Activities of the Open-Ended Online Forum (2014-2016)
Return to the list of threads...
|
Forum closed. No more comments will be accepted on this forum. |
RE-OPENING of the discussion (for 24 hours only)
[#8035]
Dear all,
There was a small typo in the Moderator's opening message to the effect that the discussion would close on 29 June, when in fact it should have read 27 June.
To avoid that anyone is penalized by not having a chance to post, the discussion will be re-opened for another 24 hours starting now.
I once again would like to thank those who have contributed and invite those who did not have a chance to contribute to take this opportunity to do so. Many thanks also to Maria Mercedes for her challenging task of moderating the discussion.
Best regards, Manoela
posted on 2016-06-29 11:23 UTC by Ms. Manoela Miranda, UNEP/SCBD
|
RE: RE-OPENING of the discussion (for 24 hours only)
[#8036]
Dear all,
Taking the advantage of this extra time offered, I would like to apologize not to participate in previous days, and also to thank The Secretariat and Maria Mercedes for the efforts to have a productive discussion. As well summarized by Thomas Nickson [#8021] and others like Luciana and Paulo (to nominate some), we need a good and well-founded document to offer to COP MOP. So, I add my voice to those participants / posts that feel guidance on SynBio is premature.
Thanks for this late opportunity
Deise
posted on 2016-06-29 12:15 UTC by Dr. Deise Maria Fontana Capalbo, Brazil
|
RE: RE-OPENING of the discussion (for 24 hours only)
[#8037]
Dear all,
Thank you very much to Maria Mercedes for moderating and facilitating this discussion and to Manoela for clarifying the deadline misunderstanding and providing an extension. I would like to support the views and edits to the draft document (Doc1 - “Possible considerations during ERA of LMOs developed or created through approaches commonly referred to as “synthetic biology”) made in many comments, such as #7985, #7991, #8001, #8002, #8026, #8010, #8011, #8021 and #8036. I agree that the basic risk assessment principles on which the roadmap is based, can be applied to most of the synthetic biology products developed to date. I have not yet seen any specific examples that suggest that a different approach must be taken, therefore it would be very difficult to develop guidance based on hypothetical cases for which we do not have any practical experience. I do support Maria Mercedes’ proposal for the preparation of factual information for the upcoming COP/MOP, so a decision can be made. Best regards Monica
posted on 2016-06-29 14:39 UTC by Dr Monica Garcia-Alonso, Estel Consult Ltd
|
RE: RE-OPENING of the discussion (for 24 hours only)
[#8038]
Dear all,
I also want to take this opportunity in order to share some comments.
I´m agree with the comments of different colleagues that mention the lack of real cases and experience with synthetic biology. In this sense, I don´t consider a good idea to make decision in order to over regulate a methodology and its products based on limited examples.
I also recommend foster the draft document (“Possible considerations during ERA of LMOs developed or created through approaches commonly referred to as “synthetic biology”) in the next COP/MOP in order to evaluate it´s usefulness with real cases and the identification of gaps.
Another recommendation is to promote the integration and participation of institutions with experience in synthetic biology in order to gain experience related to the ERA in LMOs created through synthetic biology.
Best regards, Pedro Macias
posted on 2016-06-29 16:11 UTC by SR PEDRO MACIAS-CANALES, Mexico
|
RE: RE-OPENING of the discussion (for 24 hours only)
[#8039]
Dear colleagues, First I want to congratulate and thank Maria Mercedes to moderate this very lively and interesting discussion. I followed this forum with great interest and taking advantage of the reopening I would like to express my complete agreement with many posts that have incorporated valuable suggestions which clearly justify and give more arguments in favor of the conclusions that Maria Mercedes has developed in the Doc 1 to provide the COP / MOP an objective and transparent vision of the opinions of participants of various fora on this controversial issue. I want to stress that there is still a need to advance on a robust and useful Guidance on environmental risk assessment of LMO, and even those LMO which now seem to belong to a new category call SynBio, as was concluded by two AHTEG and SBSTTA, do not offer so far new challenges than those who have already been approached by some countries on LMO, such as the case of the recombinant yeast evaluated in Brazil. In my opinion, the effort and resources of the experts and the BCH should be focus mainly in task of improve the current Guidance, particularly the Part 1 and the use of problem formulation methodology on the risk assessment of any LMO. Thank you for the opportunity to comment. Regards, Patricia Gadaleta
posted on 2016-06-29 16:51 UTC by Dr. Patricia Gadaleta, Argentina
|
RE: RE-OPENING of the discussion (for 24 hours only)
[#8042]
Dear all, I would like to thanks Maria Mercedes for moderating this forum, to all of you for share so interesting views and experience and thanks to the Secretariat for the 24-hours re-open. I would like to express my support to the comments shared by Paulo Paes [#7984], [#8006]; Luciana Pimenta [#7985] and [#7995]; Lúcia de Souza [#7986]; Gutemberg Sousa [#7993]; Pedro Macias [#8038], among others. I saw some very interesting papers about “Synbio product”, but all of them in R&D area, or non commercial purposes. As many of the messages expressed, I consider too that there is a lack of real-life examples of synbio products. I guess the basic principles of risk assessment could be applied to the Synbio product developed until now. I mean that there is a base to beginning. Kind regards. Laura
posted on 2016-06-29 21:33 UTC by Dra. Laura Esther Tovar Castillo, Mexico
|
RE: RE-OPENING of the discussion (for 24 hours only)
[#8043]
Thank you Manoela for the extension.
I would like to essentially support posts by other colleagues that a guidance on synthetic biology would at this point be premature, particularly given the limited experience available.
Regards
Kelebohile
posted on 2016-06-29 22:00 UTC by Ms. Kelebohile Lekoape, Bayer CropScience
|
RE: RE-OPENING of the discussion (for 24 hours only)
[#8044]
Dear All,
My warm thanks to Maria for her continued commitment to moderate this discussion, and to Manoela for recognising the typo and for reopening this exchange.
Following the moderator’s request I provide my comments as track changes in the attached document.
In addition, some general observations:
1) Several of my text proposals are aimed at making clear in the document that the task at hand is to answer the question whether additional guidance for the ERA of Annex III would be helpful, and not whether the methodology of ERA in Annex III itself needs to be revised.
2) The current document is peculiar in the sense that the fact that many participants – me included- are of the view that for now no further guidance is needed is reflected in one short paragraph, while on the other hand the observations of a small number of participants that there are considerations that warrant additional guidance is reflected in a full page. This needs further explanation in the introduction as to how this came about.
3) In addition, the document should also underline that most, if not all, of the points mentioned are not unique to LMOs developed through SynBio. I have included suggestions to that effect.
Regards to all,
Piet
posted on 2016-06-29 22:06 UTC by Mr. Piet van der Meer, Ghent University, Belgium
|
RE: RE-OPENING of the discussion (for 24 hours only)
[#8045]
Dear colleagues, First of all thanks to the Secretariat for the 24-hours re-open.
It is evident that we are planning with complexity.
1) There are not consensus about the operational definition of SynBio, 2) At present there are not suitable real-life examples of synbio products, 3) We have not enought salient and legitime information about if the current guidance could be applicable in a comprehensive way to SynBio or not, 4) Many colleagues consider that it is premature to develop a guidance on SynBio.
Thus, it has to call for a more adaptive governance process (in a broad sense) capable of dealing with the inherent complexity and uncertainty of social–ecological systems’ and challenges of technological innovation.
Taking into account the comments posted by several others participants, in a adaptive governance approach, the guidance should be based in a continuous problem-solving process by which institutional decisions, comparators and ecological knowledge will have to be tested and revised in a dynamic, ongoing, self-organized process of learning by doing. We already have this approach on RA of LMO, nevertheless, it is important think about their enforcement to SynBio. However, in order to reduce the possibility of making wrong decision, this approach suggests a fundamental paradigm shift from understanding a single part of an ecological system for controlling its variables to understanding the dynamics of the whole social–ecological system for managing its capacity to absorb change and dealing with uncertainty and unexpected events. In addition, we should not forget that the above consideration lead us to strengthen current monitoring frameworks.
Best Regards,
Mario Pérez.
posted on 2016-06-29 22:32 UTC by Biologist Mario Eduardo Pérez Hernández, Mexico
|
RE: RE-OPENING of the discussion (for 24 hours only)
[#8046]
Dear All-
I wish to thank Maria Mercedes for doing an excellent job to moderate this discussion. And I wish to thank Manoela for reopening the discussion for one more day.
I suggest to incorporate the changes in the background document provided by both Luciana [#7985] and recently by Piet [#8044].
At the last face-to-face meeting, the AHTEG 'decided' to develop an outline of the issues surrounding synbio to assist the COP MOP to decide about the need for additional guidance, but it was also 'decided' to wait until after the report of the SBSTTA was available. This must have been so that we could take into consideration the outcome of the discussion under SBSTTA. It seems that the changes to the background document suggested by Luciana and Piet better reflect the outcome of the SBSTTA and this current forum of the AHTEG on RA&RM, and will therefore be more informative to the COP/MOP for their decision.
Thanks to everyone who has participated constructively in this discussion. It has been very enlightening.
Regards, Karen
posted on 2016-06-30 01:19 UTC by Dr. Karen Hokanson, Agriculture and Food Systems Institute
|
RE: RE-OPENING of the discussion (for 24 hours only)
[#8048]
Dear colleagues
Firstly, I thank sincerely to Maria Mercedes for moderating and summarizing this discussion with a great patience.
I believe the document we are working on is a very good basis to inform COP/MOP about the subject. There were many valuable suggestions to change the document. I'd like to highlight Piet's contribution as very appropriate. In my view the discussion on SynBio is necessary and not premature regardless whether we are going to develop a new guidance or just supplement the existing in the near or far future.
Best regards Ruth Rupreht
posted on 2016-06-30 07:05 UTC by Ms. Ruth Rupreht, Slovenia
|
RE: RE-OPENING of the discussion (for 24 hours only)
[#8051]
Dear Colleagues,
I am not surprised to see many similar views coming in during this extended discussion duration. Highly appreciate the quick responses from Judy and Ruth. I do agree that the lagged definition of synbio does not necessarily block the progress of risk assessment.
I eventually accept the concept of responsible innovation and understand that many big scientific projects of biotechnology always include a component part of biosafety and public communication. We shall also remember the lessons learned from the GM crops, until the very developed stage of today, there are still lots of different views and a lot of people doubted on the safety of the GM crops.
It is a good start point for a synbio project also going with a biosafety subcontract as we see currently in the European projects that do want to make transparent progress in technology while ensuring the biosafety issues to be understood by public people. That allows the technology development and biosafety discussion develop sympatrically together. The simultaneously developed biosafety discussion and regulation will help to promote the progress of biotechnology other than a barrier.
Thus although some critical synbio techs have been not yet commercialized, it is the right time to look into methodologies on the risk assessment of synthetic biotechnology.
Best wishes
Wei
posted on 2016-06-30 08:01 UTC by Mr. Wei Wei, China
|
RE: RE-OPENING of the discussion (for 24 hours only)
[#8047]
Mario Eduardo Pérez Hernández [8045] has summarised well some of the arguments that have been given by others against developing specific guidance on SynBio thus: “1) There are not consensus about the operational definition of SynBio, 2) At present there are not suitable real-life examples of synbio products, 3) We have not enought salient and legitime information about if the current guidance could be applicable in a comprehensive way to SynBio or not, 4) Many colleagues consider that it is premature to develop a guidance on SynBio.”
I would like to respond to those arguments as follows:
(1) There is no consensus amongst most scientists for most areas of science. When I was working for my State government to identify, investigate and control infectious diseases, there was not even consensus between the State governments of Australia about something as basic as an operational definition of what constituted a case of measles. (Did a clinical diagnosis suffice or did you need a blood test to confirm?) Yet this situation did not prevent us from doing surveillance for cases of measles. Nor did it stop us from controlling the spread of the organism by e.g. immunisation. That is, we did NOT use the argument summarised by Mario Eduardo Pérez Hernández, because that would have meant us saying: there is no consensus for a case of measles, therefore we will not specifically discuss measles and we hope that general methods we have developed for other organisms (eg tetanus), will somehow also work for measles. Trouble is, while both are infectious diseases, measles is a different organism to tetanus, producing different symptoms, transmitted in a different way and is FAR more contagious than tetanus.
I argue that SynBio may be in a better situation that that, because experts on SynBio that are members of the AHTEG on SynBio have considered at length what may constitute a definition of SynBio, and they have provided us with that definition. I therefore argue that we should use their carefully-considered and expertly-crafted definition.
(2) If you are arguing that there “are not suitable real-life examples of synbio products”, then you must be using some kind of definition of SynBio in order to allocate all the current products of biotechnology out of that category. I would be delighted if you would be able to provide that definition to the discussion, as it may aid the discussion.
(3) As others have described, a decision has been made to explore the development of specific guidance on SynBio.
(4) In contrast, many colleagues consider that it is timely to develop a guidance on SynBio.
Thank you again to the Secretariat, Maria and contributors to the discussion on this very interesting discussion
Best wishes to all
Judy
posted on 2016-06-30 06:25 UTC by Dr Judy Carman, Institute of Health and Environmental Research
|
RE: RE-OPENING of the discussion (for 24 hours only)
[#8049]
Good morning, I`m supporting comments in the background doc. provided by Sarah in her post with Ms. Birgit Winkel comments in [#8024], and provide a couple of my comments to the document. With best wishes, Galina.
(edited on 2016-06-30 07:57 UTC by Galina Mozgova)
posted on 2016-06-30 07:53 UTC by Ms. Galina Mozgova, Belarus
|
RE: RE-OPENING of the discussion (for 24 hours only)
[#8050]
Dear All Thank you very much to the organisers for allowing an extension to this discussion. I would like to support the comments of those who believe that the COP-MOP should be advised that additional guidance on the risk assessment of organisms produced by synbio is not required (for example: #7986, #7995, #7999, #8001, #8002, #8006, 8018, #8026). My own views particularly resonate with those comments provided by Boet Glandorf (#8010) and so I have used her version as a template to add a few additional comments. Kind regards, Martin
posted on 2016-06-30 07:55 UTC by Martin Cannell
|
RE: RE-OPENING of the discussion (for 24 hours only)
[#8052]
Dear All-
I, too, would like to thank Maria Mercedes for moderating this discussion. I also thank Manoela for reopening the discussion for one more day, something that has yielded constructive input to the charge that Maria Mercedes described on the first day of this discussion for us to comment on the two-page "doc1".
I would like to see the final document to incorporate the suggested track changes and comments offered by both Luciana [#7985] and by Piet [#8044]. These suggested changes give a more balanced view of the nature of the overall discussions to date.
I think that Karen [#8046] makes a very good point as to why the changes offered by Luciana and Piet will help the document to better reflect the outcome of the SBSTTA, the current forum of the AHTEG on RA/RM, and thereby provide a clearer picture for the Parties at the upcoming COP/MOP.
Regarding comments on the text, in the attached file I have offered a single sentence to be added just prior to the list of considerations on the second page, namely: "It should be noted that for the considerations cited below, these are not unique to LMOs or organisms developed through the use of synthetic biology techniques, but rather are considerations in the environmental safety evaluation of organisms developed via traditional selection and breeding techniques."
I think it is important for the readers of this document to recognize that these considerations are not unique to organisms developed by certain techniques, but rather are something that reflects the need to look at the resultant phenotype of an organism when evaluating the ways that the organism may interact in the environment.
Best regards,
David Heron
posted on 2016-06-30 11:21 UTC by David Heron, United States of America
|
RE: RE-OPENING of the discussion (for 24 hours only)
[#8053]
POSTED ON BEHALF OF RICARDA STEINBRECHER
----
I thank Maria for the moderation of this discussion and the Secretariat for providing this useful background document. I largely agree with all the points, but would like to see some alterations as indicated in the attached document. For example, I would like to make sure that the definition is clearly understood as an operational definition for use within the CBD. This needs to be clarified in the text.
I agree with the many contributions that find the listing of techniques and approaches that are used in or referred to as synthetic biology useful and important. Whilst gene or genome editing may also be used in other branches of modern biotechnology, this can be clarified by an additional sentence as suggested by Margaret Engelhard. Genome editing techniques, esp. CRISPR/Cas9, are a major tool of synthetic biology with a wide range of usability, including for example the repeated or multitargeted use of genome editing that can give rise to profound changes within the genome.
Equally, I find the inclusion of Gene Drives of crucial importance. Counter to the opinion of some members of this forum I find it is in urgent need of a deliberation and of guidance material. May I refer to those that work with this technique and that have helped develop the CRISPR/Cas9 Gene Drive, who themselves are of the opinion that any future use of this technology requires further and intense deliberation. Eg: Esvelt KM, Smidler AL, Catteruccia F, Church GM. Concerning RNA-guided gene drives for the alteration of wild populations. eLife. 2014; 3:e03401. doi:10.7554/eLife.03401. As said in this publication and elsewhere, Gene Drives have the “possibility of unwanted ecological effects and near-certainty of spread across political borders”, and “several published gene drive architectures could lead to extinction or other hazardous consequences if applied to sensitive species.” Ethan Bier said in 2015: “I believe it's going to transform the world of genetics, because it's going to allow researchers to bypass the rules of genetics in many different spheres of activity.” As already pointed out by Wei Wei [#7989], gene drives override the rules of Mendelian law, which is outside any current risk assessments and guidance material. It is a technique that allows intentionally or unintentionally the modification of whole populations and species and the engineering of whole ecosystems, which does bring challenges to risk assessment. I regard it as exactely our task to bring this information – in form of a listing - to the Conference of the Parties to aid deliberation and decision making.
Kok Gan Chan suggested to perhaps state “that the examples given are not an exclusive list”, which might be helpful here.
I also agree with Kok Gan Chan [#8027] and many others that any indication ov voting in the summary (or the background document) is misleading and should be avoided. Many have found no time to participate in this Forum, and it is not of importance how many times a point is being made or by how many, but rather that it is being made, especially when it has relevance to risks vis a vis the three objectives of the convention.
In this context paragraph 6 could be reworded to indicate that it is not the intention of the document to only reflect consensus expert opinion, as the forum is not a consensus building exercise, but rather to report on points raised that are relevant to the task at hand, irrespective of being expressed by a majority, minority or all.
I fully agree with the inclusion of all 5 headings/points in the background document provided by the secretariat as well as an extra point on Speed of Development, as also suggested by others.
I fully support the points raised by Jack Heinemann and his comments in background text.
I find myself in agreement with the comments by Judy Carman, esp. [#8012], but would like to comment on her last point, that where she suggests to addtext from a previous round saying: “ “A possible way forward is for the COP-MOP to establish a mechanism, such as an online forum, to monitor biotechnological development and enable the identification of such examples”. The guidance should be regularly updated to include new developments.” Whilst this is clearly important, it needs to be clarified whether such a process would be better served under the CBD or the Cartagena Protocol, and it should thus be considered by both COP and COP-MOP. Under the CBD, the mandate is clearly wider as it covers not only organimsm derived through synthetic biology, but also compounds and products, and their potential impacts vis a vis the three objectives of the Convention.
The points raised by Francisca Acevedo [#7980] are very helpful and I agree that it is of importance to already explore and deliberate on which additional questions need to be asked, eg in the context of comparators, base lines, but also in the context of ‘alternatives’, especially when organisms derived through synthetic biology are intended as solutions to given problems.
Finally, it would be good to avoid mixing up different terms or categories that are being used differently by us or within different regions or constituencies. For example the term “products” as well as “new breeding techniques”. If I recall right, Paulo Paes de Andrade used the term ”products” to mean LMOs derived through Synthetic Biology. As “products” of synthetic biology is used differently under the Convention and in the AHTEG on Synthetic Biology, it needs specific attention to avoid misconceptions. The issue around “new breeding techniques” (NBTs) – including ODMs - is worth while a whole discussion on its own. This is especially so when suggesting they may not be GMOs, whilst according to EU regulation and definitions and legal opinions they are GMOs. Whilst of course we do not all share the same interpretation or opinions, and what for me is clearly a GMO might look different for someone else. So we of course could discuss this, but in this online debate on Synthetic Biology we possibly are better off by putting a big square bracket around NBTs and what they are or are not, as it is not essential to the tasks at hand.
I thank everyone for a most interesting debate and – if time was plenty – I would have liked to pick up numerous points for debate.
With kind regards,
Ricarda
(edited on 2016-06-30 11:51 UTC by Manoela Miranda)
posted on 2016-06-30 11:50 UTC by Ms. Manoela Miranda, UNEP/SCBD
|
RE: RE-OPENING of the discussion (for 24 hours only)
[#8054]
POSTED ON BEHALF OF AYAKO YOSHIO
-----
Dear colleagues,
Thank you very much to Maria Mercedes for moderating this forum and to secretariat for providing us this opportunity.
My understanding on the current situation regarding synthetic biology is totally same to the points presented by Mario [# 8045]. I also agree that synthetic biology should not considered as some specific technologies (e.g., genetic engineering and gene drive) as Luciana and many other colleagues mentioned. I would like to support Patricia’s comment [# 8039] that the effort and resources of experts and the BCH should be focus in improving the current guidance.
Best regards, Ayako
posted on 2016-06-30 11:52 UTC by Ms. Manoela Miranda, UNEP/SCBD
|
|