Third Real-time Online Conference for WEOG and CEE, 12 April 2012 from 9:00 to 12:00 GMT
Download the conference documents here.
Dear Participants,
Good morning! Welcome to the Third Real-time Online Conferences on Risk Assessment and Risk Management for WEOG and CEE. It is a great pleasure for us at the Secretariat to be gathered here once again with all of you.
Your input today is very important and will serve as a basis for the deliberations by the AHTEG at its fourth meeting which will take place in Montreal, Canada from 4 to 8 June 2012.
Moreover, the outcome and recommendations of the real-time conferences will be forwarded to the Parties of the Cartagena Protocol at their meeting in October 2012.
I have a couple of technical notes before we proceed with the conference:
1. I would kindly ask you to type or paste your intervention on the Text Box (centre-bottom of the screen) before requesting the floor because you will have only 60 seconds to send your intervention once the floor is given to you.
2. The Secretariat is available to answer questions through the HelpDesk. To access the online HelpDesk, please use the tab in the top-left corner of the screen. In case of emergency please call us at +1-514-287-6681. This number is also available at the top-right corner of the screen.
We have a full agenda and, without further delay, I would like to welcome all of you to this conference and invite the Chair, Dr. Helmut Gaugitsch from Austria, to preside over the conference.
The Secretariat wishes you a very fruitful discussion! |
Thank you, Secretariat.
Distinguished colleagues,
Good morning and welcome to the third real-time conference for WEOG and CEE. It is an honour for me to chair this conference again.
Since the last meeting of the Parties to the Protocol in 2010, following the mandate in decision BS-V/12, the Open-ended Online Expert Group and the AHTEG have made considerable progress in revising the Guidance on Risk Assessment of LMOs. The Open-ended Group and the AHTEG also developed two new guidance documents: on “post-release monitoring of LMOs”, and on “risk assessment of LM trees”. |
Our work today will focus on providing comments to these guidance documents as well as on considerations about the need for further guidance on specific topics of risk assessment and risk management, and recommendations to the COP-MOP including considerations for future activities related to the Guidance on Risk Assessment.
The outcome of the third series of online conferences will serve as inputs for the deliberations by the AHTEG during its fourth meeting scheduled to take place from
4-8 June 2012 in Montreal, Canada.
This series of real-time conferences is, therefore, the last chance that experts in the Open-ended Online Forum will have to provide input to the work of the AHTEG before it submits its final outcome to the Conference of the Parties of the Protocol (COP-MOP) in October 2012.
The importance of active participating and sharing your views today cannot be stressed enough.
On this note, I declare our conference open and look forward to your active participation throughout the conference.
We will move now to Item 2. Organizational Matters; sub-item 2.1 Adoption of the agenda. |
The task before us is the adoption of our agenda. I invite you to turn to the provisional agenda contained in document UNEP/CBD/BS/REGCONF-RA&RM/3/1, which was prepared by the Secretariat and reflects the objective of our meeting.
Unless you have amendments or objections to any of the items, I propose that we adopt the agenda of the meeting as contained in document UNEP/CBD/BS/REGCONF-CB-RA&RM/3/1. |
I see no requests for the floor.
The provisional agenda as before us is adopted.
Let us now turn to agenda Item 2.2 Organization of work. |
I hope that our conference today will end at about 12:00 (GMT), plus or minus 30 minutes as needed to complete our task today.
Also, I propose that we have a break of 15 minutes half-way through the conference or as needed.
I trust that you have prepared your interventions on the basis of the annotations to the provisional agenda that was circulated by the Secretariat as document UNEP/CBD/BS/REGCONF-RA&RM/3/1/Add.1.
I would like to propose that we use the guiding questions, which were circulated by the Secretariat by email prior to the conference, to assist our deliberations today on each substantive item in our agenda.
Due to a full agenda, I will attempt to progress swiftly through its items and I kindly ask that you take part in the discussion in a prompt, direct and open manner.
Is there any objection to this organization of work? |
| Sorry, I have to leave at 12:00 GMT sharp. This is no objection, just a comments |
OK Hans, we will try to stick to our time.
I see no objection. The proposed organization of work is adopted.
I will now invite you to turn to item 3 on the agenda.
ITEM 3. SUBSTANTIVE ISSUES |
Under this item, our first substantive issue is:
ITEM 3.1. COMMENTS ON THE GUIDANCE DOCUMENTS PREPARED BY THE OPEN-ENDED ONLINE EXPERT GROUP AND THE AD HOC TECHNICAL EXPERT GROUP ON RISK ASSESSMENT AND RISK MANAGEMENT
We will have three sub-items under 3.1 as follows:
(a) Guidance on Risk Assessment of Living Modified Organisms;
(b) Monitoring of living modified organisms released into the environment;
(c) Risk assessment of living modified trees.
The latest draft versions of the guidance documents, which have been circulated by the Secretariat on 2 April 2012, will be used as the basis for our discussions today.
This being an extensive agenda item, we will likely spend approximately half of our time today or roughly one and a half hour discussing these sub-items. |
I will now open the floor for your reactions to the first guiding questions under:
(a) GUIDANCE ON RISK ASSESSMENT OF LIVING MODIFIED ORGANISMS
(i) Does the Guidance provide a useful tool to assist you in performing or reviewing an LMO risk assessment? What amendments would you propose to increase its usefulness?
The floor is open for your comments. |
| Yes, for the first question I think that Guidance may be an useful tool in evaluation and review of LMOs but, for the secon question, I propose a more easy and immediate lecture with, ad example, some picture, different types, particular evidence of the most important points, and so on.... |
| Thank you Maria Antonietta, any more inputs or reactions? |
The Guidance on its own provides useful information (lots of it), but was not conceived to be the only tool, on its own. The idea was that the Guidance would also show the way to the reader to where he can find background documents.
A start has been made for COP-MOP 5, to collect relevant documents from the BIRC, and allocate them to places in the Guidance where they would be relevant.
This concept should not be lost, and will not be lost: the AHTEG, according to its mandate, still has to discuss procedures and a mechanism how to keep such a list of documents up-to-date, and the AHTEG will make (I expect) recommendations to COP-MOP 6 on this issue. |
| Thank you Hans, you are right, this is a very important point. Any more views? |
| From Item 7 of the annotated agenda to this conference:
1. I note that the testing of the Roadmap confirmed this point:
“7. Parties, other governments and relevant organizations were invited to submit the Guidance to their experts involved in risk assessment of living modified organisms for testing it for its overall utility and applicability. Similarly, the Secretariat also invited experts in the Open-ended Forum and participants to training courses in risk assessment to carry out the testing of the Guidance. A total of 24 Parties, one other Government and three organizations took part in the testing. Thirty-seven participants of capacitybuilding activities organized by the Secretariat also took part in the testing…The great majority of Parties also consider the Guidance a useful tool to assist countries in conducting and reviewing risk assessments of living modified organisms introduced into various receiving environments, in a scientifically sound and case-by-case manner.”
See http://bch.cbd.int/onlineconferences/ra_guidance/testing.shtml. |
| Thank you David for referring to the results of the testing. Anybody else? |
| To start the discussion: We are very pleased with the guidance n RA of LMOs. It has clearly improved during the different processes since the last COPMOP. The structure of the roadmap is logic and follows the basic theoretical structure of risk assessment. Moreover, two issues that we would like to highlight; the roadmap gives sound and clear advice on two complex issues of RA; quality and relevance of data and how to deal with uncertainty. The whole document is an outstanding achievement. We have no additions at this point. |
| Thank you Marja for your feedback. Who else would like to add his/her input? |
| Hi All,
I think that Maria raised an important point, i.e. the guidance is not easy to read. Often long or difficult sentences that are not easy to comprehend and certainly not easy to translate.
Further, I fully support Hans's point that the guidance is not a stand alone guidance but should provide access to more and more specific information. A bit like the BCH, which is intended to be "information about information". |
| Thank you Piet for your input. Any more views from colleagues? |
Thank you very much. The second question related to the Guidance is:
(ii) Is there any issue or concept that is missing from the revised Guidance that should be included? If so, please propose a draft text to address the missing issue(s).
The floor is now open for your reactions. |
| We appreciate and support Marja´s comments of above - concerning the complexity of the document as addressed by Piet (not Marja) I find that this is in a way unavoidable with a quite complex subject. |
| Thank you Michael, any more comments on the second guiding question on this point? |
| Carrying out RA is a complex task. We think that the document is very logic to follow. However, it is of course true that background documents are essential. |
| There are issues with continuity of concepts that have arisen with the development new specific guidance documents that are in advanced stages of completion, and that need to be addressed in the Roadmap. For instance, from the Monitoring document is the concept that an LMO risk assessment may be conducted “in a step-wise manner” (Lines 42 and 43) , yet this concept (which mirrors the “step-by-step approach” outlined in Directive 2001/18/EC) does not appear in the Roadmap.
My concrete suggestion is that this missing concept could be addressed by explicit mention of the “step-by-step approach”, similar to Directive 2001/18/EC to appear in the Roadmap, at line 228. The sentence starting on this line would read: “For small-scale releases, especially at early experimental stages or where environmental releases of an LMO are conducted in a step-wise manner, the nature and detail of the information that is required or available may differ compared to the information required or available for large scale or commercial environmental release.” |
| Thank you David. Hans you have the floor. |
| I don't think there are really missing issues (maybe after I have read David's text ...), but the text is very much focused on crop plants. This could me remediated by having more guidance docuents (we will talk about that later on). This is not easy to remediate in this text. |
| Thank you Hans. Any more views under this guiding question? |
| I think Davids suggestion is a good one and I would support it |
| As the guidance is intended to build on knowledge and experience accumulated over the years, I believe that a section should be added that gives links to the experiences of countries where confined and unconfined releases have been conducted. |
| We would also like to support the step-by-step approach and David's suggestion. |
| Thank you Beatrix, Piet and Marja. Any more views? |
| In principle David is right, but the Roadmap is about the RA as it is done in each step. How to tajke steops goes beyond what is addressed in Annex III. But still, it is of course a crucial concept. |
| David, you have the floor. |
| It seems to me we should be careful when considering the experiences of other countries, which mayb be using different legal frameworks, scientific requirements, etc. than the Protocol, for providing relevant information to RA on a case-by-case basis depending on the environmental context of introduction. |
| dear all, just a short reminder, please type or paste (Ctrl+V) your text in the text box prior to requesting the floor because you will have only 60 seconds to send your message once the floor is given to you. |
| I agree with David, and I think that it is necessary the concept of step-by-step and case-by-case because it is impossible consider all the possibilities in a guidance |
Dear All,
The Guidance on Risk Assessment of Living Modified Organisms was broadly used and largely discussed in Moldova during the meetings and trainings with academia, researchers, university staff and students, and also during the university courses for undergraduate and master students we used. Taking into account that Moldova by now does not have the practical experience in proceeding with the risk assessment and risk management of LMOs, participants to the meetings, as well as students have mentioned the usefulness and relevance of the Guidance to rise the national scientific capacities in RA-RM, and also mentioned that this Guidance is a comprehensive, explicit, understandable and very helpful for eventual applications. It would be advisable to have this document available in national languages. A Training Module on Risk Assessment would be also welcomed to train students and young researchers. |
| Thank you Angela for sharing your experience with us. Very good! Any more comments under this point? |
| Concerning experience sharing, I would like to remind on the ongoing activities in submission of RAs and regulatory docs to the BCH for reference to previous RAs and the regulatory framework to conduct these. |
| Thank you Michael, any remaining comments? |
| I would propose that the Guidance on RA of LMOs should integrate a cross-sectorial approach defining clearly issues related to the environment, agriculture, human health and their interrelations. This would help the RA experts to clearly underline issues related to the specific aspects. We would suggest also that the human health aspects should be broadly addressed in the Guidelines, taking into account not only the toxicity and allergenicity, but also the immunologic effects, hereditary, gastrological and other diseases risks, as well as the long-term effects on human health. |
| It is indeed important to address that the step by step approach means that the level of detail of information will vary , depending on the case. as teh Diretcive says: "Not all the points included will apply to every case."
I agree with Micheal that links to RA results in teh BCH should be amde and with Angela that the documents should preferably be trasnlated into national languages |
| Thank you Angela and Piet, your suggestions will be taken into account. Any more comments? |
| In our view, it would be more appropriate to incorporate Public Awareness and Participation and also Socio-Economic issues as the component parts of the Guidelines document, not only as related issues, namely, decision-making process. It is connected with the fact that LMOs cultivated in agricultural fields, could represent considerable risks to the local communities, farmers, farmer associations and their traditional agricultural practices including the cattle-breeding, and other local economies. Ethical aspects are also an important parts of the RA, so Public Awareness and feedback are considered appropriate during the procedure of Risk Assessment. |
| Thank you Angela, any remaining comments? |
I thank all of you for your discussion on the Guidance. I propose that we move now to the next sub-item:
(b) MONITORING OF LIVING MODIFIED ORGANISMS RELEASED INTO THE ENVIRONMENT
and I invite your reactions to its first guiding question:
(i) Are all relevant scientific issues properly addressed in this guidance document? If not, please specify what amendments you would advise.
The floor is now open for your reactions. |
| I appreciate the efforts of the subWG to revise the document to achieve the objective of drafting a concise yet comprehensive guidance paper, which appropriately outlines the general concepts and considerations for the development LMO monitoring. In my opinion the current document very well enables people to further explore the issue in a targeted manner concerning necessary details, which are not (or: no more) included in the document itself. |
| Thank you Michael, Wiebke you have the floor. |
First of all I would like to thank you all for this further developed version of the document, which in my view turned out very well. It is precise, streamlined and readable and it covers the relevant aspects to be considered when implementing a LMO-monitoring.
I would like to comment three issues of the document:
- Line 10 and line 103: I would like to suggest to change the wording “before the consequences are realized” in e.g. “as early as possible and/or before the consequences are realized”. Explanation: Taken the monitoring parameter ‘abundance of a specific bird species’, a detected decrease of the population itself can be an adverse effect - or in other words a already realized consequence. Therefore, the decline should be signalled as early as possible.
- Line 181: I would like to suggest to add a hint, that a location register would be a useful information tool for LMO-monitoring and the selection of relevant monitoring sites/regions.
- Annex I , Topic : Monitoring to evaluate the efficacy of specific risk management strategies.
For the understanding of the examples, it would be useful to mention 1. a possible management strategy and 2. directly linked to it the possible activity to evaluate its efficacy, like:
1. Efficacy of herbicide resistance management to avoid development of herbicide tolerant weeds; 2. Recording weed populations in herbicide-tolerant crop fields or adjacent areas. |
| Just a word about Angela's concerns, still. It is our experience that the different issues that Angela mentions can better be approached separately, in their own right, and after that be taken into account in one overarching consideration, on the problems of decision making. |
| Thank you Hans. Moving back to Monitoring - do colleagues have more comments to make? |
| As an editorial comment: Use of wording, i.e. LMO, LMOs, LMO(s) should be checked throughout the document; in some cases monitoring measures need to target more than one LMO (e.g. LMOs with similar or synergistic traits). In practical implementation e.g. in the EU this is already taken into account e.g. for monitoring resistance development against Bt-traits. |
| Thank you Michael, any more views? |
| We are pleased with the document as a whole. The document stresses the importance to choose meaningful statistical analyses and sound scientific methods, when preparing the monitoring plan. This is very good and essential in order to get meaningful data. |
| Agree with Hans's comments in reply to Angela.
As regards the monitoring document: I too believe that the monitoring document has improved a lot, and enjoyed the discussions in Bonn on the document.
Yet, I believe that we will need some more effort to clarify the concept of general monitoring and general surveillance, which is conducted irrespective of releases of LMO/GMOs. (Also agree with Michael's point that the document needs to be checked for consiustency of terminology).
Further, with people submitting in this debate large chunks of prepared detailed text, it gets a bit difficult to read it all and react quikcly enough. |
| Thank you Piet and I will try to allow good reading and reacting time! Maria Antonietta, you have the floor. |
| yes, I think that relevant scientific issues are properly addressed, but indicators and parameters seem too generic and perhaps must be descripted in a more exaustive way with the right concept of case-by- case and potential future considerations |
| I see that I typed too much in haste, I meant: general monitoring/ surveillance (different terms for the same concept). |
| Thank you Piet for the clarification. Any more comments? |
| Stringency of terminology in general has improved very much - thanks for much work done, fine points still need some consideration. |
| Yes, as Piet says we could clarify GS better. Puzzlingly, the SWG was quick to adopt “case-specific monitoring” similar to how it is conceived by th EU but at the same time reject “general survelliance”! The term “General Monitoring” has been used in its place, but is not an internationally recognized term. |
| I agree wth Piet: better easy way to describe same things |
| We very cautiously got rid of the term general surveillance, for reasons of reaching global agreement on the text. |
| Thank you David, Maria Antonietta and Hans. Any more views under this guiding question? |
| In relation to Wiebkes comments which I support and which should be taken in consideration. Further to Annex I:
Annex 1 would need some further consideration: first bullet (Effects on biogeochemical cycles) of CSM-Monitoring to evaluate the efficacy of specific risk management strategies should be moved to the previous section. “Monitoring to efficacy of (biological) containment measures, if applicable” may be included instead. |
| Thank you Michael, any additional comments from participants? |
Thank you. Let us please move to the second question regarding the guidance document on “Monitoring”:
(ii) Do you have any bibliographic reference relevant to this guidance document which you would like to suggest?
The floor is open for your suggestions. |
The EFSA documents regarding PMEM (sh)(c)ould be referenced here.
We do have a number of references to our own studies on General Surveillance (please read that as 'general monitoring'), that would be relevant in the context of general monitoring, as it is used and explained in the document. Some of these documents we have already sent in during the drafting of the docuent.
We propose that we will post these documents on the BIRC. |
| Thank you Hans, and yes, please do so. More comments? |
| Concerning bibliographic references there are a lot of recently published documents addressing the topic in general
(e.g. EFSA Panel on GMO (2011): Scientific Opinion on guidance on the Post-Market Environmental Monitoring (PMEM) of genetically modified plants. EFSA Journal 9(8), 2316. doi:10.2903/j.efsa.2011.2316; Züghart, W., Raps, A., Wust-Saucy, A.-G., Dolezel, M., Eckerstorfer, M. (2011): Monitoring of Genetically modified Organisms. A policy paper representing the view of the National Environment Agencies in Austria and Switzerland and the Federal Agency for Nature Conservation in Germany. Umweltbundesamt Wien, Reports, Volume 0305, ISBN: 978-3-99004-107-9, etc.)
as well as addressing specific issues.
I am happy to share available references with the sub WG and post on the BIRC. |
| Thank you Michael for this input, please submit these documents to the BIRC. Piet you have the floor. |
| I also propose to include reference to the work of the Swiss ART institute (Romeis et al) - I will send docs to CBD Sec separately , |
| Thank you Piet, any more suggestions from colleagues? |
| Piet, please post the docs to the BIRC directly as we now have the possibility to link the docs to the guidance |
| I had some from Michael's list, and a few other, but for now:
Züghart, W., Benzler A, Berhorn F, Sukopp U, Graef F. 2008. “Determining indicators, methods and sites for monitoring potential adverse effects of genetically modified plants to the environment: the legal and conceptional framework for implementation.” Euphytica 164: 845-52. |
| Thank you David. Who else would like to propose additional references? |
| Long-term and large-scale effects of genetically modified organisms
require specific environmental monitoring designs
Wiebke Züghart
Ill send the full reference....dont have it handy... |
| David, it would be great if you too could submit it directly to the BIRC |
| Thats fine. Please submit the full reference to the BIRC. Further suggestions? |
Thank you very much for your interventions. Let us please proceed to the third sub-item under 3.1.:
(c) RISK ASSESSMENT OF LM TREES
and I would like to invite you to comment on the first guiding question:
(i) Are all relevant scientific issues properly addressed in this guidance document? If not, please specify what amendments you would advise.
The floor is open for your reactions. |
| I think that the Document has to describe better the variety of biological characteristics of trees that actually are important as LMOs trees and particularly, the different ways of dissemination in the air or with the necessary aid of impollinators of reproductive parts |
| Thank you Maria Antonietta, any further views? |
| Dear colleagues, do you have additional views under this guiding question before we move to the next? |
| Maria, can you give some examples ? |
| While Maria thinks I give the floor to David. |
| Looking at the document, it seems to lack a clear distinction from the start on why trees deserve special attention here - It would be good to have a first statement in the docuement on the importance of this guidance given the specific characteristics of trees like longevity, late onset of maturity, multiple means of propagation, high number of propagules, different vectors for distribution, etc...maybe this is some examples addressing Piets question. |
| Thank you David, any more views or reactions? |
| This is the final chance, OK Marja you have the floor! |
| We think that this is a good addition to the specific guidances. And highlights well the differences between annual and perennial plants. However, we do not oppose David's comment; maybe we are due to our geography very familiar with trees :) |
| Excuse for retard. Yes, is too generic. Ad example, fruit trees are very different each other as flower, seeds, times of fruits, why use only the term fruit-tree? |
| Thank you Maria for your response. Now Beatrix has the floor. |
| I agree that the specifics could be emphasized more. we will careful work on that again. And as an explanation to Maria it was a decision by the AHTEG-SWG to concentrate on fruit trees |
| Thank you Beatrix, any remaining comments? |
| Maria, thanks for the clarification.
Although I don't think that the points raised by David are the things Maria mentioned, I do agree that it will be good to clarify the focus on LM trees. PArt of which is simply because teh MOP requested it. In addition, there are indeed aspects of trees that are different form crop plants, some of which may simplify RA and RM, and some of which may make it more challenging |
| Thank you Piet, any more views before we move to the next item? |
| I believe the introduction needs to specify the dangers inherent to LM trees due to the widespread incidence of wild relatives--which if contaminated would continue the chain of contamination without cease. This makes the social and ecological dangers of LM trees highly distinct from that of crops. |
| Thank you Anne for your contribution. Any more comments from participants? |
| I disagree with the term fruit tree. For example, olive tree is different from plum or cherry tree, and different from lemon or orange tree. |
| In respons eto Anne I don't think that there are dangers 'inherent to GM trees'.
Also believe that we should stay away from the term 'contamination'. There is no such thing as 'dirty' or 'clean'; DNA. |
| Thanks Maria, we will take that in consideration but the term was meant to endorse also olive trees |
| OK, thank you Maria Antonietta, Piet and Beatrix. We will now move to the next question. |
I invite you to turn to the last question regarding the guidance on “LM trees”:
(ii) Do you have any bibliographic reference relevant to this guidance document which you would like to suggest?
The floor is open for your suggestions. |
| Yes, I agree but flowers and dissemination of pollen is different from olive tree (without flowers) and almond or plum tree! |
| Genetically Engineered Trees & Risk Assessment
An overview of risk assessment and risk management issues.
Contents
Ricarda A. Steinbrecher with Antje Lorch, May 2008. |
| Thank you Maria Antonietta and Anne. Further contributions? |
| Can I suggest in the interest of time that we simply submit proposed bibliographies to the BIRC, rather then posting them in this debate since we are not going to have a discussion on those documents |
| Anne, could you please submit the article to the BIRC? If you have any question on how to do it please contact me and I can try to help |
| Yes, Piet this is a good suggestion. I still invite colleagues to make some suggestions here and then you may follow-up by submitting additional ones to the BIRC. |
| of course. IN response back to Piet, there are certainly dangers inherent to LM trees, which is presumably why there is a special document pertaining to risk assessment of LM trees. |
| OK, let us focus on the bibliographic references now. Any additional ones colleagues would like to suggest? |
| There are a lot of studies about monitoring of air pollution with analysis of briophytes and lichens that live on trees. may be interesting evaluate if the same results are obtained with LMOs trees |
| If there are any referenced studies please submit them. |
| In response to Anne: no, the reaosn to have a special document on LM trees is not because there are "inherent dangers". We better clarify this better if this kind of misperceptions have arisen. |
| Thank you colleagues, any further references on LM trees which you woul like to mention here? |
| Yes, there are some very good studies of pollen flow related to monitoring of air pollution. Finding tree pollen thousands of kilometers from the source, for example. Again why trees need special assessment. |
Thank you very much for all the interventions.
Before we have a short break, I would like to proceed to agenda item 3.2.
ITEM 3.2. FORMAT OF THE GUIDANCE FOR CONSIDERATION OF THE CONFERENCE OF PARTIES SERVING AS THE MEETING OF PARTIES TO THE CARTAGENA PROTOCOL ON BIOSAFETY AT ITS SIXTH MEETING.
As you are aware, the three background documents that form the basis for our discussions today will be brought for consideration by the COP-MOP at its sixth meeting.
Under this agenda item, you are invited to share your views on how the three documents should be formatted and presented to the COP-MOP. |
I will now open the floor for your reactions to the first guiding question under Item 3.2.:
(i) How could the background documents (Guidance on Risk Assessment of LMOs; Monitoring of LMOs released into the environment; and Risk assessment of LM trees) be formatted to facilitate its consideration by the Parties at their sixth meeting? For example, should the three documents be merged into one or should they remain as separate documents?
The floor is open for your comments. |
| I suggest that the format of Guidance should be merged as a single Guidance document comprising Part I (Roadmap) and Part II (Specific LMOs or traits). |
| Thank you Angela for your clear suggestion. Beatrix you have the floor. |
| I would like to propose the following: to merge the three documents into a single one and have the following structure: part one: the Road Map, Part two: Specific LMOs or traits comprising the documents on stacked genes, abiotic stress resistence, LM mosquitoes and LM trees, Part three: Monitoring. I consider this as a logical, easy to understand structure. The Roadmap as overarching document, the complementing specific documents on traits or LMOs and the Monitoring document belonging more on a Risk management side. |
| We see all the documents as a package: Roadmap, Specific guidance (stacked genes, mosquitoes, abiotic stress resistence, LM trees), Monitoring. |
| I think that the three documents should be merged into one because are different aspects of the same matter |
The present Guidance contains 4 documents that are more fully developed than the documents on monitoring and LM trees. That could be a reason to present the ne documents separately.
Still, this would look odd, and might be misunderstood in COP-MOP.
Therefore, I would propose to collect all six documents in one Guidance, part I being the Roadmap, Part II being the documents on organisms and traits (stacked genes, abiotic stress, mosquitoes and LM trees), and a new part III being a document on monitoring, a further explanation of the concept that is crucial in the Roadmap. |
| Thank you Beatrix, Marja, Maria Antonietta and Hans. David you have the floor. |
| I support this idea presented by Beatrix and Hans. It seems that Monitoring is a specific topic but not specific guidance on classes of LMOs like the other 4 documents, so yes, perhaps a Part III for monitoring would be useful for the user. |
| I would support this idea too. |
| Given that the specific guidance documents build on the roadmap, it does indeed make sense to combine them in a package. All suggestions for a package made are fine with me. |
| Thank you David, Wiebke and Piet. With this you are to quite some extent already adress the next guiding question. Any remaining point under this item before we briefly move to the next? |
| I also support the Part I-II-III approach as above. I feel that a tramendous amount of work went into the mon and tree doc which are mature also. |
| I agree with suggestion to put "monitoring of LMOs released into environment" at he end of Document, as separated Part, because complements the Roadmap |
I will now open the floor for your reactions to the second guiding question under Item 3.2.:
(ii) If merged into a single guidance document, how should the resulting document be structured? For example, can the two new documents (“monitoring” and “LM trees”) fit into the existing structure of the Guidance comprising Part I (Roadmap) and Part II (Specific LMOs or traits)?
And as I said, you already adressed this question, so the floor is open for any remaining comments. |
I thank you all for your participation and interesting interventions that we had so far.
I now suggest that we break for 15 minutes.
We shall continue our discussion on the next substantive issue on the agenda (Item 3.3) as soon as we return from the break.
I kindly ask you to be back to your computers in exactly 15 minutes, that is 10:30 (GMT) as we still have important discussions ahead of us. |
| We will reconvene in 30 minutes at 10:30 GMT. |
| Correction: We will reconvene in 15 minutes at 10:30 GMT. |
Dear colleagues,
Welcome back to our conference. I hope you had time to rest a bit and, without further ado, I invite you to turn to the third substantive item in our agenda:
ITEM 3.3. CONSIDERATION OF THE NEED FOR DEVELOPMENT OF FURTHER GUIDANCE ON SPECIFIC ASPECTS OF RISK ASSESSMENT AND/OR RISK MANAGEMENT OF LIVING MODIFIED ORGANISMS
As you may be aware, a number of Parties to the Cartagena Protocol have indicated a need for guidance on various specific topics of risk assessment and risk management. For the last four years, following a mandate by the COP-MOP, the Open-ended Group and the AHTEG have developed guidance on general risk assessment of LMOs (i.e. the Roadmap) and on 5 specific topics of risk assessment and risk management (i.e. LMOs with stacked genes or traits, LM crops tolerant to abiotic stress, LM mosquitoes, LM trees, and monitoring of LMOs released into the environment).
Under this agenda item, you are invited to express your views as to whether and how the CBD Secretariat should continue to facilitate a process for developing further guidance on risk assessment and risk management. |
I will now open the floor for your reactions to the first guiding questions under Item 3.3.:
(i) Is there a need for the development of further guidance on risk assessment and risk management? If so, on which specific topics should further guidance be developed?
The floor is open for your comments. |
| Just as a general comment: yes, there are a number of topics for which it could be urgent to develop a guidance document, for instance micro-organisms (cellular micro-organisms), viruses, fish, and others. |
I like to draw your attention to the different topics we prioritized as AHTEG in our first session in Montreal back 2009 where receiving environment, transgenic microorganism and viruses, pharmaplants and gm fish were high on the agenda too. and to decision IV/11. In the terms of reference there is special reference under ii)
(ii) Taking into consideration 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); (ii) introduced traits; and (iii) receiving environments, as well as monitoring of the long-term effects of living modified organisms released in the environment, prioritize the need for further guidance on specific aspects of risk assessment and define which such aspects should be addressed first, taking also into account the need for and relevance of such guidance, and availability of scientific information;
Some of in both documents adressed topics we dealt with others are still open like gm fish, pharmaplants or GM algae. In the decision of COP-MOP IV and during our prioritization process receiving environments were ranked high. |
| Beatrix, some text seems to be missing in your intervention. I will give the floor to others first and then maybe you want to come back. |
| Yes, I think is there a need for the development of further guidance, first because evaluation is possible only after a long time, and second, because actually is really difficult imagine what possibilities may be observe in the future, in consideration of adaptative capacity of living organisms.
I think, moreover, that we have to put particolar attention in the future, to questions regarding ecological aspects and capacity of interaction with a wide variety of plants, animal and microrganisms as fungi and bacteria in the soils.
Then, also considerations regarding a long-term impact on environment represented by circulation of water and of air (winds) are important |
| Yes, I think new guidance would be useful, particularly on classes of LMOs, or types of releases that are already being released into the environment but where there is significant scientific information regarding the safety of their use. The development of further guidance should utilize, where appropriate, instruments such as AHTEGs and consultative workshops.
My proposed list is 1. LM Viruses, 2. LM Animals (including fish), 3. Risk Management (and interface with RA and decisionmaking), 4. LMOs intended for release in unmanaged ecosystems, and 5. LM microbes.
I note that LM viruses is a key group considered in one of the AHTEG’s background documents, “Norway Canada Expert Workshop on Risk Assessment for Future Applications of Modern Biotechnology.” |
| It would be important to (re)develop the criteria that would apply, how to prioritize these issues. That goes betyond the present discussion, but is one of the most important first questions. |
| Thank you Maria Antonietta, David and Hans. Now I give the floor to Beatrix again. |
sorry, there was a part missing This is how it continues:
Some of in both documents adressed topics we dealt with others are still open like gm fish, pharmaplants or GM algae. In the decision of COP-MOP IV and during our prioritization process receiving environments were ranked also high.
I would not envision a certain process for the time being but like to underline that there is further need |
| Thank you Beatrix for the completion, now David has the floor |
| apologies.... it should read "where there is NOT significant scientific information regarding the safety of their use"...correction from my last post... |
| One of the specific topics for further guidance of RA I would suggest a Broader ecosystem and landscape considerations, including cumulative effects due to the presence of various LMOs in the receiving environment. |
| I agree with list of argoments proposed by David and with idea of (re)development of criteria of Hans |
| Thank you Angela and Maria Antonietta, now Piet has the floor. |
| Hans just made the point I had typed - we need to agree on the criteria for developing any further documents and also keep assessing to what extent the current documents are actually being used and to what extent people find them useful in practice |
| We support the previous interventions. GM fish, GM algae and pharmaplants are on our list too. We have no clear priority as of yet. |
| Some specific suggestions on the existing documents:
In the text on Risk Assessment of LM trees, in the section on Exposure of the Ecosystem at line 235, under points to consider, there are three points I suggest are important to add:
1. Impacts of the LM tree on surface and ground water--potential of the LM trees to monopolize water sources
2. Allelopathy of the LM trees--specifically leaf litter and leachates and the impact on soils and biodiversity
3. Volatility of the LM tree--the potential for causing or contributing to wildfires and firestorms. |
| Thank you Piet, Marja and Anne. The issue of criteria somehow refers to our second guiding question and we come to that very soon. Any remaning comments before? |
| Consideration of cumulative or combinatory effects as well as risk management seems to me of high importance for the further work. |
| Thank you Wiebke, further suggestions? |
Thank you very much. Let us please move to the final question under Item 3.3.:
(ii) If a need for further development of guidance exists, what kind of process(es), facilitated by the CBD Secretariat, could be considered for addressing this need?
The floor is now open for your reactions. |
| I recognize that you partly already adressed this question in the discussion which we just had before but may I invite for any further comments on a possible process for this future task? |
| I could envision a process where Parties are asked to submit there priorities and a decision is taken during the next COP-MOP VII |
| Similar to Beatrix, I would suggest to ask Parties:
1) for their suggestions for criteria
2) feedback an actual use of the guidance docs in real cases |
| Thank you Beatrix and Piet. Further views on this item? |
| I note Beatrix's suggetsion that there be no AHTEG between MOP6 and MOP7 ... |
| Yes, the question of how to prioritize, and the reasons and rationales behind lists of priorities, is most important. |
| For the time being I would like to let that open, it is up the the COP-MOP |
| We support the role of Parties in prioritizing the future work. |
| I would like propose the consideration that environment is not strictly near LMOs, but every thing may be everywhere in global environment. So we have to study possibilities to note future changes of the nature and, possibly, provide to repair possible damages that may occur in environment |
| Thank you Piet, Hans, Beatrix, Marja and Maria Antonietta. Any remaining suggestions? |
| The question whether there will be another AHTEG is up to the COPMOP.
But, it would be safe to assume that there will be none.
In that case, discussions would have to be structured in well-moderated fora, like what we are doing now. A similar set-up could be envisaged also for non-real time discussions. |
| Broader stakeholder consultations could be a part of any process or fora. |
| I support Hans, it would be a good idea to use the on-line platform for discussions of further RA issues |
| Thank you Hans, David and Angela for some concrete and practical suggestions. I get the flavour that in case tehre will be no AHTEG after COPMOP6 an open-ended online forum or similar system could be put in place for these tasks. Could you probably react on such a suggestion and provide some even more concrete suggestions on how that could work in practice? |
| Let me add: another important aspect would be what would be the objectives of the discussions in any such forum? |
| The main thing that is missing during the fora that we have had until now is a moderator that draws conclusions, and asks questions, leads the discussion (without being 'leading').
That could stimulate a real exchange of ideas.
Still, the main problem will be to find time to participate ... |
| Thank you Hans. Any additional views? |
| I think the bigger issue Hans is what the practical outcome would be. How would these discussions advance to something integrated into the Protocol. Thats the difficulty (not to mention the time to spend on an activity with little valued outcome, though discussion is nice...) |
| Agree with Hans, and I love the idea of a year or two with less travel
I assume that the purpose of the online discusions is to discuss 1) experience with current guidance, 2) criteria for including en guidance. |
| I think Piet's proposal is a good start. |
| I can see a process where Parties are asked via the secretaeriat on their Priorities and needs. Based on this online fora could focus on a process to choose those items Parties then will decide on |
| Thank you, as an ad hoc summary I see the idea emerging that on the basis of suggested and identified priorities moderated online-fora could discuss experience with existing guidance and criteria for developing new and addiotional guidance by the most efficient process. Any comments on this before we move? |
| I would also think that online dicussions would tackle a number of issues, including elaboration on uncertainties and gaps in knowledge in RA, implementation of the Precautionary Approach, etc. |
| We support Beatrix. Knowing that there are different views on the AHTEG process, we would however like to restate our support for this type of process in the future work - if Parties see this a good way forward. |
| I think some contemplation of what we need in broader terms, and what is realistic to embark upon, would be good, before people are asked for specific things. But, I start repeating myself (that's old age) |
| Thank you Hans, sometimes repetition is good. Dabid you have the floor. |
| I also would like to endorse Beatrix's suggestion for the reasons already stated by Marja. |
Thank you very much for your comments. Let us please move to the last substantive item of our agenda:
ITEM 3.4. RECOMMENDATIONS TO THE CONFERENCE OF PARTIES SERVING AS THE MEETING OF PARTIES TO THE CARTAGENA PROTOCOL ON BIOSAFETY, INCLUDING CONSIDERATIONS FOR FUTURE ACTIVITIES RELATED TO THE GUIDANCE ON RISK ASSESSMENT
The sixth meeting of the COP-MOP will take place in October 2012 in Hyderabad, India. At that meeting, the Parties to the Cartagena Protocol will deliberate on a number of issues including risk assessment and risk management.
Similar to the practice at the face-to-face AHTEG meetings organized by the Secretariat, you are invited to provide recommendations to the Parties with regard to risk assessment and risk management, including considerations for future activities related to the “Guidance on Risk Assessment of Living Modified Organisms”. |
I will now open the floor for your reactions to the first guiding question under Item 3.4.:
(i) What recommendations with regard to risk assessment and risk management would you like to propose for consideration by the COP-MOP at its sixth meeting?
The floor is open for your comments. |
| I am expecting a important conference call any minute, so just first to thank thanks to all and particularly Helmut and the Secretariat. Its been fun!
Three activities:
1. Further development of guidance.
2. Integration of the RA guidance document to the training manual should be made, in accordance with decision BS-V/12, Risk assessment and risk management (Articles 15 and 16) Part II.Capacity-building in risk assessment:
(c) Improve the training manual "Risk Assessment of Living Modified Organisms" in cooperation with relevant United Nations bodies, other relevant organizations and expert reviewers by revising it on the basis of the recommendations provided during the regional and subregional capacity-building activities and feedback from Parties, in such a way that any further improvements of the training manual, on the one hand, and of the Guidance through the process outlined in paragraph 6 above, on the other hand, is made in a coherent and complementary manner;
3. More intesive efforts for capacity building and training, utilizing the information developed by the AHTEG is concert with Training Manual. |
| Thank you David for all your contributions and all the best for your conference call. See you soon.
Now, do colleagues have additional comments under this item? |
| To adopt the results of the AHTEG and facilitate any work stemming from that, along the lines that we have just been discussing.
I have no comments yet on the training manual. |
| I agree with program of David, with my considerations send in the precedent item |
| Agree that it will be important to check the training manual that is currently used by the Secretariat in traning sessions, for consistence with the guidance documents once adopted by the MOP. |
| I can cancel my own intervention, it is in line with Davids
Taking up the point under our last item I would propose to have a recommendation in that direction asking parties to submit their priorities and needs
And I agree with Hans it is obvoius to ask the Parties to endorse the documents we developed |
| I agree a training manual on overal guidance and specific topics along with e-training modules would be welcomed to propose for consideration of COP/MOP |
| Thank you Angela, Beatrix, Piet, Maria Antonietta and Hans for your clear suggestions. Are there any further suggestions on what you would like the AHTEG to recommend to the COPMOP? |
| A series of regional/sub-regional training meetings also would be useful to make the guidance understandable and have also a feedbak from participants |
| Thank you Angela, are there any remaining comments? Before we move to the next question which is quite related to the current one and which to some extent you already answered. |
| The relationship between the emerging Guidance and the training manual has been mentioned by some of you. Do you have any concrete suggestions on what could/should be done to harmonize the two documents? |
| OK, if not then I think we will move to the next guiding question. |
| Angela's earlier point is pertinent and underlines what has been said earlier, the current guidance is so dense that people need training to understand the guidance. This also underlines the wisdom of asking Parties for their experiences in actually using the guidance in real cases, and which parts they feel need clarification.
As regards the relationship with the manual and the guidance, if the guidance is adopted by MOP, then I trust that someone will go through the manual for consistency |
Thank you for your interventions.
I would like to proceed to the second and last guiding question under Item 3.4.:
(b) Would you like to make a recommendation to the COP-MOP regarding any consideration for future activities related to the Guidance on Risk Assessment?
I will now open the floor for your reactions. |
| I know that partly you already addressed this question in your interventions before. But do you have additional and concrete suggestions on future activities related to the Guidance? |
| we already discussed that, right? |
| Yes, I just wanted to see if colleagues would like to add any additional thoughts before we move on. Last chance ... |
| That is implicit in our previous comments.
A mechanism should be devloped to tackle questions on RA/RM, and to prioritize needs for what needs to be developed. We will not be able to do all that we want. |
OK, we are well with respect to timing and in the interest of keeping the work programme that we agreed at the beginning of the conference, I will now close the discussion on item 3.
Thank you all for your interventions. |
| I would suggest to address the capacity building needs for RA to be considered for further implementation of RA principles according the guidance. |
| OK, thank you Angela, this is a very important point. We will now move on. |
We will now move to
ITEM 4. OTHER MATTERS
I will open the floor for approximately 5 minutes or more if needed for any suggestions, comments etc that you may wish to make that are relevant to the mandate of this conference.
The floor is now open. |
| OK, I do not see any requests for the floor. Again last chance .... |
Fine, dear colleagues, we are approaching the end of our conference, but before I move on to the next agenda item, I would like to invite the Secretariat to make some final remarks.
Secretariat, you have the floor. |
Thank you, Helmut.
Dear all,
We are approaching the end of the Real-time Online Conference for WEOG and CEE.
It was a great pleasure for us at the CBD Secretariat to be gathered here today with the purpose of discussing important issues on risk assessment of LMOs. The outcome of our conference is a clear set of views and recommendations that will not only assist the AHTEG in their deliberations but also be brought for consideration by the Parties.
I would like to thank all of you for participating in this conference and for the fruitful discussions. I would like to give special thanks to Dr. Helmut Gaugitsch for chairing this conference in a very skilful and efficient manner.
The full transcript of this conference will be available at this same address for future reference.
I hope to see you all soon either in person or online. Thank you all, have a good afternoon! |
| May be interesting provide a yournal (on-line?) where interested Persons may be write their experience about results of RA in their experience |
| Thank you Maria Antonietta, the AHTEG will reflect on your suggestion. Angela, you have the floor. |
| that is good idea to share the countries experience on RA. |
| Thank you very much for the interesting conference. |
| Thank you very much to Helmuth, the secretariat and all participants; and all the best for you all also in the name of Beatrix |
Thank you, dear colleagues and thank you Secretariat.
I would like also to thank all the participants and guests who have joined today for making this groundbreaking initiative a success. I would also like to thank the colleagues in the Secretariat for their tireless efforts and extremely valuable assistance in making this Conference possible.
With that, I now declare the Third Regional Real-time Online Conference on Risk Assessment and Risk Management: WEOG and CEE, closed.
Thank you! |
| Thanks to all from myself too! |
| Thanks and Good afternoon to all |
| Bye to all and thank you all. |
List of Participants
| Chair Person |
# |
|
Helmut Gaugitsch
Federal Environment Agency
|
95 |
| Party |
# |
|
Michael Eckerstorfer
Austria
|
9 |
|
Marja Ruohonen-Lehto
Finland
|
10 |
|
Beatrix Tappeser
Germany
|
10 |
|
Wiebke Züghart
Germany
|
4 |
|
Maria Antonietta Toscano
Italy
|
18 |
|
Hans Bergmans
Netherlands
|
17 |
|
David Quist
Norway
|
15 |
|
Angela Lozan
Republic of Moldova
|
11 |
| Observers |
# |
|
Anne Petermann
Global Forest Coalition
|
5 |
|
Antje Lorch
EcoNexus / Ecoropa
|
- |
|
Les Pearson
ArborGen, LLC
|
- |
|
Piet van der Meer
Public Research & Regulation Initiative (PRRI) / University of Ghent, Belgium
|
20 |
| Guests |
# |
|
Antonio Fernández y Garcia de Vinuesa
Ministry of Environment, Fisheries and Rural Affairs
|
- |
|
Hajara Oyiza Yusuf
National Biotechnology Development Agency
|
- |
|
Hartmut Meyer
Deutsche Gesellschaft fuer Internationale Zusammenarbeit (GIZ)
|
- |
|
Rodrigo Diaz
Ministerio de Medio Ambiente, Medio Rural y Marino
|
- |
| Secretariat |
# |
|
Charles Gbedemah
UNEP/SCBD/Biosafety
|
- |
|
Giovanni Ferraiolo
UNEP/SCBD/Biosafety
|
- |
|
Manoela Miranda
UNEP/SCBD/Biosafety
|
9 |
|
Stéphane Bilodeau
UNEP/SCBD/Biosafety
|
- |
|
