Second Series of Regional Online Conferences on RA&RM
WEOG and CEE, 9 February 2010 - Full Transcript
Dear Participants,
Good morning! Welcome to the Second 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 virtually once again with all of you.
Your input today is very important since the outcome of the second regional real-time conferences will serve as a basis for deliberations by the AHTEG at its second meeting in Ljubljana, Slovenia from 19 to 23 April 2010.
In turn, the outcome of the AHTEG will be forwarded to the Parties of the Cartagena Protocol at their meeting in October 2010.
On a technical note, I would kindly ask you to type or paste your intervention on the Text Box (center-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.
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 second real-time conference for WEOG and CEE. It is an honour for me to chair this conference again.
Since our first series of real-time conferences a year ago, and with the continued help from the Open-ended Online Expert Group, the AHTEG has made considerable progress in developing four draft guidance documents on specific topics of risk assessment and risk management, namely Roadmap, LMOs with stacked genes, LM crops resistant to abiotic stress, and LM mosquitoes.
Our work today will focus on providing input to these four guidance documents as well as on possible modalities for cooperation in identifying LMOs or traits that may have adverse effects to the sustainable use of biodiversity and, last but not least, recommendations for a way forward.
The outcome of the second series of online conferences will serve as inputs for the deliberations by the AHTEG during its second meeting scheduled to take place from 19-23 April 2010 in Ljubljana, Slovenia.
The second 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 2010.
Therefore, the importance of active participating and sharing your views today can not be stressed enough.
On this note, I declare our conference open.
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/2/1, 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/2/1. |
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 14:00 (GMT). However, due to an extremely busy agenda, we may need to stay a little longer than planned. I hope I can count on your understanding and cooperation on this matter.
Also, I propose that we have a break of 30 minutes half-way through the conference or as needed.
I trust that you have prepared your interventions on the basis of the guiding questions contained in the annotations to the provisional agenda that was circulated by the Secretariat as document UNEP/CBD/BS/REGCONF-RA&RM/2/1/Add.1.
I would like to propose that we use these questions 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? |
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 DRAFT GUIDANCE DOCUMENTS PREPARED BY THE AHTEG ON RISK ASSESSMENT AND RISK MANAGEMENT
We will have four sub-items under 3.1 as follows:
(i) Roadmap for risk assessment of LMOs
(ii) Risk assessment and risk management of LM mosquitoes
(iii) Risk assessment and risk management of LM crops with resistance or tolerance to abiotic stress
(iv) Risk assessment and risk management of LMOs with stacked genes or traits
These topics were selected by the AHTEG during its first meeting for the development of guidance documents. The latest draft versions of the guidance documents, which have been circulated by the Secretariat, 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 two hours discussing these four sub-items. |
| Dear all, just a short note, we have the pleasure to have the Chairs of three AHTEG Sub-working Groups among us today. Hans Bergmans (Roadmap), Beatrix Tappeser (Stacked Genes) and Eliana Fontes (LM Mosquitoes) will be available to answer direct questions you may have on the guidance documents prepared by their respective AHTEG Sub-working Groups. |
| Thank you Manoela and welcome to Hans, Beatrix and Eliana as chairs of the subworking groups. I am looking forward to your assistance. Beatrix you have the floor |
| Excuse me I have some problems with copy and paste, I will manage it in some minutes |
I will now open the floor for your reactions to the first guiding question under:
(i) ROADMAP FOR RISK ASSESSMENT OF LMOs
(a) Does the draft “Roadmap for Risk Assessment of LMOs” provide a useful, complete and user-friendly tool to assist you in performing an LMO risk assessment? What amendments would you propose to increase its usefulness and user friendliness?
The floor is open for your comments. |
| Didier you have the floor |
First of all, my compliments to Hans and all the people who contributed in the preparation of the roadmap.
My first comment relates to the exact purpose of this document. My feeling is that, for people who are already familiar with risk assessment, the roadmap will not add so much to what is currently existing in regulations, guidances and scientific literature on the subject. In that respect, the only real added-value I can see is to used the roadmap as a direct access to useful references. But then we will have to discuss what kind of references should be made available, under which structure, validated by whom…
Regarding the use of the roadmap as a capacity building tool, we must keep in mind that the document (as written now) is very conceptual and theoretical and therefore will most probably not be self-sufficient. I can’t imagine using this document without having in parallel as much concrete case studies as possible. And then the roadmap could be used as a sort of guide for structurizing the case-by-case approach of a case study .
I will end up this first intervention with a concrete suggestion :Wouldn’t it be useful to add in the roadmap a flowchart summarizing the different steps. I think that a pictural and schematic view would ease the overall understanding of the document. |
| Thank you Didier for your comment and clear suggestion. Who would like to come in? |
| Beatrix, you have the floor |
First of all I like to thank Hans for his hard work. He really did a good job. Alltogether my impression is that the road map will help risk assessors together with case studies and some additional internet tools explaining different aspects and techniques like the Biosafety Assessment Tool. That has been mentioned also in the real time online conferences of Africa and Asia To my understanding the Road Map fulfils what the MOP asked for: to give a more elaborate version of the Annex and combine it with existing guidance and working tools for risk assessment.
However as with all documents of such a complexity there are some comments and suggestions for change.
I do feel that we all have a bias towards plants as mentioned in the introduction to the Road Map. For example only outcrossing and seed dispersal is mentioned when spread and dispersal is addressed but with some additional words like interbreeding and escape also animals would be included. That refers to a number of places in the document.
I see some problems with the categorisation setting within the steps because the judgement of major or minor is very much dependant on the protection goals and legal framework of the parties and in addition value and interest driven. The recommendation of a description of these terms is a really hard one and may be best solved with the help of examples. May be some reference to the Convention itself, the national biodiversity strategies and instruments of conservation biology could be of some help and may be integrated in the text. |
| Thank you Beatrix for your comment. Any other reactions? |
| Good morning everyone. I am happy to join you in this conference.
Complementing Didier''s comment, I would add that the importance of the roadmap is that it will be a reference to countries that are still developing their own biosafety regulations, in this regard, I think it is very usefull an opportune.
My suggestion is that we might need a test on a LMO other than crops. |
| Dar All,
Good morning and thanks to Hans, The draft Roadmap for Risk Assessment gives further guidance to the procedure of risk assessment foreseen in Annex III of the CPB. |
| The bias towards plants is due to our present experience, which is largest in that area. The Roadmap says that it 'is intended as a living document that will be shaped and improved on with time, as and when mandated by COPMOP, in the light of new experience, information and developments in the field of applications of LMOs. |
| Thank you Eliana and the 2 Hans. I will now give the floor to observers. |
| Good morning all. Re roadmap par a): Thanks for the tremendous work on the roadmap by all, and especially Hans. I find – overall - it is a helpful addition to Annex III, para 8. Whilst the wording or use of language is not always exactly user friendly, it has been pointed out that it is a living document and can be improved over time. Lines 77/78 “setting criteria for relevancy and requirement of data…” is such an example that could benefit from clearer wording – but I have nothing to suggest right now. -
I agree with the flow chart suggestion. And I think referring to Convention, national biodiversity strategies etc would be important - as suggested by Beatrix. |
| Dear all! I too would like to compiment the good work! At this point nothing specific to add. I think the RM is very comprehensive and easy to read. Marja RL |
| good morning all, I agree with Beatrix , that a case study on something other than crop would be a useful example to make the roadmap more user friendly. |
| On the development of a flowchart, I can imagine Helmut might have been looking at me at this point if we were in the same room!
Yes, Didier, this idea of a flowchart was proposed by myself in the last AHTEG-Roadmap meeting, and is being undertaken by AHTEG members Sol Ortiz-Garcia from Mexio, Vilasini Pillai from Malaysia, and myself. The latest version of the roadmap would be the basis of this flowchart, and discussed and (I hope) adopted at AHTEG 2. |
| David, you are right. Virtuality and reality merged at this very moment. Thanks for your clarification and offer to continue to work on the flowchart! |
| Good morning to all of you and thank you for the great job on the roadmap.
I support Didier suggestion of a schematic pictural view of the Roadmap.
I have the feeling that most of the roadmap is describing an assesment of a single event LMO. Most of the GMO plants autorisations we receive under the EU regulation are stacked or multiple events. Do we need to have some consideration for this issue ? Speaking for example of gene productS in lines 168-170. |
| Thank you Philippe, we will come back to the stacked events later on our agenda when we discuss the respective draft guidance document. Any other requests for the floor? Didier, please |
| Thank you for the information, David.
Happy to see that this flowchart idea is shared by others |
Thank you for sharing your views. Let us now please turn to the next question under the Roadmap:
(b) Is the draft Roadmap applicable to all types of LMOs and applications within the scope of the Protocol?
The floor is now open. |
| Sorry I am a bit late, that concersn the last agenda item.
I like to support Didiers comment regarding the references, that will be an important part of the road map and I strongly support the suggestion of a flow chart. That will help a lot. And I do now as David said there are people working on it.
Concerning stacked genes that is - hopefully - taken care by the draft of the subworking group. We tried to define the different approaches. |
| The Roadmap is flexible and can be applied to all types of LMOs. |
| Thank you Hans-Jörg. Any other requests for the floor? |
| Control or suppression of mosquito populations has the explicit purpose of reducing biological diversity by reducing or even eliminating a vector species. Is there adequate consideration of this application? |
| I still have concern that the roadmap will be deficient to cover new, emerging classes of LMOs. Specifically those that are designed particularly to reduce biodiversity.
For example:
- LMOs that are immunocontraceptive parasites (viral, protozoan or eukaryotic) to reduce populations of pest/invasive animals (e.g. rabbits in Australia, possums in New Zealand) by triggering an immune response against reproductive components
- LMOs designed specifically to reduce genetic diversity (the release of such large numbers of sterile males (sterility and male-only characteristics through GM) into a population to outcompete fertile wild-type males, leading to a population 'crash' in the subsequent generation
- LMO arising from transient viral transformation systems.
- LMOs arising from infectious vaccines for conservation of threatened wildlife |
| Thank you Mark and David. Mark, we will come back to the mosquito issue and your point also later on our agenda when we discuss the respective guidance document! |
| Good morning!
I am very happy to stay here in occasion of this second on-line conference.
I agree with Didier Breyer: this document is very useful but too theoric in relation to different cases, geographical areas, types of LMO, different social conditions, and so on. Only case-by-case valutation may be useful for determination.
The work for this roadmap was surely tremendous, but it is complete, extensive and well described. Thanks to expert authors! I think the roadmap very important like general way to begin, and continue single valuations |
| The roadmap is ment to be applicable to all LMOs in general, whilst specific LMOs will be delt with by specific guidance material additional to the roadmap. So that should be fine and cover it all in principle and in time. Should be mentioned in the roadmap though that there is specific additional guidance material. And David Q. has a good point there. So we might have to rethink a bit later on in the agenda. |
| Dear all, I am glad to joint you. As a Party I would like to thank Hans for his effort to finalize the draft RM, which I find clear, understundable and veryuseful for the countries with limited capacities for RA/RM. It can be helpful to undertake a testing of the proposed draft RM for different types of organisms and cases. |
| In principle I think it is applicable to all types of LMOs with small additions as I said. But we do need additionaol guidance to special forms of LMOs as mentioned by David and Mark |
| Camilla, I will come back to you soon, I will just give the floor to the few Party delegates first. Thanks for your patience! |
| Regarding LMOs for specific purposes, as Hans said, the RM should be a living document. Let us cross that bright when we come to it. |
| A potential difficulty I can see regarding the application of the roadmap is the definition of a solid baseline to do a comparative risk assessment. Will it work with LM mosquitoes or LM plants resistant to abiotic stresses in the same way than with current GM plants ? Maybe the roadmap is too general in that respect. |
| There could be a potential issue with LM insects as there is rarely a defined"release site", merely a set of defined GPS points from which insects are released. Should the " release site" reference therefore cover the natural range of the insect ? Perhaps this should be addressed in the LM mosquito document ? LM mosquito releases are imminent in several countries. |
| Thank you Camilla, again we will come back to the more mosquito specific issues a bit later. Any other comments on this guiding question before we move on? |
| I imagine conceptually we will have trouble dealing with all classes of LMOs, which points to the importance of keeping our however if our framings are flexible. Yes Hans-Jorg, a living document approach is what we should be after. |
| I think the point concerning the comparative approach is an important one. We should give that some sorts unter 3.3. perhaps |
Thank you. I invite you to move on to the next question under the Roadmap:
(c) Are the concepts presented in the draft Roadmap clearly and accurately described? Please specify what concepts could be presented better, and what amendments you would advise.
The floor is open for your interventions. |
| Concerning point b)
I fully agree with a living document approach. It will also fit the quick evolution of scientific techniques.
Concerning point c)
The comparative issue is a difficult one. In most of the case, comparisons are made in experimental conditions and in non exactly reproducible situations. In Line 69-70, we should be aware of the difference between the « environment that the LMO is introduced into » and « the environment the LMO is tested. » They are often not identical. |
In general:
As a roadmap for a word wide forum the document has to be open for interpretation according to national requirements and cannot serve as a “cook book”.
Specifically:
Line 32: The objective of the risk assessment is to narrow. Other issues such as impact on abiotic environment or cultivation management should also to be considered in the risk assessment.
Line 43: It is unclear what is meant by “non-modified recipients” It should be clarified if the near isogenic variety and/or the currently used conventional varieties should be considered. Furthermore, the current agricultural practise should be also taken into considerations.
Line 165: It is not clear what is meant by “interacting with other changed genes”.
A possible interpretation could be “characteristics of the non-modified recipient that, if changed by or interacting with the genes that were inserted into the LMO, could change the interaction of the non-modified recipient with the environment in a way that could cause adverse effects”.
Since this is already covered by paragraph ©, lines 172 to 181, it should be considered to delete the words “or interacting with other changed genes”. |
| I find that a few points are not precise enough, are lacking components and need amending. These include:
Point (c) under Step 1 (lines 172-181): this does not address consequences of reading frame alterations, which for example is addressed by CODEX guidelines. As this is important I suggest the following addition to point c), following on from line 181: “Characteristics of the LMO that may lead to adverse effects should also include the identification of any open reading frames within the inserted DNA or created by the insertions with contiguous LMO genomic DNA including those that could result in fusion proteins.”
Point (d) under Step 1 (lines 182-184): the following should be added: “these may include changes on the transcription and translation level, and may be due to the insert itself or genomic changes incurred due to the transformation process.”
Point (i) under Step 1 (lines 205-206) This presently gives a false emphasis to LMOs that are bacteria, whilst HGT from any type of LMO needs to be covered if this roadmap is to be applicable to ALL LMOs. I would thus like to have the following amendment: “(i) Adverse effects as a consequence of horizontal gene transfer from the LMO. Concerning HGT to bacteria and viruses, particular attention needs to be given to bacteria or virus derived sequences present in the LMO as well as cases where the LMO itself is a bacterium or a virus.” |
| Thank you Phillipe, Hans-Jörg and Ricarda for your very clear and precise suggestions on specific parts of the draft roadmap. This is very helpful. Any more comments to this guiding question? |
| I support these suggestions by Ricarda and clarifications by Hans-Jorg. |
Two concrete proposals for minor changes:
- On page 5, line 199 : The second sentence under (h) should start with « the potential consequence… »
- On page 6, line 205-206 : The current wording for point (i) is a bit unclear and could lead to some confusion with the points under step 3. Sorry but I do not have a better wording to propose for the moment. |
| Ricarda, could you explain what mechanisms your thinking of for HGT to viruses? |
| Hi all,
apologies to be late due to IT problems. |
| No problem Adrian and welcome! Thanks again to all of you. Ricarda, could you briefly respond to Hans-Jörg`s question before we move on? |
| response to Hans-Jorg: eg from GM plants/animals with viral sequences where these sequences are taken up again by infecting viruses. I have a doc on that and can send it to you if you are interested. |
| Thanks Ricarda for your fast response! |
Thank you very much. The last question related to the draft Roadmap is:
(d) Is there any issue or concept that is missing from the current draft Roadmap 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. |
| Ricarda, thank you, I understand that, but had that under a diffent topic. |
I would like to point out an issue which does not seem to have been dealt with in the roadmap. It is well known that interpretation of a same set of scientific data will differ from one expert to another, leading also sometimes to different views as regards safety aspects. In my opinion, it is important to emphasize this issue somewhere in the roadmap (could be under « overarching issues ») and to recommend to have when possible multiple and contradictory expertise.
This issue could also be linked to the uncertainty analysis that is mentioned on page 3 in the roadmap. |
Thanks. Would have some comments also...my opinion is that we have to keep the Road map as general as possible and provide the details in the links. Please find below some comments :
I am sorry that I may have to bring you back but here they are:
Amendment 113-128:
113 • FRAMMING THE RISK ASSESSMENT
by identifying “the context and scope of risk assessment as laid down in existing policies and strategies,
114 based on for instance regulations and international obligations of the Party involved as well as
115 guidelines or regulatory frameworks that the Party has adopted; identification of protection
116 goals, end-points and management strategies, derived from these policies and strategies.
117 Consistency with these policies and strategies within the scope of the risk assessment may
118 involve a process that includes risk assessors, decision-makers and various stakeholders prior
119 to conducting the actual risk assessment.”
120 • IDENTIFY THE CASE
and define “the risk assessment process, taking into account the expected (potential) conditions of
121 handling and use of the LMO, taking into account customary practices and habits, that could
122 affect the protection goals or end-points; identification of relevant questions to be asked for
123 that purpose.
124 • METHODOLOGY AND ANALYTICAL REQUIREMENTS
“Identification of methodological and analytical requirements to achieve the objective of the
125 risk assessment, as laid down for instance in guidance on risk assessment published or adopted
126 by the Party involved, that must be complied with in risk assessment; including means of
127 reviewing whether the risk assessment is in compliance with the methodology and
128 requirements of the applicable guidance.” |
| Thank you Adrian and no problem as you came in a bit later. |
| Perhaps this is better suited to (c) above, but the issue of uncertainty and variability analysis is an important one and needs further clarification...
The treatment of uncertainties in the RA is an essential component of the risk assessment, which is, in the end, a communication tool. The goal of this guidance should be to assist the RAer to identifty and characterize uncertainties at each stage of the RA in a usable and consistent manner. Uncertainty analyses (UA) must be conducted at each step of the RA and consistently reported to rarrive at a communication of overall uncertainty in the process. Further, UA is an important process to facilitate the introduction of new knowledge and methods into the assessment.
First, I want to make clear that we must be careful not to fall into the trap of framing uncertainty as merely a function of imperfect or deficient information that can be resolved by more complex tools or further research. That is, it is important to recognize that further research can sometimes increase uncertainty or lead to new sources of uncertainty, and that in complex systems some level of uncertainty are permanent states that cannot be overcome by empirical evidence or modeling. This can be strengthened by including that all the three dimensions of uncertainty (discussed below) in our roadmap.
Uncertainty assessment (UA)
Some of you may be saying “UA is complex and difficult, how can we expect a RA will be able to perform it?”. Of course, analyzing uncertainty will require some more advanced conceptual understanding of risk analysis from the roadmap user, but this level of understanding is no less than what would be expected from a competent and dedicated risk assessor. The outcomes will likely be qualitative, as with probability estimates of this kind. What we should be aiming for, to paraphrase von Hayek, is to be “roughly right rather than precisely wrong”. The qualitative assessment can help identify where more intensive quantitative methods would be useful.
One challenge will be to find the analytical level required. This is largely dependent on the decision context, and the goals and outcomes set in the planning phase of the risk assessment.
Any estimate of probability or likelihood within each step of the RA will require an analysis of uncertainties in the information available (including quantity, and relevance of) for the probability estimate. The reporting of uncertainties will should capture an explicit treatment of:
1) The level of uncertainty (statistical uncertainties, scenario uncertainties, recognized and total ignorance)
2) the source of uncertainty (contextual/framing, data input, study/model design, parameters, conclusions from results)
3) the nature of uncertainty (stoichastic, epistemic).
Variability assessment (VA)
In characterizing variability, its application will be dependent on the nature of the information provided. It is important to recognize that a fundamental conceptual difference between uncertainty and variability analysis (VA) is that variability can be characterized, but not reduced, and hence must be dealt with using strategies that are likely different from UA. An important aspect of the VA would be to identify vulnerabilities of exposed populations or elements (individuals, populations, environments, etc). Some examples include differences in susceptibility of different groups within the population under investigation resulting from various factors (e.g. those that increase biologic sensitivity or reduce resilience, prior exposures, social and economic factors that increase/reduce exposure, etc.
With this in mind, both the UA and VA can help identify vulnerable populations or individuals, systems, etc. that may be more vulnerable, susceptible or highly exposed to the LMO under assessment.
How to acheive this in the roadmap?
With the UA assessment, which would apply to all steps of the RA, the 3 dimensions of uncertainty listed above have been used in the development of a simple matrix scheme developed by Walker et al 2003 could be modified for our use, as has been done elsewhere for similar objectives. To date, the matrix represents the most simplified yet still comprehensive scheme for the treatment of uncertainty. We may need to integrate other tools, but this is a good starting point we should follow up on.
Most importantly, the UA must be set in a manner that can explain the basis of the UA with sufficient clarity to be understood by members of the public and decision-makers.
I look forward to further developments! |
| Again Didier mentioned an important point and I like to support his last suggestion and I appreciate David Q.intervention. |
| In my oppinion, the roadmap still nees to be tested by less experience risk assessors, and further improvent may be needed to make it more friendly to people who did not have the opportunity to test in their own native, or othrewise more familiar language, particularly in developping countries. Since the AHTEG may not have the time or resourses for this process, may be this could be suggested to the COP/MOP. |
| I fully agree with David contribution.
It is a major issue as the common feeling of public and decision makers is that risk assesment always decreases uncertainty. |
| for point b) I think that roadmap is not applicable when LMO enter, modify o alter other organisms like bacteria, fungi, virus (like mosquitos and other vectores). In such cases will be necessary a larger documentation, and different ways to procede about possible effects on biodiversity.
for point c) I agree with necessity to evaluate new ways to study LMO while they live in their natural environment and to study new models in laboratory to try to recreate same living conditions! Obviously it is very difficult and now I do not know how will be possible its application, but because we talk about ecosystem, we have to think about experimental models, like for other scientific researches!
for point d) I think will be useful a particolar attention and a focal point about ecological relationship between LMO vectors and other organisms (bacteria, virus, ecc) for biodiversity, using experimental models to approach the problem in laboratory, but also in vivo, in their natural environment.
Excuse for large period and considerations |
| Thanks to all of you! If there are no more interventions on the roadmap I intend to move to the next subject on our agenda! |
Another point regarding documents that could be accessed through the roadmap : there are many documents that could be useful to illustrate the different steps of the risk assessment. The key questions here are : Who will provide these documents and how ? How to make a decision about what is relevant and what is not relevant ? Under which quality standards ? Who will take such decisions ? …
Is that something we are supposed to dealt with during the current online conference ? |
| Thank you David, this is a pertinent point. We can discuss it here but certainly will not be able to solve it. We will also address this later in our agenda when we discuss the way forward! |
Fully agree with Eliana, the RA should be usefull for beginers and as well experienced assessors....and keeping the RRA general with links to specific will allow that.
Hereafter couple of more proposed ammendments that may improve clarity and its use:
Amendment 169-171
169 “(b) Relevant characteristics of the genes that have been inserted into the LMO (e.g. functions of
170 the gene product in the donor organism, with particular attention to characteristics that, when
171 transferred to the recipient,” could cause adverse effects);”
I propose to delete could “cause adverse effects” because to my understanding is restrictive and in a way implies that one should describe “relevant characteristics of the genes” only if the could cause adverse effects. Since we anyway have to describe them during RA then we imply that any gene characteristics may cause adverse effects.
Amendment 175-176
Similar amendment as for 169-171.
Amendment 216-217
216 “LMO, and the expression level, dose and environmental fate of transgene products. Other aspects that
217 are usually taken into account here are the potential of the LMO, or its derivatives (i.e. sexually”
I propose to change the underlined text with “Other aspects to be considered are” because it is not understood from the current wording by whom and to which extent that is important.
Amendment 222
222 “example, highly likely, likely, unlikely, highly unlikely, whereby it is recommended that the use of”
Proposal to change “example, highly likely, likely, unlikely, highly unlikely, whereby recommended that the definition and use of”.
Amendment 249
249 ‘that the use of these terms has been described for instance in guidance on risk assessment published or’
Proposal to introduce the word definition: “that the definition and use of these terms has been described for instance in guidance on risk assessment published or”
Amendment 258
258 (b) “Direct and indirect, immediate and delayed effects, as well as cumulative or combinatorial and”
The link from line 260 should contain explanations of the terms used in line 258.
Amendment 275
275 “uncertainty or lack of knowledge, whereby it is recommended that the use of these terms has been”
Proposal” uncertainty or lack of knowledge, whereby it is recommended that the definition and use of these terms has been”.
Amendment 299-300
299 “The recommendation(s) made during this step will be considered by the decision-makers in reaching 300 their decision.”
I would propose to rephrase this sentence to give the regulator the liberty to use the outcome of the RA and not impose it and the text should read: “The recommendation(s) made during this step may be considered by the decision-makers in reaching”. Honestly I believe that this phrase could even be deleted.
Amendment/Question 302-304
302 (a) The criteria for the establishment of the acceptable/unacceptable levels of risk, or set out in
303 the national legislation, as well as the protection goals of the Party, as defined in when
304 setting context and scope for a risk assessment;
When these criteria are not defined how should the risk assessor proceed? Should we add a wording on this? No inspiration for a clear amendment.
Amendment 326-331
I propose to exclude all these lines from the RRM because to my understanding they are not part on an environmental risk assessment. They might help the risk manager in achieving its tasks but are definitely not part of the RA. |
| I disagree with Adrian suggestion. As we are in a risk assesment framework it is normal to focus on adverse effects. |
| Hans, would you like to comment as the chair of the subworking group of the road map on some of the issues before we move on? |
| I give the floor to a few others first! |
| I agree with Philippe, as attention to potential adverse effects is central to Hazard ID, which is what is being considered in this step of the Roadmap. |
| I find the item regarding the ecosystem approach and relations between GM and other organisms are the critical issue and needs to be developed as a modelling in laboratory as well as in natural conditions. Thisw needs suplimentary research and investigation, and expected long term activ ities, wich may be proposed to be considered for meetings od Parties. |
| David, Philip...we should not imply GM any GM causes adverse effects |
Agree with Eliana’s suggestion that the RM should be tested by the people for whom it is intended, and support Didier’s pertinent question.
Disagree with David’s suggestion that RA is a communication tool. RA is science based a tool for informed decision making, how to communicate that is a different thing.
Could I suggest that we keep interventions short. Real time conferences are not really the most appropriate tool for discussing lengthy detailed statements.
Piet |
| I agree! potential adverse effects are surely part of hazard |
| As we are dealing with risk assessment, we have and are obliged to look at the adverse effects - so I think Philip and David are right. |
| Thank you all for your extensive comments, that we will take into account when preparing a new, and final, version of the Roadmap for submission to COPMOP.
There are some issue that clearly need more consideration in the second session of the AHTEG.
We are already working, for instance, on the issue of uncertainty, for which we need a clear paragraph in the Roadmap, and probably a number of references to supporting material.
There will obdiously be more issues to take care of, probably in a similar way.
I think the issue of testing the Roadmap is also of importance.
Thanks very much again! |
| Thank you Hans and thanks to all of you, this was a very rich discussion, we will now move on! |
I thank all of you for your lively discussion on the Roadmap. I propose that we move now to the next sub-item:
(ii) RISK ASSESSMENT AND RISK MANAGEMENT OF LM MOSQUITOES
and invite your reactions to its first guiding question:
(a) Is the structure of the draft guidance on “Risk Assessment and Risk Management of LM Mosquitoes” clear?
The floor is now open for your reactions. |
5) Under points to consider it would be desirable to include objectives for risk management. Much of the document seems to address hazard identification, rather than the full likelihood*consequences of risk assessment. Risk management might address both likelihoods and consequences, and in any event decisions about mitigation would need to have some guidance on risk objectives (How much of it do we not want? What kind of hazards are more or less serious? Are certain issues more the responsibility of particular stakeholders, that is who owns the risks? And so on). This might provide better guidance for designing and conducting risk assessment, so that it better meets the needs of decisions about risk management to meet particular (or even vague) objectives.
6) The layout of points to consider is a mix of outcomes (for example, biodiversity; effects on human health) and processes (gene flow; evolutionary response; persistence of transgenes). Making more of this distinction might lead to families of responses. For instance, evolutionary modelling might help us think about what to monitor in real time during implementation so that we could observe when things (processes) were going as we expected, so we could then either revise our understanding and accept that it was still all right, or revise our understanding and take mitigating action.
7) And there is a mix of issues related to the process working as planned (and going wrong for some unforeseen reason) and not working as planned (and going wrong because part of the design or operations were screwed up). The former would benefit from very clear statements of expected development in the field and the assumptions behind that, which could be challenged by peers and proper monitoring could be designed to check (as above). The latter may be a relatively straightforward process control challenge to ensure that everything is being done according to the accepted plan. Issues might include the timescale of for observing sufficient deviation from plans or standards to allow effective and efficient responses. |
| I agree with Camilla but case by case |
Point No. 7 of Camilla: Under "Ecologically mediated effects to human health:" In the context of production failures: This is a possibility that can be monitored and minimized during production. It is a quality control issue. Of greater concern to this committee should be the changes in gene expression after release and transmission of this trait to progeny. Therefore I suggest the following language:
"Gene silencing or other changes in expression may occur in the environment after release or among progeny, thus increasing the vector population or pathogen transmission." |
| OK, thank you very much Mark, Maria Antonietta and Camilla. Any other requests for the floor before we move to the next guiding question? |
First of all I would like to mention that I do not have a lot of practice in the environmental risk assessment and management of GM mosquitoes. Therefore, I will only provide general comments to the draft guidance document.
I already touched about that during the discussion on the roadmap. It seems to me that a key point with this type of LMO could be the limited amount of available information, not only to support the different steps in the risk assessment but also to define the baseline to do a comparative risk assessment. Maybe in this case having first a clear picture of what information is already available would help to move on in the development of a productive guidance ? |
| But in suggestion of MarK Benedict I would consider also reduction or soppression of a caracter, not only increment of popolation and trasmission of pathogenicity |
Thank you. Let us please move to the second question regarding the guidance document on “LM mosquitoes”:
(b) Are all relevant scientific issues properly addressed in the draft guidance document? If not, please specify what amendments you would advise.
The floor is open. |
| Under "Risk Management Options:" one item listed is "genetic control", but I am not sure what this means. Is this suggesting regulation of the transgene built into the LMM that could be invoked if needed or some independent control effort using a genetic means? Further clarification is required. |
| One point that could be highlighted is the potential impact climate changes could have on the geographical distribution of the LMO itself but also of the target population(s). Shouldn’t it be mentioned in the draft guidance ? |
1) Introduction mentions fruit flies as the only example of GM EIS; should also include pink bollworm on cotton. The point remains valid that it is agricultural, although the marker systems have wide implications. Additionally the lethal system described (tTAV and TetR) will be used in some of the GM insects that are likely to be in the field soon.
10) Under risk management there is inclusion of “Stringent controls on release mechanisms/strategies” . I would prefer to put this as: Operational management processes should carefully follow the design criteria for implementation, on which the risk assessment was done and the risk management was agreed.
11) Further Guidance on monitoring strategies would be useful, although we expect this would develop over time and depend on the type of genetic modification being released as it has done with crop plants. |
| I think that these considerations of Katia, very important, derive from case by case valuation: are stricktly connexed. |
| The issue of mosquitoes as pollinators of crop plants is not correct. Mosquitoes are not pollinators of crops and are only certain species are obligate pollinators of one orchid species in N America. |
| I think monitoring concepts and parameter will be of paramount importance. |
| Thanks to all of you. Are there any further comments or reactions to the points raised before we move to the next guiding question? |
| Mr Chair, I have a little problem here as that I got some comments to mosquitos sent by a colleague this morning. Yet these comments don’t fit the format of today’s questions at all – and there is no time now to adjust it to the format. May I send them directly to the chair of the mosquito subworking group via email (including suggested literature)? Points raised include vertical and horizontal gene flow, molecular characterization, genetic drive elements, transboundary movements etc. So this is just to let everyone know that I will send the material to Eliana directly. Thank you. |
| Thank you Ricarda. I would suggest that you post the comments here, even if they do not fit precisely to the format of our questions. I do hope that the text is not too long. Certainly you can in parallel submit the information directly to Eliana as the chair of the SWG as well! |
| Camilla Beech and I would also be interested in submitting relevant literature for the mosquito section. We can provide this if you wish. |
| Mark and Camilla, please do so as well. I am sure Eliana will be happy to receive further input for the subsequent work of the SWG! |
| Colleagues, any further input before we move on? |
| We will provide this within a couple of weeks. |
Thank you once again. Let us please turn to the next question under “LM Mosquitoes”:
(c) Is there any other scientific issue that should be included in this guidance document? If so, please propose a draft text to address the missing issue(s).
The floor is open for your comments. |
| I would like to return to the issue of reducing biodiversity that David Quist and I raised. Do the member feel that this has been adequately anticipated as a likely application of LMOs? |
| sorry, Helmut. Text is rather long and not ment as an intervention (as its got thinking bubbles in it, if you know what I mean). Need to tidy it up first - so maybe I can send it to the secretariat later - if this is preferable to sending it to Eliana alone? |
| OK Ricarda, that is fine, pls. send to Eliana, all other subworking group members and the Secretariat, thank you! |
| Perhaps the chair could send this text to the participants? |
| Thank you, I am sure that Eliana will take care of the circulation of the material among the relevant experts. |
Thank you. I invite you to turn to the last question regarding the guidance on “LM Mosquitoes”:
(d) Could you please suggest bibliography on the biology, ecology and genetics of mosquitoes that are relevant to this guidance document?
The floor is open for your suggestions. |
| For David Quist and Mark Benedict: I think that reduction of biodiversity, at the end, will occur in according to Darwin concepts. Natural mutation occurs, and also for future aggregates of organims, LMO or not, something will occur. |
| Camilla Beech and I will propose a bibliography list. |
| I think Mark has a point here and Eliana's text should be sent to all the participants of today FYI. |
| one additional comment to Mark. and David: reducing biodiversity is not only an aspect when dealing with mosquitos but a number of applications in the context of crop plants are also meant to reduve biodiversity like Bt-plants and HR-plant. But may be we should deal with that questions a bit more |
| Thanks to all of you. Especially the last item I think is adressed in the roadmap as a key issue and can be elaborated there if needed. Any more comments? |
| Good point Beatrix. More discussion needed. Marja |
| we need to consider this reduction in biodiveristy in the context of other interventions, such as the use of other control methods - pesticides etc |
| Dear colleagues, I would now finally like to give the floor to Eliana as the chair of the SWG on LM mosquitoes before we move to the next draft guidance. Eliana please. |
Thank you all for your suggestions which will be taken into account in the preparation of the current draft.
I will be glad to receive any further contribution that you might still have before submitting the final draft for discussion during the April meeting of the AHTEG.
We must not forget, however, that the guidance documents should have a general guiding nature, and be a complement otothe road map. The specifics should be informed in suggested literature. So, I will be very glad to receive all scientific bibliography that supports the document.
Thanks again for the contributions.
Eliana |
| Thank you Eliana and thanks to all of you again for a very scientific and rich discussion! |
Let us please proceed to the third sub-item under 3.1.:
(iii) RISK ASSESSMENT AND RISK MANAGEMENT OF LM CROPS WITH RESISTANCE OR TOLERANCE TO ABIOTIC STRESS
And would like to invite you to comment on the first question:
(a) Is the structure of the draft guidance on “Risk Assessment and Risk Management of LM Crops with Resistance or Tolerance to Abiotic Stress” clear?
The floor is open for your reactions. |
| The document as such may confuse the reader, especially a beginner in RA, and it doesn’t seem to follow the logical five steps of RA. Moreover when we will have the Road map finalized this could be attached to it as a link for specific cases and not as a stand alone document. |
| Thank you Adrian. In fact the guidance documents shall be seen in context with the roadmap and the appropriate links foreseen. Any comments from Party colleagues? |
| I fully understand that but more clarity would help.
I believe also that the definition is definitely not complete and we should consider “development” as part of it also, and not limit to effects on “growth and reproduction”. |
| I agree with Adrian. If the guidance has to be seen as an appendix to the roadmap, it would gain in clarity if it would follow the same basic structure. |
| I would propose to list the steps of RA in it and allocate all those comments to a specific step. |
| Any further interventions before we move to the next guiding question? |
| I also think that the draft as it stands now is a bit too narrow and not as clear as it should be. |
| I think that the complementing documents (mosquitoes, abiotic stress, stacked genes) maybe should have a common format. And if/when possible follow the titles of the roadmap. Sorry - I do not have a more concrete suggestion yet. Marja |
| Agree with Adrian, Didier and Marja - each document should stand on its own adn not require reading the road map |
| concerning section b of the draft guidance - an aspect seems to be missing that looks at the spreading of the LMO to other climatic or geographic zones. As there is for example a link between climate and agriculture and biodiversity, this should be covered here as far as stress tolerance is part to it.
I agree with others, that a common format would be helpful. |
| although Piet we should not go into the details of the Road map but rather use it as a cross- reference |
| agree - the idea is to follow the same basic steps in the same way |
| Dear colleagues, I think thats the point, the guidance documents should be stand alone but if possibly follow a comparable structure and be related to the roadmap. That is indeed helpful for our subsequent discussion in the AHTEG, thank you! |
| Since there were no comments on the definition...Do we all agree that the definition has to be reworked a bit? |
| Adrian, we will deal with that under guiding question d) |
Thank you. You are now invited to address the second question regarding the guidance document on “Abiotic Stress”:
(b) Are all relevant scientific issues properly addressed in the draft guidance document? If not, please specify what amendments you would advise.
The floor is open. |
| I agree with previous Ricarda's point about the importance to consider climatic aspects (as already mentioned also by Katia in the discussion about LM mosquitoes). |
| Thank you Didier, any further comments before we move on? |
| Concerning the comparative approach I have two comments: with the help of new characteristics in the context of abiotic stress a “normal” comparative approach may not be possible because the crop plant was never grown in that region and in that climate etc. in addition the abiotic stress tolerant crop may change management procedures. These aspects are not addressed very clearly in the draft and should be improved. |
Thank you once again. Let us move on to the next question under “Abiotic Stress”:
(c) Is there any other scientific issue that should be included in this guidance document? If so, please propose a draft text to address the missing issue(s).
The floor is now open. |
| Should we have something about epigenetic changes in the guidance doc ? I know this is an issue that is relevant for all LMOs, but as far as I know it is particularly relevant in the case of abiotic stress tolerance. |
| Good point Didier, any comments or reactions before we move to the next guiding question? |
| I think Didier has made an important point here. epigenetics in this context should be covered in the guicance material (as its also relevant to gene silencing) |
| Think it would help people if we were to include a general para somewhere about epigenetics, because it is source of much confusion and often mixed with pleiotropic effects |
| Beatrix and others - should we say something about this in the roadmap i.e. say that comparative approach has some "limitations". Marja PS. I keep loosing connection! HELP! |
| Marja, our IT colleague is trying to solve the problem. PLease hang on and hopefully the connection will be stabilized soon. |
| I don't think we should say it has limitations...every RA it is a case-by-case. |
| Limitations was in parenthes: I mean that comparative approach is not always straight forward. Marja |
| agree with adrian - yet it would probably be good to expand a bit more on the comparative approach, explaining that different steps in the RA may require different appropriate comparators. |
| I also agree with Marja, Beatrix and others that comparative assessment (in the way it is applied with traditional GM plants) could be challenged in this specific case and that the guidance doc should address this. |
| fully agree Piet, and the choice of comparators it is case-by-case and may depend on your intended GM..
not clear what Didier means...could you detail? |
| I was disconnected for a while sorry for that |
| We do not always have a clear comparator. Marja |
| OK, thank you. Knowing that there is still some connection problem with some colleaugues - are there any further comments before we move on to the next item? |
| To Adrian:
To build up on what Beatrix said: the non-GM comparator could never have ben grown in that region and under these climate conditions... So the choice of the good comparator(s) could be a challenge. |
| Due to our remaining connection problems I would like to give the floor to the Secretariat for an announcement! |
| Dear all, we are having some connection problems as you know. I would propose that we anticipate our break for 30 min to give our IT colleague the chance to fix the problem. We will reconvene at 12:35GMT.
PLEASE KEEP YOUR COMPUTER CONNECTED so that our colleague can check each of the connections |
| Dear colleagues, please be back in half an hour, 12:35 GMT. We are continuing our discussion at that time, see you! |
Dear all,
We are still having problems with the connection and are trying to solve it.
Let us please re-start the conference at 13:00 GMT (25 min later than initially announced).
If you see that there are still problems then, please check your email again. We are very sorry for this.
Hope to read from you soon at the conference.
Thanks and regards,
Manoela |
| we are re-starting in one minute |
| Could everyone please request the floor. We need to test if it is working. Please post "test" once the floor is given to you. Thanks. |
| David Quist and Lucette, could you please request the floor? |
| David Heron, I believe you are still having problems to request? |
| David H. we are trying to solve your problem and will reconnect you |
| david heron please try again? |
| floor requested...testing.. |
| Camilla, Ricarda, could you please request the floor? |
| we have eleven guests now instead of 2 ...can we see the names? |
| Adrian, it is showing 10 but there is really only one guest connected. I believe the remainining 10 are those who were not yet able to come back to teh conference. Press the + sign next to the Guest list |
| The forum system wasn't letting me to offer any interventions earlier, so I hope you will understand that this comment is a bit "old" now. I do want to comment briefly that the discussion around epigenetics and pleiotropy reinforces the importance of spending more time looking at the phenotype of the organism rather than spending time characterizing genotypic (e.g., sequences, insertion sites, etc). Much of the genotypic information is not predictive of the resultant phenotype, so it's important to look at the phenotype (this is the same as our experience with non-LMOs). |
| We are very sorry for the interruption and hope that the problem has been solved. I would like to invite Helmut to continue chairing the conference.
Thank you for your understanding.
Manoela
========================================== |
Distinguished delegates,
Welcome back to our conference. I am sorry for the technical connection problems which have emerged and delayed our work a bit. Thanks to the tireless efforts by the Secertariat these problems seem to be solved now, a big thank you for that!!
I will have to press a little bit with respect to the time, and I suggest that we try to finish our remaining work within the next 90 minutes. Without further ado, I invite you to turn to the the next question under “Abiotic Stress”:
(d) Do you think the definition of “abiotic stresses” shown in the draft guidance document is accurate? If not, please provide a draft text to improve it.
The floor is open for your comments. |
| Sorry to advance the discussion before...please consider my previous comment that the definition needs some more detail... the proposed change is "growth, development and reproduction". |
| David H., your point is well taken knowing that you had problems with the connection. Thank you Adrian for iterating your point. Any more comments before we move on? |
| Are abiotic stresses only detrimental for organisms? I guess there are also organisms which take profit of these stresses to grow and reproduce. |
| Not sure why the def says "some types ... include.." should it be Some types are .. or Tpes include ? |
| The SWG will look at your point Ricarda. Any more comments? |
| Regarding the definition of abiotic stress, we might consider some additional examples such as air pollution (nitrous oxides, ozone, etc). |
Thank you. Let us proceed to the last question regarding “Abiotic Stress”:
(e) Could you please suggest references to publications that are relevant to this guidance document?
The floor is open for your suggestions on relevant publications. |
| Are there any final comments on LMOs with abiotic stress tolerance? |
Thank you very much for all the interventions.
I would now like to proceed to the last sub-item under 3.1.
(iv) RISK ASSESSMENT AND RISK MANAGEMENT OF LMOs WITH STACKED GENES OR TRAITS
and invite you to comment on its first question:
(a) Is the structure of the draft guidance on “Risk Assessment and Risk Management of LMOs with Stacked Genes or Traits” clear?
I will now open the floor for your reactions. |
| Same comments concerning the structure as for the abiotic stress: we should follow the Road map’s steps detailing where necessary. |
| I have a more general question : Taking into account the draft outline on stacked events could still be subject to improvements with time, my question relates to the status of the finalised documents compared to existing guidance documents such as the EFSA-guidance (2007). |
| Thank you Adrian and Katia. Dear colleagues, any more comments or reactions on this first guiding question? |
| The draft uses a definition of stacked events which includes also re-transformation of a transformation event; such a transformant has to be regarded as a new event anyhow. Taking into account the increasing number of stacked events this issue should be integrated into the Roadmap of Risk Assessment, as the general risk assessment has to cover possible unintentional stacked events. Furthermore, the draft on stacked events is not a stand alone paper and gives no real guidance. |
| As far as I remember we had some guiding questions/structure of how to build the guidance materials. This is how the stacked trait guidance is now structured. I do not think that the guidance material needs to reiterate each point of the roadmap but that all the guidance docs must be structured in a similar way to each other. |
| Also, the terminology "stacked" is not consacrated in EU...and "combined events" is currently used.. |
| OK, thank you. Any more comments, in particular from Party colleagues? |
| The definition does not include retransformation only hybrids of assessed events. I agree that retransformation creates a new LMO which will beassessed according the Road Map. The definitions follow the literatuere but there are different ones |
| I think we should give definitions to / explain additive, cumulative, synergistic and antagonistic effects. Maybe try to give examples too. |
Thank you. Our next question under “Stacked Genes”:
(b) Are all relevant scientific issues properly addressed in the draft guidance document? If not, please specify what amendments you would advise.
The floor is open. |
| By following the same structure as the road map it scuold be possible to integrate the relevant isssues into the road map. |
| a forgoten comment for point c)
retransformation is a new event and different from the one obtained by conventional crossing because it needs full risk assessment while the RA for conventionally obtained relies also on the RA of the single parents... |
Point to consider 1 - Assessment of the intactness of the inserted loci and genotype
There is no indication that additional molecular characterisation is needed after cross breeding. Recombination at the site of integration occurs during the process of transformation. Inserts in plants remain remarkably stable (BEETLE Report 2009). There is no indication that cross breeding may change the molecular organisation of the inserts. – The foot note is not specific for stacked genes.
Point to consider 2 - Assessment of potential interaction between combined events and the resulting phenotype
Interaction of the genetic modification with other genes – unmodified or modified - is part of the general risk assessment. The influence of the genetic background may as well occur in plants transformed by a single event
Point to consider 3 - Assessment of additive, cumulative, synergistic or antagonistic traits
The possible occurrence of varying unintentional stacked events applies to single events as well as to stacked events. At least three different single event varieties of the same species grown in the same area could possibly result in varying unintentional stacked events. |
| See my comment on question a). There is no need for a specific risk assessment of stacked events. There is the general requirement for the risk assessment to every modification resulting from a transformation event as foreseen in the Roadmap. |
| We think that stacked genes should be kept in a separate/stand-alone document. There are clearly many specific issues related to this topic and a separate guidance helps to outline these aspects. |
| Thank you Hans-Jörg and Marja. Any more comments before we move to the next question? |
| comments to the points of Hans:
Point 1: molecular characterisation of the stack it is stil necessary according to teh EU requirements
Comment to Marja:
allow me to disagree that we need a separate document for stacks; we should rely on the Road map and have the links where there are specificities; we reli a lot on the singles for the RA when we perform the RA on the stack. |
| Im looking at the definition of a transformation event. The way it is written suggests that a transformation results in a single locus insertion, which is not necessarily the case...One transformation event can involve multiple insertions (although usually the single insertion is lab-selected). Need to revise? |
| Yes, there are specific issues, but they will fit in the risk assessment process as described in the Roadmap. I mean, we should take care that they fit in also when drafting the Roadmap, also when they are described seperately. |
| To Adrian, suggested by EFSA guidance, not a requirement under Dir 2001/18/EC. |
| Let me just observe from my side that the AHTEG as a group has decided to develop a separate document on stacked LMOs which fits to the roadmap and complements it. That is the path we are following and I thank you for your valuable comments in that respect. We will now move on! |
Thank you. Let us move on to the next question on “Stacked Genes”:
(c) Is there any other scientific issue that should be included in this guidance document? If so, please propose a draft text to address the missing issue(s).
The floor is open. |
| not shure it relates to agenda point c) , but ..
One line needs further clarification : point 3 “ indirect effects of changed managments procedures combined with the use of transgenic stacked event LMO should be taken into consideration” . What is meant by “changed”? Changed compared to which situation (wild type or the TraEv)? Are the “management procedures” referring to agricultural practices? |
| Thank you Katia, I think this comment fits well here. I am sure the SWG will have a look at it. Any further comments? |
Thank you very much. Next question under “Stacked Genes”:
(d) Do you think the definitions provided in the draft guidance document are accurate? If not, please provide a draft text to improve them.
The floor is open. |
| yes management procedures are referring to the agricultural practises with the conventional crops |
| Thank you Beatrix for that clarification. Any more comments? |
If not, then thank you. Our final question for “Stacked Genes”:
(e) Could you please suggest references to publications that are relevant to this guidance document?
The floor is open. |
| Ther is no need do define an "unintentional stacked event".
I will come back on this in a second with additional comments. |
| still for point d)
To my understanding the stack document reffers only to the stacks obtain by conventional crossess of singe GM parents. Do we need to discuss the events obtained by retransformation of LMOs? I propsoe to remove that fromt eh definition.
In the definition of stacked events: we do not insert constructs in the GMP but pieces of DNA. |
| As for all these document, including the Roadmap, I would suggest that we will have links to the BCH where we can provide updated lists of relevant publications, also after the document has been published. |
Relevant reference
Risk assessment of GM stacked events obtained from crosses between GM events
A. De Schrijver, Y. Devos, M. Van den Bulcke, P. Cadot, M. De Loose, D. Reheul and M. Sneyers
Trends in Food Science and Technology, 2007, 18, 101-109 |
| Thank you. Are there any more commenrs under question e)? Hans-Jörg you wanted to come back with some additional comments? |
There is no need to define unintentional stacked events. An unintentional stacking results in a stacked event.
There is no need to define a transformation event; this is covered by the term LMO of the CPB.
There is no need to define an “unintentional stacked event”. The definition of a “stacked event” should be revised to make it compatible with the definition used by OECD in the “OECD Guidance for the Designation of a Unique Identifier for Transgenic Plants” (OECD document ENV/JM/MONO(2002)7/REV1 (07-Nov-2006). This guidance has been adopted for the Cartagena Protocol on Biosafety. The OECD guidance refers to stacked events as “… plant products having one or more traits obtained through the use of recombinant DNA techniques and stacked by conventional crosses…”. The wording could be adopted by using “modern biotechnology” instead of “recombinant DNA techniques”. |
| Thank you.
Beatrix, would you like as chair of the SWG make some final remarks before we move to the next item on our agenda? |
I like to thank all for your interventions and comments. We will take these into account in preparing the final draft for the face to face meeting in Lubljana.
I will also be glad to receive additional bibliographic hints.
Concerning the legal status. To my understanding when decided upon by the MOP it has a binding status but the legal framework of the member state (and the EU) is respected but should not contradict. But I am no lawyer.
Once again thanks to all of you |
| Sorry, the last para revers to the term stacked events. Copy and paste mistake. |
| Just for a quick clarification, I think the term "unintentional stacked event" is supposed to describe the offspring of two LMOs that cross without human intervention. Some have referred to these as "field stacks". |
Thanks to all of you.
I now invite you to turn to the second substantive item in our agenda:
ITEM 3.2. MODALITIES FOR COOPERATION IN IDENTIFYING LIVING MODIFIED ORGANISMS OR SPECIFIC TRAITS THAT MAY HAVE ADVERSE EFFECTS ON THE CONSERVATION AND SUSTAINABLE USE OF BIOLOGICAL DIVERSITY, TAKING ALSO INTO ACCOUNT RISKS TO HUMAN HEALTH
Under this agenda item, you are invited to discuss possible modalities or potential mechanisms by which cooperation may be established by the Parties to the Protocol to identify LMOs or traits that may have adverse effects on biodiversity.
I kindly emphasize that this is a procedural issue. Therefore, I invite you to focus your comments on “modalities for cooperation” rather than on content because this is the mandate we have received from the COP-MOP. |
I will now open the floor for your reactions to the first guiding question under Item 3.2.:
(a) Which modalities (or mechanisms) would you like to recommend for cooperation in identifying living modified organisms or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health?
The floor is open for your comments. |
| Sorry, I understood that like the Roadmap these documents cannot be legally binding. Only the Protocol has a legally binding status. Our documents will be guidance documents. |
| I like to emphasize the need for good monitoring concepts and their implementation in that context. The European legal framework foresees a case specific monitoring and general surveillance to gather data on commercial use. Regional workshops on possible monitoring concepts and parameters could be a way The baseline for comparison is an important aspect in identifying possible adverse effects. As said during the discussion forum regional workshops could help in trying to outline what would be the boundaries of accepted agricultural practise and its impact taking into account the aims and targets described by the Convention itself. |
| Identification of LMOs or particular traits that may have adverse effects would be greatly helped by some sort of monitoring and by drawing on a set of helpful questions. I believe the questions around monitoring and identification of foresaid LMOs and traits require a dedicated discussion best served by a workshop. Such a workshop could develop questions, criteria and a monitoring plan, establish timelines and further modalities. My suggestion is thus to first have a workshop and then to follow the process designed by the workshop, involving wide participation. |
| In can see this is a procedural issue.
But we should be clear about the scope of the issue. Do we all have a common understanding of what is meant by "living modified organisms or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity" in this specific context? |
| We strongly support Beatrix and Ricarda. |
| Thank you Helmuth for this question. I would propose to develop the regional and subregional approaches and capacities for identification of LMOs, including the regional detection laboratories. An other usseful isuue would be training system for identification as well based at regional approach. This could overcome the language barriers and the administrative system compatibility. An joint monitoring system for countries in region wouls be the same helpful and appreciated. |
| This task, of identifying problematic LMOs or traits, as an a priori exercise would be contrary to the established principle set out in Annex III that case-by-case analyses should be used to make decisions about an LMO. It is not clear how this request from the Parties during the last MOP can be reconciled with this fundamental approach to RA laid out in Annex III. |
| Thank you colleagues for all the excellent comments so far. Any more interventions before we move to the next guiding question? |
| Besides our current agenda. Thank you Hans for your comment on the legal status, of course you are right |
| Monitoring should involve existing networks. But this is still not in practice in the EU after years of discussion. On the other hand I do not see the legal basis in the CPB. |
Thank you very much. Let us please move to the second question under Item 3.2.:
(b) Who should be involved in this cooperation?
The floor is now open for your views. |
| Again a procedural issue. Are there any views before we move to the next question? |
| I think a transdisciplinary approach could be helpful especially involving different stakeholders. in the context of scientists I think of involving conservation biologist would be good |
| It has been suggested in previous real time conferences that we could start the process by reporting on our findings on LMOs with adverse effects on the BCH. |
| With regards to the workshop I suggested, I think involvement/participation should include/draw on the BCH, the members of this AHTEG, risk assessors, representatives of indigenous and local communities, civil society experts and experts on different plant/animal/microorganism systems and experts on soil, water and animal diseases – to mention a few. Whatever the design of the process afterwards, the same involvement/participants might be chosen - or s selected subgroup. |
| I believe that the applicants and risk managers, etc.
To elaborate on Hans' comment: existing networks are used by the applicants and COM strongly recomends that and it is mentioend in teh monitoring palns. |
| The suggestion of Hans seems very plausibel. |
| Thank you very much. Any more comments? |
| This is a good point, Hans, and reinforces that utility of involving decisionmakers and stakeholders in the formative steps/design of the RA, to help insure that decision-makers needs are met within the decision context. |
Thank you for sharing your views. I will now proceed to the final question under Item 3.2.:
(c) What should be the terms of reference and timeline for this cooperation?
The floor is open. |
| Any comments under this point before we move on? |
| researchers in different relevant fiels, and plant and animal biologists, microbiologists, agricultural research, also decision makers and stakeholders. |
| Building on my previous comment and some comments from others, the scope should be clearly delimited in the Terms of reference. It seems to me that what should be addressed here isnot "LMOs or specific traits that may have adverse effects" but rather "LMOs or specific traits for which RA has demonstrated that they have adverse effects" |
| Monitoring in general (of information, knowledge, LMOs, biodiversity, eco systems) and identification of LMOs or particular traits that may have adverse effects will have to be continuous, as more knowledge and experience is gained and can feed into the process. With regards to the workshop and devising the questions, criteria and monitoring scheme itself I suggest for this to take place between this and the next CBD COP. Such workshop could report back directly to COP or to SBSTTA.
Thus in my mind we are talking about two different processes and timelines. First the one to develop the scheme and then to carry it out. Whilst the first is limited in time, the second would be a reiterative/ongoing process. |
| Thank you Angela, Didier and Ricarda for your very clear suggestions. Any more interventions? |
If not then let us please proceed to the next and final substantive issue of our conference today:
ITEM 3.3. NEED FOR FURTHER DEVEOPMENT OF GUIDANCE ON RISK ASSESSMENT AND RISK MANAGEMENT OF LMOs AND THE WAY FORWARD
Under this agenda item, you are invited to express your views as to whether and how the process of developing further guidance on risk assessment and risk management should continue. |
To guide our discussions on this item, I would like to propose that we focus on the first guiding question under item 3.3.:
(a) Is there a need for further development of guidance on risk assessment and risk management of LMOs?
The floor is open for your interventions. |
I like to reitereate what a gave as imput to the online discussion forum at the end of the last year. The additional topics identified during the online discussions and the first AHTEG meeting in Montreal (see report) should be the starting point.
As a second point I would like to raise the question how risk assessment could be better linked and reflect decisions taken by our mother convention, the CBD. Risk assessment is done in a comparative manner. That comparison links the use of LMOs and the accompanying management to current agricultural practises and their impact on biodiversity and the environment. The CBD recommends very clearly that there is the urgent need to improve the situation and for example stop the loss of biodiversity - to name one of the prominent recommendations. As a consequence there would be a need not only to link RA to a status quo but to develop criteria if and how RA could reflect these overarching goals and help or contribute to achieve these. In addition these questions have a lot to do with the choice of the appropriate comparator or comparision. |
| With regard to further guidance it could be helpfull for Parties with low capacity to make use of OECD consensus documents . This mmay be pointed out. |
| This is probably outside the scope of this discussion but even with a clear framework and some guidance there will be a problem of capacity in many countries to act on the guidance within a framework (both intellectual capacity to make complex decision and resources to implement appropriate decisions). |
| As Beatrix pointed out - we still do have the list we drew up at our first AHTEG meeting in Montreal with LMOs/traits requiring further guidance material. This list was also based on/informed by the feedback from regional workshops and include fish, algae and trees. We have to decide how to present the list of outstanding items to COP10, but it is evident that we have not been able to cover all the ground that parties had wished for. Thus further development of guidance deems necessary. |
| Guidance documents on LMOs of which there is littel RA experience can be very instructive, informative and help to form capacity, particularly in developing countries |
| I would like to support Beatrix. I have read earlier her comments on the comparative/comparision approach. This issue needs further discussion and further guidance. |
| I am convinced that the guidlenes for other LMO organisma should be developed, as ex for fish, animals etc. This would provide the helpful guidline materials for Parties. The guidlines will provide the common requirements and understanding for Parties and RA assessors |
| Uncertainty and variability analysis, as stated earlier.
Also, we might consider where a checklist may be of value to ensure the most critical elements of the RA are carried out. This is not only of value to the novice but experienced assessor...same reason commercial pilots use checklist on every flight. |
| Thanks to all of you for your thoughtful suggestions. Any more comments? |
| there is guidance material on GM insects being developed in other fora -e.g World Health Organisation. It would be useful to look at this as well as relying on OECD consensus docs. |
Thank you for your interventions.
I would like to proceed to the second and last guiding question under Item 3.3.:
(b) If a need for further development of guidance exists, what kind of process(es) could be considered for addressing this need?
I will now open the floor for your reactions. |
Regarding the identified need for further guidance I think a new AHTEG would be the right instrument.
Regarding the second thematic area I think a mixture of internet based tools and face to face meetings could be appropriate. A broder workshop to identify and discuss the relevant decisions and recommendations of the convention to crearte useful links could be a helpful start. |
| I think a consultation to the parties is needed, providing information material to inform their decision. |
| Again, I would support Beatrix. A new AHTEG is my first thought on this. |
| Thank you Beatrix, Eliana and Marja for your very clear suggestions. Are there any further comments or procedural suggestions? |
| I support Eliana's suggestion. |
| on-line conferences and face to face meetings of experts would be appropriate fools for these needs |
In the interest of time and keeping the work programme more or less in line with what we agreed at the beginning of the conference, I will now close the discussion on item 3.
Thank you all for your interventions. |
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. |
I have been incommunicado for a while – curing a little screen that told me my computer was trying to reconnect – my wife just returned with my laptop and now I am back, just in time to say that I have to leave to get my daughter from school.
Good discussion –
Regards , Piet |
Thanks to all of you for that very interesting conference !!!
I had connection problems since a long time when you announced it .
I did not take the floor inbetween , because
- I did not participate to the preceding conferences , and had very few time to collect and read the documents, already a while ago, and
- I have even not absolutely all documents in front of me ( this is presently not part of my direct job , and I am enough overloaded without that ) .
- I also could not stay all the time behind my PC today .
- It' s the 1st time I participated to that kind of online conf.
But , as a Belgian national focal point of the Cartagena Protocol , I found it necessary to at least look at , since Belgium will be president of the EU during MOP5 .
I summarize here some of the important points that retained my attention, and I at the same time give my opinion for some of them :
General roadmap : should stay very general , applicable for all LMOs , but with many links to specific documents for specific LMOs , and to reference guidance documents . Should indeed be friendly enough for new users .
but , who and how will be decided what are the right documents ?
In any case , the Roadmap and guidelines should be living , adapted as fast as possible to the most recent scientific information and techniques .
The question of baseline : important for new LMOs ( mosquitoes, stress tolerance , ….. , taking into account a.o. climate change , impacts of vectors , viruses , …. On biodiversity ) , but also for plants GM ( ? different views on biodiversity , ecosystem notion, wild but also agricultural biodiversity ,…. )
Uncertainties and variabilities : the level of uncertainties accepted and the methods to measure variability and to give it significance partly depend on preliminary choices on the level of risks accepted . Uncertainty notion and measuring and considering is not very friendly to new RA & RM actors from some countries .
Address the question of epigenetic and pleiotropy properly .
Mosquitoes are a world of biodiversity in themselves, with many different habits of life, they are less known than cultivated plants especially by most “biosafety experts” , and they do not know about borders ! I personnally find that especially the draft roadmap for mosquitoes should be sent and commented by various specialists in mosquitoes systematics , and in mosquitoes implicated in human and animal diseases , as pests , …..that do not participate regularly as biosafety experts and are not part of the AHTEG or of the experts registered for thoses conferences .
I don’ t catch exactly why the non-GM comparator could not be grown at the same place for plants resistant to abiotic stresses ( but I was precisely disconnected when this was discussed , and I left inbetween )
Stacked genes should be obtained only by conventional crossing of signel types of genes ( so is it anyway in the EU legislation , that also edited a special document on that issue ). The Belgian biosafety Committee also prepared a document on that issue . Obviously stability , intactdness of the loci compared with the single genes should be studied , and various unintendedinteractions bu that should also be studied for single events .
Modalities for cooperation in identifying LMOs that may heve adverses effects :
concerning adverse effects on health , viruses etc.. , there should already be bio-medical networks and databases . For adverse effects on environment , less obvious .Reporting experience on BCH could be an approach , but the BCH precisely contains case/case RA , and not considerations on general characters that could have adverse effects . THose could indeed be defined in workshops , defining criteria that could be adverse effects to environment and type of traits that could bring those effects , without pointing precise LMOs . All kind of stakeholders should participate , but mainly those having knowledge in environmental aspects and potential adverse effects .
Surely develop further roadmaps for other LMOs in development like those discussed in the Montreal Workshop . ( The question of GM viruses is particularly important and special ! ) , and insects in general ( for this , the roadmap on mosquitoes will help a lot ) . OK for a new AHTEG .
tM ( ? different views on biodiversity , ecosystem |
| The only comment I want to make is: Thanks to you Helmut and especially to the secreteriat given the additional problems they had to solve.
Goodbye to all of you |
| Thank you all for the interesting and lively discussion.
Goodbye to everyone,
Adrian |
| I find the conference very interesting and successful. Thank you Helmut to chairing the conference in an intelligent and professional way, thank you for all participants for usseful contributions.
best regards
Angela |
| thank you all for this discussion. I enjoyed it. Till the next time. over and out. Ricarda |
| Thanks to the Secretariat for their early risings and our fearless chair Helmut for the online conference. I enjoyed the discussion!
Best, David Quist |
| Thank you Helmut, thank you all, and especially the secretariat who had to struggle with the technical problems. All the best to you all. Marja |
| Thank you Helmut and the Secretariat for your coordiantion of the Conferencek and again to all of you for the contributions given to the mosquitoes documento. Bye! |
| Just to recall my previous comment about the need to develop clear methodology and criteria concerning the collection of documents to illustrate the different steps of the risk assessment.
And I would like to thank you, Helmut, the Secretariat and all participants for this very interesting exercice.
Looking forward to work with you again next time.
Didier |
| Thank you Helmut, good job. Thanks to the secretariat for the efficient support.
Best regards,
Hans-Jörg |
Thanks to all of you for your kind words and final reflections.
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. |
Dear all,
We are approaching the end of the Real-time Online Conference for WEOG and CEE. We are sorry for the connection problems we had earlier on.
Nevertheless, despite the momentary problems, this innovative online tool has allowed you, Experts in Risk Assessment, to gather here today with the purpose of discussing important issues on risk assessment of LMOs. The result of our conference is a strong set of views and recommendations that will assist the AHTEG in their deliberations.
I thank you all 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 manner.
The full transcript of this conference will be made available at this same address in a few minutes for future reference.
We will keep you informed of upcoming activities under the Open-ended Online Forum.
Thank you all, have a good afternoon! |
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. Special thanks for solving the technical problems so efficciently!
With that, I now declare the Second Regional Real-time Online Conference on Risk Assessment and Risk Management: WEOG and CEE, closed.
Thank you! |
List of Participants
| Chair Person |
# |
|
Helmut Gaugitsch
Federal Environment Agency
|
93 |
| Party |
# |
|
Didier Breyer
Belgium
|
18 |
|
Eliana Fontes
Brazil
|
6 |
|
Hans Bergmans
Netherlands
|
7 |
|
Angela Lozan
Republic of Moldova
|
7 |
| Non-Party |
# |
|
David Heron
United States of America
|
5 |
| Observers |
# |
|
Adrian Peres
Bayer Bioscience NV
|
23 |
|
Austin Burt
Imperial College London
|
1 |
|
Beatrix Tappeser
Federal Agency for Nature Conservation
|
21 |
|
Camilla Beech
Oxitec Ltd
|
8 |
|
David Quist
GenØk - Centre for Biosafety
|
11 |
|
Hans-Jörg Buhk
Federal Agency of Consumer Protection and Food safety
|
19 |
|
Ivan Pejić
University of Zagreb, Faculty of Agriculture
|
- |
|
Katia PAUWELS
Scientific Institute of Public Health
|
4 |
|
Lucette Flandroy
General Directorate (DG5) Environment
|
2 |
|
Maria Antonietta Toscano
Chair of Microbiology
|
10 |
|
Marja Ruohonen-Lehto
Finnish Environment Institute
|
13 |
|
Mark Benedict
unaffiliated
|
8 |
|
Penny Hunst
Bayer CropScience
|
1 |
|
Phil McDonald
Canadian Food Inspection Agency (CFIA)
|
- |
|
Philippe Baret
Université catholique de Louvain
|
4 |
|
Piet van der Meer
Horizons sprl / PRRI, Belgium
|
6 |
|
Ricarda Steinbrecher
Federation of German Scientists (Vereinigung Deutscher Wissenschaftler)
|
17 |
| Guests |
# |
|
Jean-Francois Sarrazin
Bayer BioScience NV
|
- |
|
Lúcia de Souza
ANBio (Associação Nacional de Biossegurança - Brazilian Biosafety Association)
|
- |
| Secretariat |
# |
|
Giovanni Ferraiolo
UNEP/SCBD/Biosafety
|
2 |
|
Manoela Miranda
UNEP/SCBD/Biosafety
|
14 |
|
Philippe Leblond
UNEP/SCBD/Biosafety
|
- |
|
Stéphane Bilodeau
UNEP/SCBD/Biosafety
|
- |
|
Ulrika Nilsson
UNEP/SCBD/Biosafety
|
- |
|
