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.

2) Share information on methodologies and approaches that have been used for other horizon scanning processes that you believe could be useful for the horizon scanning on synthetic biology under the CBD and provide examples if possible.

----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

Greetings everyone! I am Leocris S. Batucan Jr, a fellow for the National Committee on Biosafety of the Philippines. We are in the middle of conducting a horizon scan on gene editing and synthetic biology and for now I would like to share the criteria we used in identifying information sources (i,e. experts/respondents) for our scan.

1. expertise and model organism - we made sure our cohort have diverse expertise - with respondents working with fungi, bacteria, virus, plants, animals, etc. and practicing different but allied disciplines (i.e. bioethics, synbio, metabolic eng, genetics, molecular bio, chemistry, biophysics, etc.)
2. regional representation - the Philippines is an archipelagic country with diverse language, culture, and challenges faced, we made sure experts from the major island groups are represented
3. career level - we made sure that we have junior-, mid-, and senior-level experts present in the cohort. There is a need to balance the wisdom & experience of the seniors and the idealism & vigor of the juniors.
4. gender representation - we made sure that males and females are equally represented.
5. employment background - we made sure that government offices, academic & research institutions, NGOs, and industry representatives were present
5. country of residence - we made sure that the Filipino diaspora is capitalized on. The views and challenges faced by local Filipino experts are nuancedly different from Filipino experts in other places - this gives us valuable insight that would otherwise be missed if all we focused on were local information sources.



Our scan borrows from Kemp et al, (2020) and NASEM (2020).

Kemp L, Adam L, Boehm CR, Breitling R, Casagrande R, Dando M, Djikeng A, Evans NG, Hammond R, Hills K, Holt LA, Kuiken T, Markotić A, Millett P, Napier JA, Nelson C, ÓhÉigeartaigh SS, Osbourn A, Palmer M, Patron NJ, Perello E, Piyawattanametha W, Restrepo-Schild V, Rios-Rojas C, Rhodes C, Roessing A, Scott D, Shapira P, Simuntala C, Smith RD, Sundaram LS, Takano E, Uttmark G, Wintle B, Zahra NB, Sutherland WJ. Bioengineering horizon scan 2020. Elife. 2020 May 29;9:e54489. doi: 10.7554/eLife.54489. PMID: 32479263; PMCID: PMC7259952.

National Academies of Sciences, Engineering, and Medicine 2020. Safeguarding the Bioeconomy. Washington, DC: The National Academies Press.
https://doi.org/10.17226/25525.

Thank you.

A Synthetic Biology Horizon Scan was conducted by the Australian Council of Learned Academies (ACOLA) in 2018.  Unlike many syntheses and reports on Synthetic Biology, this one has a section focused on applications in the Environment and Biocontrol space, which is particularly relevant to this forum:

https://acola.org/wp-content/uploads/2018/12/2018Sep-ACOLA-Synthetic-Biology_Report.pdf

I would appreciate if we could have an overview of the entire list of questions which will be posed. As a lawyer I am particularly interested in questions concerning policies and legal regimes evaluating and regulating SynBio products. Will there be any questions of that sort?

Dear Mr Winter, the only questions that will be asked are the ones that are already displayed in the forum. However, I have formatted the questions and background context into a single page and attached to this message in case that is useful. Even so, we'd encourage participants to note that for each of the questions there is a thread, and we kindly request that you answer under each thread to avoid mixing of information and to facilitate compilation. Kind regards, Martin

In Burkina Faso we have all the organisations resulting from the CBD with the protocols.  For some years now, there has been a reflection on new techniques of plant modification, notably gene editing, gene drive and synthetic biology. We are supported by the government and the African Union through its specialised agencies

I would like to share with you my experiences of horizon scanning procedure used for Marker Assisted Breeding (MAB) in Ethiopia. MAB has been undertaken for a variety of crops worldwide, including Ethiopia. And. a number of research findings has been generated. These finding are made public through publication that are simple for anyone to access. However, a considerable number of findings are unpublished. It is clear that, these findings are found to be shelved with limited access to other users. Therefore, these unpublished findings need to be compiled and disseminated for users. To facilitate this, National MAP platform was established with the participation of scientist from biotechnology affiliated institutions based in Ethiopia. The primary goal of the platform was to gather, examine, and record information in the form of scientific lead review articles that could be used as references for teaching plant biotech courses and as a basis for future research. This scanning procedure may be helpful for on going or unpublished synbio tech research.

I am Kamal Kumar Rai, IPLC representative, the number of methodological approaches regarding horizon scanning process, technologies, biotechnologies, institutions on synthetic biology and related implementation.

Horizon scanning knowledge system, technological approaches, implication and impacts in biodiversity, food chains, ecosystems, health and socio-cultural economic consideration and relationship of IPLCs, women, youth and girls as whole society harmony with Mother Nature and Earth.

The wider information, innovations and use of these science and technologies must have inclusion monitoring, precautionary mechanism under Convention on Biological Diversity and its provisions.

Kamal Kumar Rai
IPLCs

I am Ma. Lorelie U. Agbagala, Philippines’ BCH national Focal Point. In the context of synthetic biology under the CBD, some methodologies and approaches that have been used for other horizon scanning processes that could be useful include:
• Delphi method: This is a consensus-based approach that involves iterative rounds of surveys and feedback from experts in the field. The Delphi method can be used to identify emerging technologies, assess their potential impacts, and prioritize them for further analysis. An example of the Delphi method being used for horizon scanning is the UK Government's Foresight program, which used the method to identify emerging technologies in various sectors, including biotechnology.
• Scenarios: Scenarios are plausible stories about the future that explore different possible outcomes based on various drivers of change. Scenarios can be used to identify key uncertainties, explore alternative futures, and inform strategic planning. An example of scenarios being used for horizon scanning is the Global Business Network's (GBN) scenarios for synthetic biology, which explored four possible futures based on different levels of public acceptance and regulatory oversight.
• Environmental scanning: Environmental scanning involves systematically gathering and analyzing information from a wide range of sources to identify trends, emerging issues, and potential threats and opportunities. Environmental scanning can be used to identify emerging technologies, assess their potential impacts, and inform policy and decision-making. An example of environmental scanning being used for horizon scanning is the European Environment Agency's (EEA) environmental scanning report, which identified emerging environmental risks and opportunities in Europe.
• Expert panels: Expert panels involve convening a group of experts in a particular field to provide insights and recommendations on emerging trends and issues. Expert panels can be used to identify emerging technologies, assess their potential impacts, and prioritize them for further analysis. An example of expert panels being used for horizon scanning is the National Science Foundation's (NSF) Emerging Frontiers in Research and Innovation (EFRI) program, which convenes expert panels to identify and fund high-risk, high-reward research in emerging areas of science and engineering.
These are just a few examples of methodologies and approaches that have been used for horizon scanning in other fields and sectors. They could be useful for horizon scanning on synthetic biology under the CBD, depending on the specific objectives and context of the analysis.

Very best wishes.

I am Ma. Lorelie U. Agbagala, Philippines’ BCH national Focal Point. In the context of synthetic biology under the CBD, some methodologies and approaches that have been used for other horizon scanning processes that could be useful include:
• Delphi method: This is a consensus-based approach that involves iterative rounds of surveys and feedback from experts in the field. The Delphi method can be used to identify emerging technologies, assess their potential impacts, and prioritize them for further analysis. An example of the Delphi method being used for horizon scanning is the UK Government's Foresight program, which used the method to identify emerging technologies in various sectors, including biotechnology.
• Scenarios: Scenarios are plausible stories about the future that explore different possible outcomes based on various drivers of change. Scenarios can be used to identify key uncertainties, explore alternative futures, and inform strategic planning. An example of scenarios being used for horizon scanning is the Global Business Network's (GBN) scenarios for synthetic biology, which explored four possible futures based on different levels of public acceptance and regulatory oversight.
• Environmental scanning: Environmental scanning involves systematically gathering and analyzing information from a wide range of sources to identify trends, emerging issues, and potential threats and opportunities. Environmental scanning can be used to identify emerging technologies, assess their potential impacts, and inform policy and decision-making. An example of environmental scanning being used for horizon scanning is the European Environment Agency's (EEA) environmental scanning report, which identified emerging environmental risks and opportunities in Europe.
• Expert panels: Expert panels involve convening a group of experts in a particular field to provide insights and recommendations on emerging trends and issues. Expert panels can be used to identify emerging technologies, assess their potential impacts, and prioritize them for further analysis. An example of expert panels being used for horizon scanning is the National Science Foundation's (NSF) Emerging Frontiers in Research and Innovation (EFRI) program, which convenes expert panels to identify and fund high-risk, high-reward research in emerging areas of science and engineering.
These are just a few examples of methodologies and approaches that have been used for horizon scanning in other fields and sectors. They could be useful for horizon scanning on synthetic biology under the CBD, depending on the specific objectives and context of the analysis.

Very best wishes.

Morning all from South Africa!

I am from our National Department of Science and Innovation, with particular responsibility for (driving/enabling) bio-innovation (ie. innovation associated with life/biological resources).

There are two main areas where monitoring synbio (ie. horizon scanning) must be focussed. (1) Academic R&D, and (2) Commercial development and innovation.  The former can relatively easily be assessed through the normal academic outputs - ie. publications and conference presentations. And public and philanthropic funding foundations will have records too of what they are funding.

The commercial side is more interesting.  While patent searches may assist for some, secrecy around an innovation can be an important component of the commercialisation strategy.  But ultimately the commercial application will need regulatory approval, and hence the responsible authority can provide information on developments.  (This may leave relatively little time for risk assessment development processes if it is associated with a new advance/different application, but would normally be based on an academic capability some time before).

The third reason for monitoring may be for illegal/"terror interests", but I am not competent to comment on how best one can scan for these beyond reliance on existing (military/intelligence/whistleblower) monitoring methods.

We should recognise that the vast majority of synbio applications is of the type where the CBD and the CPB are capably 'managing', ie. the normal run of genetic modification and genome editing applications in agriculture and industrial biotech, and some in vaccine development.  What we should be monitoring, in my humble opinion, is where there is something beyond the more mundane applications.  Ie. where new risks may be/are associated, or where there is not an existing living comparator on which to base an assessment of difference.

Good day, My name is Adanna Mgbojikwe-Loto. I work with the National Biosafety Management Agency (NBMA), Nigeria as a regulatory scientist with a background in Biochemistry. I have garnered experience in risk assessment review and regulations for GMOs in relation to confined field trials and commercial releases. I currently serve as the Secretary of the synthetic biology regulation draft committee.

In the process of developing a draft regulation for Synbio, we explored the idea of creating a database where the academia within Nigeria could 'register' their research work on Synthetic Biology at its inception to enable the NBMA to be updated on ongoing research in this field.

Data to be filled would comprise- research topics; known trends which these topics fell under or novel areas; details of the research team, information on the institution and more necessary information.

The main objective of the database would be to establish a system which supplies the regulatory agency information on synbio research at inception, as it evolves and on any novel trends in that field, a form of 'automated' horizon scanning, if you will.

Institutional Biosafety Committees in these research institutions, which were instituted by NBMA, would then form an additional, localised monitoring body for details on synbio research.

As our synbio regulation is still in development, we continue to explore shared ideas on a global scale and on this forum to enhance our work.

Best wishes.

I am Enrykie Fortajada, a Fellow from the National Committee on Biosafety of the Philippines. I totally agree to the importance of creating a country-wide platform or database that will gather, examine, and record information of all the studies on gene editing and/or synthetic biology being conducted in a specific country, including information about the proponents/experts. In this way, there will be a centralized communication platform between experts and everyone will be informed on the research undertakings on gene editing and synthetic biology in a country, the Philippines for instance.

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

Dear Enrykie Fortajada, I think you are right to have national level platform or database system regarding Synthetic Biology and related technologies, products and scenergies. If so we can have map of the communication of the Synthetic Biology and its related Development in national level. Equally, it is also more important and is being crucial to have guidance, mechanism of monitoring, and protection, sharing, safeguarding systems, legal framework the unknowing impacts on Food change, Waters, Health ecosystems and Mother Nature from the development

Thanks with regards
Kamal
IPLC

I agree with Enrykie Fortajada, that a national platform will be hands on and every country can contribute the developments it may be monitoring.  This is not to say that more centralized means (eg. Publication scanning), should not also be persued…

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. Our approach combines systemic horizon scan of relevant research, selection of most relevant publications by using criteria such as the protection of biodiversity or new technological developments. The findings were also filed for peer reviewed publications and more background information is provided which  can be found on the website of the FGU.

I think the proposal by Mr. Enrykie B. Fortajada is an important one. In practice, it may be challenging to avoid reporting bias and unrecognized conflicts of interest. Also crucial will be obtaining all the relevant data: say, while people love to publish/upload positive results, how can we know about NEGATIVE results that are NOT made public and reported?

Kia ora koutou (greetings to all)

I am Jack Heinemann, a professor of molecular biology and genetics at the University of Canterbury in Aotearoa New Zealand. My work is relevant to biosafety, evolution, microbiology, and One Health. It is a pleasure to be working with everyone in the forum.

My intervention primarily addresses information gathering issues as the first step that may determine what is not available (and perhaps should be) to all subsequent steps (compilation, assessment, and reporting).

(1) As others have indicated, negative results and commercial activities (ie, those that are kept secret for development or protection of intellectual property rights) are the most opaque to horizon scanning. But we shouldn’t underestimate the challenge of getting accurate reviews of the most accessible sources, such as academia. By the time work from academic institutions is published, it is already often several years old. So in each of these cases, we are looking backward rather than at the horizon in front of us.

Expert panels are one means to help address this issue. However, most technical experts are also part of the communities that benefit from, or feel that they must practice, secrecy in the work that makes them relevant to the panel.

Therefore we are sorely in the need of incentives or other mechanisms to balance the long-standing and powerful forces that determine the behaviour of our biotechnology communities. NGOs, such as TWN and TestBiotech, can be sources of experts with different interests. Perhaps encouraging this sector more would help. So too might diversifying the career structures of academics in science and technology. Finally, we could (re)consider the role of higher education institutions that must balance their roles for inquiry and 'technology transfer'. Is it really possible to be both dispassionate and vested at the institution level?

(2) Most interventions have discussed horizon scanning as an exercise in identifying new and emerging technologies or products. This is of course relevant, but not sufficient because biotechnology does not emerge only from its internal properties. It has a cultural, economic, and legal context. That context has a large effect on what biotechnologies grow to a scale that warrants evaluation at earlier stages.

For example, some forms of genome editing for the purposes of genetic engineering, such as the use of oligonucleotides as done in the 1980s and 1990s, might not seem like horizon issues today. However, should these techniques and products made using them also be deregulated, as is being discussed by many countries, the implications would propel these techniques well into relevance for horizon scanning. This is because their deregulation could fundamentally alter where they were used, on what organisms, by who they where used, and how often, without any intervening assessment of the effects. A change in practice, not just a change in available techniques, alters what could be on the horizon.

Therefore information gathering should rigorously extend to technical literature in law, social sciences, and anthropology, among other disciplines, and other sources of information such as civil society.

Plausible stories of the future, as discussed by Ms Agbagala [2596], should also be composed for scenarios that look deeply at the intersection of technological developments and social context. These scenarios should be built upon the technological imaginaries that drive horizon scanning, but not just these. Scenarios should be diversified to allow for stories that perhaps present alternatives to technology as the centre of the scenario. There should be room for serious consideration of stories that may be currently suppressed, ignored, or overlooked. Such stories need active encouragement, protection, and curation because they must compete with stories that are promoted by actors with disproportionate influence on determining what technologies get the most attention.


Thank your allowing me to participate in the forum. I look forward to reading more interventions.

Greetings. My name is Tom Wakeford and I am a researcher based at ETC Group, which monitors the impact of emerging technologies and corporate concentration on human rights, agri-food systems and the web of life. I would like to build on the Jack Heinemann [#2617]'s helpful call for the "serious consideration of stories that may be currently suppressed, ignored, or overlooked."  

There are many examples of horizon scanning relating to new industrial biotechnologies that address the need Prof Heinemann has identified. They have been carefully designed to include peoples and knowledges in all their diversities. They are therefore able to draw on a variety of inter-cultural perspectives (detailed in my answer to Topic 2, Question 1). 

Three examples are:
TECLA - Latin America’s civil society network established for the regular horizon scanning, monitoring and assessment of technologies (see attached and http://www.redtecla.org).
L’ECID Mali – a citizens’ jury on the potential future use of biotechnology in Mali – see attached and https://link.springer.com/article/10.1007/s10460-021-10221-1
Prajateerpu – a scenario workshop and citizens’ jury in India on the potential future use of biotechnology in agriculture and the conservation of biodiversity (see attached and https://www.iied.org/sites/default/files/pdfs/migrate/14562IIED.pdf?#page=13)

These are just three examples demonstrating the importance of civil society as organisers of horizon-scanning processes on new biotechnologies, as opposed to those organised by corporate and state actors). Details of more examples, including the African Technology Assessment Platform, are here: https://assess.technology/. All are characterised by their inclusion of inputs from a diversity of professional experts and those whose expertise comes from their life experience. This ensures that, in drawing together their conclusions, the participants in the process can draw on a wide range of perspectives. The same approach of participatory action research (PAR - https://assess.technology/wp-content/uploads/2020/11/Action_Research_SP-1.pdf), the broad principles of which have been critically applied in each of these three examples, can be followed in the design of horizon scanning processes on synthetic biology.

Greetings. My name is Tom Wakeford and I am a researcher based at ETC Group, which monitors the impact of emerging technologies and corporate concentration on human rights, agri-food systems and the web of life. I would like to build on the Jack Heinemann's helpful call for the "serious consideration of stories that may be currently suppressed, ignored, or overlooked."  [#2617]

There are many examples of horizon scanning relating to new industrial biotechnologies that address the need Prof Heinemann has identified. They have been carefully designed to include peoples and knowledges in all their diversities. They are therefore able to draw on a variety of inter-cultural perspectives (detailed in my answer to Topic 2, Question 1). 

Three examples are:
TECLA - Latin America’s civil society network established for the regular horizon scanning, monitoring and assessment of technologies (see attached and http://www.redtecla.org).
L’ECID Mali – a citizens’ jury on the potential future use of biotechnology in Mali – see attached and https://link.springer.com/article/10.1007/s10460-021-10221-1
Prajateerpu – a scenario workshop and citizens’ jury in India on the potential future use of biotechnology in agriculture and the conservation of biodiversity (see attached and https://www.iied.org/sites/default/files/pdfs/migrate/14562IIED.pdf?#page=13)

These are just three examples demonstrating the importance of civil society as organisers of horizon-scanning processes on new biotechnologies, as opposed to those organised by corporate and state actors). Details of more examples, including the African Technology Assessment Platform, are here: https://assess.technology/. All are characterised by their inclusion of inputs from a diversity of professional experts and those whose expertise comes from their life experience. This ensures that, in drawing together their conclusions, the participants in the process can draw on a wide range of perspectives. The same approach of participatory action research (PAR - https://assess.technology/wp-content/uploads/2020/11/Action_Research_SP-1.pdf), the broad principles of which have been critically applied in each of these three examples, can be followed in the design of horizon scanning processes on synthetic biology.

I am an independent multidisciplinary researcher with a Ph.D. in Biomedical Sciences, a Ph.D. in Mathematics, and a Habilitation in Cryptography and Data Security. I would like to apologize that in my first post I did not introduced myself appropriately as we have been struggling with a family emergency. I thought I would be unable to not be able to be part of this important forum. Yesterday, when I finally had some time to read some of the very insightful comments, I was overwhelmed by the sincerity, commitment, and excellent ideas, to the point I knew that I would want to do everything possible to be engaged the best I can. I am writing this, as I feel this same sense of commitment – integrated into a network of open-minded and skilled individuals – ought to be at the core of ANY type of policy.

As we have increasingly been relying on computers and AI, we must not forget the strength and power that lies within our humanity, as individuals each playing their role at the right time and the right place. In this sense, thank you for providing such a context for fruitful discussion. I feel very privileged to be a part of this.

Also along these lines, I am suggesting some horizon scanning procedure that has been at the core of information security (IT) sciences and has proven most helpful in assessing and anticipating future risks and security issues. As a side-note: security now more and more overlaps with safety: even though traditionally the former had to do with intentional forms of misuse and the latter was related to accidents (oversimplified), in recent years the lines between these two has become more blurred. This is in part due to technology itself as computers and automation do not always give you what is expected, and since inherent underlying safety gaps (leading to unintentional vulnerabilities) can easily intentionally be exploited.

I have been advising The European Union Agency for Cybersecurity (ENISA) on a project of how to predict, understand, assess, and help mitigate the existing/emerging risks/benefits that arise due to the overlaps of biotechnology with computers and AI. (Please see https://www.enisa.europa.eu/publications/research-and-innovation-brief/@@download/fullReport; a more detailed report on “cyberbiosecurity” will soon be published).

One of the most promising approaches that we are trying to extend to the lifescience sector is the notion of “game playing.” While traditionally, game-playing has been the core to anticipate safety risks in the Information-technology sciences, the great potential of this approach is that it lends itself to other applications where it is important to gain better insights about future dangers that have not materialized (fully) and those which may not be on the horizon at all.

Traditionally, the game was played between two entities called Alice and Bob (which were either real people but also computer programs etc) who communicated over an insecure channel (e.g. the internet) but wanted to keep their communication secret. However, there was an intruder (traditionally called Oskar or Eve) who would try to intercept and learn some of their secrets. The game was played with different scenarios as to what Alice and Bob considered feasible or relevant to secure their communication (e.g. what type of encryption method or algorithm to use). Usually, the roles of Alice, Bob, and Oskar/Eve were then exchanged, and the game continued. In fact, these important types of simulation games even shape the underpinnings of modern IT security analyses.

Such game playing has great potential to be extended to synthetic biology horizon scanning: the players can be any physical entity from subcellular to gross (e.g. ranging from a protein in a certain biological pathway all the way to machines, plants, animals, or the entire environment); players can also be biochemical processes and interactions; or they can represent some social or religious belief system that is represented as an “entity”, etc.

The potential of game playing and switching roles has independently been used in Psychology and Trauma resolution, (e.g. called Family Constellations) where these activities have helped break-up deadlock situations and conflicts,  as switching roles often helps people see the world through their opponent’s eyes, facilitating understanding of previously more obscure agendas and influences. This is what helps facilitate the comprehension of security/safety unknowns that otherwise may not be readily anticipated.

All these activities make use of empathy and human intuition – to be able to sense into and solve problems. As noted before by Mr Heinemann [2617], horizon scanning may benefit greatly from inquiry and critical independent thinking. Ms Agbagala [2596] described the value of stories of the future. Game playing, as proven so important for the information security sciences for decades, has the additional benefit of not merely looking at pre-conceived potential drivers of change, but allowing intuition to truly “play” previously unrecognized scenarios – which may better surface in a “play,” i.e. a playful setting. From my experience in cryptography I can tell that such played scenarios, which often initially seem too much “out there,” often prove to be of greater practical relevance than initially thought.

Thank you again for allowing me to participate.

Thank you Tom for this follow up to my post. It further illustrates the critical contributions of civil society such as made by ETC and others. I think that horizon scanning could be improved by providing further mechanism to support the work of this sector.

Generally speaking, an horizon scanning process is a highly data-driven task requiring a detailed methodology for collecting information and evidence, interpreting and validating the findings required for making informed decisions, and developing policies and strategies. It involves some iteration of the cyclical actions of scanning, analyzing, synthesizing, and communicating information. Horizon scanning techniques include environmental scanning, trend analysis, gap analysis, risk assessment, and similar approaches. Expert input from various credible sources is critical to the success of a horizon-scanning process.

Horizon scanning is an effective tool to:
• assess whether one is adequately prepared for future changes or threats.
• assist in policymaking by identifying important needs or gaps.
• bring experts in different subject areas together to discuss a common issue and develop viable solutions
• provide for an ongoing timely identification of additional safeguarding strategies that may be needed, and for assessing new technologies' implications.

Generally Horizon scanning comprises the following stages
1. Signal detection and information collection:
Signals are detected from various sources such as - Literature reviews; - Patents; - Input from industry and industry associations; - Other observatories; - Media;  - International institutions and forums; - Individuals, committees, and expert groups; - Surveys; - Government bodies; - Meetings and conferences; - Other organizations; and - Grey literature.

Workshops can also help bring together diverse experts (chosen based on their specialization, breadth of knowledge, publications, and commitment to the process) to discuss areas of novel science and technology and to scan the horizon from different points of view collaboratively. Creating a steering committee, think tank, or 'idea radar', including representatives of the scanning organization, appropriate stakeholder groups, external consultants, and policy-makers may prove valuable for sustainable and continuous horizon scanning.
Delphi studies are widely used to pool knowledge and build consensus around emerging issues. There are two or more rounds involved. In the first, participants identify relevant issues, which are then pooled and ranked; the second round sees these issues discussed, followed by their re-ranking. This process is iterated until a consensus is reached. Several Delphi variations have been described, from more conventional workshop formats to online tools such as Nvivo (quantitative analysis of text) or Wordle.net (a word cloud tool). The design of a Delphi study should consider the sample size and confounding factors, such as the level of conformity in the group.

2. Filtration criteria and methods
The following filtration criteria and methods are commonly used to discard irrelevant signals.
Filtration criteria such as - Potential impact; - Size of the affected population or global relevance; - Novelty; - Level of innovation; - Evidence; - Organisational impact; - Plausibility; - Levels of stakeholder and media interest; - Policy priority; - Stage of development; - Ethical and social issues; and - Time frame
and filtration methods such as - Classification criteria; - Automated text-mining tools; - Individual and group filtration; - Peer review; and -Expert Participation

3. Prioritisation criteria and methods for assessing signals
The signals which have met the filtration criteria can then be prioritized.
• Prioritization criteria include - Potential impact on outcomes; - Size make-up of the affected population; -  Expected variation of impact; - Likely time frame; - Evidence of effectiveness; - Relevance to strategic and political priorities; Effect on other related policies; - Desirability; - Factual basis; - Requirement of availability of expertise; and – Novelty
• Prioritization methods include - Qualitative approach; - Quantitative or semiquantitative approaches; - Rating and ranking; - Best-worst scaling; - Risk analysis; - Standardisation of signals; - Delphi approach; - Public consultation; - Engagement of experts; and - Mixed methods

4. Signal assessment and methods
The signals which have met the prioritization criteria are then assessed.
• Signal assessment includes - Impact, for example, resource (financial) implications; - Level of innovation; - Expected utilization and diffusion; - Risk assessment; - Actions required and time to impact; - Legal and ethical issues; - Barriers to market;  and - Stakeholder perception.
• Assessment methods include – ExpertLens; - Driver analysis; -Scenario planning; -Expert, user and policymaker participation; and - Peer review

5. Dissemination and evaluation of the results of horizon scanning
The key elements involved in disseminating and evaluating the results of horizon scanning can be listed as follow
• Dissemination: - Format; - Methods; - Audience; - Frequency; Updating
• Evaluation: - Short, medium and long term; - Process and output audit; -  Validation and sensitivity; - Focus groups; - Metrics; and - Access to database.

Updating horizon-scanning data is a related activity that links distribution and evaluation.
Four key components make up this: (1) constant review and source pruning based on usefulness, relevance, and evolution; (2) periodic horizon scan refresh; (3) signal reassessment when sufficient new data are available or a step change in technology has occurred; and (4) annual validation, for instance, of the horizon-scanning updated by a team of expert researchers, practitioners, and journalists.

Dear All,
I am a retired professor of environmental law at the university of Bremen, with a background of research and consultancy on the regulation of genetic engineering. Horizon Scanning is new for me as a method of inquiry in new developments such as SynBio, but it seems to have potential as a source of information not only for the R&D community but also for regulation. While the focus of horizon scanning obviously is on describing current and predicting future SynBio developments the value of this information could possibly enhanced in the regulatory perspective. Having four of the core regulatory principles in mind I could imagine four kinds of additional information:
1. Concerning risks for human well-being, the economy and the environment: what studies exist for each new development; what studies need to be undertaken? (example: how does artificial vanilla production affect traditional vanilla agriculture? What side-effects does an insecticide plant have on non-target butterflies?)
2. Concerning benefits for human well-being, the economy and the environment: what precise kinds of advantages are expected, and are the advantages reasonable? (example: does a herbicide resistant plant enhance environmentally sound agriculture?)
3. Concerning testing alternatives: what alternatives exist that entail less risks than those of the SynBio development (examples: traditional methods of nature conservation as compared with gene drives; supply of enhanced nutrition as compared with golden rice)
4. Concerning participation of the public: has the public access to information about risks and benefits of SynBio developments? Is the public enabled to participate in R&D programming and regulatory assessment?
I would appreciate if the experts on horizon scanning methodology respond to these suggestions.

A perspective from SA:  I find Prof Winter's post (#2631) very reasonable - how will the the Synbio products affect health, socio-economics & the environment? And how does broader society have a say?  This surely must underpin any new products introduced.  In South Africa such considerations are all included under our legislation, including public input on all environmental releases.

There are two considerations, however, that result from this:

Firstly, how much information is reasonable?  Some territories will ensure the safety of a product to a certain level, and then allow the market to decide.  Others will have a much stronger centralised control, and others much more responsive to their society's interests. Each territory will thus have its balance, and may object - on sovereignty grounds - to external standards being imposed.

While relevant information is always useful, in risk management approaches we also need to be careful not to raise the 'bar' too high to prevent relevant, safe, productive and enabling technologies and applications from reaching the market.  We have experienced this in SA, where the only genetically engineered products we have commercially available, have been developed elsewhere in the world by companies with deeper pockets than our local companies.  So whilst the approved LMO products are undoubtedly useful, we thus are not able to produce niche, locally-relevant and local employment-creating LMO products.

In signing up to the CBD, we all agree on the importance of the conservation & sustainable use of biodiversity for global wellbeing, but not necessarily on the exact measures and exact approaches.  We need to find a 'reasonable' standard that is an agreeable compromise, but also allow individual countries to set higher standards.

The horizon scanning thus must be designed to be useful and relevant, so potential synbio risks can be identified and hence measures developed for risk assessment and management.  This is not an exhaustive process to identify every possible 2nd, 3rd or 4th order risks. And this needs to be in context of the other risks and impacts humanity is having on the environment that are not arising from the biotechnological domain.

Hi comrades,
My names are Otim Geoffrey, the Founder and CEO of SynBio Africa-a synthetic biology entity focused on creating awareness and knowledge sharing towards the acceptance and development of synthetic biology in Africa.
I would like to give my submission on the above question based on my personal perspective.
There are several methodologies and approaches that have been used for horizon scanning processes in other fields that could be useful for the horizon scanning on synthetic biology under the CBD (Convention on Biological Diversity). Here are a few examples:
1. Scenario planning: Scenario planning involves the development of plausible future scenarios to explore the potential impacts and risks of a particular issue or technology. This approach can be useful for identifying potential futures for synthetic biology and its impacts on biodiversity, as well as for assessing the potential consequences of different policy or management options. For example, the UK Synthetic Biology Roadmap used scenario planning to identify potential future applications of synthetic biology and their associated risks and benefits.
2. Delphi technique: The Delphi technique is a structured method for obtaining expert opinions and consensus on a particular issue or question. This approach can be useful for identifying and prioritizing potential risks and impacts of synthetic biology on biodiversity, as well as for assessing the likelihood and severity of these risks. For example, the European Food Safety Authority used the Delphi technique to obtain expert opinions on the potential environmental risks of genetically modified organisms.
3. Literature review and synthesis: A comprehensive review and synthesis of the scientific literature can be useful for identifying and assessing the potential impacts of synthetic biology on biodiversity. This approach can be used to identify gaps in knowledge and areas for further research, as well as to assess the potential risks and benefits of different synthetic biology applications. For example, a recent review of the literature on synthetic biology and biodiversity identified potential impacts on ecosystem functioning, species interactions, and genetic diversity.
4. Multi-criteria decision analysis (MCDA): MCDA is a method for evaluating and ranking different options or scenarios based on multiple criteria. This approach can be useful for identifying and evaluating potential policy or management options for synthetic biology and biodiversity. For example, MCDA has been used to evaluate the environmental and social impacts of different renewable energy technologies.

I would like to thank our moderator and all colleagues in this forum for a very interesting and inspiring discussion so far. I am Helmut Gaugitsch, Head of Scientific Management Biodiversity at the Environment Agency Austria. I was a member of the previous AHTEG on Synthetic Biology.

Like others (see e.g. #2638 by Ms. Li Ching Lim) I think that the report of the 2019 AHTEG, including its annex, is a very good basis for our discussions.

Horizon scanning can be regarded as a foresight tool used to systematically scan or review various sources to detect early signs of potentially important developments. These developments are often at the edge of current thinking, such as weak (or early) signals, emerging issues and trends. A set of criteria can be used to guide searching and filtering. The time horizon can be short, medium or long term (EC, 2015).

Foresight can be regarded as a discipline of exploring and anticipating the future in a structured and systemic way. Its purpose is to help build and use collective intelligence to anticipate developments and shape the future we want (EC, 2021).

The Eionet Horizon Scanning Guide (2021) by the European Environment Agency (see e.g. https://eionet.kormany.hu/download/2/bf/b2000/Horizon_Scanning_Guide.pdf) suggests a very practical approach to horizon scanning, which contains a “futures mindset for horizon scanning” and a step-by-step approach along the following lines:

• Step 1: Signal spotting – locating the “weak” signals
• Step 2: Signal scanning – collecting the “weak” signals
• Step 3: “Sensemaking”
• Step 4: Communicating the output

Suggested tools for implementing the various steps are provided.

Methods such as modelling as well as development and assessment of scenarios should play a very important role in concrete implementation of horizon scanning. Scenario thinking means addressing options and alternatives, both in terms of the technological developments as well as the further refinement of accompanying methods for assessment and evaluation. These are moving targets and should be seen in parallel. Technological developments, such as in the area of synthetic biology, as well as progress concerning the methods to assess the impacts of the technology and its products should be seen vis-à-vis the social and socio-economic context and its developments (see e.g. #2617, Prof. Jack Heinemann). Horizon scanning should look at the whole package or triangle of “Technology – impact – society”.

Therefore a horizon scanning, monitoring and assessment process in the area of synthetic biology should take account principles of inclusiveness, participatory and being open concerning the results (see e.g. #2630, Dr. Tom Wakeford).

A precautionary approach, which also respects knowledge gaps, uncertainty of data etc. can contribute to the long-term resilience of the horizon scanning process. Horizon scanning, monitoring and assessment, if designed in an appropriate manner, can contribute a lot towards increasing of robust knowledge and filling data gaps.

I am looking forward to many interesting further postings in this forum. All the best
Helmut

Literature:
EC, 2015: Models of horizon scanning: how to integrate horizon scanning into European research and innovation policies, Directorate-General for Research and Innovation, European Commission. http://publications.europa.eu/resource/cellar/88ea0daa-0c3c-11e6-ba9a-01aa75ed71a1.0001.01/DOC_1
EC, 2021: Strategic foresight, European Commission, https://commission.europa.eu/strategy-and-policy/strategic-planning/strategic-foresight_en

Dear Mr Helmut, quite an Interesting analysis of Horizon Scanning you brought out which is in line with my strong believe that horizon scanning of SynBio should look at the whole package. However, I am always of the view that the whole package will be clearly extended from the Triangle of "Technology - Impact- Society to Squared of "Technology - Application -Impact - Society". This brings more emphasis on "participatory" as one of the key principles in horizon scanning in the area of SynBio.

The "Application" process involved with the technologies of SynBio have so far being a key consideration for a proper risk assessment of SynBio product and as well a major contributor to increase in robust knowledge and filling of data gaps.

I am Onyeka Nwosu, Senior Scientist with National Biosafety Management Agency (NBMA), Nigeria. An active participant in the biosafety risk assessment reviews and development of regulatory guidances.

I am Bob Friedman.  I introduced myself in a post to Topic 1, Question 1 [#2659].  I would like to discuss two “families” of horizon scanning processes that I believe include useful components for horizon scanning by the CBD.  Neither set of examples is a perfect fit for the CBD in my view, but by combining the most appropriate components from each, I believe it is possible to design a pragmatic and useful approach for the CBD. 

The first “family” of horizon scans relies on the iterative Delphi method, implemented by a small number of experts.  As mentioned previously by Leocris Batucan, Jr. [2586], this has been performed twice for synthetic biology, first in 2017 and again in 2020 (Kemp et al. eLife 2020;9:e54489. DOI: https://doi.org/10.7554/eLife.54489).  And if I am interpreting his post correctly, a similar approach is currently being tried in the Philippines.  The methodology used by Kemp et al. was modified from an annual series of horizon scans to identify future conservation issues.  “A global biological conservation horizon scan of issues for 2023” is the 14th conservation-focused horizon scan by a small group of researchers. (Trends in Ecology & Evolution, 2023 https://doi.org/10.1016/j.tree.2022.10.005.) Each year since 2009, a group of researchers have identified 15 new and emerging issues with potential positive or negative impacts for conservation.  Starting in 2019, they also perform a retrospective review of the issues identified 10 years previously. 

The second “family” of horizon scans are those performed by the Australian Council of Learned Academies (ACOLA) at the request of the Chief Scientist of Australia to help inform “policy responses to significant scientific and technological change.”  Owain Edwards identified the ACOLA horizon scan on synthetic biology as particularly relevant for the CBD [#2588].  Also of note is the ACOLA horizon scan on “The Future of Agricultural Technologies” https://acola.org/wp-content/uploads/2020/09/hs6_agricultural-technologies_acola_report.pdf.  (Synthetic biology and omic technologies are included as key technologies for agriculture).  Other horizon scans in the series look at such topics as precision medicine and artificial intelligence.

The first family of horizon scans I mentioned above uses an approach that is like having all four horizon-scan steps specified by the COP performed by the multidisciplinary AHTEG alone.  This becomes particularly constraining for the information gathering step.  Fortunately for the CBD process, COP assigned this very important step to multiple actors (an open call for information, this Online Forum, and additional information gathering by the Secretariat staff and consultants.  The outputs from this first family of horizon scans (assessment and reporting steps) are 1) selection of the top 15 to 20 key issues or technologies, prioritized from a much longer list using modified Delphi methods and 2) paragraph length descriptions of each summarizing key controversies and unknowns. 

The second family of horizon scans is far more resource intensive in time, labor, and dollars.  They begin with an exhaustive information-gathering step not unlike that specified by the COP (assuming significant consulting support is made available).  ACOLA expert committees are also multidisciplinary, chosen from the four Australian “Learned Academies” (science, engineering, social sciences, and humanities). The expert committee meets several times and gathers additional information by inviting stakeholders to their meetings or through written submissions. The outputs of these horizon scans also prioritize key issues or technologies for attention, but the additional analyses and written outputs are far more extensive.  These reports approach the level of detail of technology assessments, including chapter-length discussions of the opportunities and challenges presented by the technologies; societal, ethical, and legal issues; and key messages for decisionmakers.  However, the resource requirements far exceed those devoted to previous CBD processes that rely on AHTEGs as sources of advice and are no doubt out of reach for this purpose.

In my view, the “sweet spot” is to choose methods similar to those used by the second family of horizon scans for the first two steps of the process specified by COP (information gathering, organization, and synthesis) and methods similar to first family of horizon scans for the assessment and reporting steps.  Though the assessment step (in my view, a prioritization process) could be done by relying on traditional group discussions, there are advantages to more structured group techniques (e.g., Delphi, IDEA protocol, etc.) that might be extremely helpful to a multidisciplinary (and multinational) AHTEG for this particular task.

Best regards,
Bob Friedman

Dear colleagues,

my name is Swantje Schroll and I work at the German Federal Office for Consumer Protection and Food Safety as a scientific consultant in the secretariat of the German Central Committee for Biological Safety (ZKBS). The ZKBS is an expert panel installed by the German government according to the provisions of the German Genetic Engineering Act. Its members act on a voluntary and independent basis and have a broad variety of expertise in topics such as microbiology, virology, genetics or cell biology. The ZKBS examines and assesses safety-relevant questions of genetic engineering and gives advice to the Federal Government and the Federal States in Germany. One of the ZKBS´s tasks has been a monitoring of synthetic biology applications, which has been conducted for more than 10 years already and focuses on biosafety and the applicability of existing German and European regulations. I´d like to share the methodologies used for this monitoring.

The monitoring focuses on published peer-reviewed literature, which is gathered through literature research. The literature is retrieved from platforms such as Pubmed with the keyword “synthetic biology”, from newsletters (specialized ones such as the SynBioBeta newsletter [synbiobeta.com] as well as generalized ones such as Nature Briefing [https://www.nature.com/nature/articles?type=nature-briefing]) or directly from journals specialized in the area of synthetic biology (e. g. ACS Synthetic Biology). This information gathering is done by the scientific consultants in the ZKBS´s secretariat, while the compilation and assessment are done by a small group of experts serving as rapporteurs for the Committee. This group meets on a regular basis to assess the gathered literature. The outcomes of the monitoring are then reported by the ZKBS in form of a monitoring report, which is published every two to three years (see annex), and a continuous monitoring on the ZKBS homepage (https://www.zkbs-online.de/ZKBS/EN/SyntheticBiology/Current_developments/Current_developments_node.html).

Dear colleagues,
I am a policy officer working in the biotechnology unit of the Directorate-General for Health and Food Safety of the European Commission. There I am responsible for matters of synthetic biology and Gene Drive, genetically modified microorganisms and GM pharmaceuticals. My scientific background is in biochemistry and molecular biology, with a PhD in molecular virology.

The European Commission has previously asked the European Food Safety Authority (EFSA) to commission horizon scans on developments in synthetic biology regarding microorganisms and plants for applications in the agri-food sector. The results (attached) have been published in 2019 and were the basis for the four scientific opinions on risk assessment guidelines my EFSA colleague Yann Devos referred to in his post [#2670] on Topic 1, question 1a.
The methodology used in both papers should be suitable for the horizon scan under CBD, as well.

To keep pace with the rapid development in genetic engineering the European Commission has also mandated EFSA to prepare new horizon scans on applications of genetically modified microorganisms obtained through new developments in biotechnology and on genetically modified animals, including those obtained through synthetic biology. These works will be used to prepare two scientific opinions on potential novel hazards or risks these developments may pose. Simultaneously, EFSA has initiated preparatory work on updated risk assessment guidance for gene drive modified insects.

Kind regards,
Kathleen Lehmann

Hello, I am Fanny Coppens, I have been working since 2015 in the Service Biosafety and Biotechnology of Sciensano (the Belgian public institute for health), where I have been involved in the biosafety-related topics of the CBD and the Cartagena Protocol. I'm also the National Focal Point for the Biosafety Clearing House.
I have read the previous posts with great interest, and I would like to contribute to this forum topic by pointing to the WHO's recently published document "Emerging trends and technologies: a horizon scan for global public health" (https://www.who.int/publications/i/item/9789240044173). This horizon scan uses the IDEA protocol, that was briefly mentioned in post [#2669], see the Methods section of the document.

Hello, my name is Taemin Woo. I have a background in Science and Technology Studies(STS) and Science and Technology Policy(STP), and currently, I am working at Korea Biosafety Clearing House(KBCH) as a postdoctoral researcher. I have observed the previous online forums on synthetic biology since 2015, and I’m glad to be part of this process as a participant. First of all, I appreciate all the participants of the online forum because I believe that the progress on the issue of synthetic biology at CBD has been built upon this informative, constructive, and highly-committed conversations here.

Regarding the process of horizon scanning, I would like to resonate the impartance of “inclusivity” that we need to consider from the very early stage of "information gathering". As other participants pointed out, horizon scanning is a highly data-driven task. While aiming at collecting data as comprehensively as possible, it is also important to consider how to identify viewpoints that are not produced in the form of "data". In this sense, identifying and reporting such gaps in data (not in terms of knowledge, but including viewpoints of diverse stakeholders) would be useful for the next round of horizon scanning and also to fill those gaps. Furthermore, the following process of “evaluation” should be carefully designed to harness the power of “inclusivity” by considering which knowledge or viewpoints matter under the context of CBD.

Lastly, for the effectiveness of the horizon scanning, it is necessary to closely review the results of horizon scanning on synthetic biology that has already been performed (as shared in this forum) or will be performed in each country, and to re-contextualize them considering the three objectives of the CBD. In the long term, it would be useful to establish a CBD-taylored horizon scanning process to facilitate similar practices in each country.

Thank you.

I eco with others and believe that the step of gathering information in horizon scanning should seek input from all sources and from a diverse range of actors including IPLCs, local communities and civil society. It also should build on the work of national/ regional and international relevant horizon scanning or technology assessment processes. This collected information will need to be filtered and prioritized.

O.A.El-kawy

I am an independent multidisciplinary researcher (two PhD’s - in Mathematics and Biomedical Sciences). Recently, I have had the opportunity to advise ENISA (The European Union Agency for Cybersecurity) on specific aspects of biosafety and biosecurity risk assessment that are highly relevant for synthetic biology horizon scanning.

While I very much appreciate the many insightful points offered here, I would like to raise awareness of a problem that is not fully known, and much less captured. This concerns the risks that arise from the way how synthetic biology is being conducted – i.e., based on information and communication (ICT) based technology.

R&I in synthetic biology and most biotech applications is to a large part now computerized and automated. ENISA, in its role as advisor to the European Institutions and Member States, is currently preparing a report to identify the new challenges and risks that arise in this regard, and steps to help address the existing and emerging issues.

While ENISA’s risk assessment initially focused on susceptibility to intentional attacks only (security issues), we have now recognized that the line between security and safety (unintentional issues) is radically blurred. This is because of the following reasons – which engender major issues which ought to be considered during synbio horizon scanning (see especially my article doi: 10.1016/j.bsheal.2020.09.007 "Facing the 2020 pandemic: What does cyberbiosecurity want us to know to safeguard the future?" and my forthcoming book chapter "Potentials of pathogen research through the lens of cyberbiosecurity, or what threat actors can learn from the Covid-19 pandemic" in ISBN-13: 9783031260339):

• Computers and automated processes do not always work as intended, so that even in the ICT sector, the notions safety and security cannot readily be distinguished. E.g., inherent weak-spots can deliberately be exploited in a malicious way, and intentional forms of misuse can be blamed on technology.

• Many unknowns in biology, e.g. from the large-scale applications of synthetic biology and many other grey areas involving knowledge gaps that stem from the interconnectedness and complexity of nature. As before, inherent grey areas involving synbio R&I can either unintentionally lead to some negative outcomes, deliberately be tasked to lead to something adverse, or with high likelihood engender some negative effects in a susceptible context, and then be blamed on technology or nature.

• The fact that many research projects in synthetic biology are dual-use (DU). The problem with this is that risk assessment methods face the dilemma of two opposing viewpoints - which makes it impossible to be modeled without inherent bias. Automation and machine learning are themselves highly susceptible to various forms of bias, a problem there is considered extremely difficult even in a context without DU (the ICT disciplines are themselves experiencing a huge replicability crisis). Especially when automated, such inherent challenges of AI are vastly exacerbated in a DU context and can have disastrous consequences: in essence, this leads to the dilemma of not being able to tell what is right or wrong, and not being able to differentiate between “the thief and the police officer.” In the ICT sciences, the latter has for many years been one of the most troubling issues to enable misuse (e.g. via social engineering attacks). The same problem is vastly increased in a DU context – especially as there is always an inherent GAP between a computer model/process and the actual bioengineered entity, say. In a situation where mis- or disinformation is determined/monitored by computers, or where AI is meant to make sense of BigData, we may find ourselves in a situation where it is next to impossible to discern scientific truth. AI could thereby not only advance the spread of mis-/disinformation, it would be extremely difficult to even spot such inherent computer generated mis-classifications, and would severely impair genuine research.

Not only do these problems create enormous biorisks. If used in a malicious context, the inherent synbio safety vulnerabilities can be combined with ICT based security weak spots, and, thanks to the plausibility to misuse technology to misclassify right from wrong, it would truly seem that bad actors could masquerade as well-meaning officials – enabling them further spreading of misinformation and illegitimate access to sensitive processes, biomaterial, equipment and the like (and conversely). All this would also seriously undermine research and activities involving synbio horizon scanning, monitoring and assessment.

There are many other areas where computerized technology, networked systems, and automation lead to numerous novel biosafety and biosecurity risks that are largely not understood and vastly underappreciated. These, as well as possible steps forward, are described in ENISA's report (soon to be published).

Altogether, while ICT has helped to advance synthetic biology, it is imperative to be aware of the new and emerging cyberbiosecurity problems and to carefully balance the use of computers and AI (as used for synbio R&I as well as risk assessment) with tacit knowledge, skill, experience, independent and logical thinking.

Dear all,

My name is Luciana Ambrozevicius, I work for the Ministry of Agriculture and Livestock in Brazil. 

I think a useful process would include the participation of the research community with various fields of expertise representing different geographical locations and with a gender balance to contribute in the horizon scanning process equally. Also in my opinion is necessary, after the information gathering and compilation steps, to filter the technological developments that might most directly either help or hinder meeting the three objetives of the Convention with a length description of the scientific evidence considered by the secretariat and consultants.

In this discussion, the #2632 made a very important point: “The horizon scanning thus must be designed to be useful and relevant, so potential synbio risks can be identified and hence measures developed for risk assessment and management.  This is not an exhaustive process to identify every possible 2nd, 3rd or 4th order risks. And this needs to be in context of the other risks and impacts humanity is having on the environment that are not arising from the biotechnological domain.”

I also agree with some points already made by other participants in this discussion: 
#2588 about the relevance of the ACOLA report for the current discussions: https://acola.org/wp-content/uploads/2018/12/2018Sep-ACOLA-Synthetic-Biology_Report.pdf;
#2669 the relevance of Synbio as a key technology for agriculture: https://acola.org/wp-content/uploads/2020/09/hs6_agricultural-technologies_acola_report.pdf 
#2685 about the necessity to closely review the results of horizon scanning that has already been performed

Thanks,
Luciana

Dear Participants to the forum on Topic 2
My name is Ana Atanassova and I am participating in this forum as a representative of the Global Industry Coalition (GIC). Thank you for the rich exchanges and sharing of ideas on the points to consider when performing horizon scanning, monitoring and assessment of recent technological developments.
The COP has already specified that the process should include the steps of (a) Information gathering; (b) Compilation, organization, and synthesis of information; (c) Assessment; and (d) Reporting on outcomes.
Many of the comments in our forum focus on “how” these steps should be best performed and consensus is in place that a successful process must be inclusive and allow the broad participation of different groups. Such broad representation and inclusivity potentially can be a strong differentiating feature of the process under the CBD.
Given the aim of broad scoping and the likely inclusion of different types of information – from peer reviewed scientific materials to value based perspectives of different stakeholder groups – it would be helpful that the compilation, organization and synthesis of information and its consecutive assessment and reporting be subdivided into different categories (e.g. scientific, socio-economic and cultural) that are then represented in separate sections. This would help the identification of factual, scientific, or empirical information on the one hand, and the description o fvalue-based views and opinions held by different groups on the other.
For example, one element of the reporting can be focused on providing purely scientific and empirical information on technological developments using credible and verified information sources (e.g., the increase of efficiency of a process used in biotechnology, or the development of a new process). Another element can describe the views held by different groups about the same technological developments and anticipated trends. Such differentiation can be helpful to decision makers of the COP in their evaluation of new technologies and their anticipated societal impacts as seen by different stakeholders and groups in society.
A helpful and highly recommended example of how information can be rigorously organized and communicated can be taken from the IPCC who have extensive procedures for ensuring that their reports are comprehensive and balanced assessments of the state of knowledge on topics related to climate change. One particularly relevant element that can help the robustness of the intended horizon scanning exercise under the CBD is the guidance on Consistent Treatment of Uncertainties (Uncertainties Guidance Note - IPCC AR5). Given the broad range of views that are expressed in the forum on synthetic biology – a consistent and calibrated language for communicating key findings can be highly relevant for the success and usefulness of the exercise for decision makers.

With kind regards  and looking forward to further exchanges
Ana

My name is Margret Engelhard, I am working at the German Federal Agency for Nature Conservation (BfN) 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 once more for moderating this session!

My agency has in recent years been increasingly involved in horizon scanning and technology assessment of synthetic biology, to serve our obligations as risk assessors and assist the CBD horizon scanning process. We have commissioned a series of broad horizon scanning projects, including on new genomic techniques in plants, living modified (LM) viruses, LM microorganisms and LM animals and RNAi applications. The projects are prone to publish first results in the course of this and next year.

Each horizon scanning project explicitly covers the four steps (a)-(d) of the CBD process. Under (a), we have used methodologies of a similar range as suggested previously in this forum, e. g. literature, patent and database searches, and stakeholder consultations. Under (b) we prioritise application scenarios for in-depth case studies. Criteria for prioritisation were potential impact on the goals of the convention, and representation for a specific case or different approach, so that we can learn from these cases also for other cases. Under (c), our focus is on assessing the adequacy of current EU regulation and risk assessment guidance for new technological developments as exemplified in our case studies. In some projects we included a technology assessment step as well. All projects plan to report (d) their results in peer review publications. Reporting to a wider audience is so far realised in one of the projects (on new genomic techniques, with a focus on living modified plants (https://fachstelle-gentechnik-umwelt.de/en/home/, conducted by Testbiotech and mentioned by Christoph Then in post #2610); reports on the other projects are in progress.

We increasingly try to accommodate the point made by Jack Heinemann [#2617], that legal, economic and cultural context has a large effect on which biotechnologies are brought closer to market. One example would be the observation by Guy Reeves regarding the recent development of virus applications for release into the environment [#2650 in Topic 1 Q1a]. Heinemann’s important points also resonate with those brought forward by Gerd Winter [#2631] and Helmut Gaugitsch [#2662], as well as the ethical aspect noted by Trine Antonsen [#2677] and the inclusivity stressed by Taemin Woo [#2685]. We also see the importance of contextualisation, of making the framing explicit already at the stage of knowledge gathering (a) and synthesis (b), and to include intercultural perspectives, as detailed in practical terms by Tom Wakeford [#2619 & #2620] and set in the context of the CBD horizon scanning, monitoring and assessment process by Lim Li Ching [#2638].

Acknowledging the importance of multi- and transdisciplinary assessments, BfN has commissioned, in addition to the horizon scanning projects, a series of technology assessment (TA) research projects that explicitly seek to integrate the normative and intercultural dimensions of knowledges. Foci of the TA projects have been transboundary issues (e. g., environmental impact in the country of cultivation of an LMO that is imported into the EU; potential environmental impact of an LMO in a different country than where it is released), the agro-ecological and local community context of SynBio applications, as well as ethical aspects.
One ongoing TA project at BfN is conducted by ETC Group and highly relevant for the CBD SynBio process: “Intercultural Assessment of Synthetic Biology Applications - Developing a new set of guidelines for the intercultural assessment synthetic biology applications that could have an impact on biodiversity (ICulA)”. ICulA develops a strategy for including grassroots communities such as Indigenous peoples, smallholder farmers and pastoralists in evaluations of new biotechnologies, while avoiding that consultation outcomes are influenced by funders/organisers/facilitators. ICulA thus has the aim to draft guidelines for the exchange of knowledge and evaluation across cultures, based on participatory action research approaches, in order to promote transparency and legitimacy with regard to the way the issues are framed (e. g., validity of assumptions about biodiversity in the view of local communities), the choice of topics, as well as procedures of organisation, facilitation and communication of the assessment process. We anticipate that these guidelines might assist the assessment step of the CBD horizon scanning process.

Hello everyone.  My name is Jen Rowland and I am a Science Advisor in the New Technologies and Production Methods Division of the Foreign Agricultural Service at the U.S. Department of Agriculture.  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.

In the United States, we have seen an increasing number of potentially beneficial applications of biotechnology tools with relevance to the objectives of the Convention.  There is a broad range of new applications and products using synthetic biology techniques that have the potential to deliver beneficial applications, including public health and medicine, agriculture and livestock, biomanufacturing, industrial processes, species conservation, environmental remediation, water resources management, and invasive species control, to name a few.  For each of these potential new products, the United States applies a coordinated, risk-based system to protect the environment as well as 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 encourages independent and cooperative scientific research, development, and capacity building in fields relevant to biotechnology, including synthetic biology, both domestically and with partners around the world.   The United States encourages all to make use of the Convention on Biology Diversity and of the mechanisms that have already been deployed (e.g., the Cartagena Protocol on Biosafety, AHTEGs on Synthetic Biology, Open Ended Online Fora, Biosafety Clearing House) to support the objectives of the Convention while ensuring support for the global research community as it continues to conduct responsible research and development.
 
This wide array of biotechnology applications also suggests the need for regulatory flexibility to address the present set of innovations as well as successive generations of technology.  Reference has already been made to several excellent reports and technology assessments.  These are the types of horizon-scanning exercises that provide timely information from multiple sectors with extensive expertise in biotechnology and can be used as fodder for domestic and international discussions such as this online forum.

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 contribution of Dr. Wakeford (#2620) providing us with three examples of methodologies employed by civil society organizations to guarantee an inclusive and diverse process of biotechnology horizon scanning.

As mentioned in our contribution to Topic 2. Question 1. we believe that a participatory action research (PAR - https://assess.technology/wp-content/uploads/2020/11/Action_Research_SP-1.pdf) would serve as a solid basis for the horizon scanning process established by the mAHTEG.

SBOF-T2q1


Dear colleagues,

Thank you all for this interesting and most useful compilation of information and experience.

In the following I would like to share our experience with horizon scanning and analysis, which is in its way a response to both question 1 and question 2 of this topic. Apologies for not being able to draw a clear line between them.

Our group has recently undertaken two separate horizon scanning surveys on gene drive development. One on current and proposed insect targets (Wells and Steinbrecher 2022) and one on current and proposed non-insect targets (Wells and Steinbrecher 2023, preliminary report), both published as reports and attached to this post.

Our process in horizon scanning and assessment followed broadly the same steps as specified here by the COP.

However, we had an additional step in the beginning, where we needed to define what the questions were we wanted to have answered and develop the relevant criteria, we also needed to clarify, where we would be looking for it, what leads to follow and how we would register, collect and enter the information and data. We did a scoping trial before starting a full horizon scanning process.

As we were attempting to answer numerous questions in the same process, such as which organisms were being targeted, for which purpose, with which type of gene drive (and constructs), how far had developments gone, were they still continuing or had it been abandoned, what were the hurdles, etc - we accordingly needed to design data entry sheets, partially in parallel to the information gathering, to enable multiple people working on it.

With regards to b) it was important to have entries easily accessible to many, to have it organised in such a way that allowed easy grasping as well as retrieving the detail when needed. This turned out to be a strong pre-requisite for the stage of analysis.

Concerning the analysis (c) it helped that we had done the horizon scanning for a long time frame, in this case screening the literature from when the term gene drives first were being used. This allowed us to understand the sequence of developments as well as those developments that stopped moving forward. The danger of a too narrow time frame for the horizon scanning is that its analysis will be out of context with regards to the background (that what was and had been established). This in turn will likely reduce the ability to identify or understand trends, or to be able to differentiate between actual possibilities and hopeful ideas.

For reporting outcomes it is helpful to find graphical ways to do so, if possible. We have not quite succeeded in that aspect but can see the value of it.

Having developed the screening methodology and the criteria and the sharable database we can now easily continue, i.e. do the monitoring, which I believe should be a regular exercise to allow not only for updates but for understanding of trends and knowledge.

With best wishes,
Ricarda

apologies, I clicked continue before I had been able to attach the files, so here they are:

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

Dear Participants,
I am grateful for the rich discussions that we have had during this online forum. The multidisciplinary AHTEG will have a wealth of information and examples to digest and guide the process moving forward. Under this last topic and question, I would like to thank you for your important views, experiences and specific examples on the horizon scanning process for synthetic biology. It was certainly encouraging to and is important to have the concrete examples from various agencies globally that have performed similar exercises. I will work hard with the Secretariat to ensure all of your valuable inputs and specific examples are represented in the summary of these online discussions.
Best regards,
Martin