Second Series of Regional Online Conferences on RA&RM
Africa, 2 February 2010 - Full Transcript
Dear Participants,
Good morning! Welcome to the Second Real-time Online Conferences on Risk Assessment and Risk Management for Africa. 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, once the floor is given to you, you will have only 60 seconds to send your intervention.
The Secretariat is available to answer questions through the HelpDesk. To access the Helpdesk online, please use the tab in the top-left corner of the screen. In case of emergency a direct phone number to Montreal, Canada, is also available in 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, Ms. Hajara Yusuf Sadiq from Nigeria, to preside over the conference.
The Secretariat wishes you a very fruitful discussion! |
Distinguished colleagues,
Good morning and welcome to the second real-time conference for Africa. 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the continued help from the Open-ended Online Expert Group, the AHTEG has made considerable progress in developing four draft guidance documents on specific topics of risk assessment and risk management, namely Roadmap, LMOs with stacked genes, LM crops resistant to abiotic stress, and LM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 have no objection, it is in order. |
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. |
| Chair, thanks for the direction. I have no objection |
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. |
| The party, the floor is still open |
On the whole, I find the roadmap to be generally useful although it is difficult to read in places and in places very wordy - I believe it is generally consistent with the appraoch taken by the IPPC though the language and presentation style differ from what we are used to. I would be inclined to distill it down to the simplest possible language and perhaps make more use of formatting and white space to bring out points more clearly.
I also suggest that it might be helpful to insert a figure to portray the flow of the five main steps in their process. Maybe something inserted between lines 146-147 and introduced by a sentence or two would help focus the reader's attention and help them see the flow of logic between steps. I will try to insert a diagram in my next comments |
| waiting for more comment please |
| The road map has the essential tool to carry out RA. I Will also suggest that specific information guidance be given for Notification |
| The new version of January 15 has been quite improved in terms of "accessibility" and understanding. Nevertheless it is , correctly, referred to the BCH for additional guidance or supporting material. If we want to have the roadmap a useful tool, those additional documents must be set up relatively quickly. Anyway I fully support this approach |
| For Step 2, I think some editing might help in the Rationale. The second sentence, beginning "In order to determine", for instance, is particularly convoluted. Severe editing to make sentences more readable would be very helpful, especially if one considers the need for translation to other CBC languages and the need for many people to use this guidance in a language other than their first. |
| good suggestion by you all |
| The roadmap is a very good base document that provides a good basis for sound understanding of the core principles of risk assessment. As a country that is actively engaging in risk assessments for LMOs i would suggest that early on in the risk assessment process some guidance on scope of the application is provided. the steps to be taken in a risk assessment will only be determined by the scope of the application. |
| Thanks chair, i think that the Roadmap version is correct and it is not difficult to be applied taking into consideration thatb risk assessment itself is a complicated processThis guide aims at facillating such process by giving countries the choice to apply it as appropriate |
| I generally agree with Andrea, but I think more clarity on distinguishing between CFT's and commercial release. For example in lines 160-162, I think it should be mentioned that not only would there be difference in the level of information, but that due to the nature of CFT's the considerations under exposure are more relevant. |
| I strongly agree with the suggestions made by Andrea Sissons. |
| Thank you all for your comment |
| another comment - Under Step 3, there seems to be a lack of detail or examples provided here. It might be helpful to provide a checklist of the kinds of consequences one might encounter in a risk assessment of this kind, (you can look at ISPM 11 Section 2.3.1. for an example in the phytosanitary world) Perhaps this is what the proposed "links to BCH pages" will do, but without having the time to look in more detail at these pages, I cannot say. Some examples might include issues like: effects on domestic and export markets, changes to producer costs including control costs, changes to domestic or foreign demand for a product, environmental and other undesired effects of control measures, potential effects on plant communities, ecological process, toxicity, allergenicity , etc |
| thanks for your suggestion Andrea |
| thank you all once again, your suggestion will be taking care of |
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. |
| the floor is still open for your comment |
| The roadmap has not focused on the LMO FFPs specifically. In addition, the roadmap could be strengthened by provding specific guidance on LMO applications that are of indigenous organisms. This is a particular concern when one considers centres of origin |
| I think that It has a general character and can be applied to any LMOs and at any scale or activity provided that some modifications can be made |
| Thanks,
The draft roadmap as it is, is strongly related to plants.It is not a great problem because they are the majority of the LMO's that will undergo such a risk assessment. However it could be good to mention it and to precise that specific documents, like the three other ones, will precise adaptation top other LMO's. Therefore in the specific doscuiments we should link to the roadmao, but we will probably discuss that point later on. |
| I think that we accept that Annex III is applicable to all types of LMO's. If that is the case, then the roadmap should be as well. Going back to Andrea's previous comments, it could be simplified, and as well, some points to consider that are somewhat confusing should be reconsidered regarding whether they should remain. For example, lines 172-181. I would like to know if these are at all helpful to people and how they would implement such guidance in a risk assessment. |
Dear All,
Among us here today are Hans Bergmans and Eliana Fontes. They are the Chairs of the AHTEG Sub-working Groups on Roadmap and LM Mosquitoes, respectively. Please feel free to ask them any specific questions that you may have on these subjects. |
| if you have any comments on teh Mosquitoes guidance material, please wait until we are discussing that topic. Comments only on the Roadmap for now, please. |
| do will still have more comment |
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. |
| Step 5 seems to leap from the end of risk assessment to the end of risk analysis with not just conclusions about whether or not the risks are acceptable but also recommendations on strategies to manage them. Perhaps some guidance on selecting and evaluating options as part of this step would be helpful. |
| As well, the section on relevant related issues is interesting but not very helpful, and again I wonder if some kind of figure would be helpful in demonstrating the relationships between risk assessment and these issues. It might also be helpful to include a statement in each of lines 326 to 331 to indicate the nature of the issue identified |
| Please the floor is still open for comment |
| Does the guidelines used in most countries for LMOs risk assessment follow the principles established by the Roadmap methodology |
| As I understand the scope of the document is risk assessment and not risk management. If we include risk management and decision making considerations in it, they should be in a distinct and separate part, otherwise the risk is that would make it confusing. |
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. |
| Gado, as to your question: as far as I am aware, the Roadmap is in line with the methodologies used by countries. I expect no problems there. |
| Not so much a concept that is missing as a reminder that your colleagues in the IPPC world are also conducting risk assessments on plants and may be able to share information particularly on non-gmo plants that may be used as comparators. In many cases the same assessors are working with both LMOs risk assessments and IPPC risk assessments - and I am encouraged to see that our methodologies are not that different - some differences in terminologies perhaps but the concepts are all similar. It may be helpful to know who your National Plant Protection Organization people are under the IPPC and collaborate with them on occasion |
| Globally all the concepts are there. On the contrary it has been mentionned that it could be simplified, for example in putting some parts in supporting material, but I hva no suggestion on which one. |
| thank you all for your comment |
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. |
| The concepts are quite of global standard |
| Generally, i suggest that the road map and risk assessment should be more specific on the target LMO. |
| This will help regulators in their decision-making process |
| Binta, please, coul you make your suggestion a little bit more clear? Thanks. |
| I have a general comment that is valid for the other documents. Because theyare linked to the roedmap it would be helpful to mention in each paragraph to which part of the roadmap they refer to. |
| the floor is still open for more reaction |
| PErhaps the non target impacts could also be included. Further guidance on the role of mosiquitos in the ecosystem may be helpful in this regard |
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. |
| There is the need to include measures to recall GM mosquitoes in the event of adverse impact |
| Binta, could you please send your comment to the secretariat to help you post it |
| Excuse me, I would like to make a comment that belongs to the previous section, on the discussion on risk management, see the intervention of Jean Francois. The mandate that the Parties gave us is (i) Develop a "roadmap", such as a flowchart, on the necessary steps to conduct a risk assessment in accordance with Annex III to the Protocol and, for each of these steps, provide examples of relevant guidance documents.
Step 5 in Annex III asks for possible RM strategies to be listed or considered. Risk management will therefore be treated in the Roadmap only in this respect. |
| Our expert who has more comments will participate to the latin america conference, please apologize for my "quietness" |
| There is the need to make a link with relevant guidance documents available in the BIRC of the BCH |
| Do we still have more comment |
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. |
| party, we need your comment |
On behalf of Hajara, since she is having problems, 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. |
| Please, if you have any problems posting messages, please send your comments to:
riskassessment.forum@cbd.int
and we will post them on your behalf. Thanks! |
| I find Gado's comment on supplying references to the BIRC quite useful. It could be done in a similar way as we will be doing it for the Roadmap. |
| I guess that we will do in the following conferences. |
| Jean-Francois, do you mean in the real-time conferences for the other regions? |
| As i have suggested we can make a link of this topic with relevant guidance doc in the BIRC |
| Yes, particularly in the real-time conference for Latin America |
Dear all, I am with Hajara on teh phone and she is having problems with the connection and asked me to post the following on her behalf:
Thank you very much for your interventions. 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. |
| Regarding structure, I don't think it is clear what part of the Roadmap (specific steps or points to consider) this additional guidance applies to. |
| the floor is open for comment please |
| I have the same comment as Hector. It would be better understandable if the structure was similar to the roadmap. |
| party, we need your comment please |
| Thank you Hector and Jean for your comment |
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. |
| For the two paragraphs a) and b), I think there is too much emphasis on selective advantage. We really have to ask the question whether the crop has been fundamentally changed such that it has become more invasive. I would be interested in learning from Andrea whether in the IPPC experience, the focus is on selective advantage or on more basic plant biological characteristics? |
| The structure of the document is not a major concern in my view. Guidance documents should not be too prescriptive but rather provide a more generic framework to assist the process |
| With regard to Hector's point for (a). This and other sub working groups have had to work in parallel as the roadmap has been developed. As such, clear linkages to the roadmap have not been integrated. I think it is the intention of the sub working groups to do this in the coming months. It is important because we recognize that the roadmap is the overarching guidance. |
| For the IPPC type of risk assessment the focus when doing a weed risk assessment is on plant biological attributes that may enhance or lead to invasiveness |
| Thank you all for your comment |
| I am not sure that the document has to follow the precise Roadmap. But it should make clear what aspects of the Roadmap are relevant in relation to tyhis document. As Tom says (I guess) when you are reading the document, it should be clear what lines it is commenting on, or relating to. |
| The challenge with this trait is that it is too descriptive. Since risk assessment is always case-by-case, the discussion on stress traits can be (overly) theoretical and lack a basis in reality. Every risk assessment deals with a specific product that has specific characteristis. |
| On the second matter - the issue of other unintended consequences on biological diversity could also be considered. For instance - if the abiotic stress genes resulted in changes in land use etc, presumably the trigger for other processes would be the land use change rather than the LMO aspects. The guidance should therefore include other biodiversity related triggers |
| Thank you Hans, Thomas and Wadzanayi for your comments |
| Yes, I agree - there could be a list of indirect as well as direct effects to consider |
| Regarding land use change and other effects as a result of cultural practices, we should be careful to place this in the context of other crop varieties and changing cultural practices. |
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. |
| Our colleague from South Africa raises and interesting challenge with these guidance documents. Countries value different biodiversity components differently and thus will protect their environments based on their national laws. We have struggled in the AHTEG with identifying general endpoints that could be incorporated in guidance documents. |
| the floor is still open for comment |
Thank you. Let us please move on to 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. |
| I agree with Thomas We can include the possible list end-points that may be valid for guidance documents |
| The definition itself seems clear to me |
| The definition will have to be broad to reflect the many possibilities and the fact that agricultural crops have been bred for many years to account for environmental stress. |
| thank you Jean and Thomas |
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. |
| if no request, can we proceed please |
| Also here it would be good to have links to pages in the BCH, where further references can be found and added, as we plan to do for the Roadmap. |
| I think this sub working group has done a good job selecting literature. It is not clear that all the information that has been submitted is reflected in the bibliography at this time. |
Thank you very much for all the interventions.
Before we break for lunch, I would 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. |
| Generic comment on the stack traits guidance. This is a key issue for many regulatory authorities - particulalry those such as South Africa who have a history of LMO releases. Stacking of traits is now considered a key component of resistance development strategies. Perhaps some specific guidance on resistance management and the role of stacks in this regard would be useful. |
| The current structure and use of abbreviations will need to be clarified. For me the current version is hard to read. |
| Thank you Thomas for your contribution |
| Isn't the comment on resistance management guidance more applicable to risk management? |
| This is seen as one of the important functions of the Roadmap to help risk assessors by pointing at available guidance documents this will be possible by the form of links with BIRC of the BCH |
| It is probably appropriate for the document to acknowledge that stacking is a good approach to developing further resistance management products, crops that are more robust. |
| It's difficult to judge off-hand, but I have the same feeling as Hector, that this would take us into risk management issues. |
With regard to stacked products, this guidance document has not been as well developed as the roadmap. The challenge for this sub working group has been the lack of publications on the subject from which any general guidance can be drawn. Another challenge has been the fact that regulation of stacks around the world is highly variable. For example, the United States Department of Agriculture does not consider that stacks are regulated. They have determined that once a material has been deregulate (approved) it is safe to use in breeding programs. Other world areas look at this differently, but generally ask the question “is there a reason to regulate the stack?” This is where the approaches vary, but they usually center on the question what harmful outcome could occur as a result of combining the GM traits that could not be predicted by simply the straightforward addition of two traits. In other words, does the stacked product show signs of synergy?
Unlike the roadmap which has a lot of background information from existing guidance and publication, we are not as fortunate with stacked products. As such, the sub working group must be careful to provide guidance that is proper and informed. |
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. |
| I support the proposed deletion of point 1. I don't think there has been sufficient scientific support given for retaining it; the Morisset et al. paper does not really apply. For points 2 and 3, I think it should be mentioned that the product characterization data that are normally obtained by a developer would be adequate to answer these points. |
| I agree with Hector suggestion |
| The history of breeding is underdeveloped in this document. The is a lot of information available from having stacked traits through breeding. |
| if no more comment, we move on please |
| I am of the view that for most of the parties who will benefit from the guidance documents - the information presented by applicants will not be in a format that makes it easy to address points 2 and 3. In many cases - the single traits are not yet "deregulated" and the regulators must assess the traits already in the stacked form.
I take note of the fact that there is little expereince to uide this discussion futher |
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. |
| Regarding Wadzi's comment, I think the history of this discussion is that the stacked genes guidance would be applied to genes stacked by breeding. The situation she is describing would fall into the standard Roadmap. |
| We can learn a lot from the few examples of where traditional breeding has resulted in problems. These could point us in the direction of how to prevent problems from breeding GM materials. |
| Thank you Hector and Thomas |
| I meant stacking GM materials. |
| Please we need to move on now because of time |
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. |
| Floor is open for comment please |
| if there is no comment, please lets move to the next question |
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. |
| please we need your comment |
| Codex Alimentarius (2009) FoodCodex Alimentarius (2009) Foods derived from modern biotechnology. Second edition. FAO/WHO. Rome. Italy. http://www.codexalimentarius.net |
| Unfortunately, there are only 2 or 3 publications relevant to this subject and the sub working group have captured them. |
| please comment from secretariat |
Thank you Hajara and all for your participation and interesting interventions that we had so far.
I now suggest that we break for 30 minutes.
We shall continue our discussion on the next substantive issue on the agenda (Item 3.2) as soon as we return from the break.
I kindly ask you to be back to your computers in exactly 30 minutes as we still have two agenda items ahead of us.
The meeting is adjourned until 12:45 (GMT). |
| If this sub working group were to consider traditional breeding as suggested above, we would have more literature to draw from. It also might be instructive for risk assessors. |
| thanks Tom, we will adjurn the metting now for 30 min.
See you all soon. |
| thank you all for your comment, we break now for lunch |
| We will start again in 4 minutes |
Distinguished delegates,
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 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. |
| welcome back from break, please send your comment |
| The BCH should remain an important mechanism. If a country, through appropriate risk assessment identifies an LMO that may have adverse effects, then that risk assessment will be made available to others. |
| I take the opportunity to say Hello to all of you though you are dealing with another item now . I have the chance to join for one hour. Unfortunately I could not join earlier when you discussed the draft on Stacked Genes. I realized Tom explained a little bit. But I wanted to emphasize that especially fot the first popint there has been quite good support by parties |
| good that you could join us Beatrix, thank you |
| Speaking about "modalities" this approach seems in opposition with the case by case principle. Therefore the only way for such a thing is exchange of information through the BCH as Hector suggests |
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. |
| I agree with Hector that the CBH remain an important mechanism and would add that Parties could inform others when they first receive application for environmental releases of LMOs or traits of which that has been no risk assessment experience available, for instance. |
| Following from my previous comment, then the Parties and non-Parties who have conducted risk assessments should be encouraged to be active in posting information to the BCH |
| Agai also I remind you that your colleagues in the IPPc world are also evaluatin gplants for planting and may have some risk assessments to share |
| continuing... in the case o LM mosquitoes, |
| thank you all for your contribution |
| I would like to understand a bit more from Eliana. How would this communication work? How would this relate to a conclusion or finding of adverse effects? |
| It is important also to make a clear distinction between assumptions or claims and actual outcome of the risk assessment, and if any notifications of adverse effects duly verified. |
| Elena could you make youir suggestion more clear |
| I echo the comment from Andrea. The most significant problems created by plants are familiar to the IPPC world. |
| to my opinion we should get involved a number of other disciplines from conservation biology, ecology. And we should have a closer link to the CBD taking into account its decisions and goals. |
| thank you all for your comment |
| I meam, Parties could share with others about the relevant iniciative proceedures they are taking regarding RA for these new LMOs or trais, for instance if they are are having expert consultation, etc. |
Thank you for sharing your views. I will 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. |
| This question implies that there is a perceived need for a separate activity or project, but I don't see that we have come to that point in our discussion today. |
| Do we still have more comment please |
Thank you very much for your comments. 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. |
| The answer to this question will be on a case-by-case basis and we have not had any cases yet. |
| To mu understanding thare were a list of priorities identified for further input and guidance. We should therefore set timeframes related to the various COP/MOPs - and agree on the other areas that still need further engagement such as long term monitoring |
| My comment referred to 3.2(c). |
| sorry i have posted the next question before your comment, thank you |
| There should be a section in the BCH where experinces on specific issues should be posted |
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. |
| the floor is open for your comment please |
| THe IPPC has developped a training package for risk assessment and the manual is quite extensive and would in many places cover some of the same material - if anyone would like to see a copy of it it is available at www.ippc.int As well on this site it may be worth your while to look at ISPM 11 and 2 which directly relate to risk analysis and which may be of interest. in many places these again comlement the road map and the work being done on LMOs |
| The application of the Roadmap in the future will allow to determine the changes or modifications required |
| thank you Andrea and Gado |
| Further developments: we have already the roadmap that is an overarching document that potentially covers all LMO's. Other bodies , like OECD, are also doing a similar work. In defining priorities we should also take into account this work. |
| thanks Jean for your contribution |
| There is a lack of guidance materials for emerging applications of modern living modified organisms including: transgenic fish, trees, pharmaplants and viruses for the management of animal populations, and guidance on specific types of risks pathways. There is also limited guidance with regard to risk management, including post-release monitoring of the impacts of living modified organisms released into the environment. . |
| still waiting for more comment please |
| There may also be a need to consdier the LMO itself as a pathway for diseases or insect pests - the LMO may not be the problem but it may bring with it a problem |
| Perhaps a useful excercise would be to see how well these other applications can be addresses first without further guidance but applying the Roadmap as it is. Then the areas where the Roadmap leaves a gap can be identified. |
| With regard to agricultural applications of LMOs (plants), there is a lot of guidance that has been developed over the last 23 years. Perhaps the focus should be on other applications of biotechnology. |
Thank you for the 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. |
| After the next MOP; appropriate supporting guidance materials for example handbook on interaction of organisms ; laboratory studies must be provided |
| I would support the use of AHTEGs. This gives the flexibility to access the proper experts for the specific task. |
| I agree with Gado that we should think of ways to keep the Roadmap and other documents up-to-date This is also mentioned in the Roadmap, for instance, where it is called a living document. There it says that initiatives can be taken as mandated by the Parties (or words like that). Therefore, if this is needed we should indicate this clearly to the Parties, in COPMOP. |
| thank you all for your comment |
| Future AHTEGs with appropriately selected experts could make the refinements to the roadmap needed in the future. |
| The use of AHTEGs is recommended. The secretariat will however also need a mechanism to share this information. To this end, a number of resource people may be required for the hands on training of parties on the materials. |
| thank you Thomas and Wadzi |
| Do we still have more comment on this |
We will now move to
ITEM 4. OTHER MATTERS
I will open the floor for approximately 15 minutes 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. |
| As chair of the SWG Roadmap I would like to thank you all for your comments to the development of the Roadmap. Your comments have been very thoughtful. We will take them into account when developing, in the next session of the AHTEG, our version of the Roadmap that will be submitted to the Parties. |
Thank you, my dear colleagues and the Secretariat!
Thanks to all the participants and guests for your constructive participation. I really appreciate everybody’s cooperation during the conference. I would also like to thank the colleagues in the Secretariat for a job well done. They have tried all their effort to make this conference a success by providing all the necessary assistance. It is a great pleasure to be part of this conference and even given the opportunity to chair for the second time.
I now declare the second Regional Real-time Online Conference on RA-RM for Africa closed.
Thank you all |
Dear all,
The real-time conference for Africa has once again brought you, Experts in Risk Assessment, together with the purpose of discussing important risk assessment issues and the result is a strong set of 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 Ms. Hajara Yusuf Sadiq for chairing this conference in a very skilful manner.
For future reference, the full transcript of this conference will be made available in this same internet address in a few hours.
We will keep you informed of upcoming activities in the Open-ended Online Forum.
Thank you all, have a good afternoon! |
| I would like to know how we can get more parties to become active in this and other processes related to the protocol. Is there something that we as individuals interested in this work can do to get more active participation? |
| Tom, this is a very good point we indeed need Parties to participate. I think it would be useful if each of us would use personal contacts for this purpose. |
| Thank you all for allowing me to particpate - I would be willing to continue to function with this group and as a liaison role with the IPPC and the protocol |
| I like to join Hans and say thank you to all of you especially to Hajara and the secretaeriat. |
| It is big challenge and we should help the Secretariat to, improve the level of participation |
| I have had a very interesting engagment this fternoon and regret not having particiapted earlier. Thank you to the Chair and the Secretariat |
| the conference is close, thank you all for participating |
List of Participants
| Party |
# |
|
Eliana Fontes
Brazil
|
4 |
|
Hans Bergmans
Netherlands
|
8 |
|
Hajara Oyiza Yusuf
Nigeria
|
112 |
|
Rufus Ebegba
Nigeria
|
5 |
|
Mahaman Gado Zaki
Niger
|
17 |
|
Wadzanayi Goredema-Mandivenyi
South Africa
|
12 |
| Observers |
# |
|
Andrea Sissons
International Plant Protection Convention
|
12 |
|
Beatrix Tappeser
Federal Agency for Nature Conservation
|
3 |
|
Binta Balarabe Musa
University of Abuja
|
4 |
|
Hector Quemada
Program for Biosfety Systems/Calvin College
|
12 |
|
Jean-Francois Sarrazin
Bayer BioScience NV
|
13 |
|
Remi Akanbi
AfricaBio
|
- |
|
Thomas Nickson
Monsanto Company, USA
|
21 |
| Secretariat |
# |
|
Charles Gbedemah
UNEP/SCBD/Biosafety
|
- |
|
Giovanni Ferraiolo
UNEP/SCBD/Biosafety
|
- |
|
Kathryn Garforth
UNEP/SCBD/Biosafety
|
- |
|
Manoela Miranda
UNEP/SCBD/Biosafety
|
14 |
|
Philippe Leblond
UNEP/SCBD/Biosafety
|
- |
|
