asking for guidance however I did ask for justification. Maybe justification is too strong a word. What I am interested to know from a country that has asked for a specific guidance is this because they know that they will soon be asked to do a particular risk assessment, or they are currently trying to do a risk assessment, or they have turned down an application because they did not have the capacity to do a risk assessment. This information would help me and other to understand what the needs of countries are.

Regards
Geoff Ridley, New Zealand Environmental Protection Authority
posted on 2013-03-01 23:17 UTC by Dr. Geoff Ridley, Environmental Protection Authority
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4313]
Dear Participants;

As I could not find time to join so far, this is my first intervention on the current forum.
First of all, I would like to thank you Francisca for moderating our discussions and appreciate the enthusiastic discussion of the participants.
I support comments from Ryosuke Fudou(#4152), Paulo Paes de Andrade(#4154), Katherine Bainbridge(#4172), Andrew Roberts(#4181), Kazuo Watanabe(#4189), Sol Ortiz Garcia(#4191), Victoria Colombo Rodoriguez(#4194), Boet Glandorf(#4251)and similar comments from other participants, and lots of comments from Geoff Ridley.
As Geoff has mentioned (#4308), the COPMOP6 decision states that new topics are to be “selected on the basis of the Parties’ needs and their experiences and knowledge concerning risk assessment”.
Therefore it is quite important to find what would be the Parties’ needs.  It would necessary to develop measures to identify such needs in a transparent manner.  Also, the selected needs should be justified to all the Parties to the Protocol, if the development of such documents would use CBD budget and resources.  It is expected such needs would be practical and may be suggested by experts, but may not be based only on the needs of those experts.
Typically, the needs may be revealed in the case where a Party would like to introduce LMO into its environment in order to improve agricultural production, but could not perform risk assessment due to lack of experiences.  Perhaps the authority in the country would look for information on CBD homepage or other different sources, or ask assistance to the experienced countries.  In this context, following questions would be raised;
-Are existing documents enough for the assessment?
-If not, are those cases common among at least some Parties?
-What kind of documents (or “guidance”) is needed?
-Who and how should develop the documents?
Such questions might indicate an answer to the question presented by Francisca in #4192, i.e. “1. what documents (i.e. guidance on new topics of RA&RM) are intended to accomplish, 2. what process should be followed in creating them”.

best regards

Isao TOJO
Ministry of Agriculture, Forestory and Fisheries, Japan
posted on 2013-03-01 02:09 UTC by ISAO TOJO, Ministry of Agriculture, Forestry and Fisheries
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4327]
Dear Participants and Francisca:
I agree with Geoff that the issue of asking for further guidance for risk assessment in a center of origin highlights many interested points.
The roadmap, although hoping to be useful for all LMOs, was developed based mainly on crops (because there is where there is more experience). Vavilov´s concept of center of origin is use for crops. The roadmap, makes explicit references in several “points to consider” and some in “rationale” to centers of origin and genetic diversity. Obviously during risk assessment, this is also taken into account implicitly when you evaluate the relevant aspects of the receiving environment, where there are also references to centers of origin in the roadmap. It is also mentioned in the other parts of the Guidance.
It would be very interesting to know the criteria/reasons of those who feel the need for further guidance on risk assessment for centers of origin. Have they tried to actually use the roadmap and find it not useful for this? If so, could it be better to fix it (once having answered the questions posted by our moderator: “what a guidance document should be aiming at” “what are the principal aspects that, under your personal view, should be included in such a document”,) before choosing this topic as a recommendation for COP-MOP7?
So I will emphasize again and supporting previous postings, new topics are to be “selected on the basis of the Parties needs and their experiences and knowledge concerning risk assessment”. Parties needs is an important component, please let´s not forget experiences and knowledge. If there is not experience and knowledge, needs cannot be properly resolved.
I strongly agree with professor Elizabeth Hodson when she mentions that “we must strengthen our knowledge and understanding of our specific conditions and experiences in order to perform a sound, scientific based RA, and we should use the guidelines as the very valuable orientation they are, but the road map cannot solve or answer our concerns”. This is especially true when it seems that there are Parties that want to use the guidance for a different purpose not related to scientific based risk assessment.
Kind regards
posted on 2013-03-01 14:48 UTC by Ms. Sol Ortiz García, Mexico
Forum: Risk Assessment and Risk Management: Consideration of thedevelopment of further Guidance on new topics - A new message has beenposted to the forum [#4329]
Dear participants,

Here a 2nd and may be last intervention of mine in this round of the forum:

Taking into account that, during the testing phase, the applicability of the Roadmap to all kinds of LMOs should indeed been analyzed, I had proposed, in a previous posting, that complementary guidance should nevertheless be useful for RA of modified organisms phylogenetically very far from plants, in particular viruses and fishes, whereas I was more flexible on a 3rd priority topic for new guidance, that  could be among other prokaryotic microorganisms.

I would like to add a few comments on the late postings of David Heron, Beatrix Tapesser and Helmut Gaugitsch, and Sol Ortiz Garcia.

David Heron wrote that "many LM virus reviews.... have been done in countries using LM viruses in the environment " for animal vaccines.
I am not a particular specialist of this field, but I saw already several files of such vaccines as a risk assessor, this issue was covered in the Canada- Norway Workshop, and I talked about this also with virologists and scientists more involved in this field: it appears that the RA that are made are largely limited to the clinical and "peri-clinical" aspect and phase, and to the traceability of the viral genes in this phase, but that much less attention is given to potential unforeseen interactions with and impacts on the rest of the environment.

The ERA in the centers of origin of biodiversity ( in particular centers of origin of cultivated plants ), asked by several participants as a priority topic for new guidance, is concerning, as said by Beatrix and Helmut, the preservation of the pool of important cultures not only for the regions of these centers of origin but for the sake of future food security of the population of the whole planet. If I did not point this topic as a priority for a new guidance in the context of the Protocol, it is not because I did not find it important;  but I considered that, as said by Sol Ortiz Garcia,  this should be tackled during any good RA based on the present roadmap developed mainly, as we said, with GM plants in mind.  Besides, it seems to me that this problematic of preservation of biodiversity in the centers of origin is somehow linked to the wider problematic of the indeed badly called "contamination" ; indeed, the potential impacts of this "contamination" are concerning not only the potential introgression of the specific transgenes of LMOs in non-modified counterparts ( which could but not necessarily lead to negative effects ), but also more widely the potential "dilution" and thus impoverishment of the genetic pool of numerous local and traditional in situ adapted strains by their crossing with one single strain modified in a laboratory. And this does not actually seem to me to be tackled in current RA.

So, as said by Sol Ortiz Garcia, it should be important, during the testing phase to look if the Roadmap is sufficiently adequate to evaluate this aspect. If not, it could indeed be among important issues to tackle for complementary guidance.

Finally, whereas this was not the subject of this round of the forum, Dr. Geoff Ridley ( who would without doubt be the winner of this session if a prize was given to the most numerous postings ....... ), who made a lot of dispersed remarks concerning the divergence of understanding of the nature and the purpose of a RA guidance - but without giving a very clear explanation of this, following me -, could maybe give, in one synthetic posting, a CLEAR  explanation of his view of such a guidance and of what globally does not correspond to this view in the current roadmap; this could be one posting of him eventually useful for further work to understand each other.

With best regards


Dr. Lucette Flandroy

Disclaimer : http://www.health.belgium.be/eportal/disclaimer/
posted on 2013-03-01 17:45 UTC by Ms. Lucette Flandroy, Belgium
RE: Forum: Risk Assessment and Risk Management: Consideration of thedevelopment of further Guidance on new topics - A new message has beenposted to the forum [#4330]
Dear Francisca and Participants
Thank you for this opportunity to join in the very lively discussion even though it’s the last minute (Have been unable to do so earlier due to heavy work schedule) and thank you Francisca for taking on this heavy task as a moderator.

I would like to support all the previous postings that we focus our efforts on testing the Roadmap and all the other guidance documents already developed before embarking on developing new ones. Only once we test the Roadmap and make the necessary changes to address the shortcomings and gaps identified during the testing process, will we know if at we need any new guidance developed. As many have said previously, developing guidance for each new LMO will be a never ending task and this will not be the best use of limited resources available. The absence of guidance on a specific kind of LMO must not be seen as a barrier as there is always the Roadmap that will be tested and further improved that can be used or as suggested by Paul Keese is that assistance can be provided to those Parties that wish to undertake risk assessments but for whatever reasons they are currently unable to do so. To this effect, the Malaysian regulators have been working closely with those at the Australian Regulatory Office on many aspects of Biosafety and I am sure will continually do so and with also other experienced regulatory agencies from other countries. I full endorse Maria Roca’s [#4255] comment that we “we take one step at a time and finish one task well, before we tackle the next.”

I would also like to fall back on the wise words of Boet and also others that stated “that the Roadmap should in principle be applicable to all kind of LMO’s. Testing (and adjusting) of the Roadmap could therefore also include testing of other LMO’s than plants to see in which extent the Roadmap will be applicable also for these groups. In cases where it is not applicable, it can be indicated which aspects are different for the ERA of this specific group of LMO’s and those would be the aspects that need further study. Experts can then be invited to deal with these latter issues. In this way we keep a more consistent approach in the ERA for all LMO’s.”  This has also been supported and suggested by many other participants.

Therefore, I remain of the view that before new specific guidance 'documents' are developed, the existing guidance should be tested and subsequently improved to “provide the guidance needed to address many of the additional topics that have been suggested in this discussion, in accordance with Annex III of the protocol” as stated by Karen Hokanson.


Thank you
Kind Regards
Vilasini Pillai
Ministry of Science, Technology and Environment, Malaysia
posted on 2013-03-01 18:28 UTC by Vilasini Pillai, Ministry of Science, Technology and Innovation - Chair real-time conference Asia
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4318]
Dear all;

Concerning Wei Wei’s recent comment (#4312), I would like to provide more correct information on Japan. 
First of all, Japan is not the center of origin of Canola.  However to make sure whether they enlarge their growing areas or not, we have been monitoring self germinated canola, including authorized GM canola, along transport routes due to spillage during commodity transport.  So far, no adverse effects on Japanese biodiversity have been observed. 
Second, Japan would not be the center of origin of wild soybean, but near the center of origin and wild soybean are popular in the environment.  Japan imports lots of soybean, including authorized GM soybean, from the U.S. etc.  Before approving such GM soybean use, we evaluate, of course, the safety of GM soybean for food, feed use and risk on the Japanese biodiversity, including the effect on wild soybean, according to relevant National Laws.

Isao TOJO
Ministry of Agriculture, Forestry and Fisheries, Japan
posted on 2013-03-01 03:03 UTC by ISAO TOJO, Ministry of Agriculture, Forestry and Fisheries
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4322]
This is my first post in the current discussion, and I wish to thank Francisca for moderating this very lively discussion and for giving me the opportunity to comment.  At the risk of taking us all the way back to where we started, I just want to agree with one very important point which many of the participants have already made, because it becomes more evident as the discussion continues. 

I understand (I think) that the purpose of this forum has been to consider whether parties see a need for additional guidance on specific topics and what those topics might be. (I fear we have strayed a ways from this purpose.)  The Secretariat has made it clear that no decision will be made about ‘whether and when’ any additional guidance will be developed until the recommendations based on this and other discussions have been considered at MOP7.  I was happy to know that this is the case.

However, I think the important point that many have made in this discussion is that a decision about ‘whether and when' additional guidance should be developed should depend on ‘whether’ the current roadmap is sufficient or can be improved such that it will provide the guidance needed to address many of the additional topics that have been suggested in this discussion, in accordance with Annex III of the protocol.  I agree with those who have suggested that the roadmap, once it has been tested and revised, will provide this guidance.  I sincerely hope that the recommendation from many is this discussion to postpone ‘when’ any additional guidance is developed until the roadmap has been tested, including testing whether it is sufficient to address the many topics suggested during this discussion (eg adverse effects in centers of origin), will be conveyed during MOP7 and seriously considered.

Thank you.
Karen Hokanson
Program for Biosafety Systems
posted on 2013-03-01 03:30 UTC by Ms. Karen Hokanson, University of Minnesota
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4331]
Dear all,
I am glad to have the opportunity to participate in this discussion, which brings again subjects, that I thought were suppurated years ago.
As many of my colleagues (that I will not mention because they are to many) I consider that there is no case to develop more guidance until the Roadmap is tested and agreed.  I had the opportunity to participate is the workshops to test the roadmap as well as actually doing the risk assessment of many events in my country that is center of origin of more than one GM crop. With this experience I can tell that these are two different ways to test the roadmap as guidance and the last one, actually doing the risk assessment is the best one. The workshops and questionaries are a good intention (Quite expensive), but are just theoretical. I will use the example presented by Dr Ortiz “imagine someone developing guidance on how to do brain surgery if the guidance author had not done many such surgeries”… but have the theory. There is no best way to test the guidance than use it. Only the parties using it on their regular environments will be able to say if it is useful or not. And it will take some time.
Thank you
Adriana
posted on 2013-03-01 19:11 UTC by Dr. Adriana Otero-Arnaiz, Mexico
Response to #4331 [#4336]
Dear Participants

I would like to pick up on the analogy that Adriana Otero-Arnaiz [#4331] repeats from Dr Ortiz : “imagine someone developing guidance on how to do brain surgery if the guidance author had not done many such surgeries”. This is the point I have been making. The first brain surgeon did not have a guidance document but the experience from that surgery was used to write the first guidance. As more surgery was done the guidance was updated and rewritten from the experience, new questions were developed and asked, and more complex surgery became possible. I do not see that the process for risk assessment guidance should be any different.

Regards
Geoff Ridley, New Zealand Environmental Protection Authority
(edited on 2013-03-01 22:12 UTC by Geoff Ridley)
posted on 2013-03-01 22:06 UTC by Dr. Geoff Ridley, Environmental Protection Authority
RE: Response to #4331 [#4337]
I disagree with the brain surgery theory on this matter. Even in medical field there are guiding principles. What we are saying is that there should be  guide for those who wish to use them in risk assessment.
Rufus
posted on 2013-03-01 22:17 UTC by Dr. Rufus Eseoghene Ebegba, Nigeria
Response to #4337 [#4339]
Dear Participants

In response to Rufus Ebegba [#4337] I would note that the brain surgery is offered as an analogy not a theory. Rufus quite rightly draw attention to guiding principle. Surely that is what the road map is and we need to test it to determine whether or not it is currently fit for this purpose.

Rufus’s second point was “What we are saying is that there should be guide for those who wish to use them in risk assessment.” I would turn this around and ask would you want to be making decisions on a document that untested and not based on real experience? If I was doing a risk assessment I would determine the guidance to be a hazard with a risk of a wrong decision being made. Currently I would treat any of this guidance with a high degree of caution.

Regards
Geoff Ridley, New Zealand Environmental Protection Authority
posted on 2013-03-01 22:37 UTC by Dr. Geoff Ridley, Environmental Protection Authority
RE: Response to #4331 [#4344]
Leaving aside the brain surgery analogy, but picking up on by Mr. Rufus Ebegba's comment that "there should be  guide for those who wish to use them in risk assessment."  This is entirely the point.  The Roadmap provides that Guidance.  Until the existing guidance has been tested (by real cases) and any flaws, gaps, new concepts determined it is downright dangerous to start developing specific guidance documents that (if the Roadmap were shown to be flawed) would probably need to be rewritten.
Let's get on with the testing, and start to develop the criteria we need to determine what (if any) further guidance is required.
regards
janet gough
posted on 2013-03-01 22:59 UTC by Janet Gough, Environmental Protection Authority
RE: Response to #4331 [#4340]
Dear Participants

Thank you Rufus for comment on the brain surgery metaphor.
It is ridiculous to think that the first brain surgery was conducted anything like this suggested vacuum. The first brain surgeon would have benefited from a huge volume of guidance of relevance to every aspect of the care and treatment of the patient, including standards developed by those who never did surgery themselves. The surgeon would have consulted with ethicists, other surgeons, infection control specialists, anesthetists, nurses and technicians who built or ran all the very sophisticated equipment in the theatre, and probably other experts as well.

Geoff has been openly critical of the opinion of others (e.g. [#4308]: “I am constantly amazed by the use and acceptance in this discussion of unsubstantiated statements.”) Perhaps before this metaphor is used we should see some substantiation of the history of medical guidance development.

Certainly the process or guidance development described by Geoff was also in play before the first brain surgery. The first brain surgeon would not only have benefited from advice developed by past experiments on animals and cadavers, but also on learned bodies developing standards and guidance that would have been available for review by this pioneer. The next brain surgeon would not only seek the input of those who went before, but also seek any available guidance available.

Similarly in this AHTEG exercise, those who wrote and reviewed the guidance brought experience from conducting risk assessments for their governments, employers, professional communities and/or civil society, and they brought other relevant areas of expertise to the development of the guidance. The RA guidance is based on the cumulative compilation of expert advice to date, supported by the latest research literature, just as the first brain surgeon was and the next is sure to be.

Nothing so far precludes the process that Geoff is suggesting. In fact, I would say that this has very much been part of the process because the guidance was written by practitioners and is tied overtly to the research literature. Nothing so far that I have seen justifies a move to restart the development by a process that requires someone to first have done a risk assessment in the absence of guidance. Those conducting an assessment on an LMO for the first time, or those assessing the first LMO of a kind, and who want to have the accumulated wisdom brought together by the Parties to the Cartagena Protocol should be able to receive guidance and not have to conduct an ad hoc process of their own if they don’t want to. 

Thanks for a stimulating forum!
Jack
posted on 2013-03-01 22:40 UTC by Mr. Jack Heinemann, University of Canterbury
Response to #4340 [#4343]
Dear Participants

I don't disagree with Jack's comments [#4340] and I am sure that he will be vindicated by the testing.

So let’s get on with the testing so we have that certainty and then we can look at developing new guidance.

Regards
Geoff Ridley, New Zealand Environmental Protection Authority
posted on 2013-03-01 22:54 UTC by Dr. Geoff Ridley, Environmental Protection Authority
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4332]
Dear all,
How it was mention since the first participation by Dr. Ryosuke Fudou (#4152) the COPMOP decision was not about new subjects for guidance, but more about the process. Even that, there are two subjects that I think are very important and needs by the parties:
1) How to develop national biotech products to resolve local and regional needs.
To develop this guidance the procedure could necessarily involve countries with the experience doing that, as it is the case of Brazil.

2) How to use biotech products to conserve the natural resources. For example in my country we have more that 50 landraces of corn. Many of this will be conserved because of their commercial value. However there are others that grow in very difficult environmental conditions that are been worst with climate variability. The use of genetic modifications in these varieties that let them resist better drought and/or cold could help to conserve this resource for future generations.
Thank you
Adriana
posted on 2013-03-01 19:30 UTC by Dr. Adriana Otero-Arnaiz, Mexico
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4348]
POSTED ON BEHALF OF FRANCISCA ACEVEDO
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Dear participants to the forum:

I would once again like to thank the participants for all the postings made during the last two weeks of the Forum! It was indeed a very vivid and intense discussion!!!!

I will summarize the main ideas, proposals and discussions that are within the scope of the topic of discussion and respond directly to the guiding questions posed at the beginning of the forum. I must admit that there were other equally important key issues raised in the interventions that were not directly related to the discussion towards realizing the expected outcome stated in paragraph 3(c) of the annex to Decision BS-VI/12. I have been advised by the Secretariat that these issues may need to be addressed in due time under the discussions relating to Articles 15 and 16 through the COP-MOP process.

Thank you all for giving me the opportunity to have this firsthand experience in such a lively discussion!

¡Un abrazo desde México a todos!
Fran
posted on 2013-03-01 23:54 UTC by Dina Abdelhakim, SCBD
RE: Consideration of the development of further Guidance on new topics of risk assessment and risk management [#4401]
POSTED ON BEHALF OF FRANCISCA ACEVEDO
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Dear Participants of the Open-Ended online forum,

Thank you once again for everyone’s intense participation! There were many ideas that were shared and discussed during this forum.

The forum discussion invited participants to:
“Consider the development of guidance on new topics of risk assessment and risk management, selected on the basis of the Parties’ needs and their experiences and knowledge concerning risk assessment.” as outlined in paragraph 1(c) of the annex to decision BS-VI/12.

The objective of the round of discussions was to review the need of Parties for the development of new guidance on risk assessment and risk management and, if so, discuss which topics should be considered based on these needs.

Two guiding questions were posed to help focus the discussion:

1.Do Parties to the Protocol have a need for guidance on new topics of risk assessment and risk management to be developed?

2. If such a need exists, which topics should be considered based on your experience and knowledge concerning risk assessment?

The discussion was aimed at contributing to realizing the expected outcome as stated in paragraph 3(c) of the annex to Decision BS-VI/12:
"A recommendation on how to proceed with respect to the development of further guidance on specific topics of risk assessment, selected on the basis of the priorities and needs indicated by the Parties with the view of moving toward the operational objectives 1.3 and 1.4 of the Strategic Plan and its outcomes". 

As indicated in the decision, and clarified by the Secretariat, the objective of this discussion was to provide input to the above recommendation to COP-MOP7 for its consideration and that there is no mandate to develop any new guidance during this intersessional period.

A total of 50 participants contributed to this discussion. Below is a summary of the responses to the guiding questions provided to steer this discussion.

28 participants, 18 of which represented Parties, were opposed to the development of further guidance at this point in time. These participants indicated that the primary focus of the use of resources and efforts should be placed on the testing of the Guidance. Among the reasons given is the notion that testing and improving the Guidance will provide a robust living document useful enough for the assessment of any LMO without further need for additional specific guidance. Some participants further suggested that by testing the Guidance first a better assessment would be made as to what topics may need additional guidance. It was indicated that the testing would highlight whether or not there are any particular areas relating to specific LMOs that are not fully addressed by the Guidance and would thus require the development of additional Guidance.

19 participants, 12 of which represented Parties, supported the suggestion of developing further guidance at this point in time. Participants were of the view that further guidance should be developed because there is a need that is being expressed by Parties to do so. This need, it was noted, is based on a number of different factors including the rapid technological advances in the field of LMO development.  It was thus considered that further guidance needs to be made available to Parties such that they can cope with the assessment of LMOs that are the products of these new and emerging technologies and ensure that the methodologies used to conduct a risk assessment are in line with the most up to date best practices. It was also indicated that further guidance on specific topics would provide additional scope to practising risk assessors who may not necessarily have expertise with LMOs that are outside their area of speciality and thus may not be able to fully grasp all the details linked to conducting such an assessment. Further, it was indicated that it would also be useful to novice risk assessors as a capacity building tool. Additionally it was highlighted that to delay the development of further guidance until the testing is complete would place an unfair burden on those countries that have a current need for guidance.

Among the participants who supported the development of further guidance, some made concrete suggestions for possible topics to be considered. These included, in no particular order:

• Risk assessment living modified organisms for production of pharmaceutical and industrial products, including effects on both vertebrate and invertebrate pests;
• Risk assessment of living modified animals, including fish;
• Risk assessment of living modified microorganisms and viruses;
• Risk assessment of living modified organisms introduced in centers of origin and genetic diversity;
• Guidance on integrating human health into the environmental risk assessment;
• Risk assessment of nutritionally altered living modified plants;
• Risk assessment for living modified organisms created through use of dsRNA techniques;
• Risk assessment of living modified organisms produced through synthetic biology;
• “Co-existence” between LMOs and non-LMOs in the context of small scale farming;
• Socio-economic considerations in the context of environmental risk assessment;
• Risk assessment of living modified algae;

As indicated in my earlier closing remarks, some interventions made on the broader issues of risk assessment and management may have to be considered in other processes.

Once again I would like to thank all the participants for their contribution to this discussion.
Best regards y un fuerte abrazo,
Fran
posted on 2013-03-12 13:26 UTC by Dina Abdelhakim, SCBD