Past Activities 2019-2020

Welcome to the Open-Ended Forum on Synthetic Biology. In its decision 14/19, the Conference of the Parties decided to “extend the Online Forum on synthetic biology taking into account the work on risk assessment under the Cartagena protocol, to support the deliberations of the AHTEG".
To give effect to the COP’s decision, 7 topics have been selected for discussion under this forum.
The topics are:
Topic 1: New technological developments in synthetic biology since the last meeting of the Ad Hoc Technical Expert Group
Topic 2: Recommend 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: Consider 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
This forum is co-moderated by Mr. Casper Linnestad from Norway (Norwegian Ministry of Climate and Environment), and Ms. Maria de Lourdes Torres from Ecuador (Universidad San Francisco de Quito).
During the first week, topics 1 and 2 will be open for discussion. The second week will consider topics 3 and 4, the third week topics 5 and 6 and the fourth week will be for discussion on topic 7.
Each moderator will take the lead in supporting discussions under one of the two topics each week, and they will work together for the moderation of topic 7. For the topics that will be open for discussion this week, Ms. Torres will moderate topic 1, and Mr. Linnestad topic 2.
We now request participants to the Online Forum to provide submissions on topics 1 and 2 for the next week. Discussions under these topics will close at 1 am GMT on Sunday 10th March. You can see the schedule for discussions on other topics on the forum page.
We suggest that submissions are always as specific as possible to facilitate the analysis of the information as well as the interpretation of each post from other forum participants. We kindly request you to refrain from commenting on topics that are not yet open for discussion, and only provide inputs to the discussions that are open on each particular week.
In addition, if you would like to respond to another post, we would like to encourage you to mention the # of post you are responding to, for example: “in response to post # XXXX, …”. This will also facilitate the understanding of others.
Please post your responses under this thread. We also advise you to review the general guidelines for the forum on the main webpage of the discussion.
We thank you for your participation in this forum, and we look forward to an interesting discussion.
Sincere regards
Casper Linnestad and Maria de Lourdes Torres
Co-Moderators

Dear all,

Greetings from Iran!

Congratulations to both (Topic 1 and Topic 2) moderators of open-ended forum on synthetic biology and all participants. Looking forward to have an interesting and useful discussion.

I have a question about Topic 2. Are we supposed to discuss about para 3 of decision 14/19 or 14/9? I am confused, because decision 14/9 is not related to Synthetic Biology.


Best regards

Samira Kahak

Dear Samira, thank you for pointing out this important and misfortunate error in your message #9353. Yes, indeed, the correct bacground Reference for the discussion under Topic 2 is para 3 of decision 14/19, not decision 14/9. The Secretariat will fix this shortly. Thank you so much for pointing to this. All the best, Casper.

Dear all,
Regarding information that could be useful to analyze how the horizon scanning process should be carried out, my proposal is that in addition to the four mentioned by our moderator Casper, some additional could work as well:
 A New CBD Technical Series on these issues.
 Surveillance of relevant information (of at least, inter alia, mayor Congresses, Symposiums, Workshops, Technology Surveillance Reports) and work on a database with this information.
 Working together with other Experts groups inside and outside of the CBD (respectively The Risk assessment Expert Group and the Implementation Support Unit (ISU) of the Biological and Toxin Weapons Convention (BTWC) based in Geneva which  review of developments in the field of science and where we can find also Technical Working Paper on Genome Editing, Presentations on the issue of Synbio in general and gene editing by CRISPRCas in particular

Best regards,

L. Regalado

Dear all,

My name is Boet Glandorf and I work at the Dept. of Gene Technology and Biological Safety, which is part of the National Institute of Public Health and the Environment in the Netherlands. I also had the honour to be a member of the AHTEG in 2015 and in 2017.

First of all my congratulations and best wishes for our moderators.

Regarding the topic at hand, the options for carrying out the regular horizon scanning, monitoring and assessing of developments referred to in para 3 of decision 14/19, I agree with approaches as indicated by Nicolay (#9367). This will result in a compilation of published literature and reports from local or regional initiatives. But as also indicated by Claudia (#9368), by keeping up with the most recent developments one needs to talk to scientists working in the main biotechnology institutes.  This could be done by an easy accessible online-survey, but also other options could be explored.  Such as expert meetings organized back-to-back with major biotechnology meetings or back-to-back with iGEM competitions. Other options could be organizing yearly teleconferences with experts, which would take even less time for the experts involve.  In my opinion, multiple options could be combined.
Information thereafter has to be collated  by the CBD Secretariate for consideration at the relevant CBD bodies, as indicated by Nicolay.

Kind regards,
Boet

Dear all, thank you for providing views on topic 2 (Recommend options for carrying out the regular horizon scanning, monitoring and assessing of developments referred to in para. 3 of decision 14/19). I highly appreciate your input. From the posts so far, it seems that most of you welcome the use of some of the familiar CBD "tools" also in the future, such as Notifications asking for information and facilitating discussions by online fora like this one. Then, in addition, you have suggested several other means and mechanisms such as online surveys, teleconferences, e-mails or letters reaching out to the scientific community. These are all valuable inputs and will be reflected in the report from this forum.

I agree with Boet (#9389) and others that multiple options in combination is the way forward. Furthermore, it is of key importance that the various activities are launched in the right order within a given intersessional period. Under the CBD umbrella, typically, we are talking about "two year wheels" as the Conference of the Parties are scheduled every second year.

Nikolay (#9367) raised the point of also being proactive and how to retrieve information on technologies that are only just emerging, thereby not limiting the horizon scanning to recent developments. Morover, that also developments within several adjacent technologies might be relevant (i.e. nanotechnology).

Your posts and input will feed nicely into the subsequent deliberations to be made by the AHTEG on synthetic biology. The AHTEG is to discuss this matter further and recommend options  on how to carry out a CBD horizon scanning.

Already at this point, I think you have pointed towards some key factors for carrying out a high quality horizon scanning. Please submit more views this week, and also, be kindly reminded that the window for submitting views on Topic 2 closes on Sunday!

Thank you again,
best wishes,
Casper.

Dear All
I am Gerd Winter, a law prof teaching at the university of Bremen, Germany. I have studied regulatory issues of gene technology since long.
I wonder if para 3 of decision 14/19 when asking for "broad and regular horizon scanning, monitoring and assessing of the most recent technological developments" could not also understood to mean collecting information of governance approaches in different countries. There are huge differences in regulatory approaches of countries concerning SynBio which will make it very difficult for the CBD/Cartagena bodies to develop and agree on more than very broad regulatory principles. It is not sufficient to just upload national legislation to a central database (as it is already done) because national approaches are often difficult to understand, not to mention language problems. A seminal collection of governance approaches would require that a list of more specific regulatory topics is put together that could be suggested as guidance for governance information. I am only seeking the advice of the moderator if such endeavour would be covered by the scope of para 3 decision 14/19. In the affirmative case I would volunteer, hopefully together with other experts, to put a list of say 10-15 topics together.
Best regards
Gerd

Dear Casper,

in response to #9400, I do agree we need to act in multiple ways. However, I also very much agree with Boet (#9389) that we need to be much more proactive and approach those scientists working in the field, visiting iGEM meetings etc. Based on my experience with conservation surveys - online questionnaires are often coming back with very low response rates, though.
One option would also be to publish an annual review paper - Bill Sutherland and colleagues do that now for several years on global conservation issues and I would see a substantial impact, especially as those brainstorming documents reduce the typical time lag between research findings and publication as mentioned previously.
Saying this it all comes down which persons/organisation will do the actual scanning and Bob (#9461) has already pointed out the relevant questions.

Gernot
Gernot

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

Thank you Mr Casper Linnestad for volunteering to moderate this discussion topic.  As always, I’ll try do my best to stay on topic.

By way of introduction, my name is Jim Louter from Canada working in the federal department of ‘Environment and Climate Change Canada’ where our small group has been conducting environmental risk assessments of living organisms since 1997 when our regulations were implemented.  This includes assessment of both naturally occurring organisms as well as those that have been genetically modified. ‘Synthetic biology’ is not a defining term in our regulatory scheme but rather, the application of science and engineering to the organism or to the use of the organism is. 

I agree with the comments from Boet Glandorf above and also want to mention the publication of Australia of the Horizon Scanning document on Synthetic Biology that ACOLA published last year.  I brought a copy of it with me to COP14 and to the Contact Group on Synthetic Biology as an example of what 'horizon scanning' on this topic would look like - it would make a lot of sense for us to build on the work done by others as much as possible when considering such options.

However, we will need a clarification on the periodicity of ‘regular’ when looking at options – this may be a consideration for the AHTEG to look at.

Sincerely,

Jim Louter, Environment and Climate Change Canada.

Considering  that the achievements of this technology at present do not constitute the limit of this technology, support the needs of an effective horizon scanning and monitoring  as referred in decision 14/19. I´m fully agree with Mr. Lázaro Regalado [#9362].
In addition, a survey from the CBD Secretariat will be a tool to compile information on the subject, in an organizad manner. National authorities related to the three objectives of the CBD play an important role in the collection and preliminary review of these information.
The permanent monitoring of publications, symposiums and workshops, provide us with current information on the subject; so we suggest identifying these sources of information first as thoroughly as possible, to support this work.
regards,
Leyenis

Dear Colleagues,
My name is Nikolay Tzvetkov and I work at the Bulgarian Ministry of Environment and Water. I also had the honour to participate at the AHTEG meeting in 2015 and in 2017.

First I would like to congratulate the moderators and wish them success in their work.

Regarding the options for carrying out the regular horizon scanning, monitoring and assessing of developments referred to in para 3 of decision 14/19 the following considerations should be taken into account:
1. The Synthetic biology is not the only field where recent technological developments are relevant for the objectives of the Convention and its Protocols. For example the behaviour of nanomaterials in the environment and their impact on the human health and biological diversity are not fully understood. Thus it will be much more effective if the regular horizon scanning, monitoring and assessing of developments covers all technological developments that can be relevant. For this reason information should be sought actively from the leading research institutions
2. Relying only on published literature, due to the time lag between the actual research and publication, is not going to provide complete picture of the developments in some of cutting edge fields. For this reason information should be sought actively from the leading (100-200) research institutions (universities, research institutes, companies). This should be done by letters addressed to them. The main effort will be to prepare initially the mail list, which then will have to be maintained and updated. My personal experience is that many of those institutions and the individual scientists will be willing to provide their views. Such an approach will be cost effective as well.
3. Request for information should cover not only the recent technological developments, but also the emerging technologies whose relevance is not yet entirely clear. This will provide advanced warning and will facilitate a proactive approach.

Regarding the specific questions posed by the moderator,
• What are suitable steps in a horizon scanning process?
• Cost-effective and effective mechanisms are always preferable.
• How to secure input from relevant sources in a timely manner?
I would like to suggest a process along the following lines:

The CBD Secretariat submits annually request for information on the recent technological developments (incl. in the field of Synthetic biology) and on the emerging technologies that might have impact on the objectives of the Convention and its Protocols. This should be done by Notification addressed to the Parties and other relevant stakeholders and with personalised letters to the leading 100-200 research institutions (universities, research institutes, companies). The Secretariat should collate and summarise the received replies and present them (every year or every two years) for consideration at the relevant CBD bodies, most like SBSTTA. If necessary the information can also be presented to other bodies, such as relevant AHTEGs or online forums that are active at a given moment. If necessary and mandated so draft recommendations can be prepared for SBSTTA. SBSTTA can prepare draft decisions for COP and COP-MOPs if necessary.
Overall such a process will be relatively cheap and efficient and won’t require lengthy scan of published literature. It also has the advantage that it will be driven by the Parties, the other relevant stakeholders and the research institutions themselves.

Best Regards,
Nikolay

Along with posts #9367 Nikolay Tzvetkov, #9401 Todd Kuiken, #9403 David Castro, and #9425 Lim Li Ching, and others that have offered a range of places to find timely information, I would recommend frequent comprehensive review of the registration of intellectual property rights, such as patent databases.

With best regards and thanks for an interesting forum
Jack

Dear colleagues,

Greetings! My name is Claudia Vickers. I work at CSIRO, Australia's Federal research agency, and also at The University of Queensland, Australia. I am pleased to contribute to this Forum and I look forward to to coming discussions, in this case around Topic 2.

I agree with Nikolay (#9367) that the best way to obtain information on recent developments is to go to the community and ask. This should be done in such a way that makes it easy to engage, for example, through an on-line survey; and it should be concise and brief  in order to get sufficient and appropriate engagement. Designing of the questions of such a survey would obviously be critical.

Regards,
Claudia

Dear colleagues,
My name is Swantje Straßheim and I work at the German Federal Office of Consumer Protection and Food Safety in the secretariat of the German Central Committee for Biological Safety (ZKBS, https://www.zkbs-online.de/ZKBS/EN/02_UeberUns_Aufgaben/ueber_uns_aufgaben_node.html).

The ZKBS has been carrying out a monitoring of Synthetic Biology since 2010 and has published two monitoring reports so far (BCH record IDs 110828 and 113533). In these reports, the ZKBS has focused on the question whether the outputs of Synthetic Biology so far are considered as genetic engineering. For this monitoring, the ZKBS and its secretariat explore and review recent literature, participate in symposia and workshops and have organized two symposia to gain more detailed insight into Synthetic Biology.

I would propose to explore a similar strategy for the CBD: The horizon scanning process could start with the online forum or a platform where Parties, other governments, relevant organizations and experts nominated by these could upload new papers, expert panel´s monitoring reports or information gained through conferences etc.  In a subsequent evaluation process, which should include scientific and CBD expertise, the information should be streamlined considering the scopes of CBD and its protocols. Developments that are covered by the provisions of the CP would not need to be considered further under the horizon scanning process. I also agree with the idea to create a process driven by research, other relevant stakeholders and Parties [#9367] and the further elaboration of this approach in post [#9384] and [#9389].

Best regards,
Swantje

Thank you to Swantje (#9390) for describing the German Central Committee for Biological Safety's experience in undertaking horizon scanning activities. I can add the experience of Australia's Office of the Gene Technology Regulator.

Within Topic 1, Claudia (#9383) referred to her involvement in the Australian Council of Learned Academies September 2018 report  ‘Synthetic Biology in Australia: an outlook to 2030’, a horizon scanning report on synthetic biology commissioned by Australia’s Chief Scientist on behalf of the Commonwealth Science Council (available here: https://acola.org.au/wp/sbio). This horizon-scanning report in turn informed a review of Australia's gene technology regulatory system, which reported in October 2018 (report available here: http://www.health.gov.au/internet/main/publishing.nsf/Content/gene-technology-review). The review concluded that synthetic biology continues to remain within the scope of Australia's regulatory system, and that a watching brief on synthetic biology should be maintained into the future.

The Office of the Gene Technology Regulator has found that regular reviews of our legislative framework, which include horizon scanning efforts, are necessary to ensure the legislation keeps pace with scientific developments. The ongoing experience of regulators informs these reviews, as do the expert views of scientists engaged in research.

Best regards,
Louisa

Greetings again. My name is Todd Kuiken and I work in the Genetic Engineering & Society Center at North Carolina State University. 

I would like to support the many suggestions made by Mr. Nikolay Tzvetkov (#9367,) Ms. Swantje Strassheim (#9390), and Ms. Boet Glandorf (#9389). In particular, to utilize the iGEM competition as a specific component of the horizon scanning process. 

I have been affiliated with the iGEM competition for the past 10 years as a judge and member of its human practices and biosafety committees.  The competition meets every fall and last year hosted nearly 6,000 young people from 42 countries. It is the largest gathering of synthetic biologists where teams present the latest applications of synthetic biology that they had developed, or dreamt up, over the course of the prior year. We frequently invite members of governmental regulatory agencies to attend the competition in order for them to see the potential applications that may come across their desks in the coming years.

As a member of iGEM’s biosafety committee and a co-chair of its human practices committee, I can tell you that each year the new ideas team’s present, and the positive and negative impacts they may pose, challenges us. Specifically in relation to biosafety, environmental impacts, regulatory systems and broader societal impacts if they were to be fully developed (most of the projects do not actually work).  Each team documents their work in the form of a wiki which is permanently housed on the iGEM website and freely available for anyone to examine.  It would be relatively simple for the UN CBD to attend the competition, or simply scan the team wikis as part of a horizon scanning process.

Another component of the horizon scanning process should examine funding trends of research and development.  I have produced numerous reports examining the public funding of synthetic biology. I found it a valuable tool that can identify major scientific areas of interest, potential application areas and gaps in other subsequent research agendas.  For instance, through this process, I identified that the U.S. was not investing in ecological impact research on synthetic biology at the time and that the U.S. military was the primary funder of synthetic biology (reports attached).  The UN CBD could request from member states their funding levels in synthetic biology and related technologies. There are also industry associations and investment firms that regularly produce reports examining the private investment in synthetic biology, which the UN could access, and include in the horizon scanning process.

Kindest regards,
Todd Kuiken

Dear participants,

My name is Luciana Ambrozevicius and I work in the brazilian Ministry of Agriculture. First I would like to send my congratulations to the moderators and to the forum participants for all the interesting messages and articles already shared.

For the Topic 2, I understand that a horizon scanning mechanism already exists under CBD through the on line forum, the AHTEG, the BCH, the SBSTTA, the submissions from countries etc to keep track of progress in the synthetic biology field. But I aso agree that this process could be improved and it is important to keep up with the most recent developments by talking with scientists and research institutes as suggested by many other participants (#9367, #9384, #9389, #9390).

Is it also important to have in mind that this monitoring will allow the identification of aspects that could represent the necessity to update or to adapt the existing general principles  and methodologies for risk assessment under the Cartagena Protocol as the examples we have till now are LMOs and can be assessed under existing regulations.

Best regards,

Luciana Ambrozevicius
Ministry of Agriculture - Brazil

I would like to concur with [#9402] in that a system already exists for horizon scanning and there is no need to re-invent the wheel.
Regards

Kelebohile

Dear all, my name is David Castro and I work at the Direction of Genetic Resources & Biosafety from peruvian Ministry of Environment.

In addition to mentioned above, one way to follow the advances in the SynBio would be generate RSS (via email) or Feedly (https://feedly.com/) alerts from specialized journals or preprints (like BioRxiv https://www.biorxiv.org/collection/synthetic-biology). Google Scholar and PubMed also have tools to generate search alerts. It's very helpful for keeping abreast and monitoring the latest research on the subject.

Best regards,

David.

Thank you for providing examples on Synbio horizon scanning excercises both in Germany (Swantje #9390) and Australia (Claudia #9383 and Louisa #9405). Participants may be aware of even more horizon scanning processes around the world? Please also keep in mind that horizon scanning mechanisms covering OTHER FIELDS than synbio also could serve as valuable examples.

Sincerely,
Casper

My name is Jean Roger RAKOTOARIJAONA and I work at the Madagascar National Office for Environment. I also had the honor to participate at the AHTEG meeting in 2015 and in 2017
The issue of the impacts of synthetic biology on biodiversity and human health is fundamental for developing countries in general and for biodiversity hot spots like Madagascar in particular. If there is a huge need for information it is especially in these countries.
The conventional system of the United Nations and international organizations of requesting only periodic reports is only effective if the following conditions are met:
- A monitoring system at the level of each country is in place. This monitoring system should be able to respond to requests for information by the international level but it must also be useful for the country, it is a necessary condition for the country to integrate this monitoring system among priorities which will motivate it to finance and operationalize the monitoring, surveillance and data collection activities related thereto. Sending information internationally would be a routine.
- What we are talking about is clear. This is not yet the case with synthetic biology. A clear and accepted definition is therefore critical. This clear definition will also enable each country to put in place the appropriate legal and institutional framework
- Capacities to manage the monitoring system are available. Capacities are understood here human, technical, institutional and financial. We have listed some of them in our submission (bch.cbd.int/database/attachment/?id=18920).
- The different entities involved work in a coordinated manner. In this context, it is essential to launch a debate at the national level on biosafety in general and synthetic biology in particular because not only we are lacking capacities but especially the concept is still poorly known despite its rapid development internationally

Hello again everyone. My name is Jenna Shinen and I am a Senior Advisor contracted in the Office of Conservation and Water, at the U.S. Department of State.  I am pleased to see the continued discussion on the forum, and thank the moderators for their work and the thoughtful comments of the other participants in the forum.

The United States encourages independent and cooperative scientific research, development, and capacity building in fields relevant to biotechnology and biological engineering, both domestically and with partners around the world.  The United States encourages the developers and users of these technologies  (e.g., biotechnology companies, researchers, funders) to consider norms, standards, best practices, or technical safeguards that can identify and mitigate potential negative impacts while encouraging innovation that maximizes the potential benefits.  The United States supports Convention making use of the mechanisms it already has at its disposal (e.g. the Cartagena Protocol, AHTEG on Synthetic Biology, Open Ended Online Fora, Biosafety Clearing House) to support a broad and regular horizon scanning process while ensuring support for the global research community as it continues to conduct responsible research and development.

Dear all

Thank you for the informative discussions thus far. There have been many useful suggestions as to how the horizon scanning process can be carried out, as ably summarised by our moderator (#9400).

I’d like to point out a couple of important aspects for additional consideration:

1) Horizon scanning is of course a means to an end – that of identifying the impacts of synthetic biology on the three objectives of the Convention and its Protocols, as spelt out in Decision 14/19. So while the first step may generate a mass of information that is useful for understanding the status of technological developments, there needs to also be another step which includes a process of evaluating the information to focus on that which is relevant, for example, to flag technological developments that may have potential risks to the conservation and sustainable use of biological diversity, taking into account risks to human health.

2) Equally important is what is done with the results of the horizon scanning process. There needs to be a clear procedure to ensure that the information that is collected by a horizon scanning process is reported back to Parties in a timely manner.

One potential tool that I don’t think has been mentioned yet is the importance of contained use monitoring, because many new developments in the field will be occurring at the laboratory research level. Some Parties at the national level may have processes to do this, for example as required by their biosafety laws (in so far that these capture synthetic biology). In Malaysia, for example, the Biosafety Act 2007 requires prior notification for contained use activities involving LMOs and for importation of LMOs for contained use activities. This allows the competent authority to keep track of such activities and prescribe specific measures if necessary. Parties that have such information that is relevant to synthetic biology could be requested to submit this information to the CBD Secretariat for compilation. As suggested by post #9367, such requests for information could also be made independently to research institutions.

At the international level, I am aware that under the Biological and Toxin Weapons Convention, Parties, particularly those with substantial biological defence programmes, have to provide annual reports on specific activities, including: data on research centres and laboratories and information on national biological defence research and development programmes. Such an annual reporting process could be a more formalised tool that could be used by the CBD for horizon scanning.

I look forward to continued productive discussions!

kind regards
Lim Li Ching
Third World Network

Li Ching Lim (9425) has raised an important point that a crucial aspect of horizon scanning is evaluating the information collected to focus on what is relevant. That aspect of the task needs to be considered in light of the CBD having limited resources. The same post also suggested contained use monitoring as a means to collect information, and I see many difficulties with that approach when looked at through the lens of focusing on the relevant information.

Putting aside the recurring question of what is a relevant activity to report (ie what is synthetic biology, as opposed to modern biotechnology), observations from Australia’s LMO regulatory system illustrate the difficulty. Much contained research with LMOs in Australia can be authorised through institutional oversight and notification to the Office of the Gene Technology Regulator. This applies to specific classes of LMOs that pose low risk provided standard risk management measures, which focus on maintaining containment, are followed. These notifications cover a vast array of research, much of which is never intended to be developed into LMOs for environmental release. While over 9500 contained activities have been notified since 2001 (listed here: http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/nlrdrec-1), only 167 applications relating to environmental release of LMOs have been made in the same time (listed here: http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/ir-1).

In this context, and with CBD resources to evaluate information being limited, I don’t see that reporting contained activities is the best way to collect information on developing applications that have relevance to conservation and sustainable use of biodiversity. Instead, more targeted horizon scanning activities are needed.

Best regards,
Louisa

It is a pleasure to join the Synthetic Biology online forum and share my experience related to the proposed topics. My name is Rodrigo Carvalho de Abreu Lima, a Brazilian lawyer with 14 years of experience at the CBD negotiations and agendas.

Topic 2, relates to the establishment of broad and regular horizon scanning, monitoring and assessing of the most recent technological developments of synthetic biology aimed at allowing a proper assessment of 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.

The first argument that deserves attention in this regard, relates to the fact that Parties agreed that the process is needed for reviewing new information, regardless there is no clear, objective and proper access of synthetic biology towards the new and emerging issue outlined on paragraph 12 of Decision IX/29. Despite the ATHEG and the COP decisions recognized that the NEI criteria have not been met, Parties agreed to the need of establishing such a process with no substance of how it should be done.

Topic 7 will address the relationship between synthetic biology and the criteria set out in decision IX/29, which seems essential to allow a proper assessment of the issue. But at this point, it seems quite relevant to connect the need of a regular horizon scanning process or mechanism if, at the end, the NEI criteria are not accomplished. The imminence of risks and the significance of those risks connected to the Convention objectives will continue to be critical to the agenda.

Mapping and collecting sound information and evidences about the technologies is an approach that deserves support. However, it seems premature to create a mechanism, possibly implying costs to the Parties and therefore, managing obligations to the Secretariat, when they were not successful in presenting data that could lead to the establishment of examples of synthetic biology techniques and positive and/or negative impacts.  

Parties has been exchanging information on synthetic biology under the Convention since 2010, with submissions, online forum, SBSTTA and ATHEG meetings, as well COP meetings.

The present online forum should be the locus to gather information and take it to the Ad Hoc Technical Expert Group on Synthetic Biology that has the mandate up to the next COP in 2020.

Parties could also exchange information using the Biosafety Clearing-House, that is the Convention and its Protocols tool to collect and share official and non-official documents and information. A specific new mechanism to synthetic biology, without sufficient evidences of its need up to now, does not seem to be a proper manner to advance the agenda.

Several issues would need to be tackled if the horizon scanning mechanisms is to be formally created as:

• Does it will address only new developments of synthetic biology as per the language adopted on Decision 14/19?
• What would be the structure and scope of the mechanism?
• Does it will be linked to the BCH or it will be a separate online mechanism? Or it will work with defined periods, coordination and timelines?
• The mechanism could be established and start to operate even if the criteria of NEI are not met?

There are plenty of doubts that deserves attention from Parties. Those are just some issues that in my perspective should be considered.

Kind regards

Rodrigo C A Lima

Dear all,

Taking as reference the definition of genetic resource and genetic material of the Convention on Biological Diversity:

"genetic resources" means the genetic material of real or potential value.

"genetic material" means any material of plant, animal, microbial or other origin that contains functional units of the inheritance.

The genetic resource can be understood as the genetic material of organisms, that is, the DNA / RNA molecule, for this case a tangible DNA / RNA molecule and as it is found in nature, taking into account that synthetic biology other things designs, manufactures and modifies genetic materials, living organisms and biological systems partially or totally artificially, the principle and objectives of the agreement may not reach the organisms, components and products of synthetic biology, for this reason I consider that It is difficult to show the benefits and adverse effects of these organisms, components and products in the framework of the objectives of the Convention on Biological Diversity:

1. The conservation of biological diversity
2. The sustainable use of the components of biological diversity
3. The fair and equitable distribution of the benefits derived from the use of genetic resources.

The three objectives of the agreement are related to access to genetic resources, which are provided by countries of origin and are in situ conditions. However when we refer to organisms, components and products of synthetic biology, these principles are not applicable since the developments of synthetic biology are obtained artificially.

At present, it is not clear how the objectives of the Convention on Biological Diversity can be applied, if synthetic biology is based on genetic sequences and digital chemical structures for the development of organisms, components and products, since the definitions of genetic resources and genetic material of the agreement speak of "material" that is to say a totally tangible molecule but it does not link the sequences and digital chemical structures and that are in databases.

Dear forum participants,

In my contribution under topic 1, I emphasized that for these discussions to be useful, there needs to be a focus on new applications that are realistically foreseeable, relevant to the scope of the CBD, and not in the scope of the Cartagena Protocol. I agree with others (#9402, #9427) that horizon scanning mechanisms are already in place under the CBD, these include the information submissions on synthetic biology since 2010, and the online forum and AHTEG since 2015. The horizon scanning approaches reported here, e.g. Germany (#9390) and Australia (#9405), demonstrate how Parties can survey developments within their own jurisdiction, as well as evaluate the application of their regulatory frameworks, and this should be encouraged within the existing mechanisms.

Before additional mechanisms are warranted under the CBD, there is the critical issue of the need to complete the analysis of whether synthetic biology is a “new and emerging issue relating to the conservation and sustainable use of biological diversity” against the criteria of decision IX/29. The Global Industry Coalition, along with several Parties, have long pointed out this need before the continued extension and expansion of the synthetic biology work program under the CBD can be justified. Therefore, in the absence of a robust analysis, and a decision by the Parties that synthetic biology is a new and emerging issue, we do not support the establishment of new processes that go beyond the current information sharing mechanisms (information submissions and this online forum). We will comment on this in more detail under topic 7.

Many suggestions have been made under this topic for additional horizon scanning mechanisms, but I question how the CBD could practically manage detailed surveys (e.g. of publications, research institutes globally, workshops globally) considering the sheer volume of material this would generate. For example, considering articles alone, a simple search of “synthetic biology” “since 2018” in Google Scholar yields 42,100 results (9 Mar 2019), and this includes only those articles that include the term “synthetic biology” in their text – and may not include technologies/applications that are the focus of much of the discussion in topic 1 (e.g. genome editing, gene editing, gene drives). Further, much of the information collected from such surveys will concern research concepts/new technologies/fundamental research/early research, as opposed to realistically foreseeable applications that are relevant to the CBD. Furthermore, I agree with the observation in #9367 that biotechnology/synthetic biology is not the only area of technology development that may have relevance to the objectives of the CBD, and question the disproportionate focus on it under the CBD.

Ms. Li Ching Lim and Dr. Louise Matthew (#9405) have raised very important points in horizon scanning activities.  Whereas information is easily obtained from internet sources and websites of research institutions and international organizations, assessing the quality of such information and their relevance to the CBD goals are much more problematic.  Perhaps information sharing can be facilitated by opening a portal in the BCH showing links to literature but there must be a mechanism for screening relevant information that would be posted through this portal. 

We appreciate Dr. Matthew’s post (#9405) on their horizon scanning series, which we have found to be very useful and informative.  Parties with such established activities may be encouraged to post links to these publications in a BCH portal.  As to the evaluation of quality, relevance, and focus, perhaps each party should first submit their lists to their local scientific societies for this kind of evaluation, before responding to calls from the CBD using established information sharing mechanisms (congruent with Ms. Felicity Keiper’s call for no new processes that go beyond the current, #9436). The preliminary vetting by national scientific bodies can significantly limit the amount of material that need to go into the information sharing portals.

We view with much interest Mr. Rodrigo C A Lima’s post (#9427) on Synthetic Biology and the NEI criteria and look forward to very interesting discussions on Topic 7.

Dear participants, I am delighted to see that we are at good speed and that you are all bringing important information and views to the table! Gerd (#9422) has raised an insteresting question on whether para 3 of decision 14/19 asking for "broad and regular horizon scanning, monitoring and assessing of the most recent technological developments" could be understood as also meaning collecting information of governance approaches. Absoluteley, there are big differences in how parties/counties regulate Synbio. My interpretation of decision 14/19 is that, for now, we are to focus on the technical delvelopments and Scientific frontiers, keeping the three objectives of the Convention in mind. At this stage, we will not so much discuss and work on how to develop regulatory principles. However, information on how Parties/countries regulate this Field is very interesting and helpful, so please feel free to submit information also on this. You are very welcome!
Cheers,
Casper

Dear all,
My name is Margret Engelhard and I work for the Federal Agency for Nature Conservation in Germany and I had the honor to be an active member of the AHTEG in 2015 and in 2017.

I would like to thank Casper and the secretariat to facilitate this discussion, that had already gathered many valuable proposals for the horizon scanning process.

Most of the contributions focused on the information gathering step of the horizon scanning process and I think that very helpful suggestions have been made for that step. Looking back at the work of the previous online fora in 2015 and 2017 and at the very informative current discussions under Topic 1, I do think that the established tools (Submission of information by Parties, other Governments, relevant organizations and IPLCs submitted to the Executive Secretariat, followed by an online forum) have proven to be very successful and should in my opinion stay at the heart of this practice. They also do not produce high costs. However, I think that the proposals to reach out to the scientific community and other international fora (including making use of national horizons scanning processes) could be a valuable add on. Information collected by the reach out practice should feed in the online discussion, and thus be collected prior to it.

In addition, for the subsequent evaluation steps an established reach out to the knowledge of IPLC could prove valuable for the tasks ahead.

When looking back to the decision 14/19 para 3, the horizon scanning process includes several features, which I would like to summarize as follows:

1.) Information gathering step (elucidated by “scanning and monitoring” in the decision): This step can be fulfilled by Submission of information, reach out and online-forum as discussed above.

2.) Assessing step: In decision 14/19 para 3 it is agreed that an assessment is needed. As pointed out earlier and as it becomes clear also during the current discussion in Topic 1 the information that will be gathered could be numerous. They must at one point be evaluated and filtered with respect to potential positive and potential negative impacts vis-à-vis the three objectives of the Convention and those of the Cartagena Protocol and Nagoya Protocol. Again, I would think that the current established way forward is the most obvious solution: that is to commission an AHTEG to fulfil this task. In this case the recommendation would be to establish an AHTEC or equivalent body on a regular basis.

This assessing and evaluation step should have a well-defined general term of reference. Since this body is established at the level of the convention, it could also make scientific recommendations to the SBSTTA which of the new information gathered are relevant to the convention itself and which information is more relevant to the Cartagena Protocol and Nagoya Protocol. By this a coordinated approach could be ensured.

3.) Reporting back step: A reporting back step is crucial to the horizon scanning process. The reporting back to the relevant CBD bodies (COP and Cop-MOPs via SBSTTA) ensures that the gathered and assessed information is of valuable use to the convention and its protocols.

4.) Finally, it had been agreed that the horizon scanning process is regular. To ensure this, regular reporting intervals have to be established and I fully agree with Casper, that a meaningful reporting interval is a given intersessional period of two years until the Conference of the Parties reassembles. This is also an adequate time period from a scientific point of view, since only after a certain period of time new developments can be expected. Thus, one reporting round of the regular horizon scanning should be fulfilled after two years.

I am very much looking forward to the further work on this topic, that needs to find a good balance of being adequate and not too exaggerated and at the same time effective enough to filter and pinpoint the information that matters to the convention and its protocols.

Kind regard,
Margret

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


Dear Colleagues,

My name is Jim Thomas . I am Co-Executive Director of the ETC Group . We are an international Civil Society Organization whose mission includes carrying out horizon scanning, monitoring and assessment of  developments in emerging technologies including synthetic biology and new modern biotechnologies. We are extremely grateful to the Secretariat and teh moderators for the opportunity to address this important topic which we remind colleagues is core to meeting  the mandate of the Convention on Biological Diversity. Indeed it is explicitly  expressed in article 7(C) of the convention to carry out identification and monitoring of processes or activities likely to have adverse effects on the conservation and sustainable use of of biological diversity - as well as being key to the realization of the precautionary principle.

Regarding the first 2 elements, horizon scanning and monitoring of emerging technologies, there is much good practice that can be drawn from  for example the work of national and regional Technology Assessment bodies such as those represented by the EPTA network of European Parliamentary Technology Assessment Offices. We agree with earlier  suggestions  that tools such as analysis of patent landscapes, surveys of scientific literature, mining of social media, traditional media monitoring , science journals,  proceedings of conferences and the results of  national, regional and international foresight exercises all provide elements for constructing a baseline survey that could be synthesized by the CBD secretariat or external consultants  empowered to undertake the collation and presentation of such baseline literature . investment and sharing in tools  could be resourced within the CBD as an extension of clearing house activities. These could be carried out as technical series publications.

However to be useful  horizon scanning is not just a dry listing of new technological developments. In reality the meaning of horizon scanning is to be able to sort out patterns, identify emerging trends and pinpoint areas and clusters of technological development or associated agendas that require particular governance. Nor is the horizon simply a technological one. It is the social, ideological, economic, political, environmental, cultural, historical and psychological factors that determine how new technologies emerge, are leveraged, adapted and whether they will become embedded in new or existing  systems of cultural, economic and institutional arrangements. In view of this it would be a mistake for a group charged with horizon-scanning activities under the CBD to be limited only to technical and scientific experts or draw only on technical literature. Representatives of social science, legal and economic experts , indigenous, civil society, peasant and farmer knowledge, even knowledge from art and culture is also relevant to  understanding the technologically determined horizon.

Tools for building a landscape view and horizon scanning around new technologies may include scenario development and also progressing through a series of deeper dive case studies and sector studies. Often it can be through exploring a narrow segment of technological applications (e.g. synthetic biology developments in agriculture, energy or  data storage and understanding their context) that wider trends begin to surface.  In the CBD context either SBSTTA , COP or the AHTEG could request such sectoral and  deeper dive studies of the secretariat or engage technology assessment bodies and organizations to convene such studies. Once again bringing different types of knowledge and experience beyond just technological and technical expertise will be essential. There is for example a growing body of work engaging artists in scenario-setting as part of horizon scanning and even more so in bringing perspectives to the the assessment phase (many who have attended the recent SBSTTA and COP will be familiar with the Pink Chicken project - http://www.pinkchickenproject.com -  for example which uses an artistic scenario to explore gene drive ethics and implications). 

We agree with Nikolay Tzvetkov and other in this forum who advocate for the importance of horizon scanning to extend beyond just ‘synthetic biology’ or even ‘modern biotechnology’ - in an era of converging technologies/Fourth industrial revolution/frontier technologies it is in the convergence spaces between technological platforms that significant new developments become apparent (for example the use of blockchain for DNA or the rapid expansion of use of synthetic nucleic acids for data storage).  ETC Group also advocates that a robust horizon scanning methodology is to identify, cluster and then explore relevant economic, ideological and social agendas. For example ideas such as ’the bioeconomy’ or  ‘the circular economy’, ‘cellular agriculture’ or ‘climate-smart farming’ become  impetuses in innovation as well as organizing forces for funding that shape the technological landscape and can help give form in horizon scanning.

There are other UN fora where technology horizon scanning, monitoring and Assessment of ‘frontier technologies’ is becoming a key agenda item and collaborations and mutual learning between the CBD and these fora could be both efficient and doubly effective. For example the UN Technology Facilitation Mechanism established in  NY under the 2030 agenda for sustainabile development and co-ordinated by UN DESA has incorporated Horizon Scanning into the purpose of its annual multistakeholder Science Technology And Innovation (STI)  Forum and also convenes a cross-system co-ordination group and is developing digital tools for technology facilitation that could in time include horizon scanning and monitoring. These activities under the TFM and STI forum are enhanced by 2 UN  General Assembly resolutions on frontier technologies introduced by the Government of Mexico. Since the current chair of CBD SBSTTA is also the representative of the government of Mexico there may be some synergies to explore there.  The UN Commission on Science and Technology for Development that meets under the auspices of UNCTAD in Geneva similarly is currently prioritizing horizon scanning in its annual discussions and  UNEP also undertakes regular horizon scanning and review activities through its Frontiers report and foresight activities o. CBD might consider deciding to incorporate technological horizon scanning and assesment into the planning and execution cycle of its own flagship publications such as the Global Biodiversity Outlook.

In some of these other fora ETC Group has proposed an approach and methodology for integrated horizon scanning and technology assessment that we call GOATS - Global Overview Assessment of Technological Systems. The 5 steps of the  GOATS approach may be a useful framework for CBD to adopt in developing Horizon scanning, monitoring and assessment processes around Synthetic Biology. Those steps are Survey, Situate, Sample, Assess and Suggest and we respectfully encourage participants in this forum to  browse this short, simple introduction to the GOATS methodology:    http://www.etcgroup.org/content/wisdom-goats-global-overview-assessments-technological-systems

As already noted by Lim li Ching of Third World Network, the real point of horizon scanning and monitoring is as a precursor to Technology Assesment and policy formation and we feel its very significant and should not be overlooked that the mandate to this group includes recommending options for regular ASSESSING of developments - not simply horizon scanning and monitoring. Regarding the Assesment component ETC Group  have the following suggestions:

While the open online forum and AHTEG discussions are good tools towards assessment their format is limited and in the case of the AHTEG need to be reauthorized from COP to COP. It is also limiting that they are only carried out in English. Establishing a standing working group under the CBD would be preferable or  establishing the work on Synthetic Biology as its own work stream. the latter should not be difficult to do once parties have concluded that Synthetic Biology is accepted as a new and emerging issue. This would also enable translation.
Best practice in technology assessment draws on a variety of knowledge and experiences rather than being limited to  only technical and technocratic experts. This can include incorporating lay knowledge through exercises such as citizens juries, people’s tribunals, citizen assemblies or participative online tools such as wikis and video conferencing. Deliberative tools that move away from narrow expertocratic  risk assessment towards allowing different types of engagement and knowledge may include multi criteria mapping, red team-blue team exercises, scenario setting and serious games. As mentioned above artistic provocations can also facilitate more rounded assessment drawing on different forms of knowledge.
In the context of the CBD and biodiversity it would be important to explore with Indigenous Peoples and Local Community representatives  what assessment forms are most appropriate to their own cultures - There is much experience to draw from on incorporporating indigenous technology assessment into policy TA exercises - for example I recall that the NZ Royal Commission on Genetic Modification in 2000 was designed  with a component of assesment organized through the Maori Hui system. The IIFB or the working group on 8J may be asked for their proposals how to incorporate indigenous TA..
As well as some of the existing parliamentary technology assessment  bodies mentioned above, ETC Group would encourage the CBD to formally engage with bottom up and citizen led technology assessment networks. Along with other civil Society groups ETC group is involved in the formation of regional technology Asseement Platforms (TAPS) such as Red TECLA in Latin America (https://redtecla.org) which bring together different movements (women, environment, trade union, indigenous, farmers) to collaborate on technology assessment exercises, peoples conferences and  case studies. A CBD framework for horizon scanning, monitoring and assessment of synthetic biology n related technologies could provide channels for formal inputs and interactions with these civil society-led platforms, parallel to how Todd Kuikn  proposed formal interaction with the annual IGEM competition.

For resources on Technology Assessment, including participatory technology assessment approaches some of the following may be useful:

http://www.etcgroup.org/sites/www.etcgroup.org/files/ETCGroupBriefing_Case4TA%40Rio_170312_0.pdf

https://www.wilsoncenter.org/article/reinventing-technology-assessment-for-the-21st-century
https://www.wilsoncenter.org/sites/default/files/ReinventingTechnologyAssessment1.pdf

https://www.researchgate.net/publication/242533926_Democratising_technology_Reclaiming_science_for_sustainable_development


Thank you

Jim Thomas
ETC Group

Monitoring and Horizon scanning.

the views of contributors on definitions of SynBio vary and thus it would be very difficult to develop a systematic Evidence Map without clearly defined search terms.  We also have suggestions that topical and oral applications of materials that effect gene expression are within the remit of synbio. I suggest that those which cause generational or heritable changes should be included.   Perhaps the answer is as suggested by Jim Thomas (#9443) that we consider biotech as a continuum of technologies which have the potential to change organisms or create novel ones and thus have the potential to have novel impacts on Biodiversity, just as "traditional" breeding methods have in the past.  Thus we move the focus away from ill defined technologies towards novel organisms or products.
However the main environmental impacts of novel crops come not from their introduction per se but on how they are exploited and managed. For example GM soy and corn are fairly benign plants but when cultivated over vast areas, encourage cultivation of virgin land and are treated with broad spectrum herbicides, considerable impacts on biodiversity result.
Thus Monitoring and Horizon scanning should also include studies of the applications and use of biotech in order to get a more complete picture of actual and potential impacts .

Dear all,

my name is Helmut Gaugitsch and I am working at the Enviornment Agency Austria, having had the honour to participate in the two AHTEG meetings on synthetic biology, in 2015 and 2017.

Let me thank the Secretariat for setting up this important round of discussion and our Moderators for their skillfull guidance. Thank you Caspar for steering our discussions and motivating us to post to the point and have a broad mind in the context of this important topic.

I regard the issues of horizon scanning,monitoring and assessing as outlined in para 3 of Decision 14/19 as very important. In addition to the many valuable comments by experts I would like to add my voice on the following points:

1. In general and as a Basis I think that the instruments we have under the CBD and ist Protocols work well also for horizon scanning, monitoring and assessing. Information gathering by Parties, other governments, IPLCs and relevant organizations, compilation by the SCBD and subsequent online discussions can work well for horizon scanning. An AHTEG, SBSTTA in preparation for the COP and COPMOPs can complement by focussing on the monitoring and assessment task. The Clearing House mechanism of the Convention as well as of its Protocols (BCH etc.) can be pertinent instruments for information sharing.

2. However, some of these instruments are established for a limited time period and we are aiming at a more constant and long-term mechanism, which may mean some challenges for the future. Also with respect to being broad and cost/resource-efficient at the same time.

3. I regard it as very important that horizon scanning, monitoring and assessment are implemented in a structured and systematic way, by keeping in mind what is the purpose. So the goal of the exercise, in our case the three objectives of the Convention and its Protocols (conservation and sustainable use of biological diversity, fair and equitable sharing of benefits) should be the guiding principle.

4. Horizon scanning should of course include the current and most recent literature (focussing on but going beyond what is published in scientific journals), but should also be prospective, forward-looking and proactive. Experience in Technology Foresight, Technology assessment, social sciences etc. should be taken into account for that purpose.

5. The research community (academia but also the private sector) should be included in an appropriate way. Due to the step-by-step approach what is going on in contained use as well as scanning of patent (IPR) databases can be very relevant sources for that purpose.

Thank you very much and I am looking forward to participating in this and further rounds of discussion. A nice and inspring weekend to all of you, kind regards

Helmut Gaugitsch

Dear all,

For horizon scanning, some commented on additional means of gathering information beyond the systems already in place like the online fora, submissions, AHTEG, BCH, etc. The suggestions included talking with scientists, research institutions, specialized journals, iGem, etc to add more information. These are all good ideas and actually, these are in many cases among the ways how parties and other stakeholders are gathering the information they are sharing. It is interesting that people share the ways they use to get informed, but not necessarily means that one has to add more systems to the existing ones.
I believe that [#9425] (#9405) [#9439] raised an important point, which relates to the importance of relevance to the objectives of the Convention on Biodiversity and the Cartagena Protocol, besides quality and prioritizing to foreseeable future.
As pointed out in [#9427] [#9436] [#9439] an important step in this discussion is the conclusion of the analysis of whether synthetic biology qualifies as a NEI (New and Emerging Issue). And even if the system of identifying NEI is efficient. There is an urgent need to concentrate efforts to preserve biodiversity in a more effective way, identifying the areas where we can do most with limited resources (time, money…) is crucial.

Best regards, Lúcia

Dear Casper and Maria
A process for "carrying out the regular horizon scanning, monitoring and assessing of developments referred to in para 3 of decision 14/19" needs to include the following steps:
- Step 1. Information collection: Information need to be collected from various sources such as parties, countries and non governmental organizations submissions, commissioned studies, publications. additionally the open ended forum on SynBio could serve as an entry point for receiving information.
- Step 2. Information compilation and processing: need to be conducted by the Secretariat, commissioned studies could be useful in this regards
- Step 3. Drafting recommendation to COP for possible decisions/ actions aiming for the conservation and sustainable use of biological diversity: this step needs to be performed by an established body such as an open ended experts group.

I believe that any process that does not include the 3 steps is an incomplete one and will have no added value in assisting parties in the effective implementation of the CBD.

Best regards,
Prof.Dr . O.A.El-Kawy

Dear forum participants,

My name is Delphine Beeckman, and I’m for the first time participating in the CBD online forum on Synthetic Biology. As a biosafety officer, focusing on the use of regulated and non-regulated biological materials in containment (e.g. labs, greenhouses, animal facilities), I am following up on developments in legislation for different types of biological materials, including synthetic biology.

In support of the messages from regulators participating in this forum, referring to reports indicating that currently known activities labelled as synthetic biology are in scope of their national or regional regulatory mechanisms (see [#9390] and [#9405]), I share the following reference, authored by (scientific experts to) regulators in NL, DE and BE: van der Vlugt, et al., 2018 “A Framework for the Risk Assessment and Management of Gene Drive Technology in Contained Use”. This framework is based on the European Union’s Directive on the contained use of genetically modified microorganisms (GMMs), and its general principles of risk assessment are used and included in the legislation by several European countries to assess and manage other genetically modified organisms (GMOs) in contained use, including plants and animals. These principles are consistent with Annex III of the Cartagena Protocol. A concrete example is the Belgian regional contained use legislative framework that is broad in scope, covering GMMs, genetically modified organisms (GMOs) and pathogenic organisms. Other examples can be found in the Netherlands, where specifically for gene drives already in 2016 a legislative amendment to the GMO Regulation was made, which decreed that permits must be requested for all applications using gene drives (RIVM - https://www.rivm.nl/publicaties/risicobeoordelingsmethode-voor-organismen-met-gene-drive-toegepast-onder-ingeperkt ), and, as already mentioned in this forum, the Biosafety Act 2007 in Malaysia (see[#9425)].

I would also like to support the comments of [#9432] indicating that only few contained use activities lead to applications relating to environmental release of LMOs. As a result, including monitoring of contained use activities in the horizon scanning is not directly relevant to collect information on new developments or applications that have relevance to conservation and sustainable use of biodiversity.

Kind regards, Delphine

Greetings. My name is Nada Babiker Hamza, Director/Commission for Biotechnology & Genetic Engineering, (Sudan).  It is my first time to participate in online forums on synthetic biology, very interested by the discussion.
Regarding the options for carrying out the regular horizon scanning, monitoring and assessing of developments referred to in para 3 of decision 14/19.
According to previous discussions, many participants still ask for a more precise definition for synthetic biology, therefore, first of all, I suggest to provide a tentative list of what falls under synthetic biology according to the knowledge of today that are relevant for the objectives of the Convention and its Protocols, so that all be on the same page. I agree with Moderator Casper approaches as well those indicated by Mr. Lazaro Regalado (#9362). Additionally, meeting with scientists from leading research institutions, University Research Centers, Industrial Companies, etc. is very important to gather information on technologies that are not yet fully developed.
National Focal Points of the CBD and its protocols can play a substantive role in identifying the institutions to be surveyed in the country. Developed countries with known institutions producing significant techniques, these should be priority. Concerning availing information in the BCH, several countries don’t update their profile and upload the required information (e.g. Biosafety information). Therefore, this should be tackled. I agree with the steps/options provided by Nikolay Tzvetkov (#9367), to proceed after the information is gathered.

Dear all—

I am Bob Friedman, a researcher with the J. Craig Venter Institute (JCVI), a non-profit genomics research institute that includes a leading-edge synthetic biology program.  I was fortunate to have had the opportunity to participate in both the 2015 and 2017 Synthetic Biology AHTEGs.

I thank our moderators and my fellow participants for very useful comments on this topic.  Boet Glandorf outlined an impressive list of horizon scanning activities in the Netherlands in her posting in Topic 1 [#9385].  Swantje Stassheim [#9390] listed activities in Germany and Louisa Matthew [#9405] for Australia.  Others listed additional activities and no doubt some already completed activities are missing.

Nikolay Tzetkov [#9367] and Claudia Vickers [#9384] suggested that horizon scanning must include the input from of the synthetic biology research community.  I completely agree and have several suggestions for accomplishing that goal.  These fall into two categories: who might be willing to participate and how might the process work.

First, who might be willing to participate?  JCVI, my own research institute, could easily “cover” those areas in which we work.  Other research institutes with large programs would probably be willing, as well.  Several “network” organizations already exist, that is organizations that are networks of scientists in several areas of synthetic biology of interest to the CBD.  For example, the Engineering Biology Research Center covers synthetic biology broadly.  The Foundation for the National Institutes of Health (FNIH) runs the Gene Drive Research Forum, with a narrower focus on safe and ethical conduct of gene drive research. Synbiobeta regularly reports the activities of the nascent synthetic biology industry.  Felicity Keiper under Topic 1 [#9435] informed us of syntheses form the Global Industry Coalition and Jim Thomas [#9443] informed us of the activities and approach used by ETC Group. Others exist, as well. 

Next, how might this work?  The CBD’s current approach for information gathering is very useful, but quite “top down”.  The Secretariat issues a call for information from Parties and others, then an on-line forum for discussion.  Some very useful interaction occurs during the week-long period, but nevertheless, it is limited by the timeframe. 

My suggestion for horizon scanning is for the Secretariat to first identify and enlist those organizations willing to participate in a horizon scanning exercise in their particular areas of expertise.  Key to success would be communication among the organizations to minimize duplication of effort and to ensure that areas are not left uncovered.  Sufficient time must be given to these organizations to do the needed syntheses, as well as exchanges of drafts among groups for review and comment.

I make these suggestions mindful of the observations of already made by several participants: synthetic biology is but one of many technologies of relevance to achieving the objectives of the CBD.  That said, if the Parties determine that it is one that deserves more in-depth focus, the process adopted should meet the objectives stated by our Moderators:  be both effective and cost-effective.

I look forward to continued discussions on this and the other Topics covered in our on-line forum.

Regards,
Bob Friedman

Greetings all, my name is Michele Garfinkel and I am the head of the science policy programme at EMBO (European Molecular Biology Organization), participating here by nomination of IUCN. I add my thanks to the moderators of both of these topics and to all of the participants for the very interesting interventions. I want to add only two brief remarks:
First, I want to push even further of the critical importance of the "assessment" step in scanning, monitoring, and assessing. Among others, the posts from Jim Thomas [#9443] (hello Jim!) and Robert Friedman [#9461] (disclosure: my previous boss at JCVI) both capture much of my thinking on this topic. I want to extend those by adding that as part of the community of people concerned about these issues that I am less concerned about any adjectives preceding "technology assessment" (real time, global overview/GOATS, 21st century) and more that we do it at all. As those who have been involved in these processes know, this work looks cheap ("it's just a few people") but is actually expensive. So although not exactly an option, as part of fulfilling the mandate, the importance of fully supporting and resourcing technology assessment should always be linked to calls for scanning, monitory, and assessing.
Related, as noted by Gerd Winter [#9422] on including regulatory scanning, I agree this is of great importance. I am currently involved in a European project on standards in synthetic biology, and the work package that I am part of focuses precisely on the issues of understanding not only current regulation but also, in essence, trying to understand emerging regulation, just as we try to understand "emerging technology" in the strict sense. We can look at this in both directions: it is not just what regulation tells us about synthetic biology (what can be done, how it can be done, etc.) but the reverse as well: what synthetic biology tells us about regulation (based on the advances outlined in Topic 1, what will become of regulation?).
Looking forward to continuing the discussions!
Michele

“For carrying out the regular horizon scanning, monitoring and assessing of developments referred to in para 3 of decision 14/19, very relevant points are indicted by most of the participants. In addition, keeping track the permits of national authorities is really vital that they usually give special permits: for research demonstration and educational purpose, contained use permit: for synbio products to be produced, destroyed or used isolated by physical and chemical barriers and advance informed agreement: for any transaction of modified organisms including synbio organisms, products and components. Therefore, creating strong link with national authorities could be as important as including the input from of the synthetic biology research community indicated by #9367, #9384, #9461. Clearing house mechanisms would also play significant role in carrying out the regular horizon scanning, monitoring and assessing of developments referred to in para 3 of decision 14/19.

I am Philip Shapira, a faculty member at the University of Manchester (UK) in the Manchester Institute for Innovation Research. I am also lead for responsible research and innovation with the Manchester Synthetic Biology Research Centre for Fine and Speciality Chemicals (SYNBIOCHEM). Anticipating developments in synthetic biology and their economic, societal, and environmental implications, and facilitating societal and technological alignment, is one of the core aspects of our work. In reading and reflecting on the discussions on horizonal scanning in synthetic biology in this forum, I thought that it might be of interest to share the following. In 2017, I participated in a horizonal scanning exercise of the opportunities and risks presented by engineering biology. The horizontal scan was coordinated by the Centre for the Study of Existential Risk at the University of Cambridge and involved participants from the US and Europe. It was thus a "transatlantic" perspective, not a global one (as in this forum). Nonetheless, the approach may be of interest. From a larger set of potential issues, we prioritized 20 that we anticipated would have significant impacts, grouped by societal risk relevance (approximately) in the near term (<5 years), medium-term (5-10 years), and longer-term (> 10 years). A series of issues raised by engineering biology were highlighted for sectors including health, energy, agriculture and the environment. The horizontal scanning methods and results are discussed in a peer-reviewed paper (Wintle et al, 2017) published in eLife, it is available in open access at https://elifesciences.org/articles/30247 (and also attached as a PDF). While there are multiple methods for horizon scanning in synthetic biology (as for other emerging technologies), the approach taken in this exercise is one that is do-able, timely and replicable. It suggests the value of multiple decentralized (non-governmental) approaches to horizon scanning, in addition to scans undertaken by government agencies and international bodies. And, it highlights the importance of ensuring that horizon scanning engages a wide range of perspectives of stakeholders in countries around the world, and of anticipating how different stakeholders may be impacted by, and can feed into the design of, particular emerging synthetic biology developments.

Dear all,

I am Tom Nickson, an independent consultant working with the Global Industry Coalition.  I have been following the negotiations on synthetic biology and risk assessment and risk management for many years having formerly worked for Monsanto Company.  It is an honor to share my views with this group of highly engaged people. 

It seems obvious to me that information exchange is critically important to the Convention especially in the context of facilitating “the exchange of information from publicly available sources relevant to the conservation of biodiversity” (Article 17.1).  However, I do not believe that the indiscriminate collection of scientific information spanning from conceptual ideas to well-developed applications serves the purposes of the Parties.  Assuming horizon scanning, which is undefined, involves gathering the information to fulfill Article 17.1, then several of the processes currently in use and mentioned in this string could work nicely.  Several governments are collecting information as noted in #9385, #9390, and #9405.  Furthermore, the CBD has processes in place for Parties to report on their efforts to enhance the conservation and sustainable use of biodiversity.  Perhaps these mechanisms like national reports should be leveraged further for the purposes of informing Parties.

In my opinion, any horizon scanning must be within the context of the CBD; it must be workable, cost-efficient, and be readily interpreted (again in the context of the CBD); and it must not prejudge the risks or benefits.  I echo those who have urged for caution and focus with regard to future horizon scanning.  The process described by some as (1) collection, (2) compilation, and (3) reporting would be unwieldy without critical assessment and selection based on agreed criteria.  I believe Parties need, what others have called, a structured and focused approach to information exchange.  In this way, the reported information will be objective, usable and understandable. 

Finally, I share the concern expressed by others that this forum is being asked to propose a program of work under Topic 2 when there is no consensus definition for synthetic biology, and importantly, no New and Emerging Issue has been identified in accordance with the process laid out in decision IX/29.  Perhaps this forum will help define a process that meets the spirit of Article 17.1 where information exchange is improved with a goal to facilitate the conservation of biodiversity by all Parties.

Dear forum participants,
Thank you for your interventions. This topic is now closed for comments.

Secretariat

POSTED ON BEHALF OF Ms. Yolanda Teran, La Red de Mujeres Indigenas sobre Biodiversidad de America Latina y el Caribe
(Note: this message arrived at the Secretariat before the closing of the discussion.)

I am Yolanda Teran, an Indigenous person from the Kichwa nation of Ecuador.
First of all I would like to congratulate the co-moderators of the online forum on Synthtic Biology. I will be reviewing participants's comments to learn and also share my views as an Indigenous woman considering the impacts and efects of new technologies on human beings, Indigenous Peoples livelihoods and on Mother Earth.
All the best,
Yolanda