When establishing the process, the COP specified that the process for broad and regular horizon scanning, monitoring and assessment should consist of the following steps:

(a) Information gathering;

(b) Compilation, organization and synthesis of information;

(c) Assessment; and

(d) Reporting on outcomes.

Thus, participants are kindly invited to share their views on the methodologies that could be used for the overall process, as well as any experience they may have in performing similar processes.

The following questions are meant to guide the discussion. Participants are encouraged to consider them when intervening, for their potential  to facilitate a systematic analysis of the information.

1) What particular points should be considered when carrying out each of the steps specified by the COP for the process for broad and regular horizon scanning, monitoring and assessment?

----Posted on behalf of Dr. Martin Cannell---

Welcome to the Open-Ended Online Forum on Synthetic Biology!

My name is Martin Cannell, I am a regulatory scientist with a background in plant molecular biology and biotechnology. I have extensive experience working on the risk assessment and regulatory requirements for living modified organisms both within the laboratory and relating to environmental releases.

I am honoured to serve as moderator of this forum and as such, I intend to provide support and guidance to the discussions as they progress.

When planning your intervention, please note that if you would like to respond to a post, we would like to encourage you to reply directly to that post. This will also facilitate the understanding of others. In addition, when posting information, kindly provide the URL, the DOI or use the attachment function.

As a kind reminder, discussions will close on 17:00 (5pm) EST on Friday, 31 March 2023.

We thank you for your participation in this forum, and we look forward to an interesting discussion.

Sincere regards,
Dr. Martin Cannell

Tēnā koutou katoa, my name is Dan Tompkins and I am the Science Director | Kaiwhakahaere matua – Pūtaiao for the New Zealand crown-owned company Predator Free 2050 Limited, and an Honorary Professor at the University of Otago, both in Aotearoa New Zealand.

I would like to offer that some process of prioritization is threaded through the steps specified by the COP. This is to address the issue that the breadth of the synthetic biology field is such that without prioritization, the stages of monitoring and assessment may never be able to be given the attention required in this process.

The expected time horizon to trials or application beyond containment is one possible determinant of priority to consider, to allow for recommendations on both acceptable and unacceptable applications to be reached in a manner that is timelier for all stakeholders.

This is not a suggestion in any way that any less rigor be applied to any aspect of the consideration of any type of synthetic biology. Rather, it is a point of workload staging to allow more effective progression and resolution of considerations.

Testbiotech has been conducting a project in horizon scanning https://fachstelle-gentechnik-umwelt.de/en/home/ on new genomic techniques that is also relevant for Synbio applications. We experienced that in addition to systematic research on Synbio applications, tools are needed to inform the public about the relevance of the specific findings. In this context, we see urgent need for horizon scanning and public communication from the perspective of the protection goals as agreed in the Convention.

I wish to contribute an additional potential process point for consideration by the forum. Assessments regarding synthetic biology frequently conflate potential risks and benefits of synthetic biology application with actual and potential risks and benefits of other management and technology applications already used or being considered for the same goal.

For example, species interactions, other ecological interactions, and any evolutionary consequences that may result from the suppression or eradication of pests, are not assessment characteristics of the approach used to achieve that management goal (be it trapping, toxin use or potentially synthetic biology), but are characteristics of the efforts to achieve, and actual achievement, of the management goal itself. Conflating consideration of specific approaches with them is thus not valid.

While we should always be aware of all potential consequences and impacts of any application of any technology to biodiversity and conservation, care needs to be taken to separate what is relevant to consideration of the application goals (which have their own forums for consideration, debate and decision making) from what is specifically relevant to the technology under consideration.

This is also a further process point to allow more effective progression and resolution of considerations. While it is not a suggestion in any way that any less rigor by applied to the consideration of applications with potential risks or benefits for biodiversity and conservation, it is recognizing that application goal considerations have already occurred (or are occurring) in other more relevant forums.

There is wealth of evidence suggesting that approaches to horizon-scanning, technology assessment and monitoring will only reach competent conclusions if they meet a set of criteria, each of which contribute to allowing them to be inclusive of the perspectives of a diversity of groups in society, enabling intercultural dialogue and transdisciplinary approaches to learning (https://assess.technology/). One criteria is that deliberative processes should be open to a broad diversity of groups in society, particularly local communities and Indigenous peoples, each of which bring different kinds of knowledge and perspectives (https://www.etcgroup.org/content/protecting-legacy-precaution, https://www.etcgroup.org/sites/www.etcgroup.org/files/files/etc_goats_us_may2017.pdf).

A second criteria is that civil society (i.e. non-corporate and non-state actors) must have a central role, not just as participants, but as organisers and facilitators of processes by which an inclusive group of people can take an active part in regular horizon scanning, monitoring and assessment, according to the principles of cognitive justice (https://www.researchgate.net/profile/Colin-Anderson-2/publication/321137577_Everyday_Experts_How_people's_knowledge_can_transform_the_food_system/links/5a0f4cab0f7e9bd1b2bdc49e/Everyday-Experts-How-peoples-knowledge-can-transform-the-food-system.pdf#page=98).

Third, such processes must be organised in a way that is influenced by those who are critical, (and may even end up opposing), some (or all) new technologies that could potentially arise from synthetic biology. The inclusion of such perspectives is essential in order that the assumptions and expertise of those predisposed to advocate the development of such technologies are open to critical scrutiny (https://food.berkeley.edu/wp-content/uploads/2020/02/405-6995-1-PB.pdf). 

It is therefore vital the agenda-setting for such processes should not be dominated by those who are personally invested (though their professional role and/or commercial interests) in the development and/or deployment a new technology, as has taken place in some cases in recent years with synthetic biology, (e.g. https://etcgroup.org/content/has-synthetic-biology-industry-hijacked-iucn). Such dominance, and exclusion of alternative perspectives risks bringing bias and groupthink to any such process, driving it towards outcomes that suit their commercial and/or professional interests.

Regular horizon scanning, monitoring and assessment initiatives will most likely to meet the three criteria outlined above if they are based on the critical and inclusive applications of participatory action research (PAR) approaches, rather than ones framed by scientism and based on unquestioned - often colonial - assumptions and consequently drawing on a narrow range of evidence ( https://assess.technology/wp-content/uploads/2020/11/Action_Research_SP-1.pdf)

The COP indicated that the broad and regular horizon scanning, monitoring, and assessment process should include the following steps: 1) Information gathering; 2) Compilation, organization, and synthesis of information; 3) Assessment; and 4) Reporting on outcomes.

Points to consider regarding Step 1 of the Horizon scanning, monitoring, and assessment process, namely Information gathering:
1. What needs to be included in the scope of horizon scanning?
2. Where can we find such information?
3. What are the methodologies/ entry points for a process to collect the information?

Concerning the first point, I think the scope of horizon scanning should be broad to include the following:
a) New technological developments/ more sophisticated methods, for example, new genome editing techniques, more complex metabolic engineering, and artificial intelligence/machine learning to redesign biological systems.
b) New applications of existing technologies, for example, the use of synthetic biology for non-biological purposes such as in data storage.
c) All SynBio technology products, including those that do not fall within the scope of Cartagena protocol, such as i) Organisms whose genomes had been edited without the use of nucleic acids using only protein reagents introduced into the cell; ii) Virus-like macromolecular assemblies which do not have all functions required for a complete viral life cycle and are not capable of transferring or replicating their genetic material; iii) Chemically modified organisms that are modified with non-canonical amino acids; iv) Living protocells;  v) Living organisms generated by multiplexed DNA free ZFN/TALEN/MN applications; vi) Part of organisms such as DNA circuits, vii) Products that contain detectable genetic materials belonging to a SynBio organism,…
d) Transient modification (in the lab and in the field), such as using nanoparticles and RNAi spray.

Concerning the second point, information can be found in
a) Scientific literature, such as original research articles and review articles, 
b) Applications received by countries for approval of use, including contained use
c) Countries’ decisions on received applications
d) Risk assessments based on regulatory or non-regulatory processes
e) Already established databases, including those established by NGOs and CS 

On the third point, recalling that the COP decision call for a broad and regular process of horizon scanning, a long-term process where the CBD CHM and CPB BCH act as primary mechanisms to collect such information, should be considered and established. And in this regard, in addition to the submission received by parties/ NGOs/ non-parties on the issue of horizon scanning, there might be a need to consider the following:
a) Adding a section in the Parties’ report on implementation to assist in Horizon scanning by including relevant new techniques, applications, and organisms
b) Creating new types of records on the BCH to capture such information and add appropriate filters to assist in screening the results
c) Parties might need to put an obligation to publish information on the received application of synbio products when the notification is received. A new category of record (application) should be created on the clearing houses to include information on applications waiting for a decision. This way, we can get more information even on application retracted before a decision is taken.
d) Cross-referencing major external databases with the clearing houses.
e) Information should be collected in the form of a standard common format to be approved by the COP to facilitate indexing of information in the clearing house mechanism databases and to ease the searching for information using filters and analyzer tools

Points to consider regarding Step 2 of the Horizon scanning, monitoring, and assessment process, namely Information Compilation, organization, and synthesis of information:
a) The information compiled and synthesized should be made available through the clearing house mechanism
b) A simplified process should be envisaged so that added information can be easily analyzed and filtered

Points to consider regarding Step 3 of the Horizon scanning, monitoring, and assessment process, namely Assessment:
It is essential to highlight that two things need to be assessed:
1. The information that was collected
2. The effectiveness of the process of Horizon scanning and how it can be improved for future cycles

Concerning the Assessment of information, it should not be restricted to potential positive and negative impacts but also highlight the gaps in knowledge, the areas requiring further investigation, the availability of tools to monitor, detect and identify, the availability of risk assessment, monitoring, and emergency measures. The Assessment also needs to reflect the multidisciplinarity of the AHTEG to include not just scientific issues but also socioeconomic, legal, and cultural aspects

Concerning the effectiveness of the Horizon scanning process, it is crucial to note that The Parties are mandated per art. 7 of the CBD to :
‘ ..(c) Identify processes and categories of activities which have or are likely to have significant adverse impacts on the conservation and sustainable use of biological diversity, and monitor their effects through sampling and other techniques; and
(d) Maintain and organize, by any mechanism data, derived from identification and monitoring activities..’

Horizon scanning should be envisaged as one of the means to assist Parties in complying with their obligations under art.7 of the CBD

Points to consider regarding Step 4 of the Horizon scanning, monitoring, and assessment process, namely reporting on the outcome:

The reporting should focus on:
1. The collected information, including knowledge gaps, new techniques, trends and products and
2. The process of Horizon scanning and how it can be improved for the upcoming cycles aiming for  a ‘broad and regular’ process as agreed in the COP decision

O.A.El-Kawy

Thank you for the interesting and informative discussion thus far! I’m Lim Li Ching, from the Third World Network. I was a member of the previous AHTEG on Synthetic Biology.

In response to this question, the report of the 2019 AHTEG, including its Appendix (Overview of possible elements of a process for broad and regular horizon scanning, monitoring and assessment), actually provides several important considerations for the process of broad and regular horizon scanning, monitoring and assessment.

I’d like to provide some points for consideration, approaching this at a higher order level. As already pointed out by Dr Wakeford [#2619], approaches that are multi- and trans-disciplinary and participatory are particularly important. These can help “broaden out” and “open up” technology assessment (see Ely et al., 2014, https://doi.org/10.1016/j.respol.2013.09.004), helping foster “technical robustness and social legitimacy in subsequent policy-making”.

The 2019 AHTEG report also highlighted these aspects: “Expertise from a broad range of disciplines, as well as interdisciplinary and intercultural expertise, would be necessary, especially for the assessment step” (para 41(f) of the report)” and “The assessment step should employ tools and approaches to enable a participatory assessment process” (para 41(h) of the report)”. Special mention should be made  about the knowledge and participation of indigenous peoples and local communities, especially in the context of the CBD and its three objectives.

Furthermore, the 2019 AHTEG report also points to the need to consider “multiple dimensions” when carrying out assessments of the current state of knowledge, such as environmental, human heath, cultural, socioeconomic and ethical dimensions as well as the implications for indigenous peoples and local communities. Of course, the COP in Decision 13/17 also invited Parties to take into account socio-economic, cultural and ethical considerations when identifying (i.e. horizon scanning) the potential benefits and potential adverse effects of organisms, components and products resulting from synthetic biology techniques.

Such considerations will be better aided by multi- and trans-disciplinary and participtory approaches. This also implies that the steps specified by the COP, particularly that of information gathering and assessment, have to encompass cultural, socioeconomic and ethical dimensions, as also highlighted by Prof. Ossama AbdelKawy [#2624].

Another consideration is that of precaution. As pointed out by Prof. Ossama AbdelKawy [#2624] it is pertinent for the horizon scanning, monitoring and assessment process to also highlight knowledge gaps. The response to such lack of full scientific certainty is a precautionary approach, as well set out in the Convention.

----Posted on behalf of Mr. Kamal Kumar Rai---

We IPLCs thanks for the structural steps and the outcomes from the COP on broad and regular horizon scanning, monitoring and the assessment process need to consider the four main steps such as (1) Gathering Information (2) Compilation, organization and synthesis of information; (3) Assessment; and (4) Reporting.

1) What are the fields and errors, complications and challenges of horizon scanning, considere in biology, ecology, environmental and social (IPLC) ? 2) What are the procedures and methods to identify, analyze, tabulate and distribute the information regarding broder and horizon scanning and its techniques? 3) What are the monitoring methods and actores and accessible?

The scope must be broad and accessible,  new and emerging technologies, methods and its impacts and establish a mechanism to procedural of the monatoriam under the area of Cartagena Protocol on Biosafety and the spirit of the Convention, socio-economic consideration and implement the CBD Technical series 100 on Synthetic Biology and Guidances. 

Full and effective participation of IPLCs are equally very important at all level in respect to human rights

Kamal
IPLC

Dear participants,

We are now one week into the online discussions. I would like to thank you for the insightful inputs and references that you shared. I would also like to take this opportunity to kindly remind you that the forum will close on Friday 31 March at 17:00 EDT. Thus, for those that have not yet done so, I kindly encourage you to share your views as there is still time to have input into the important process of broad and regular horizon scanning, monitoring and assessment for synthetic biology. For those that have been active, I appreciate your continued engagement and contributions in the process. The multidisciplinary Ad Hoc Technical Expert Group will surely benefit from all the inputs.

I look forward to the continued collaboration and suggestions in this second week,

Martin

I am Bob Friedman with the J. Craig Venter Institute, a nonprofit genomics and synthetic biology research institute in the United States.  Along with several other colleagues participating in this Online Forum, I was a member of the previous Synthetic Biology AHTEG.  Earlier in my career, I worked for a nonpartisan agency that advised the US Congress on science and technology issues, employing both horizon scanning and technology assessment methods.

Our moderator invited us to share our views on the methods that could be used for each step specified by the COP.  In my view, the challenge of answering this question is to choose methods that are: 1) appropriate for each of the coordinating actors assigned to each step by the COP in Decision CBD/COP/DEC/15/31 and 2) at a level of effort (and budget) consistent with previous CBD processes that rely on AHTEGs as sources of advice.  We need to focus on doing a few important, achievable things… and doing them well.

A very helpful overview of the wide variety of available horizon scanning methods is provided by Hines et al., who review about 100 exercises examining many different emerging technologies and trends.  (Hines P, 2019, “Scanning the horizon: a systematic literature review of methodologies.” https://bmjopen.bmj.com/content/9/5/e026764.)   Some horizon scanning exercises are quite elaborate and expensive, others much simpler. But the key concept is that horizon scanning “provides an early warning of ‘signals’, rather than a comprehensive study of their impact.” 

CBD/COP/DEC/15/31 assigns the first two steps, “Information gathering “ and “Compilation, organization, and synthesis of information” to the Secretariat with the support of consultants, as appropriate.  This Online Forum and the open call for information requested in Paragraph 7 are key components of the first step, as well.  I urge the Secretariat to augment these two methods of information gathering with research by consultant(s) to produce a more systematic review of the synthetic biology/engineering biology scientific literature that is growing at a rate of 4,000 publications per year.  Other sources of information should be consulted as well.  For example, the Engineering Biology Research Consortium (EBRC) in the United States has to date published 5 technical research roadmaps on various aspects of engineering biology.  https://ebrc.org/focus-areas/roadmapping/ These have been developed by and for the research community as aspirational guides for development of the field over the short-, medium-, and long-term.  The most recent effort focuses on “Engineering Biology for Climate and Sustainability”. 

A key component of the second step is “filtration” of the extensive information submitted and gathered in the first step.  While many important aspects might be included, the terms of reference for the multidisciplinary AHTEG clearly direct the AHTEG to focus on “technological developments in synthetic biology and their potential positive and negative impacts vis-à-vis the objectives of the Convention”.  Much of the field of synthetic biology includes developments only indirectly related to the three objectives of the Convention.  To be most useful to the AHTEG’s deliberations in the third step (and ultimately to the COP itself), the Secretariat and consultants should make a concerted effort to “filter” the longer list of technological developments to those that might most directly either help or hinder meeting the three objectives of the Convention.  For example, these might include developments that most directly affect the most important drivers of biodiversity loss, such as climate change and invasive species. Dan Thompkins suggested another useful filter: time to anticipated trials or applications beyond containment must be within a specified time frame [#2593].

The multidisciplinary AHTEG’s role is “assessment”, though that word can have many meanings.  In my view, given the limited meeting time available to AHTEGs, even cursory technology assessments (as that term is traditionally used) would be too ambitious a goal.  I believe a more practical expectation and useful goal would be to prioritize the filtered list, again, by how significantly (or not) these technical developments might help or hinder meeting the three objectives of the Convention. Dan Thompkins suggests another very useful criterion for prioritization:  risks and benefits from synthetic biology applications should be compared to other technology applications already used or being considered for the same goal [#2614]. 

By definition, the AHTEG itself is an expert panel, hence one of the methods to be used.  The prioritization and further filtering of developments could be accomplished by an iterative Delphi process (as mentioned by Lorelie Agbagala [#2596], Ossama AbdelKawy [2627], and Otim Geoffrey [#2641]) or by using more traditional guided panel discussions.  The goal would be to identify the subset of high-priority technological developments, both positive and negative, to bring to the attention of the Parties.

My apologies for such a long intervention.  I promise that my subsequent interventions will be shorter! Again, my hope for this long intervention was to offer a pragmatic view of methods 1) appropriate for each of the coordinating actors assigned to each step and 2) at a level of effort (and budget) consistent with previous CBD processes that rely on AHTEGs as sources of advice. 

Regards to all,
Bob Friedman

Dear all panelists,

Thanks for a rich and informative discussion so far. I am Dr. Trine Antonsen, appointed by the Norwegian Ministry of Climate and Environment. I am senior researcher at the National Competence Centre for Biosafety, NORCE Norwegian Research Institute. We do research on all aspects of biosafety and my own field is ethics, RRI and ELSA (Ethical, legal and societal aspects) of gene- and biotechnology. 

Several panelists have written about the inclusion of broad considerations/multiple dimensions in horizon scanning for new developments in synthetic biology in order to meet the three objectives of the Convention. (e.g. Prof. Tompkins #2587, Prof. Ossama AbdelKawy #2624, Dr. Wakeford #2619) I post my comment here as a reply to Ms Lim Li Ching’s informative post about these aspects in the AHTEG (#2638) and I will share some of our experiences and research on ethical issues.

First of all, and as you may be aware, for GMOs and GE, The Norwegian Gene Technology Act (GTA) includes criteria for assessment of ethical aspects, social utility and sustainability. Thus, there are documents to support the operationalization of the criteria for each. These are useful for a broad and multidisciplinary assessment of the potential positive and negative impact of new technical developments in synthetic biology. Norway has also started the process of updating the legislation adjusting to new developments. 

As a researcher, I have engaged particularly with the ethical aspects and how a broad assessment of not only ethical impact but also framing and assumptions underlying research and innovation can guide development and transdisciplinary co-production of knowledge in such processes.

(1) In developing the ethical guidelines for operationalization under the GTA, it was debated how a framework can balance a sufficiently broad set of values, to represent cultural, societal and individual diversity of moral standpoints, to its usefulness as an assessment tool and guide for developers. The guidelines are not yet translated into English, but a policy brief discussing the range of values proposed to be included and the roles and tasks of the case officers who are making the ethical assessment can be found here: https://link.springer.com/article/10.1007/s41055-021-00091-y

Furthermore, my group have assessed how framing affected a participatory process/consultation regarding the Norwegian GTA. https://www.mdpi.com/2071-1050/13/14/7643 Framing and ´problem understanding` may be particularly useful to focus on in the Step 1 (Information gathering) of the Horizon scanning. The EU EGE’s report on genome editing also emphasized framing as an aspect of ethical assessments. https://op.europa.eu/en/web/eu-law-and-publications/publication-detail/-/publication/6d9879f7-8c55-11eb-b85c-01aa75ed71a1

Building reflexivity (see also below) beyond impact assessments and the inclusion of a broad set of values as well as ethical and epistemological approaches are essential for pursuing the Convention’s objectives. The horizon scanning should furthermore pay attention to connections and collaborations between research environments developing new Synbio technologies or products and environments pursuing social and ethical research on these topics. 

(2) We also use, evaluate and develop RRI tools and ethical assessment tools. In the context of new developments in Synbio vis-a-vis the Convention’s three objectives, the task of building ethical reflexivity within research groups of scientists in the early stages of development of projects and/or new technologies, or in the practical involvement with organisms is crucial. We are currently testing a new tool which has the promise to be particularly useful: Ethics in Research Cards. These are developed at the University of Nottingham by Peter Craigon, Richard Hyde and Kate Millar.  The cards are designed to help researchers, managers and research participants identify, explore and reflect on their ethical responsibilities in research and innovation. The cards have 14 categories: Social, environmental and economic implications, values and principles, participants and stakeholders, provocations in research, structural issues, research quality assurance, questions, planning, practice, dissemination, and engagement, and research misconduct. An expanded scope of horizon scanning should include more than potential positive and potential negative impact, and thus new and updated tools for ethical assessments and for building ethical reflexivity is needed.

Dear fellow participants,

My name is Delphine Beeckman, and I have previously introduced my background and interests in a post on Topic 1, question 1a. [#2683].

I would like to draw the attention to different biosafety organisations such as the European Biosafety Association (EBSA), the American Biological Safety Association (ABSA International), the African Biological Safety Association (AfBSA) and the Asia Pacific Biosafety Association (A-PBA) that provide fora for its members to discuss on technological developments (incl. synbio), and risk management practices as they are identified and encountered from the earliest stages of research.
Against this background, such organisations should be much more actively involved in these international discussions.

Kind regards, Delphine

I am Amelie Wamba, Coordinator of Gene Drive project at PAMCA and I would like to agree with Delphine Beeckman. I work with African institutions very interested in innovative technologies however they lack the guidelines and capacity to adopt and implement them. In Cameroon where I am based, there is the need for more capacity around knowledge sharing, guidelines to develop policy and regulations. The different stakeholders do not have enough information and support to even engage the subject. It would be helpful if this could be facilitated by central organizations like the UN, AU especially the AUDA-NEPAD already working with several countries to develop and adopt the guidelines at the country level. I am happy to be part of any such taskforce to contribute in forwarding this for my country Cameroon and the Central African region. Academicians and researchers in Cameroon would benefit greatly from any capacity building opportunities around this topic and this will trinkle down to the students and personnel they train.

Thank you and best regards,

I am Laurence Vernis, main researcher in France, I have a background in molecular biology, and in yeast and fungi genetics. My work is relevant to biosafety, microbiology, and redox biology.
I would like to emphasize how synthetic biology might help in the climate crisis we are now facing. Combating climate change is not only a question of reducing CO2 production it is also a question of removing CO2 from the atmosphere. One field that synthetic biology might help with is CO2 capture and sequestration. Several works demonstrated the possibility of using microorganisms to capture CO2: conversion of CO2 into magnesium and calcium carbonates in seawater can be boosted by bacteria, developing synthetic microorganisms based on/mimicking photosynthetic Cyanobacteria to capture CO, etc. These are just few examples.

My name is Camilla Beech and I am an independent regulatory consultant, based in the UK with a long history of working with a variety of  biotechnology innovations ranging from engineered enzymes to genetically modified crops and insects.

Regarding TOPIC 2 –  There is a wide range of horizon scanning methods as highlighted by others in the forum. However as raised by Bob Friedman [#2659]  it is important that the methods used are appropriate and proportionate to the task.
Horizon scanning should use a systematic approach  and in this regard I would like to draw the forum’s attention to guidance from
1) the UK Government  [https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1113574/A_Brief_Guide_to_Futures_Thinking_and_Foresight_-_2022.pdf
and 2) the  non-profit Institute of Risk Management [https://www.theirm.org/media/7423/horizon-scanning_final2-1.pdf]

To ensure that horizon scanning is useful and avoids duplication , it should focus on novel developments that have not previously been examined by AHTEG’s and SBSTTA’s.  Horizon scanning is not necessarily about predicting the future, but reviewing options so that evidence based decisions can be made in defined timeframes.   However, as stated by Amelie Wamba [#2686 ] without relevant capacity building for institutions, engagement in the process may be limited.

Thank you

I am Bob Friedman.  I introduced myself in an earlier post to this thread [#2659].  First, I would like to thank all my fellow participants for this informative and insightful discussion.

In my earlier post, I stressed the importance of the information gathering step of the horizon scanning process.  In-depth, comprehensive reviews, while more time-consuming, provide much more confidence that one does indeed have a broad view of the technological horizon… and is not just being distracted by a few interesting places.  

Future synthetic biology innovations and applications will be highly influenced by two pressures: “bottom up” technology push and “top down” technology pull.  Schwantje Schroll [#2761] describes the methods ZKBS Germany to survey the scientific literature and industry-focused newsletters. Becky Mackelprang, EBRC, [#2691] demonstrates the value of detailed community-driven roadmaps using 11 examples of research underway, and the technical advances needed, to achieve the goals identified by the community.  These are both important bottom-up views.  Examination of government R&D programs and priorities, i.e., top-down, technology pull, provide another very informative view of the synthetic biology horizon.

Nicole Buan [#2678] includes descriptions of, and links to, recent “top-down” initiatives by US President Biden to foster synthetic biology research and development in the United States.  Synthetic biology has also been included as a major component of the recently passed CHIPS and Science Act of 2022, which established key research priorities for the United States. 

The US is not alone identifying synthetic biology as a top R&D priority.  UK Prime Minister Sunak announced a new Science and Technology Framework that includes synthetic biology as one of 5 “transformational technologies” being aggressively pursued by the UK (https://www.gov.uk/government/publications/uk-science-and-technology-framework).  In 2021, Australia published “A National Synthetic Biology Roadmap”, citing the results of the horizon scanning effort I mentioned in my earlier post. (https://www.csiro.au/en/work-with-us/services/consultancy-strategic-advice-services/csiro-futures/future-industries/synthetic-biology-roadmap).   Taemin Wu mentions ongoing governmental initiatives in Korea. [#2682].  Ben Durham briefly mentions initiatives in South Africa’s National Department of Science and Innovation [#2600].  China, Singapore, Thailand and quite a few other countries have identified synthetic biology as among their top priorities for research and development. 

Given the influence of governmental funding and other policy support on the R&D endeavor, careful examination of the priority areas and types of synthetic biology research that each of these initiatives are encouraging will provide very helpful information for the CBD roadmap.  Synthetic biology applications for environmental protection and sustainable development are included among the top priorities.

Of course, as pointed out by quite a few participants, whether a research idea transitions “from the horizon” to an actual application depends on many factors, including successfully passing case-by-case environmental, health, and safety reviews, as pointed out by Piet van der Meer [#2673], Delphine Beeckman [#2683], Galina Mozgova [#2660], Luke Alphey [#2690], and others.

At the risk of being too much of a policy wonk, perhaps in addition to being an important source of information about future research directions, national synthetic biology strategies or policies should be added as an answer to Topic 1: Question 2, i.e., a trend not specifically identified by the AHTEG that should also be explicitly considered during the horizon scan?  Policies for technology transfer to developing countries, mentioned by quite a few participants, could also be considered.

Best regards,
Bob Friedman

Dear all,

My name is Luciana Ambrozevicius, I work for the Ministry of Agriculture and Livestock. I am a former member at National Biosafety Commission in Brazil and I was a member at the SynBio AHTEGs.

I agree with the view expressed at https://www.fs.usda.gov/nrs/pubs/jrnl/2018/nrs_2018_hines-a_001.pdf with a US Federal Agency example of horizon scanning. “The goal of horizon scanning, therefore, is not to try to accurately predict the future, but to identify, compile, and analyze the various signals of change”. On this regard I also agree with #2659, #2689 to use the available methods that are appropriate and proportionate to the task and I specifically support the suggestion regarding “the necessity to “filter” the longer list of technological developments to those that might most directly either help or hinder meeting the three objetives of the Convention”.

Thanks,
Luciana

My name is Hector Quemada. I am retired biosafety scientist, having spent most of my career in the area of biosafety policy and regulations as well as risk assessment. My subject areas have ranged from LM crops to, most recently, the development of gene drives to alleviate disease. My thanks to Martin Cannell for moderating this session, and to all participants in this online forum. It has been a wide ranging and informative discussion.

As this online forum draws to a close, I would like to share my observation that the many contributions in response to Topic 2 have been very useful, especially in the sharing of methodologies and approaches for horizon scanning. However, it seems to me that while we are focused on the how, we should not forget the why. I think we can agree that at the heart of the horizon scanning efforts is the goal of achieving the three objectives of the Convention on Biological Diversity, However throughout this forum, with respect to both topics 1 and 2, there seems to be little mention of those objectives. In fact, I only see two interventions that specifically mention them (#2556 and #2608). I believe we should continue to keep these in mind, namely

-   the conservation of biological diversity;
-   the sustainable use of its components;
-   the fair and equitable sharing of the benefits arising out of the utilization of genetic resources.

Therefore two of the three objectives assume that the technologies we are discussing should be used. This of course is consistent with Article 19 of the CBD, which assumes that benefits will accrue from biotechnology and therefore should be shared. To unnecessarily hinder the realization of those benefits defeats the objectives just mentioned.

In addition to remembering why we are doing horizon scanning, we should also remember what we are scanning for--developments in synthetic biology that might be injurious to the three objectives. But the wide-ranging discussion so far sometimes seems to consider any new development in biotechnology to be synthetic biology. This problem, in my view is due to the continuing lack of common understanding of what synthetic biology is, despite (because of?) the operational operational definition we are supposed to keep in mind:  “[S]ynthetic biology is a further development and new dimension of modern biotechnology that combines science, technology and engineering to facilitate and accelerate the understanding, design, redesign, manufacture and/or modification of genetic materials, living organisms and biological systems”. This has led to the mention technologies that certain contributors have considered to be part of the area we call synthetic biology, but which are stretches at best. Examples are marker-assisted breeding (not modification of genetic materials, in a manner different from traditional breeding, not through modern biotechnology), sterile insect technique (with a couple of recent exceptions, not using modern biotechnology to produce the insects), big data (a generally utilized development in computer capabilities, not unique to modern biotechnology), and null segregants (not genetically modified organisms, and therefore proposed to be exempted from regulation by some countries; see for example Zimny T, Eriksson D (2020) Exclusion or exemption from risk regulation?: A comparative analysis of proposals to amend the EU GMO legislation. EMBO Reports 21:. https://doi.org/10.15252/embr.202051061). Therefore, it would be a useful step in the horizon scanning, to keep in mind the operational definition of synthetic biology, to be certain that the horizon that is being scanned is appropriate in scope.

Thanks for the opportunity to comment.

Hector

Hello Hector!

Amelie Wamba here. I am very happy to read your comment here and happy that even in your retirement, you continue to contribute. It was an immense pleasure to work with you and Dave.

I was happy to attend my first COP meeting last year in Montreal and so honored to be a part of this conversation even though I am mostly able to read, be informed and learn. I decided to make this post to acknowledge you and your contribution to the field and to partnership in Africa. I would like to appreciate you and others now retired for paving the way for us and working to equip young Africans with the capacity to contribute to decision-making in matters that concern them. I would also like to thank you for building capacity in Africa by working with different partners on the continent which has provided more opportunities to African scientists and academicians to gain more visibility and have access to important platforms such as this. I really appreciated working with you and being inspired by your energy and enthusiasm. I wish you a happy and restful retirement and look forward to seeing your contribution whenever possible.

I will like to thank the CBD for the opportunity to be a part of this conversation and to learn from very experienced experts like Hector who have given their all. I am grateful for the opportunity to serve and contribute, not only to my country Cameroon but to Africa and the rest of the world. Much gratitude for capacity building and empowerment!

Best regards,

Dear colleagues,

this is Dr. Kellmann, trained plant biologist and working for more than 30 years in the area of gene technology, plant physiology and biochemistry, and transgenic plants approaches. I am deputy member of the German Central Committee for Biological Safety (ZKBS). The ZKBS is an independent and voluntary expert panel responsible for examining and assessing safety-relevant questions of genetic engineering. The expert panel delivers position statements on this matter and gives advice to the German government and the German Federal States. The ZKBS has been monitoring synthetic biology research for more than 10 years with a focus on biosafety and the applicability of existing German and European regulations. Further information has already been posted by Mrs Schroll [#2671, #2672].

I have followed with interest the discussion and all the detailed information and assessments provided in this forum. In addition, of course of meanwhile being one of the "seniors" in this field, I follow the history from the advent of gene technology and biotechnology until today, including all the discussions and controversaries about. In this context, I am deeply grateful to the contribution from Mr Reynante Ordonio [#2709], saying that "Synthetic Biology is just a new paradigm and so, we should strive not to mix it up and confuse with the existing GM and some new plant breeding techniques like gene editing. I also hope that products of modern biotech that genetically resemble conventional crops will not be branded as “synthetic” because this will have an impact on public acceptability".

In the former times, especially at public panel discussions in the 1980ies and 1990ies, e.g. terms like "genome research", i.e. non-invasive, analytical technology, and "gene technology", i.e. invasive technology, have dangerously been mixed up and this mixture still has impact on public understanding of the science behind and its acceptability. Regarding the term "Synthetic Biology", ZKBS hence has decided to distinguish between five subtopics:
1. Synthesis of genes and genomes
2. Design of genetic signalling circuits
3. Metabolic engineering
4. Minimal cells: Genome reduction and production of protocells
5. Xenobiology.
While monitoring all the publications embarked with the keyword "synthetic biology", we carefully scrutinize if a given paper belongs to one of the topics. Actually, as Mr Ordonio already pointed out, quite a few publications are originary gene technology rather than SynBio.

I appreciate if our experience and insights will be considered within this forum, making the discussion about synthetic biology more transparent and focussed.

Dear participants, it has been a great opportunity to read the views from participants from around the globe with different priorities and expectations, nevertheless sharing the ambition to contribute to the progress of the CBD objectives.

I am Patrick Rüdelsheim, Belgian, holding a PhD in Biology and lecturing at the University of Ghent and the University of Antwerp. My main professional activity is assisting researchers and developers in risk assessment and management of biologicals as well as compliance with biotechnology regulations. As such I have followed the Synthetic Biology developments closely and was honoured to serve as technical editor of the CBD Technical Series 100 publication.

As pointed out in the CBD Technical Series 100, a fundamental bottleneck of the discussion remains the lack of an agreed definition of “Synthetic Biology”. I like to support comment from Hector Quemada (#2706) and invite the contributors to this forum and the follow-up to address this point.

Today, “Synthetic Biology” is used to refer to a broad range of techniques that can be used for different purposes and in different contexts. The wide range of applications makes it difficult to define the field precisely and to identify specific uses or industries it is most relevant to. “Synthetic biology” can describe both top-down and bottom-up approaches to engineering biological systems. A top-down approach involves taking existing biological systems and modifying them, while a bottom-up approach involves designing and building biological systems from scratch. This further contributes to the broadness of the term.

While this broadness can be beneficial for promoting interdisciplinary research, it can also make it challenging to define the field precisely and to communicate its goals and applications clearly. This broadness may lead to wrong conclusions by extrapolating of case-specific considerations. While many contributions to this forum have stressed the need for case-by-case determination, there is no reflection on how to differentiate these under the huge, artificially defined umbrella of “Synthetic Biology”.

While horizon scanning for new and emerging issues that may impact, positively and/or negatively, the CBD goals is indisputably an important task to keep the international efforts up to speed, it is misleading to identify all such developments within a single, temporary since 2016, “Synthetic Biology” definition.

My name is Margret Engelhard, I am working at the German Federal Agency for Nature Conservation in the area of GMO Regulation and Biosafety and I was a member of the previous Synthetic Biology AHTEGs. My scientific background is micro- and molecular biology and interdisciplinary technology assessment research.

First of all I would like to thank Martin Cannell for moderating this session, and to the fellow participants in this online forum!

I would like to explicitly support and make some additions to the comprehensive suggestions made by Ossame AbdelKawy [#2624] regarding what needs to be included in the scope of horizon scanning at step (a). We agree that the list should include new technological developments/more sophisticated methods, new applications of existing technologies, all SynBio products, and products of transient modification. We would like to add convergence with nanotechnology (as pointed out by Sarah Agapito [#2680 in Topic 1 Q1a]). Current important examples of novel applications include viruses (see Guy Reeves [#2650 in Topic 1 Q1a] and living modified trees now being brought to market).

Another point regarding step (a) is the early inclusion of context, framing and different knowledges (see my upcoming post in question 2, and Jack Heinemann [#2617], Gerd Winter[#2631], Helmut Gaugitsch [#2662], Trine Antonsen [#2677], Taemin Woo [#2685]). This would be somewhat in contradiction with Dan Tompkins’ view [#2614] that application goal considerations should be kept separate from risk and benefit evaluations. When discussing potential positive or negative impacts of Synbio, also context evaluations are central, for example when analysing Synbio research approaches that are being developed in part for nature conservation purposes. My agency has recently analysed multiple aspects of these applications including risk aspects and conceptual and legal challenges (see https://bit.ly/gen-engin-conserv).

At the synthesis (b) and assessment (c) steps, while acknowledging Bob Friedman’s [#2659, #2669] suggestion to follow a pragmatic scheme, the need to adapt the process to the available resources, and the relevance of the suggested methodological approaches, I would like to caution against prioritising the use of resources for the horizon scanning of the technologies at the cost of the assessment since - as I have elaborated just before - are internal parts of the evaluation. A comprehensive technology assessment analysis could in future profit from also being included to the online forum discussions, to make use of the brought technology assessment research literature and expertise that already exists. It is important to keep the ambition and not reduce step (c) assessment to lists of priorities and summaries of controversies. I would strongly urge to pay attention to the input by Lim Li Ching [#2638], by Tom Wakeford [#2619], and by Mr. Kamal Kumar Rai [#2652] detailing the need for broad and inclusive assessments.

I early introduced myself on one of question. I am Prof Nicolas BARRO, Director of foodborne diseases epidemiology and surveillance laboratory, Focal point of Carthegena protocol and former Director General of National Biosafety Agency, Ouagadougou, Burkina Faso West Africa. For a horizon scanning process it is a hardy task taking into account advancement levels of different countries, and harmonised among the expert the concepts, vision, application field, knowledges on the subject of Synbio.
Today they are a big gap in practise and technology between developed countries and low income countries. However many of findings must be applied in less developed countries.
As argued by Prof. Dr. Ossama AbdelKawy, Egypt, I support strongly the processes describe by him in approaches to carried out the question 2 of topic 2.

I am Lúcia de Souza, a biologist. I was vice-presidente of the Brazilian Biosafety Association and one of the former members of previous Synthetic Biology AHTEG. I am here with PRRI (Public Research and Regulation Initiative).

Synthetic biology offers opportunities to address many global challenges such as clean water, energy, mitigation of climate change effects, preparedness and resilience to pandemics, major drivers of biodiversity loss; etc. If managed effectively these innovations could benefit all of the 3 aims of the Convention on Biodiversity. The challenge of making a useful and feasible horizon scanning will include:
• well defined inclusion criteria and systematic method to select and filter only real synthetic biology developments that are relevant for the aims of the CBD.
• refined prioritisation criteria and questions to gather information such as:
o   of potentially novel threats to drive the development of new capabilities to realize the emerging opportunities;
o Identify potential benefits that are most imperative to conservation of biodiversity, such as to predict and prioritize major biodiversity loss drivers such as trends in  invasive species

Dear all,

my name is Eder Toppa, I've been working for the Brazilian Ministry of Agriculture and Livestock for the past decade and currently I am also member of the National Biosafety Comission. I've attended the COP / MOP meetings held in Montréal last december.

Apologies for only writing now.

I would like to strongly support what have said Mr. Robert Friedman [#2698] and Ms. Luciana Ambrozevicius [#2702]
Also from my perspective the greatest challenge of this process is to single out the huge ammount of information gathered taking into account indirectly developments related to the objectives of the Convention and the short-term to do that.
Moreover, it's important to recall the paragraph 3 of the Decision 15/31 to stress that synbio and any procedures such as the horizon scannings should not be seen as permanent under the convention.

Best regards

Dear Colleagues - my name is Kelebohile Lekoape a regulatory Affairs Manager with extensive experience in risk assessment and biosafety spanning the government, UN bodies and the private sector.  I am honoured to be nominated by the South African government to participate in this forum.

From the perspective of a developing country with limited capacity and resources, this exercise can be an excellent tool for capacity building that could help keep us abreast of research and technological developments globally.

If conducted properly, information collated from horizon scanning can be valuable to Competent Authorities for prioritising and focussing on relevant developments while understanding the potential challenges associated with expected timelines and deployment of applications. 

In order to meet the three objectives of the CBD, horizon scanning:
- should start with a concise and agreed definition of synthetic biology;
- enlist technologies that can realistically be foreseen in the near future;
- identify opportunities for collaboration, technology sharing and transfer
- assist our national process in implementing the White Paper on Conservation and Sustainable Use of Biodiversity.

Thank you

Hello everyone.  My name is Adam Cornish and I work in the Office of Agricultural Policy 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 believes that horizon scanning, monitoring and assessment of emerging technologies should be conducted in a manner that supports the safe handling of organisms and protects safety, health, and the environment while avoiding unjustifiable barriers to innovation, stigmatization of new technologies, or creation of trade barriers.  Monitoring and assessment should be based on the best available scientific evidence, and with sufficient flexibility to continually accommodate new knowledge, taking into account the evolving nature of emerging biotechnologies and their applications.

The U.S. regulatory agencies have a coordinated, risk-based system to protect the environment and human, plant and animal health, to assess and manage any potential health and environmental risks posed by biotechnology products, and to ensure biotechnology products are safe for the environment, health, research, production, and trade.  This system facilitates oversight of planned introductions of biotechnology products into the environment and focuses on the characteristics of the biotechnology product, the environment into which it will be introduced, and the application of the product – not the process by which the product is developed.

The United States believes that transparency in decision-making and public dissemination of methodologies used to develop and finalize decisions are essential to the development and review of national risk assessment efforts.  The United States has a transparent, robust, risk-proportionate, science-based approach to enable the safe use of organisms for a variety of applications including education, research, medical fields, food production, crop production, and animal husbandry.  This approach embraces the spectrum of tools common to regulatory frameworks, ranging from guidance for best practices, to laws that set standards for product attributes, to regulations for specific activities and uses.  The United States has mechanisms in place to ensure safety, as well as to detect and monitor adverse health outcomes for humans, plants, animals, and the environment.  We encourage sharing of these best practices in order to effectively evaluate all products that would be brought to the market.

Hello,

In order ensure an overall assessment it would be relevant to consider the following:
Species whether produced by more traditional recombinant DNA techniques, synthetic biology or sophisticated breeding will by their presence change existing ecosystems and if they exchange genetic material with wild relatives they will change existing biodiversity, potentially reducing viability.

There is also a risk that these novel organisms may become invasive, out competing or displacing existing species, a particular risk to species that are endemic or rare. Genetic transfer between novel organisms and wild relatives could lead to hybrids that outcompete transgenic and wild varieties. Such risks also attend use of novel organisms for direct conservation purposes (to restore polluted or degraded ecosystems) and these situations will require careful research and analysis, and careful balancing of potential risks.

Biodiversity conservation would also be affected by broader environmental, social and economic impacts of novel organisms. Human rights and environmental organizations have already begun to develop a vocal and focused anti-synthetic biology movement that could affect the ways in which synthetic biology will develop.

The potential impacts of synthetic biology that concern this community include effects on biodiversity but there is particular concern about the impacts that novel organisms could have on the rural economy and society in the developing world.

Angela Lozan,
Moldova

My name is Christoph Lüthi, I hold a PhD degree in evolutionary ecology and I work as a scientific officer in the Biotechnology Section at the Federal Office for the Environment (Switzerland).

Firs of all, I would like to thank the CBD secretariat for their work on making this forum happen, Dr. Martin Cannell for the moderation of this topic and all the colleagues for providing valuable input.

Our Office is responsible for the enforcement of the Federal Act on Non-Human Gene Technology. As part of our work, we do a regular horizon scanning on the ongoing developments in biotechnology applications that are relevant for the environment. Because of our limited resources, we depend on reliable available information gathered by others. Therefore, I want to emphasize the value of CBD's efforts for carrying out a horizon scanning, monitoring and assessment on synthetic biology, and for inviting the community to participate in the process.

I would like to focus on two aspects:

The definition of "synthetic biology". It is vital to have a definition of "synthetic biology" to be able to perform a horizon scanning. It is a valuable accomplishment of the CBD to provide a definition in their Technical Series No. 100. However, the definition is so broad that too many applications of modern biotechnology fall under the definition (this is relevant for step a: information gathering). On the one hand, this complicates the horizon scanning because of the overwhelming range. On the other hand, a too wide range of information in the reporting on outcomes makes identification of relevant applications more demanding (this is relevant for step a: information gathering).

The focus on applications with highest potential impact on the environment. I Switzerland and in other countries and regions, the regulation of biotechnology aims at protecting human beings, animals and the environment from abuse of the technology. Hence, the evaluation of the information gathered in step a need to be compiled, organized and synthesized (step b) and subsequently assessed (step c) in a way that allows to identify those applications that pose a relevant risk for the above protection aims. The categorization based on the intended use as provided in the Technical Series No. 100 is certainly useful here. In my professional role, I am mainly interested in the risks. However, I want to acknowledge the chances provided by synthetic biology applications.

Kind regards,
Christoph Lüthi

Dear colleagues,

Thank you very much for the interesting discussion so far. I am Barbara Pilz, Campaign Manager at the non-profit Save our Seeds in Berlin, Germany. In the context of synthetic biology, my organisation has been particularly focused on highlighting the risks of potential applications/environmental releases of organisms containing engineered gene drives.

We welcome the suggestion made by Dr. Wakeford (#2619) that regular horizon scanning, monitoring and assessment initiatives will most be productive if they are based on the critical and inclusive applications of participatory action research (PAR) approaches (https://assess.technology/wp-content/uploads/2020/11/Action_Research_SP-1.pdf). As Lim Li Ching (#2638) already pointed out multi- and trans-disciplinary and participatory approaches can help “broaden out” and “open up” technology assessment (https://doi.org/10.1016/j.respol.2013.09.004).

In order to comply with the COP Decision 13/17 inviting parties to also take into account socio-economic, cultural and ethical considerations, we believe that the information gathered for the horizon scanning, monitoring and tech assessment process should come from as many different sources and disciplines as possible. It should therefore not be limited to information available solely in English, and from scientific journals, but should also include information only available in other languages, non-written information, and indigenous and interdisciplinary knowledge.

This includes, as mentioned by other contributions, avoid making this process overly data driven by including viewpoints that are not available in the form of data.

Seen that the COP decision is calling for a broad and regular process of horizon scanning, we invite the mAHTEG to establish a process that does not serve only for a one-time-scanning but as a blueprint for a truly broad and regular process.

As recalled by other contributions, the first two steps (‘information gathering’ and ‘compilation, organization, and synthesis of information’) will be supported by consultants “as appropriate”. Accordingly, we believe is crucial for decision 14/33 (on conflict of interests) to also apply in this case. Meaning that information collected from individuals or institutions (and their affiliates) that do not comply with that resolution should be assessed with outmost precaution and that such individuals should not be contracted as ‘consultants’ in this process.

Many thanks for this opportunity for me as a lawyer to learn about developments and evaluations of SynBio (whatever that term may mean). While there is wide agreement about developments less consensus seems to be on evaluations. Many contributors propose a balancing of risks and benefits but its concrete shape can be very different, if you only compare the utilitarian US and the more inclusive Norvegian approaches. There is thus much additional horizon scanning needed concerning a comparison of evaluative and finally regulatory approaches in different legal cultures which may be undertaken in a separate round of a discussion forum  .
I have one more concern having followed the discussion, and that is the almost complete lack in our forum of discussions on the third CBD objective, i.e. access to genetic resources and benefit sharing (ABS). The problem here is discussed under the heading DSI (digital sequence information) in ABS rounds. DSI tends to cut links between the origin of a genetic resource and the final product made on its basis. The question for our forum would be if (and if any what) SynBio techniques can be understood to still make use of genetic properties of a genetic resources collected from a country of origin. But this is of course too late to be answered.
All the best
Gerd Winter

Dear online forum participants,

My name is Felicity Keiper and I am participating in this forum as a representative of the Global Industry Coalition (GIC). We have been following the contributions in this round of discussions with interest, and have posted comments addressing the Topic 1 questions. There are posts made throughout this discussion, and in particular under Topic 2, commenting on the private sector, and there are aspects of these comments that warrant our response.

Post #2619 points out that horizon scanning should be inclusive of diverse perspectives, but then elaborates on the extent to which certain stakeholders should/should not be involved due to their “bias” (also alluded to in #2617). We note that “those who are critical” of synthetic biology are amply represented – while the private sector is relatively absent – from the synthetic biology work under the CBD. The narrative that the private sector is the only participant with vested interests, that it is dominating agenda setting, or that it is excluding the perspectives of any other stakeholder, is misleading. Further, while GIC members have been actively engaged in this forum for more than two decades, we do not represent the entire private sector with relevant activities, and broader representation should be sought out for contribution to this work.

We have already commented (Topic 1, Question 1(a)) that the private sector collaborates broadly and is a participant in the scientific community. The private sector has unique perspectives and expertise to contribute to the horizon scanning process, given its experience in technology development, as well as the realities of R&D timelines, global regulatory requirements and processes, and relevant regulatory policy developments, which extend well beyond the CBD world. It is our intention to contribute factual information based on real-world experience to the horizon scanning process.

We appreciate the constructive posts made for this Topic that contribute relevant examples of previously conducted horizon scans (e.g. #2588, #2671, #2676) and examples of approaches that could be considered in this work under the CBD (e.g. #2596, #2689, #2717).

Regards,
Dr Felicity Keiper

----Posted on behalf of Dr. Martin Cannell---

Dear Participants,
Thank you for providing your views on the particular points that should be considered when carrying out each of the steps specific for the process of broad and regular horizon scanning, monitoring and assessment. For the overall process, it was raised that the process of prioritization of topics might be necessary to have an effective and useful process which avoids duplication and focuses on newer developments that have not been the subject of previous scrutiny, and the need to properly communicate the results. In addition, a greater involvement and participation by an increased number of stakeholders would yield better results. However, challenges may lie in determining the appropriate coordinating actors, the volume of new developments and the effort required to feed into the multidisciplinary AHTEG. For the gathering and compilation of information steps, the use of consultants was suggested to manage the volume of information. Further, a filtration step could be an important component of the second, information compilation step. When assessing the collected information, there might be a need to compare the applications with the current use of other technologies to achieve similar goals. It was also suggested that knowledge gaps should be examined in addition to the potential positive and potential negative impacts. Some other constructive and concrete points were proposed to assist with each of the steps, including taking advantage of existing mechanisms within the Secretariat. With the assistance of the Secretariat, I will capture the references and inputs shared during this discussion.
Best regards,
Martin