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Opening of the discussion on "Other Matters"
Dear participants to the Online Forum,
The discussion on “Other Matters” is now open and will run till 12 May 2014 at 1 a.m. GMT.
Similar to a face-to-face meeting, the objective of this discussion is to wrap-up the work of the Online Forum by offering participants an opportunity to raise issues or make concluding remarks relevant to the work of the Online Forum and the AHTEG.
Ms. Angela Lozan has kindly agreed to moderate this round of discussion.
posted on 2014-05-05 01:45 UTC by Ms. Manoela Miranda, UNEP/SCBD
I missed posting my thanks to Angela and the Secretariat for their intense work in the first round of discussions. Here are my general comments after reading the many submissions on the analysis of results of the testing done by parties. I will also summarize my impressions and those of my colleagues at the ICABB (Central American Initiative for Biosafety and Biotechnology).
1. The ICABB and other regional organizations (IICA, universities) have invested considerable resources in the last few years, to train regulators in biosafety, risk assessment and the implications of approving, or stalling processes for GM crops on the basis of their risk, safety and/or benefits. Risk assessment is central to this process of moving forward, or stalling into inaction. For most countries in our region, the inaction now lags for more than ten years and a black market has been created from countries where specific technologies have been tested as safe and have been approved.
2. We have conducted several risk assessment training sessions through face-to-face seminars and on-line webinars, with international experts on risk assessment (from Brazil, Argentina, Canada, the US, UK and Honduras). We also had a recent “pre-testing” webinar on how to conduct the testing, since there was widespread confusion on the task ahead. All countries in the ICABB participated, but very few did the testing or submitted their comments. We need to ask why. I did recently.
3. We had another ICABB webinar three days ago (May 2), joined by other countries in South America and found the following conclusions:
a) Parties, without a paid and dedicated taskforce find it difficult to allocate time and resources to tasks such as the testing of the guidance --they have other more pressing priorities to occupy their time. Parties with biosafety projects, such as those finaced by UNDF-GEF, engage a little more, but only as long as the project is active. There is a high turn-over of trained government personel and this creates a problem, as trained resources by projects are often lost.
b) Most regulators found the task daunting and confusing, as they find the guidance dense to read, interpret and thus analysing it for the use, practicality, etc. Their silence should not be considered as approval. It is too simplistic to extrapolate silence = approval, at least in our region.
4. My own experience with students validates the observation from ICABB countries. Students who do not understand a complex technical issue, or are afraid of giving the “wrong” answer in front of an audience, tend to stay silent not to “make a fool of themselves”. This is a very human trait. Anonymous answers are easier.
The testing of the guidance was very public exercise that intimidated many. Silence from parties needs to take this into account. I speak from experience. As a representative from a small, developing country, it took me years of attending MOPS, studying endless documents, attending training seminars, listening to countless discussions and finally understanding the intricate workings of the Secretariat, to pluck up the courage to give my opinions. I made mistakes and was chastised in public. I have the great advantage that I speak English and Spanish. Most of my colleagues, only have rudimentary or no English. The translations are often even more confusing and daunting than the original documents in English.
I will comment on the "wrap-up the work of the Online Forum by offering participants an opportunity to raise issues or make concluding remarks relevant to the work of the Online Forum and the AHTEG" as Manoela requested.
posted on 2014-05-05 04:54 UTC by Dr. Maria Mercedes Roca, CIBIOGEM, Mexico
Dear Participants to the Online Forum,
My greetings and best wishes to those colleagues who are celebrating in these days the Victory/Commemoration Day of the Second World War and the Europe Day.
I'd like to remind you that there are just few days remaining for the online session on "Other Matters" and I encourage you to share your comments, opinions and suggestions related to this topic.
posted on 2014-05-09 05:12 UTC by Angela Lozan
First I would like to thanks the Secretariat for facilitating the forum and Angela for being a moderator.
Regarding the whole process of on line forums:
- The COP-MOP decision requested to the Secretariat to: “Gather and analyse, in a transparent manner, feedback provided as a result of testing on the practicality, usefulness and utility of the Guidance…” The ´transparency´ is indeed an essential component in this process and is necessary to know the criteria in a very clear way that is being adopted to accept or reject the suggestions along the various on line forums and doc editions.
- The development of any document by Parties of Cartagena Protocol should be entirely attached to the Protocol. For example, the Decision BS-VI/12 instructed Parties to test the documents in "actual cases of risk assessment and in the context of the Cartagena Protocol on Biosafety". Therefore, it is clear that the Guidance must not go beyond the scope of the Protocol. Nonetheless, the section "Related Issues" in the Road Map is dedicated not to risk assessment itself but to "other issues that may be part of the decision-making process.”
Regarding specific points of the Guidance documents:
- The Guidance proposal is to provide information relevant for RA of ´all types of LMOs´ and in this sense there is no necessity to create specific Guidance each time a new GMO will be evaluated. The assessment method should remain the same with differences only on the required information and consequence evaluation of potential adverse effects.
- Although the RoadMap was proposed to be applied to ´all types of environmental releases of LMOs´ in the case of small scale release the RoadMap does not correctly address the information required and does not mention the controls that are important to avoid the GMO spread. In this case based on what is presented in the RoadMap it will be difficult to select which information will be essential for a RA of a small scale release.
- The Guidance does not allowed an easy selection and integration of the information listed in the "points to consider" in a logical way to make the right questions about how the assessment endpoints will respond as a result to the exposition to the LMO and to use the data presented by the applicant to answer those questions.
Ministry of Agriculture, Livestock and Food Supply / Brasil
posted on 2014-05-09 19:26 UTC by Ms. Luciana Ambrozevicius, Brazil
First I would like to thanks the Secretariat for Facilitating the forum and Angela for being the moderator.
Importantly, all efforts on the creation of a guide must be strictly correlated to the scope of the protocol, since this is the legal text that should support all decisions of the participating countries.
Clarify the criteria for selection of suggestions also seems critical, since scientific advances are present and create a text that contemplates such advances should be a challenge to the group.
Thus, reinforcing the concern of Dr. Luciana, concerning points by that Party.
posted on 2014-05-09 19:55 UTC by Mr. Gutemberg Delfino Sousa, Brazil
Thanks Angela for stepping up again to moderate the forum.
As the deliberations wrap up, it seems timely to reiterate the need to ensure that the feedback from the testing is fully captured in order to ensure the charge from the COP-MOP is respected. As Maria has noted, a considerable amount of time and effort has gone into the conduct of the testing of the guidance. In the case of Canada and I am sure many others, extensive inter-departmental effort, discussion and work took place to produce a final product. The richness of the input received should be fully considered. The Netherlands and Belgium have made very useful suggestions on how this input could be incorporated and I am sure this can only provide more credibility to the final product.
Jack has argued quite accurately that need to know and nice to know will vary depending on your perspective. For a risk assessor operating inside a national framework, this perspective is much clearer and with the restrictions of imposed time standards, expectations from stakeholders and international obligations, leisurely introspection and making unfocussed data request is certainly not possible. I have yet to be part of any risk assessment training that is conducted in a regulatory context, whether it concerns IPPC compliant pest risk assessment, Codex equivalent food safety assessments or the safety of products of biotechnology that has not stressed the need to ensure that risk assessments are proportional, necessary and stay within scope. Using the perspective of existing national frameworks as a reference, the guidance still stresses considerations that stray away from risk assessment practice as it is conducted by competent authorities, has its own confusing, potentially non-translatable terms and encourages data collection over the use of familiarity and scientific judgement. Refinement is still required to create guidance for a risk assessor that will help them to provide the necessary and sufficient science advice to a decision maker in a real world situation. For risk assessors in the developing world, Maria has made a strong case that there is still work to do to ensure that their needs are met when time and resources are limited and as she has stated, silence does not necessarily equal agreement.
I look forward to the rest of this discussion which will surely continue at the face to face meeting in Bonn.
Enjoy the weekend.
posted on 2014-05-09 22:19 UTC by Mr. Phil Macdonald, Canada
My gratitude to Angela once again for taking on this important task.
I feel confident that the testing now completed has provided the AHTEG with high quality and practical information. It has established beyond reasonable doubt that the Guidance package can, does and will serve the needs of the intended audience. It also has provided very valuable information that will be used to improve the Guidance prior to the next MOP.
The Guidance is a document written by a large group of authors influenced by many rounds of even larger numbers of reviewers and finally testers. It therefore will not be perfect to everyone. No such document is. My plea is for us to not let perfection become the problem. While I generally revile from the standard 'good enough', I think we should not forget that the Guidance is in nearly every place, as determined by the best evidence we have at our disposal, good enough<Guidance<perfect to all of us.
The Guidance is written not for one or few or even the dominant regulatory philosophy, but for the variety of regulatory frameworks that countries have. That diversity was made apparent during the years of writing the Guidance even by the limited number of representatives around the AHTEG table and participating in the forums. It is highly unlikely to be aligned to the national framework in all ways in any particular country because of the diversity of frameworks the Guidance had to cater for. To suggest that it is in some particular way unaligned to every framework will require some additional evidence to be presented to the group.
I look forward to the work of making the Guidance clearer where we can, better where this is possible, and preserving the flexibility in the document as is appropriate for the needs of many different risk assessors in different countries - a final goal that is certainly true to the Protocol.
Finally, while it is true that the Roadmap is relevant to all types of releases and all types of LMOs, it also acknowledges that it is heavily informed by examples of plant-derived LMOs. That inter alia, is why it is important to many stakeholders in this process to entertain further work on Part II.
I have benefited from the robust, frank and insightful comments I have read in these various forums over the years and I thank all the participants for that.
posted on 2014-05-09 23:02 UTC by Mr. Jack Heinemann, University of Canterbury
I join others in congratulating the Secretariat and the colleagues that have undertaken the task of guiding and moderating this complex process.
Here are some wrap-up remarks from the perspective of a regulator from a small developing country, relatively new to the AHTEG.
Honduras has taken the bold step of embracing 21st century science in the form of agricultural biotechnology (GM corn), to address some technical problems like low yields, pest control and weed management. The adoption of this technology has been beneficial and will be published shortly in project reports and peer-reviewed journals. In Honduras, we evaluated the risk and the benefits of adopting this particular GM technology, and also evaluated the risk of NOT adopting it, and maintaining the status quo. We concluded (in 2003) there were considerable risks associated with maintaining the status quo. We used a different risk assessment approach to that of the Secretariat’s guidance. We feel that following the Guidance approach, in its current state, would have led to inaction.
Our group of regulators /risk assessors is not charged with the task of addressing the ills of a globalized crowded world, loss of biodiversity because of agriculture, modern industrial agriculture, monopolies by big companies and other huge challenges associated with conventional or GM agriculture.
We have one task and one mission: we ask an evaluate if a LMO can cause harm to human health and the environment. The other harder questions are not part of risk assessment and are left to our risk managers, such as our Ministers and other decision-makers. They make that political decision and take into account socio-economic considerations. We believe that mixing the central question of risk assessment (a technical issue done by our group) with those issues of risk management (a political process done by decision makers), would greatly confuse our job and lead us to inaction and to maintaining the status quo. We see this clearly happening in other countries of the ICABB.
Having followed the many discussions, the AHTEG members seem to be divided in two broad groups (with some exceptions):
a. Those who have experience in agriculture, in the discipline of risk analysis and who work on risk assessments in their countries. These countries have typically already approved GM crops and other LMOs and draw on this experience during the risk assessment process. This group, who has used other approaches to risk assessment, finds the AHTEG’s guide deficient and asks for significant improvements.
b. Those with a background in ecology or other environmental sciences, maybe members of anti-GMO activist groups, and/or members who have a deep distrust of industrialized agriculture. This group also seems to have a deep distrust of GM technology and find the guide very useful and practical in its current state.
I make no apologies for saying I belong to the first group, since I am a plant pathologist and work in plant protection and agriculture in a developing country, with experience in testing and approving GM technology (corn so far). The risks of any technology need to be assessed against the benefits, or the risk of inaction. All technologies have benefits and risks.
If I put myself in the shoes of the second group, I would candidly say, I would also find the Guide useful and practical for a risk assessment process that will delay an approval process, even with technologies widely tested and approved as safe in many countries in the world. There is ample and growing evidence showing this.
I recognize that as humans, it is very difficult to be totally objective and unbiased. This is where the Secretariat, the moderators and those who analyze survey results, play a crucial role. Ideally, moderators and analysts of the testing results of the guidance should not belong to either groups a) or b). They need to be totally transparent, objective and not lean towards one group or the other. They have the duty to represent all opinions fairly and objectively. I recognize this is a tall order for anyone, because we are all human and find it difficult to escape our particular biases.
I also recognize that the complex discussion continues. There is a lot at stake in our discussions.
I wish you all a pleasant weekend and look forward to reading your opinions and learning from you.
posted on 2014-05-10 05:28 UTC by Dr. Maria Mercedes Roca, CIBIOGEM, Mexico
thank you Maria, Luciana, Gutemberg, Phil and Jack for your interesting and useful comments to the forum.
Looking forward for continuation of the discussion and other suggestions for "other matters".
Have a nice weekend!
posted on 2014-05-10 05:45 UTC by Angela Lozan
Dear Angela, my gratitude to you that once again accept to take this important task. Thanks also to the Secretariat that has been giving the support to all this work and discussion.
As indicated since the beginning, the objective of this discussion is to wrap-up the work and to raise issues or make concluding remarks.
So, reviewing the previous interventions I´ve made, I would like to emphasize the need for ´transparency´ in the process of finalizing the documents discussed till now and to clearly indicate, in the documents, the criteria used throughout the process of the Open Ended discussions that lead to the final document to be sent for COP-MOP discussion. More specifically, the criteria to accept or reject the suggestions along the various fora, in order to garantee that the feedback from the testing is fully captured.
The Guidance has to allow easy selection and or integration of the information in a logical way; in this sense, the document need to be improved and this could be the most difficult task for the AHTEG and the Secretariat in the next meetings. Luciana, Phil and Jack presented some of the key topics already so I just join my voice to their suggestions.
I also would like to support the intervention presented by Maria Mercedes, since I do believe that “mixing the central question of risk assessment (a technical issue) with those issues of risk management (a political process done by decision makers), would greatly confuse the analysis and lead to inaction and to maintaining the status quo that proved not to be the best.
Finally I thank all the participants for the frank and insightful comments that were posted in the various for a till now, I also have benefited from them.
Regards and a nice wekend for you all!
posted on 2014-05-10 11:40 UTC by Dr. Deise Maria Fontana Capalbo, Brazil
First I would like to thanks the Secretariat for support this forum and Angela for take the task of moderate.
I really concur with the frank and insightfully intervencions of the participants so far. But I would like to hear the voices of the Parties, non Parties and Organizations that had expressed their agreements with this version of the Guidance.
I wonder, if they have experience on risk assessment, what are their opinions about the comments and sugestions done for others?, and, if they aren´t so familiar with risk assessment, what kind of doubt or reflexions they have in regard of the different point of view?.
I believe that these kind of intervencion in this on line forum could be beneficial for the AHTEG work in Bonn, and also a good feedback for effort done by the Secretariat during this period of debate before de MOP-COP.
Thanks and good weekend.
(edited on 2014-05-10 19:01 UTC by Patricia Gadaleta)
posted on 2014-05-10 18:52 UTC by Dr. Patricia Gadaleta, Argentina
As this final online discussion on "other topics" draws to a close, let me briefly thank all for sharing their thoughts. I find that the comments of Maria Mercedes Roca (comment #5987), Luciana Ambrozevicius (comment #5982), and Deise Capalbo (comment #5989) have captured very well my perceptions and concerns about the work done to date and the work that lies ahead for the members of the AHTEG and the Secretariat to prepare the report for the Parties.
The points in their comments that have resonated most strongly with me are the following:
1. The scope of the Guidance is supposed to be in the context of the Cartagena Protocol on Biosafety, as Luciana has summarized so eloquently in her comment. It seems out of place to me when Jack Heinemann makes the contrary statement that the Guidance is "for the variety of regulatory frameworks that countries have" (comment #5986).
2. The Guidance focuses almost exclusively on risk assessments for unconfined environmental releases, with virtually no practical information on guiding someone doing a risk assessment prior to a confined releases of LMOs. Worldwide, people have done risk assessments for tens of thoushands of confined environmental releases of LM plants over the past 27 years, yet this extensive experience is not described in the Guidance.
3. I agree totally with the comment from Deise for "the need for ´transparency´ in the process of finalizing the documents discussed till now and to clearly indicate, in the documents, the criteria used throughout the process of the Open Ended discussions that lead to the final document to be sent for COP-MOP discussion. More specifically, the criteria to accept or reject the suggestions along the various fora, in order to garantee that the feedback from the testing is fully captured."
I look forward to seeing the final products of the AHTEG and Secretariat, and I wish them success in the work that lies ahead.
posted on 2014-05-11 20:29 UTC by David Heron, United States of America
A number of constructive proposals have been made during the last round of discussion, and good practical approach has been made on how to trying to capture the valuable proposals made by testers (Parties, Other Governments and Organizations). Now it is very important that the well-defined and transparent mechanisms of the information (proposals) inclusion into the Guidance will be established. Realizing that the AHTEG meeting would be very soon, I call on to think about that and try to work out them. I was reading this week-end the testers`proposals and agree with Dr. Jack Heinemann that the information received from testing is high quality and in many cases is very practical. Also I am aware that the Guidance is the result of work of large group of people and many rounds of discussions on different levels and it is rather difficult to do the agreeable. But nevertheless, I consider (as a newel risk assessor, but first of all, as a researcher) that it contains all that is needed for risk assessment process. I feel that stages of the risk assessment, points to consider is well described and the authors of the Guidance tried to capture all the relevant to the risk assessment process considerations. Yes I feel that some of them could be placed to the other more appropriate parts of the Guidance, and that in the text of the Guidance must be accompanied by the explicit references from real cases of risk assessments and more clear explanations of the "points to consider", that is needed for better integration into the overall risk assessment framework and avoidance of ambiguity , but it is not a reason to accuse of that the Guidance is prescribing. I hope to see you soon during face to face meeting and strongly hope for its efficiency.
With best wishes, Galina.
(edited on 2014-05-11 20:45 UTC by Galina Mozgova)
posted on 2014-05-11 20:42 UTC by Dr. Galina Mozgova, Belarus
I would like to take this closing opportunity to say thank you to you all for this challenging, but enriching experience. By participating in the AHTEG for over a year and a half, I have grown enormously in my understanding of technical issues of GMOs, risk analysis and international UN conventions.
But most importantly, I have learned much about negotiation, compromise, respecting others views even if you don´t agree, politics and transparency, “the number’s game” (when the majority wins) and above all, diplomacy in the face of frustration.
Even though my father was a diplomat, I still need to learn much more form him about diplomacy, and I humbly and publicly apologize for often being outspoken on delicate matters.
I will not be able to participate on the face-to-face meeting in Germany so I wish you all a very successful meeting in June. I will also share a summary of my last view in my next posting.
Best regards to all,
posted on 2014-05-11 22:29 UTC by Dr. Maria Mercedes Roca, CIBIOGEM, Mexico
Here is my candid bird´s eye´s view on the dynamics and the process to develop the AHTEG’s Risk Assessment Guide :
1. Until I took a two week course in Risk Analysis at Texas A & M (2009), took risk assessments seminars and exercises and got really actively involved in the AHTEG, I was not aware there is more than one approach for risk assessment. After studying the discipline of risk assessment, as a component of risk analysis, I know of at least 5 different approaches to risk assessment for GMOs. I have made a comparative study of the strengths and weaknesses of these approaches, to come to my conclusions, especially for the testing of the Guidance.
2. Most regulators, especially in developing countries, don’t know there is more than one approach to risk assessment for LMOs, other than the AHTEG Guidance. I consider this knowledge incomplete, which could lead to harmful and misguided policies. Most at risk from formulating bad policies are developing countries, as they don’t have experienced personnel and in sufficient numbers.
3. Most inexperienced regulators, have only been exposed to the AHTEG Guidance and have little to draw on, for knowing if the Guidance developed by the AHTEG is useful and practical or not. This may be the reason so few parties tested the guidance. It was a hard and intimidating exercise for many. It is difficult to “test” something without a comparison and without expert technical knowledge of what you are testing.
4. Regarding the analysis of the results, I would propose to define “useful and practical”, depending on what you need to use the guidance for. Regulators may find themselves in one of the two groups mentioned in my earlier message with different missions or agendas:
a). Regulators with an agricultural mission, with a food security agenda and charged with overcoming technical challenges such as drought, pest and weed management and increase yields. They will find the Guidance not useful and not practical, as it unnecessarily obstructs the adoption process for a GM crop or other LMOs that can offer potential benefits. These regulators are more open to work with industry or universities, if they perceive industry or academia has useful products or processes to solve problems. They are the minority in biosafety committees and in this AHTEG.
b. Regulators with an environmental mission, with a conservation agenda to “protect” their country from the harm of intensive agriculture and corporate business. They will find the Guidance very useful, as it promotes and justifies inaction and non-adoption of GMOs. These regulators may deeply distrust GM technology as “non-natural”, especially if they follow the Precautionary Principle and have a marked corporatist dislike (maybe justified in some cases). They are the majority in biosafety committees and in this AHTEG.
5. Majorities rule, and when it comes to voting, it is a “number’s game”. It is the human condition: those who are more and speak louder, normally win. More votes however, do not necessarily mean better judgment. And keeping silent does not mean agreeing.
6. Biosafety committees, especially in developing countries that have funding and follow guidelines from the Convention of Biological Diversity (mainly through UNDP-GEF projects) are mainly run from Ministries of Environment and have a conservation agenda. They tend to belong to group (b) and tend to be more numerous in inter-institutional committees, and thus are more dominant than group a). My sense is that that prominent members of these biosafety Committees would prefer to block adoption of GM crops. The Guidance provides the justification they need.
7. It may be of interest to analyze where regulators have been trained. It is my understanding that many go to Genok in Norway for their training, or receive training from instructors with anti-GMO biases. On the other hand, regulators in group a) have been trained mainly by instructors with experience in agriculture and risk assessment, in countries which have already adopted GMOs with good experiences.
8. For Latin America, the prominent countries (Brazil, Argentina, Mexico and Colombia) provide guidance for many technical issues in many fields for the smaller countries (Caribbean, Central America and Andean regions). Canada and the US are also Pan-American countries, so we collaborate closely with them.
9. With reference to point 2, 3 and 8, a group of Latin American regulators, biotechnologists and risk analysts developed an Environmetal Risk Assessement Guide for Genetically Modified Organisms. Part I of the Guide has the conceptual basis for risk assessment and Part II, actual examples (5) or case studies from Latin America (Brazil, Argentina, Colombia and Mexico).
The first edition in Spanish was published in 2012. A second revised and improved edition will be published in 2014, together with an English translation of the improved second edition. The Guide includes a much needed glossary of terms and concepts in both English and Spanish, developed by bilingual risk analysists. Many members of this AHTEG – mainly belonging to group a) have generously contributed their time and knowledge to the LA (Latin America) guide.
I would respectfully ask the Secretariat if there is scope to publish this additional resource for risk assessment of LMOs in the BCH. Although the LA Guide was developed with a Latin American audience in mind, it is useful for any regulator from any region, once the English edition is available.
The main difference between the LA ERA Guide and the AHTEG Guidance can be summarized as follows:
• The LA Guide is less prescriptive and describes the process of assessing risk, in what we believe is a more logical fashion.
• There is more emphasis on the LA Guide on how to go through the steps and complete an assessment, focusing on what is needed. By contrast, the AHTEG Guidance lists all possible hazards, ways of exposure and several other issues, leaving risk assessors at a loss on what to do and feeling the process is very complicated.
• The AHTEG guidance lists the steps of the ERA, but does not show how to link them. The LA Guide explains this better.
• The LA Guide starts from a neutral point from which a finding can go either way. By contrast, the AHTEG Guidance starts with the implied premise that there is a hazard there that must be found, and if it cannot be found, a process of monitoring must continue.
I thank you again for your patience and open mind, in allowing a regulator from a small developing country to share views with the group.
Again, I wish you a very productive meeting in Bonn.
(edited on 2014-05-11 23:18 UTC by Maria Mercedes Roca)
posted on 2014-05-11 23:15 UTC by Dr. Maria Mercedes Roca, CIBIOGEM, Mexico