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Topic 7: Relationship between synthetic biology and the criteria set out in decision IX/29

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Welcome message - synbio forum - topic 7 [#9675]
Dear Participants,

We have come to the last topic of the forum. Thank you all for your active participation and thorough discussions on the forum. For this final topic, we will discuss the relationship between synthetic biology and the criteria set out in decision IX/29, paragraph 12, in order to contribute to the completion of the assessment requested in decision XII/24 on determining if synthetic biology is a new and emerging issue.

The Conference of the Parties has underlined the importance of reducing the number of agenda items for consideration in order to improve the effectiveness of its proceedings (decision VIII/10, para 14). Thus, the Subsidiary Body on Scientific, Technical and Technological Advice (SBSTTA) was tasked with identifying new and emerging issues related to the conservation and sustainable use of biodiversity.

As such, the following list of criteria (decision IX/29, para 12) should be used for identifying new and emerging issues:

(a) Relevance of the issue to the implementation of the objectives of the Convention and its existing programmes of work;
(b) New evidence of unexpected and significant impacts on biodiversity;
(c) Urgency of addressing the issue/imminence of the risk caused by the issue to the effective implementation of the Convention as well as the magnitude of actual and potential impact on biodiversity;
(d) Actual geographic coverage and potential spread, including rate of spread, of the identified issue relating to the conservation and sustainable use of biodiversity;
(e) Evidence of the absence or limited availability of tools to limit or mitigate the negative impacts of the identified issue on the conservation and sustainable use of biodiversity;
(f) Magnitude of actual and potential impact of the identified issue on human well-being;
(g) Magnitude of actual and potential impact of the identified issue on productive sectors and economic well-being as related to the conservation and sustainable use of biodiversity.

Please note that, as of yet, there is no further guidance on how to apply these criteria. Yet, prior to SBSTTA-22 in 2018, the Secretariat prepared an information paper (see uploaded file) based on the reports from the AHTEG on synthetic biology and grouped elements of the AHTEG reports according to the seven criteria.

We finally take the opportunity to kindly suggest that you reply to this message when making interventions. This will facilitate the subsequent work on summarizing the information and writing the report. Additionally, when making your intervention, please indicate which of the subparagraph(s) (the ones listed above) you are referring to and the # of a particular post if you are responding to it.

Kind regards,

Casper Linnestad and Maria de Loudres Torres
posted on 2019-03-25 01:02 UTC by Mr Austein McLoughlin, Secretariat of the Convention on Biological Diversity
RE: Welcome message - synbio forum - topic 7 [#9676]
Dear Maria and Casper,

Thanks again for moderating and guiding us through all the topics.
Please find below my answers to the questions posed. Iam sorry if I repeat myself.

(a) Relevance of the issue to the implementation of the objectives of the Convention and its existing programmes of work

Organisms, components and products of synthetic biology can have neutral, positive or negative effects on biodiversity. This has to be assessed on a case-by-case basis. Since synthetic biology may result, on a case-by-case basis, in potential negative effects on biodiversity, synthetic biology is relevant for the implementation of the objectives of the Convention and its existing programmes of work.

(b) New evidence of unexpected and significant impacts on biodiversity

Up to now, there is no evidence for unexpected and significant impacts on biodiversity resulting from synthetic biology.

(c) Urgency of addressing the issue/imminence of the risk caused by the issue to the effective implementation of the Convention as well as the magnitude of actual and potential impact on biodiversity
 
The speed of development of organisms, components and products from synthetic biology is high. Since some of these developments may result in potential negative effects on biodiversity, we also consider the urgency of addressing synthetic biology in the effective implementation of the Convention to be high. 
Potential negative effects -if any- will most probably result from living organisms obtained by synthetic biology. Organisms obtained by synthetic biology that are (or will be) introduced in the environment in the near future fall under the definition of a living modified organism (LMO) and their safety is therefore addressed under the Cartagena Protocol on Biosafety. Taking this in account, addressing synthetic biology in the effective implementation of the Convention does not have high urgency. Urgency would be higher for organisms obtained by synthetic biology that do not fall under the definition of an LMO and that could pose a negative environmental effect.

(d) Actual geographic coverage and potential spread, including rate of spread, of the identified issue relating to the conservation and sustainable use of biodiversity

All organisms obtained by synthetic biology and that are released so far are LMOs. The actual geographic coverage and potential spread is therefore equal to the actual geographic coverage and potential spread of the current LMOs.

(e) Evidence of the absence or limited availability of tools to limit or mitigate the negative impacts of the identified issue on the conservation and sustainable use of biodiversity

All current and near-future organisms to be released into the environment obtained by synthetic biology are LMOs and their safety is therefore addressed under the Cartagena Protocol on Biosafety. So far no LMOs have been released that negatively impact conservation and sustainable use of biodiversity and where tools are absent or limited to mitigate these negative effects. However, in the future fast replicating and fast-spreading LMOs (such as some insects) with engineered gene drives can be released that may pose negative effects on biodiversity and where tools to mitigate these effects are so far limited.

(f) Magnitude of actual and potential impact of the identified issue on human well-being

As stated before, organisms, components and products of synthetic biology can have neutral, positive or negative effects on biodiversity. The magnitude of these potential effects cannot be predicted in a generalized manner and has to be assessed on a case-by-case basis.

(g) Magnitude of actual and potential impact of the identified issue on productive sectors and economic well-being as related to the conservation and sustainable use of biodiversity.

Organisms, components and products of synthetic biology can have neutral, positive or negative effects on several productive sectors such as agriculture, medical sector, in biofuel production and food sector (e.g. additives, colorants, flavorings).
posted on 2019-03-25 11:41 UTC by Ms. Boet Glandorf, Netherlands
RE: Welcome message - synbio forum - topic 7 [#9677]
Dear colleagues

My name is Professor Paul Freemont and I am an active researcher in synthetic biology and have been engaged in development in the field since 2004. I have been following the excellent discussion and exchange of ideas in the forum and I thank again the moderators and colleagues for their extremely thoughtful interventions. The forum has already accumulated a large body of knowledge from different perspectives on the field and its future relationship with the CBD community.

I earlier posted a summary of the field and what it is aiming to achieve but wanted to reiterate a few points as they seem to keep coming up in different forms and i hope this offers some clarity.

1. Synthetic biology also known as engineering biology or modern biotechnology and is an enabling platform technology

2. The molecular biology ‘toolkit’ has been rapidly expanded (e.g. Crispr etc) which combined with DNA synthesis and automation has allowed an expansion for modifying organisms at the genetic level.

3. As synthetic biology is an enabling technology the same LMO can be produced using traditional molecular biology tools (albeit slow and inefficient) as the concept of a ‘synthetic biology’ LMO is confusing and does not address the major issue which is that introducing large-scale genetic changes into living organisms is becoming more technically feasible.

4. Irrespective of the methods used to generate an LMO, each LMO should perhaps be considered separately in relation to the convention and its aims.

5. This scale and complexity of engineering living systems at the genetic level is increasing with a current ability to design and assembly large fragments of DNA to whole genomes / chromosomes (e.g. the Sc2.0 project is perhaps the most significant see http://syntheticyeast.org/sc2-0/).

6.  By combining this with the utilisation of automation and the application of engineering principles in the Design-Build -Test-Learn cycle with the concept of biofoundries the scale and complexity of LMOs will inevitably increase.

7. In parallel to these ‘mainstream’ developments, there are very active research projects around recoding genomes (non-canonical amino acids), new chemical mimetics of the genetic code, and the building of protocells or cell-like entities.


In terms of the key question of detection methods, I offer the following observations

1.  Long -read and deep sequencing with next-generation sequencing can allow LMO’s to be fully characterised even at a single base pair resolution.  This has recently been exemplified by analyses of T-DNA inserts in plants which produce highly complex genetic changes. (see https://journals.plos.org/plosgenetics/article?id=10.1371/journal.pgen.1007819)

2. Natural variation is a major issue for identification (as mentioned by Margaret and others [# 9643]) given that we do not have the sequencing information for every natural variant (near impossible- see below), it will therefore be difficult to distinguish single base changes from genome editing techniques to variants that already exist in nature.

3. Another major complexity is that natural variation can be produced by other interventions than synthetic biology e.g. HIV drug resistance (e.g. see https://hivdb.stanford.edu/), pathogen adaptation (e.g. see https://jcm.asm.org/content/42/12/5783) , antimicrobial resistance (e.g. see https://ardb.cbcb.umd.edu/) all produce significant genetic changes and it would be near impossible  to know whether such an organism was engineered / designed or occurred naturally through adaptation.

4. Genetic sequence information is only one level for detection. Using ‘omics’ technologies, proteins, metabolites, transcripts and other biochemical markers can be used for fully characterise biochemical phenotypes arising from any genetic changes with the possibility of perhaps developing a ‘biochemical fingerprint’ to support the genetic analyses.

5. It is plausible that LMOs that are designed to comprise particular traits (e.g. via genome editing) can be assessed using omics technologies. Some of these technologies have already been proposed to assess ‘natural’ versus ‘synthetic’ products produced by LMOs which I fully support.
posted on 2019-03-25 12:19 UTC by Mr. Paul Freemont, Imperial College London
RE: Welcome message - synbio forum - topic 7 [#9717]
Dear moderators and other colleagues,

I'd like to support the positions taken in posts [#9698] (Ilaria), [#9689] (Angela) and [#9684] (Helmut) and [#9682] (Lazaro) betwen others about the use of the Secretariat’s report as a starting point for deliberation on whether or not is needed further assessment of synthetic biology against the criteria set out in paragraph 12 of decision IX/29.

I agree with the comments [#9691](Galina) that potential spread and the rate of spread of such LMOs, especially gene drives, can be significantly higher than LMOs that have been released up to date, the impact of released LMOs also can be higher relating to the conservation and sustainable use of biodiversity.

Gene drive could be more precise tool for genetic ingeneer but a the same time, the number of traits that could be induced by these tehniques in a short period of time, can altere population dynamics in a higher manner than occurs with LMO released currently, affecting human well being consequently. So, adequate knowledge of their ecological effects are needed as well as mitigation measures.

We need to analize not only current aplications but challenges of gene drives in future, to consider these thechnologies and tools as an emerging issue to follow under objectives of the Convention.
regards,
Leyenis
posted on 2019-03-29 13:49 UTC by Ms. Leyenis Garcia Santos, Regulatory and Environmental Safety's Office
RE: Welcome message - synbio forum - topic 7 [#9719]
Dear Friends
IPLC express to need analyze the status of current applications including challenges  and impacts of gene drives, LMO and its future negative and adverse impacts on biodiversity, agro-biodiversity, wild or native species, ecosystem, nature and culture, spiritual and livelihood of IPLC.

IPLC  agree to be consider these technologies and tools as an emerging issues of Synthetic biology to follow under objectives of the Convention, article 8(j), 10c

Thanks with regards
IPLC
Kamal Kumar Rai
(edited on 2019-03-29 14:51 UTC by Kamal Kumar Rai)
posted on 2019-03-29 14:50 UTC by Mr. Kamal Kumar Rai, Society for Wetland Biodiversity Conservation - Nepal
RE: Welcome message - synbio forum - topic 7 [#9678]
Topic 7: Relationship between synthetic biology and the criteria set out in decision IX/29 (ie. the criteria for ‘new and emerging’ issues)

Thank you to the Moderators for all they have done to get us to this last question which has, finally, been brought to our collective attention.  Canada has submitted information to respond to the Secretariats analyses (the latest being CBD/SBSTTA/22/INF/17) which consisted of finding paragraphs of text from the reports of the two previous AHTEGs on this subject and presenting them in a table format in an attempt to align those paragraphs with the seven criteria below. 

It is worthwhile to repeat the introductory text from the moderators to underscore that the purpose of this exercise is to improve effectiveness and avoid duplication:  
The Conference of the Parties has underlined the importance of reducing the number of agenda items for consideration in order to improve the effectiveness of its proceedings (decision VIII/10, para 14). The Subsidiary Body on Scientific, Technical and Technological Advice (SBSTTA) is to identify new and emerging issues related to the conservation and sustainable use of biodiversity. The following list of criteria (decision IX/29, para 12) should be used for identifying new and emerging issues:
(a) Relevance of the issue to the implementation of the objectives of the Convention and its existing programmes of work;
(b) New evidence of unexpected and significant impacts on biodiversity;
(c) Urgency of addressing the issue/imminence of the risk caused by the issue to the effective implementation of the Convention as well as the magnitude of actual and potential impact on biodiversity;
(d) Actual geographic coverage and potential spread, including rate of spread, of the identified issue relating to the conservation and sustainable use of biodiversity;
(e) Evidence of the absence or limited availability of tools to limit or mitigate the negative impacts of the identified issue on the conservation and sustainable use of biodiversity;
(f) Magnitude of actual and potential impact of the identified issue on human well-being;
(g) Magnitude of actual and potential impact of the identified issue on productive sectors and economic well-being as related to the conservation and sustainable use of biodiversity.

With respect to (a), while synthetic biology can be said to be relevant to the implementation of the objectives of the Convention and its programmes of work, Canada also acknowledges that living organisms that are products of synthetic biology are LMOs and therefore are already covered by the Cartagena Protocol on Biosafety (CPB) and therefore are not ‘new and emerging’ with respect to the first two objectives of the Convention (conservation of biological diversity and sustainable use; see Art 1 of the CPB). 

With respect to (b), there simply is no evidence of unexpected and significant impacts on biodiversity arising from the living organisms that are products of synthetic biology. This criterion is not supported by any statements made in the reports of the previous AHTEGs on this subject. There are many statements in those reports on ‘potentials’ and also statements on the need for rigourous risk assessment processes but there is no evidence of unexpected and significant impacts. Since the organisms we have been describing to date are all LMOs, they would need to comply with the CPB rules for risk assessment.  

With respect to (c), (“urgency of addressing the issue/imminence of the risk…”)  some believed that ‘rapid pace of developments’ is a cause for concern.  However, when the AHTEG identified this aspect in their reports, they recognized, when saying so, that rapid change is not unique and not inherent to this technology.  Indeed, experts identified this aspect as primarily administrative in nature (eg. hiring enough risk assessors with the appropriate expertise; keep regulations and guidelines evergreen, etc.) and not related to an urgency as such. Also, the concern about the rapid pace of development speaks more to the need for capacity building and not the need to identify the issue as new and emerging. Since all synthetic biology organisms so far are LMOs, then Annex III of the CPB provides a framework for their risk assessment.  Even if one had a particular concern for genetically engineered gene drives,  there is no ‘imminent’ risk; in addition, they are all LMOs. 

Regarding (d) “…geographic coverage…” and the first two objectives of the Convention, there is no evidence that this criterion is met by any products of synthetic biology over and above any other LMO.

Regarding (e), (evidence of the absence or limited availability of tools to limit or mitigate the negative impacts … on the first two objectives of the Convention), the reports of the two AHTEGs indicated that  prudence is important in research and in risk assessment, but there was no evidence of absence or limited availability of tools to limit or mitigate potential negative impacts of organisms that result from synthetic biology techniques.  Such organisms are LMOs and are covered by the CPB and therefore are not ‘new and emerging’. 

Regarding (f), (…actual and potential impact … on human well-being), again two AHTEGs did not uncover evidence to support this criterion as ‘new and emerging’ in their reports.  We agree with text provided by Boet Glandorf (post #9676) in this respect that “organisms, components and products of synthetic biology can have neutral, positive or negative effects on biodiversity” (and presumably on human well-being as that may be a consequence of an effect on biodiversity) and that “The magnitude of these potential effects cannot be predicted in a generalized manner and has to be assessed on a case-by-case basis.”

And finally, with respect to (g), (magnitude of actual and potential impact … on productive sectors and economic well-being as related to the conservation and sustainable use of biodiversity), the two reports of the AHTEG did not uncover evidence to support that organisms resulting from synthetic biology would cause ‘new and emerging’ impacts on productive sectors and economic well-being as a consequence of an impact on biological diversity over and above other changes to biological diversity caused by other factors.  Agriculture, including classical biotechnology, information technology, and other technological changes, as well as migration, economic factors and human behaviour, have impacts on biological diversity and therefore on productive sectors and economic well-being but these are not ‘new and emerging’. Under the CPB, socio-economic factors should only be considered where this is an adverse effect on biodiversity. This criterion is not met for the ‘issue’ of synthetic biology organisms.

The text above is relevant for the living organisms that are products of synthetic biology and (mainly) the first two objectives of the Convention.  The impact of living organisms resulting from synthetic biology that are qualifying ‘genetic resources’ on the third objective of the Convention (namely, fair and equitable sharing of benefits arising from use of genetic resources) is covered by the scope of the Nagoya Protocol and therefore, once again, would not meet the ‘new and emerging’ criteria for precisely that reason. 

Components and products are not within the scope of the CPB.  So the question for us becomes “are the ‘new and emerging’ criteria applicable to components and products?” For example we are talking about assessment of possible impacts on biological diversity of DNA-based test kits, iGEM bio-blocks, certain vaccines, perhaps proto-cells, etc.  (components) and assessment of possible impacts of certain biofuels, certain perfumes, certain biologicals or drugs, certain flavourings (products) and whether these ‘issues’ meet the criteria for ‘new and emerging’.  It is fair comment to say that human activity (agriculture for example) can lead to reductions in biodiversity in order to create plantations of certain crops or trees in order to harvest a desirable product and that synthetic biology may lead to new ways of producing these products leading to economic impacts.  This is not ‘new and emerging’ and is as old as agriculture. Certain test kits, certain DNA sequences and certain chemicals are already covered by domestic regulation or international agreements that regulate end products; there are no ‘new and emerging’ factors that arise through their production using synthetic biology means.

Lastly, components and products are also covered by the scope of the Nagoya Protocol with respect to the sharing of benefits.  Therefore, the benefits arising from a certain DNA-based test kit, certain vaccines (if a qualifying genetic resource used), or the benefits arising from certain a new anti-cancer drug, a new plant variety, a new vaccine, a new pesticide (if a qualifying genetic resource was used) are covered and do not meet the criteria for ‘new and emerging’. 

Sincerely,
Jim Louter, Environment and Climate Change Canada
posted on 2019-03-25 16:27 UTC by Mr. Jim Louter, Canada
RE: Welcome message - synbio forum - topic 7 [#9679]
Dear Moderators thank you for guiding us
In addition to Margaret (9676) and Jim (9678) in relation to (a) relevance of the issue to the implementation of the objectives of the Convention and its existing programs of work the impact of digital sequence on access and benefit sharing may have a new perspective. Otherwise if standard operating procedures that prevent or minimize risks to the insignificant level are in place, the impact of synbio will be as same as the LMOs, and the potential negative and positive impact shall be investigated case by case.
Regarding (b) new evidence of unexpected and significant impacts on biodiversity;
Although there is no unexpected and significant negative impact on biodiversity so far, it is wisdom to learn from any negative impact arising from LMOs and Invasive alien species to be more proactive.
Regarding the items c, e f and g I agree with Margaret (9676) and Jim (9678).
posted on 2019-03-26 07:26 UTC by Mr. Taye Birhanu, Ethiopia
RE: Welcome message - synbio forum - topic 7 [#9681]
Topic 7 Relationship between synthetic biology and the criteria set out in decision IX/29

Further to my posting yesterday on this topic, I realize that Canada’s submission on the Secretariat’s analysis of the ‘new and emerging criteria’ was not completely transmitted last month but was belatedly posted as ‘other relevant information’.

The Secretariats analysis was posted in the introduction to topic 7:
http://bch.cbd.int/synbio/open-ended/discussion/ with the title CBD/SBSTTA/22/INF/17

Canada’s response (for the new and emerging analysis) was posted on the bottom of page:
http://bch.cbd.int/database/record.shtml?documentid=114321 as ‘other relevant information’.

Thank you
Jim Louter, Environment and Climate Change Canada
posted on 2019-03-26 13:35 UTC by Mr. Jim Louter, Canada
RE: Welcome message - synbio forum - topic 7 [#9680]
Dear moderators, Dear Maria and Casper
many thanks for the way you are guiding this forum. Honestly, I am learning a lot from all participants and I appreciate all contributions to the discussion.

Regarding (f), I also agree with text provided by Boet Glandorf (post #9676) in this respect that “organisms, components and products of synthetic biology can have neutral, positive or negative effects on biodiversity” (and presumably on human well-being as that may be a consequence of an effect on biodiversity), and that “the magnitude of these potential effects cannot be predicted in a generalized manner and has to be assessed on a case-by-case basis.”

The methods to look after were perfectly listed by Paul Freemont (post #9677).

1. Long -read and deep sequencing with next-generation sequencing. Even if, as he posted: „it would be near impossible to know whether such an organism was engineered / designed or occurred naturally through adaptation“.
The high level of heterogeneity between cells means that simply sampling from large populations of cells is not necessarily a reliable approximation of an individual cell's response. As a result, there have been numerous developments in the field of single-cell analysis to address this lack of knowledge.

2. „Omics technologies, means proteins, metabolites, transcripts and other biochemical markers can be used for fully characterise biochemical phenotypes. “
The increased resolving capabilities of capillary electrophoresis have been utilized for interesting biological applications at the single-cell level. These advancements in CE have expanded the knowledge of metabolites (the composition and quantity of metabolites can be indicative of how well an individual is functioning), proteins (to date, one of the smallest (approximately 20 µm) cell types to be analyzed by CE is PANC-1 cells https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5149395/pdf/nihms833487.pdf), nucleotides, and unicellular organisms (e.g. those that are similar in size (~2 mm) to Aplysia neurons; doi: 10.1039/C8AN00752G). 
A current publication explores multi-omic studies using capillary electrophoresis-mass spectrometry (CE-MS) https://reader.elsevier.com/reader/sd/pii/S0162013417302817?token=5688B42362CF6FE2EAEF6C82399ED74B20A254EB62EE9D39F3BF3306F1F591984F3CD47C88B6580911DA9E7ABA7DF288

We can anticipate more applications in this area in the near future. Single-cell analyses have benefitted greatly from the incorporation of CE and MS into experimental workflows, in order to address questions of cell heterogeneity and classify cell subtypes more confidently and accurately.

Progress in this area has also demonstrated capabilities in the quantitation with the use of chemical tags https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2882495/pdf/nihms191059.pdf

Best regards                 Zuzana Sekeyova
posted on 2019-03-26 09:25 UTC by Ms. Zuzana Sekeyova, Institute of Virology, Biomedical Research Center, Slovak Academy of Sciences
RE: Welcome message - synbio forum - topic 7 [#9682]
Dear moderators Maria and Casper and other colleagues,

First of all, I would like to say that in my view the contribution introduced by the Secretariat (information paper) based on the reports from the AHTEG according to the seven criteria is useful, make sense and is starting point to support deliberation on whether or not is needed further assessment of synthetic biology against the criteria set out in paragraph 12 of decision IX/29

The objective of a risk assessment under the Cartagena Protocol “is to identify and evaluate the potential adverse effects of living modified organisms on the conservation and sustainable use of biological diversity in the likely potential receiving environment, taking also into account risks to human health” (Annex III) and it is also connected with our task

Regarding criterion or subparagraphs I’m going to add also some paragraphs, public information and comments in support to the analysis:

(a) Relevance of the issue to the implementation of the objectives of the Convention and its existing programmes of work;

Paragraph 11, CBD/COP/DEC/14/19

“Calls upon Parties and other Governments, taking into account the current uncertainties regarding engineered gene drives, to apply a precautionary approach,  in accordance with the objectives of the Convention, and also calls upon Parties and other Governments to only consider introducing organisms containing engineered gene drives into the environment, including for experimental releases and research and development purposes, when:
(a) Scientifically sound case-by-case risk assessments have been carried out;
(b) Risk management measures are in place to avoid or minimize potential adverse effects, as appropriate;
(c)….. the “free, prior and informed consent” or “approval and involvement”  of potentially affected indigenous peoples and local communities is sought or obtained, where applicable in accordance with national circumstances and legislation;”

Advanced Gene Editing: CRISPR-Cas9. Dec 2018    https://crsreports.congress.gov

- Gene Drives and Environmental Concerns

“Anticipation of potential benefits of CRISPR-Cas9-enabled gene drives to human health, agriculture, and the environment is accompanied by concern over potential negative consequences to other species and ecosystems. …The fast moving nature of this field is both encouraging and concerning. While gene-drive modified organisms hold promise for addressing difficult to solve, persistent challenges, …. these proposed applications are based on limited proof-of-concept studies. The presumed efficiency of gene-drive modified organisms may lead to calls for their release in perceived crisis situations, before there is adequate knowledge of their ecological effects, and before mitigation plans for unintended harmful consequences are in place.”

-Social Acceptance and Ethical Concerns
“According to the National Academy of Sciences, “there is insufficient evidence available at this time to support the release of gene-drive modified organisms into the environment,” and a considerable amount of research and evaluation is still necessary”
“Concerns about environmental justice and who will be responsible for addressing unanticipated public health or environmental harms may also be an issue as developing countries may be primary locations for the use of gene drives.”

The CRISPR tool kit for genome editing and beyond
Nature Communications volume 9, 2018 Article: 1911

-…. sufficient considerations need to be devoted to the social and ethical implications of such technologies so that they will be accessible to all layers of society and benefit all humankind.

(b) New evidence of unexpected and significant impacts on biodiversity;

I agree with the view of several participants that “organisms, components and products of synthetic biology can have neutral, positive or negative effects on biodiversity” but also to human health, the economy and society. At the same time these effects could be broader and more wide ranging taking into account the complexity of Synbio and their applications, that’s why the interest in research, and also in the market. See Table 1 attached
“Off-target effects are also a concern in gene edited farm animals, such as pigs and cattle,65 and have been detected in gene-edited mice66 and human cells67. However, some studies report a lack of detectable off-target effects in gene-edited animals.68 This could be because, although the off-target effects may be present, it is difficult to distinguish between off-target effects and natural genetic variation.69
Gene-edited organisms in agriculture: Risks and unexpected consequences Sept 2018 http://www.foe.org

On the other hand the lack of evidence about negative impacts originated by Synbio doesn't mean their absence.

(c) Urgency of addressing the issue/imminence of the risk caused by the issue to the effective implementation of the Convention as well as the magnitude of actual and potential impact on biodiversity;

Once again “organisms, components and products of synthetic biology can have neutral, positive or negative effects on biodiversity” but also to human health, the economy and society. At the same time these effects could be broader and more wide ranging taking into account the complexity of Synbio and their applications. Urgency is relative but possible, for instance:

“The presumed efficiency of gene-drive modified organisms may lead to calls for their release in perceived crisis situations, before there is adequate knowledge of their ecological effects, and before mitigation plans for unintended harmful consequences are in place”
Advanced Gene Editing: CRISPR-Cas9. Dec 2018  https://crsreports.congress.gov

(e) Evidence of the absence or limited availability of tools to limit or mitigate the negative impacts of the identified issue on the conservation and sustainable use of biodiversity;

“Speakers also commented on known limitations and bottlenecks with the use of genome editing tools.
Using the tools to do single nucleotide substitutions is still a challenge, ... Their applicability for epigenome editing is still on the horizon, …. The fact that the action of genome editing needs to be validated by polymerase chain reaction sequencing is also a bottleneck
…. the need for information on delivery to different tissue types, as well as methodological input for standardization and optimization. The existence of improved gRNA design algorithms and improved prediction of off-target effects could also help environmental health research move forward
The fact that genome editing knock-outs are different from knock-downs may give prospective users pause, …
The Promise of Genome Editing Tools to Advance Environmental Health Research: 2018
https://doi.org/10.17226/25136

A recent workshop examined key questions concerning effects of development and use of gene drives in varied species and contexts

“Toward integrated risk management
(i) Before any primary drive is released in the field, the efficacy of specific reversal drives should be evaluated…
(ii) Long-term studies should evaluate the effects of gene drive use on genetic diversity in target populations
(iii) Investigations of drive function and safety should use multiple levels of molecular containment to reduce the risk that drives will spread through wild populations during testing.
(iv) Initial tests of drives capable of spreading through wild populations should not be conducted in geographic areas that harbour native populations of target species.
(v) ….

(ix) To assess potentially harmful uses of drives, multidisciplinary teams of experts should be challenged to develop scenarios on deliberate misuse
This lead time enables public discussion of environmental and security concerns, research into areas of uncertainty, and development and testing of safety features. It allows adaptation of regulations and conventions in light of emerging information on benefits, risks, and policy gaps. Most important, lead time will allow for broadly inclusive and well-informed public discussion to determine if, when, and how gene drives should be used.”
Regulating gene drives  http://www.sciencemag.org/content/early/recent

- ….the need for improved algorithms to predict off-target effect of gRNAs and improved methods to detect inadvertent germline editing or other off-target effects in the genome, including insertions, deletions, and chromosomal instability and unwanted immunogenicity……
The Promise of Genome Editing Tools to Advance Environmental Health Research: 2018
https://doi.org/10.17226/25136

(f) Magnitude of actual and potential impact of the identified issue on human well-being;

Likewise “organisms, components and products of synthetic biology can have neutral, positive or negative effects on biodiversity” also to human health, the economy and society. At the same time these effects could be broader, taking into account the complexity of Synbio and their applications.

(g) Magnitude of actual and potential impact of the identified issue on productive sectors and economic well-being as related to the conservation and sustainable use of biodiversity.

“Over the next 5 to 10 years, the National Academy of Sciences projects a rapid increase in the scale, scope, complexity, and development rate of biotechnology products, many enabled by CRISPR-Cas9. Concomitant with the promise of potential benefits, such advances may pose new risks and raise ethical concerns
In August 2018, Ireland-based Research and Markets estimated that the global market for gene editing will grow at a compound annual growth rate (CAGR) of 33.26% from $551.2 million in 2017 to $3.087 billion in 2023.
India-based Markets and Markets estimated that the global market for gene editing will increase from $3.19 billion in 2017 to $6.28 billion in 2022
A February 2017 projection by the U.S.-based market research firm Grand View Research anticipates the global market for gene editing will reach $8.1 billion by 2025.
Advanced Gene Editing: CRISPR-Cas9. Dec 2018  https://crsreports.congress.gov

An important issue in this regard is the fair equitable sharing of the benefits. I remember an appeal of Mr. Matthew Legge during the first round of online Forum in 2015 who pointed out:

“It is clear to us that the profit motive does not necessarily work to support the goal of the preservation of biological diversity or the fair sharing of costs and benefits between developed and developing countries. At present, there appears to be a concentration of decision making power and control related to synthetic biology in the hands of a limited number of stakeholders, most of whom are driven primarily by a profit motive and who do not bring an ecological perspective to their decisions. “

Respectfully,
Lazaro Regalado
posted on 2019-03-27 15:30 UTC by Mr. Lazaro Regalado, Cuba
RE: Welcome message - synbio forum - topic 7 [#9683]
With respect to criterion  “(g) Magnitude of actual and potential impact of the identified issue on productive sectors and economic well-being as related to the conservation and sustainable use of biodiversity”: 

Post #9678 presents market forecasts of the global market for gene-editing (3 to 8 billion USD) and raises the question of fair and equitable sharing of benefits. The post closes with the appeal made by Matthew Legge in the 2015 online discussion: “[T]here appears to be a concentration of decision making power and control related to synthetic biology in the hands of a limited number of stakeholders, most of whom are driven primarily by a profit motive and who do not bring an ecological perspective to their decisions.” 

One can extend Legge’s observation. The limited number of stakeholders also “do not bring an [economics] perspective to their decisions.” That perspective centers on the modality of the Global Multilateral Benefit-Sharing Mechanism (GMBSM) of Article 10 of the Nagoya Protocol for transboundary resources.  Just as the market system deems monopoly rents over artificial information efficient and equitable (intellectual property), the market system would also deem oligopoly rents for natural information efficient and equitable (a GMBSM). Why doesn’t it happen? Nothing augments the profit motive more than privatizing the benefits and socializing the costs. Quasi-socialization occurs  through bilateral ABS, which eliminates rents through competition among Providers (see Post #9527 in Thread 4). 

The economics remains studiously ignored (http://www.lead-journal.org/content/11052.pdf).
posted on 2019-03-27 16:50 UTC by Mr. Joseph Henry Vogel, University of Puerto Rico-Rio Piedras
RE: Welcome message - synbio forum - topic 7 [#9684]
Dear all,

thank you Maria and Casper for guiding us through the last round of discussion during this online Forum.

This is an important issue and it has been discussed at length in previous Settings.

I regard the information paper prepared by the Secretariat prior to SBSTTA-22 and uploaded as file by our moderators as an adequate analysis of the work on this matter, done by the AHTEG on synthetic biology during its two meetings (September 2015, December 2017). Therefore I think that this information paper is a good basis for our discussion during this online forum and beyond. Fully respecting the list of criteria of decision IX/29, para 12, I would like to note, that in many of the listed criteria not only the concept of “actual” (spread, impact etc.) is included but also the concept of “potential” (spread, impact etc.). This acknowledges the fact that with new and emerging issues the focus should not only be restricted to what has already been identified (it would not be new and emerging any more then in a strict sense) but also include forward-looking scenarios what may happen. It can therefore be argued that the information paper by the Secretariat based on the analysis by the AHTEG meetings, suggests that the topic of synthetic biology fulfills the criteria set out in decision IX/29, paragraph 12, and therefore should be regarded as a “new and emerging issue”. I therefore suggest that the upcoming AHTEG reviews this document, amends it if necessary and finalizes the exercise on that basis to be submitted to SBSTTA.

I am looking Forward to our further debate, all the best

Helmut Gaugitsch
Environment Agency Austria
posted on 2019-03-27 17:38 UTC by Mr. Helmut Gaugitsch, Austria
RE: Welcome message - synbio forum - topic 7 [#9685]
Topic 7: Relationship between synthetic biology and the criteria set out in decision IX/29

Replying to post # 9684 (Helmut Gaugitsch) in which he characterized the Secretariats analysis as “adequate” I would like to quote the instruction from COP (UNEP/CBD/COP/DEC/12/24) in which the COP said  “Awaits the completion of a robust analysis using the criteria set out in paragraph 12 of decision IX/29”.  Perhaps it is a matter of opinion that this is adequate, but placing a sample of selected text from the two AHTEG reports in a table underneath headings for the criteria does not qualify as a robust analysis. 

It is my understanding that the purpose of the ‘new and emerging’ criteria is a means for achieving efficiency and avoiding duplication; if I do not understand correctly, then we accept, for example, that we will be discussing a hypothetical genetically engineered gene drive (which are all LMOs) in an AHTEG on synthetic biology AND an AHTEG under the Cartagena Protocol at least with respect to the first two objectives of the Convention. I suppose if the hypothetical genetically engineered gene drives was based on a qualifying genetic resource, then ABS implications would also be subject to the Nagoya Protocol; will we discuss that as well under this heading?  Shouldn’t such discussion occur under that agreement and not under the AHTEG on synthetic biology (to avoid duplication)?

Some have said “but we still need a venue to discuss these issues” – I don’t disagree but these issues need to be discussed in the appropriate forum and under the appropriate CBD agreement with the scope and mandate to cover them.   If genetically engineered gene drive LMOs are our primary concern then a combined AHTEG under the SBSTTA to cover all the objectives of the Convention would be a more efficient way to deal with those concerns.

Sincerely,

Jim Louter
Environment and Climate Change Canada
posted on 2019-03-27 21:00 UTC by Mr. Jim Louter, Canada
RE: Welcome message - synbio forum - topic 7 [#9686]
In addition to #9685 I strongly agree that we need a robust analysis. Avoiding double efforts should also be a major focus. I think this is an important point I only can second.
posted on 2019-03-28 06:33 UTC by Mr. Gernot Segelbacher, University Freiburg
RE: Welcome message - synbio forum - topic 7 [#9687]
Thanks to Mr Joseph Henry Vogel for this post #[ 9683]. I would like to take this opportunity to reiterate our preoccupation with biopiracy, which seems to us insufficiently dealt with in the CBD and which nevertheless presents considerable economic impacts for the genetically plundered countries like Madagascar. Please refer to our post [# 9518] in Topic 4. Thus, a better organization of the agendas could be useful.
Anyway, I totally disagree with those who think that “This criterion is not met for the ‘issue’ of synthetic biology organisms.
posted on 2019-03-28 07:36 UTC by M. Jean Roger Rakotoarijaona, Madagascar
RE: Welcome message - synbio forum - topic 7 [#9689]
It is a very interesting discussion on emergency measures under the decision IX/29. I would like to refer to the posts of Margret (#9658), Felicity (#9656), Jack (#9644) and others, under the topic 5, who bring examples of SynBio products that could not be considered as living modified organisms (ex. no reproduction), but while disseminated may have potential impact to biodiversity.  As the Cartagena Protocol has it's main objective that reffers to ensuring safety to biodiversity, focusing on advers risks to the biodiversity causing from LMOs and its products, therefore my reading is that the CBD imply the scope to ensure biosecurity from all possible factors that might have potential impact to biodiversity. In my view it is time to enlarge the area of focus of the Cartagena protocol  spreading safety procedures to the SynBio that are not LMos, including development of additional specific procedures for risk assessment for new developments (Annex III).
With regards to the opinion new developments of SynBio may have positive, neutral and negative impact and should be a topic of RA, my understanding is that risk assessment procedures have to be applyed exclusivelly to the negative impact, as it is refers to the precautionary principle that is implyed by the CBD.  I do not minimise consideration and importance of SymBio applications for human interests, as it mentioned Lazaro in figures (#8930).
I support the point of view of Helmut (#9684) considering the potential impact of SynBio applications, even there is no evidence of negative impact at the time, but taking into consideration the speed of research and new applications, it would have a critical needs to suggest procedural elements to make possible assessment of potential risks and its emergecy management as well, as it is suggested by the desicion IX/29.
posted on 2019-03-28 10:33 UTC by Ms. Angela Lozan, Republic of Moldova
RE: Welcome message - synbio forum - topic 7 [#9688]
Dear colleagues,

I think that the analysis prepared by the secretariat is a good starting point, but in some points cannot provide the evidence asked for in the criteria laid out in decision IX/29, paragraph 12. 
However, there seems to be broad consensus that organisms developed with the help of synthetic biology so far and in the near future are considered LMOs as defined in the Cartagena Protocol (see discussion on topic 5 and also the AHTEG reports). The impacts of organisms produced with synthetic biology would thus in great parts be comparable to those of LMOs:

a) Relevance of the issue to the implementation of the objectives of the Convention and its existing programmes of work
As already stated synthetic biology organisms are LMOs. LMOs are relevant to the objectives of the Convention and are addressed under the Cartagena Protocol.

b) New evidence of unexpected and significant impacts on biodiversity
There is no reliable evidence on unexpected and significant impacts on biodiversity. At the moment, no organisms produced with synthetic biology are known that do not fall under the definition of an LMO according to the Cartagena Protocol (this includes organisms containing engineered gene drives). Thus, the impacts on biodiversity are expected to be comparable to those of LMOs.

c) Urgency of addressing the issue/imminence of the risk caused by the issue to the effective implementation of the Convention as well as the magnitude of actual and potential impact on biodiversity
Some organisms of synthetic biology may become close to a deliberate release or a market launch in the next few years. However, these organisms (e.g. organisms containing engineered gene drives) are LMOs and can be addressed according to the Cartagena Protocol. Therefore, there is no urgency of addressing these organisms. As stated in post #9676, “Urgency would be higher for organisms obtained by synthetic biology that do not fall under the definition of an LMO and that could pose a negative environmental effect”.

d) Actual geographic coverage and potential spread, including rate of spread, of the identified issue relating to the conservation and sustainable use of biodiversity
In case of organisms containing engineered gene drives, potential spread and impact on wild populations is intended. These specific characteristics need to be considered on a case-by-case basis in risk assessment. For other organisms produced with synthetic biology the rate of spread is similar to that of current LMOs.

e) Evidence of the absence or limited availability of tools to limit or mitigate the negative impacts of the identified issue on the conservation and sustainable use of biodiversity
The geographic restriction of organisms containing engineered gene drives may potentially be more difficult compared to other LMOs. The extent to which this can have negative effects must be examined on a case-by-case basis. For other organisms produced with synthetic biology there is no evidence of the absence of tools to limit potential negative impacts. These organisms are LMOs and are covered by the Cartagena Protocol. Furthermore, some organisms produced with synthetic biology are developed for very special conditions for use in a lab or in manufacturing and will only have limited viability outside these conditions making their unintentional spread unlikely.

f) Magnitude of actual and potential impact of the identified issue on human well-being
Organisms produced with synthetic biology are a highly variable group making it difficult to describe their impact on human well-being in general. These issue would have to be addressed on a case-by-case basis. The impacts are, however, comparable to those of current LMOs.

g) Magnitude of actual and potential impact of the identified issue on productive sectors and economic well-being as related to the conservation and sustainable use of biodiversity
Economic impacts of synthetic biology cannot be addressed in general, but are dependent on the individual product.

Best regards,
Swantje
posted on 2019-03-28 10:28 UTC by Ms. Swantje Strassheim, Germany
RE: Welcome message - synbio forum - topic 7 [#9691]
Dear Maria and Casper, dear colleagues,

I agree in general with the arguments presented in the post of Boet [#9676] on most points.
At the same time I have some considerations.
(d) Actual geographic coverage and potential spread, including rate of spread, of the identified issue relating to the conservation and sustainable use of biodiversity

Potential spread and the rate of spread of such LMOs, especially gene drives, can be significantly higher than LMOs that have been released up to date, the impact of released LMOs also can be higher relating to the conservation and sustainable use of biodiversity. But evaluation need to be done on case-by-case.
(e) Evidence of the absence or limited availability of tools to limit or mitigate the negative impacts of the identified issue on the conservation and sustainable use of biodiversity

Although many of the existing tools can be used to identify a number of LMOs developed by synthetic biology, and there is a great potential for using sequencing, Omics technologies [#9680], all of this may make sense, at least for now, for laboratory detection or for use in risk assessment schemes for estimation of potential effects to human health (for example, to show substantial equivalence of new organism or synthesized substance). In the case of monitoring (for example, gene drives during field trials or subsequent unauthorized release of new LMOs or unintentional leaks of LMOs) all this is much more complicated. And such methods may not work fast for this purposes, at least for now. At the same time, it is necessary to take into account that the development of LMOs by synbio is proceeding at a rapid pace, and for some of them, really fast and accurate monitoring methods need to be made available when released to the market.
In some cases, such a tool of reducing the impact can only be risk management. For such cases (again on case-by-case basis) there will be a need to develop the right measures and procedures to control such risks. Only it must be done not after but before.

Best wishes,
Galina
(edited on 2019-03-28 13:42 UTC by Galina Mozgova)
posted on 2019-03-28 13:09 UTC by Dr. Galina Mozgova, Belarus
RE: Welcome message - synbio forum - topic 7 [#9693]
After reading #9691 and many others contributions, I think it is worth reiterating that there are gene drives that theoretically can spread over the entire geographic range of a species, but there are other gene drives that can only spread very locally.
If we keep just referring to "gene drives" it is easy to develop the assumption that all gene drives have unlimited capacity to spread. When discussing the risks of unlimited gene drives, it would be helpful to use the term "unlimited gene drives"
If we continue to just use the term "gene drives" it might result in not recognizing that every time a group considers using gene drives, it has a choice between limited and unlimited gene drives.
posted on 2019-03-28 13:49 UTC by Mr. Fred Gould, North Carolina State University
RE: Welcome message - synbio forum - topic 7 [#9690]
Dear Colleagues,

This is an elaboration of the position expressed in the Bulgarian reply to Notification 2018-103 (https://bch.cbd.int/database/record.shtml?documentid=114407) with which I certainly agree.

Some addition explanations of my position should be given:
1. We prefer somewhat more narrow view of synthetic biology and we think the defining feature of synthetic biology is that it allows introduction into living systems (ecosystems, organism, cells) of functionally important components (organisms, proteins, nucleic acids, lipids, metabolites, etc.) or processes (metabolic or signal transduction pathways, gene circuits, etc.) that are do not exist in nature or are significantly different from those that exist in nature. Such view falls within the definition developed by AHTEG, but is more specific and captures key features of new technologies that have appeared in the recent years.

2. Gene drives probably fall within the broader scope of ecosystem engineering technologies in particular those that change the genetic structure of the populations. They are on the only example, but they use relatively recent technologies and it seems that they are close to the stage when their application will be practically feasible. We fully appreciate that gene drives are not a single technology and there are important particularities that should be taken into account, in particular in risk assessment. Nevertheless, low threshold global drives seem to be in the most advanced stage of development and the applications that are foreseen at present – elimination of disease vectors or IAS or total genetic modification of their entire population to eliminate the ability to spread disease(s) will benefit and actually might require use of gene drives that spread at or eliminate fast the entire population starting from relatively low allelic frequency.

3. One can argue whether gene drives are synthetic biology or not, or if they might sometimes be based on synthetic biology applications. We appreciate such concerns and to some extend share them, but analysis for fulfilment of the criteria for a New and Emerging Issue is a legal one, not a scientific one. Science is very important but only in providing the data needed.

4. When doing this analysis we believe that all criteria should be met, which is very stringent and literal approach. And along this line we also believe that the criteria should be read as they are and not make any additional assumptions. So the analysis that I will try to provide is a pretty formal one.

5. I agree that all or almost all organisms developed through synthetic biology or likely to be developed in near future are LMOs. Thus Cartagena Protocol (CP) is a very relevant legal instrument. But stating this we have to consider a few issues:
a) CP objective is “is to contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and specifically focusing on transboundary movements.” Thus the CP is focused predominantly on transboundary movements of LMOs (my interpretation is that it is not focusing exclusively on them). Such view is also supported by the Article 4 of CP on the scope. It is also not focusing on the third objective CBD, which is reasonable. So CP does not cover all aspects biosafety relevant for the CBD objectives. In addition CP is binding only for the Parties to it, but not to all CBD parties.

b) CBD has three broader objectives that are binding to all Parties to that treaty. In the narrower sense of Article 8(g):  “Each Contracting Party shall, as far as possible and as appropriate: …(g) Establish or maintain means to regulate, manage or control the risks associated with the use and release of living modified organisms resulting from biotechnology which are likely to have adverse environmental impacts that could affect the conservation and sustainable use of biological diversity, taking also into account the risks to human health;…”. It is absolutely clear that the requirements Article 8(g) go well beyond the scope of CP and the Protocol elaborates only on some of them. Just because a synthetic biology organism is a LMOs and falls within the scope of CP does not excludes it from the requirements of CBD Article 8(g).

c) Nevertheless CP, as rightly pointed by some of contributors, is a very important and relevant instrument for ensuring the safe handling of synthetic biology organism that are LMOs. I hope that no one opposes such a view. If we accept that CP as the main instrument for safe work with synthetic biology organisms in the context of CBD, this means that much more active work under CP than we see at present.

We have tried to classify in the Bulgarian reply the main fields of development of synthetic biology and we believe that most of them do not fulfil the criteria set out in decision IX/29, paragraph 12. Main reason for this the development is in a rather early stage and we lack sufficient data, or it is closely related to LMOs developed through classical (whatever classical means in this case) genetic engineering. Thus Synthetic biology as a whole does not fulfil the criteria for a new and emerging issue.

Gene drives deserve more detailed analysis. Under “gene drive” understand “systems of biased inheritance in which the ability of a genetic element to pass from a parent to its offspring through sexual reproduction is enhanced” (Gene Drives on the Horizon, 2016, ISBN 978-0-309-43787-5). This definition covers all different types of drives considered at present.

What follows is analysis for each of the individual criteria:
(a) Relevance of the issue to the implementation of the objectives of the Convention and its existing programmes of work;
Gene drives can, at least in theory, remove whole populations from the ecosystems or can significantly alter their genetic structure. Thus they can affect the conservation of biological diversity directly (by removing or altering whole species or populations) or indirectly (e.g. by changing the relations between species), both negatively (e.g. directly removing whole populations or indirectly by removing the food base of some non-target species) or positively (e.g. by elimination invasive alien species, vectors or pathogens). The objective of the sustainable use of biological diversity components can also be affected positively (e.g. by eliminating important pests) or negatively (e.g. by affecting species used by local communities).
Taking into account the above considerations the criterion can be considered fulfilled.

(b) New evidence of unexpected and significant impacts on biodiversity;
Evidence here should be understood not only as experimental data but also of scientifically sound theoretical (modelling) studies.
The practical experience with release of gene drives into the environment is very limited. At the same time the modelling studies show that even very inefficient gene drives are likely to be highly invasive and practically impossible to control (Current CRISPR gene drive systems are likely to be highly invasive in wild populations, Noble et al., eLife 7, e33423). Such modelling studies seem to be in-line with the experiments with laboratory populations (A CRISPR-Ca9 gene drive targeting doublesex causes complete population suppression in caged Anopheles gambiae mosquitoes, Kyrou et al., Nature Biotechnology 36, 1062-1066). Taking into account that the relations between species in an ecosystem are non-linear and complex, elimination or altering of genetic structure of a whole natural population may result in effects whose nature or magnitude will be very hard to predict.
Taking into account the above considerations the criterion can be considered fulfilled.

(c) Urgency of addressing the issue/imminence of the risk caused by the issue to the effective implementation of the Convention as well as the magnitude of actual and potential impact on biodiversity;
The concept behind the gene drives is rather old, but in the last five years there has been significant progress in its implementation. It seems likely that in near future organisms that carry efficient gene drives might be released into the environment. Currently no effective technology to control gene drives is available. The magnitude of actual or potential impacts on the biodiversity is hard to predict but is might to be significant (see point b) above) at least in some cases.
Taking into account the above considerations the criterion can be considered fulfilled.

(d) Actual geographic coverage and potential spread, including rate of spread, of the identified issue relating to the conservation and sustainable use of biodiversity;
The actual geographic coverage and potential spread, including rate of spread are likely to be depend of different factors, such as the type of gene drive used, genetic structure of the populations (e.g. the presence and frequency of resistance alleles), effective size and geographic spread of populations affected, reproduction times, etc. In some cases, such as mice or mosquitoes, the potential effects can be global and the rate of spread can be high.
Taking into account the above considerations the criterion can be considered fulfilled.

(e) Evidence of the absence or limited availability of tools to limit or mitigate the negative impacts of the identified issue on the conservation and sustainable use of biodiversity;
Different approaches to control or eliminate gene drives that have been released into the environment have been proposed (For some examples see Champer, Buchman and Akbari, Nature Reviews Genetics 17, 146-159) but so far we are not whether any of them to have proven to be effective in natural context. In addition their development still lags behind the development of efficient gene drives. So for the time being the released of gene drives into the environment should be considered irreversible (taking into account the stochastic nature of the process of establishment, which is likely to be efficient or the self-elimination due to the eradication of the whole target population).
Taking into account the above considerations the criterion can be considered fulfilled.

(f) Magnitude of actual and potential impact of the identified issue on human well-being;
Importantly criteria (f) and (g) talk about actual and potential effects. Well-reasoned expectations would also be acceptable. And those two criteria should consider both the negative and positive impacts.
No gene drives have been released into environment in a large scale, so only potential impact can be considered at present. Those impacts can be both positive (e.g. elimination of pathogens, pests or vectors for important diseases, such as malaria) or negative (e.g. effects of some pollinators) and of significant magnitude.
This criterion can be considered fulfilled.

(g) Magnitude of actual and potential impact of the identified issue on productive sectors and economic well-being as related to the conservation and sustainable use of biodiversity;
Similar to the issue above, only potential impact can be considered. Those impacts can be either positive (e.g. increased crop yields due to pathogens or pests elimination) or negative (e.g. effects of some pollinators) and of significant magnitude.
This criterion can be considered fulfilled.

Our overall conclusion is that the gene drives are very likely to fulfil formally all the criteria for a new and emerging issue as set out in decision IX/29, paragraph 12.

Best Regards,
Nikolay
posted on 2019-03-28 11:56 UTC by Mr. Nikolay Tzvetkov, Bulgaria
RE: Welcome message - synbio forum - topic 7 [#9692]
I am Nada Hamza from Sudan. Thank you, I am learning a lot from the interventions and discussions.  There  is high need for consideration of the ethical implications of  living modified organisms, components and products developed through synthetic biology to the objectives of the convention.

c) Urgency of addressing the issue/imminence of the risk caused by the issue to the effective implementation of the Convention as well as the magnitude of actual and potential impact on biodiversity:

Risks on biodiversity exist, e.g. the wide application of the RR cotton had drastic effects on natural populations, and health of farmers. The use of glyphosphate is increasing regardless of the hazards it leaves behind.
Moreover, in several countries there is still a challenge to conduct risk assessments, due to lack of training and capacity building, also need for SOPs.
posted on 2019-03-28 13:12 UTC by Ms. Nada Hamza, Commission for Biotechnology & Genetic Engineering
RE: Welcome message - synbio forum - topic 7 [#9694]
Dear all:

My answer to this topic are as follows:
1.Synthetic biology is an engineering transformation of biological systems, organisms or their derivatives for specific purposes. It is a method of artificial synthesis to redesign and transform natural biological systems. At present, the applications of synthetic biology technology are concentrated in the medical fields. Although, according to the definition and connotation of synthetic biology, the working objects of synthetic biology may be biological resources, including genetic resources, there are still insufficient evidences that the applications of synthetic biology have direct impacts on the protection and utilization of biodiversity, as well as the ecological environments, compared with the impacts of habitat loss and invasion of alien species.
2.Regulators and decision makers of parties may face great challenges in adequately identifying and addressing the potential positive and negative impacts of synthetic biology on biodiversity. Currently, synthetic biology belongs to cutting-edge technology, and developing very rapidly, which causing most of the parties lack in the ability to scan the risks comprehensively and to evaluate the positive and negative effect on biodiversity conservation and utilization. Actually, regulators and policymakers still face challenges in judging the impact of synthetic biology on biodiversity and in developing targeted regulatory regimes and methods.
3.New technologies that may be related to synthetic biology should be further explored and studied in relation to the Convention. The obvious or definite positive and negative impacts on biodiversity and ecological environment are still unknown. In recent years, some technological work have carried out researches on the advantages and disadvantages of these technologies, however, the results have not been published. Therefore, the relevance of these technologies related to synthetic biology to the Convention still needs to be further explored and studied.
4.In view of the differences in the capabilities of the parties to the Convention in the application and technology of synthetic biology, it is encouraged to strengthen international communication and discussions on synthetic biology in order to meet the needs of the parties in judging whether synthetic biology is a "new and emerging issue" of the Convention.

Regards,

Jiang Chang

CRAES,China
posted on 2019-03-28 15:47 UTC by Mr. Jiang Chang, CRAES
RE: Welcome message - synbio forum - topic 7 [#9699]
POSTED ON BEHALF OF Ms. Idah Sithole Niang, Zimbabwe:

I agree with Mr Jiang Chang that the speed with which products are developed, the repertoire of the products thereof (and going beyond medicine), and the lack of a footprint still presents challenges of detection and providing adequate oversight, especially in resource-limited settings.
I have enjoyed the rich discussions that have gone on, and feel immensely privileged to have been on this forum. Going forward I can engage much more meaningfully when these discussion are held at country level.
Thank you,
Idah Sithole-Niang
Zimbabwe
posted on 2019-03-28 19:37 UTC by Ms. Melissa Willey, UNEP/SCBD/Biosafety
RE: Welcome message - synbio forum - topic 7 [#9695]
Dear colleagues,

I would like to show some points below:

Regarding (b) New evidence of unexpected and significant impacts on biodiversity
I agree with Ms. Boet Glandorf. Up to now, there is no evidence for unexpected and significant impacts on biodiversity resulting from synthetic biology.

Regarding (f) Magnitude of actual and potential impact of the identified issue on human well-being
Synthetic biology is ushering a very exciting time for the biotechnology industry and medicine, filled with new applications, new products, and new biotic diagnostics and therapeutics. Considering the new biotic diagnostics and therapeutics, engineering indigenous microbiota community members and nonresident probiotic bacteria by synthetic biology is a promising method as biotic diagnostics and therapeutics that can probe and improve human health. (Annu Rev Biomed Eng. 2018 Jun 4;20:277-300. doi: 10.1146/annurev-bioeng-062117-121019.). If the microbiota community members are engineered by synthetic biology, it absolutely affect the biodiversity. However, the magnitude of these potential effects cannot be predicted and has to be assessed on a case-by-case basis.

Yet, synthetic biology also raises important public policy considerations about whether the field is being developed in line with the public’s interest, as well as biodiversity, biosafety and biosecurity concerns. The practitioners of synthetic biology also need to attend to concerns about the biodiversity, safety and security of the field, as well as work to ensure that the work is conducted in the public interest.

Sincerely,

Zhiwen Wang
posted on 2019-03-28 16:30 UTC by Mr. Zhiwen Wang, Tianjin Univeersity
RE: Welcome message - synbio forum - topic 7 [#9696]
Dear Participants,

Thanks again to you all for your thoughtful contributions and to the moderators for their guidance throughout this forum.

The United States understands synthetic biology as it is discussed in the research and development community: a continuum of biological engineering tools and techniques that can lead to progressively advanced biotechnology products.  More than forty years of research, education, and product development using recombinant DNA techniques have led to clear benefits relevant to the Convention’s objectives, and these benefits will continue with continued application of these biological engineering tools and techniques.   As to the relationship between synthetic biology and the criteria set out in decision IX/29, paragraph 12, the United States supports efforts to complete this formal evaluation.  We share the view of other posts (#9678,  #9685, #9686) that the CBD Secretariat’s contribution (SBSTTA/22/INF/17) to the completion of the assessment requested in decision XII/24 and reiterated in decision XIII/17 was not procedurally appropriate.  Specifically, much of the content of the Secretariat’s document was extraction of phrases out of context from AHTEG meeting reports rather than strict adherence to the consensus recommendations provided by AHTEG members.  In the U.S. view, the relationship of synthetic biology to the criteria for new and emerging issues set out in decision IX/29 has not been properly evaluated.  It is the work of the AHTEG on Synthetic Biology to explicitly conduct this analysis and provide its recommendations to SBSTTA – an effort that will undoubtedly benefit from views expressed in this discussion.

Best,
Jenna
posted on 2019-03-28 16:39 UTC by Ms. Jennifer Shinen, U.S. Department of State
RE: Welcome message - synbio forum - topic 7 [#9697]
Dear All
I am still struggling with lit a) of the points raised in round 7. As you know it says:
(a) Relevance of the issue to the implementation of the objectives of the Convention and its existing programmes of work;
The AHTEG explained this point as follows:
“The AHTEG noted that the conservation and sustainable use of biodiversity, and the fair and equitable sharing of the benefits arising out of the utilization of genetic resources may be affected, both positively and negatively, by living organisms resulting from synthetic biology, as well as by non-living products or components.”
The Forum rounds including the current no 7 have largely focused on risks of SynBio based LMOs, that is on issues raised by the Cartagena Protocol. Risks (or the conservation of biodiversity) are however only one concern of the CBD,  the other two being the sustainable use of the biodiversity components and the fair and equitable sharing of benefits from the utilization of genetic resources.
There was only one significant contribution concerning benefit sharing: the idea repeatedly proposed by Joseph Vogel and others of a multilateral system that establishes a kind of collective intellectual property in information on genetic resources (called natural information), allows for free R&D on the same, collects charges on revenues from the marketing of products, and distributes the funds for various purposes including the conservation of biodiversity. This is a highly interesting idea (I hope I got it right, Joe!) that would deserve further deliberation. It could be a very adequate reaction to the fact that SynBio more and more detaches itself from the genetic material and thus the control of provider states, by storing and publishing huge masses of information (often called  DSI although it vastly extends beyond sequence information) and by developing (“synthesizing”) new and finally marketable products. I believe such thoughts have high “Relevance of the issue to the implementation of the Convention”.
The same is true for the objective “sustainable use of biodiversity components”. This has largely been an empty phrase endlessly repeated without closer reflection. It must be admitted that sustainability is an elusive term that has been given many different meanings. It is however not without content. One component is certainly that economic profit shall not have priority over the two other concerns - social welfare and the environment. For instance, one could debate if the substitution of agriculturally grown vanilla by vanilla produced by bacteria modified by application of SynBio is compatible with the social dimension of sustainability. Another instance is the notion of benefit in risk-benefit concepts, or of “positive” versus “negative” effects of SynBio products. Many discussants in the Forum have referred to Risk-Benefit or “positive-negative” balancing but without exploring its intricacies and the difference of regulatory cultures in that regard, notably in the US and the EU. SynBio which is more and more aiming at intentional modification of “nature” must seriously be examined as to by what methodology the intentions can be regarded as “beneficial” or “positive”.
Best wishes
Gerd Winter
posted on 2019-03-28 17:34 UTC by Mr. Gerd Winter, University of Bremen
RE: Welcome message - synbio forum - topic 7 [#9698]
Dear All,
Thank you for the interesting discussion and special thanks to Maria and Casper for moderating it.
As I mentioned in my post under another topic, I think that the operational definition of synthetic biology, as proposed by the AHTEG on synthetic biology in 2015, is a good description of the domain, clearly indicating that synthetic biology is a further development of modern biotechnology. While showing new and broader potential, synthetic biology is the result of technological and scientific developments in biotechnology and other sectors, which evolve in a continuous manner. In this respect, it might prove difficult to demonstrate that synthetic biology as such is a new and emerging issue.
There is general agreement that current and near future applications of synthetic biology are LMOs and therefore are covered by the CP. However, as stated by Nikolay (#9690): “CP does not cover all aspects of biosafety relevant for the CBD objectives. In addition CP is binding only for the Parties to it, but not to all CBD parties”. Furthermore, the fact that the topic is covered by the CP does not imply that it does not deserve attention. There is the need to monitor whether new developments in modern biotechnologies challenge existing governance system with regard to the objectives of the CBD and CP (and the inclusion of gene drives into the work of the AHTEG on Risk assessment under the CP goes in this direction as well as the horizon scanning exercise). The question is how we want to do this.
I am among those who believe that the analysis provided by the Secretariat based on the AHTEG’s reports is a good starting point. And I agree with Helmut (#9684) that the criteria of decision IX/29 refer both to the concept of “actual” and “potential”. At the same time, I do feel that it is difficult to apply these criteria to the broad and very diverse area of synthetic biology. It would be more practical to break the big package into pieces (i.e. sub-areas such as xenobiology, minimal cells, etc.) and test the criteria against these sub-areas. Nikolay has made this exercise successfully with gene drives in his post (#9690) and I fully agree with his conclusions. Maybe we could extend this approach and maybe this could facilitate future work in this area.
With my best wishes.
posted on 2019-03-28 17:39 UTC by Ms. Ilaria Ciabatti, European Commission
RE: Welcome message - synbio forum - topic 7 [#9700]
Dear All,

According to decision IX/29, para 12 to identify new and emerging issues:

(a) Relevance of the issue to the implementation of the objectives of the Convention and its existing programmes of work;
Engineered gene drives: risk assessment and risk management carry out case-by-case in the long term doing monitoring effects on the ground (CBD/COP/DEC/14/19). I believe we should consider real urgent necessity to apply   “precautionary approach” to deliver in ecosystem, especially protected areas, and indigenous people and local communities’ territories. We need to think very carefully if CRISPR-based gene drive could be a global conservation solution or threat. https://www.pnas.org/content/112/34/10565.full

(b) New evidence of unexpected and significant impacts on biodiversity;
I would like to invite to think on huge difficult to know the impacts of synthetic biology (SB) organisms, components or products deliver at different ecosystems in this short time that this technology developed.  On the other hand, we could not conclude SB should not have negative impacts in the future on wildlife populations and their ecosystems functions, structure or processes.  As Mr. Lazaro recalled, the lack of evidence about negative impacts originated by Synbio does not mean their absence (#9682).

(c) Urgency of addressing the issue/imminence of the risk caused by the issue to the effective implementation of the Convention as well as the magnitude of actual and potential impact on biodiversity;
The urgency of addressing is to have a specific international regulation. It is vital to agree organisms, components or products from synthetic biology fall in or out scope of Cartagena Protocol, indeed it is urgent enhances capacities to assess and monitoring the SB effects on ecosystems components on the ground. https://jme.bmj.com/content/36/11/687.short, https://www.sciencedirect.com/science/article/pii/S0167779918301689

(d) Actual geographic coverage and potential spread, including rate of spread, of the identified issue relating to the conservation and sustainable use of biodiversity;
Scientists have minimal experience engineering biological systems for evolutionary robustness. Drive-induced traits and altered population dynamics must be carefully evaluated with explicit attention to stability. Long-term studies should evaluate the effects of gene drive use on genetic diversity in target populations. Integrated benefit-risk assessments informed by the actions recommended above should be conducted to determine whether and how to proceed with proposed gene drive applications. http://science.sciencemag.org/content/345/6197/626
(e) Evidence of the absence or limited availability of tools to limit or mitigate the negative impacts of the identified issue on the conservation and sustainable use of biodiversity;
Risk assessment, management assessment and monitoring effects to synthetic biology organisms on the ground to evaluate positive or negative interference on ecosystems. https://onlinelibrary.wiley.com/doi/abs/10.1111/cobi.13292  and https://aip.scitation.org/doi/abs/10.1063/1.5053816

(f) Magnitude of actual and potential impact of the identified issue on human well-being;
It is more important to human well – being to conserve dynamics ecosystem’s resilience and adaptation. The Precautionary Principle should be a necessary policy to use ecosystems components at all systems since we cannot manage or control all multivariable of nature (biotic and abiotic) in the long term. https://www.resilience.org/stories/2018-05-23/sustainability-is-not-enough-we-need-regenerative-cultures/

(g) Magnitude of actual and potential impact of the identified issue on productive sectors and economic well-being as related to the conservation and sustainable use of biodiversity.
Synthetic biology incorporates elements of biology, engineering, chemistry and, when it leaves the laboratory, environmental science. Synthetic biology can be regarded as a platform technology that cuts across several key market sectors, such as energy, chemicals, medicine, environment and agriculture. Bioeconomy strategies at national (e.g. Sweden and South Africa) and regional levels (e.g. Flanders) (Sormann, 2012) are under development. R&D in synthetic biology has initially addressed biofuels, which are themselves contentious, and products such as bio-based chemicals and plastics, which are hallmark products of a bioeconomy. A second phase, which involves a much broader spectrum of industry sectors, such as food, cosmetics, pharmaceuticals and medicine, is now emerging for synthetic biology. (OECD (2014), Emerging Policy Issues in Synthetic Biology, OECD Publishing. http://dx.doi.org/10.1787/9789264208421-en). In this regard, this technology should use in into ecosystems, sine qua non, conserves the biological diversity components in the long term.

Kind regards,

Dr. Marina Rosales Benites de Franco
posted on 2019-03-28 20:57 UTC by Ms. Marina Rosales Benites de Franco, National University Federico Villarreal
RE: Welcome message - synbio forum - topic 7 [#9701]
Implied in the parenthetical comment of Post #9697 “(I hope I got it right, Joe!)” is uncertainty.  Although I would say that Prof. Winter’s description of my proposal for a Global Multilateral Benefit-Sharing Mechanism is approximately “right”, the devil remains in the details.  Below I cut and paste passages from his post. My elaboration of the details follows the excerpts and are enumerated within the square brackets:

“...Risks (or the conservation of biodiversity) are however only one concern of the CBD,  the other two being the sustainable use of the biodiversity components and the fair and equitable sharing of benefits from the utilization of genetic resources.
There was only one significant contribution concerning benefit sharing: the idea repeatedly proposed by Joseph Vogel and others of a multilateral system that establishes a kind of collective intellectual property in information on genetic resources (called natural information), allows for free R&D on the same, collects charges on revenues from the marketing of products, and distributes the funds for various purposes including the conservation of biodiversity...” (Gerd Winter)

[1.  Besides myself, Tim Swanson and Chris Stone also published about the economics of ABS in the early 1990s. For the trajectory, see “Foreword ‘On the Silver Jubilee of ‘Intellectual Property and Information Markets: Preliminaries to a New Conservation Policy’, Joseph Henry Vogel  in Manuel Ruiz Miller, pp xii-xxv, Genetic Resources as Natural Information: Policy Implications for the Convention on Biological Diversity, Routledge, September 2015. Open access at https://s3-us-west-2.amazonaws.com/tandfbis/rt-files/docs/9781138801943_foreword.pdf, also available in Spanish, at: https://spda.org.pe/?wpfb_dl=4131   It is significant that Swanson, Stone and I converged on a multilateral system independently. It is also not surprising. Once genetic resources are recognized as information---”the central dogma of molecular biology” [1958]--- conventional economics implies a multilateral system. Since 2011, I have adopted “bounded openness” as the best handle to describe the modality of the GMBSM.  See “Bounded Openness as the Global Multilateral Benefit-Sharing Mechanism for the Nagoya Protocol” Joseph Henry Vogel, Klaus Angerer, Manuel Ruiz Muller and Omar Oduardo-Sierra. Pages in Charles R. McManis and Burton Ong (eds) Routledge Handbook on Biodiversity and the Law (London, Routlege, 2018), 377-394.

2.  I used the term “natural information” for the first time in 1991 to explore equal treatment with “artificial information” ("The Intellectual Property of Natural and Artificial Information". CIRCIT Newsletter, Melbourne, Australia, June 1991, p. 7.)  Only many years later did I realize that the neologism was not self-explanatory. Manuel Ruiz Muller, Klaus Angerer and I define “natural information”  as : “An expression generated and extracted from matter that is living or was once alive, where ‘expression’ refers to any distinction, non-uniformity or difference that was unintentional.”  (“Proposal: Legal Elements for the “Global Multilateral Benefit-sharing Mechanism” as contemplated in Article 10 of the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity. Version 1.0” also available in Spanish and forthcoming in French, https://uni-giessen.academia.edu/KlausAngerer/Drafts)

3. The financial concept of fungibility is always lost in these discussions. ABS should not displace existing funding commitments. Hence, “distributes the funds for various purposes including the conservation of biodiversity” is not strictly correct. “Bounded openness” aligns incentives to conserve habitats through monetary benefits, which may not necessarily require any expenditure on conservation projects.  For example, not opening a road into the Amazon forest does not require a project, nor does not building a dam on a river require a project and so on. They require an alignment of incentives whereby the destructive economic activity would lower the participation of the Provider in claims for utilization of transaboundary genetic resources by Users. Shares of royalty revenue would be based on habitat.]

“...It could be a very adequate reaction to the fact that SynBio more and more detaches itself from the genetic material....” (Gerd Winter)

[4. “Material” is not defined in either CBD or the AHTEG operational definition of “synthetic biology”. At COP14, the European Union, Switzerland, Japan and others, voiced the position that “genetic resources” are “tangible material”.  Although scientists will cringe, any silence lends support through the legal doctrine of stare decisis]

“... and thus the control of provider states, by storing and publishing huge masses of information (often called  DSI although it vastly extends beyond sequence information)“ (Gerd Winter)

[5.  The phenomenon of interest for Users is natural information, whose medium of communication varies. Originally that medium was biological matter.  Today digitization is ascendant. Other media also exist, most notably print and film.]

“...and by developing (‘synthesizing’) new and finally marketable products. I believe such thoughts have high ‘Relevance of the issue to the implementation of the Convention’.” (Gerd Winter)

[6. Because the AHTEG definition of synthetic biology does not refer to information, it is non-operational for ABS. From the perspective of economics, an operational definition of synthetic biology should include not only information but also the notion of extreme intensity of human capital  in such endeavors (accumulated knowledge and know-how). The percentage royalty fixed by a GMBSM for synthetic biology would reflect that asymmetry, i.e., it would be lower, ceteris paribus, than biotechnologies which are intensive in natural information. Because “fair and equitable” means quid pro quo between artificial and natural information, sometimes no royalty would be due. Surprise! For example, no royalty would be due in cases where intellectual property is not sought over the value added or when the natural information of an invention has appeared in another invention whose intellectual property has expired.]

“The same is true for the objective ‘sustainable use of biodiversity components’. This has largely been an empty phrase endlessly repeated without closer reflection. It must be admitted that sustainability is an elusive term that has been given many different meanings. It is however not without content. One component is certainly that economic profit shall not have priority over the two other concerns - social welfare and the environment. For instance, one could debate if the substitution of agriculturally grown vanilla by vanilla produced by bacteria modified by application of SynBio is compatible with the social dimension of sustainability. Another instance is the notion of benefit in risk-benefit concepts, or of ‘positive’ versus ‘negative’ effects of SynBio products. Many discussants in the Forum have referred to Risk-Benefit or “positive-negative” balancing but without exploring its intricacies and the difference of regulatory cultures in that regard, notably in the US and the EU. SynBio which is more and more aiming at intentional modification of ‘nature’ must seriously be examined as to by what methodology the intentions can be regarded as ‘beneficial’ or ‘positive’.” (Gerd Winter)

[7.  That “capital displaces labor” goes back to David Ricardo (1772-1823) and became a commonplace with Karl Marx (1818-1883).  The observation is robust and enduring, regardless of ideology. Modern economies have responded by creating a social safety net which includes re-training, re-location and/or financial assistance for workers displaced by labor-saving capital.  For countries where the social safety net is inadequate, the GMBSM could alleviate the social costs of “capital displacing labor”.  For example,  mega-diverse Madagascar would be a tremendous beneficiary of a GMBSM which distributes royalty revenues to the countries of origin proportional to habitat. The stewards needed to protect biodiversity could be drawn from workers  displaced by synthetic biology. ]
(edited on 2019-03-29 02:44 UTC by Joseph Henry Vogel)
posted on 2019-03-28 21:12 UTC by Mr. Joseph Henry Vogel, University of Puerto Rico-Rio Piedras
RE: Welcome message - synbio forum - topic 7 [#9702]
Dear All,

In our task of contributing to the completion of the assessment requested in decision XII/24 in relation to synthetic biology, we are well advised to follow the suggestion of Jim Louter [#9678] that we should look at the purpose of this exercise:  The Conference of the Parties has underlined the importance of reducing the number of agenda items for consideration in order to improve the effectiveness of its proceedings. To that end, the COP established the criteria listed by Casper and Maria.

I endorse the views of Gernot Segelbacher [#9686], Jim Louter [#9685] and others that establishing whether a specific topic or area falls under these criteria requires a thorough, robust, evidence-based assessment. As the COP decision XII/24 and the question phrased by Casper and Maria make clear, such an assessment has not yet been completed, and we are asked to help complete the assessment.

In that perspective I agree with the posts of Boet Glandorf [#9676] and others that up to now, there is no evidence for unexpected and significant impacts on biodiversity resulting from synthetic biology.

The comment of Helmut Gaugitsch [#9684] that in the listed criteria also the concept of “potential” is included fails to mention that this term “potential” is linked to “identified issues”, which in turn require that there is “evidence for unexpected and significant impacts on biodiversity resulting from synthetic biology”.

With regards!

Piet
posted on 2019-03-28 21:21 UTC by Mr. Piet van der Meer, Ghent University, Free University of Brussels, Belgium
RE: Welcome message - synbio forum - topic 7 [#9703]
Dear Forum participants,

The GIC addressed each of the criteria from paragraph 12 of decision IX/29 in detail in its recent submission of information (Feb 2019: https://bch.cbd.int/database/record.shtml?documentid=114285). While there is no guidance on how these criteria for identifying a new and emerging issue (NEI) should be applied, we believe that is it evident in decision IX/29 that all of them should be addressed, and that they all need to be considered collectively with no individual criterion alone sufficient to identify a NEI. We also view paragraph 12 as building on the requirements of paragraph 11, which provides the framework for a NEI proposal.

In our analysis, we found that it is challenging, if not impossible, to apply the paragraph 12 criteria in a meaningful way to the undefined term “synthetic biology”, rather they need to be applied to plausible, technically feasible, foreseeable applications. As mentioned by others, some of the criteria include consideration of both “potential” and “actual”, but a “robust analysis” requires that “potential” scenarios are informed by “actual” evidence. We could not conclude that “synthetic biology”, or specific applications such as “gene drives”, meet any of the NEI criteria apart from (a) (relevance to the CBD - due to it falling within the CBD definition of “biotechnology”).

We cannot support the use of the Secretariat’s “analysis” (CBD/SBSTTA/22/INF/17) as contributing to, or providing a basis for, the "robust analysis" against the paragraph 12 criteria that Parties have called for (decision XII/24). This document is problematic for several reasons: the AHTEGs did not even discuss these criteria in this context; it is unclear how “relevant statements” were selected; and AHTEG reports do not contain consensus statements, rather the text captures the range of views expressed by its members, sometimes of one or few individuals.

The first NEI proposals for synthetic biology were made in 2010 and the topic has been formally addressed by SBSTTA once, where it was concluded that there was insufficient information to finalize an NEI analysis (SBSTTA-18 Recommendation XVIII/7). Since then, there have been further submissions of information, online discussions and deliberations by two AHTEGs on a range of topics, some linked to the NEI criteria. Instead of these activities contributing to formally completing the NEI analysis, it has been left open for almost ten years. This compromises the credibility of the whole process, which, as pointed out by others, was intended to improve efficiency. In this time, "synthetic biology" has since become a mechanism for debating early research concepts and enabling technologies that have emerged or been contemplated in the field of biotechnology, despite an absence of evidence that they cannot be managed by existing regulatory approaches.
(edited on 2019-03-29 00:54 UTC by Felicity Keiper)
posted on 2019-03-29 00:53 UTC by Ms. Felicity Keiper, BASF
RE: Welcome message - synbio forum - topic 7 [#9705]
Dear participants,

Thank you for the moderators and for all the contributions in this interesting discussion.

I would like to agree with the excellent arguments already presented by #9676, 9677, 9678 and to highlight the following points:

I do not consider adequate the paper prepared by the Secretariat prior to SBSTTA-22 as the completion of a robust analysis required in the AHTEG mandate. If we consider that using some sentences from the report is enough for such analysis we also have to consider the following conclusion from the AHTEG report:  “The AHTEG agreed that living organisms developed through current and near future applications of synthetic biology are similar to LMOs as defined in the Cartagena Protocol”

This main conclusion means that the criteria in the paragraph 12 of Decision IX/29 will not be fulfilled, in particular the items:

(b) New evidence of unexpected and significant impacts on biodiversity:
If synthetic biology organisms are LMOs and there is no evidence till now of unexpected and significant impacts of LMOs on the biodiversity the criteria is not applicable


(c) Urgency of addressing the issue/imminence of the risk caused by the issue to the effective implementation of the Convention as well as the magnitude of actual and potential impact on biodiversity:
The general principles of risk assessment, Annex III of the Cartagena Protocol, remain applicable to the risk assessment of LMOs developed through synthetic biology. If there is already a framework for risk assessment and risk management in place it cannot be considered an urgent issue to be addressed under CBD.


(e) Evidence of the absence or limited availability of tools to limit or mitigate the negative impacts of the identified issue on the conservation and sustainable use of biodiversity:
It might be challenges in the future developments in the field of synthetic biology, but there is already the experience of decades with risk assessment and risk monitoring of LMOs as a good basis to face those challenges and to present tools to limit or mitigate potential negative impacts


It is the first time that the criteria established in the paragraph 12 of Decision IX/29 is being used to analyze a topic to be considered a NEI. In this sense a very strict and robust evaluation against those criteria is necessary to not open a precedent for future topics. Any topic included in the CBD means a lot of efforts and resources and I consider that we already have a very ambitious agenda to meet Aichi Targets and to build the post 2020 agenda.

Best regards,
Luciana Ambrozevicius - Ministry of Agriculture - Brazil
posted on 2019-03-29 02:25 UTC by Ms. Luciana Ambrozevicius, Brazil
RE: Welcome message - synbio forum - topic 7 [#9704]
Dear colleagues

Thank you Maria and Casper for your moderation of this topic.

We note that some activities covered by the operational definition of synthetic biology, per decision XIII/17 paragraph 4, have the potential to meet some of the criteria for a new and emerging issue laid out in decision IX/29, paragraph 12.  However, we do not believe that the activities meet all criteria.

Notwithstanding the above, New Zealand sees value in the CBD keeping this issue under review.

We would also note that the statements quoted in SBSTTA/22/INF/17 reflect AHTEG discussions of other issues, not the ‘new and emerging issue’ criteria specifically, and they lose meaning taken out of context or without analysis.  Therefore, SBSTTA/22/INF/17 cannot be relied on as an authoritative document in determining whether or not synthetic biology meets the ‘new and emerging’ criteria.

We support the points made in post #9685, and particularly that the needs of discussion around synthetic biology organisms primarily centre on their risk/benefit assessment as LMOs, so a combined synthetic biology/risk assessment-risk management AHTEG would suit well to avoid duplication of work. We also support the points made in post #9688, and our comments are broadly reflective of these.

We restrict our comments to organisms.

Our specific comments in relation to the list of criteria in decision IX/29, paragraph 12, are as follows:

a. Relevance of the issue to the implementation of the objectives of the Convention and its existing programmes of work

As noted by #9676, organisms from synthetic biology can have positive, negative, or neutral impacts on biodiversity, and hence the objectives of the Convention. These impacts, and therefore their relevance to the objectives of the Convention, can only be assessed on a case-by-case basis.  These assessments should be science-based.

b. New evidence of unexpected and significant impacts on biodiversity

We do not consider that the activities covered by the operational definition of synthetic biology meet this criterion, as to date there is no evidence of unexpected and significant impacts on biodiversity. This has also been recognised by previous AHTEGs on synthetic biology.

c. Urgency of addressing the issue/imminence of the risk caused by the issue to the effective implementation of the Convention as well as the magnitude of actual and potential impact on biodiversity

To date, Parties agree that synthetic biology organisms already in existence, or currently in development, are covered by the LMO definition in the Cartagena Protocol on Biosafety (the Protocol). There is nothing in the characteristics of current synthetic biology organisms that makes them any riskier per se than any other LMO. The risk assessment and risk management provisions of the Protocol therefore apply to these organisms. There is abundant, fit-for-purpose guidance already in existence to address the risk assessment and risk management issues of LMOs. We do not consider that the speed of development of synthetic biology technologies is, in and of itself, a risk factor. Therefore, there is not particular urgency or imminence of risk presented by synthetic biology organisms that impinges on the implementation of the Convention, nor is the magnitude of impact, either actual or potential, on biodiversity any higher than any other LMO currently in existence.

d. Actual geographic coverage and potential spread, including rate of spread, of the identified issue relating  to the conservation and sustainable use of biodiversity

We agree with #9676 that synthetic biology organisms developed to date are LMOs. We therefore consider that the activities covered by the operational definition of synthetic biology do not meet this criterion. 

e. Evidence of the absence or limited availability of tools to limit or mitigate the negative impacts of the identified issue on the conservation and sustainable use of biodiversity

We do not consider that the activities covered by the operational definition of synthetic biology meet this criterion. There is already a wide range of tools that limit or mitigate negative impacts on the conservation and sustainable use of biodiversity. Links to more than 50 guidance documents were provided in the last online forum on risk assessment and risk management prior to SBSTTA-22.

f. Magnitude of actual and potential impact of the identified issue on human well-being

We note that there are many LMOs that have substantial impact on human well-being, eg, LM bacteria that produce insulin for the treatment of diabetes, or rennet for most cheese production globally. We point out that there are also many LM crops that are considered safe, and have regulatory approval for growth and human consumption in many countries, including some that are party to the Protocol. These LMOs have beneficial impacts on human well-being, and their risks are mitigated by controls in regulatory approvals. We suggest that there may also be synthetic biology organisms that meet this criterion as well. However, any impact of any LMO, whether a synthetic biology organism or not, must be considered on a case-by-case basis, as they will all have different characteristics, and therefore different risks and benefits as they pertain to human well-being.

g. Magnitude of actual and potential impact of the identified issue on productive sectors and economic well being as related to the conservation and sustainable use of biodiversity

As discussed above with regard to human well-being, there are existing LMOs, and potentially, existing synthetic biology organisms that impact productive sectors around the world. The examples we name above in our response to criterion f. apply equally well to this criterion. Again, it is our view that the magnitude of actual and potential impact of any modified organism, whether a synthetic biology organism or not, can only be considered on a case-by-case basis.

With regards
Mariska
posted on 2019-03-29 01:46 UTC by Ms. Mariska Wouters, New Zealand
RE: Welcome message - synbio forum - topic 7 [#9706]
Dear all—

I would also like to add my thanks to Maria and Casper for moderating, and to all participants for contributing to, this month-long series of very interesting discussions.

On to topic 7, the relationship between synthetic biology and criteria set out in Decision IX/29.

First, I agree with Jenna [#9696] and several others who think that the Secretariat’s information document (SBBSTA/22/INF/17), based on extracts from the 2015 and 2017 AHTEG reports, will NOT be a productive way for the 2019 AHTEG to begin the analysis requested by COP.  Though paragraph (a) of the AHTEG’s Terms of Reference asks the AHTEG to “build on” the Secretariat’s preliminary analysis, I interpret this as a request to use it as one background document among many others.

And as suggested by Jim [#9685] and Piet [#9702], additional guidance about the task posed to our Online Forum and the upcoming AHTEG can be obtained from other paragraphs of Decision IX/29.  As Piet pointed out, the need to “identify new and emerging issues related to the conservation and sustainable use of biodiversity” is balanced with the “need to reduce the number of agenda items” at SBSTTA meetings “to improve the effectiveness of its proceedings”.  Thus, I interpret the request as a priority-setting exercise, not an intellectual exercise of meeting a definition.

The AHTEG’s operational definition of synthetic biology is that it “is a further development and new dimension of modern biotechnology…”  Thus, in my view, the goal of the exercise is not to determine *whether* synthetic biology is a “new and emerging issue”, rather *how* new and different, *how quickly* are the new and different parts emerging (to address the question of urgency), and how they compare to other priorities that SBSTTA and the COP need to address.

Felicity [#9703] points out that Paragraph 11 of Decision IX/29 also provides helpful context.  In particular, this paragraph states that SBSTTA should also consider “c) Thematic programmes of work and/or cross-cutting issues that could contribute to the resolution of the issue” and “(d) Work already under way by relevant organizations addressing the issue.” Much work is already underway.

I agree with Boet [#9676], Jim [9678], Swantje [9688] and others that the analysis of the seven criteria in paragraph 12 can be summarized as 1) there is no evidence of unexpected and significant impacts on biodiversity and 2) for most of the other criteria, the answer (magnitude of positive, neutral, and negative impacts) depends on the particular application under consideration.  And as pointed out by many (including by me) during topic 5, there is no living organism developed thus far (or close to development) using the techniques of synthetic biology, that is not considered an LMO under the Cartagena Protocol. 

Moreover, I believe that these conclusions apply equally well to LMOs with engineered gene drives, in contrast to the analysis presented by Nikolay [#9690].  Fred [#9693] also makes this point: one cannot generalize about the entire category of LMOs with engineered gene drives. The magnitude of positive, neutral, and negative impacts will depend on the type of gene drive and the particular application under consideration

Regards to all,
Bob Friedman, JCVI
posted on 2019-03-29 02:45 UTC by Mr. Robert Friedman, J. Craig Venter Institute
RE: Welcome message - synbio forum - topic 7 [#9707]
Dear colleagues

I'd simply like to register my support for the positions and interpretations taken in posts [#9698] (Ilaria), [#9689] (Angela) and [#9684] (Helmut) and perhaps others about the use of the Secretariat’s report as a starting point and the central importance of the word potential along with actual as it is applied to the criteria.

Furthermore, I’d like to emphasise a point made in [#9700] (Marina) “Scientists have minimal experience engineering biological systems for evolutionary robustness. Drive-induced traits and altered population dynamics must be carefully evaluated with explicit attention to stability”. We have lots of experience causing evolutionarily robust changes, eg antibiotic resistance, as an unintended consequence of our technologies and socioeconomic choices. Where the recall or limiting mechanism is another form of modelling and assumption-based tool created through genetic engineering or syn bio (where it might be different), the experience is even less.

There have been a number of commentators that have said that so long as syn bio is an LMO, then there already exists the tools to avoid or mitigate harm (ie, in referring to point (e)). I find such confidence perplexing if for no other reason than because the track record of unapproved spread of existing LMOs is well documented, from Starlink through to LL rice and RR wheat and the Prodigene vaccine. There were tremendous financial and legal incentives to prevent those escapes. If we had the tools to ensure that a syn bio LMO could not cause harm through unintended spread I think that those tools would have already been put to work.

Best wishes
Jack
posted on 2019-03-29 05:45 UTC by Mr. Jack Heinemann, University of Canterbury
RE: Welcome message - synbio forum - topic 7 [#9708]
Dear Colleagues,
Let me first thank to Maria and Casper for moderating the on-line forum the last month and to the participants for the many comments most of which I find very useful and illuminating.

Every new technology poses challenges and promises, so the whole point is to try to gain as much benefits from it in a safe manner. History shows that no matter how hard we try problems will occur, but that’s not excuse for not trying to work in a safer way. In this respect Synthetic biology (whatever it is) is and will be no different. Usually when we deal with a new engineering problem the most likely outcome is that it won’t work the second most likely is that it won’t work as expected.

In previous post I looked at the engineered gene drives, which of course is not a single thing but a group of (somewhat) related technologies. Of course I could have been even more specific, but anyway the field is more specific than Synthetic biology in general. Plus the main applications envisioned at present like vector control or IAS eradication will benefits most from gene drives that spread fast throughout the population before resistance develop or the drives spreads to other species or populations (none of those two options is problem per se, but can be problem under certain circumstances).

Gene drives are actually are just a recent example of ecosystem engineering, which is neither new nor emerging, as it has been practiced for almost 10000 years since the emergence of agriculture in the Middle East. I agree that the use of LMOs in agriculture has proven so far to be largely safe (partially due to robust risk assessment and management done). But that is not the most relevant example to draw conclusions about gene drives, much better examples are those related to introduction of new species into the environment and pest control and eradication programs. Here the things are more mixed bag. Gene drives adverse effects are most likely to occur via the environment and to affect the biological diversity. So CBD is probably the most relevant international forum for such discussion.

What I have been trying to say is that we don’t have to ban any new technology, that’s not reasonable and simply won’t work. We need to have something of a “code of conduct” when we are contemplating ecosystem engineering exercises. This means robust prior evaluation should be done in each case, taking into account the specifics in each case, using methodologies that all potentially affected parties consider sound. Especially when transboundry transfer of the organisms can occur the interested states and other stakeholders should be informed in advanced.

I personally find Synthetic biology, and gene drives in particular, to hold great promises for human health and protection of the environment. But any irresponsible and overenthusiastic activities can seriously undermine the public trust in them and make their acceptance very difficult. I guess we all can recall such examples of PR mishaps in the field of modern biotechnology.

Once again thank you all for your contributions from which certainly derived personal intellectual profit and to the moderators for their hard work.

Best Regards,
Nikolay
posted on 2019-03-29 08:09 UTC by Mr. Nikolay Tzvetkov, Bulgaria
RE: Welcome message - synbio forum - topic 7 [#9709]
I would like to support the comments posted by [#9698] (Ilaria), [#9689] (Angela0 [#9684] (Helmut) and [#9707] Jack.
However, I want to emphasize that if many parties believe that synbio should be treated as being new and emerging issue you do not need to check if it fits into some criteria or not. I want also to highlight that to that those points should not be seen as criteria but rather elements to be considered. A topic to be considered as new and emerging issue does not necessary mean that it has to comply and fit with all those elements.

Best regards,
posted on 2019-03-29 08:13 UTC by Mr. Ossama Abdelkawy, Syrian Arab Republic
RE: Welcome message - synbio forum - topic 7 [#9710]
Dear all,
Once again, many thanks to Maria and Casper for their continuous very helpful work in guiding us through this interesting and important discussion.

This discussion is in my opinion especially important, because it in essence ask how and on what level a meaningful and sound horizon scanning can be organized. It is a clear decision by the parties, that “that broad and regular horizon scanning, monitoring and assessing of the most recent technological developments is needed for reviewing new information regarding the potential positive and potential negative impacts of synthetic biology vis-à-vis the three objectives of the Convention and those of the Cartagena Protocol and Nagoya Protocol” (CBD/COP/DEC/14/19). Here it is expressed that it is not sufficient to treat synthetic biology only on the level of the CP, since not only the goals of the CP are to be examined. In my view, this also makes sense, since synthetic biology touches not only the level of safe handling but also other levels that can only be discussed at the CBD level. Ilaria (#9698) already mentioned the need to monitor whether new developments in modern biotechnologies challenge existing governance systems.

Let me give you an additional example that has to be tackled on CBD and nor CP level: I have already pointed out in previous posts that direct LMO applications for nature conservation require additional assessment in relation to the three objectives of the Convention. The further the synthetic biology project to create artificial nature progresses, the greater its influence on our concept of life and nature will become and this might have great impact on nature conservation strategies. The discussion as to whether genetic engineering is permissible in nature conservation must therefore also focus on the search for boundaries between the nature and biodiversity that has naturally emerged and a (genetically edited) nature that has been (man) made. We must ask ourselves whether the use of genetic engineering in nature conservation is not a critical crossing of this border. This debate can and must be conducted on the CBD and not the CP level. Some colleagues in this discussion have pointed out that current synthetic biology applications are usually LMOs (I have already mentioned the exception of CMOs). In summary, I would like to emphasize that the tasks that lie ahead cannot be accomplished by the CP alone . 

I the following I would like to share some thoughts on some keywords in the criteria, that might be worth discussion in more detail:

The first is “urgency”. Urgency is given, when the impact has the potential to be relevant and no tool is available to tackle the problem. As I just gave an example certain synthetic biology application have the potential to affect the implementation of the convention, that are not covered by the CP.

We should also further analyze the concept of “evidence”. Evidence could be interpreted on a level of measurable data and on the level of concepts and models. As also stated in an earlier post, in the context of “New and Emerging issues” it is evident that the latter has to play a key role. If we only spot new and emerging developments, when negative impacts on the objective of the convention are already measurable, the tool of “New and Emerging issues” has failed, because it only takes effect after “the child has already fallen into the well” (This is a German saying, when things have already gone wrong.)

On this background and also considering the point made by Helmut (#9684) that the criteria of decision IX/29 refer both to the concept of “actual” and “potential” I believe that we will come to the conclusion that all criteria are fulfilled for a brought rage of synthetic biology applications and it will be the task of the horizon scanning process to pinpoint the most important once.

I am looking forward to our further debate,
With my best wishes,
Margret
posted on 2019-03-29 11:08 UTC by Dr. Margret Engelhard, Germany
RE: Welcome message - synbio forum - topic 7 [#9711]
Topic 7 is pivotal to the whole process related to synthetic biology since Parties started to discuss this topic at the Biofuels and biodiversity scope from 2008 up to the COP10 Decision X/37. At New and Emerging Issues Decision X/13 adopted at the same COP10, Parties agreed that future submissions of proposals for new and emerging issues should relate to the conservation and sustainable use of biodiversity and the fair and equitable sharing of benefits arising from the use of genetic resources.

The connection of a specific issue to the CBD’s objectives is a "sine qua non" condition to incorporate the agenda item at the scope of the work to be developed by the Parties.

The picture we have up to now, with the online forum debates, the ATHEG work and reports and the synthetic biology decisions does not accomplished the criteria of paragraph 12 of Decision IX/29.

The information paper prepared by the Secretariat CBD/SBSTTA/22/INF/17does not provide evidences that Parties fully accomplished the aim of addressing paragraph 12 criteria, as stated by some responses. This view prejudge the need to address each of the NEI criteria with substance aimed at presenting effective and updated basis related to its correlation with the Convention objectives.

Rather, the document lacks a robust analysis related to paragraph 12 criteria. Basically the report of the ATHEG captures views of one or few members about the topics, with no Strong evidences and consensus, as a way to justify its conclusion. At this point I would like to take a very formal stance from an international law perspective, considering that the CBD should be a Party driven process, which brings to the Parties the obligation to address the agenda items with the support and, more importantly, the guidance of the ATHEG.

This simply does not happened up to now at the synthetic biology discussions. This is, in my view, what Parties should address using the Decision 14/19 as a motivator.  Otherwise, the debate will continue allowing a Decision without the full and comprehensive fulfillment of the NEI criteria.

The key reason this would lead to a weak outcome, after years of debate, is that it lacks substance of evidences of how synthetic biology impacts and/or threatens biodiversity and the urgency of addressing the risks based on plausible and science based information.

Not even the concept of synthetic biology is a tangible and well defined scope. 

I would strongly suggest that Parties already agreed a concept of damage and significant, at Article 2.b and Article 2.3 of the Nagoya-Kuala Lumpur Supplementary Protocol. And it is relevant to quote that Parties struggled to get to this concepts.

If Parties really want to address how synthetic biology relates to the CBD objectives, they must pursue the challenge to give precise and concrete answers to the paragraph 12 criteria. Otherwise, Parties will get to a future decision that does not help to achieve the goals but merely creates obstacles to synthetic biology as a field of innovation. 

Based on this reasoning, I would stress that if the Convention aims to improve its effectiveness and allow Parties to manage effective issues that deserves attention when it comes to its objectives, Parties should fulfill each paragraph 12 criteria to allow a proper and fundamented debate and future decision about how to address synthetic biology.
posted on 2019-03-29 11:55 UTC by Mr. Rodrigo C A Lima, Agroicone Ltd
RE: Welcome message - synbio forum - topic 7 [#9712]
Dear colleagues,

I would like to thank Casper and Maria once again for their moderation throughout these weeks in such important topics.

I believe that the information paper prepared by the Secretariat based on the analysis by the AHTEG meetings is a good basis for these discussion and beyond.

I can only echo the interpretations made by Helmut #9684 on the concept of “actual” and “potential”, acknowledging that new and emerging issues should not be restricted to what has already been identified. The “novelty” criteria here is inversely linked to the concept of “history of safe use”.

I also agree with Angela #9689, Ilaria #9698 and Jack #9707 who have put emphasis on the fact that not all the tools are already available to avoid and mitigate harm posed by such organisms even if they are LMOs under the CP. Margret #9710 further links this to the idea of “urgency”, when the release of such organism has a potential relevant impact and no tools available to tackle the problem. This is also reflected under Topic 6, in which “detection and identification” challenges (the very first step in line to assess one LMO is to be able to say it is a LMO) have been recognized for certain synbio organisms.

Best regards,

Sarah
posted on 2019-03-29 11:58 UTC by Ms. Sarah Agapito-Tenfen, Brazil
RE: Welcome message - synbio forum - topic 7 [#9713]
"MESSAGE POSTED ON BEHALF OF MARJA RUOHONEN LEHTO"

Dear colleagues, dear moderators,

I will start by thanking each and every one of you for this very interesting, educating and important discussion. And of course the moderators, you are doing a very valuable job. I have followed the discussions carefully (all the topics) but have not had the opportunity to comment earlier. However, having followed many discussions and negotiations on the topic 7, I would like to say the following. The compilation of the Secretariat, based on the work of the AHTEG, is a very thorough analysis of the topic and I (and so has Finland as a Party) find it adequate and sufficient. My wish is that the AHTEG in June looks at this, updates it if so needed and finalizes the work. The AHTEG has many other important tasks that it should concentrate on.

Thank you, looking forward to the future work on this important issue.

Marja Ruohonen-Lehto, Finland”
posted on 2019-03-29 12:02 UTC by Marianela Araya, UNEP - SCBD
RE: Welcome message - synbio forum - topic 7 [#9714]
Dear Maria, Casper and Colleagues.

I would just like to emphasize and support the post by #9676 Margaret, #9684 Helmuth and #9688 Swantje.

With synthetic biology we need to take into account that (and I quote from #9676), "organisms, components and products of synthetic biology can have neutral, positive or negative effects on biodiversity” (and presumably on human well-being as that may be a consequence of an effect on biodiversity), and that “the magnitude of these potential effects cannot be predicted in a generalized manner and has to be assessed on a case-by-case basis"

Furthermore as said by Helmuth in #9684, that we should acknowlegde the fact that a new emerging issue not only focus restricted to what has already been indentified, but also can include forward-looking scenaries. This point is important to take into account when discussing whether Synthetic Biology is a new and emerging issue, due to the fact that allready ecsperiments is peformed to create new species with etc. gene drives, that can have negative and positive impacts on nature and the enviroment.

Lastly I would like to make a point concerning synthetic biology and the Cartegena protocol. I agree that most organism developed by Synthetic Biology can be included under the instrument in form of the Cartegena protokol, but we should also think forward and consinder whether some new developments from Synthetic Biology could be consideres outside the definition of an organisme (LMO).

Thank you Maria and Casper for hosting these discussions.
Best regard, Selina Kruuse Hansen, Danish EPA
posted on 2019-03-29 12:47 UTC by Ms. Selina Kruuse Hansen, Danish Enviromental Protection Agency
RE: Welcome message - synbio forum - topic 7 [#9715]
POSTED ON BEHALF OF Ms. María Curipan, Organización del Parlamento Mapuche - Tehuelche
*******
Estimados moderadores y grupo de expertos:

Saludamos a todos ustedes y expresamos que teniendo en cuenta nuestra condición identitaria , compartimos la contribución y posterior discusión que tan claramente ha sido presentada por el Sr. Lázaro Regalado, respecto del objetivo de una evaluación de riesgo según el Protocolo de Cartagena , en particular el  Párrafo 11, CBD / COP / DEC / 14/19, destacando  el punto c

“Invita a las Partes y otros gobiernos, teniendo en cuenta las incertidumbres actuales con respecto a las unidades genéticas diseñadas por ingeniería genética”, a aplicar un enfoque de precaución, de acuerdo con los objetivos de la Convención, y también exhorta a las Partes y otros gobiernos solo deben considerar la introducción de organismos que contengan unidades genéticas modificadas por ingeniería genética en el medio ambiente, incluso para lanzamientos experimentales y con fines de investigación y desarrollo, cuando:
(a) Se han llevado a cabo evaluaciones de riesgo caso por caso científicamente sólidas;
(b) existen medidas de gestión de riesgos para evitar o minimizar los efectos adversos potenciales, según corresponda;
(c) ... se solicita u obtiene el "consentimiento libre, previo e informado" o "aprobación y participación" de los pueblos indígenas y comunidades locales potencialmente afectados,

Al respecto queremos expresar que desde nuestro profundo territorio existen sobradas experiencias en cuanto a  la falta de solicitud del "consentimiento libre, previo e informado" o "aprobación y participación" de los pueblos indígenas y comunidades locales potencialmente afectados.

De manera tal que mucho de aportes significativos y valiosos sobre  Unidades  
Genéticas, preocupaciones ambientales, -Aceptación social y preocupaciones éticas - Preocupación por la justicia ambiental , Conocimiento Tradicional en relación y comparación con la biología sintética, faltan discutir o quedan en el camino , al menos en nuestros espacios territoriales. Estos son de profundas reflexión y valiosos contenidos de conocimientos .

Agradecemos el hecho de aprender  con ustedes y seguir compartiendo conocimientos.

Atentamente , Ma. Olga Curipan – Mauel Tolza.
posted on 2019-03-29 12:47 UTC by Ms. Melissa Willey, UNEP/SCBD/Biosafety
RE: Welcome message - synbio forum - topic 7 [#9716]
Dear Forum participants

The Secretariat experienced a technical problem and was unable to close the forum at 1 am GMT as has been announced.  Based on this, some participants posted after the closing time. To give the opportunity to all forum participants to react to these comments, the forum will be open until Sunday 31st March 1 am GMT.

Thank you for your understanding.

Secretariat
(edited on 2019-03-29 13:04 UTC by Marianela Araya)
posted on 2019-03-29 13:01 UTC by Marianela Araya, UNEP - SCBD
RE: Welcome message - synbio forum - topic 7 [#9720]
Topic 7: Relationship between synthetic biology and the criteria set out in decision IX/29
My name is Benson M. Kinyagia from Kenya.

Thank you Moderators for all you have done and the Secretariat even for extending the time.
The Currents Products of Synthetic Biology are further development of LMO and hence their relevance to the Convention, its protocols and its existing programmes of work. As for new evidence of unexpected and significant impacts on biodiversity different from what would be expected of ordinary LMO, I would say none so far as noted by #9676. The Urgency of addressing the issue is there as new complex tools are being developed very quickly as stated by #9677 and there is need for guidelines on release of synthetic biology products that may be expected to have potential impact on biodiversity. However, guidelines already developed for LMOs may suffice in most cases and where appropriate they can be reviewed or others developed. 
Regarding actual and potential impacts of synthetic biology on humans well-being, I agree with #9678 that the impacts can be neutral, positive or negative and thus should be dealt with on case by case. On productive sectors and economic well-being as related to conservation and sustainable use of biodiversity, this is an area that need more care, attention and engagement of the local and indigenous community in developing countries and those economy in transition and depend on natural products, agriculture and conservation for their well-being.
posted on 2019-03-29 14:51 UTC by Mr. Benson Kinyagia, National Commission for Science, Technology and Innovation
RE: Welcome message - synbio forum - topic 7 [#9718]
Dear Participants!
As the Secretariat just announced, due to a technical problem, the discussion under topic 7 has been extended until this Sunday, 31st of March at 1 am GMT. This was done in agreement with the moderators.

As to be expected, your views differ on this discussion topic. We have no Clear guidance on how to apply the Criteria set out in decision IX/29 para 12. At the same time, based on your interventions, some of you think that synthetic biology fulfills the criteria, while others don't 

The ball will soon be passed over to the AHTEG for further deliberations. Let's make good use of the extra time in this forum!
All the best,
Casper.
posted on 2019-03-29 14:17 UTC by Mr. Casper Linnestad, Norway
RE: Welcome message - synbio forum - topic 7 [#9721]
Dear Casper, Maria and AHTEG members:
I appreciate your contributions through all this forum. I am learning a lot.
In general, I see that questions for topic 7 have been mostly covered by the AHTEG and that there is a broad agreement that Synbio organisms may be considered LMOs as defined by the Cartagena protocol, although some may fall outside of this definition. I reiterate on the importance to distinguish, as has been pointed out by myself and other members that not all genome edited organisms should fall under Synbio. 
I agree with Nikolay [#9708] in that “Every new technology poses challenges and promises, so the whole point is to try to gain as much benefits from it in a safe manner” “… We need to have something of a “code of conduct” ..
I also agree with Boet #9676 in that "organisms, components and products of synthetic biology can have neutral, positive or negative effects on biodiversity” and that “the magnitude of these potential effects cannot be predicted in a generalized manner and has to be assessed on a case-by-case basis" as has been seconded by others.
I want to add under c) Urgency of addressing the issue/imminence of the risk caused by the issue to the effective implementation of the Convention as well as the magnitude of actual and potential impact on biodiversity:
That careful consideration shall be needed, particularly for tropical countries with large biodiversity where capacity building will be necessary to conduct case-by-case decision making as well as risk assessment and management.
posted on 2019-03-29 15:12 UTC by Ms. Luz Barrero, Corporacion Colombiana de Investigacion Agropecuaria
RE: Welcome message - synbio forum - topic 7 [#9722]
Dear Forum participants,

Let me first thank Casper and Maria for moderating these interesting discussions on the topic of Synthetic Biology.

Having reviewed the submissions to Topic 7 so far, I would like to support the messages indicating that a robust and evidence-based analysis whether synthetic biology qualifies as a New and Emerging Issue (NEI) according to the criteria set out in decision IX/29 paragraph 12 has not yet been performed [e.g. #9685, #9686, #9696, #9703, #9704, #9705, #9711]. Therefore, I do not consider the Secretariat’s information document (SBBSTA/22/INF/17) as a solid starting point for the NEI analysis that Parties have called for (decision XII/24).

As to the point by point reply to the seven criteria in paragraph 12, I would like to refer to other posts in this forum that have already answered in great detail, and who’s interpretation I support (e.g. Boet #9676, Jim #9678, Swantje #9688, Mariska #9704), nicely summarized by Bob in post #9706, and am therefore of the opinion that synthetic biology does not meet the criteria to be identified as a NEI, nor do specific applications such as “gene drives”.

Kind regards, Delphine
posted on 2019-03-29 15:50 UTC by Ms. Delphine Beeckman, Belgian Biosafety Professionals
RE: Welcome message - synbio forum - topic 7 [#9723]
I daresay a consensus exists on at least two points: (1) the inherent and incommensurable value of the online discussions (2) the need that the posts remain easily accessible.  The latter point is essential for academics who study the CBD and wish to cite the insights expressed by participants. If the source cited in a manuscript cannot be located, a conscientious editor will advise against its inclusion. Law journals assiduously check every reference. Thus discussions not easily accessible preclude peer-reviewed scholarship which analyzes the posts.  One recalls an observation made by E.O. Wilson, en passant, in The Social Conquest of Earth: “Science grows in a manner not well appreciated by non-scientists: it is guided as much by peer approval as by the truth of its claims” (2012, p. 276).

The concern is not hypothetical. The 2013 Online Discussions on Article 10 of the Nagoya Protocol was the subject of refereed publications.  For example, Sarah Winands-Kalkuhl. and  Karin Holm-Müller published a comprehensive article (some 22,000 words!) entitled “Bilateral vs. Multilateral? On the economics and politics of a global mechanism for genetic resource use” (Journal of Natural Resources Policy Research, vol 7, no 4, pp305-322, http://dx.doi.org/10.1080/19390459.2015.1097022).   Note 15 on page 310, offers an intralink:

“The online discussion (online: http://absch.cbd.int/Art10groups.shtml, last 10.01.2014.) served the purpose of the broad consultation on Art. 10 which was instructed by the COP 11 in decision XI/1 B (UNEP/CBD/COP/11/35, XI/1 B, p. 76). It uses the list of questions included in decision XI/1 (UNEP/CBD/COP/11/35, XI/1, Annex I, p. 79 f.”

Clicking on the intralink of Note 15 generates this message: “404 Error Message: Page Not Found”.  The persistent reader may enter the CBD portal and type into the Search Engine: “Article 10 nagoya protocol online discussion". She will be disappointed: “No Results”.  In 2018, I experienced the same problem with citing the 2013 Online Discussion of Article 10 in “Bounded Openness as the Global Multilateral Benefit-Sharing Mechanism” (for full citation, see Post##9701). In the references to the chapter, I cited the 2013 Online Discussion as: “CBD Secretariat (2013b) ABS Clearing-House: Pilot Phase, https://bch.cbd.int/abs/art10_groups/searchforum/”.  However, the link broke between acceptance of the final page proofs and publication. Clicking now generates: “404 Error Message: Page Not Found”.

I hope this technicality can also be  fixed.
posted on 2019-03-29 17:04 UTC by Mr. Joseph Henry Vogel, University of Puerto Rico-Rio Piedras
RE: Welcome message - synbio forum - topic 7 [#9724]
Dear all,
I am also happy for the extra time, because otherwise I would not have the chance to post. Thanks to the technical problems, the secretariat had!
I would like to support the posts made by Ilaria # 9698 and Jack # 9707, questioning that why should all SynBio- organisms that are LMO do not need to be addressed under the CBD.
I not only want to question this conclusion, because of the reason that the objectives of the CBD have a much broader aim. I would also like to draw your attention to the idea that SynBio is a further development of genetic engineering. So, only the fact that they are still LMO does not mean that there potential is not bigger than organisms produced through classical genetic engineering. It would be like comparing first machines with modern robots. In opposite it seems that we are almost all of the same opinion that the potential (negative or positive) of Synthetic Biology is far bigger than that of classical genetic engineering. So, SynBio organisms, as long as they are LMO have to be treated under the Cartagena-protocol AND under the CBD, because they have a much bigger potential to impact the three objectives of the CBD as they are a further development.
Second I also want to question that the fact that not all SynBio organisms may negatively affect the objectives of the CBD leads to the conclusion that SynBio is not an issue for the CBD. This conclusion in my opinion would only be valid, if NO SynBio organism poses any risk to the objectives. Only if we have an effective horizon scanning installed and only if products developed through SynBio that may negatively affect biodiversity are identified and put on the agenda of the CBD for discussion, a case to case decision can be made!
Concerning “urgency” and “evidence” I would like to remind you of the precautionary approach. Evidence in this case can not mean that we already have unexpected and significant impacts on biodiversity, but if we use our knowledge we can expect the impact. Otherwise as Margret # 9710 pointed out we were only able to act when it might already be to late. Urgency in my opinion is always given when it occurs that not reacting leads to a situation where it may already be to late!
Thank you
Birgit
posted on 2019-03-29 17:15 UTC by Ms. Birgit Winkel, Germany
RE: Welcome message - synbio forum - topic 7 [#9725]
Thank you Casper and Maria for guiding us through the discussions and thanks to everyone participating in the forum.

Regarding topic 7, here my opinion on the list of criteria:
a) There are plausible risk scenarios on how a intended or unintended release of synbio organisms into the environment could have an impact on biodiversity. Such an impact could both be positive or negative and depends on both the organism and the receiving environment. Thus, synthetic biology is relevant for the implementation of the CBD objectives and programmes.
b) Except from hypothetical synthetic biology applications, there do not seem to be new evidence for such impacts.
c) Synthetic biology is a very broad and highly dynamic field of research. Those applications of synthetic biology I am aware of will result in LMO and, therefore, will be assessed on a case-by-case basis. But because there might be future developments that might not fall under this definition, and it is difficult to predict when this might be the case, the issue should be addressed now.
d/e) I do not expect that any synthetic biology organisms would behave differently than LMO with gene drive mechanisms, which might serve as “worst case comparator”. Therefore, the situation is comparable to LMO.
f/g) Again, I think is comparable to LMO in general. The impact and its magnitude can only be assessed case–by-case.

Regards Christoph
posted on 2019-03-29 19:50 UTC by Mr. Christoph Lüthi, Switzerland
RE: Welcome message - synbio forum - topic 7 [#9727]
Dear  moderators, dear collegues,"

I join Birgit  in thanking the Secretariat and the moderators in extending the forum for a couple of more days.

As opposed to industrialized countries who may have dedicated and paid personnel for biosafety oversight, which is very expensive and onerous to implement, many developing countries do not have the resources to devote to biosafety issues. Biosafety issues are indeed  important, but not  necessarily the top priority for already overstretched government ministries and programs, who need to deal with an ever-growing list of concerns and very real threats to biodiversity and to human,  animal and plant/crop health.  To name but a few issues in Latin America (not at all new or emerging!), we have huge problems stopping  melting glaciers, deforestation (by agriculture, forestry and narcotrafic activities), water shortages and desertification, damage to coral reefs, invasive species, and emerging human, animal and plant diseases  -- the list  and the problems seem endless. Thus, I applaud the COP request to reduce the number of agenda items to improve the effectiveness of the next COPs-MOPs decisions and future (costly) implementation.

In addressing our moderator’s request  to assess the relationship between synthetic biology and the criteria set out in decision IX/29, I thank Boet (# 9676), Jim (# 9678) and  Mariska (# 9704) and others for  systematically  and usefully addressing each of  the 7  (a-g) criteria for the CBD to consider a topic as a New and Emerging Issue (NEI) as it relates to the Netherlands,  Canada and New Zealand and I strongly support their party’s conclusions.

I also  read with great interest, but little surprise,  how many participants representing Europe, North America, Latin America and Africa (# 9676,  #9678, # 9685,  #9686,  #9688, # 9696,  #9702, #9703, #9704, #9705, #9706, #9711, # 9720, #9721)  feel that many of the 7 criteria have not been fulfilled and state that :

1. Products of synthetic biology are LMOs and are covered by the Cartagena Protocol, which include criteria for case-by case risk assessment under Article III.

2. There is no evidence that the current LMOs derived from synthetic biology (definition still not agreed by parties) pose an unexpected and significant impact on biodiversity. This is especially true when the potential risk to biodiversity and health are compared to the very real threats mentioned above.

3. Socio-economic considerations and benefit sharing issues that impact production and economic and human well-being are already dealt by the Cartagena and Nagoya Protocols.

4. Gene drives and genome editing are umbrella terms for genetic engineering techniques and thus, their products should be assessed on a case-by-case basis as LMOs, and not under the umbrella term of synthetic biology.

Thus, I strongly support Jenna (#9696), Felicity (#9703) and Luciana’s (#9705) statement that considering synthetic biology as a NEI under the CBD has been procedurally incorrect from its inception and further support Joseph Henry’s  (#9723) request that technicalities and guidelines to follow procedures should be fixed.  Not fixing these issues now could be very costly in the future, as we saw when we rushed procedures in the AHTEG for RA & RM.

Fully realizing that we cannot discuss things forever,  I concur with Bob (#9706) that we should aim to help  parties craft biosafety policy for LMOs by engaging in evidence-supported, meaningful intellectual discussions (such as this forum) and not rushing with “priority setting exercises” to advance to the next point on the agenda, just to comply.

I finalize this long intervention with a reflection: do we need a 4th Protocol under the CBD to deal with synthetic biology to protect biodiversity, if we already have the  Cartagena and Nagoya Protocols?  Is “more” better?

We already have 3 Protocols and implementing them is costly and very difficult, especially for resource-poor developing countries, who may end-up simply not being able to comply with the onerous regulation and forced to act “illegally. I see this happening already for the Cartagena Protocol  in most Central American countries and in Bolivia (countries that I know well). Mexico, with more resources, is doing much better but is also overstretched.

To act responsibly, ethically and fairly while developing technology is paramount and should be thought in biotechnology programs.  By developing ever more onerous biosafety regulation,  do we want to promote, or to stifle innovation of technologies that may help address many of the urgent issues that threaten our planet and our health?

I look forward to the last few days of this important and interesting discussion.

Maria Mercedes Roca
posted on 2019-03-29 23:28 UTC by Dr. Maria Mercedes Roca, CIBIOGEM, Mexico
RE: Welcome message - synbio forum - topic 7 [#9726]
I would like to say I have personally found it a valuable experience to read the comments by people who have clearly thought deeply about the topics they address.

How one might best  apply the letter and spirit of the criteria to identify new and emerging issues in synthetic biology versus already covered LMOs, is clearly a complex issue, given the space that has been devoted here to this matter.
The fact that biological developments are almost always incremental, combined with the  observation that when  attempting to prospectively identify the first tipping point or first point of “emergence” one will almost always be wrong (as they are largely retrospective concepts in practice, particularly for firsts).  The combination of these two factors means that it is almost always possible to make a case that nothing is sufficiently new or radical to warrant attention (either the nature of changes or their impact). Consequently,  I am skeptical that improved definitions or refined criteria could significantly resolve the inherent subjectivity.  This would be  the case even if there was a definition that separated “conventional”  LMOs from synthetic ones (maybe along the lines of the very credible ones proposed (a-d) in topic 5 [#9606] by Ben).
I suspect that what is selected for successful prospective horizon scanning as new and emerging issues in Synbio will in practice be a matter of identifying cases most likely to be perceived as sufficiently radical by stakeholders AND in receipt of sufficient  funding .  With the numbers of issues examined and their scope being dictated by the resources available.
If there  really was general agreement that there is nothing on the horizon that is worth any resources to examine within this forum (even for the sake of capacity building), one might wonder what its actual purpose is? Surely its role  cannot be just to consider “damage” that is imminent or has occurred.

Observation on criteria (e)
Evidence of the absence or limited availability of tools to limit or mitigate the negative impacts of the identified issue on the conservation and sustainable use of biodiversity
CONSIDER & [or over reliance on tools that may share similar vulnerabilities to the systems they are expected to mitigate/ reverse];
Where  an environmental intervention  has been deemed to fail or requiring reversal, the wisdom of relying on systems with the same underlying technology (and vulnerabilities)  for mitigation requires  forethought.  By analogy, while it is indeed possible to fight fires using fire, this is only likely to prove a reliable measure  if a history of considerable practical experience with fire already exists.

observation on criteria (d)
Actual geographic coverage and potential spread, including rate of spread, of the identified issue relating to the conservation and sustainable use of biodiversity;

The value of mathematical modelling is undeniable, predicting for example the potential range or temporal persistence of  interventions, as highlighted by other contributors (eg Austin[#9587] or Margret [#9577]).  However, it is important to recognise that the capacity of modelling to capture  the practical  consequences of very rare events is often limited (ie the variance of estimates  can be too high to be useful).For example despite strong commercial  incentives to predict the time period until genetic resistance arises  to chemical insecticides or herbicides, models (or experimental approaches)  attempting to do this have enjoyed little prospective success. 
While it is a distinct point, this has not limited the capacity to deploy strategies to delay resistance or develop management strategies once it arises.

Finally, I also strong agree with Joesph [#9723] that for future study posts to this forum need to  remain easily accessible.

Regards

Guy
posted on 2019-03-29 21:14 UTC by Dr. Guy Reeves, Max-Planck-Institut für Evolutionsbiologie
RE: Welcome message - synbio forum - topic 7 [#9728]
Dear moderators and other colleagues,


a) Relevance of the issue for the implementation of the objectives of the Convention and its existing work programs;

in relation to the numeral a):

It is important to define the scope and impact of synthetic biology developments within the framework of the objectives of the biodiversity convention:
1. How access to genetic resources and derivatives is addressed when genetic and chemical information for the development of components and products of synthetic biology is obtained through bioinformatics.
2. In the case of using genetic and chemical information found in databases of public use to develop components and products of synthetic biology and that this configures access to genetic resources and their derivatives as the provisions and object are enforced of the CBD.
3. How is the distribution of the benefits derived from access to genetic resources and derivatives when components and products of synthetic biology are developed from the information found in bioinformatic media of said genetic resources and derivatives.
posted on 2019-03-29 23:40 UTC by Mr. Carlos Augusto Ospina Bravo, Colombia
RE: Welcome message - synbio forum - topic 7 [#9729]
Dear all,

Please let me add a few thoughts to these intense and informative deliberations.

It has also been mentioned by others - the wording of the criteria is not prescriptive in a way that it would only allow an issue to be new and emerging if their was actual proof and evidence to all points. Points f) and g) for example talk of “actual or potential” impacts, indicating the forward looking aspect of the criteria, a point similarly raised by Helmut (#9684).

In relation to this I find the point Casper brought our awareness to of real importance, namely  “Please note that, as of yet, there is no further guidance on how to apply these criteria.”

Personally I do not consider these criteria are meant to all have to apply for any given issue at consideration, as in fact it appears that some points may be mutually exclusive. We have discussed this repeatedly and perhaps it might be helpful to look at what these criteria are meant to serve. Are they meant to help identify issues that are of real concern to the objectives of the convention and that should be investigated until one is either sure that no harm will arise, or, if found to hold substantial risks, to intiate procedures or guidance that will help prevent the realisation of such risks. What if the criteria -when ALL need to be fulfilled- turn out to become an insurpassable door-locks? No more new and emerging issues?

So in a way we need to solve one in order to solve the other. This also has been said before. I feel the AHTEG may want to look at the “ALL or SOME” aspect and its implications - prior to reviewing and updating the information paper prepared by the secretariat prior to SBSTTA-22.

Linked to this – and also mentioned by others - I regard horizon scanning as crucial, and this cannot take place if an issue is not recognised as an issue. Which brings me to gene drives.
Gene drives have been recognised as potentially as a technology under development (within synthetic biology) with potentially serious implication to biodiversity – and there will be other technologies, or further developments of gene drive systems that require special attention. Some seem to argue that because a synbio organism fits the criteria of an LMO it is sufficient to deal with it under the Cartagena Protocol.

Yet we have a different decision under the CBD, recognising wider implications, impacts and responsibilities. The protocol was negotiated to regulate intentional transboundary movement, and movement to be shipments of LMOs in containers, moving along with documentation, including an approval of the LM event by the importing country. Dealing with a technology and LM organisms that have the capacity to spread actively and intentionally beyond the area of release and the national boundaries requires special reflection, regulation and agreement – and risk assessment.

I find it important to recall that gene drive technology has also been recognised as a dual use technology, meaning it can also serve military purposes and it has the potential for serious misuse. The 2016 report by the US National Academy of Sciences gives a reflection of the deliberations on that topic, marking it clearly out as an issue requiring special guidance and regulation.

REF: NAS. 2016. Gene Drives on the Horizon: Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values. in Gene Drives on the Horizon: Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values. The National Academies Press, Washington (DC).

With kind regards,

Ricarda
posted on 2019-03-30 01:11 UTC by Ms. Ricarda Steinbrecher, Federation of German Scientists (Vereinigung Deutscher Wissenschaftler)
RE: Welcome message - synbio forum - topic 7 [#9730]
Dear Forum Participants,

On March 1st we started this forum, and  have discussed the following topics during these four weeks:

Topic 1: New technological developments in synthetic biology since the last meeting of the Ad Hoc Technical Expert Group.

Topic 2: Recommended options for carrying out the regular horizon scanning, monitoring and assessing of developments referred to in para 3 of decision 14/19.

Topic 3: Review of the current state of knowledge.

Topic 4: Possible impacts of synthetic biology applications that are in early stages of research and development, on the three objectives of the Convention.

Topic 5: Considerarions on whether any living organism developed thus far, through new developments in synthetic biology, fall outside the definition of living modified organisms as per the Cartagena Protocol.

Topic 6: Sharing of experiences on detection, identification and monitoring of organisms, components and products of synthetic biology.

Topic 7: Relationship between synthetic biology and the criteria set out in decision IX/29.


Your contributions have enriched each of these topics. The discussion on synthetic biology has multiple angles, there are different positions and points of view, and the purpose of this forum was exactly this, to gather the different opinions and perspectives on each of the discussed topics. With the help of the Secretariat, Caspar and I will do our best to write a comprehensive report that reflects the fruitful conversations we have had during these weeks. As you know, this report will be an important input for the upcoming meeting of the AHTEG.

Thank you very much for your support, your commitment and for this enriching debate.

For me it has been an honor to moderate this forum.

Best Regards,

Maria
posted on 2019-03-30 05:06 UTC by Ms. Maria de Lourdes Torres, Universidad San Francisco de Quito
RE: Welcome message - synbio forum - topic 7 [#9731]
Thanks for the moderators, secretariat and the participants for this interesting discussion.

Jim post #9678 raised an important point: The Conference of the Parties has underlined the importance of reducing the number of agenda items for consideration in order to improve the effectiveness of its proceedings (decision VIII/10, para 14). This reminded me of the CBD Executive Secretary C. Palmer opening statement during the last COP/MOP. She pointed to meaningful progress on the conservation and sustainable use of biodiversity but that these successes are not enough to halt the ongoing loss of plant and animal diversity on Earth — a fundamental worldwide extinction crisis, deepening every year, and severely impacted by — and also severely driving — climate change. We on developing and developed countries, need to make sure that we do not divert resources from strategically important efforts.

I agree with Boet [#9676] and others that: “Organisms, components and products of synthetic biology can have neutral, positive or negative effects on biodiversity. This has to be assessed on a case-by-case basis.” There is strong agreement that current and foreseeable applications of Synbio result in LMOs and are covered by the Cartagena Protocol. I also echo several participants that mentioned that there is no evidence for unexpected and significant impacts on biodiversity resulting from synbio. 

In addition, I also agree with several participants that a proper analysis of whether Synbio meets the criteria for a New and Emerging Issue is important. Though we thank the secretariat's efforts to contribute to this by fishing bits from past AHTEG's reports, the topic was not discussed and thus can't produce a robust conclusion. 

Warm regards, Lúcia
posted on 2019-03-30 10:52 UTC by Ph.D. Lúcia de Souza, PRRI - Public Research and Regulation Initiative/ANBio (Associação Nacional de Biossegurança - Brazilian Biosafety Association)
RE: Welcome message - synbio forum - topic 7 [#9732]
I reiterate the thanks many others have expressed to Maria and Caspar for their efforts as moderators throughout this forum and to other participants for an informative and engaging exchange of ideas and knowledge.

In relation to the criteria listed in paragraph 12 of decision IX/29:
For (a), synthetic biology clearly has relevance to the conservation and sustainable use of biodiversity, and so has relevance to the three objectives of the Convention. The effects of synthetic biology on biodiversity may be positive, negative and neutral (as noted in posts #9676, #9678, #9704, #9706, #9731 and others).

For (b), I agree with #9676, #9678, #9702, #9704, #9706 and #9731 that there is no new evidence to date of unexpected and significant impacts on biodiversity from synthetic biology. Additional to the lack of evidence of these impacts, there is no evidence that the risks of synthetic biology organisms would be significantly different to the risks of other organisms (eg products of conventional breeding or products of modern biotechnology) or that the risks of synthetic biology products would be significantly different to the risks of other products (eg industrial chemical products).

For (c), in light of there being no evidence of unexpected and significant impacts on biodiversity, and synthetic biology organisms developed to date being within scope of the Cartagena Protocol as LMOs, I do not consider there is urgency to address synthetic biology as an issue. I agree with the points well made by others, that the characteristics of synthetic biology organisms don’t make them any riskier than LMOs per se (#9704), and that general principles of risk assessment remain applicable (#9705).

For (e), I point to existing international and domestic regulatory frameworks which minimise the risks to biodiversity from LMOs, as key tools to limit or mitigate any negative impacts of synthetic biology on the conservation and sustainable use of biodiversity, noting again that all synthetic biology organisms to date are LMOs. I agree with #9676, #9705 who point to the risk assessment and risk management framework of the Cartagena Protocol as being appropriate for synthetic biology, backed up by an abundant range of guidance for LMOs (as noted by #9704), and decades of experience with risk assessment and risk management of LMOs (as noted by #9705).

Best regards,
Louisa
posted on 2019-03-30 11:15 UTC by Dr. Louisa Matthew, Office of the Gene Technology Regulator, Australia
RE: Welcome message - synbio forum - topic 7 [#9733]
Dear Colleagues,

Casper [#9718] has rightly pointed out that in this forum currently very different opinions have been brought forward in the discussion on whether the criteria set out in decision IX/29 are fulfilled or not.

To move forward in the discussion to support the AHTEC in their final analysis, I would like to focus on the points where we witness brought agreement among the experts of the AHTEC in 2015 and 2017 and among the experts in this online forum and most importantly among parties at the COP14. That is that synthetic biology is a „rapidly developing and a cross-cutting issue, with potential benefits and potential adverse effects vis-à-vis the three objectives of the Convention on Biological Diversity” (See CBD/COP/DEC/14/19). The highlighting of the pace of developments in synthetic biology was also one of the main outcome of the AHTEG in 2017 that resulted in the recommendation for a horizon scanning process. The COP14 decided that a regular and brought horizon scanning process is needed, and those of you that where present in the plenary on this topic, will recall that this topic was largely undisputed write from the beginning. In conclusion, when we continue in our analysis, we will have to bear in mind, the most recent decisions by the COP14. If we take into account the “rapidly developing” and “cross-cutting” side of synthetic biology with “potential benefits and potential adverse effects vis-à-vis the three objectives of the Convention”, we will also come to the conclusion that applications of synthetic biology have features that go beyond mere risk assessment (“cross cutting”) and that will be challenging due to the enormous speed of the developments and depth of intervention (i.e. organisms and ecosystems).

The crosscutting nature of certain synthetic biology organisms can be illustrated on synthetic gene drive organisms (GDO), for which we have performed an analysis also on wider implications of GDOs (DOI: 10.15252/embr.201845760).

In summary when we perform the analysis on the criteria that COP 9 decided on, we will also have to bear in mind the more resent decision of the COP14 on synthetic biology.

All the best to Maria and Casper,
With kind regard,
Margret
posted on 2019-03-30 12:37 UTC by Dr. Margret Engelhard, Germany
RE: Welcome message - synbio forum - topic 7 [#9734]
Dear participants of the forum,

I would like to take advantage of the extended submission window given by the Secretariat to join in the discussion on topic 7.

First, I would like to add my support for the views shared on this forum that the document prepared by the Secretariat (CBD/SBSTTA/22/INF/17) entitled “Analysis against the criteria set out in paragraph 12 of decision IX/29”, does not present an analysis of the issue. I note that the Secretariat laconically described the “methodology” of their analysis as follows: “The analysis was performed by linking relevant statements in the AHTEG reports to the criteria [set out in paragraph 12 of decision IX/29]. The analysis includes only statements reflecting statements across the AHTEG, avoiding using statements that clearly reflected the views of only some members.”  There is no further explanation about how the Secretariat decided what are “relevant statements”, or how they judged which statements “reflected the views of only some members”. A good example of what steps must be met towards a robust analysis can be taken from “Principles and process for dealing with data and evidence in scientific assessments” (EFSA Journal 2015;13(5):4121), which identifies the following necessary elements: 1) Planning upfront a strategy for the assessment; 2) Conducting the assessment in line with the planned strategy and documenting the modifications to it; 3) Verifying the process; 4) Documenting and reporting the process, results and conclusions, and ensuring accessibility of methods and data.

I hope that the upcoming AHTEG will take into account the critical comments regarding analysis methodology raised in this forum and address the issue of whether synthetic biology meets the criteria for new and emerging issue in a systematic way using a clear, well defined and transparent methodology.


As to the question about the relationship between synthetic biology and the criteria set out in decision IX/29, paragraph 12, I join those who stated that synthetic biology does not fulfil the criteria of new and emerging issue (e.g. #9685, #9686, #9696, #9676, #9678, #9688, #9703, #9704, #9705, #9711, #9722, #9731, #9732) and would like to elaborate briefly on some specific points below.

a. Relevance of the issue to the implementation of the objectives of the Convention and its existing programmes of work

Many have agreed here that organisms from synthetic biology can have positive, negative, or neutral impacts on biodiversity (e.g. #9676, #9678, #9688, #9695, #9696, #9703, #9704, #9706, #9714, #9720). I would like to add that positive, negative, or neutral impacts on biodiversity are likely to occur from the use of any organism, be it LMO or otherwise, and be it via human intervention or in natural environments. Therefore, synthetic biology, as part of “biology” is relevant, however only case-by-case assessment of specific applications would produce meaningful insights.

b. New evidence of unexpected and significant impacts on biodiversity

I join those who have stated that to date, there is no evidence of unexpected and significant impacts on biodiversity (#9676, #9678, #9700, #9702, #9703, #9704, #9705, #9706, #9731, #9732). In our forum discussion, as well as in previous work on synthetic biology under the Convention, many potential impacts, ranging from plausible to highly speculative have been postulated. I would argue that all of these (including the most speculative ones) are “expected”, even if theoretically, for the very reason that they were identified and discussed here and elsewhere. So, what would be an “unexpected” impact? I favour that this is something that was not predicted nor anticipated, but was observed and for which we can provide evidence. Or is it something that was not observed, and for which we do not have evidence, but was predicted, or hypothesized about (the discussion in this forum about potential and expected future impacts is a good illustration for this point)?

The fact that no evidence of unexpected and significant impacts has been identified in this forum points to the fact that current regulatory mechanisms are providing the necessary tools to address potential impacts on biodiversity arising from the use of LMOs and these are equally applicable to LMOs that are derived from synthetic biology applications.
I agree with the comments that it is important to focus resources on building capacity for good implementation of the exiting provisions (#9678, #9705, #9706, #9711, #9727, #9731, #9732) rather than to divert resources in multi-year discussions (since 2008 as indicated in #9711) on a topic that is successfully handled under exiting regulatory provisions – under the CBD and other frameworks at national or international level, as appropriate.


c. Urgency of addressing the issue/imminence of the risk caused by the issue to the effective implementation of the Convention as well as the magnitude of actual and potential impact on biodiversity

Following on question b), in the absence of evidence of impacts, beyond the impacts that are already handled via existing regulatory provisions, there could be no urgency in addressing the issue. This point also applies to gene drives where existing regulatory mechanisms would provide the necessary risk assessment structure prior to release in the environment.


Thank you all for interesting discussion,

Best wishes, Ana
posted on 2019-03-30 13:37 UTC by Dr. Ana Atanassova, BASF Agricultural Solutions NV
RE: Welcome message - synbio forum - topic 7 [#9735]
Dear all,

Let me start by thanking everyone for their participation in this forum.  I found all the contributions to be thought provoking.  I also thank Maria and Casper for taking on the challenging task of moderating and wish them well as they endeavor to develop a report from this forum. 

Recognizing that the COP-MOP extended that AHTEG on synthetic biology and in light of paragraph (a) of the Terms of Reference for the AHTEG (decision 14/19), I believe that providing advice to the AHTEG to consider “on the relationship between synthetic biology and the criteria set out in decision IX/29, paragraph 12” is critically important.  To date, the assessment requested in decision XII/24, paragraph 2 has not been completed despite publication of the “preliminary analysis prepared by the Executive Secretary in document CBD/SBSTTA/22/INF/17”.  Because of this publication, I share the deep concerns expressed in #s 9685, 9686, 9696, 9703, 9704, 9705, 9711, 9727 and 9732 that the report generated by the Secretariat fails to meet the needs for a robust analysis according to the criteria in decision IX/29.  It extracted statements made in the course of discussions and attempted to place them in a different context.  There was no purposeful discussion within the AHTEG on the criteria. 

Clearly analyses of varying robustness and dubious objectivity have been completed in the past and in this forum.  It seems that it is time to finish the job that was requested years ago, and this must be a priority for the AHTEG.  I also believe that the criteria outlined in paragraph 12 of decision IX/29 must be considered in an inclusive manner. 

Regarding the information that the AHTEG should consider, I accept that the reports from previous AHTEG’s will likely be included.  However, there is additional and perhaps better information for inclusion in the expert’s discussions.  I particularly note, and thank, those who provided thorough and thoughtful analyses of synthetic biology in accordance with the criteria set out in decision IX/29 in this forum.  In my view, contributions 9676, 9678, 9682, 9690, 9700, 9703, 9704, 9705, 9732 and 9734 together with the attachment referenced in 9703 and clarification given in 9704 should feature prominently in the discussions of the future AHTEG. I also believe that interventions 9685, 9686, 9693, 9702, 9708, 9727 offered appropriate cautionary notes to some of the personal speculation, and the balance conveyed in these contributions is wise counsel and should be considered.  

Best,

Tom Nickson
posted on 2019-03-30 15:21 UTC by Mr. Thomas Nickson, Consultant
RE: Welcome message - synbio forum - topic 7 [#9736]
Just two brief comments:

1. Modelling is generally considered to be a pretty strong scientific and engineering approach. Especially when the models are logically and mathematically consistent and reflect the available at that point experimental results. It suffices to say that some of the main scientific breakthroughs in the 20th century started as mainly theoretical insights (models that is), e.g. general and special relativity, quantum mechanics, complex systems. Models are widely used in designing airplanes, integral circuits or for stockpile stewardship. The predictions of those models are later tested only partially and are not dismissed outright.

2. It is not necessarily true that even conventional LMOs that have been long used are always safe and don’t cause any problems. E.g. Example 3 in this governmental contribution on different technological topic, highlights the problems for the weed management coming from herbicide resistance (https://www.cbd.int/abs/DSI-views/CGRFA-DSI-2.pdf). Resistance that might be result of direct flow of transgene into wild relative, e.g. Brassica rapa (https://link.springer.com/article/10.1007%2Fs11356-017-0726-3) or indirectly due to, at least partially, increased use of herbicides due to cultivation of LMO crops, e.g. Kochia scoparia.

What I am trying to say is that if we do formal check against the criteria for New and emerging issues we should not overlook potential problems, just because most synthetic biology applications are very likely to be pretty safe. To go back to the engineered gene drives (certainly not a single technology), the strongest clue that there are significant potential adverse effects the stance of the scientists who actually develop the gene drives. It is them who advocate special care and conduct their research in stepwise fashion (I hope its not necessary to provide the references). Ultimately that’s the right way to go forward with new technologies.

P.S. A few years ago, we did some informal in house exercise to check the technologies we think fall within Synthetic biology against the criteria for a new and emerging issue as set out in decision IX/29, paragraph 12, taking into account paragraph 11. I think the results are still valid and I tried to present them briefly in #9690.

Best Regards,
Nikolay
(edited on 2019-03-30 21:24 UTC by Nikolay Tzvetkov)
posted on 2019-03-30 21:18 UTC by Mr. Nikolay Tzvetkov, Bulgaria
RE: Welcome message - synbio forum - topic 7 [#9737]
It is apparent that there are a least two camps when considering whether the document produced by the Secretariat (information document CBD/SBSTTA/22/INF/17) constitutes a robust analysis of the 'criteria for new and emerging' .  Taking for a moment the perspective of the difficulty the Secretariat must have had to produce such a document knowing that some would be pleased with their efforts and others not, I wonder if a middle way can't be found? 

Could the AHTEG take the INF document to the next step and add a structured 'analysis' for each criterion including consideration for the three objectives of the Convention and it's Protocols.  Wouldn't that be the proper task of an AHTEG? 

Jim Louter, Environment and Climate Change Canada
posted on 2019-03-30 21:23 UTC by Mr. Jim Louter, Canada
RE: Welcome message - synbio forum - topic 7 [#9738]
Dear all,

I will also take advantage of the extended time given to this topic to briefly comment on the Cartagena Protocol (Protocol). I (many and others) have stated the view throughout this online discussion series that organisms developed through “synthetic biology” approaches are LMOs within the scope of the Protocol – and I will again qualify my view that this does not include mutants developed with the use of genome editing tools.

This means that the Protocol’s regulatory provisions, including it risk assessment framework (Annex III), apply to LMOs developed through synthetic biology. This has evoked questions in this discussion about the regulatory scope of the Protocol; this stated in Article 4 and reproduced here:

“This Protocol shall apply to the transboundary movement, transit, handling and use of all living modified organisms that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health.”

A narrow interpretation of this would restrict it to “transboundary” situations, however in practice its scope is broad, showing consistency with Article 8(g) of the CBD ("use and release"). To provide a practical example, an environmental release of an LMO (plant, animal, microbe) will be subject to a risk assessment regardless of whether it was locally developed or imported (i.e. via a transboundary movement). The purpose of the risk assessment is to “… identify and evaluate the possible adverse effects of living modified organisms on the conservation and sustainable use of biological diversity, taking also into account risks to human health” (Protocol Article 15.1).

The risk assessment principles and methodology enshrined in the Protocol provide the foundation for LMO regulation in many countries. Concerns have been expressed that there are Parties to the CBD that are not Parties to the Protocol, but Article 8(g) of the CBD applies. In fact, many CBD Parties that are not Parties to the Protocol have regulatory frameworks that pre-date the Protocol, they are among the most experienced countries in undertaking risk assessments for releases of LMOs, and their general risk assessment principles and methodologies are consistent with the Protocol.
posted on 2019-03-31 00:58 UTC by Ms. Felicity Keiper, BASF
RE: Welcome message - synbio forum - topic 7 [#9739]
Dear Participants,
Thank you for your active engagement in this forum.
This forum is now closed for comments.

Thank you,
Secretariat
posted on 2019-03-31 01:00 UTC by Marianela Araya, UNEP - SCBD