First Regional Real-time Online Conference on RA&RM for Asia (February 17th 2009 3:00 – 7:00 UTC/GMT)
Conference Documents - Final report
Full transcript of the conference
Dear Participants,
Good morning, Good afternoon! Welcome to the Regional Real-time Online Conferences on Risk Assessment and Risk Management: Asia. It is a great pleasure for us at the Secretariat to gather here with all of you.
As you may know, at its last meeting in Bonn, the COP-MOP established an Open-ended Online Expert Forum on Risk Assessment and Risk Management and an Ad Hoc Technical Expert Group (AHTEG) on Risk Assessment and Risk Management.
The Executive Secretary was requested to convene ad hoc online discussion groups, two AHTEG meetings and at least one real-time online conference per region prior to each of the two AHTEG meetings.
Therefore, the Secretariat is implementing a continuous process comprising the following events: a) the establishment of an open-ended online forum, b) discussion groups on specific topics, c) two series of sub-regional real-time conferences (one series prior to each AHTEG meeting), and d) two AHTEG meetings.
Your task in this virtual meeting is extremely important.
On the one hand, the outcome of the regional conferences will serve as a basis for deliberations by the AHTEG, whose first meeting will take place in Montreal from 20 to 24 April 2009.
On the other hand, from the technological point of view, the way we are gathered here today is a breakthrough from the usual face-to-face meetings. Real-time conferences may open a door of infinite possibilities for the exchange of opinions among the Parties and with the Secretariat. Our conference today concludes the first series of Real-time Regional Conferences on Risk Assessment and Risk Management, and I hope you share our excitement in looking forward to a fruitful exchange of ideas and opinions.
On a technical note, I would kindly ask you to prepare 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.
Without further delay, I would like to welcome all of you to this conference and invite the Chair, Dr. Vilasini Pillai from Malaysia, to preside over the conference. |
Thank you, Secretariat.
Distinguished Participants,
Good Day. I am honoured to chair this conference which is the last of the series of Real-time Online conferences on Risk Assessment and Risk Management of LMOs as mandated by decision BS-IV/11. This is a new experience for many of us and I take this opportunity to welcome all of you.
As all the other Real-time Online conferences that have taken place, we will focus today primarily on issues regarding the development of a roadmap for conducting risk assessment and then on further guidance materials on specific aspects of risk assessment and risk management.
The outcome of this online conference together with the others that have taken place thus far will serve as inputs for the deliberations by the AHTEG on Risk Assessment and Risk Management of LMOs scheduled for 20 – 24 April 2009 in Montreal.
In my earlier email message to you all, I had sent some guiding questions in an effort to maximize our use of the limited time we have at our disposal. The technical guidance we have been provided by the Secretariat on this new experience will also be very useful to guide us during this morning’s deliberations. On this note, I declare our conference open.
We will proceed directly to Item 2 of the provisional agenda.
ITEM 2. ORGANIZATIONAL MATTERS |
I invite you now to turn to the provisional agenda contained in document UNEP/CBD/BS/REGCONF-CB-RA&RM/1/1.
The next item before us is the adoption of our agenda. The provisional agenda was prepared by the Secretariat, and it reflects the objective of our task.
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/1/1. |
I see no requests for the floor so the provisional agenda as before us is adopted.
Let us now turn to agenda item 2.2 on organization of work. |
As you may be aware, our conference today will end at about 7.00am (UTC/GMT).
We have three substantive issues on the agenda and I would like to propose that we spend approximately 60 minutes on each. We will have a 40 minute break in between the 2nd and 3rd substantive issues.
I would also like to propose that we use the Chair’s guiding questions sent to you all earlier to help facilitate discussions.
Do you have any differing views or objections to this proposal? |
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. Development of a “roadmap”, such as a flowchart, on the necessary steps to conduct a risk assessment in accordance with Annex III to the Protocol.
The face-to-face AHTEG in April will 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;
In your intervention, you may wish to provide:
-> information that may be needed in developing a roadmap/flowchart other than that contained in Methodology and Points to consider of Annex III to the Cartagena Protocol.
-> guidance materials that are directly applicable to the steps and points to consider listed in paragraphs 8 and 9 of Annex III to the Protocol. |
The Chair’s first guiding question under Item 3.1 is:
(a) What information may be needed to produce a roadmap / flowchart, other than those contained in Methodology and Point to consider of Annex III?
The floor is now open for your interventions on this question. |
Good morning everyone! I would like to propose to produce following information. The first point is related to the 8 e) in Annex III. In case that the trait is tolerant to stress environment tolerant and/or growth control, the idea of “Familiarity” does not always fit to consider acceptance/management of risk. Because different growth itself is the important trait. Therefore we need the other idea than risk assessment and management.
The second point is related to 8 a, d or f in Annex III. In case of stacked gene/traits, they have interaction, especially in the traits which affect on metabolism. In addition, when the stacked genes segregate in the progenies, it may largely change phenotype or trait. Therefore we need the steps to consider whether the each trait can be separately assess or not in stacked LMO. |
| Do we have any more requests from parties |
| I don't understand point 1 - what do you mean by saying "does not always fit to consider acceptance/management of risk"? |
| Do you want to comment Yasuhiro |
If I may comment on the very initial phases of doing an assessment.
We need to first understand the relationship between the Precautionary Approach (referred to several times in the text of the Protocol) and the elements of Annex III. Despite the repeated description of risk assessment as “scientific,” in reality we must recognize that risk itself (defined as the probability of a hazard) has subjective elements. .
The FAO has noted:
Risk assessment is considered to be the “science-based” component of risk analysis, while risk management is the component in which scientific information and other factors, such as economic, social, cultural and ethical considerations, are integrated and weighed in choosing the preferred risk management options. In fact, risk assessment may also involve judgments and choices that are not entirely scientific, and risk managers need a sound understanding of scientific approaches used by risk assessors. The interactions and overlaps of science and nonscientific values at various stages in risk analysis will be explored in more detail in subsequent chapters concerned with risk management and risk assessment. [FOOD SAFETY RISK ANALYSIS FAO/WHO (FAO Food and Nutition Paper 87) 2006. p. 7]
These subjective aspects include:
• The choice of phenomena to research [eg, note that only a small amount of public money is devoted to looking at the environmental risks of LMOs];
• The definition of what is a “hazard” (ie, undesirable) [eg, is the displacement of peasant farmers by agribusiness part of the “modernization processes” or an instance of cultural annihilation?];
• How to actually measure a hazard, especially if it combines different aspects not subject to a single metric [eg, the death of a bee deprives us of both honey and pollination];
• How to account for incomplete knowledge, uncertainty, etc. in the nature/consequences of the hazard as well as its probability;
• Who has the burden of proof of developing the necessary data—the proponent of the technology, the regulatory agency, or consumer/environmental citizen organizations?;
• How to account for the social distribution of risk, since hazards impact different sectors/classes in society differently [Monsanto shares may increase in value while family farmers are driven off the land];
• How to discount future events in light of present actions [will an endangered species be driven to extinction before other recovery efforts might be mounted];
• How to monitor a risk, and how much surveillance is “worth” in both monetary and non-monetary terms [eg, the absence of a law requiring the labeling of GE food is also a decision that monitoring the long-term cumulative effects of eating such products is not very important to the decision-makers]; and
• How to balance risks against “benefits“, since benefits involve all the above factors as well.
The managers and assessors need to address these issues transparently at the beginning. |
| Thank you Bereano for that substantive comment |
| Good time every body from Iran. |
| agreed - I see this as the 'context' for the risk management process and extremely important that these matters are addressed/understood as early as possible |
| Thank you Janet. I mean that "not fit" is such trait is aiming the different grwoth than the noe-LMO. Therefore sometimes there growth will more than the familiality in view point of size and so fotrth. |
| Thank you for the clarification |
| Hi everyone and good morning,
According to annex III, I think RA should not only focus on safety issues but also pay attention to the non-safety issues as well. RA should not restrict any case by the nature of the LMOs.
Pisey |
| Do we have any reponse to that comment |
| and I thought Janet was agreeing with my posting! Thank you, however, Cambodia. |
| Hello, Pisey. Can you let us know eny example on non-sefety isses? |
| Yes Yasshuhiro,
Non-safety issue such as damage to economic, culture and political aspects as well etc.
Pisey |
| Do we have any more comments or interventions |
| I would like to raise the question of "the risk of not using LMOs on the biodiversity". for clarification I would like to give an example. In our research we have shown that when we use transgenic rice, then the on target organisms in particular the parasitoids and predators population increases significantly compared to the traditional chemical based insect control. My proposal is that every risk assessment should include the impact of rejection of the given LMO in mind. |
| This is effectively assessing the benefits of the LMOy |
| Such an approach (cambodia's) will not allow a risk assessment to be made in a reasonable period of time. And I do agree with Iran's point - too long an assessment is also costly |
| Thank you Pisey. I understand well. It is also important to point out. However, It will be difficult to discuss here within the limited time here RT conference. |
| Well, in one way we could say that. We could always include the socio-economic aspects in RA, but explicitly mentoning the impact of the rejection on a given technology is useful to be included in the RA., Janet. |
| Are there any more interventions or comments |
| primary impacts (say to biodiversity) have secondary impacts (such as economic, cultural, etc). The frequent discussions of trade issues during the negotiation of the Protocol indicates a concern for such a set of impacts (they weren't defined as primary or secondary). Why should we only be concerned with the economic impacts of wealthy trading nations and not the economic interests of less developed ones like Cambodia. |
| i think we should also consider the resources we have to dedicate to a protracted risk assessment. if the points considered are so open-ended, the manpower, time, and money invested may be too much for developing ountries to afforrd. |
| surely the test should be how much information is required to make a 'good' decision |
| Hi Yashuriho,
Time is not important but the correct framework for undertaking the RA to be acceptable. I guess we are not assessing the damage to economic etc. here. |
| Do we have any more comments before we move on |
I thank all for your informative interventions.
I would now like to move on to the next guiding question under the Item 3.1.:
(b) Which additional guidance materials are DIRECTLY RELEVANT to each risk assessment step listed in paragraph 8? Please specify name of the document and which step it is related to.
I will now open the floor for your reactions to this question. |
| Agree with both Philippines and L. Bereano. I guess we need a simple, and managable RA protocols enabling developing countries to get involved as wee. More suffisticated RA regims may not be appropriate for developing countries. We also need to think of having access to the economic benefits of GM technology in developing countries. |
| thank you Behzad. Can we move on to the next topic which has been posted |
If I can move on to the 3(b). I am sorry that I have no clear guidance document in my mind. But I am pleased to have any references on the following points.
Firstly, trait with stress environment tolerant should be tested in the each domestic environment in step 8 e). Since Japan is import country of crop, we do not need such trait, but we have to assess whether such event may adversely affect on the biodiversity in domestic environment.
Secondary, we should know the interaction between stacked trait and phenotype/trait after the segregation in 8 a) or d), as I mentioned before. What will happen is case by case. Therefore it will be difficult to generalize the guideline. |
| Good points. Any references that can guide these points |
| Reagarding the comment made by Yasuhiro, I do not think that RA is essential for each and every environment if it is not intended to be re;leased in environment (for example in the case of food, feed or processing). |
Hello and good morning to everyone,
First of all let me share some views, not an expert on RA, on agenda 3.1. My name is Pisey Oum, Min. of Environment of Cambodia. Regarding the roadmap, such as flowchart, on necessary steps to conduct RA according to annex III of the Protocol. I think to conduct risk assessment of a particular LMO, risk assessor should focus on:
1) Understand the context of RA of that particular. Is it for contained use, food, feed, processing or for field trial. This would trail the way for following steps of risk assessment. You can set criteria against which risks will be evaluated should be established and the structure of the analysis defined.
2) Then you go to identify risks. You should answer where, when, why and how events could prevent, degrade, delay or enhance the achievement of the objectives.
3) In analyzing risks, you should identify and evaluate existing controls. You should determine consequences and likelihood indicating the level of risk. This analysis should consider the range of potential consequences and how these risks could occur.
4) After this step, you should compare estimated levels of risk against the pre-established criteria and consider the balance between potential benefits and adverse outcomes. This enables decisions to be made about the extent and nature of treatments required and about priorities
5) Once you know risks of that LMO, you develop and implement specific cost-effective strategies and action plans for increasing potential benefits and reducing potential costs.
This suggesttions seems very generalized but assessing each risk assessment of each LMO is very specific.
That's all I can contribute on this part. Also, as a part of a decision-making you need to assess not only safety issues but non-safety issues as well. Pisey |
| Thank you Behzad. I agree with your opinion. Only I would like to mention is to get the information for domestic environment, when we introduce such trait. Even though we seldom grow such event. |
| 1) An insufficient RA may increase the possibility of damages--"haste makes waste", as we say in the US--this is on the point 3/1
2) 8(b , c and d) We already know, in the real world, that "confidential business information," secrecy, etc by developers of LMOs have made it difficult for assessments to be very accurate. The laws on CBI vary by country--certainly the importing country should use its own, not the law of the developer's country.
3) One of the impacts of FFP importation is escape to the local environment in cases where the LMO is a seed/grain--eg Mexico's contamination of landraces by GE elements. |
| It is suggested that any new guidance must use existing information as the foundation following a science-based approach, and without prejudice or bias based on purely theoretical perceptions of risk or potential adverse effects to the conservation and sustainable use of biodiversity.
Let us take advantage of existing expertise as well as the certain other international fora in which such guidance is being developed |
| Could you please add specific references to the comments you make. Thank you |
| In that case, Yasuhiro, it is not restricted to the stressed environment tolerance, it could also be true for any trait. I mean if you are intending to release any given LMO into new environment, then you need to conduct RA. the extent of RA will be dictated by the trait and we should conduct it on a case by case manner. |
| I agree with Bereano's comments, especially 2) and 3). |
| We need additional guidance documents taht are directly relevant to each risk assessment step, please |
| OECD Working Group on Harmonization of Regulatory Oversight in Biotechnology and the International Plant Protection Convention? |
| Thank you Behzad for your good suggestion. I conpletely agree your opinion. |
| Hi,
Sometimes, not the RA framework itsself dictates the process but the domestic law on biosafety too, which annoy some risk assessors. |
| We are intermittently getting disconnected and reconnected. Is this problem unique to us, or are the others experiencing such difficulties? |
| Does any body have any guidance documents that can help out with the steps in the RA process please? |
| Guidance document: The FAO/WHO publication I noted before, [FOOD SAFETY RISK ANALYSIS FAO/WHO (FAO Food and Nutition Paper 87) 2006] is very detailed. While the assessement practices are described in terms of foods, they are easily applicable to LMOs, whether foods or not. |
Thank you, chair and hello everybody.
I'm sorry to be late as I had a meeting.
My name is kazuyuki suwabe and I'm dealing with risk management of LMOs in the Ministry of agriculture, Janpan.
I will be happy if the table 2 & 3 in our guidance help to RA steps, especially through (a) to (d) in paragraph 8
The guidance is available in English ;
http://www.bch.biodic.go.jp/download/en_law/en_assessment_guidence.doc
thanks. |
| Dear Flerida, our IT person is confirming that the problem is isolated to you. The HelpDesk will contact you shortly. |
| thank you for those references, Bereano and Kazuyuki |
| It would be helpful to get more entries in databases about the biology of more plants, especially trees. Many of the plantation trees are not native to some receiving environments. Are there databases for forest species? |
| Hi Vila,
You may check with OECD guidline, NZ guidline, Australian too. Cambodia is trying to develop its own guideline on RA and RM. Pisey |
| Thank you Oum. Can yoy please be a bit more specific for it to be recommendation |
| We need to be flexible with respect to relevant risk assessment frameworks and operate on a case-by-case basis. There is a great deal of good information out there about (a) risk assessment approaches, and (b) specific scientific informatiuon that can be usedin risk assessments.
Coming back to the question that is being asked, I am unclear as to whether you are looking for guidance documents specific to (a) or (b) - the way the discussion is going is that people seem to be looking more for science rather than risk analysis guidelines.
Or am I way off the mark?? |
| Dear Mr. Chairperson, there is a very useful text called "GM food safety assessment: tools fro trainers" published by FAO. Though this is a very comprehensive text with a lot of teaching material and slides and examples (case studies), but can be used as template to prepare similar text in a much more brief format for RA for biodiversity. |
| We are looking for guidance documents that are can be used by the AHTEG that are specific to steps need to carry out RA |
| Hi Dr. Carino, PROSEA would have a database for forest species. They had a publication on this, however, I am not sure if the info on biology would be sufficient. Perhaps, a good start? Or, CIFOR may have a database as well. |
| Can you please provide specific references to the secretariat at a later stage |
| You might all be interested in the forthcoming ISO31100 (risk management techniques covering idenitficaiton, assessment and evaluation) which will be published later this year - it will havea quick overview of about 30 technqiues. |
| The Codex Alimentarius is supposed to be putting together an international database on LMOs contaminating food shipments (information about the LMOs). It is supposed to be linked to the BCH, but I do not know what is happening. FAO is to manage it. Anyway, this might be an additional source of information useful for addressing points 8 and 9, although I do not understand it to contain assessments itself. |
| Any more references for guidance documents before we move on |
Participants,
We shall now move on to the next substantive issue on the agenda:
ITEM 3.2. Development of further guidance material on specific aspects of risk assessment and risk management.
The AHTEG shall also prioritize the need for further guidance on specific aspects of risk assessment and define which aspects should be addressed first, taking also into account the need for and relevance of such guidance, and availability of scientific information.
In your interventions, you are invited to recommend to the AHTEG, the topics of the previous Discussion Groups in order of priority:
(a) Risk assessment and risk management of transgenic fish;
(b) Risk assessment and risk management of transgenic trees;
(c) Risk assessment and risk management of transgenic microorganisms and viruses;
(d) Risk assessment and risk management of transgenic pharmaplants;
(e) Risk assessment and risk management of LMOs with stacked genes or traits;
(f) Post-release monitoring and long-term effects of LMOs released into the environment; and
(g) Risk assessment and risk management of specific receiving environments.
When you are prioritizing the topics, please take into consideration
-> the availability of scientific information on these topics,
-> the main knowledge gaps, and
-> any other specific aspects of risk assessment and risk management that may be considered for the development of guidance materials. |
I will now open the floor for your reactions to the first Chair’s guiding question under Item 3.2.:
(a) Which of the specific topics discussed in the Discussion Groups should be prioritized by the AHTEG for the development of further guidance?
The floor is open for your reactions to this question. |
I will prioritize as follows.
1) specific receiving environment: This including stress environment tolerant and growth control. It means that not only the trait but also receiving environment is very important.
2) stacked genes or trait: I mentioned before.
3) microorganisms and viruses in open field use: We do not need to pay attention to closed system.
4) pharmaplant: It produces biologically active substances, which is the potent allelochemicals.
5) monitoring: It is important how to design the monitoring in each receiving environment for prevention of unexpected adverse effect, and for verification of risk assessment. |
| Thank you, Yasuhiro. Do we have any more please |
Thank you, chair.
I consider every topic important.
Regarding with the comment made by Yasuhiro,
in Japan, now we, risk managers, continue to try more appropriate way in order to carry out risk assessment of LMOs with stacked genes and traits which have interaction.
Many LMOs with stacked genes and traits are developed now.
thanks. |
| Thank you Kazuyuki. Would anybody else like to give more comments. Your comments here willl be very important for AHTEG to get on with theri tasks as there are too many topics |
| I will prioritize as the following, emphasizing that every topic is important.
1) Staked genes since more than 27 million ghectars are devoted for crops having stacked genes. I beleive the RA conducted for each trait should be sufficient for accepting/rejecting any specific LMO with stacked traits in it.
2) transgenic fish. Regarding the risk assessment and management of transgenic animal including fish, there is a very useful proceeding from a expert consultation meeting published by FAO/WHO: "safety assessment of foods derived from genetically modified animals including fish".
3) Microorganisms and viruses
4) Pharmaplant
5) monitoring |
| Differnt countries will have different priorities and these will vary according to current sceince and 'applications' - I think it is very difficult to priotitise in general terms |
| But we need to begin from one of them any way, janet. |
| in which case I would suggest microorganisms |
| Thank you, Janet. The AHTEG needs your help in prioritizing the topics for them to work on. They cannot work on all as it is too much |
| Thank you Swwabe san. We are actively discussing the stakced evens now in Japan, since stacked events increasing in imported crops, and the what will be happening is unknown in some case scientifically and in view point of RA. |
| Good morning Mr. Chairperson ana all participants.
I am sorry for late due to having problem with accessing to this conference web. My name, andi and I am entomologist at the University of Gadjah Mada, Yogyakarta, Indonesia. Thank you. Andi |
| I agree with Janet, but with all due respect must dissent regarding Iran's first point. A genome is not static, like a LEGO set, so that combining 2 constructs you can "combine" their impacts. It is interactive, and a staked plant needs a separate assessment. Codex produced a document a few years ago on this question.
There is an inadequate knowledge base about most LMOs (see my early comment about CBI, etc) and lack of transparency.
From a recent news account about Syngenta’s new corn-for-ethanol LMO: “The government lacks ‘adequate scientific data or documentation necessary’ to evaluate the crop's impact on food and feed products, according to a letter to the US Department of Agriculture from trade groups representing food industry corporations such as General Mills, ConAgra and Archer Daniels Midland.” |
| Vila,
Are you discussing stacked genes of all types of living things as suggested in the agenda? Pisey |
| We are discussing all topics. In the case of stacked genes, it involves all types of living things |
| yes, stacked trait guidance would be important since there are so many combinations possible. however, we should always consider data provided for the individual traits as very important starting point, then deduce probable (theoretical) interactions. Would be good to have guidance on how to deduce possible interactions.
We would like some more guidance on GM animals, especially the ones which may be used for food rather than production of pharmaceuticals. Our guidance documents on possible environmental impacts of GM animals are not as exhaustive nor numerous as for crop plants. In the last Biosafety conference, Australia presented a paper on their research on GM animals that may be used for food. We should anticipate their coming into the pipeline. |
When you are prioritizing the topics, please take into consideration
-> the availability of scientific information on these topics,
-> the main knowledge gaps, and
-> any other specific aspects of risk assessment and risk management that may be considered for the development of guidance materials |
| Yes, I agree with Bereano, What I ment is we do not need to repeat the RA conducted for each trait again. We just need to look at the interaction of the traits. that is all. WE do not need to go to the details of molecular analysis, establishment of substantial equivalence or defining the transgenes and all the details of each RA conducted already for each of the traits. |
| Are there any more suggestions for the AGTEG group on this question |
Thank you for the interventions.
I will now move to the second guiding question under the Item 3.2.:
(b) Is there enough scientific information available for developing guidance materials on the topics above and which are the main knowledge gaps?
I will now open the floor for your reactions. |
| apology--I just checked the Codex website and I was mistaken, The document I was thinking of was about "pharmaplants" not stacked genes.
Thanks Behzad for the clarification. |
I will simply answer NOT enough. For example, Because following information is limited, it means knowledge gap. I hope someone will introduce me of the uesful suggestion.
- Stacked genes or trait: interaction and/or segregation of traits
- Microorganisms and viruses in open field: gene introgression and effect on the microbial flora
- Pharmaplant: Reproductive strategies, such as dormancy |
| Bereano, could you please give the exact reference then |
| To the best of my knowledge, we, in Indonesia, do not have suffcient information |
| Hi Vali,
I think there not so many cases on RA undertaken. These cases should be collected and shared at the ATHEG for developing the guidance materials. Pisey |
| Chair, Codex did not address stacked genes, so there is no reference. The other materials they worked on regarding GE are in 7 reports from the Task Force which met in Japan. |
| Thank you Bereano for your information. I will check the reports from theTask Force later. |
| Any more knowledge gaps that you can identify? |
| We shall move on if there are no more interventions. |
It's difficult question to answer.The knowledge gaps depends on the topics.
And I think there are a lot of knowledge gaps on every topics.
Becouse we cannot conduct RA on avobe topics.
Regarding with the stacked traits LMOs, as Mr YOGO mentioned before, I also feel it necessary how to assess interaction. |
| I am sure for all countries there wil be knowledge gaps with respect to effects on specific local environments that will need to be addressed individually. However, there will be also areas where we can share information. New Zealand is at a very early stage as we have not had any releases of LMOs so we will be keeping an eye on what is availabel more generally from data banks |
| The initial reaction almost always tends to be NO, we do not have enough information, but I would suggest that the results of conventional breeding and introduction of novel organisms have even greater uncertainty, but the associated risks are still considered acceptable (even without a rigorous RA!). |
Thank you for the interventions.
Before we break for lunch, I would like to proceed to the third and last guiding question under the Item 3.2.:
(c) Are there other specific aspects of risk assessment and risk management that should be given priority to for the development of guidance materials?
I will now open the floor for your reactions. |
| Agree with australia. In fact there are several recent publications showing that the unintended effects of traditional breeding and in particular mutation breeding are far more that what is seen in transgenic approach! |
Transparency and communication among all interested parties, For example:
From FOOD SAFETY RISK ANALYSIS FAO/WHO (FAO Food and Nutition Paper 87) 2006:
1.2.2. Carrying out risk analysis
The risk analysis process normally begins with a risk management step, to define the problem, articulate the goals of the risk analysis and identify questions to be answered by the risk assessment, if and when one is required (see Chapter 2, section on preliminary risk management activities). The science-based tasks of “measuring” and “describing” the nature of the risk being analysed are performed during the risk assessment phase (see Chapter 3). Risk management and risk assessment are performed within an open and transparent environment involving extensive communication and dialogue, in which a variety of interested parties may participate at appropriate points. The risk analysis process often culminates with the implementation of risk-reducing measures and continuous monitoring of their effectiveness by government, the private sector and other stakeholders. (p. 7)
Although figures depicting risk management (see Figure 2.1) and risk assessment (see Figure 3.1) may suggest a linear process that moves from one step to the next in a sequence, in reality risk analysis is highly iterative and ongoing, with many feedback loops and steps that are repeated as needed, or as better information is developed. A unifying overall characteristic is repeated interaction between and among risk managers, risk assessors and other participants. Risk analysis also does not end once a decision is reached and implemented. Members of the risk analysis team and others (e.g. industry) regularly monitor the success and impact of their decision, and may make modifications to control measures that have been implemented if that is indicated from new information being incorporated in the risk analysis. (p. 8)
Risk analysis is also a systematic discipline that fosters broad perspectives (such as “production to consumption” approaches), wide-ranging collection of data (for instance, on risks and on risk management options), and comprehensive analysis of alternatives. It is based on a philosophy of transparent, fully documented decision-making and open processes in which participation by all parties affected by the risk or by measures to manage it is solicited. (pp. 8-9)
During this “preliminary” phase, good risk communication is important. Communication with external interested parties often is needed to fully identify the food safety issue, obtain sufficient scientific information for risk profiling, and formulate questions to be answered by the risk assessment. Internal communication between risk managers and risk assessors is vital for many reasons, such as to ensure that the scope of the risk assessment is reasonable and achievable, and that the results are presented in a readily understandable form. The second phase of the RMF consists of identifying and evaluating a variety of possible options for managing (e.g. controlling, preventing, reducing, eliminating or in some other manner mitigating) the risk. As before, effective communication is a prerequisite for success, as information from and opinions of affected stakeholders, particularly industry and consumers, are valuable inputs to the decision-making process. (p.14) |
| Benzad hareyazie of Iran, please share references on the unintended effects of traditional breeding esp. mutation breeding. I don't think we have those in our collection |
In 3.2 (c), there are several point should be given priority.
1. How to assess the risk of non-intensive and minor escape of LMO, in comparison to intensive and cultivated crop?
2. How to differentiate to assess the risk between open field for commercial use and isolated field for experimental use?
3. How to assess the phenotype/trait of stress environment tolerant events under different stress condition? |
| I wish to raise the question of excemption. When and how we are going to excempt the LMOs (or at least traits/genes) that do not have advers effect on biological diversity taking into account human health? If RA is conducted and the LMO is produced for 15 years and no verifiable advers effect is reported in any place in the world, do we still need to conduct RA? I do not mean to cancell RA at all, What I mean is those questions that have already been answered should be excempted sometimes. |
I agree with Behzad and Paul, however, many (or some) consumers needs RA on LMOs, that is in novel breeding.
So, I think, we need to conduct RA and continue to make efforts about risk communication too. |
| L. Bereano has provided some useful material that summarises the issues very well. Yes, communication is extremely important at all stages of a risk assessment. And as part of this we need to make sure that we are upfront about communicating uncertainties. The iterative nature of risk analysis is important also as we need to be aware that by mitigating risks in one area we may increase risks in another. There will need to be value judgements made as to weights given to different risks (on the environment or human health for eaxmple).
And in response to Behzad, I repeat my earlier comment that environmental effects will differ between environments. |
| The problem for us to implement the currently suggested risk management is the area. Most of growers in Indonesia is small holders farmers. More than that the socio cultural conditions may also need to be considered during RA |
Dear Participants, I thank you all for your participation and interesting interventions that we had so far.
shall we now break for 20 minutes instead of the 40 that was suggested earlier?
We shall continue our discussion on the next substantive issue on the agenda (Item 3.3) as soon as we return from the break. |
| I also agree with Kazuyuki and Janet's comment. Risk communication is very important point. We have very limited information on LMO to the citizens in Japan. |
| Discussion is very useful.
But, Sorry, I would like to have 40 min break. |
| Vilasini, I agree with you, if someone need more break it is also OK! |
| What about 30 minutes?. See you all after lunch |
| I understood the break was to start in 10 minutes and last for 40 minutes - I will be return in 40 minutes from now (dinner for me) |
| Dear Flerida; These are only a few that I could trace right now. Please contact me for more infor at: [email protected]
Batista et al., PNAS 105:9, 2008.
Baudo et al, 2006, plant biotechnology journal 4, pp 369-380.
and
http://www.botanischergarten.ch/Organic/Baudo-Impact-2006.pdf |
| Ok then we shall break for 40 mins. We shall reconvene at 05:25 UTC/GMT |
| Dear all, welcome back. I would like to invite the Chair to re-start the meeting. |
Distinguished Participants,
Welcome back to our conference. I hope you had time to rest a bit and, without further ado, we shall move on and start our discussion on the third and last substantive issue on the agenda:
ITEM 3.3. Defining an action plan for the development of guidance materials on specific prioritized aspects as well as the “roadmap”.
The AHTEG shall define an action plan to produce, prior to the second meeting of the Group, modalities for the development of guidance documents on the specific aspects that were identified as priorities and for testing of the roadmap. This action plan should include the details of a process for monitoring and reviewing the progress made on each of the specific aspects.
You are invited to provide recommendations to the AHTEG on the action plan for the development of guidance materials and the roadmap. Furthermore, you may also wish to identify the experts you deem necessary for the development of guidance materials and the roadmap. |
To guide our discussions on this item, I would like to propose that we focus the interventions on the Chair’s first guiding question under item 3.3.:
(a) Do you have any suggestion to the AHTEG on how to define its action plan for the development of guidance materials and the roadmap?
Please note, participants, that this question is more on how you think the AHTEG should go about performing its tasks. Thank you
The floor is open for your interventions. |
| Hello, Sorry I missed the morning sesion. Looking forward to joining the exciting discussions.
My starting comments on guidance material is that all should include the context of the recieving environment. I am sad to say there is very little information or data on eg tropical recieving environments and so some regional focus could be good for the AHTEG . |
| Welcome Yasmin. Thank you for joining us |
| Mr. Chairman, may I reply to one of the questions raised by participants in the previous session? I do understand and appreciate the point Janet is repeatedly reiterating that environmental effects will differ between environments. But what about human health? When we rae conducting risk assessment, when we are refering to consumers needs (Kazuyuki), or communicating with the public most of the questions go for the effect of certain genes/traits (such as Bt) on human health (including carcinogenicity, allergenicity, toxicity etc.). My point is when are we going to exempt at least these aspects of RA of certain traits/genes THAT DO NOT HAVE ADVERSE EFFECT? Risk communication is some thing different. We can communicate wit the public and stake holders the risk assessment data that we already have for these traits/genes that is enormous. |
| Sorry that I interapt you, Behzad. In 3.3 (a), since Cartagena Protocol deal with environment and biodiversity, and including non-safety issues, not only international harmonization but also regional aspects are needed, as we discussed in the precious sessions especially in prioritization. For this reason, Plan-Do-Check-Action should be considered as action plan with sharing information and in each local case. |
| Can you please elaborate a bit more on your comment please Yasuhiro. Thank you |
| I'm not sure what is meant in the question by "modalities for the development of guidance documents"?
Interesting point Behzad - yes, the issue is how to communicate this information in a way that it is believed/accepted/trusted |
| What we are refereing to here is how should the AGTEG proceed to develop the guidance documents. The process that they should follow in your opnion. |
| Okay - guidance documents
Probably the only practical way is to collate what is known and currently available and to seek consensus (or is that too optimistic!!). SOmeone needs to take a lead and start the process. |
| I would like to propose that for each guidance document an expert consultation followed by the physical AHTEG meeting is required. The outcome then would be provided to the COP-MOP 5 and 6. I do understand that we need money for that. |
| Thank you Vilasini. If I can elaborate the PDCA cyclem in the meeting, I think that Plan is to decide concept, Do is to build up the draft and Check is to discuss and revise plan, and Action is to publish the document. Usually PDCA cycle use with practical situation, there for it will be a bit difficult to conduct. |
| Thank you for the clarification Yasuhiro |
| Are there any more suggestions on how the AHTEG should proceed with their tasks |
| In addition, I think another action is to bring back to each country and to do the next PDCA for the RA and RM. |
| There are so many variations in receiving environments that it would be almost impossible to have a one-size-fits-all type of a guidance document. Harmonization would be nice, but some data are simply not portable. The environmental data would most probably fall in this category. Environmental conditions over time and space are difficult to replicate even within a country.
maybe we should work on having a consensus on what data are portable. Then, the national risk assessors would be able to concentrate their efforts on gathering and evaluating information on non-portable data (like environment-GM interactions, specific vulnerabilities, limitations of the receiving environments, etc.). |
What the most important is, I think, the feasibility.
In order to develop fruitful guidance materials or roadmap,
if appropriate, actual risk assessors or RA conductors should take part in this process.
They and risk managers (in most case, administrators) should exchange opinions. |
| Dear Participants, for clarification, the AHTEG will meet in April 2009 and again in 2010. During this one year between meetings, the AHTEG will have to address the issues that were set up by the COP-MOP (Governing Body of the Cartagena Protocol) during their last meeting. This conference offers the opportunity to give recommendations to the AHTEG as "how" they should proceeed between the 2 meetings. |
| I agree with Kazuyuki's opinion. I think that the persons with different section or view points will be needed in order to have success the feasibility. |
| hank you Miranda for clarification. Then, I would recommend again having an expert consultation meeting specifically for preparation of a guidance document to be used as a draft by AHTEG. |
| Any more suggestions on how the AHTEG should go about performing their tasks? |
| Yes expert consultation meetings should be conductied and perhaps there could be a gudnace on the constituens of the pre meetings. |
| Do you want to clarify what the constituents of the pre meetings are, please Yasmin |
| To me this recent discussion highlights my ignorance on the process - rather than taking up time here, is there some documentaiton yuo could direct me to so that I could get some more history |
| How about anothere (or more) on-line conference(s), much like what was done last november? Then th draft can be prepared, reviewed and evaluated with more time for consultation with other risk assessors in our own countries. then inputs can be submitted, incorporated and reviewed again. If we cannot resolve certain issues, teh expert consultation at least would have fewer points to discuss. |
| Yes that is one way to go . Thank you Flerida |
| sounds good to me Flerida - I thinwe need to be more specific than we have been so far this evening/monrning |
| Yes Janet. The AHTEG will definetly appreciate specific action plans. Thank you |
| Though there is no doubt about that the real time meeting is useful, but for preparation of a real gudance document, people need to spend more time (say 3 full days (and nights) rather than just sharing information and exchanging ideas and interacting with each others. this is a raection to comment on on-line real time conference. |
| Budget from sCBD are only sufficient for 2 AHTEG meetings and that is also the mandate give COP/MOP. Are there any more suggestions on what the action plan for the AHTEG should be like before we move on? |
Thank you Miranda for clarification.
And I would like to know what outputs are expected in the 1st AHTEG.
Any spesific draft guidance docs is prepared in the 1st AHTEG ?
And I agree with Behzad, some documents help to facilitate discussion on topics, not only exchanging information. |
| maybe we can put up on line (via BCH?) some more documents we have on specific receiving environments so that we at least have some baseline data on biota, land use, climate, etc. for various receiving environments.
Also, we can request the secretariat to prepare a draft document on risk assessment (or adopt an existing one, just for discussion - Australia's might be a good starting point, should Australia agree) then make specific comments on each section (adopt, modify, add more, delete) - Might be better than crafting a new document from scratch. |
| I understand your reaction Behzad, but if we are serious about developing a guidance document this is what has to be done.
I am involved with standards development and it requires considerable time commitment - if peopole put their name formward to be involved they need to be prepared for that commitment |
| I have no idea how many expert will attend the AHTEG Meeting in April. The needs for the expert consulting meeting prior to the AHTEG Meeting is depending on that. |
| idea of a draft document is greta and I would support starting with the OGTR (Australian) document |
| Adding to Flerida's suggestion, there is also a published material by Michigan State University on risk assessment of agricultural biotechnology. |
| With limited funds, better I think to start with on-line meetings, then thresh out contentious issues only during a face-to face- AHTEG. Other docs can also be inputted into teh Aus document |
Dear Kazuyuki,
With regard to your first question, you may find the terms of reference defined by the COP-MOP at http://bch.cbd.int/protocol/decisions/decision.shtml?decisionID=11690
Concerning your second question, and according to the terms of reference, during the first meeting the AHTEG will define an action plan to develop the specific guidelines.
Dear Yasuhiro,
the AHTEG will be composed by 15 experts from Parties to the Protocol and a similar number of observers. |
| Thank you, Manoela for the clarification on the queries. |
| Are there any more suggestions to be added on please? |
| No, Vila. Thank you for facilitating this real time conference. Pisey |
| Thank you Miranda for clarification.
No, chiar, thanks. |
Thank you for all the interventions.
I would like to proceed to the second and last guiding question under the Item 3.3.:
(b) Would you be available, and on which topic, to offer assistance to the AHTEG in case it decides to establish working groups for the development of guidance materials and the roadmap?
I will now open the floor for your reactions. |
What I can help or contribute is as follows. In case that I need to specify more, please let me know.
(d) Pharmaplants: weediness, plant physiology and metabolism.
(e) Stacked genes and traits: plant physiology and metabolism
(f) Monitoring and long-term effects: based on the information of soybean, canola and maize in Japan
(g) Specific receiving environments: based on the discussion in domestic meeting on Cartagena protocol in Japan |
| Thank you, Yasuhiro for your generous offer. |
| Yes I will, particularly on issues related with resistance management and non-target impacts (diversity) |
| I will be available for risk assessment and risk management of transgeic fish and staked traits as well as the effect of LMOs on non target organisms. |
| Thank you, Andi and Behzad for your help to help on specific issues. |
| Happy to help at a higher level in terms of best practice risk analysis (all aspects)
Can also provide access to peer review in some areas that we have experience in (noting at we are still working at the containment level) |
| Yes, on toxicological risk assessment, molecular data analysis, metabolism, insecticide mode of action and resistance mechanisms. We've had experience on RA of GM maize on a limited release and commercial level, contained trials for maize, papaya, eggplant. |
I am interested in topic (e) RA & RM of LMOs with stacked genes and traits and (f) Post-release monitoring and long-term effects of LMOs released into the environment.
As I deal with RM of LMOs, I will be available for monitoring.
I would be happy if I can help. |
| The Plant Science Industry would also be interested to offer/share knowledge or expertise. Please let us know. |
| Can you please be a bit more specific on the help that the plant svcience industry can help with |
| my areas of expertise, that I would be happy to offer, concern risk management, comparison of alternatives, risk communication, etc. |
| Yes, we are happy to share some of experiences in developing RA and RM guideline in general despite we have no expenrices in conducting a real risk assessment of a particular LMO because the government has not approved any yet to release into the environment. Pisey |
| Thank you all for the very generous offers to help out. Are there any more? If not we shall proceed |
In the interest of time and keeping the work programme that we agreed at the beginning of the conference, I will now close the discussion on item 3.
Thank you all for your interventions. |
| Thank you for letting me share in the discussion on risk assessment and risk management. It is heartening to see that all countries are pondering the same questions with regard to evaluating effects of transgenics in the environment. We have been examining stacked traits for some time now with combined Bt pest resistance genes. Determining an interaction is a difficult issue.
I am especially excited to see that parties are considering the risks of cultivating LMOs in comparison to traditional agriculture and taking into account the costs of not adopting the technology. We have seen great benefits to biodiversity in agriculture and less pressure on the remaining environment with widescale growth of LMOs. There has been improved pest control with fewer pesticides and better weed control without tillage and soil erosion. The use of documents on risk assessment by international fora like OECD and individual countries like Australia, Canada and the US are helpful starting points. It is important to take advantage of existing work and not reinvent the wheel.
I am sure the US will be happy to provide expertise on RA & RM that we have done for LMOs approved for use in the US. |
| Environmental/food safety RA and RM, IRM, stacked/combined genes, detection methods, etc. |
| Thank you, Sonny for that. |
| I would just like to suggest another form of assistance that may be useful for AHTEG. To develop harmonized guidance documents and a roadmap, we also need to understand better the current status in each country. To this end Janet Gough and I have set up a simple summary table to allow a ready comparison between countries of the legislative requirements, risk assessment/management methodology and risk communication strategies for GMO releases into the environment (just New Zealand and Australia at the moment), if any one is interested in seeing it. This could be added to by other countries willing to contribute (offline). |
| I would like to thank you Mr. Chairman for your wounderful leadership in this conference and thank all the participants for their interesting and useful inputs. |
We will now move to
ITEM 4. OTHER MATTERS
I will open the floor for approximately 5 minute 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 |
| Yes, I agree with Paul regarding harmonization of the RA and RM guideline. Pisey |
| Dear Paul, thanks for mentioning it. If you could send us the summary table it will be sent to the AHTEG together with the other recommendations. |
For the other matters, if I can change the topics a little bit. Since Japan has small mosaic farmer's field. Therefore we have larger risk than the large field like in the continent.
Therefore, the other point will be “Coexistence” with non-LM crop. It does not directly affect on the biodiversity and human health. But citizens are keen to know what may happen especially cross contamination in view point of quality. |
| As a non-State, an Observer, I want to thank you all and the Secretariat for the privilege of participating in this process as colleagues. |
Thank you all. 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. |
| I second Mr. Yasuhiro Yogo's comment. Small scale and mosaic farm is also the characteristic of Indonesia. Therefero coexistence is very urgent issue. Biodiversity however, should be included, since it is part of the mosaic landscape |
I appreciate you, Vilasini, for your leadership.
And thanks to all, thanks to the Secretariat by past midnight in Montreal. |
| We also have the mosaic type of cultivation. Small farm holdings in the country are approx. 3 hectares only. we would be happy to share our experience with small holdings farmers with you. |
Dear all,
We are coming to the end of our real-time conference for Asia and to the conclusion of the first series of regional real-time online conferences.
The result of this conference is an important set of recommendations that will assist the AHTEG in their deliberations. Furthermore, it also shows that innovative communication means may assist the Parties to the Protocol in carrying out more cost-effective meetings.
I thank you all for participating in this conference and for the fruitful discussions. I would like to give special thanks to Dr. Vilasini Pillai for chairing this conference in a highly skilful manner, and for the dedication with which she took up this task.
For future reference, the full transcript of this conference will be made available in this same internet address in a few hours.
Our work continues until COP-MOP5 in October 2010. Thank you all, have a good afternoon, and we are looking forward to future discussions! |
| Thank you for all, especially Vialsini and Manoela for exciting and fruitful discussion. |
| I just want to mention that industry should get involved in developing the guidance since the beginning. Similar to the comment made by Yasuhiro: earlier I mentione to pay little bit more on specific issues related with area, since in some countries farmers have only a small land next to each others. Thanks |
| Thank you so much for allowing us to participate |
| Thank you M. Chair and thank you to all other participants for your patience and forebearance in the face of 'silly' questions |
| Thanks so much, especially to the chairman, for the leadership and to all for a very important conference. Till next ime. |
| thank you, secretariat, for staying up late. Thank you also, Vilai. And to everyone here, many thanks. |
| Thank you Mr. Chairperson and all participants for fruitful conference. |
| Thanks to CBD for the apportunity. i will support future on line and in person consultative efforts. Thank you Vila and nice meeting you all. |
I take this opportunity now to thank all the participants, observers and non- parties who have joined us today and participated actively with constructive comments and suggestions on this last Regional real-time online conference on risk assessment and management. I would also like to thank our colleagues in the Secretariat for their tireless efforts and extremely valuable assistance in making this Conference possible and a great success.
With that, I now declare the First Regional Real-time Online Conference on Risk Assessment and Risk Management: Asia, closed.
Thank you. |
| Thank you for bringing this innovative way of communicating to us. I appreciate the inclusion in the conference - very new to me but very informative. Thanks again. |
List of Participants
| Chair Person |
# |
|
Vilasini Pillai
Ministry of Science, Technology and Innovation - Chair real-time conference Asia
|
68 |
| Party |
# |
|
Pisey Oum
Cambodia
|
11 |
|
Andi Trisyono
Indonesia
|
8 |
|
Damayanti Buchori
Indonesia
|
2 |
|
Behzad Ghareyazie
Iran (Islamic Republic of)
|
19 |
|
Kazuki Harada
Japan
|
- |
|
Kazuyuki SUWABE
Japan
|
10 |
|
Yasuhiro Yogo
Japan
|
23 |
|
Flerida Cariño
Philippines
|
13 |
| Non-Party |
# |
|
Paul Keese
Australia
|
2 |
|
John Kough
United States of America
|
1 |
| Observers |
# |
|
Arash Shahsavarani
Fisheries and Oceans Canada
|
- |
|
Janet Gough
Environmental Risk Management Authority
|
20 |
|
Katherine Terdich
Florigene
|
- |
|
Kazuhiro Nakajima
National Research Institute of Fisheries Science, Fisheries Research Agency
|
- |
|
L. Bereano
University of Washington
|
12 |
|
Michael DeShield
Belize Agricultural Health Authority
|
1 |
|
Rofina Yasmin Othman
Ministry of Science, Technology and Innovation (MOSTI)
|
4 |
|
Sonny Tababa
CropLife Asia
|
6 |
|
Tetsuji Masaoka
Incorporated Administrative Agency, Fisheries Research Agency
|
- |
| Guests |
# |
|
Marja Ruohonen-Lehto
Finnish Environment Institute
|
- |
| Secretariat |
# |
|
Andrew Bowers
UNEP/SCBD/Biosafety
|
- |
|
Giovanni Ferraiolo
UNEP/SCBD/Biosafety
|
- |
|
Kathryn Garforth
UNEP/SCBD/Biosafety
|
- |
|
Manoela Miranda
UNEP/SCBD/Biosafety
|
7 |
|
Philippe Leblond
UNEP/SCBD/Biosafety
|
- |
|
