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Opening of the discussion on the 2nd draft of the guidance on "Monitoring of LMOs Released into the Environment"
[#2801]
Dear participants to the Open-ended Online Forum and AHTEG, I am pleased to inform that the online discussion on the second draft of the guidance on "Monitoring of LMOs Released into the Environment" is now open at http://bch.cbd.int/onlineconferences/discussiongroups_ra.shtml#topic1 . Your feedback on ways to improve this draft guidance document is very welcome and may include your views on, for instance: a) Whether all issues relevant to this topic have been included in this draft and, if not, which ones should be added; b) Suggestions for improvements to the current text and/or structure; c) Suggestions for background documents to be included (please provide the full reference and indicate to which section(s) of the guidance the background material is relevant). As per the AHTEG Action Plan, this round of discussion should focus on concrete text proposals. It is appreciated if your suggestions could be made directly to the text of the draft guidance (attached) in "track changes" mode. This discussion will close on 19 November 2011 at 1:00am GMT. Please do not hesitate to contact me ( manoela.miranda@cbd.int) if you have any question or encounter problems when posting comments. Best regards, Manoela
(edited on 2011-11-04 18:40 UTC by Manoela Miranda)
posted on 2011-11-04 18:39 UTC by Ms. Manoela Miranda, UNEP/SCBD
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RE: Opening of the discussion on the 2nd draft of the guidance on "Monitoring of LMOs Released into the Environment"
[#2803]
POSTED ON BEHALF OF HIROSHI YUSHIKURA
----
Dear Manoela,
The following is my comments to the second circular of “Monitoring of LMOs Released into the Environment”. As usual, I should be very grateful to you if you post for me to the open-ended Group web site. It is always difficult for me to post it from my office. My comments are as follows;
1. During the risk assessment, we regularly monitor the consequence of introduction of LMOs into an environment. Through such risk assessment, we identify items that need to be monitored during risk management to verify whether the consequence of the use of the LMO is as intended or not. In codex alimentarius, the (post-market) monitoring is included in risk management measures (See Principles for the Risk Analysis of Foods Derived from Modern Biotechnology, paragraph 19).
2. The monitoring conducted during the risk assessment is done before the completion of the risk assessment. Therefore, it has to be more comprehensive and exhaustive as the present text wants to implement. However, the monitoring performed during the risk management after approval of environmental release will be focused to the items that were identified through the risk assessment. Repeating the same monitoring already done during the risk assessment in a larger scale in the risk management level is not desirable. The monitoring strategies are to be decided based on the risk assessment at the decision-making (See Annex 1).
3. Monitoring for risk assessment and that for risk management are entirely different processes. The former is done during the small-scale experimental release and scale-up processes to determine the effects of LMO in the environment. The latter is done in principle after approval of environmental release of an LMO to check if an LMO is used as expected from conclusions obtained during the risk assessment. From the chart in Annex 1, I understand that this monitoring document deals with the latter. Therefore, the present document should consistently deal with “monitoring as risk management” and not “monitoring as risk assessment”. If a guidance of monitoring for risk assessment is necessary (in principle it should be given by the risk assessment text), it should be developed separately.
4. As the present draft is quite ambiguous as to whether this guideline applies to the risk assessment, risk management or the both, the draft text needs extensive redrafting. I note that the provisions given to (1) identification and prioritization goals, potential adverse effects and the choice of indicators/parameters, (2) identification and description of appropriate monitoring methods and establishment of baselines, (3) determination of duration and scale of the monitoring activities, and (4) determination of monitoring sites and regions, as described in the proposed draft, are mostly belong to risk assessment.
5. More comments are given directly to the draft text in the attached file.
Sincerely yours, Hiroshi
posted on 2011-11-04 19:02 UTC by Ms. Manoela Miranda, UNEP/SCBD
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RE: Opening of the discussion on the 2nd draft of the guidance on "Monitoring of LMOs Released into the Environment"
[#2807]
Firstly, I would like to thank for the effort of this exercise to provide guidance for risk assessment and management. This post release environmental monitoring guidance draft is still very confusing and while certain points are very repetitive other relevant ones are missing. Monitoring according to the Cartagena Protocol and the Convention of Biological Diversity (CBD) is an option to be considered on a case by case basis, i.e. depending on the level of uncertainty on the specific issues of concern, not always, and as far as possible and as appropriate (please also read article 7 of the CBD, http://www.cbd.int/convention/articles/?a=cbd-07 important details are missing on lines 40-43 of this guidance when refering to this article). There are very important reasons to consider monitoring only when useful and appropriate as suggested in the CPB and CBD. While the draft guidance repetitively enphasises on the importance of monitoring. It lacks considerations on limitations and drawbacks when not appropriately used. Monitoring of "unexpected and incongruous risks" as opposed to risk hypothesis/ problem formulation based, not only will be expensive, but in addition, lacking reasonable considerations such as the focus of testing hypothesis it is likely to mean gathering information that is difficult to scientifically establish cause and effect (causation) and to reach reliable conclusions. If unnecessary monitoring is carried on, it can postpone the introduction of technologies that can reduce the environmental impact of for instance agriculture (just to cite one of many examples). Besides it can prevent the development of the public sector's products and others because the costs for monitoring can make projects financially unviable. Before going to a complex monitoring program one should ask some basic questions to see if it is a useful approach, such as: a)Does it make sense when a LMO is identified as unlikely to cause an adverse effect to the environmnet (those that e.g. experience has shown that the impact is similar to conventional methods, do not proliferate beyond the field of cultivation…)? b)Does it make sense when the level of risk and uncertainty can be significantly reduced by management practices? c) Does it allow any scientifically tenable conclusions to be drawn/or trigger futher experimentation considering the inherant natural fluctuations and the comparative non-LMO alternative? d) Is monitoring in the specific case in question, the best option to protect from significant adverse impacts on the conservation and sustainable use of biological diversity or is it more effective to invest otherwise on something else such as protection areas? Etc. If the need and usefulness of monitoring is recognized, under the CPB and the CBD the points to be systematically followed should focus on uncertainties related to the specific risks and protective goals identified. If to consider a list of examples of monitoring subjects indicators (annex II of this monitoring guidance) in order to prevent from unwanted confusion, those should be usuful for all types of LMOs under the multiple environmental characteristics and conditions of the receiving environment, etc. This annex II unfortunatly give several examples that might be for certain LMOs under certain conditions interesting, but not always. Instead of it, it is much more reasonable and appropriate to consider the CBD’s Article 7- Identification and Monitoring annex I that sets down an indicative list of categories regarded to help identify components of biological diversity important for its conservation and sustainable use. warm regards, Lucia
posted on 2011-11-13 09:17 UTC by Ph.D. Lúcia de Souza, PRRI - Public Research and Regulation Initiative/ANBio (Associação Nacional de Biossegurança - Brazilian Biosafety Association)
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RE: Opening of the discussion on the 2nd draft of the guidance on "Monitoring of LMOs Released into the Environment"
[#2808]
Dear Manoela, dear members of the SWG/AHTEG and participants to the forum,
Many thanks to the sub-WG for their dedicated efforts to establish a guidance document on of LMOs Released into the Environment and specifically for providing a second draft for the document. I appreciate the redrafting which significantly improved its clarity. I also acknowledge the focused treatment of monitoring as reflected in the revised title. In the current document consideration of long-term effects is included as an important issue for this kind of monitoring, but not as a topic as such, which enhances the clarity and comprehensibility of the document very much. All in all this revised draft is a big step forward towards a solid and useful guidance on the topic of monitoring within the framework of the Cartagena Protocol on Biosafety. The different purposes of monitoring as discussed in the introduction should be specified more clearly and the different objectives for the different types of monitoring should be included: For monitoring of the release for field trials in the framework of risk assessments the primary objectives are the evaluation of efficacy of management measures and the confirmation of risk assessment assumptions. Monitoring as a measure concerning unconfined releases will focus on the monitoring of adverse effects as identified during risk assessment, the assessment of uncertainties associated with risk assessment conclusions and thus the accuracy of the overall risk assessment as well as the monitoring for effects unanticipated during risk assessment. I appreciate the streamlined general structure of the document which clearly outlines the different types of monitoring activities (CSM and GS) as regards their aims and characteristics. The considerations for devising specific monitoring strategies and the discussion of these issues in separate chapters clearly indicate relevant points for considerations for each of the issues. While being appropriate as general guidance the breath of the scope of the document (“all types of LMOs at any scale of release”) will necessitate that users of the guidance will need to take specific considerations as regards the particular LMO application to be monitored. The necessity of case-by-case considerations could be illustrated by reference to different examples of applications, e.g. use of LM-crops, the application of LM-insects to reduce the transmission of human pathogens etc.. In chapter 5 the guidance document describes how existing networks should be evaluated as regards appropriateness of their results for monitoring of LMOs. However few countries have yet implemented monitoring systems which are designed with a view to the requirements of monitoring of LMOs or appropriate to be implemented in a LMO monitoring strategy without adaptions. Therefore the guidance needs to indicate that other monitoring approaches should be implemented in case no appropriate existing networks are available. Please see enclosed document for some additional comments.
Kind regards Michael Eckerstorfer
posted on 2011-11-14 10:14 UTC by Dr. Michael Eckerstorfer, Austria
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RE: Opening of the discussion on the 2nd draft of the guidance on "Monitoring of LMOs Released into the Environment"
[#2809]
Since the file attachment didn´t work for my post as well as this reply I will send the mentioned file to Manoela for posting. Thanks for help, and I regret any inconvenience. Best regards Michael
posted on 2011-11-14 10:24 UTC by Dr. Michael Eckerstorfer, Austria
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RE: Opening of the discussion on the 2nd draft of the guidance on "Monitoring of LMOs Released into the Environment"
[#2810]
POSTED ON BEHALF OF MICHAEL ECKERSTORFER
Please see attachment.
posted on 2011-11-14 15:57 UTC by Ms. Manoela Miranda, UNEP/SCBD
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RE: Opening of the discussion on the 2nd draft of the guidance on "Monitoring of LMOs Released into the Environment"
[#2813]
POSTED ON BEHALF OF MOISES BURACHIK ---- Dear Colleagues, I thank very much to Manoela, Michael and all the members of the SWG/AHTEG and participants to the forum for your work and for the opportunity to participate in this interesting forum. I will like to elaborate on two specific sentences in Michael's posting. These are: "For monitoring of the release for field trials in the framework of risk assessments the primary objectives are the evaluation of efficacy of management measures and the confirmation of risk assessment assumptions. Monitoring as a measure concerning unconfined releases will focus on the monitoring of adverse effects as identified during risk assessment, the assessment of uncertainties associated with risk assessment conclusions and thus the accuracy of the overall risk assessment as well as the monitoring for effects unanticipated during risk assessment." While I fully agree with the first of the above sentences, as it refers to a part of the fundamental reasons for field trials, I wish to say something about the unconfined releases, which I understand refers to commercial releases (i.e., placing in the market). In a complete RA procedure, the assessment body must verify (proof or reject) all the reasonably formulated risk hypotheses, in terms related to statutory environment protecting goals. Consideration of potential adverse effects is the basis for respective risk hypotheses, which are dealt with by a problem formulation/endpoint assessment measurement procedure leading to accepting/rejecting the hypotheses. The process must have a highly predictive power, which would allow the risk managers to make decisions. Monitoring of adverse effects after the causative connection hazard risks/harm have been identified during the RA is not a valid purpose for monitoring, because if the risk has been proved to cause harm, no unconfined release should be allowed anyway and if it has proved not to cause harm, there is no longer need to monitoring it. Although there is always the possibility of unforeseen risks, the assessors must be experienced enough so as to reach a high level of certainty on "the accuracy of the overall risk assessment". As an interesting illustration of how a RA manager operates, please let me reproduce here an excerpt from the Chairman’s Foreword to ACRE’s 1999 Annual Report (ACRE, UK, 1999): ""...perhaps ironically, the widening of the risk assessment is, in my view, unlikely to bring the increase in certainty or provide the yes/no answers that many people undoubtedly want. More and more the expert advisers and the recipients of that advice can expect to meet, and to have to deal with, the uncertainty and variability which characterizes biological systems, especially semi-natural ecosystems. This is not new or unique to the GM debate – we cannot hope to know everything about any new technology at the outset – be that advances in medicine, engineering or agriculture. However we can … acknowledge that uncertainty will always exist but in doing so accept that we do know enough … to be able to confidently take the first precautionary steps. More and more we will call on the relatively young science of ecology where patterns and processes are well described and frequently understood but where prediction is still developing fast. I am optimistic that the science will serve us well and that much research to help reduce uncertainty is already underway. But …We must learn to operate within the bounds imposed by our understanding of nature, to accept that our calibration of biodiversity is imperfect, and, perhaps most importantly, to be very clear about how we employ such terms as ‘risk’, ‘harm’, ‘impact’ and ‘change’.""" With my best regards, Moisés -- Dr. Moisés Burachik Asesor Científico de la Dirección Dirección de Biotecnología Ministerio de Agricultura, Ganadería y Pesca Av. Paseo Colón 922, piso 2, of. 247 C1063ACW - Buenos Aires Argentina Tel.: 54-11-4349-2074 Fax: 54-11-4349-2178 mburac@minagri.gob.ar
posted on 2011-11-15 15:14 UTC by Ms. Manoela Miranda, UNEP/SCBD
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RE: Opening of the discussion on the 2nd draft of the guidance on "Monitoring of LMOs Released into the Environment"
[#2811]
Dear Participants,
Thank you for the opportunity to comment on a document which will affect efforts in my field: preventing diseases of relevance to humans that include dengue and malaria. The decisions that this group makes will likely have practical affects on human health, the least of which may be the risks due to LMOs that we are discussing.
My comments on the second Monitoring draft possibly reflect more of my concerns about the process of developing the drafts than the specifics of the document itself. After the first draft was released, the issue of general surveillance (GS) was widely discussed by participants. Of the 19 participants whose views I tabulated (beside mine and the author), 12 were opposed to the inclusion of GS, many strongly and unequivocally. Only four strongly supported it, and another four expressed opinions that were equivocal (in my judgment). While I do not expect the revision process to be a democratic decision, I think it is reasonable to expect revisions to reflect the concerns expressed by the participants, particularly when they are so specific and frequent.
Rather than minimizing GS in this draft, it has become more entwined with case-specific monitoring (CSM), and the line between them blurred such that in the second draft, the recommendation is being made that CSM could be replaced by GS altogether (emphasis in caps below mine).
“In conclusion, a risk assessor may, on a case-by-case basis, and depending on whether the national biosafety legislation or policies have any requirements to this effect, make a recommendation for the implementation of ONE AND/OR the other type of monitoring, i.e. CSM and GS, and include a comprehensive plan for a monitoring strategy.”
However, those designing the monitoring plan are still faced with developing…
“…a description of a scientifically rigorous and effective monitoring strategy. This monitoring strategy can utilize, as appropriate, EITHER one or the two types of monitoring identified above (i.e. CSM and GS)…”
GS cannot be dressed up as a “scientifically rigorous and effective monitoring strategy.” If it were scientific, the risks (speculative or not) can be addressed in a CSM plan. I cannot state strongly enough that inclusion of GS in this document will sanction a false assertion. The residue will be a confusing and impractical document for those planning monitoring programs. The quality of the guidance will suffer and the likelihood of it being adopted reduced.
Annex 2 starkly illustrates the direction that the second draft has taken is diametrically opposed to the most prevalent recommendation of the respondents to the first draft. Annex 2 specifies six categories of CSM protection goals. I believe these are all reasonable and science-based. TEN categories of GS protection goals are now listed. While the purpose may be to stimulate a broad assessment of possible risks, without a hypothesis-driven relationship between the LMO and the protection goal, GS offers nothing that is scientifically rigorous or effective.
Sincerely, Mark Q. Benedict Univ. Perugia, IT
posted on 2011-11-14 16:16 UTC by Mr. Mark Benedict, Centers for Disease Control and Prevention
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RE: Opening of the discussion on the 2nd draft of the guidance on "Monitoring of LMOs Released into the Environment"
[#2812]
1) I agree with the majority that the guidance should focus on CSM. The current version implies that there is a distinction between CSM and GS but does not differentiate between these approaches in practice. As the detail in the guidance does not reflect the concept of GS as it is applied in the EU (please refer to EFSA guidance) where GS plans are mandatory in applications to market (but not trial LMOs) this should be removed. 2) I support comments about the lack of objectivity in the guidance. The previous version included a list of objectives, which were confusing; however, instead of removing them, the purposes of monitoring should have been rationalised and the descriptions clarified (and supported by examples). 3) On the subject of objectives the text does not make the distinction between the objectives of the RA and monitoring sufficiently clearly. The guidance implies that regulators/ notifiers start from scratch when designing monitoring plans, which should not be the case. It is important that monitoring is not portrayed as an alternative to RA or that it is an open-ended process. Case-specific monitoring may not be required after an RA has been conducted, for example. 4) The use of monitoring for RA as well as RM is confusing. I agree with Hiroshi that the guidance should be restricted to RM. 5) I agree with Michael that the post-trial monitoring of small scale research and development trials is not captured by the guidance. It is likely that CSM will associated with a greater proportion of trial releases because, in general, there is less empirical evidence and an emphasis on RM in research trials. The guidance should state that it does not deal with small-scale trials, if this is the case. 6) I agree with Lucia that the guidance implies that monitoring is a data collecting exercise, which is very unlikely to generate information that will help decision-makers. The guidance needs to promote a more systematic, evidenced based approach. At present there is no sense of proportion or prioritisation. Annex 2 provides a list of examples that include parameters that are not necessarily linked to an adverse effect (e.g. gene flow and persistence) 7) I have attached some comments in the document. I will send these to the secretariat directly.
Regards, Louise.
(edited on 2011-11-15 14:57 UTC by Manoela Miranda)
posted on 2011-11-15 11:01 UTC by Ms. Louise Ball, United Kingdom of Great Britain and Northern Ireland
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RE: Opening of the discussion on the 2nd draft of the guidance on "Monitoring of LMOs Released into the Environment"
[#2814]
I thank those who have commented on this most recent version of guidance. In particular, Drs. Ball and Benedict provided very clear insights and suggestions on how to get this work on track toward an useful outcome.
I submit the attached for your consideration an edited version of the chair's text that, in my opinion, addresses the main problems. It is greatly reduced in length to make it consistent with other guidance documents. Furthermore, it has been edited to achieve objectivity along with clarity of ideas. This draft is focused on CSM but briefly references GS and monitoring regulated releases (field trials).
Thank you for this opportunity to contribute to this discussion.
Tom Nickson
Apparently the upload functionality is not working. So, I will have to send the file to Manoela for distribution.
(edited on 2011-11-15 16:19 UTC by Manoela Miranda)
posted on 2011-11-15 15:35 UTC by Mr. Thomas Nickson, Consultant
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RE: Opening of the discussion on the 2nd draft of the guidance on "Monitoring of LMOs Released into the Environment"
[#2815]
Dear Participants,
I've made comments and suggestions directly in the text attached. Overall, my comments are consistent with the comments posted by others, especially regarding the subject of general surveillance as it is elaborated in this guidance. I see that Tom Nickson has posted a proposed document that is clearer and more focused. If the comments and text changes I suggest are followed, the outcome would have many similarities to that proposed document.
Regards,
Hector
posted on 2011-11-15 17:36 UTC by Mr. Hector Quemada, Retired
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RE: Opening of the discussion on the 2nd draft of the guidance on "Monitoring of LMOs Released into the Environment"
[#2816]
Dear participants,
I understand that the purpose of this monitoring guidance document is to explain plainly the monitoring procedure shown in the Cartagena Protocol and its AnnexⅢ, according to the BS-Ⅴ/12. As Dr. Adriana Otero-Arnaiz pointed out in the previous on-line forum on this guidance (Sep.13), GS should be excluded in this document because GS would not be the part of the monitoring as established in the AnnexⅢ.
The main amendments related to the above are as follows; 1)Line 106-line 112: Be deleted. Because GS is unnecessary. 2)Line 152-line 160: Be deleted. Because the explanation of the relationship between CSM and GS is unnecessary.
The other amendments are as follows; 1)Line 24-line 27: Be deleted. As the CBD is formally the different agreement from the Protocol, it is not appropriate to quote articles from CBD. The Protocol is “recalling Article 19, paragraphs 3 and 4, and Article 8(a) and 17 of the Convention”, but not Article 7. 2)Line 46: “or cumulative effects” should be deleted. Because the concept of cumulative effects by LMO would not be reached the consensus within the Parties. 3)Line 167-line 169: “(e.g. when monitoring for possible cumulative effects of LMOs growing in the same area, measuring indirect or direct uptake of transgenic products in non-target organisms)” should be deleted. The reason is the same as shown above. 4)Line 358-line 359: “or unintentional/illegal transboundary movements of LMOs” should be deleted. It is inconsistent with line 74-line 76, saying “unintentional/illegal transboundary movements are outside of the scope of this guidance”. 5)Line 390: “Cost and capacities to conduct an effective monitoring” should be deleted. It is inconsistent with line 60-line 62, saying “associated costs are policy issues that will not be addressed in this document”.
Best regards,
Isao TOJO Senior Adviser for Biosafety, Ministry of Agriculture, Forestry and Ficheries Tokyo, Japan
posted on 2011-11-16 05:07 UTC by ISAO TOJO, Ministry of Agriculture, Forestry and Fisheries
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RE: Opening of the discussion on the 2nd draft of the guidance on "Monitoring of LMOs Released into the Environment"
[#2817]
Dear Manoela, Dear David Many thanks for the wonderful work undertaken so far.
I just would like to remember ourselves that article 32 of the Protocol establishes the relation between the Convention and the Cartagena Protocol. The Cartagena Protocol is an additional protocol that complements on the Convention and does not need to repeat everything that is there in the Convention; trying to separate them is not appropriate noting that the issue of monitoring is covered by both treaties and that they are linked according to article 32 of the protocol.
The issue of general surveillance is mandatory as per the Convention and is needed to establish baselines so that you will be able to detect any harmful effects. I have been working a lot in African countries and I would like really to emphasize the idea that many countries are hoping that this document would help us to perform General surveillance in addition to the case specific monitoring and I believe that is the role of the AHTEG; to help those countries. O.A.El-kawy, PHd
posted on 2011-11-16 10:05 UTC by Mr. Ossama Abdelkawy, Syrian Arab Republic
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RE: Opening of the discussion on the 2nd draft of the guidance on "Monitoring of LMOs Released into the Environment"
[#2830]
Dear all,
I greatly appreciate the opportunity to comment this 2nd draft. I am surprised that this second draft did not consider the strongly supported recommendations of the reviewers about the elimination of the General Survillance. It seems that we are starting from cero and I feel the same frustration reflected on the comments of those that have taken the time to read carefully and give scientific and commun sense arguments in order to improve the first draft. As Dr. Benedict, I review the participants arguments and with exception of four of 22 participants the issue of general survillance inclusion was the must commun critique, including the views of five members of the AHTEG. Even there were strongly suggestions that for now it should be suspended further work on the documents on monitoring and GM Trees and first properly finalise the road map and other guidance documents.
Reading this second draft I am not surprised that some of the reviewers offer a clear new text that cover the main concerns reflected on the previous process. I am wonder which will be the result presented in the Conference to the Parts, if the drafter do not consider the comments it will be an obstacle for the adoption.
Again in this new version there are issues that are irrelevant to this topic and have been included in this draft, for example all the related with general surveillance, this is not part of the monitoring as established in the Anex III.
Suggestions for improvements to the current text and/or structure: Again it is suggested that the Secretariat conforms AHTEGs for each particular subject (trees, monitoring, mosquitoes, etc). It is acknowledged the effort on the development of the drafts. But, in the document is reflected the valuable effort of only one person, which totally ignores the Articule 16 of the CBD about the use of biotechnology for the conservation of the biodiversity, instead of a group of experts with experience on the kind of monitoring referred on the Anex III of the Protocol.
The redaction of the draft is again redundant and not clear, I support all the suggestions made by Lucia de Souza, Mark Q. Benedict, Louise Ball, Hector Quemada and Isao Tojo.
It is suggested that this guidance stay focus on monitoring that may be used for addressing or evaluating uncertainties associated with the level of risks, considering that the determination of when monitoring is appropriate and what should be monitored in the receiving environment is made within the process of RA case by case and directed by well developed hypothesis. It is clear that not in all cases monitoring is needed.
Sincerelly
Adriana Otero Arnaiz Coordinator of Biosafety Program National Institute of Ecology Ministry of Environment
posted on 2011-11-16 23:12 UTC by Dr. Adriana Otero-Arnaiz, Mexico
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RE: Opening of the discussion on the 2nd draft of the guidance on "Monitoring of LMOs Released into the Environment"
[#2831]
Dear all:
Being a member of the RA AHTEG, I would refrain to intervene often in order to promote relevant discussions freely, but I would like to confirm a couple of issues here.
1) The language and context should follow under the Cartagena Protocol on biosafety to be concomitant, while language may not fully corresponded between the protocol and CBD. We are under Protocol, and some language discrepancy should be sorted out between MOP and COP. 2) However, relevant consideration should be made over the CBD articles to support CBD as well as supporting implementation of parties of the Protocol relevantly and effectively. 3) Going back to the initial mandate of RA AHTEG, and also looking at the time availability of members and forum colleagues, yet consolidation and testing shall be made at first on the Roadmap, and deviation and dilution of the efforts should be avoided to extended further adding o modifying other documents. 4) working with many of parties from developing regions worldwide such as SubSaharans, GLULAC and LDC at SE Asians, and taking the feedbacks from those countries on their view of the RA documents, yet I feel testing of the Roadmap document should be taken more than adding up documents as in the present discussion over monitoring and LMO trees.
Kazuo Watanabe
posted on 2011-11-17 00:55 UTC by Prof. Dr. Kazuo Watanabe, University of Tsukuba
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RE: Opening of the discussion on the 2nd draft of the guidance on "Monitoring of LMOs Released into the Environment"
[#2832]
Dear Manoela, dear David and dear participants,
Thank you very much for this second draft of the guidance on “Monitoring of LMOs Released into the Environment”. In my view it is really a step forward.
I would like to make the following comments:
The revised title is more consistent with the content and the structure of the document.
The structure of the document is much more stringent and clearer.
Again, I would like to point out that the surveillance of long-term, cumulative and potential unanticipated effects is an integral part of a scientific sound and responsible environmental monitoring. Moreover, as just stated by Dr. Ossama El-Kasy, general surveillance is mandatory as per the Convention. Therefore I strongly support the approach of the guidance document.
Please find some additional comments in the enclosed document.
Best wishes Dr. Wiebke Züghart Federal Agency for Nature Conservation, Germany
posted on 2011-11-17 08:17 UTC by Ms. Wiebke Züghart, Germany
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RE: Opening of the discussion on the 2nd draft of the guidance on "Monitoring of LMOs Released into the Environment"
[#2833]
Dear colleagues,
(1)I do not agree with other colleagues that General Surveillance should be excluded. It could be a useful tool to observe changes in the environment, but it would not be able to provide data on cause-effect-relationships. Therefore continuative activities/experiments are needed. (2)In the text in several paragraph it is mentioned that ‘identified potential adverse effects’ are objective of the monitoring. I do not agree on this point. The identification of potential adverse effects is part of the problem formulation within the ERA. It is part of the risk assessment to assess whether the potential adverse effects bare a risk or not. Only the identification of (i) a risk, (ii) critical knowledge gaps or (iii) significant level of critical uncertainty triggers monitoring. (3)The differentiation of CM and GS is not consistent in the document. I suggest to follow the approach suggested by EFSA. CSM should only be implemented when (i) a risk is identified in the ERA or (ii) important gaps in scientific information or significant level of critical uncertainty. GS has more the character of an environmental observation safeguard general protection goals. Therefore it is sufficient that GS is focus on these protection goals. In my view the current approach introduced a second risk assessment after authorization e.g. in line 88 a general verification whether the conclusions of the risk assessment are accurate or not could not be the task of an environmental monitoring. That is not useful. (4)Annex 2: The examples for CSM are confusing. There should be a clear distinction between CSM and GS. (compared EFSA GD) (see comment above).. Therefore objectives indicating a CSM can only defined after the ERA is finished. As a good example the CSM on insect resistance management could be presented. All other examples should be deleted. (5)Furthermore I would revise the structure of the table. I would follow the approach to translate protection goals/objectives to assessment and measurement endpoints as suggested in different papers e.g. Sanvido et al 2011 for ERA or EFSA GD for monitoring.
Please find further comments in the attached document.
Best wishes
Achim ___________________ Dr. Achim Gathmann Federal Office of Consumer Protection & Food Safety Berlin, Germany
posted on 2011-11-17 13:19 UTC by Dr. Achim Gathmann, Federal Office of Consumer Protection and Food Safety
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RE: Opening of the discussion on the 2nd draft of the guidance on "Monitoring of LMOs Released into the Environment"
[#2836]
Dear participants to the Open-ended Forum and AHTEG,
First of all I would like to thank you all for your active expert input during the last couple of days, in the course of this online discussion for the provision of concrete text proposals to the drafts on “LM trees” and “Monitoring”.
It has been suggested by some of you that we should make a pause in further developing guidance on the two new topics until we have finalized or sufficiently clarified the roadmap and the other draft guidance documents. While I understand that the workload is challenging to all of us I would like to recall that a mandate was given by the COPMOP5 which clearly requests from the AHTEG and Open-ended Forum that the work on the Guidance on Risk Assessment of Living Modified Organisms (which includes the Roadmap) should progress in parallel to the development of the additional guidance (see terms of reference of Decision BS-V/12, paragraphs 3a and c). In line with this the AHTEG decided a clear Action Plan at its meeting in Mexico City which should continue to be the basis for our work.
I would also like to note that the revision of the Guidance on Risk Assessment of LMOs (including the Roadmap) is already at a very advanced stage and well on track as per the AHTEG Action Plan.
I therefore kindly ask for your continued support as Open-ended Forum and AHTEG members so that we can deliver the expected outcomes as we have been tasked by the COPMOP.
I thank you for your understanding and continuous support and I am looking forward to our further collaboration in these important tasks. Best wishes
Helmut Gaugitsch AHTEG Chair
posted on 2011-11-18 12:13 UTC by Mr. Helmut Gaugitsch, Austria
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RE: Opening of the discussion on the 2nd draft of the guidance on "Monitoring of LMOs Released into the Environment"
[#2838]
Dear Helmut, Dear colleagues,
Being one of the participants to the Open-ended Forum who suggested that we should perhaps reconsider the timing in further developing guidance (in particular on LM Trees), I would like to take this opportunity to elaborate shortly on this.
First of all, let me restate that I greatly appreciate the efforts of the AHTEG members dedicated to develop the general Guidance on Risk Assessment and the specific guidance documents (a very difficult and ungrateful job), and that I am fully supportive of these important tasks. As Helmut rightly pointed out, the workload is challenging to all of us. So I think we should spend our time on this work as efficiently as possible in order to be able to present to COP-MOP guidance documents that appropriately address critical aspects of the risk assesment, and meet the needs of the relevant users.
According to the terms of reference of Decision BS-V/12, the open-ended online forum and the AHTEG shall work primarily online to (i) revise and test the first version of the Guidance, and (ii) assess the overall applicability and utility of the Guidance to living modified organisms across different taxa and receiving environments.
This last point (ii) is precisely what, in my opinion, has not been fully addressed for the moment. To my knowledge (and I apologize if I missed something) there is no result available yet of an assessment of the overall applicability and utility of the general Guidance specifically to LM Trees. I think such an assessment would provide a very useful guide to define what are the specific points that should be further considered in a specific guidance. This in turn would make the whole process of finalizing the current guidance on LM Trees much more efficient and straightforward.
Just my 2 (additional) cents.
Kind regards,
Didier Breyer
posted on 2011-11-18 15:05 UTC by Didier Breyer
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RE: Opening of the discussion on the 2nd draft of the guidance on "Monitoring of LMOs Released into the Environment"
[#2846]
Greetings to all.
The discussions on both PMEM and GM Trees show that there are still quite some areas where there are fundamental differences in views on topics that are not specific for either PMEM or GM Trees, and which should be clarified more generally under the roadmap. This is why I have proposed from the outset in the AHTEG that we finish and thoroughly test the roadmap first, before embarking on new guidance documents, as also Didier Breijer suggested in his recent submission.
Noting that again we are discussing basic issues that are not specific to PMEM or GM Trees, I repeat my proposal to take a pause with these documents and address those issues in the roadmap.
While I understand Helmut’s drive as chair to deliver as much as possible, we should not let quantity rule of quality. Moreover, Helmut’s observation that “the revision of the Guidance on Risk Assessment of LMOs (including the Roadmap) is already at a very advanced stage and well on track as per the AHTEG Action Plan” is a bit wishful thinking if we keep seeing in the other guidance documents fundamental discussions coming up that need to be resolved in the roadmap. Clearly the roadmap is not as far as we wish it to be.
I would prefer a few useful documents over many documents that are of little or no use to people who need guidance, and I would be surprised if MOP would feel otherwise. I am very concerned that all our efforts will be in vain if we continue like this.
NB: One of the general questions that need to be addressed in general for all the guidance documents is the nature of the guidance. If one looks at the various drafts, we see two very different approaches: One approach is to include anything that may come up in a risk assessment somewhere in the future. The other approach is to focus on elements that are likely to appear in risk assessments, and to provide guidance as to the cases in which those elements would be relevant and what to do with the information. I favour the second approach.
Whether we continue now or later with the PMEM document, a change of course is needed. Part of the reason why we have such a difficult debate with that document is that instead of starting with an overall structure and outline, which is then fleshed out in subsequent steps, we were very early on presented with a long and detailed draft, with a confusing discussion as result.
In this respect I believe that Tom Nickson’s trimmed down version would be a good start for further discussion.
My comments on the current draft are similar to the ones raised by Lucia de Souza, Hector Quemada, Adriana Otero, Louise Ball, Mark Benedict, and Hans Bergmans.
Finally, about the issue of GS: as Adiana correctly stated in an earlier round: the only place where environmental monitoring is mentioned in the protocol is para (f) of Annex III, which - given the reference to “uncertainty regarding the level of risk” is about case specific monitoring.
Others have argued that GS should be included in the guidance, with reference to the monitoring mentioned in the CBD. However, article 7 of the CBD on “Identification and Monitoring” is about monitoring in the context of components of biological diversity important that are identified for conservation and sustainable use. The starting point for that monitoring is the identification of those components regardless of whether there is mention of a release of GMOs or not. We should not confuse these things.
Regards
Piet
posted on 2011-11-18 21:26 UTC by Mr. Piet van der Meer, Ghent University, Belgium
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RE: Opening of the discussion on the 2nd draft of the guidance on "Monitoring of LMOs Released into the Environment"
[#2840]
As an Observer with a seat on the AHTEG, and someone who has invested a great deal of personal time in an effort to produce something that will be useful, I am fully sympathetic to the concerns expressed by Didier Breyer. With all due respect to our chair and his concerns about the AHTEG fulfilling its mandate, these recommendations are a cause for concern. I think it is worth asking the question of whether the process has become more important than the outcome? A significant number of divergent views on important fundamental points necessary for useful guidance remain unresolved yet the work of this group is expanding. Without a rigorous and objective process of assessment of these basic pieces, this AHTEG will only produce confusion. I respectfully challenge that this was never part of the mandate from the Parties, and we have a responsibility as scientific experts to seriously assess if and how the outcome will be of use to those who need it. We should then continue to work constuctively and collaboratively to ensure a high quality outcome in time for MOP6 to consider.
Thank you, Tom Nickson
posted on 2011-11-18 17:03 UTC by Mr. Thomas Nickson, Consultant
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RE: Opening of the discussion on the 2nd draft of the guidance on "Monitoring of LMOs Released into the Environment"
[#2841]
Dear colleagues,
I am grateful for the opportunity to react to the second draft of the guidance document on monitoring, and for the discussion that is going on in the forum.
It is no surprise that the issue of GS is debated heatedly. The concept of GS is relevant in the context of the EU regulatory system, which requires that it is performed. GS in the EU context has a very specific meaning and it cannot be stressed enough that GS and CSM are two completely different concepts. As Mark Benedict rightly states, they cannot be treated ´intertwined´, as is the case now in the dolcument. I agree completely with Mark's comment: "GS cannot be dressed up as a 'scientifically rigorous and effective monitoring strategy.' If it were scientific, the risks (speculative or not) can be addressed in a CSM plan. I cannot state strongly enough that inclusion of GS in this document will sanction a false assertion. The residue will be a confusing and impractical document for those planning monitoring programs. The quality of the guidance will suffer and the likelihood of it being adopted reduced. " This leads me to conclude that GS has to be treated, very summarily, maybe even as short as proposed by Tom Nickson, i.e., only referring to the EFSA guidance for GS, and focusing the guidance on CSM. Also, as Isao Tojo points out again, GS is not mentioned as such in Annex III, which is an additional reason not to include it in the document. If a (slightly) longer text for GS would be preferred, separate from the text on CSM, I would volunteer to make a text proposal for that purpose, that could be a basis for debate.
I also have to agree with the comment of Mark Benedict on Annex II: ' Annex 2 starkly illustrates the direction that the second draft has taken is diametrically opposed to the most prevalent recommendation of the respondents to the first draft. Annex 2 specifies six categories of CSM protection goals. I believe these are all reasonable and science-based. TEN categories of GS protection goals are now listed. While the purpose may be to stimulate a broad assessment of possible risks, without a hypothesis-driven relationship between the LMO and the protection goal, GS offers nothing that is scientifically rigorous or effective.'
The draft text has given me a lot of difficulties. This document is on a difficult subject, that requires quite some time and effort in order to obtain thoughtful guidance document that has real value. In that respect I recognize the comments made by Didier, and echoed by Tom.
I have made a number of comments in the text. For the moment I have deleted all reference to GS, as this should not be treated intertwined with CSM, and I am not sure whether GS has to figure in the text at all (see my comments above). The remaining text still gives me problems as it does not sufficiently reflect that CSM is based on the risk assessment that it is reacting to, and based more specifically on the uncertainties that were identified in the risk assessment. This should be the first notion and the first trigger for CSM. This has given me reason to propose quite a number of deletions. I have indicated deletions in two ways: in tracked changes, but also by strikethrough, in particular in cases where I wanted to mark the (striked) text for a comment.
The points to consider give me particular trouble. In many cases they are just not relevant, but also they are highly redundant, and I think this problem will remain, when we have discussed and concluded which ones are relevant. In order to evade redundancy, we may have to consider to make just one list of points to consider, that entirely covers CSM
I have made a number of text proposals. They do not necessarily exclude the text suggestions of others. In particular, Tom Nickson's proposal to drastically shorten the text may be a good start. In any case, a drastically shortened text may be a good start to see what we are still missing, and where this should be included in the text.
Best regards, Hans Bergmans
I am encountering problems posting my file. I will ask the secretariat to post it for me.
(edited on 2011-11-18 19:04 UTC by Manoela Miranda)
posted on 2011-11-18 17:33 UTC by Mr. Hans Bergmans, PRRI
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RE: Opening of the discussion on the 2nd draft of the guidance on "Monitoring of LMOs Released into the Environment"
[#2847]
POSTED ON BEHALF OF PHIL BEREANO
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Dear Manoela,
My thanks to you and other colleagues for my participation in this important dialogue. I have a few comments to make about the overall themes which have emerged from the discussion, rather than on the actual wording of the text.
I approached this task assuming that the focus would be the monitoring of a release after an RA and a decision to allow placing the LMO in the environment. And I understand that some comments are directed towards an apparently confusion due to language more applicable to observations and testing during an actual assessment (Yoshikura, Eckerstorfer, Ball). But I think that this view is unduly narrow as regards the reality of such situations. The assessment literature is virtually unanimous in understanding assessment as an iterative process; its end point is set by risk management considerations—not science or logic--since there will always be more information to gather, more variables being tweaked, more costs being incurred, etc.
Any given assessment can be refined as monitoring gives the assessors more information about probabilities and as these become more fixed and certain. Thus, while the thrust of this document should be on post-release monitoring, I believe we need to recognize that such monitoring can well be providing data for assessments of future LMO releases, as well re-assassment of the subject LMO release, and also signaling if there is any danger being manifested that needs to be combated. These processes are characterized by feedback loops, not unilinear thinking.
And there is certainly indication that engineered genomes may not be so stable, and that the targets of the engineering (such as insect and weed pests) are likely to change over time (resistance) which may well necessitate opening and re-doing the original assessment. I think some of the contributions to this discussion are premised on these situations always being stable, rather than somewhat fluid, and I do not think that is realistic.
Thus, I am confounded by Dr Burachik’s statement that: “Monitoring of adverse effects after the causative connection hazard risks/harm have been identified during the RA is not a valid purpose for monitoring, because if the risk has been proved to cause harm, no unconfined release should be allowed anyway and if it has proved not to cause harm, there is no longer need to monitoring it.” How solid is the original information about causation? Most likely it is probabilistic or even unknown. How solid id the information about the nature of the damage? It is likely to be incomplete. In addition, it is not plausible to prove a negative (“proven not to cause harm”). When one considers all the uncertainties that will come up in an assessment, and the lack of much baseline data, the possible result of modifying the original assessment blurs any hard and fast distinction between “monitoring’ as the gathering of data to feed into an assessment and that later observation which is designed to assure that nothing goes terribly wrong, etc.
While we must always use the best scientific methodology to do our observations and surveillance, monitoring in the sense of what these observations mean and what to do about them are policy decisions (risk management), not scientific ones. For example, the decision of the Canadian government to ban the use of r-BGH was based in part, as I understand it, on animal welfare data (harm to the cows); the US assessment did not look at animal welfare and allowed the use of the genetically engineered product. Even assuming both governments used the best of data and assessment methodologies, their opposed decisions are due to a policy factor, not a technical one. (Thus, I strongly disagree with Tom Nicholson on this aspect of his posting.)
Finally, the Protocol establishes a mutually agreed upon floor; as sovereign entities any State may do more and is not limited by the Protocol as a ceiling. I am thus in agreement with Drs. Abdel-Kawy and Zughart, and disagree with Benedict and de Souza-- if a state wishes to engage in GS as well as CSM it can and this document will be more useful if it indicates the relationships between the two approaches.
Prof. Philip L. Bereano Washington Biotechnology Action Council Seattle, USA
posted on 2011-11-18 21:40 UTC by Ms. Manoela Miranda, UNEP/SCBD
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RE: Opening of the discussion on the 2nd draft of the guidance on "Monitoring of LMOs Released into the Environment"
[#2852]
I agree with Michael´s comments on the streamlined general structure of the document and with the clarity showed to describe diverse methodologies. I believe that the current draft covers most of the relevant issues, and I believe that the attempts of reducing unnecessary text are welcomed for better fitting with previous documents.
I clearly do not understand the contentious debate over GS, in particular the strong need to take it out of the document. The wording is quite clear in differentiating it from CSM and defining its characteristics as a type of method that could be used (specially if it is already been in use by some parties). If the problem is the possibility of GS overtaking CSM, this can be described and solved in the wording. However I believe it is important to keep it in the text in order to show more options for monitoring. In particular when these options can be targeted for different protection goals, this is of particular importance for developing regions where strategies will have to be chosen based on potentially complex environments and technical limitations (another reason why I strongly support not to erase the examples in annex 2).
Best regards, Camilo
posted on 2011-11-19 00:14 UTC by Camilo Ignacio Rodriguez-Beltran, Universidad del Desarrollo and consultant for Third World Network
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RE: Opening of the discussion on the 2nd draft of the guidance on "Monitoring of LMOs Released into the Environment"
[#2854]
THE FOLLOWING COMMENTS WERE RECEIVED SHORTLY AFTER THE CLOSING OF THIS DISCUSSION AND ARE BEING POSTED ON BEHALF OF GEORGINA CATACORA-VARGAS
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Dear all,
As mentioned in the previous forum, Bolivia, as part of the target countries of this guidelines (re: developing countries with strong need for further guidance on RA and RM issues), we strongly welcome this second version of the monitoring guidance. We strongly believe that it is going in the right direction particularly in relation to the conservation and sustainable use biodiversity (although, we also believe that the text could address more the issues related to human health - in light of the scope of the CPB, and experimental releases). We are of the strong opinion that: i) "monitoring" is a crucial step for a safe handling, transport and use of LMOs, and it should be carried out in light of the precautionary approach and consistent consideration of uncertainty. Even when case-by-case RA results in the identification of low probable risks; and ii) monitoring should not restrict to the issue identified in the RA procedure.
We appreciate the comments sent by Dr. Michael Eckerstorfer and Dr. Wiebke Züghart. We also appreciate the reminder posted by Dr. Ossama Abdel-Kawy on the relationship of the CPB, CDB, monitoring and GS. The suggestion of maintaining GS was requested by a number of participants representing their governments / Parties in the previous e-forum. Accordingly, we appreciate that this has been taken into account. As mentioned by Dr. Abdel-Kawy, SG is mandatory in the CBD and hence, should be fully taken into account in the implementation of the CPB. In light of this, we also appreciate what was mentioned by Dr. Wiebke Züghart re: "surveillance of long-term, cumulative and potential unanticipated effects is an integral part of a scientific sound and responsible environmental monitoring". We strongly suggest keeping this wording.
Attached additional specific comments on monitoring guidance documents.
Best regards,
Georgina Catacora-Vargas Vice-Ministry of Environment Plurinational State of Bolivia
(edited on 2011-11-19 14:50 UTC by Manoela Miranda)
posted on 2011-11-19 12:59 UTC by Ms. Manoela Miranda, UNEP/SCBD
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