*** Posted on behalf of the moderator, Mr. Martin Batič (Slovenia)***

Dear Participants,

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

My name is Martin Batič. I am Head of the Biotechnology Section at the Ministry of Environment, Climate and Energy of the Republic of Slovenia and the national focal point for the Cartagena Protocol on Biosafety. I am also Secretary General of the Slovenian Scientific Committee for the deliberate release of LMOs into the environment. I hold a PhD in Biotechnology. I have previously been a member of the AHTEGs on synthetic biology.

Under this thread, we will be discussing the potential negative impacts of the most recent technological developments in the field of synthetic biology in relation to the three objectives of the Convention on Biological Diversity and the implementation of the Kunming-Montreal Global Diversity Framework (KMGBF).

To start the discussions, I would like to ask you the following:
What are examples of recent technological developments in synthetic biology since the last forum convened in March 2023?
What could be the potential negative impacts of these developments in the context of the three objectives of the Convention and the KMGF? Which targets could be negatively affected?

It will be important to highlight notable examples for the AHTEG. Thus, in sharing information, I kindly ask you to provide DOI links (or URLs where DOIs are unavailable).

I look forward to the fruitful discussions,

Martin Batič

Dear Participants,

The Open-Ended Online Forum is now open.

Kind regards,

The Secretariat

I wonder if the regulatory framework dealing with negative impacts is also part of the current discussion.

My name is Alex Owusu-Biney, UNEP currently responsible for UNEP's Biosafety and Biosecurity projects funded by the GEF

The discussions I believe will focus on regulatory frameworks guided by the most recent science that allows for risk assessment, detection methodologies and decision making measures.  Such frameworks should be holistic assessing both the potential benefits and potential negative impacts. A one size fits all approach may not always answer all the issues that will allow for informed decisions. Synthetic Biology issues may bother on Biosafety measures including risk Assessment, is Annex III of the CPB sufficient or after the scoping there will be need for updates,  They may be also issues of potential benefits in which case elements of access and benefit sharing fits in

*** Posted on behalf of the moderator, Mr. Martin Batič ***

Dear Participants,
 
I will take the opportunity to welcome you again to the discussions of this online forum.
 
Thank you to those participants that have raised the point of regulatory frameworks, which I believe can be discussed in the context of specific technological developments within the field. However, I would like to encourage you to share examples of the most recent technological developments (with references) and how these could have potential negative impacts (particularly on the targets of KMGBF) as these will be a key point of discussion of the AHTEG in May. Thus, it will be important that the AHTEG is well informed of these new developments and their potential impacts.
 
I look forward to these discussions.
 
Martin

Hello everyone,

I'm Dieudonné Nyamaifofe from the Democratic Republic of the Congo,Interim vice-president of the African Society of Synthetic Biology. I'm also a member of the DNA Synthesis Screening Consortium (DSSC), an initiative of the IBBIS.

Here below is my contribution to the ongoing discussion with regard to the recent technologies in synthetic biology and their potential negative impact:

The Science article “Simulating 500 million years of evolution with a language model” (https://www.science.org/doi/10.1126/science.ads0018 ) describes a new IA system that uses deep learning to mimic extremely long-term protein evolution and generate functional protein sequences that never existed in nature. Instead of relying on traditional lab experiments, this language model learns from huge evolutionary protein data and predicts how proteins might evolve over very long timescales, helping design novel proteins with new structures and functions. This represents a major technological advance in synthetic biology, showing how AI can now simulate evolutionary processes and enable automated design of biological molecules, speeding up discovery and expanding the range of engineered biological systems beyond what natural evolution has produced.

AI-driven design of biological molecules based on global genetic sequence databases raises concerns about digital sequence information (DSI) and benefit-sharing (Objective 3 of the CBD). Companies may design valuable products using biodiversity-derived sequence data without equitable compensation to countries or Indigenous communities from which the original genetic resources originated. Target 13 of the KMGF on fair and equitable sharing of benefits from genetic resources and DSI) and target 21 on participation in decision-making and access to information may be affected.

Dieudonné
ASSB

Hello Martin and team:

This summarizes key advances in synthetic biology (SynBio) that have occurred between March 2023 and the present, along with potential adverse impacts on all three objectives of the Convention on Biological Diversity (CBD) and the Kyoto Protocol (KP) of the Global Biodiversity Fund (GBF)—however, it may not necessarily provide an exhaustive list of potential impacted targets. Following your request, the DOI/URL reference is also included.

AI-enabled biofoundries and "autonomous" design-build-test-learn (DBTL) platforms.

More recently developed (or currently being developed post-2023): Rapid advances in artificial intelligence (AI), including large language models (LLMs), and automation/biofoundries providing the capability to rapidly engineer protein/enzyme molecules, design synthetic pathways, and perform ** autonomous experimentation (i.e., developing prototypes) via automation.

Example: autonomous enzyme engineering platform: Nature Communications (2025); doi: 10.1038/s41467-025-61209-y.
OECD “looking ahead” analysis to evaluate synbio+AI+automation (2025); doi: 10.1787/12158721-en.

Possible adverse impacts:

Biosecurity/dual-use concerns: The speed of iterative cycles in the development of harmful/beneficial organisms and traits due to rapid prototyping will lead to an increased risk of adverse impact on biodiversity and human health related to all three objectives of the CBD (described in either section above).

Governance/registration authority lag: The capacity of governments/registration authorities to provide adequate regulatory oversight of and conduct sufficient risk assessments for the speed of innovation in this area as well as the means to monitor/assess outcomes of use of these innovative technologies/approaches may be insufficient.

Targets of the GBF impacted:
T-7 - Agricultural Pollution (if released).
T-15 - Corporate Liability and Disclosure.
T-21 - Data and Science to Inform Effective Decision-Making and Assess Scientific Merit.
T-19 - Enabling Conditions for Implementation.

Next-generation gene drives (new nucleases/controllers; suppression-driven; concepts for "confinement")

Recent Developments (post-2023):
(1)  Proof of concept for Cas12a temperature-regulated gene drive (2023).

(2)  Continued interest in gene drive.
Regards,
Fatou

Hello everyone,

I'm Charity Serwaa from Ghana, steering committee secretary of the African Society for Synthetic Biology (ASSB). I write to contribute to the ongoing discussion on recent technologies in synthetic biology and their potential negative impacts.
First, in relation to vector control and invasive species, researchers are developing engineered gene drives that can spread traits (for example, sterility) through a population much faster than normal inheritance. Potential negative impacts include loss of genetic diversity, spread beyond the intended geographic or species targets, and disruption of ecosystem functions that support culturally important and other valued species. These issues are particularly relevant to the CBD objectives on conservation and sustainable use, and to KMGBF targets on species conservation, invasive alien species and biosafety. Link: https://cen.acs.org/biological-chemistry/synthetic-biology/Conservationists-clash-over-use-synthetic/103/web/2025/10
Link: https://iucn.org/our-work/informing-policy/setting-conservation-priorities/synthetic-biology-and-nature-conservation

Additionally, there has been development of self‑disseminating vaccines to control zoonotic diseases by allowing a modified viral vector to spread immunity through wildlife populations. Potential negative impacts include viral mutation that could alter host–pathogen dynamics, with possible destabilisation of ecosystems and difficulties in predicting and managing long‑term ecological effects. This raises concerns speaks directly to the need for strong biosafety and risk‑assessment measures.
Link: https://doi.org/10.1038/s41559-020-1254-y
Link: https://doi.org/10.1371/journal.pntd.0011018.

Charity Serwaa
ASSB

Dear participants,
It is undeniable that synthetic biology has a positive impact on the environment; however, the monitoring and regulation of synthetic organisms are essential. To ensure the safe and proactive management of synthetic biology organisms, rigorous biomonitoring protocols must be implemented. These protocols will allow for the assessment of the biological and environmental impacts of modified organisms and ensure their traceability and compliance with national regulations. Ongoing work in Niger focuses on identifying the potential side effects of synthetic organisms, particularly through bioassays on local aquatic fauna (fish, invertebrates). These analyses make it possible to measure interactions with natural species, anticipate potential ecological disturbances, and adjust risk management strategies.
Harouna Issa Amadou, Niger

Synthetic biology poses risks to the environment and food security, particularly in the event of the accidental release of genetically modified organisms or the pollution of gene pools in domesticated or wild species. Genetic modifications can spread in nature, compete with or contaminate existing populations, disrupting ecosystems and leading to biodiversity loss and environmental degradation. Many farming communities have expressed concerns about the industry's growing reliance on GMO crops, which tends to concentrate power in the hands of a few companies with exclusive rights, reducing food security, exacerbating socioeconomic inequalities, and diminishing biodiversity. The numerous modifications made to DNA or other biological materials cannot be fully controlled by synthetic biologists, while the effects of introducing new organisms into the environment remain unpredictable and difficult to regulate, with governance mechanisms often too slow in some countries, such as Niger.
References
Knox, O.; Hall, C.; McVittie, A.; Walker, R.; Knight, B. A Systematic Review of the Environmental Impacts of GM Crop Cultivation as Reported from 2006 to 2011. Food Nutr. Sci. 2013, 4(6A), 28-37;
Snow, A. A., & Smith, V. H. (2012), “Genetically engineered organisms and the environment: Current status and recommendations.”Ecological Applications, 22(3), 579-590; Marvier, M., McCreedy, C., Regetz, J., & Kareiva, P. (2007). “A meta-analysis of effects of Bt cotton and maize on nontarget invertebrates.” Science, 316(5830), 1475-1477.
Harouna Issa Amadou, Niger

Kia ora tatou katoa,

Synthetic biology is still in its hypothetical evolution and like gene technologies, which are continually changing and being modified, there are no essential use benefits.  Modelling of the potential successes is very inaccurate and the AI predictions are based on current knowledge with an elite few who are guiding the process. The potential for benefits are only directed to the few who can afford to develop and use the technology from patents on the technologies if commercialised. 

The lack of any environmental, animal or human real life studies does not bode well for safety.  An analogy for synthetic biology is plastic, it is very versatile and has many uses, however the inability for it to decompose cause enormous degradation and harm to birds, fish and the environment. 

Synthetic biology is not natural and so may have a short term use but long term the benefits will become pollution. 

Synthetic biology does not alleviate, only adds to, the causes of man made climate change, CO2 causes like deforestation, pesticides and pharmaceuticals destroying our soils and waterways,  fossil fuel causing air pollution and mining of rare minerals for electric batteries. Synthetic biology, AI and all new genomic technologies will become another pollution and environmental problem for future generations unless we place strict contained regulations on its use.

Dear Forum,

The rapid integration of Large Language Models (LLMs) with advanced protein-structure prediction tools such as AlphaFold 3 has significantly accelerated the design of synthetic enzymes and metabolic pathways that do not exist in nature, enabling truly de novo biological functions. While this marks an extraordinary scientific breakthrough, it also raises important governance and biosecurity questions. https://doi.org/10.1038/s41586-024-07487-w

Ecological considerations are equally significant. The suppression of a target “pest” species, even through a localized gene drive, may unintentionally disrupt food webs by removing a key prey species or a competitor that naturally regulates other invasive organisms. Such interventions, if not carefully assessed, could trigger cascading ecological effects and potential ecosystem destabilization.

Additionally, there are concerns regarding Horizontal Gene Transfer (HGT), where engineered genetic elements from synthetic organisms could move into wild relatives. If this occurs, it could result in the long-term or even permanent integration of synthetic traits into natural genomes, raising questions about ecological reversibility and long-term environmental stewardship.

Boëte C. (2025). Gene drives, species complexes, and the risks of collateral damage. Proceedings of the National Academy of Sciences of the United States of America, 122(45), e2512489122. https://doi.org/10.1073/pnas.2512489122

https://targetmalaria.org/latest/news/iucn-agrees-first-global-policy-on-synthetic-biology/

Moreno RD, Valera L, Borgoño C, Castilla JC and Riveros JL (2024) Gene drives, mosquitoes, and ecosystems: an interdisciplinary approach to emerging ethical concerns. Front. Environ. Sci. 11:1254219. doi: 10.3389/fenvs.2023.1254219

Regards,
Wendy A. Dogbegah
ASSB

Dear all,

My name is Virginie Courtier-Orgogozo. I am an evolutionary biologist and a geneticist, Director of Research at the CNRS (French National Centre for Scientific Research) working in Paris. Beyond my primary research in evolutionary genetics using Drosophila flies, I am interested in synthetic biology in general and in the links between biology and society. I am a member of the Scientific Council of the Parliamentary Office for the Evaluation of Scientific and Technological Choices in France (OPECST) since 2020 and a member of the CNRS Ethics Committee since 2021.

Regarding gene drives, a biotechnology that is still under development in laboratories, I listed four categories of potential negative impacts:

(a) ecological negative impacts, corresponding to unintended consequences on ecosystems and non-target populations;

(b) sociological negative impacts, i.e. concerns over public perception, governance, and societal acceptance;

(c) negative impacts associated with research activities;

(d) negative impacts associated with malevolent usage

Besides these potential negative impacts, there are also technical limitations, where gene drives might not be as efficient as intended, and cases where mitigation strategies may not be able to block a gene drive.

All these potential negative impacts are detailed in my review paper published in 2025: https://doi.org/10.5802/crbiol.182
https://comptes-rendus.academie-sciences.fr/biologies/articles/en/10.5802/crbiol.182/

Here are a few excerpts that may be interesting for the discussion here:

"What makes ecological [impacts] associated with gene drives especially difficult to apprehend is two-fold. First, gene drives are designed to act in native ecosystems, where multiple species interact with each other, as opposed to “classical” genetic engineering of domesticated species, which usually live in standardized environments isolated from their wild counterparts. Second, the gene drive element is a self-replicating genetic element that is extremely labile given its design: many types of mutations can occur in the gene drive element and transform an original drive into a new one, with novel potential adverse effects on the phenotype of the drive-carrier animals and on ecosystems. Indeed, a new cargo gene may insert into the element, bringing new phenotypic potentialities such as insecticide resistance or increased attraction to humans. Furthermore, mutations in the sequence of the guide RNA gene can change the cut site, and the drive may insert at a new position in the genome, using as homology arms repeated sequences distributed across genomes."
"if a resistance gene inserts within a gene drive, then its non-Mendelian inheritance can compensate its detrimental fitness effect in untreated regions, and so lead to increased spread of the resistance"

Regarding suppression drives that intend to eliminate an entire species from an ecosystem:
- " The concern here is the same as for the use of insecticides or other methods to get rid of a given species."
- "Suppressing one species may cause cascading effects, altering predator–prey relationships and food web stability"
- "The target species may have unknown ecological functions in the ecosystem, and its elimination may thus fragilize the ecosystem. For example, invasive black rats may be responsible for dispersing seeds of native plants, a function previously undertaken by the native rodent species replaced by black rats (Shiels and Drake, 2011 - https://doi.org/10.1007/s10530-010-9876-7). Eliminating black rats may then affect the dissemination of native plants."
- "a species considered to be invasive or detrimental by some communities may actually be regarded as valuable by others (Carroll, 2011 - https://doi.org/10.1111/j.1752-4571.2010.00180.x; Davis et al., 2011 - https://doi.org/10.1038/474153a)".
- "local eradication of an invasive species leaves an empty ecological niche that can trigger diverse cascading trophic effects on the distribution and abundance of multiple other species in direct and indirect interaction with the eliminated species (Zavaleta et al., 2001 - https://doi.org/10.1016/S0169-5347(01)02194-2). For instance, the removal of feral goats and pigs from Sarigan Island, a US territory in the northwestern Pacific, triggered the proliferation of the previously undetected invasive vine Operculina ventricosa, which subsequently spread within the ecosystem (Kessler, 2002 - no doi? https://www.academia.edu/22651766/Eradication_of_feral_goats_and_pigs_and_consequences_for_other_biota_on_Sarigan_Island_Commonwealth_of_the_Northern_Mariana_Islands).

Regarding propagation to non-target populations of the same species:
- "Genomic studies have shown that rodents can move between islands, often facilitated by human activities such as maritime transport (Sjodin et al., 2020 - https://doi.org/10.1111/eva.12907)."
- during the mid-20th century occurred the global dissemination of a particular piece of DNA across all Drosophila melanogaster flies over the world: "natural transposable element named the P element, which rapidly spread across all natural populations of the fruit fly Drosophila melanogaster worldwide , probably following its horizontal gene transfer from another Drosophila species (Anxolabéhère et al., 1988; J. B. Clark and Kidwell, 1997)"


Regarding propagation to non-target species:
- Using highly conserved sequences as gene drive target sites (like in recent developments of the gene drive biotechnology) increases the probability of potential negative impacts
- "the P element that had previously contaminated all natural populations of D. melanogaster is now invading wild populations of the closely related species D. simulans (Hill et al., 2016 - https://doi.org/10.1371/journal.pgen.1005920; Kofler, Senti, et al., 2018 - https://doi.org/10.1101/gr.228627.117; Nascimento et al., 2020 - https://www.scielo.br/j/gmb/a/SGkdXnRcztTRrJDbqsk7JRx/?format=html&lang=en)"
- "Gene drive elements resemble homing endonuclease genes, which are natural transposable elements that can bias their inheritance by cutting and inserting themselves at targeted sites within genomes. A homing endonuclease gene targeting the cox1 mitochondrial gene has been found in multiple species of plants, fungi and green algae. Phylogenetic studies revealed that it has been transferred independently 70 times between 162 plant species involving 45 different families (Sanchez-Puerta et al., 2008 - https://doi.org/10.1093/molbev/msn129). This suggests that genetic elements with a transmission advantage, such as gene drives, can possibly reach distantly related species by horizontal gene transfer. This suggests that genetic elements with a transmission advantage, such as gene drives, can possibly reach distantly related species by horizontal gene transfer."

Regarding sociological potential negative impacts:
- "negative public perception can rapidly spread via social media (Rodrigues et al., 2023 - https://doi.org/10.3346/jkms.2023.38.e326)"
- "an unauthorized release of gene drive organisms into the wild, whether accidental or deliberate, [..] could severely damage public trust in scientists, institutions or regulators (Esvelt, 2018 - https://mars.gmu.edu/server/api/core/bitstreams/b0f62e71-d5c1-4ca2-85be-537f0a3bd63c/content; Min et al., 2018- https://doi.org/10.1080/23299460.2017.1415586)"
- "If gene drives are overly hyped (Boëte, 2025 - https://doi.org/10.1093/jme/tjaf007), or perceived as being deployed recklessly or without full transparency, this could lead to increased skepticism toward genetic engineering and heightened public opposition to biology research activities in general, even those with clear potential benefits and little risk."
- "this could undermine trust in public health in general, and thus reduce the effectiveness of outbreak prevention and control measures (World Health Organization, 2012 - https://www.who.int/publications/i/item/communication-for-behavioural-impact-(combi))."
- "could lead to accusations of biocolonialism, where genetic technologies are imposed on vulnerable populations without adequate consultation or compensation."
- "gene drive organisms do not respect national borders: one country’s decision to use the technology could be seen as imposing risks on neighboring nations and could result in diplomatic incidents"

Regarding potential negative impacts associated with experimentation:
- accidental release of gene drive organisms and contamination in the wild
- "International discussions around gene drive research have not yet converged on a set of rules and guidelines to be respected worldwide."
- "To our knowledge, there is no independent international body examining gene drive research projects before and after they are implemented."

Regarding potential negative impacts associated with malevolent usage:
- "a possible usage of a rogue gene drive would be to target an insect species that is present in the enemy region, but not in the attackers’ region"
- "the monitoring and mitigation processes [of such rogue gene drives] can be costly and difficult, especially in low-income countries and in areas experiencing political instability. Furthermore, immunizing reversal drives are not always guaranteed to work (Rode, Courtier-Orgogozo, et al., 2020 - https://doi.org/10.1534/g3.120.401484)."
- "a first step in limiting rogue gene drives would be to exclude from scientific papers the methodological details for applying gene drive to non-model species, as for the technical instructions to make nuclear weapons (Gurwitz, 2014 - https://doi.org/10.1126/science.345.6200.1010-b)."

Sorry for this very long message. Thank you for reading until the end!

Virginie

Hi All,

Thanks again to the moderator and secretariat for this discussion.

With regard to potential negative impacts of synthetic biology is the continued development of herbicide tolerant trait via synthetic biology tools and techniques, including genome editing (related to my post in Topic 1 on current benefits). Herbicide tolerant crops have been linked to adverse impacts on biodiversity e.g. https://link.springer.com/article/10.1186/s12302-016-0100-y, and human health e.g. 10.4236/jep.2018.93016, and  increased pesticide use e.g. https://doi.org/10.1111/joac.70006

This is regardless of any level of ‘precision’ or lack thereof, when using genome editing technologies in comparison to transgenic techniques.

Despite the risks of the trait being the same – mass application of synthetic pesticides with well-established adverse impacts on biodiversity loss and human ill health. What is being presented as a synthetic biology revolution appears to be continuing in exactly the same footsteps as first generation LMOs, which despite decades of promises, remain an industry overwhelmingly dominated by herbicide tolerant traits, and insecticidal resistance. According to industry figures, globally, in 2019, the area planted to herbicide tolerant crops was 43%, and stacked traits (including both herbicide tolerance and insect resistance) was 45%, meaning that 88% of GM crops by area included herbicide tolerant traits. ISAAA Brief 55-2019: Executive Summary | ISAAA.org. (2020, November 30). https://www.isaaa.org/resources/publications/briefs/55/executivesummary/default.asp

Adverse impacts of HT crops and their associated pesticides, are also associated with broad socio-economic, ethical and cultural impacts including the undermining of food sovereignty, farmer and human rights and the ability to transition to a just food system that can support the Objectives of the Convention and Targets of the GBF.

Herbicide tolerant traits warrant urgent precautionary assessment under the Convention to carefully consider a long-needed phase out of such toxic traits, which appear to directly undermine T7 of the KM-GBF.

Thanks,
Eva

Dear Participants,

Thank you to those that have started off this important conversation. So far, we have examples of artificial intelligence in synthetic biology, engineered gene drives and self-disseminating vaccines. We also have some important environmental, socioeconomic and regulatory considerations that have been shared.

I appreciate the references shared thus far (and hope to get even more).

I would like to encourage you to continue to share specific examples and if possible, clarify their link to the KMGBF. It may also be helpful to refer to some of the technological developments shared under discussions on the potential positive impacts (Topic 2) and complement those discussions.

Finally, there is still time to add your perspectives and share additional information.

Kind regards,

Martin

Dear All,
as a lawyer I am particularly interested in the regulation of genetic engineering. The posts 3546, 3547 (Eva Sirinathsinghji) and 3510, 3514 (Pat Thomas) are very helpful in building bridges from facts about positive and negative impacts to legal rules on whether or not to accept the release and bringing on the market of genetically modified organisms. Since decades the focus of regulatory oversight has been on negative impacts, different states operating different systems of risk assessment, evaluation and management. The recent overall trend is to deregulate formerly strict requirements. The EU is even about to release an entire group of the so-called new genomic techniques from any risk oversight. For a critique see G. Winter,  The European Union’s deregulation of plants obtained from new genomic techniques: a critique and an alternative option, Environmental Sciences Europe (2024) 36:47. This deregulatory move has often been motivated with pointing to the benefits of genetic engineering. These benefits have commonly been seen in the highly profitable growth of bioeconomy. More recently ecological benefits have been propounded, agroecological improvements standing out. Many optimistic posts in this forum have been filed to that effect, with Eva’s and Pat’s posts reminding of the ostensible character of many promises. Considering this situation the following questions arise from a regulatory perspective:
(1) what risks for human health and the environment cannot be accepted from the outset?
(2) what risks may be weighed up by benefits?
(3) what benefits shall be accepted as possibly preponderant?
If these questions were to be framed as regulatory requirements, their application would need to be grounded on appropriate methodology of assessment. While the methodology of environmental risk assessment has studiously been elaborated and even legally laid out, almost no methodology at all has been developed concerning benefit assessment. Such new methodology would have to start with basic choices (shall a benefit only be accepted if contributing to agroecological improvements, excluding e.g. its use for nature conservation, or for non-sensical  improvements of products?), and it would have to go on elaborating in more detail the assessment of the chosen category of benefit, as e.g. agroecological improvement, including the required information, the steps of assessment and the criteria of evaluation. This would exclude that a risk is accepted just because a benefit is alleged but not substantiated.

One major potential negative impact of most recent technological development with emphasis on synthetic biology is the Dual-Use Risks and Misuse
The case of Pathogen Synthesis & Dual-Use: Advanced synthetic biology makes it possible to synthesize or alter pathogens. A notable case involved the synthetic recreation of horsepox virus to inform vaccine research — but critics argue such work could inadvertently lower barriers to recreating smallpox, a deadly pathogen eradicated decades ago, raising serious biosecurity.
https://www.ncbi.nlm.nih.gov/books/NBK584259/?utm

Biotechnological advances like CRISPR and automated DNA synthesis are dual-use: they accelerate valuable research (e.g., therapies) but also could enable malicious enhancement of virulence or creation of novel biological threats, especially as tools become cheaper and more accessible. This difficulty in governance and oversight raises ethical issues, potential misuse by bad actors, and the risk of accidental release from labs.
https://www.sciencedirect.com/science/article/pii/S2405805X22000291?utm

Another potential negative impact is on the use of Digital Genetic Resources Without Benefit-Sharing. Recent advances in synthetic biology allow researchers to design organisms using Digital Sequence Information (DSI)—genetic data stored in online databases—without physically accessing biological material from its country of origin. While this accelerates innovation, it also creates a major governance gap under the Convention on Biological Diversity (CBD) and its Nagoya Protocol on Access and Benefit-Sharing. Companies can possibly download genetic sequences (e.g., from tropical plants or microbes), synthesize them in laboratories elsewhere, and commercialize derived products (pharmaceuticals, enzymes, agricultural traits) without the possible compensation of the source countries or Indigenous communities who conserved or discovered those resources. This risks undermining equitable benefit-sharing frameworks, reducing incentives for biodiversity conservation, and exacerbating global inequalities between technologically advanced countries and biodiversity-rich developing nations. Indeed it has been acknowledged by several Fora that DSI presents complex regulatory and ethical challenges, particularly regarding sovereignty, fairness, and sustainable use of genetic resources

Another negative impact is in the potential threat of livelihood that is dependent on biodiversity.
Synthetic substitutes for natural products (e.g., vanilla flavor compounds produced via engineered microbes) can economically displace farmers in producing countries, threatening livelihoods dependent on biodiversity-based industries. Such displacement illustrates how synthetic biology may unintentionally weaken conservation-linked economies.

Onyeka Nwosu
Nigeria

Dear colleagues

For my contribution I wish to canvas three areas: 1. Scale and potential to apply synthetic biology in real time outside of controlled facilities; 2. Dual use and DSI, and 3. Gene drives.

Techniques such as CRISPR/Cas demonstrate efficiencies in effecting targeted changes in genomes of probably all species at a rate and to an extent unimaginable from our experience with earlier site-directed tools available since the 1970s or 1980s, such as oligonucleotide directed mutagenesis and recombinases [1a]. But synthetic biology is not just the tools that mutagenise or insert genes. It includes the chemical and virus-like tools that have improved internalisation of the genome editors etc and get them access to the genome [2].

The industrial quality of efficiency is inseparable from the potentially undesirable ability to create intended or unintended harm when these techniques are used at scale [1b]. These advances in the broader framework of synthetic biology make the possibility of creating synthetic organisms in their environments in real time - even simultaneously engineering multiple species simultaneously to effect ecosystem engineering - much more real.

In posts #3519 and #3520, Dieudonné and Fatou discuss another kind of accelerant, AI. Dual use concerns are raised by both Fatou and Onyeka [#3559]. AI can contribute here too.

This emergent agent can suggest sequences and serial changes [#3520] to one or more targets in the same genome. The novelty of the sequence space that AI can access could provide design pathways to potentially evade detection. Even if no harm is intended, the design may accidentally exceed our biological experience to predict potential adverse effects on human health or the environment. Even without AI, researchers have demonstrated the ability to wilfully evade police detection of sequences from known pathogens [3].

My addition to the comments on gene drives already presented in e.g. #3531, #3535, and #3542, concerns the potential for us to miss entire categories of gene drives because of a failure to accurately define them. The special type of drive that manipulates Mendelian ratios is a meiotic drive. That kind of drive depends on and works in species that use meiosis.

But asexual or facultatively mitotic organisms can also be engineered with gene drives and these can be transmitted using vectors of horizontal gene transfer [4]. The hazards and potential negative effects of these drives seem invisible in our discussions, and that is a potential negative impact.

[1] a. https://doi.org/10.1525/elementa.2021.00086; b. doi: 10.1016/j.ecoenv.2024.116707
[2] https://www.sciencedirect.com/science/article/pii/S0147651325019104, https://www.sciencedirect.com/science/article/pii/S2590053619300266, https://biosafety-info.net/wp-content/uploads/2019/11/Biosafety-briefing_From-lab-to-wild.pdf
[3] https://www.media.mit.edu/articles/it-shouldn-t-be-easy-to-buy-synthetic-dna-fragments-to-recreate-the-1918-flu-virus/
[4] https://doi.org/10.1038/s44259-026-00181-z, doi: 10.1093/nar/gkz1197, https://doi.org/10.1111/1751-7915.12816Digital Object Identifier (DOI)

Dear respected moderator and colleagues,
I am Saiful Effendi Syafruddin and thanks for this important and stimulating discussion. In my opinion, one of the main concerns with synthetic biology advancements such as gene-edited organism or engineered microbes is the uncertainty around ecological safety and long-term impacts. Gene edited-organisms can, in theory, lead to unintended ecological interactions, affect native species dynamics or alter ecosystem functions (DOI: 10.17226/23395).
Whilst KMGBF Objectives 1 and 2 focus on reducing threats to biodiversity and promoting sustainable use and benefit-sharing, a potential negative impact of synthetic biology is the disruption of ecosystem integrity and native biodiversity if engineered organisms alter species interactions or outcompete wild populations. Additionally, unintended ecological effects could undermine ecosystem services such as pollination and soil health that local communities rely on or potentially affect food production. In my point of view, safety uncertainties may also complicate the adoption of these technologies and equitable sharing of benefits derived from genetic resources (doi: 10.1016/j.isci.2022.105423).

Overall, while synthetic biology offers tremendous potential, we must remain prudent and proactive as uncertainties in safety, efficiency and ecological impacts underscore the need for robust risk assessment, precautionary measures and ongoing monitoring to ensure alignment with KMGBF objectives and targets. Thanks 😊

Thank you for this important discussion. I write as Director of Beyond GM, a UK-based civil society organisation that has engaged directly with the UK's regulatory process for precision breeding over the past five years. I would like to offer the UK's experience as a concrete case study of how the deregulatory trend identified by Professor Winter (#3552 posted in The potential positive impacts section) manifests in practice – and what it means for the credibility of international frameworks, including the CBD.

>>The UK Precision Breeding Act and its 2025 Regulations<<
The UK's Genetic Technology (Precision Breeding) Act 2023 [1] and the subsequent Genetic Technology (Precision Breeding) Regulations 2025 [2] represent one of the most significant national departures from precautionary oversight of gene-edited organisms in recent years. Under this framework, organisms produced through certain gene-editing techniques are reclassified as "precision bred" and removed from the regulatory oversight previously applicable to GMOs – on the entirely theoretical premise that such changes could have occurred through traditional breeding or natural processes.

To uphold this theoretical premise the Regulations, amongst other things, remove labelling and end-to-end traceability required of other GMOs, prohibit the government from applying any safety test to precision bred organisms that would not be applied to ordinary food and 20 removes precision bred organisms from the purview of the Environmental Damage (Prevention and Remediation) Regulations 2009 as an activity that could cause environmental damage.

Our organisation has challenged this framework through a judicial review [3] currently before the courts (Beyond GM v Secretary of State, listed for hearing in May 2026), on five grounds including procedural unlawfulness, violation of human rights obligations, and failures in the statutory consultation process.

>>Governance failures: Exclusion of civil society, weakening of guidance, FOI evidence<<
The process by which the UK's regulatory framework was developed is itself instructive for the AHTEG. Our A Bigger Conversation initiative produced a systematic analysis of the critique and stakeholder feedback which was ignored in creating what is in our view, a political, rather than scientific, framework. [4]  

Freedom of Information requests pursued by Beyond GM [5] revealed that Defra (the responsible government department) took active steps to exclude NGO responses from consultation analysis, and that draft guidance documents were systematically weakened between February and November 2025 through non-statutory processes, without further public consultation.

This is precisely the kind of accountability gap that Mr Winter identifies in #3552 where risk assessment is attenuated not through transparent legislative process, but through administrative manoeuvre that evades scrutiny. The fact that civil society has been compelled to seek judicial remedy simply to have these questions heard is itself evidence of the governance deficit.

These failures have direct relevance to KMGBF Target 21 (access to information and inclusive decision-making) and Target 22 (rights of civil society to participate in governance).

>>Failure to uphold international commitments<<
What makes the UK case particularly significant for this forum is the government's apparent indifference to its international obligations. The UK is a signatory to both the Cartagena Protocol on Biosafety and the Aarhus Convention on access to information and public participation in environmental decision-making. Yet neither framework has meaningfully constrained the domestic deregulatory trajectory. The procedural failures documented in our FOI evidence – and now subject to legal challenge – arguably represent a breach of the participatory standards the Aarhus Convention requires.

Furthermore, the UK government has explicitly stated its intention to seek the exclusion of precision bred organisms from sanitary and phytosanitary (SPS) measures in its ongoing negotiations with the European Union. [6]  This signals not merely a domestic policy choice, but an active effort to export the deregulatory model through trade architecture, potentially creating pressure on other jurisdictions to follow suit and undermining the coherence of international biosafety governance.

>>A 'Wild West’ of deregulation?<<
Taken together – the removal of precautionary oversight, the exclusion of civil society from consultation, the weakening of guidance without democratic accountability, the disregard for Cartagena and Aarhus obligations, and the effort to leverage trade negotiations to entrench deregulation internationally – the UK's approach represents something qualitatively different from mere regulatory reform. It represents a deliberate dismantling of the governance architecture that the CBD's own frameworks depend upon at the national level.

This has direct implications for KMGBF Target 15 (corporate accountability and disclosure), Target 7 (reducing pollution including from agricultural inputs whose risks are obscured by deregulation), and Objective 3 (fair and equitable sharing of benefits – undermined when risk governance is weakened to accelerate commercialisation).

The AHTEG may wish to consider whether a specific focus on governance erosion at the national level – as distinct from technological risk per se – warrants attention as a negative impact in its own right.

>>Links<<
[1] Genetic Technology (Precision Breeding) Act 2023 https://www.legislation.gov.uk/ukpga/2023/6/contents
[2] Genetic Technology (Precision Breeding) Regulations 2025 https://www.legislation.gov.uk/ukdsi/2025/9780348269123 
[3]  Beyond GM, We have a court Date, January 2026, https://beyond-gm.org/we-have-a-court-date/
[4] A Bigger Conversation, Filling in the Blanks,  January 2022 https://abiggerconversation.org/wp-content/uploads/2022/01/Filling-in-the-Blanks_Defra-Consultation_ABC_Jan2022.pdf 
[5] Beyond GM, FOI documents show Defra wilfully ignores public views on gene editing, May 2022,  https://beyond-gm.org/foi-documents-show-defra-wilfully-ignores-public-views-on-gene-editing/
[6] UK Parliament, Govt must seek carve outs and implementation period in EU trade deal – EFRA Committee report,  February 2026 https://committees.parliament.uk/committee/52/environment-food-and-rural-affairs-committee/news/211732/govt-must-seek-carve-outs-and-implementation-period-in-eu-trade-deal-efra-committee-report

It is not feasible to advance synthetic biology without appropriate regulatory oversight. On the one hand, the development of a transparent and internationally coherent regulatory framework is essential to ensure the safe and sustainable application of this technology and to address global challenges responsibly (10.3389/fpls.2023.1232938). On the other hand, maintaining conceptual clarity and terminological precision is equally important to prevent misunderstandings and promote consistency, particularly in supporting communication, education, public awareness, and uptake.

For example, a term “non-GMO gene editing” or similar one has recently emerged and may create confusion in public discourse. While certain gene-edited organisms may fall outside specific regulatory definitions in some jurisdictions, this does not necessarily mean they are not genetically modified (https://www.nongmoproject.org/blog/crispr-and-talen-and-rnai-oh-my/).

Thank you!

Dear participants,

Thank you to Mr. Martin Batič for moderating this discussion and all participants for the insightful comments.

My name is Luciana Ambrozevicius, I'm a agronomist with a Ph.D. on Genetic and Plant Breeding and a regulator at Ministry of Agriculture and Livestock in Brazil, a risk assessor at our National Biosafety Commission and a former member in the SynBio AHTEG and the RA AHTEG.

Governance of synthetic biology does not start from zero, it is part of the broader field of advanced biotechnologies with a long history of regulation and risk assessment and management. Under CBD, the Cartagena Protocol establishes the methodology for the risk assessment of LMOs and till the moment, the organisms obtained from SynBio are considered LMOs and are subject into this same framework.

With the development of the technology, together with AI and robotics, there are challenges related with accelerated research and innovation. A recent report from OECD identify a number of trends from SynBioxAI convergence and presents actions that could inform and support policy making including: initiate future oriented technology monitoring, assessment and foresight exercises across value chains to keep abreast of SynBioxAI developments; promote international collaboration on data-sharing infrastructures and standards; support and pilot agile policy mechanisms (e.g. regulatory sandboxes) to test adaptive governance approaches; invest in interdisciplinary education and workforce transformation (https://www.oecd.org/content/dam/oecd/en/publications/reports/2025/12/synthetic-biology-ai-and-automation_0179340f/12158721-en.pdf).

Thank you.

Best regards,
Luciana P. Ambrozevicius

Hello All,

I would like to add to the discussion some of the potential negative impacts  of microbial applications of synthetic biology.

LM microorganisms are now being commercialised, e.g. the new application of genome edited soil bacteria sold as a biofertilizer by PivotBio since 2019. LM microorganisms (including viruses and microalgae), are also being proposed for a wide variety of environments (e.g. soil, livestock guts, wild animal populations, marine and fresh water ecosystems) and applications (e.g. biocontrol, biofertilizers, bioremediation, public health (e.g. self-spreading transgenic viruses), conservation/climate (e.g. in vivo editing of animal gut microbiomes). (e.g. see https://www.genewatch.org/uploads/f03c6d66a9b354535738483c1c3d49e4/gm-microorganisms-fin.pdf)


Microorganism applications, particularly those aimed at environmental release, raise many potential negative impacts, due to their capacity for rapid replication, spread and persistence, and gene flow, introducing a lack of controllability and added evolutionary dimensions.

A central risk of spread and persistence raises concerns that applications may result in a form of ‘living pollution’ with unpredictable exposure and transboundary movement potential. Dispersal routes (in general) include air, leaf litter, pollen, seeds, insects, or soil-associated animals or fungi. Moreover, dispersed microorganisms have been shown to establish both transiently, and over the long-term, with even transient invaders capable of causing shifts in microbial communities (Sessitsch et al., 2023). Several pathogens have for example, been detected in both rain and snow samples, and rain is also a key reservoir for leaf (phlyosphere) microbiota, e.g., for tomatoes (Mechan Llontop et al., 2021). Microbes introduced by humans have a long history of becoming invasive, with potential for global impacts, with (Ladau et al., 2025) warning against the potential for ‘low probability, high consequence’ invasive events.  Such a risk increases with scalability of releases, if such applications are widely adopted (Heinemann & Walker, 2021). This issue is relevant to Target 6 of the KM GBF on reducing rates of introduction of invasive alien species.

Genetic elements such as antibiotic resistance genes, can spread through wastewater treatment sites and rivers (Cai et al., 2014; Mao et al., 2015; L. Zhang et al., 2024), and bacterial aerosols can spread in landfill sites (Cyprowski et al., 2019).

Food/feed and digestive microbiome applications are also relevant to unintended spread. Foods consumed by people can get contaminated with cattle gut microbes, as occurs with E.coli outbreaks, for example, from lettuce crops that have been sprayed with manure. Microbes could also be potentially transmitted via milk (Lyons et al., 2020).

Horizontal gene transfer (HGT) is also a significant risk, and is long recognised as a ‘pillar of bacterial evolution’ (Arnold et al., 2022). HGT raises the risk of transfer not only of engineered traits, but also of unintended mutations that may arise in a GM microbe. It may have a variety of implications depending on the trait transferred, the nature of the unintended mutations, and the behaviour of the transferred DNA within the context of the genome and biology of the nontarget organism and its environment, with implications for biodiversity and human health. E.g. Virulence factors, or metabolic traits may increase pathogenicity of microbes, or offer selective advantage to particular microbial species, resulting in shifts in community composition, with potential impacts on the functions that such microbiome communities mediate, e.g., the mediation of human/animal health by gut microbes (Borodovich et al., 2022; Dapa et al., 2023).

HGT hotspots include animal guts (relevant to applications targeting livestock microbiomes), as well as the plant rhizosphere. Bacterial-derived HGT has also been documented in animals e.g. in whiteflies, potentially underlying the rise of outbreaks following fertilizer treatments (Yang et al., 2024). The use of dead microbes (e.g. in food products) also does not ensure against HGT.

While measures are being designed to seek to contain spread, e.g., at the molecular level (known as ‘biological containment’), they remain under development, and will introduce more genetic modifications with their own risks and complexities (Ke et al., 2021).

Evolutionary dynamics presents additional risks of e.g. potential pathogenicity, or  zoonotic spillover. Concerns have been raised regarding the potential instability of genetic changes over time (e.g., Eckerstorfer et al., 2024). The dynamic nature of mutation and recombination events in wild global viromes (viral genomes), are speculated to play a defining role in spillover events (Apari & Földvári, 2023; Lentzos et al., 2022). A further concern is whether pests or diseases targeted for biocontrol by GM microbes will also evolve resistance (Eckerstorfer et al., 2024).

Uncertainties are increased by significant knowledge gaps that challenge the ability to sufficiently ensure against adverse impacts on biodiversity. E.g. with the application of GM viruses, knowing the limits of host species is very difficult, with the potential for spill-over events. Unintended impacts of the genetic engineering process or design may also alter host range. Spread and persistence are also dependent on various factors including fitness of the microbe, which cannot be easily tested in the lab due to environmental mediators. Such knowledge gaps and accompanying uncertainties cannot be resolved with additional risk assessment methods such as computer modelling.

The development of LM microorganisms also raises direct biosecurity concerns regarding potential dual use applications and unintended evolution of pathogens.

Regarding contained use, Careful oversight is also necessary to ensure that applications do indeed, remain properly contained. With a potential increase in scale of contained use applications, the risks of environmental leaks increase, warranting careful oversight of biosafety practice in preventing unintended escapes. Despite this, some industry players appear to be advocating for weakening regulations on contamination events from contained use, such as the presence of engineered DNA in food products (Lensch et al., 2024). Contamination and escape of micro-organisms has already been documented in several cases. Novo Nordisk, for example, has documented contamination with 3 different species of bacteria in three different batches of its weight-loss drugs. Reports of malpractice add to risks and are another aspect that must be properly regulated (FDA, 2023; Reuters, 2023). Antibiotic resistance genes have also been detected in food enzyme products (Fraiture et al., 2024).

It is thus my view that the risks and uncertainties associated with LM microorganism applications (generated via both first generation and genome editing techniques), leaves an absence of reliable data on LM microorganisms, and thus an inadequate basis for assessing their potential risk remains. In accordance with the precautionary approach, it remains premature for engineered microorganisms to be safely released into the environment. Such potential applications warrant further study of the broad implications of these technologies including biosafety, socioeconomic, cultural and ethical impacts.

Thanks very much, Eva


Apari, P., & Földvári, G. (2023). Domestication and microbiome succession may drive pathogen spillover. Frontiers in Microbiology, 14, 1102337. https://doi.org/10.3389/fmicb.2023.1102337

Arnold, B. J., Huang, I.-T., & Hanage, W. P. (2022). Horizontal gene transfer and adaptive evolution in bacteria. Nature Reviews Microbiology, 20(4), 206–218. https://doi.org/10.1038/s41579-021- 00650-4

Cyprowski, M., Ławniczek-Wałczyk, A., Gołofit-Szymczak, M., Frączek, K., Kozdrój, J., & Górny, R. L. (2019). Bacterial aerosols in a municipal landfill environment. Science of The Total Environment, 660, 288–296. https://doi.org/10.1016/j.scitotenv.2018.12.356

Eckerstorfer, M. F., Dolezel, M., Miklau, M., Greiter, A., Heissenberger, A., & Engelhard, M. (2024). Scanning the Horizon for Environmental Applications of Genetically Modified Viruses Reveals Challenges for Their Environmental Risk Assessment. International Journal of Molecular Sciences, 25(3), 1507. https://doi.org/10.3390/ijms25031507

FDA. (2023). FDA. https://www.fda.gov/media/172377/download

Fraiture, M.-A., Gobbo, A., Guillitte, C., Marchesi, U., Verginelli, D., De Greve, J., D’aes, J., Vanneste, K., Papazova, N., & Roosens, N. H. C. (2024). Pilot market surveillance of GMM
contaminations in alpha-amylase food enzyme products: A detection strategy strengthened by a newly developed qPCR method targeting a GM Bacillus licheniformis producing alphaamylase. Food Chemistry. Molecular Sciences, 8, 100186. https://doi.org/10.1016/j.fochms.2023.100186

Heinemann, J.A.; Paull, D.J.; Walker, S.; Kurenbach, B. Differentiated impacts of human interventions on nature: Scaling the conversation on regulation of gene technologies. Elem Sci Anth 2021;9:00086. 10.1525/elementa.2021.00086

Ladau J, Fahimipour AK, Newcomer ME, Brown JB, Vora GJ, Melby MK, Maresca JA. Microbial inoculants and invasions: a call to action. Trends Microbiol. 2025 Oct;33(10):1064-1075. doi: 10.1016/j.tim.2025.04.018. Epub 2025 Jun 12. PMID: 40506296.

Lensch, A., Lindfors, H. A., Duwenig, E., Fleischmann, T., Hjort, C., Kärenlampi, S. O., McMurtry, L., Melton, E.-D., Andersen, M. R., Skinner, R., Wyss, M., & Van Kranenburg, R. (2024). Safety aspects of microorganisms deliberately released into the environment. EFB Bioeconomy Journal, 4, 100061. https://doi.org/10.1016/j.bioeco.2023.100061

Lentzos, F., Rybicki, E. P., Engelhard, M., Paterson, P., Sandholtz, W. A., & Reeves, R. G. (2022). Eroding norms over release of self-spreading viruses. Science, 375(6576), 31–33. https://doi.org/10.1126/science.abj5593

Lyons, K. E., Ryan, C. A., Dempsey, E. M., Ross, R. P., & Stanton, C. (2020). Breast Milk, a Source of Beneficial Microbes and Associated Benefits for Infant Health. Nutrients, 12(4), 1039. https://doi.org/10.3390/nu12041039

Mao, D., Yu, S., Rysz, M., Luo, Y., Yang, F., Li, F., Hou, J., Mu, Q., & Alvarez, P. J. J. (2015). Prevalence and proliferation of antibiotic resistance genes in two municipal wastewater treatment plants. Water Research, 85, 458–466. https://doi.org/10.1016/j.watres.2015.09.010

Mechan Llontop, M. E., Tian, L., Sharma, P., Heflin, L., Bernal-Galeano, V., Haak, D. C., Clarke, C. R., & Vinatzer, B. A. (2021). Experimental Evidence Pointing to Rain as a Reservoir of Tomato Phyllosphere Microbiota. Phytobiomes Journal, 5(4), 382–399. https://doi.org/10.1094/PBIOMES-04-21-0025-R

Reuters. (2023, September 21). FDA found lapses at Novo Nordisk’s main US factory in May 2022, report says. https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-foundlapses-novos-main-us-factory-may-2022-report-2023-09-20/

Sessitsch, A., Wakelin, S., Schloter, M., Maguin, E., Cernava, T., Champomier-Verges, M.-C., Charles, T. C., Cotter, P. D., Ferrocino, I., Kriaa, A., Lebre, P., Cowan, D., Lange, L., Kiran, S., Markiewicz, L., Meisner, A., Olivares, M., Sarand, I., Schelkle, B., … Kostic, T. (2023). Microbiome Interconnectedness throughout Environments with Major Consequences for Healthy People and a Healthy Planet. Microbiology and Molecular Biology Reviews, 87(3), e00212-22. https://doi.org/10.1128/mmbr.00212-22

Zhang, L., Chen, H., Gao, S., Song, Y., Zhao, Y., Tang, W., & Cui, J. (2024). Antibiotic resistance genes and mobile genetic elements in different rivers: The link with antibiotics, microbial communities, and human activities. Science of The Total Environment, 919, 170788. https://doi.org/10.1016/j.scitotenv.2024.170788

Thank you for the interesting discussions! I’m Lim Li Ching, from the Third World Network.

Rather than focusing on the negative impacts of the technologies per se in this post, which others have already articulated well, I wanted to focus on broader and structural issues, that also count as negative impacts, particularly for developing countries.

First, as in my earlier post on the thread of “potential benefits”, there is a need to separate out the hype surrounding synthetic biology. If not, this may lead to countries being locked-in to certain trajectories, developing the infrastructure, investing large amounts of money, etc. only to find that the actual benefits are smaller than they envisaged and/or there are negative impacts of the technologies themselves, which were not anticipated. Once technological lock-in occurs (see https://doi.org/10.1162/glep_a_00566), it may become too complex and costly to change course.

Second, there could be significant opportunity costs associated with the widespread adoption of synthetic biology, at the expense of other alternatives that may carry fewer risks, or that may be more appropriate for developing country contexts. (See for example, Chapter 3 of https://genedrives.ch/report/). These opportunity costs could lead to e.g. misspending of money, or waste of human resources and time, rather than implementing existing or alternative interventions more effectively and conducting more cost-effective, diverse and appropriate R&D.

Third, while access to and transfer of technology are crucial means of implementation for developing countries, any technologies that are accessed and transferred should not negatively impact the environment or peoples, and must be locally appropriate and cost-effective. Developing countries need to be able to assess the potential negative impacts of synthetic biology, so that they are not left bearing the burden of risk management, clean up, liability and costs associated with any damages or technology failures. If such capacities are lacking, or if regulatory systems are weaker, this could result in the ‘dumping’ of risky, unsuitable or ineffective technologies on developing countries, resulting in them bearing the overwhelming brunt of any risks, a situation which is highly inequitable. (See for example, https://doi.org/10.1057/s41301-019-00214-3).

Kind regards,
Li Ching

Dear all, thank you for your valuable contributions.

Since the previous forum in March 2023, several technological developments in synthetic biology have progressed rapidly. These include: advances in cell-free biosensing platforms for environmental monitoring (https://doi.org/10.1016/j.cej.2024.155632); improved enzyme engineering approaches for plastic depolymerization and waste management (https://doi.org/10.1016/j.cej.2024.154183); the growing integration of engineering biology with digital technologies (e.g., AI-assisted design and automation) (https://doi.org/10.1038/s41467-025-58492-0); and continued progress toward field trials of gene drive mosquitoes for vector control, including frameworks for monitoring, adaptive trial design, and stopping rules (https://doi.org/10.1186/s12936-024-04952-9).

While these developments may offer potential benefits, the scientific literature also highlights significant uncertainties and governance challenges that are relevant to the three objectives of the Convention on Biological Diversity.

First, conservation risks may arise from ecological uncertainty and the possibility of transboundary spread of engineered organisms, particularly for technologies intentionally designed to persist or propagate in natural populations, such as gene drives (https://doi.org/10.1186/s12936-024-04952-9).

Second, there are potential risks for the sustainable use of biodiversity, including unintended ecological interactions or burden-shifting effects if technological deployment advances faster than environmental monitoring, governance systems, and regulatory oversight.

Third, benefit-sharing concerns remain central. Synthetic biology increasingly relies on digital sequence information (DSI), which may challenge existing access and benefit-sharing (ABS) frameworks if mechanisms for fair and equitable sharing are not clearly defined or effectively implemented (https://doi.org/10.1016/j.gloenvcha.2024.102892).

In this context, several KMGBF targets could be negatively affected if governance frameworks remain insufficient. These include Target 17 (biosafety), where gaps in environmental risk assessment and monitoring capacity may limit effective oversight; Target 13 (fair and equitable benefit-sharing), particularly regarding DSI; and Target 7 (pollution reduction) if technological “end-of-pipe” solutions divert attention from upstream prevention and systemic policy approaches.

More broadly, recent analyses emphasize that synthetic biology interventions in conservation contexts must be evaluated with caution, given their potential implications for ecosystems, cultures, rights, and livelihoods, and should therefore be assessed through transparent, participatory, and precautionary governance frameworks (https://doi.org/10.1016/j.isci.2022.105423).

We agree with posts stressing that recent SynBio advances (AI-enabled design/biofoundries, gene drives, and environmental microbes) can pose significant uncertainties and governance challenges, requiring precaution, robust risk assessment and monitoring capacity, and clear regulatory oversight to avoid transboundary/ecological harms and dual-use risks (#3508, #3520, #3531, #3535, #3562). Also, echoes concerns that DSI/ABS gaps and hype-driven “lock-in” could undermine equity if benefits are not fairly shared and locally appropriate (#3519, #3559, #3596).

Nancy Serrano Silva, PhD in Biotechnology.
“Investigadoras e Investigadores por México” program
Executive Secretariat of the Intersecretarial Commission on Biosafety of Genetically Modified Organisms (Cibiogem), Mexico.

Hello,

My name is Lorrie Boisvert and I am acting unit head in the Biotechnology, Innovation and Novel Sciences Section at Environment and Climate Change Canada.  My group is responsible for doing the risk assessment of novel organisms before they can be produced or imported into Canada.

Synthetic biology and its most recent technological developments presents several risks that require careful policy attention. Introducing a new organism into the ecosystem is not a simple task and requires careful evaluation based on scientific data.

In Canada, the New Substances program, which consists of officials from Health Canada and Environment and Climate Change Canada, is responsible for administering the New Substances Notification Regulations (Organisms) [NSNR (Organisms)] made under the Canadian Environmental Protection Act, 1999 (CEPA). These regulations ensure that no new living organisms are introduced into the Canadian marketplace before undergoing ecological and human health assessments, and that appropriate control measures have been taken, when required.

Before entering Canada, each organism must undergo a detailed scientific risk assessment, examining the potential for negative impacts;
- The genetic modifications, if any, and their stability through multiple generations.
- The biological and ecological properties of the organism, including its life cycle, resistance to metals, pesticides, antibiotics.
- The growth conditions required for the organism, and the conditions for its survival.
- Its potential for persistence and dispersal into the environment.
- The mode of action of the intended and potential uses of the organism.
- The potential for horizontal gene transfer.
- The effects to aquatic and terrestrial plants, vertebrates and invertebrates.

The exposure of the organism is also examined, looking at where will it be introduced, used, its environmental fate, i.e. how it will move and transform through time in the environment.

It is also important to note that the scope of this assessment excludes organisms which, due to their use, would fall under other Acts and Regulations different from CEPA, as listed here: https://laws-lois.justice.gc.ca/eng/acts/c-15.31/page-36.html#h-67649

Overall, the potential for hazard and exposure both need to be taken into account to assess risk. Control measures can also be taken to mitigate potential adverse effects when necessary, such as confining the organism to an isolated, controlled and secured facility, or limiting who can use the organism and for what purposes. Taking into account these different elements ensure the environment is protected while allowing to take advantage of the benefits of synthetic biology.

Dear Lorrie Boisvert, thank you for summarising the Canadian risk assessment approach. There is one question remaining, though: Do you also assess the benefits of a modified organism, and if so, in what way precisely? If not, would you suggest that such methodology should be developed?  What could be its components?

Thank you to colleagues for the very informative contributions highlighting potential negative impacts associated with recent technological developments in synthetic biology.

Several important issues have already been raised in this discussion, including concerns related to environmental release of engineered organisms, ecological interactions with natural populations, challenges associated with containment and reversibility of gene drive systems, and broader governance and regulatory capacity gaps. These contributions reflect well-established areas of consideration in the biosafety and environmental risk assessment literature and are relevant to achieving the Kunming–Montreal Global Biodiversity Framework targets.

Building on these points, it may also be useful to highlight several aspects which are relevant when assessing potential negative impacts of recent technological developments in synthetic biology:

• Evolutionary dynamics and resistance development (Targets 7, 10)
Engineered traits may change through mutation and natural selection once introduced into complex ecosystems. Experience from agricultural biotechnology shows how rapidly resistance can evolve, such as herbicide-resistant weeds associated with herbicide-tolerant crops (Unckless et al., 2017; Heap and Duke, 2018; Baucom, 2019). Comparable dynamics may arise in emerging genetic pest-control technologies.

• Cumulative and large-scale ecological effects (Targets 3, 4)
Environmental risk assessments often focus on limited spatial and temporal scales, while large-scale deployment of engineered organisms may generate cumulative ecological effects affecting species interactions, ecosystem structure and biodiversity patterns (Henry, 2005; Heinemann et al., 2021).

• Horizontal gene transfer and microbial introgression (Targets 7, 8)
Less attention has been given to potential horizontal gene transfer involving engineered microorganisms or synthetic constructs in environmental microbiomes. Given the central role of microbial communities in ecosystem functioning, this remains an important area of uncertainty (Gillet et al., 2025).

• Novel biological properties of engineered organisms (Targets 13, 14)
Synthetic biology approaches may produce organisms with redesigned metabolic pathways, synthetic genomes or expanded genetic codes. These features may introduce biological properties not previously encountered in nature, increasing uncertainty in environmental risk assessment (Schmidt et al., 2018).

• Socio-economic and ethical considerations (Targets 9, 13, 22)
Technological deployment may affect livelihoods, agricultural systems and the distribution of costs and benefits among stakeholders. Ethical considerations related to environmental interventions, particularly self-propagating technologies such as gene drives, also require attention (Agapito-Tenfen et al., 2018).

• Human and animal health considerations (Target 11)
Some applications—including engineered microorganisms or biological control agents—may raise questions regarding potential impacts on human and animal health in cases of environmental exposure or large-scale deployment (SCENIHR, 2015).

• Risk–benefit asymmetry (Targets 14, 20, 21, 22)
The existence of potential benefits does not preclude risks. Beneficial and adverse outcomes may occur simultaneously or at different spatial and temporal scales, requiring robust governance frameworks, monitoring and regulatory capacity.

Taken together, these considerations suggest that evaluating potential negative impacts of synthetic biology developments requires strengthening environmental risk assessment methodologies, long-term ecological monitoring and international cooperation will therefore remain important to support effective implementation of the KMGBF.

Thank you very much,
Sarah.

Robert L Unckless, Andrew G Clark, Philipp W Messer, Evolution of Resistance Against CRISPR/Cas9 Gene Drive, Genetics, Volume 205, Issue 2, 1 February 2017, Pages 827–841, https://doi.org/10.1534/genetics.116.197285

Heap, I. and Duke, S.O. (2018), Overview of glyphosate-resistant weeds worldwide. Pest. Manag. Sci, 74: 1040-1049. https://doi.org/10.1002/ps.4760

Baucom, R. S. (2019). Evolutionary and ecological insights from herbicide‐resistant weeds: what have we learned about plant adaptation, and what is left to uncover? New Phytologist, 223(1), 68-82.

Jack A. Heinemann, Deborah J. Paull, Sophie Walker, Brigitta Kurenbach; Differentiated impacts of human interventions on nature: Scaling the conversation on regulation of gene technologies. Elementa: Science of the Anthropocene 21 January 2021; 9 (1): 00086. doi: https://doi.org/10.1525/elementa.2021.00086

Henry, C (2005). Cumulative long-term effects of genetically modified (GM) crops on human/animal health and the environment: risk assessment methodologies. Reference: No 07-0402/2005/414455/MAR/B4. Available at:[ https://food.ec.europa.eu/system/files/2016-10/gmo_rep-stud_2006_report_lt-effects.pdf].

Gillett DL, Selinidis M, Seamons T, George D, Igwe AN, Del Valle I, Egbert RG, Hofmockel KS, Johnson AL, Matthews KRW, Masiello CA, Stadler LB, Chappell J, Silberg JJ. 2025. A roadmap to understanding and anticipating microbial gene transfer in soil communities. Microbiol Mol Biol Rev 89:e00225-24. https://doi.org/10.1128/mmbr.00225-24

IUCN (2019) Genetic frontiers for conservation: An assessment of synthetic biology and biodiversity conservation. Synthesis and key messages. Gland, Switzerland: IUCN. viii + 16pp.

Schmidt M, Pei L, Budisa N. Xenobiology: State-of-the-Art, Ethics, and Philosophy of New-to-Nature Organisms. Adv Biochem Eng Biotechnol. 2018;162:301-315. doi: 10.1007/10_2016_14. PMID: 28567486.

Agapito-Tenfen SZ, Okoli AS, Bernstein MJ, Wikmark OG, Myhr AI. Revisiting Risk Governance of GM Plants: The Need to Consider New and Emerging Gene-Editing Techniques. Front Plant Sci. 2018 Dec 21;9:1874. doi: 10.3389/fpls.2018.01874. PMID: 30622546; PMCID: PMC6308909.

SCENIHR (Scientific Committee on Emerging and Newly Identified Health
Risks), SCHER (Scientific Committee on Health and Environmental Risks), SCENIHR (Scientific Committee on Emerging and Newly Identified Health Risks), SCCS (Scientific Committee on Consumer Safety), Synthetic Biology III – Research priorities, Opinion, December 2015.

Dear Moderator and colleagues,
My name is Florencia Goberna. I am a biotechnologist working at the Secretariat of Agriculture, Livestock and Fisheries of Argentina. I appreciate the opportunity to participate in this exchange.
Argentina would like to align with the intervention made by Brazil. We agree that governance of synthetic biology does not start from zero, but rather builds on the broader field of modern biotechnologies, which have a long history of risk assessment and risk management. Within the framework of the Convention on Biological Diversity, the Cartagena Protocol establishes the internationally agreed methodology for the environmental risk assessment of living modified organisms, and to date organisms obtained through synthetic biology applications are considered to fall within this existing framework.
At the same time, Argentina recognizes that the most recent technological developments—particularly the convergence of synthetic biology with artificial intelligence and automation—may accelerate research and innovation processes. In this context, some of the potential negative impacts mentioned in this thread, such as challenges associated with faster development cycles, biosafety considerations, or the need to strengthen monitoring and detection capacities, deserve attention.
From Argentina’s perspective, these challenges should primarily be addressed through science-based, proportionate and case-by-case approaches within existing regulatory frameworks. Strengthening technical and regulatory capacities, together with international cooperation, will remain key elements to ensure that technological advances can be properly assessed and managed in relation to the objectives of the Convention.
In this sense, potential risks associated with the use of products derived from synthetic biology can be assessed through the regulatory frameworks already established for modern biotechnology. Countries with long-standing experience in GMO risk assessment have developed robust, science-based methodologies that have allowed evaluate  and manage risks effectively for decades. These principles remain applicable to synthetic biology products. In this context, rather than creating entirely new regulatory categories, priority could be given to capacity building, regulatory modernization, and improving the efficiency of science-based assessment processes.

Thank you.

See post under the potential positive impacts (most recent technological developments)

Dear colleagues in the forum,

We consider that the potential negative impacts of recent technological advancements in synthetic biology (after 2023) echo those of previous advancements. This is because a threefold fundamental blind spot in the analytical work remains.

1-The lack of an apropos analytical framework
First, we have been collectively unable to put together a transdisciplinary, integrative, and politically inclusive framework capable of accessing the potential negative impacts of synthetic biology across multiple scales beyond its molecular biosafety implications. This must be highlighted. Current assessments largely rely on biosafety risk-assessment frameworks, which focus primarily on molecular and technical safety considerations. These frameworks are not designed to capture the broader ecological, social, ethical, and democratical aspects of the integration of biotechnological innovations into ecosystems, including potential releases into the wild.  As long as synthetic biology applications are assessed primarily through traditional biosafety frameworks, many real-world potential negative impacts of synthetic biology remain insufficiently examined. A broader analytical approach is needed, one that incorporates perspective such as One Health, as well as the lived experiences, traditional knowledge and ecological practices embodied by Global South women, local communities, family farmers, and indigenous people. Such an approach would also need to address questions of accountability and decision-making power among public, private, and transnational actors involved in developing, leading, and deploying biotechnological applications for biodiversity purposes.

Without these perspectives, important questions remain insufficiently addressed. They relate, for instance, to the impacts of synthetic biology innovations on lived ecologies and on the rearrangements of multi-species relationships, as well as to the political goals of decisions-makers  (Policante and Borg, 2024: 80). Concerns along these lines are not restrained to the general public and other soft science actors. Researchers interviewing synthetic biologists during the COVID pandemics show that scientists themselves are concerned about potential inequitable impacts, including the possibility that synthetic biology could shift production away from communities that currently depend on biological resources for their livelihoods (Dalziell and Rogers, 2023). As long as we do not invest time, energy and resources in designing a multiscale impact assessment framework, many of the KMGBF targets are likely to remain rhetorical and lack grounds and impacts in the real world. In the worst cases, the Convention may support actions that will reveal ultimately to work against its own objectives.  

2-Credulity in synthetic biology promises
Second, as some synthetic biologists say themselves, the uncomfortable “five hard truths” of synthetic biology, identified more than fifteen years ago (Kwok, 2010), “are still hard and true” (Lux et al., 2023: 3; see also Hanson and Lorenzo, 2023: 1581). Nevertheless, our enduring naïveté regarding the economy of promises of synthetic biology innovations (Bensaude Vincent, 2013) still drive our discussions and mobilise our resources. Over one decade ago, the lack of scepticism has been observed as a characteristic shaping the synthetic biology community in her difficulty in making the part between “the possible” and “the actual” (Bensaude Vincent, 2013). More recently, this trait was observed in the “evangelical zeal” of the community (Hanson and Lorenzo, 2023: 1580). To be sure, synthetic biologists are also trying to survive in the precarious system of academic capitalism, which incites them to “talk-up promises to secure industrial funding” (Dalziell and Rogers, 2022). These dynamics have not yet been sufficiently integrated into discussions of the potential benefits and risks of synthetic biology. This omission is noteworthy because substantial human, financial, natural and energy resources can be directed toward technological pathways whose actual contributions to the socio-ecological goals of the Convention remain uncertain.

3- Neocolonial geographies of property and risks
Third, this economy of synthetic biology promises intersects with the global patent system shaping the distribution of benefits and risks associated with biotechnology While genome editing patents have grown from “96 patent families in 2014 to over 7,400 in 2020,” it has been shown that patents produce, on the one hand,  the privatization of the economic benefits of the (essentially public) development of genome editing technologies, while on the other hand, they socialize the socio-ecological risks (Borg and Policante, 2025). These risks are bared, for the most part, by the most vulnerable populations across the planet.

These well-delineated borders of “patent geographies” give rise to a “genomic neocolonialism,” led, most intriguingly, by a non-party of the Convention: “Multiple studies have mapped a geographical bias in this rapidly expanding ‘global CRISPR patent landscape,’ with an overwhelming majority of foundational CRISPR patents being held in the United States […]. US-based institutions hold most foundational patents on the CRISPR-Cas9 gene editing system and control over 47 per cent of patents related to its technical improvement and industrial applications” (Borg and Policante, 2025: 1531).

The possible oligopoly ownership over eventual biodiversity conservation tools produced by synthetic biology tools as CRISPR has not been integrated into the analysis of potential impacts. “While no statistical data are yet available, the globalization of genome editing technologies is likely to reproduce uneven global geographies of circulation of capital. Given the concentration of foundational patents in the United States, the more CRISPR-Cas9 is applied in global production, the more rents are likely to flow toward that part of the world” (Borg and Policante, 2025: 1532–1533).

For the CBD's Women's Caucus,
Daphne Esquivel-Sada (Ph.D)

References:
Bensaude Vincent B (2013) Between the possible and the actual: Philosophical perspectives on the design of synthetic organisms. Futures 48: 23–31. DOI: 10.1016/j.futures.2013.02.006
Borg E and Policante A (2025) The Gene Editing Business: Rent Extraction in the Biotech Industry. Review of Political Economy 37(4). Routledge: 1510–1545. DOI: 10.1080/09538259.2024.2401480
Dalziell J and Rogers W (2022) Are the Ethics of Synthetic Biology Fit for Purpose? A Case Study of Artemisinin [Point of View]. Proceedings of the IEEE 110(5): 511–517. DOI: 10.1109/JPROC.2022.3157825
Dalziell J and Rogers W (2023) Scientists’ Views on the Ethics, Promises and Practices of Synthetic Biology: A Qualitative Study of Australian Scientific Practice. Science and Engineering Ethics 29(6): 41. DOI: 10.1007/s11948-023-00461-1
Hanson AD and Lorenzo V de (2023) Synthetic Biology─High Time to Deliver? ACS Synthetic Biology 12(6). American Chemical Society: 1579–1582. DOI: https://doi.org/10.1021/acssynbio.3c00238
Kwok R (2010) Five hard truths for synthetic biology. Nature 463(7279): 288–290. DOI: 10.1038/463288a
Lux MW, Strychalski EA and Vora GJ (2023) Advancing reproducibility can ease the ‘hard truths’ of synthetic biology. Synthetic Biology 8(1). Oxford Academic. DOI: 10.1093/synbio/ysad014
Policante A and Borg E (2024) CRISPR futures: Rethinking the politics of genome editing. Human Geography 17(1). SAGE Publications: 76–82. DOI: 10.1177/19427786231215673

Dear Participants,

Thank you participants with sharing additional information on new technological developments and their potential negative impacts. I appreciate the posts that highlighted how the potential adverse impacts could negatively impact the achievement of the targets of the KMGMF. I believe this element will be important for the AHTEG to consider and I hope that in the time remaining further information related to the targets can also be posted.
I would also like to encourage you to also share considerations related to these applications under the thread on the potential positive impacts, as well as perspectives of some of the developments shared on the other thread here.
Thank you as well for being so proactive with sharing DOI links for the publication. I am sure the Secretariat appreciates this greatly.

As a kind reminder, the forum will close tomorrow at 5 p.m. Montreal time. I hope to see further contributions.

Best,

Martin

Dear Mr. Gerd Winter, the New Substances program’s official mandate is to protect the human health and environment of Canadians and focuses on the risk posed by the organisms. The benefits are not directly assessed, although they can be derived from the proposed use (e.g. bioremediation). The use itself must be demonstrated and is examined in the risk assessment.

However, other federal agencies in Canada who are responsible for administering other Acts, such as the Pest Control and Products Act (which an organism with a proposed use for pest control would fall under), conduct a value assessment.  A person notifying a new product has to demonstrate it has value, in addition to being safe for the human health and environment. One way to demonstrate value can be to provide data showing the effectiveness for pest control.

It is important to note that the value assessment is an additional requirement and can never override the human health and environmental safety aspects.

Dear colleagues—

I am Bob Friedman with the J. Craig Venter Institute (JCVI), a non-profit genomics research institute in the United States that has a very active synthetic biology research program.  My thanks to Martin our moderator, for guiding this discussion, and to all the participants for their useful perspectives and many relevant literature citations. Note that I am posting this note on both the “potential positive impacts” and “potential negative impacts” thread, as it is relevant to both.

Both Martin and I served on the first Synthetic Biology AHTEG in 2015.  One of the tasks undertaken by that AHTEG was to outline separate lists of “illustrative examples of potential benefits and potential adverse effects of synthetic biology in accordance with the objectives of the Convention” http://www.cbd.int/doc/meetings/synbio/synbioahteg-2015-01/official/synbioahteg-2015-01-03-en.pdf  Those tables of examples are still current today, though the many  useful interventions during this online forum have greatly expanded the list.

However, this binary approach often misses two important aspects: 1) what “technologies” are available to enhance the potential positive impacts and 2) what “technologies” are available to minimize the potential negative impacts?  Such technologies help determine the realized (rather than just the potential) positive impacts and negative impacts of synthetic biology.

I put technologies in quotes because many think of technological developments in their narrowest sense, focusing on wet-lab biotechnologies (e.g., CRISPR) and research technologies (e.g., AI, biofoundries).  Others use this term to mean a specific application of synthetic biology, sometimes as an idea on paper, or wet-lab pilot, application under testing, approved product ready for commercialization, or product already in commercial use.  2015 marked the early days of wet-lab pilots.  Eleven years later we are just beginning to see the first commercial products from these new developments in wet-lab biotechnologies and research methods.  This timeline is to be expected.

But the list above is missing entire categories of technologies that can enhance the potential positive impacts and minimize the negative impacts of these eventual products.  These include risk assessment methodologies, field testing methods, regulatory frameworks, national R&D and bioeconomy plans and similar “soft” technologies.  Indeed, many of the components of the Technology Action Plan mentioned by #3584, #3591, and #3610 (e.g., training programs) fall into this category. 

As one example of the importance of soft technologies, #3542 includes a long list of potential negative ecosystem impacts from gene drives.  However, among the significant technological developments that should be considered since the online forum last met in 2023 is the development of Biosafety Technical Series #7 “Additional voluntary guidance materials to support case-by-case risk assessments of living modified organisms containing engineered gene drives”, developed by a recent Risk Assessment AHTEG.  This document provides a framework for both regulators and developers to evaluate the potential negative ecosystem impacts #3542 and thereby avoid them.

Many colleagues have discussed new applications of gene editing technologies, for agriculture (and other sectors). Rather than my attempting to list the many research articles on gene editing for agricultural uses, the non-profit organization ISAAA has already done that here: https://www.isaaa.org/resources/genomeediting/default.asp. These applications of gene editing technologies (in all stages from wet-lab pilots to approved products in commercial use) have been accompanied by ongoing development of regulatory frameworks. For example, ISAAA has prepared a 2024 update on the “Global Regulatory Landscape for Gene Edited Crops” . As of 2024, the US, Canada, Brazil, Chile, Colombia, Ecuador, Guatamala, Honduras, Paraguay, Argentina, Australia, Japan, Philippines, India, Nigeria, Kenya, Malawi, and Ghana have issued regulations or guidelines for new breeding innovations.

Countries are also modernizing their regulatory systems to deal with other synthetic biology applications.  For example, in the United States, the National Security Commission on Emerging Technologies (a commission chartered by the US Congress) recently released a report entitled, The Future of Biotechnology Regulation, which includes over 50 in-depth options for modernizing US regulation of the next generation plant, animal, microorganism, and medical biotechnology products enabled by synthetic biology.  

Yet another crucial soft technology for minimizing the potential negative impacts of synthetic biology applications is procedures for field testing of modified organisms. #3575, #3599, and #3600 discuss new approaches for field testing of gene drives and other new biotechnologies.

Finally, at the broadest level of soft technology is an overarching governmental plan for biotechnology innovation and regulation, often as a “bioeconomy plan”.  These overarching plans are indeed very important new technological developments, as they include policies to both enhance the potential positive impacts of synthetic biology and to minimize the potential negative impacts as the technology develops. Several of the colleagues participating in this forum are skeptical that the potential benefits from synthetic biology will ever be achieved and feel that scarce resources could be better spent elsewhere.  In the end they may be correct, but R&D programs in the US, UK, Australia, Brazil, and quite a few other nations view synthetic biology as one of a small number of key technologies of the future.  The World Bioeconomy Association  includes links to over 25 national and multi-national bioeconomy strategies across the globe. (Note that not all of these bioeconomy strategies focus on biotechnology, rather on the broader use of biological resources.)

I do hope that the upcoming Synthetic Biology AHTEG includes consideration of these “soft” technological developments to enhance the potential positive impacts and to minimize potential negative impacts of synthetic biology in their deliberations.

Regards to all,
Bob Friedman

Dear colleagues—

I am Bob Friedman with the J. Craig Venter Institute (JCVI), a non-profit genomics research institute in the United States that has a very active synthetic biology research program.  My thanks to Martin our moderator, for guiding this discussion, and to all the participants for their useful perspectives and many relevant literature citations. Note that I am posting this note on both the “potential positive impacts” and “potential negative impacts” thread, as it is relevant to both.

Both Martin and I served on the first Synthetic Biology AHTEG in 2015.  One of the tasks undertaken by that AHTEG was to outline separate lists of “illustrative examples of potential benefits and potential adverse effects of synthetic biology in accordance with the objectives of the Convention” http://www.cbd.int/doc/meetings/synbio/synbioahteg-2015-01/official/synbioahteg-2015-01-03-en.pdf  Those tables of examples are still current today, though the many  useful interventions during this online forum have greatly expanded the list.

However, this binary approach often misses two important aspects: 1) what “technologies” are available to enhance the potential positive impacts and 2) what “technologies” are available to minimize the potential negative impacts?  Such technologies help determine the realized (rather than just the potential) positive impacts and negative impacts of synthetic biology.

I put technologies in quotes because many think of technological developments in their narrowest sense, focusing on wet-lab biotechnologies (e.g., CRISPR) and research technologies (e.g., AI, biofoundries).  Others use this term to mean a specific application of synthetic biology, sometimes as an idea on paper, or wet-lab pilot, application under testing, approved product ready for commercialization, or product already in commercial use.  2015 marked the early days of wet-lab pilots.  Eleven years later we are just beginning to see the first commercial products from these new developments in wet-lab biotechnologies and research methods.  This timeline is to be expected.

But the list above is missing entire categories of technologies that can enhance the potential positive impacts and minimize the negative impacts of these eventual products.  These include risk assessment methodologies, field testing methods, regulatory frameworks, national R&D and bioeconomy plans and similar “soft” technologies.  Indeed, many of the components of the Technology Action Plan mentioned by #3584, #3591, and #3610 (e.g., training programs) fall into this category. 

As one example of the importance of soft technologies, #3542 includes a long list of potential negative ecosystem impacts from gene drives.  However, among the significant technological developments that should be considered since the online forum last met in 2023 is the development of Biosafety Technical Series #7 “Additional voluntary guidance materials to support case-by-case risk assessments of living modified organisms containing engineered gene drives”, developed by a recent Risk Assessment AHTEG.  This document provides a framework for both regulators and developers to evaluate the potential negative ecosystem impacts #3542 and thereby avoid them.

Many colleagues have discussed new applications of gene editing technologies, for agriculture (and other sectors). Rather than my attempting to list the many research articles on gene editing for agricultural uses, the non-profit organization ISAAA has already done that here: https://www.isaaa.org/resources/genomeediting/default.asp. These applications of gene editing technologies (in all stages from wet-lab pilots to approved products in commercial use) have been accompanied by ongoing development of regulatory frameworks. For example, ISAAA has prepared a 2024 update on the “Global Regulatory Landscape for Gene Edited Crops” . As of 2024, the US, Canada, Brazil, Chile, Colombia, Ecuador, Guatamala, Honduras, Paraguay, Argentina, Australia, Japan, Philippines, India, Nigeria, Kenya, Malawi, and Ghana have issued regulations or guidelines for new breeding innovations.

Countries are also modernizing their regulatory systems to deal with other synthetic biology applications.  For example, in the United States, the National Security Commission on Emerging Technologies (a commission chartered by the US Congress) recently released a report entitled, The Future of Biotechnology Regulation, which includes over 50 in-depth options for modernizing US regulation of the next generation plant, animal, microorganism, and medical biotechnology products enabled by synthetic biology.  

Yet another crucial soft technology for minimizing the potential negative impacts of synthetic biology applications is procedures for field testing of modified organisms. #3575, #3599, and #3600 discuss new approaches for field testing of gene drives and other new biotechnologies.

Finally, at the broadest level of soft technology is an overarching governmental plan for biotechnology innovation and regulation, often as a “bioeconomy plan”.  These overarching plans are indeed very important new technological developments, as they include policies to both enhance the potential positive impacts of synthetic biology and to minimize the potential negative impacts as the technology develops. Several of the colleagues participating in this forum are skeptical that the potential benefits from synthetic biology will ever be achieved and feel that scarce resources could be better spent elsewhere.  In the end they may be correct, but R&D programs in the US, UK, Australia, Brazil, and quite a few other nations view synthetic biology as one of a small number of key technologies of the future.  The World Bioeconomy Association  includes links to over 25 national and multi-national bioeconomy strategies across the globe. (Note that not all of these bioeconomy strategies focus on biotechnology, rather on the broader use of biological resources.)

I do hope that the upcoming Synthetic Biology AHTEG includes consideration of these “soft” technological developments to enhance the potential positive impacts and to minimize potential negative impacts of synthetic biology in their deliberations.

Regards to all,
Bob Friedman

Dear All, thank you again for these important discussions.

Building on previous posts around the need to assess hype, structural risks, and opportunity costs, I think it may be useful to provide further examples of the advances, or lack thereof, of genetic approaches to the health and agriculture, and biodiversity to date. This may be applicable to Topic one on current benefits, but from the perspective of potential negative impacts regarding opportunity costs that may be incurred by diverting resources that could fund more effective, suitable and environmentally safe solutions, I have posted here. 
-         Oxitec’s LM mosquitoes: despite being commercially available, country (and expanding releases into several new countries), there yet appears to be publicly available data showing reduction in disease incidence, and only extremely limited data on showing any reductions in adult mosquito numbers. This was reported by the last multidisciplinary AHTEG on synthetic biology in 2023 https://www.cbd.int/doc/c/a26e/a6dc/571dd825eb08eef3865f85de/synbio-ahteg-2024-01-03-en.pdf. The mAHTEG report states: “To date, genetically engineered self-limiting insects have not been successful at addressing their intended objectives of controlling pests or reducing adult mosquito populations and disease burden”. The company, now Flyttr, appears to be offering AI services for predictive “intelligence and actionable decision support”, helping “organizations understand, plan and manage effective dengue control efforts”, including governments, employers, insurers, healthcare providers, military installations, hospitality services and others. It further claims to be capable of “Multi-scale risk predictions: From the national level down to individual streets and buildings, delivered in seconds”, and can “plan targeted dengue interventions up to 8 weeks ahead”. Yet, I am unable to find evidence to substantiate such claims from the information provided  https://flyttr.com/dengue/#about.

In this context, it is thus also important in my view, to critically assess the potential for other emerging LM mosquito approaches such as precision-guided sterile LM mosquitoes that utilise CRISPR-based systems, as well as the use of gene drives to achieve their purported aims. This is important in the context of alternative innovations that are progressing, as well as broader challenges to efficacy raised by issues such as drive resistance development, pathogen resistance development, the need to target multiple species, potential for niche replacement and other challenges https://doi.org/10.1093/jme/tjaf007. Moreover, Packard (2008 doi: 10.3201/eid1410.080834) notes that a narrow focus on biomedical approaches such as vector control have had limited success outside of economically well-off nations, where long term elimination is supported by healthcare systems and other social-determinants of health, and/or specific geographical locations such as islands. It is vital that synthetic biology applications are broadly assessed with regards to national contexts and needs, and not determined by external funder priorities. The development of today’s lead anti-malarial drugs from traditional medicine, also serves as a pertinent reminder of the potential for home-grown, and locally appropriate solutions to be expanded upon.  Undue focus on speculative technologies risks undermining sovereign solutions suitable to local contexts and needs.
-          Oxitec’s LM fall armyworm: this application appears to be limited for use alongside LM ‘Bt’ crops, with the aim of staving off resistance evolution to, and thus protecting the utility of, the LM crop system. This is a rising challenge that has resulted in numerous repeated crop failures with adverse negative impacts on farmers, particular small holder farmers in resource limited settings e.g. see https://www.twn.my/title2/biosafety/pdf/bio19.pdf. It appears that developers acknowledge the lack of efficacy of the LM fall armyworm outside the insect resistant LM crop context, while efficacy data even for within the LM crop context remains limited (Reavey et al., 2022 https://doi.org/10.1186/s12896-022-00735-9). This issue was also included in the 2023 multidisciplinary AHTEG, which concluded that LM self-limiting insects raise considerations including “Challenges to agrobiodiversity and sustainable use, through the extension of monoculture industrial agricultural systems.”
-      Genome edited crops: 1) a lead trait remains herbicide tolerance for both transgenesis and genome editing e.g. doi: 10.3390/genes16050553, despite the decades of promises for innovative traits to address ecological, farming and food challenges with LMO technologies. 2) One of the only crops that appears to be currently on the shelves, the high GABA tomato, also confers questionable benefits. There is a lack of data showing impacts or bioavailability of GABA following consumption. There are existing non-GM versions of this trait, and also recent reports show the edited tomato selling at astronomical prices to consumers (see review https://www.genewatch.org/uploads/f03c6d66a9b354535738483c1c3d49e4/gene-editing-left-behind-fin.pdf). One benefit may be increased consumer by-in for genome editing applications, however. Meanwhile, benefits have been advanced using agroecological approaches with regard to biodiversity, socio-economic outcomes, nutrition and food sovereignty, that warrant increased resources and capacity. https://ipes-food.org/wp-content/uploads/2024/03/UniformityToDiversity_FULL.pdf https://www.fao.org/agroecology/home/en/ https://www.fao.org/fileadmin/user_upload/hlpe/hlpe_documents/HLPE_S_and_R/HLPE_2019_Agroecological-and-Other-Innovative-Approaches_S-R_EN.pdf
-          For microorganism applications, I would like to bring attention to the recent study that performed a broader sustainability analysis of engineered microorganisms including genome edited microorganisms. Broader sustainability analyses looked at the suitability of these products in achieving their claimed sustainability and efficacy goals e.g. reducing emissions for algal biofuel products, and reducing synthetic nitrogen fertilizers, for the GM soil bacterial product. The study identified more complex questions around their potential viability in achieving their purported goals. For example, the GM bacteria for nitrogen production would “fall short of achieving EU policy targets” for reducing nitrogen fertilizer use. For the biofuels application, such assessments suggest that GM algae would be economically unattractive due to their sensitivity to environmental conditions; the potential for genetic changes and adaptability with engineering approaches, and further, that “robust containment is rather unrealistic”. https://doi.org/10.3390/ijms26073174
-    De-extinction:  LM genome edited grey wolves as proxies for extinct Dire Wolf, as well as other similar de-extinction projects have raised widespread criticism for the false claims made and questionable benefits e.g. https://www.science.org/content/article/dire-wolf-back-dead-not-exactly . De-extinction efforts may lead to opportunity costs and misplaced priorities as real conservation projects are increasingly ignored https://doi.org/10.1038/s41559-016-0053
https://www.genewatch.org/uploads/f03c6d66a9b354535738483c1c3d49e4/chimera-briefing-fin.pdf

Thank you very much
Eva

Dear colleagues

In posts #3610, #3492 and #3606 there is some important regulation information including the extension and/or update of GMO regulations to include synthetic biology. That synthetic biology regulation doesn't 'start from zero' is noteworthy and this is something the AHTEG perhaps should take into account as part of their analysis to consider risk management that is in place or being developed.

Scientific advancements should be approached with transparency, balance and adequate consideration of the potential risks and benefits. Australia supports a balanced, case-by-case, science-based risk assessment approach in relation to modified organisms and products of synthetic biology.

Australia has a rigorous scheme in place for the regulation of all living modified organisms (LMOs), including synthetic organisms.
• This includes provisions to impose licence conditions if LMOs are being released into the environment, and requirements for containment and safe handling of LMOs not authorised for release.
• All work with LMOs is supported by a thorough risk assessment and risk management process based on current science.

This regulatory framework is implemented by the Office of the Gene Technology Regulator (OGTR). The OGTR considers and focusses on understanding risks, managing risk through licensing and approvals, and managing risks arising from potential or apparent non-compliant activity (through monitoring, compliance, and enforcement).

Further this, in November 2023 Australia’s National Science Agency, CSIRO, published the Access and Benefit-Sharing for Australian Synthetic Biologists: A Tool for Risk Management.

https://research.csiro.au/aeb/wp-content/uploads/sites/448/2023/12/Access_Benefit_Sharing_Risk_Management_Tool_SynBio.pdf

The Risk Management Tool is designed to give synthetic biologists and those in related fields an introduction to access and benefit-sharing laws implemented under the CBD and its Nagoya Protocol, and guidance on assessing risks when accessing and using genetic resources from different countries. The Tool provides a risk framework to help users of genetic resources make informed decisions about access and benefit-sharing including: 
- The legal background of access and benefit-sharing and how it translates to research requirements. 

- Explanation of key terminology such as digital sequence information, prior informed consent and mutually agreed terms. 

- The process for accessing genetic resources originating from overseas and how access and benefit-sharing differs. 

- A ‘risk framework’ that balances compliance against uncertainty to deliver better ethical, legal and social outcomes. 

Guidance and publicly available information like the Risk Management Tool help users weigh the risks and responsibilities of R&D and navigate the complexities of access and benefit-sharing to facilitate comprehensive and considered research outcomes.

Dear Moderator and colleagues,
My name is Cinthia Soberanes Gutiérrez, PhD in Chemical-Biological Sciences. I am Investigadora por México affiliated with the Executive Secretariat of the Intersecretarial Commission on Biosafety of Genetically Modified Organisms (CIBIOGEM), Mexico.
Recent technological developments in synthetic biology — including programmable genome editing, engineered microbial systems, and gene-drive architectures — are frequently presented as promising tools for addressing environmental challenges. However, their potential implications must be carefully examined in light of the three objectives of the Convention on Biological Diversity (CBD) and the implementation of the Kunming-Montreal Global Biodiversity Framework (KMGBF).
From the perspective of megadiverse countries and centres of origin of crop diversity, recent developments in synthetic biology raise important biosafety and governance questions. Synthetic biology applications designed for environmental release may generate novel pathways for gene flow into wild relatives and traditional crop varieties, potentially affecting genetic diversity and long-term ecosystem resilience. Gene flow from engineered organisms to wild populations is a well-documented concern in biosafety science and remains particularly relevant for countries where domesticated crops coexist with diverse wild relatives (Ellstrand et al., 2013, https://doi.org/10.1111/mec.12348).
This issue is especially significant in centres of origin and diversification of crops, where the conservation of genetic diversity is directly linked to food security, cultural heritage and ecosystem stability. Scientific literature has highlighted that synthetic biology interventions in conservation or agriculture may challenge existing governance frameworks and raise complex ecological and ethical questions when genetic modifications interact with natural populations (Redford et al., 2013, https://doi.org/10.1371/journal.pbio.1001530; Lean, 2024, https://doi.org/10.1080/21550085.2023.2298646).
Recent technological developments such as engineered gene drives further illustrate these concerns. Gene drives are specifically designed to spread genetic traits through populations, potentially altering entire species or ecosystems. Their ecological consequences remain uncertain, particularly in biodiverse regions where species interactions and evolutionary dynamics are insufficiently understood (Esvelt & Gemmell, 2017, https://doi.org/10.7554/eLife.03401).
Similarly, synthetic biology approaches involving engineered microbes for environmental applications may introduce organisms with novel metabolic functions into complex ecosystems. While these approaches are often proposed for pollution remediation or climate mitigation, their environmental behavior and long-term ecological interactions remain uncertain (Aminian-Dehkordi et al., 2023, https://doi.org/10.1016/j.biotechadv.2023.108239).
These considerations are directly relevant to several KMGBF targets, including:
Target 4 (halting species extinction)
Target 7 (reducing pollution risks)
Target 10 (sustainable agriculture)
Target 17 (strengthening biosafety frameworks)
In this context, discussions on recent technological developments in synthetic biology should carefully distinguish between technological potential and demonstrated outcomes, and should prioritize robust risk assessment, monitoring capacity and precautionary governance frameworks, particularly in countries with high biodiversity and centres of crop domestication.
Ensuring that technological innovation does not compromise biodiversity conservation requires integrating biosafety science, socio-economic considerations and the protection of traditional agricultural systems, while fully respecting the objectives of the CBD and the commitments under the KMGBF.
Thank you for the opportunity to contribute to this important discussion.

Cinthia Soberanes Gutiérrez
Executive Secretariat of the Intersecretarial Commission on Biosafety of Genetically Modified Organisms (CIBIOGEM), Mexico.

Dear all,

thanks for the possibility to contribute to the discussion.

My name is Christoph Then, I am working for Testbiotech (http://www.testbiotech.org).  Testbiotech is a NGO based in Germany, working on impact assessment in the field of biotechnology. We evaluate available information from the perspective of the protection of health, the environment and nature.

Testbiotech is active in horizon scanning on SynBio / genome editing / new genetic engineering since nearly ten years. I give a short overview on some publicatons we were involved in that gather available information and were published between 2023 till 2026. I hope this is useful for further debates.


2026:
> “… far beyond any control or prediction”
The convergence of genetic engineering and AI: risks to biodiversity
https://www.testbiotech.org/publikation/convergence_ai_genetic_engineering/

This report examines the convergence of artificial intelligence (AI) and genetic engineering. The report focuses in particular on risks to biodiversity, including examples such as insecticidal maize, robot-adapted flowers, genetically engineered insects, microorganisms and viruses.

>A crack in creation?
Release of NGT organisms may disrupt the ecosystems
https://www.testbiotech.org/publikation/a-crack-in-creation/

The environmental risks of NGT plants have been repeatedly described in scientific literature. These include negative effects on pollinators and food webs, invasiveness, weakening of natural plant populations, yield depression, insect toxicity and effects on soil organisms. The Testbiotech report lists examples of risks and specific genetic changes of NGT organisms, that differ significantly from those found in nature or can be expected from conventional breeding.


2025:
> Use of new genetic engineering in farmed vertebrates: a critical assessment, https://www.testbiotech.org/publikation/use-of-new-genetic-engineering-in-farmed-vertebrates-a-critical-assessment/

The report gives an overview on the application of new genetic engineering (or new genomic techniques, NGTs) in vertebrates used for the production of food. The special focus of this report is on the protection of animals, health and the environment. New genetic engineering can be used to bring about genetic changes in vertebrates that go beyond what is currently possible, or might be expected, from applying conventional breeding methods.

> Koller, F. (2025) The Potential of NGTs to Overcome Constraints in Plant Breeding and Their Regulatory Implications. Int J Mol Sci, 26(23), 11391. https://doi.org/10.3390/ijms262311391

A systematic study on the differences between conventional plant breeding and new genetic engineering (NGT) was published in the International Journal of Molecular Sciences. The study includes examples such as NGT strawberries, switch grass, camelina, corn, poplars, rice, lettuce, mustard, tomatoes and wheat. The genetic changes involved are often minor, yet the results differ significantly from those achieved through conventional breeding.

> Juhas, M., Rodekohr, B., Bauer-Panskus, A., & Then, C. (2025) Combining AI and new genomic techniques (NGTs) to 'fine-tune'plants: Challenges in risk assessment. Front Plant Sci, 16: 1677066. https://doi.org/10.3389/fpls.2025.1677066

The blueprint for a genetically engineered insecticidal maize was published in the journal Frontiers in Plant Science. Artificial intelligence (AI) for production by NGTs (new genomic techniques, or new genetic engineering). The AI-design uses new genetic engineering to intervene in the gene regulation of plants, and thus increase the concentration of a specific protein that also occurs in conventionally-bred plants, but is expressed in a different manner.


2024:
> Koller, F., Cieslak, M., Bauer-Panskus, A. (2024) Environmental risk scenarios of specific NGT applications in Brassicaceae oilseed plants. Environ Sci Eur, 36(1), 189. https://doi.org/10.1186/s12302-024-01009-1

This publication in Environmental Sciences Europe highlights the environmental risks associated with oilseeds, e.g. oilseed rape, camelina or pennycress, in which genetic material has been altered with new genetic engineering techniques (new genomic techniques, NGTs). It argues for the need for NGT plants to be risk assessed before released into the environment, even if no additional genes are inserted.


> What is a mammoth doing on mars?
Why we must protect our biosphere from genetic engineering
https://www.testbiotech.org/en/publikation/what-is-a-mammoth-doing-on-mars/

This report is on recent developments in genetic engineering / SynBio and their potential environmental impacts. In this context, so-called ‘outdoor genetic engineering’ is an especially relevant. This involves releasing organisms into the environment in order to genetically engineer natural populations. The process of genetic transformation is thus being moved from the laboratory directly into the environment.


2023
> Koller, F., Schulz, M., Juhas, M., Bauer-Panskus, A., Then, C. (2023) The need for assessment of risks arising from interactions between NGT organisms from an EU perspective. Environ Sci Eur,
35(1), 27. https://doi.org/10.1186/s12302-023-00734-3

This scientific publication focuses on interactions between NGT organisms with various traits after their release into a shared environment. A large number of NGT organisms across a broad range of traits and species have been developed in laboratories in recent years. Many of them may be released into the environment in the near future.

> Koller, F., & Cieslak, M. (2023) A perspective from the EU: unintended genetic changes in plants caused by NGT—their relevance for a comprehensive molecular characterisation and risk assessment. Front Bioengin Biotechnol, 11. https://doi.org/10.3389/fbioe.2023.1276226

This review focuses on findings in regard to unintended genetic changes that can be caused by the application of NGTs. It concludes that unintended genetic changes caused by NGT processes are relevant to risk assessment. Due to the technical characteristics of NGTs, the sites of the unintended changes, their genomic context and their frequency (in regard to specific sites) can cause gene combinations (intended or unintended) that is unlikely to occur with conventional methods.

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

Application of new technologies can often carry some level of risk.  Regulatory authorities are tasked with reviewing products to support environmental, human, plant, and animal health.  The United States has a coordinated and comprehensive risk assessment system to protect the environment and human, plant, and animal health; assess and manage any plausible health and environmental risks posed by biotechnology products; and ensure biotechnology products are safe for the environment, health, research, production, and trade.  This system facilitates oversight of near-future applications of biotechnology products that focuses on the characteristics of the biotechnology product, the environment into which it will be introduced, and the application of the product, in a case-by case manner, rather than the process by which the product is developed.   

The United States believes that regulation and oversight of technologies, like some synthetic biology techniques, should protect safety, health, and the environment while avoiding unjustifiable barriers to innovation, stigmatization of new technologies, or creation of trade barriers.  Regulation and oversight should be based on the best available scientific evidence and be implemented with an awareness of the potential benefits and the potential costs of such regulation and oversight.  To the extent possible, new technologies and their applications should be considered within existing governance and legal frameworks.  As with all technologies, policies should enable innovation and investment and avoid ex ante regulation.  A balanced approach should be taken to provide sufficient flexibility to continually accommodate new knowledge, taking into account the evolving nature of emerging biotechnologies and their applications.  

Using current laws and regulations, the United States addresses a range of products developed using genetic engineering.  The United States re-evaluates its regulations and approaches as new information and techniques become available.  Governments, academia, and private sector partners should collaborate to review governance and oversight mechanisms to consider near-future applications in ways that reduce risk and realize the benefits of these technologies as described in Target 17 of the Kunming-Montreal Global Biodiversity Framework.  The U.S. government welcomes the opportunity to work with partners to better understand the state of scientific advances, near-future applications of synthetic biology technologies, and to engage stakeholders to achieve benefits and mitigate risks. 

The United States acknowledges that as synthetic biology progresses, its dual-use potential also increases.  In response, the United States is implementing new policies for nucleic acid synthesis screening and establishing rigorous review processes for gain-of-function biological research. These measures aim to ensure that the promise of synthetic biology is realized while minimizing the risk of misuse.

https://www.whitehouse.gov/presidential-actions/2025/05/improving-the-safety-and-security-of-biological-research/ 

In the United States’ experience with minimizing risk of negative impact, and when making a policy decision regarding the safe handling and use of an organism, it is most valuable to consider: 1) the modified characteristics of the organism in question, 2) the biology of the organism, and 3) the receiving environment.  Assessments should leverage familiarity with previously reviewed organisms with similar traits, focus data collection for an organism on identified risks, and consider knowledge and experience from comparable scenarios.  There are numerous internationally recognized resources that provide frameworks for how to consider the characteristics of organisms: 

United States Environmental Protection Agency (EPA): 

https://www.epa.gov/risk/risk-assessment-guidelines 

International Plant Protection Convention (IPPC):  

https://www.ippc.int/en/core-activities/capacity-development/training-material-pest-risk-analysis-based-ippc-standards/  

http://www.fao.org/docrep/009/a0450e/a0450e00.htm  

http://www.acfs.go.th/sps/downloads/34163_ISPM_11_E.pdf  

Organization for Economic and Cooperation and Development (OECD):  

http://www.oecd.org/chemicalsafety/biotrack/oecdandrisksafetyassessmentinmodernbiotechnology.htm   

https://one.oecd.org/document/ENV/CBC/MONO(2023)30/en/pdf 

World Organization for Animal Health (OIE):  

http://www.oie.int/en/our-scientific-expertise/specific-information-and-recommendations/invasive-alien-animal-species/  

World Health Organization (WHO):  

http://www.who.int/tdr/publications/year/2014/guide-fmrk-gm-mosquit/en/

Dear Moderator and colleagues,         
Several posts in this thread have highlighted the importance of regulatory preparedness and robust biosafety frameworks when considering the potential benefits of synthetic biology. In particular, posts such as #3565 (Topic 1), #3595 (Topic 1), #3508, emphasise that effective governance requires comprehensive risk assessment, regulatory capacity and precaution when technologies move from contained systems into open environmental contexts. Building on those observations, I would like to raise an example that illustrates the regulatory and ecological complexity involved: the potential use of synthetic biology to engineer bee microbiota, and how this relates to a more holistic understanding of biodiversity.
Honeybees and other pollinators host complex microbial communities that play essential roles in immunity, nutrition, pathogen resistance and overall colony health. Recent research has explored the possibility of modifying or introducing engineered microorganisms into bee gut microbiomes to address diseases such as viral infections or fungal pathogens (DOI: 10.1126/science.aax9039; https://doi.org/10.1016/j.cois.2025.101416; US Patent #US20190015528; DOI: 10.1038/nrmicro.2016.43). While these approaches are often presented as promising tools to support pollinator health, they also raise significant regulatory and ecological questions.

First, the ecological context in which bees operate makes containment extremely challenging. Unlike industrial or medical applications that occur in controlled environments, pollinators interact with diverse ecosystems across large geographic areas. Bees visit thousands of flowers, interact with numerous plant species and encounter other insects and environmental microbiomes. As a result, engineered microorganisms introduced into bee populations could spread beyond the intended host through shared floral resources or environmental exposure. This raises concerns regarding horizontal gene transfer, unintended colonization of non-target organisms and disruption of existing microbial communities (https://doi.org/10.1080/03014223.2024.2353285; DOI:10.3389/fpls.2022.839446).

Microbiome engineering also blurs established regulatory categories such as “contained use” versus “deliberate release” and “veterinary product” versus “pesticide.” Existing legal frameworks were not designed for potentially self-disseminating organisms, leaving significant gaps in regulatory oversight.

The 2025 Ad Hoc Technical Expert Group (AHTEG) on Risk Assessment under the Convention on Biological Diversity further confirms that microorganisms fall within the scope of the Cartagena Protocol on Biosafety as products of modern biotechnology. However, the AHTEG report also highlights substantial technical and regulatory challenges specific to microorganisms. Living modified microorganisms may cause adverse effects on biodiversity and ecosystems and may also have indirect implications for human health. The report therefore concludes that microorganisms present particular challenges for the current Protocol and that additional guidance may be required (Convention on Biological Diversity, AHTEG on Risk Assessment Report, CBD/CP/RA/AHTEG/2025/1/3).

Second, altering bee microbiota could have implications for pathogen dynamics. Bees act as vectors for numerous viruses and pathogens, and modifying their microbiomes could influence disease transmission pathways in ways that are not yet well understood. Changes to microbial communities may unintentionally facilitate the persistence or spread of pathogens within pollinator populations or across species. Given the central ecological role of pollinators in both agricultural and natural ecosystems, such changes could have cascading effects on plant reproduction and ecosystem functioning (https://doi.org/10.1073/pnas.2220922120; DOI: 10.1016/j.cois.2020.08.006; DOI: 10.1016/j.cois.2020.09.007).

This example highlights the importance of considering biodiversity from a holistic perspective. Biodiversity encompasses not only individual species but also the complex interactions among species, their associated microbiomes and the ecosystems they inhabit. Pollinators, plants, microbes and pathogens form interconnected ecological networks that support essential ecosystem services such as pollination, food production and ecosystem resilience. Interventions that modify one component of this network—such as the microbiota of pollinators—may therefore have indirect and cumulative effects across genetic, species and ecosystem levels of biodiversity https://doi.org/10.1038/s41467-026-70117-8; ​​https://doi.org/10.3390/f15101701.

As noted in several contributions to this forum, many synthetic biology applications remain at early research stages. Translating laboratory findings into real-world ecosystems introduces multiple layers of uncertainty. In complex ecological systems, interventions that appear beneficial at the organism level may produce unintended outcomes at population, community or ecosystem scales. This reinforces the importance of regulatory approaches that explicitly account for ecological relationships and long-term ecosystem dynamics.

In this sense, the example of bee microbiota illustrates the need for biosafety and regulatory frameworks capable of addressing not only direct effects on target organisms but also broader biodiversity interactions and ecosystem functions. Strengthening interdisciplinary risk assessment, long-term monitoring and precautionary governance will therefore be essential to ensure that emerging synthetic biology applications are evaluated within the full ecological context in which biodiversity operates.

Thank you, Dr Syafruddin (#3563), for raising the important issue of ecological uncertainty and potential impacts of synthetic biology on ecosystem integrity and ecosystem services such as pollination. Pollinators are fundamental to biodiversity, ecosystem functioning and food security, and their decline already represents a major global concern (https://doi.org/10.5281/zenodo.3402856; https://doi.org/10.1016/j.pld.2022.01.005; DOI:10.1126/science.1235464).

Recent scientific statements and assessments highlight that emerging technologies—including RNAi-based approaches and engineered microbial communities—may introduce additional uncertainties. Potential risks include non-target effects on pollinators, disruption of host–microbiome relationships (holobionts), horizontal gene transfer and cascading effects across food webs and ecosystem functions ( https://doi.org/10.1016/j.tree.2024.08.001; DOI:10.54203/jlsb.2024.10; https://doi.org/10.1525/elementa.2021.00086; https://food.ec.europa.eu/system/files/2016-10/gmo_rep-stud_2006_report_lt-effects.pdf];https://doi.org/10.1525/elementa.2021.00086;https://food.ec.europa.eu/system/files/2016-10/gmo_rep-stud_2006_report_lt-effects.pdf).

These issues are directly relevant to the objectives of the Convention on Biological Diversity, particularly Article 8 on in-situ conservation, and to the Kunming–Montreal Global Biodiversity Framework (KMGBF), including Targets 7 (pollution reduction), 13 (fair and equitable benefit-sharing) and 17 (biosafety). They reinforce the importance of precautionary approaches and robust environmental risk assessment when considering technologies intended for environmental release.

As highlighted in posts #3596 and #3592, strengthening scientific infrastructure, regulatory expertise and international cooperation remains essential to enable developing countries to independently assess and govern emerging technologies. At the same time, earlier contributions (#3508, #3608) emphasise the importance of robust environmental risk assessment and monitoring frameworks before wider application is considered. The point raised in post #3596 (regarding technology transfer and capacity in developing countries) is particularly important. While access to technologies and scientific cooperation are key implementation mechanisms under CBD Article 18, such transfers must ensure that technologies are locally appropriate, environmentally sound and supported by adequate regulatory and assessment capacity. Without sufficient safeguards, countries with limited regulatory infrastructure may bear disproportionate burdens related to risk management, liability or unintended environmental consequences.

Looking ahead to the ongoing work of the Ad Hoc Technical Expert Group (AHTEG) on Synthetic Biology and the subsequent discussions in SBSTTA, SBI and COP, it is important to recall that the potential benefits and risks of synthetic biology have already been examined extensively in previous CBD processes. These discussions consistently highlight both potential opportunities and significant uncertainties associated with emerging applications.

In this context, the proposed Thematic Action Plan on Synthetic Biology should reflect a balanced understanding of these issues. Capacity-building is indeed essential, but it should primarily strengthen the ability of Parties—particularly developing countries—to assess, monitor, regulate and manage potential risks and uncertainties. Many proposed applications remain highly speculative, and for those few products already commercialized, independent data on long-term ecological impacts—including effects on pollinators and other non-target organisms—remain limited.

A stronger emphasis on risk assessment, biosafety capacity, multidisciplinary research, monitoring and precautionary governance, consistent with CBD Articles 8, 18 and 19 and the ecosystem approach, would help ensure that innovation pathways do not outpace the scientific understanding and regulatory safeguards needed to protect biodiversity.

Ensuring that the outcomes of the upcoming AHTEG process appropriately inform future discussions in SBSTTA and SBI will therefore be important for achieving a balanced and credible framework—one that supports scientific cooperation and capacity-building while safeguarding biodiversity, ecosystem services such as pollination, and the equitable participation of developing country Parties, Indigenous Peoples and local communities.

Dear colleagues,

Thank you again for these important contributions. I would like to highlight an issue that may not constitute a negative impact in itself, but that could potentially lead to negative impacts on biodiversity.

Several colleagues have referred to genetically engineered microorganisms [#3507], [#3545] and many others. European risk assessors have examined existing environmental risk assessment (ERA) frameworks and found that the tools currently available are not well suited to assess the impacts of genetically modified microorganisms (https://doi.org/10.3390/ijms26073174).

The authors analyse two case studies, genetically modified microalgae for biofuel production and nitrogen-fixing genetically modified soil bacteria intended for use as biofertilizers, which help illustrate some of the limitations of current ERA approaches. They conclude that environmental risk assessment for genetically modified microorganisms is more challenging than for genetically modified plants. As they state: “We stress that the existing guidance for risk assessment and monitoring of GMMs is insufficient to assess and mitigate associated risks for production systems and the environment.”

This appears to raise a broader challenge for discussions under the CBD, namely that our current scientific understanding of microorganisms may still be too limited to reliably predict their potential impacts on biodiversity. In this context, applying the precautionary principle, as articulated in the preamble of the Convention, may be an important consideration.

It may also present a challenge for the AHTEG, as both robust benefit assessment tools to thoroughly explore the potential benefits of genetically modified microorganisms, and sufficiently developed risk assessment tools to evaluate their possible impacts on biodiversity, remain limited.

Dear colleagues,
Mirror life and mirror molecules are increasingly recognized as posing significant biosafety and biosecurity threats (Adamala et al., 2024. DOI: 10.1126/science.adq4111). Despite thoughtful efforts led primarily by scientists to move beyond the traditional argument that scientific exploration should remain unrestricted—even when risks appear substantial and applied benefits marginal—this emerging field demands urgent consideration within CBD frameworks.
While informal limitations have been placed on research, the absence of binding international agreements creates a regulatory vacuum. It would be incongruous for a treaty organization like the CBD not to consider mirror life within the context of its mandate, particularly given the lack of complete consensus within the affected scientific community regarding appropriate restrictions. This may also need to extend to mirror molecules (https://doi.org/10.1016/j.tree.2025.10.016) in the context of conservation.
As noted by Zhu (2025), "the scientific community remains divided on what mirror research should be proscribed" (DOI: 10.1038/d41586-025-02912-0). This uncertainty underscores the need for proactive policy development rather than reactive responses to potential threats.
Significantly, one of the primary applications promoted for mirror life involves plastic degradation in the environment, which directly aligns with all three objectives of the CBD treaty and the targets of the Kunming-Montreal Global Biodiversity Framework (KMGBF). This environmental remediation potential cannot be divorced from the associated risks when evaluating the technology's place in biodiversity conservation strategies.
As far as I can tell, mirror life has not been mentioned in any postings across the four CBD forums (please correct me if this observation is incomplete). Equally, no reference to mirror life appears in the 2024 AHTEG assessment document (https://www.cbd.int/doc/c/0294/7330/f9ea93365f931fd81964aec8/synbio-ahteg-2024-01-inf-01-en.pdf).
This omission, in my opinion, requires attention this year. The CBD process should either:
1. Address the topic — examining both the risks and benefits of mirror life research and applications
2. Provide explicit justification — explaining why mirror life continues to be excluded from consideration
The AHTEG and this forum should not selectively focus on the least problematic and most optimistic examples that synthetic biologists can envision, particularly when more challenging developments warrant serious discussion.
The willingness of the CBD to address problematic techniques is evidenced in the 2024 document by the discussion of self-spreading viral techniques (https://www.cbd.int/doc/c/0294/7330/f9ea93365f931fd81964aec8/synbio-ahteg-2024-01-inf-01-en.pdf), and in  Post #3531 (Charity Serwaa, ASSB/Ghana) and Post #3550 (Moderator Martin Batič. Recent developments in AI over the past year have further expanded the potential scope of self-spreading viral techniques:
• AI-Driven Gene Design: Recent advances in overlapping gene design using deep generative models (Byeon et al., 2025. DOI: 10.1101/2025.05.06.652464) demonstrate sophisticated computational approaches to genetic engineering.
• Bacteriophage Engineering: Novel bacteriophage design using genome language models (King et al., 2025. DOI: 10.1101/2025.09.12.675911) represents another frontier in synthetic biology with potential applications in self-spreading systems.
Additionally concerning is the restart of Australian mammalian self-spreading sterilization programs, as evidenced by recent research on virus-vectored immunocontraceptive candidates derived from felid alphaherpesvirus 1 (Cottingham et al., 2024. DOI: 10.1016/j.vaccine.2024.05.047).
The CBD's oversight of mirror life research represents a significant gap in current biosafety governance. Given the technology's potential environmental applications and inherent risks, this omission undermines the comprehensive approach necessary for effective biodiversity protection. The time for proactive engagement with this technology has arrived—waiting for clearer scientific consensus or more developed applications may compromise the CBD's ability to effectively govern emerging biotechnologies.
The international community must grapple with these challenges in BOTH mirror life and self-spreading viral techniques now, not after they become established facts. The CBD framework provides the appropriate venue for this critical discussion.
Best regards,
Guy Reeves

Hello colleagues
Thank you for these important contributions; and raising broader environmental concerns regarding emerging technologies (#3534). I would like to build on this point and the observations made in comments #3547 and #3546 regarding the continued development of herbicide-tolerant traits using synthetic biology tools, including genome editing.

Although often presented as technological innovation, many current developments appear to follow the same trajectory as earlier generations of genetically modified crops. Herbicide-tolerant systems are closely associated with large-scale applications of synthetic herbicides, which have well-documented adverse effects on biodiversity, including impacts on pollinator abundance and diversity. Herbicide-intensive agriculture can reduce plant diversity and eliminate non-crop vegetation that provides habitat and food resources for insects, birds and soil organisms. These changes can cascade through ecological networks, contributing to declines in insect populations and negative impacts on pollinators, which are essential for biodiversity, ecosystem functioning and global food production. Associated pesticide regimes have also been linked to increased herbicide use and biodiversity loss (e.g. https://doi.org/10.1098/rstb.2003.1403; https://link.springer.com/article/10.1186/s12302-016-0100-y; https://doi.org/10.1111/joac.70006).

These impacts are directly relevant to the objectives of the Convention on Biological Diversity and the implementation of the Kunming–Montreal Global Biodiversity Framework, particularly Target 7 on reducing pollution risks from pesticides and hazardous chemicals.

There may also be significant opportunity costs associated with prioritising such technological pathways. Investments in synthetic biology applications that reinforce pesticide-dependent agricultural systems could divert financial resources, research capacity and policy attention away from alternative approaches that may carry fewer ecological risks or be more appropriate for diverse regional contexts, particularly in developing countries (e.g. https://doi.org/10.1038/461472a; https://www.aphis.usda.gov/sites/default/files/24d_deis.pdf)
In this context, assessments under the Convention should consider not only the genetic technologies themselves, but also the agricultural systems and chemical inputs associated with these traits, and their cumulative impacts on biodiversity and ecosystem services such as pollination.

Dear All,

Some potential negative impacts that are particularly relevant to the environmental release of LM animals developed using synthetic biology techniques e.g. those targeted at de-extinction, gene drives or livestock farming:

- Pathogen resistance traits risk generating pathogen reservoirs with biosecurity risks of pathogen evolution; novel spillover events.  For example, a recent  paper (Ikoko-Akoh et al., 2023) on the development of genome edited chickens designed to be resistant to avian flu, reports that the mutations in the bird flu virus unexpectedly allowed the virus, that is usually limited to birds, to use the two shorter proteins, which also occur in humans, and thus the virus partially adapted itself for replication in mammals (potentially including humans). See also: (see ‘Biosecurity under threat: Gene-edited animals, plants and microorganisms’ https://www.genewatch.org/uploads/f03c6d66a9b354535738483c1c3d49e4/gw-biosecurity-briefing-fin.pdf). Nonetheless, as raised in previous posts, Porcine Reproductive and Respiratory Syndrome Virus-Resistant Pigs have been developed, and are already approved in several countries.

- A related concern is that a gene edited disease-resistant animal may be infected but not show symptoms of disease, perhaps benefitting the individual animal but putting other animals at increased risk. In animals, these problems are compounded by the difficulties described above in scaling up production to create large herds or flocks: this process is likely to be too slow to keep up with fast evolving pathogens. (see Genewatch, 2025 https://www.genewatch.org/uploads/f03c6d66a9b354535738483c1c3d49e4/gw-response-to-efsa-genetically-modified-animals-fin.pdf).

- unintended effects of GM process (e.g. on and off-target effects) resulting in novel hazards (e.g. transfer of antibiotic resistance genes in the hornless cattle (Norris et al., 2019), production of novel allergens/toxins with implications for food safety, food webs and wider ecological interactions.

- unintended effects and animal welfare issues associated with reproductive supportive techniques such as cloning, that may result in mosaicism, deformities, still births, miscarriages and early animal death that are used to generate various animal species via genetic engineering/synbio techniques. (Kirkden et al., 2012; Megraver et al., 2019; Srirattana et al 2022, Salvesen et al., 2024). Repeated cloning may also be required (e.g. Mueller et al., 2019).

- Socio-economic effects could adversely impact traditional and local farming systems, e.g. via unintended impacts such pathogen evolution, displacement of native farming species, divergence of economic resources away from proven or safer solutions (e.g. access to healthcare in the case of health applications).


Idoko-Akoh, A., Goldhill, D. H., Sheppard, C. M., Bialy, D., Quantrill, J. L., Sukhova, K., Brown, J. C., Richardson, S., Campbell, C., Taylor, L., Sherman, A., Nazki, S., Long, J. S., Skinner, M. A., Shelton, H., Sang, H. M., Barclay, W. S., & McGrew, M. J. (2023). Creating resistance to avian influenza infection through genome editing of the ANP32 gene family. Nature Communications, 14, 6136. https://doi.org/10.1038/s41467-023-41476-3

Kirkden, R. D., & Broom, D. M. (2012). Welfare of Genetically Modified and Cloned Animals Used for Food. Retrieved from Compassion in World Farming (CIWF) website: https://www.ciwf.org.uk/media/4237869/welfare_of_genetically_modified_and_cloned_an imals_used_in_food.pdf

Mehravar, M., Shirazi, A., Nazari, M., & Banan, M. (2019). Mosaicism in CRISPR/Cas9- mediated genome editing. Developmental Biology, 445(2), 156–162. https://doi.org/10.1016/j.ydbio.2018.10.008

Mueller, M. L., Cole, J. B., Sonstegard, T. S., & Van Eenennaam, A. L. (2019). Comparison of gene editing versus conventional breeding to introgress the POLLED allele into the US dairy cattle population. Journal of Dairy Science, 102(5), 4215–4226. https://doi.org/10.3168/jds.2018-15892

Salvesen, H. A., Grupen, C. G., & McFarlane, G. R. (2024). Tackling mosaicism in gene edited livestock. Frontiers in Animal Science, 5. https://doi.org/10.3389/fanim.2024.1368155

Srirattana, K., Kaneda, M., & Parnpai, R. (2022). Strategies to Improve the Efficiency of Somatic Cell Nuclear Transfer. International Journal of Molecular Sciences, 23(4), 1969. https://doi.org/10.3390/ijms23041969

Tan, W., Proudfoot, C., Lillico, S. G., & Whitelaw, C. B. A. (2016). Gene targeting, genome editing: from Dolly to editors. Transgenic Research, 25(3), 273–287. https://doi.org/10.1007/s11248-016-9932-x

Thank you very much to Mr. Martin Batič for moderating this discussion

My name is Ediner Fuentes-Campos, Environmental Engineer with a Master's degree in Environmental Microbiology, member of the National Biosafety Commission of Panama, national focal point for the Cartagena Protocol on Biosafety, and former member of the OECD expert advisory group on synthetic biology.

The Cartagena Protocol on Biosafety constitutes the internationally agreed normative framework for the risk assessment of living modified organisms, and it is worth noting that the contributions shared in this forum have not presented evidence that the technological developments described generate organisms that fall substantially outside the definition of LMO established under the Protocol. This reinforces the continued relevance of the existing framework as a solid basis for addressing the challenges raised, a perspective I share with what has been noted in #3585 and #3610, and which I also find consistent with the observations presented in #3626.

The potential impacts identified throughout this thread should be addressed in a proportionate, science-based, and fundamentally case-by-case manner. This approach, already enshrined in the Cartagena Protocol, is not a limitation but rather the methodological strength that enables rigorous and adaptable governance. In technical terms, case-by-case assessment considers in an integrated manner the genetic modifications introduced and their stability, the biological and ecological properties of the organism, the conditions of the receiving environment, the potential for environmental persistence and dispersal, the potential for horizontal gene transfer, and possible effects on non-target organisms — all articulated with the analysis of exposure and the environmental fate of the organism. This methodological rigor, already embedded in the existing framework, allows each application to be evaluated according to its specific characteristics, avoiding generalizations that do not reflect the real diversity of contexts and applications encompassed by synthetic biology. In that regard, I share the perspective of #3634 that assessments should leverage familiarity with previously reviewed organisms with similar traits, focusing data collection on the risks identified for each specific case.

I would also like to highlight the point made in #3623 on the importance of considering regulatory frameworks and risk assessment methodologies as relevant technological developments in their own right. This perspective is valuable because it reminds us that the capacity to adequately evaluate and manage emerging technologies is itself a technical achievement that deserves to be recognized and strengthened. Along these lines, #3608 underscores that evaluating potential negative impacts requires strengthening environmental risk assessment methodologies and international cooperation, and #3563 emphasizes the need for rigorous risk assessment and continuous monitoring to ensure alignment with the KMGBF targets — both positions fully compatible with the instruments already available under the Protocol. In this context, the most recent OECD prospective analyses on synthetic biology identify relevant trends arising from the convergence of these technologies with artificial intelligence and automation, and propose precisely the strengthening of adaptive governance mechanisms and international collaboration in assessment infrastructures as priority responses (OECD, 2025a; OECD, 2025b).

In that regard, I wish to emphasize that the greatest value this forum and the upcoming AHTEG can contribute is to direct available resources toward the effective strengthening of national risk assessment capacities under the Cartagena Protocol. In a context of significant budgetary constraints facing the United Nations system, it is especially important that resources be directed as a priority toward ensuring that countries — particularly developing ones — have the technical tools, trained personnel, and institutional infrastructure needed to fully implement the instruments already available. International cooperation among Parties in this direction constitutes, in my view, the most concrete and lasting contribution that can emerge from these processes.

Ediner Fuentes-Campos
National Focal Point — Cartagena Protocol on Biosafety
Republic of Panama

References
OECD (2025a). Synthetic Biology, AI and Automation. OECD Publishing, Paris. https://doi.org/10.1787/12158721-en
Robinson, D. and Nadal, D. (2025b). "Synthetic biology in focus: Policy issues and opportunities in engineering life", OECD Science, Technology and Industry Working Papers, No. 2025/03, OECD Publishing, Paris. https://doi.org/10.1787/3e6510cf-en
Thank you very much.

Dear Dr. Guy Reeves,

I fully agree with your post and was also going to raise the attention of this forum towards mirror life and mirror molecules.

The 299-page technical report (doi.org/10.25740/cv716pj4036) that was published on mirror bacteria in Dec 2024 by a group of experts from multiple disciplines (evolutionary biology, zoology, botany, genetics, immunology, biochemistry, and microbiology) is of high quality and could be used as a basis for reflection. These authors estimate that mirror bacteria could be created within 15 to 30 years, or even sooner if substantial resources are invested in a targeted effort.

With best regards,

Virginie Courtier-Orgogozo

If I can also add, that traits such as herbicide tolerance, and pathogen resistance raise biosafety considerations that cannot be mediated by technical precision, or type of modification introduced into the target species. Whether the engineered species has a targeted single base change, or an untargeted transgenic insertion, risks of mass herbicide use or pathogen evolution are not eliminated. This has implications regarding the deregulation of certain genome edited organisms, despite clear risks to biodiversity and human health. Many thanks, Eva

Dear participants,

Besides my post #3542 about potential negative impacts of CRISPR-based meiotic gene drives, I would like to add general, ethical considerations associated with synthetic biology.

Preliminary points:
0) In the governance of synthetic biology, cost–benefit assessments appear unavoidable: decisions regarding the development and deployment of biotechnological innovations inevitably require weighing potential benefits against possible ecological, social, and ethical risks.
00) Because both the technologies involved and the environments in which they may be implemented vary widely, such evaluations should be conducted on a case-by-case basis.
As Ediner Fuentes-Campos (post #3650) rightly writes: "The potential impacts identified throughout this thread should be addressed in a proportionate, science-based, and fundamentally case-by-case manner. This approach, already enshrined in the Cartagena Protocol, is not a limitation but rather the methodological strength that enables rigorous and adaptable governance."

In this post, I would like to describe two broader frameworks that may provide useful guidance for structuring these assessments and clarifying the underlying value judgments.

1) French philosopher Catherine Larrère distinguished three major orientations in environmental ethics:
- anthropocentrism: in which moral consideration is primarily centered on human interests and values
- biocentrism: where what matters most is each living being, recognizing the intrinsic value of life beyond human utility
- ecocentrism: where what matters most is the entire ecosystem, including the many species and their physical environment. In this perspective, ethical evaluation focuses not only on individual entities but also on the integrity and functioning of ecosystems.
Larrère, C. (2006). “Éthiques de l’environnement.” Multitudes, 24, 75–84. doi.org/10.3917/mult.024.0075
https://philopedia.org/topics/environmental-ethics/
In fact, each person possesses a particular mix of these three orientations, each at different levels. And for a given person these levels can change with the topic of interest.
I also tend to add two extra categories:
- econocentrism: when economical considerations play an important part
- sociocentrism: which considers that not all human beings are equal, and that certain categories (usually the wealthiest) can have rights higher than others. This later view, unfortunately still very common, is against the third objective of the CBD treaty and the targets of the Kunming-Montreal Global Biodiversity Framework (GBF) and should be prohibited.


2) Another framework to conceptualize the potential negative impacts associated with synthetic biology is to consider these general questions:
- what is the persistence of the synthetic biology element? How long will it persist in the environment?
- Can it create copies of itself? Can it spread? If so, what does it require to spread/create copies of itself? If so, are there methods to counteract its spread in case negative impacts are found?
- Can it evolve into an element with different properties? (via mutations for example)

This conceptualization has been used recently to evaluate the potential negative impacts of mirror life and mirror molecules (see also post #3644): an international group of experts from multiple disciplines wrote a high quality report in Dec 2024 on mirror life and an associated article published in Science (doi.org/10.1126/science.ads9158) where they highlight that the potential negative impacts of mirror living organisms is much larger than the ones of mirror molecules (which cannot make copies of themselves).


I think that these two frameworks can help for the cost/benefit assessment.
With best regards,

Virginie Courtier-Orgogozo

I am Marcos Filardi, Researcher at ETC Group. I would like to thank the moderator and all the participants in this online forum for their insightful reflections and offer ETC Group’s views to feed the debate on current and potential negative impacts of technological developments in synthetic biology.

1) A human rights-based approach for technological developments in synthetic biology

Section C, par. 7 g) of KMGBF indicates that “The implementation of the Framework should follow a human rights-based approach, respecting, protecting, promoting and fulfilling human rights. The Framework acknowledges the human right to a clean, healthy and sustainable environment”.
In the same line, Section C, par. 7 j) establishes that “the Framework needs to be implemented in accordance with relevant international obligations. Nothing in this Framework should be interpreted as agreement to modify the rights and obligations of a Party under the Convention or any other international agreement”.
The “Guidance on integrating human rights in National Biodiversity Strategy and Action Plans (NBSAPs)”( https://www.cbd.int/doc/nbsap/Integrating-human%20rights-in-NBSAPs.pdf ) and the Briefing Note “Applying a human rights-based approach in line with Section C of the Kunming-Montreal Biodiversity Framework”(https://www.ohchr.org/sites/default/files/documents/issues/climatechange/materials/briefing-note-applying-a-human-rights-based-approach-in-line-with-sectionc-kunming-montreal.pdf) should inform all areas of work at CBD, including the discussions on synthetic biology.
In this light, in its Advisory Opinion on “The Environment and Human Rights” (OC-23), the Inter-American Court of Human Rights (IACHR) expressed that “The obligation to ensure the rights recognized in the American Convention entails the duty of States to prevent violations of these rights” (par. 127). “Bearing in mind that, frequently, it is not possible to restore the situation that existed before environmental damage occurred, prevention should be the main policy as regards environmental protection” (par. 130). According to the IACHR, to comply with the obligation of prevention, States must:
1) Regulate;
2) Supervise and monitor;
3) Require and approve environmental impact assessments according to the following standards:
a) The assessment must be made before the activity is carried out.
b) It must be carried out by independent entities under the State’s supervision.
c) It must include the cumulative impact.
d) It must guarantee the participation of interested parties.
e) It must respect the traditions and culture of indigenous peoples.
f) Its content will depend on the specific circumstances and the level of risk involved.
4) Prepare a contingency plan
5) Mitigate if environmental damage occurs
(pars. 141-174).
The IACHR also expressed that “States must act in keeping with the precautionary principle. Therefore, even in the absence of scientific certainty, they must take “effective” measures to prevent severe or irreversible damage” (pars.175-180).
See https://www.corteidh.or.cr/docs/opiniones/seriea_23_ing.pdf
In the same line, in its General Comment 25 on “Science and economic, social and cultural rights (article 15 (1) (b), (2), (3) and (4) of the International Covenant on Economic, Social and Cultural Rights)”, the United Nations Committee on Economic, Social and Cultural Rights indicated, among other things relevant to the discussion in this online forum, that the “precautionary principle should be able to address available risks for human health and the environment, inter alia. Thus, in controversial cases, participation and transparency become crucial because the risks and potential of some technical advances or some scientific research should be made public in order to enable society, through informed, transparent and participatory public deliberation, to decide whether or not the risks are acceptable” (pars. 56-57).
See https://digitallibrary.un.org/record/3899847?ln=es&v=pdf
In ETC Group’s view, all human rights principles, standards and obligations should be integrated into CBD’s analysis, decisions and policies on synthetic biology.
Considering these principles, for example, the trend for deregulation of gene edited crops, well described in comments #3552 and #3562, might be incompatible with human rights obligations.

2) AI and Synthetic Biology

Comments #3519, #3520, #3535, #3562, #3585, #3610 and #3633 referred to the potential negative impacts of the increasing integration of large language models and synthetic biology. Along with the African Centre for Biodiversity (ACB) and the Third World Network (TWN), ETC Group produced the report “Black Box Biotech” as a timely warning about the risks, hype and inequities underpinning generative biology, where we address the implications of applying ‘generative’ artificial intelligence (AI) tools to generate novel digital sequences for genetically modified organisms (GMOs) and proteins. See https://www.etcgroup.org/content/black-box-biotechnology
More recently, ETC Group produced the report “AI's Large Looting Models? The Emerging Generative Biology Stack as the Next Frontier of Biopiracy”, where we highlight urgent data justice concerns: renewed bioprospecting to feed AI models, the conversion of biodiversity into proprietary digital assets, erosion of consent and benefit-sharing, and the acceleration of digital biocolonialism. We also analyzed how GenBio threatens to displace livelihoods, erode biocultural rights, strain biosafety regimes, and entrench philanthrocapitalist and military agendas. See https://www.etcgroup.org/content/ais-large-looting-models-emerging-generative-biology-stack-next-frontier-biopiracy
We therefore call CBD for a urgent, multidisciplinary, participatory and thorough assessment of the risks associated to the increasing integration of AI and synthetic biology.

3) Immediate halt on herbicide tolerant (HT) traits in synthetic biology applications and phase-out plans for existing ones

ETC Group fully supports comments #3547 and #3647 and, building on it, advocates for an immediate halt on the continued use of herbicide tolerant (HT) traits via synthetic biology tools and techniques, including genome editing. The impacts of herbicide tolerant crops on biodiversity have been well studied (for eg https://link.springer.com/article/10.1186/s12302-016-0100-y) and synthetic biology must not be replicated to exacerbate these harms (https://doi.org/10.1186/s12940-025-01187-2) or further drive up pesticide use. (https://doi.org/10.1186/s12940-025-01187-2). HT is simply incompatible with the Objectives of CBD, targets of KMGBF and human rights obligations. Apart from the scientific references quoted in comment #3547, almost all the human rights bodies have expressed how herbicide tolerant crops and their associated pesticides infringe the free and full enjoyment of human rights and have called States to divert from them and promote public policies of transition to agroecology. See, for eg, Report of the United Nations Special Rapporteur on the Right to Food on Pesticides and Human Rights, available at: https://www.ohchr.org/en/documents/thematic-reports/ahrc3448-report-special-rapporteur-right-food
Therefore, an immediate halt for new applications and phase-out plans for existing ones should be agreed at CBD.

4) Gene drive organisms

As referred to in comments #3531, #3535, #3542, #3562 and #3600, gene drives come with serious and irreversible risks for biodiversity. Gene drives are built to intentionally spread their implanted traits through an entire population, including to cause a whole species to become extinct or replaced. The consequences of releasing gene drive organisms into the wild is unknown and could be devastating to ecosystems, agriculture and other life support systems.
ETC Group's reports “Gene drives organisms. An introduction to a new dangerous technology putting Africans at risk”, available at https://www.etcgroup.org/content/gene-drive-organisms and “Driven to Extinction. Bill Gates and Gene Drive Extinction Technology”, available at https://www.etcgroup.org/content/driven-extinction, explore the many ways in which this dangerous technology puts communities and the environment, particularly in Africa, at risk.

5) The need for precautionary and robust regulatory frameworks for synthetic biology

Several comments (#3508, #3553, #3596, #3563. #3571 and #3600, among others, highlighted the need for precautionary and robust regulatory frameworks for synthetic biology.
In this regard, long time ago, along with Friends of the Earth and CTA, ETC Group issued the declaration “The Principles for the Oversight of Synthetic Biology”, where we outlined the following principles necessary for the effective assessment and oversight of the emerging field of synthetic biology: I. Employ the Precautionary Principle; II. Require mandatory synthetic biology-specific regulations; III. V. Protect public health and worker safety; IV. Protect the environment; V. Guarantee the right-to-know and democratic participation; VI. Require corporate accountability and manufacturer liability and VII. Protect economic and environmental justice. See https://www.etcgroup.org/content/principles-oversight-synthetic-biology

6) Threats to livelihoods of communities

Comments #3559 and #3614 raised the concern on the potential negative impact of synthetic biology applications on the livelihoods of communities.
In the report “Synthetic Biology, Biodiversity & Farmers. Case studies exploring the impact of synthetic biology on natural products, livelihoods and sustainable use of biodiversity” we outlined how 13 specific products (vanilla and artemisinin among them) are being bio-synthetically created and how traditional livelihoods may be adversely affected as these synthetic biology substitutes enter the market. See https://www.etcgroup.org/content/synthetic-biology-biodiversity-farmers

7) The need to dig deeper into the Politics of Technology of synthetic biology

In our report “The Politics of Technology”, produced along with A Growing Culture, we explored the ways in which we tend to be oriented toward technology (averse, neutral, positive) and we proposed the alternative “Political”: technological politics is a way of framing technologies as neither “good”, “bad”, or “neutral”. It suggests that, instead, technologies are the products of deeply political processes, knowledge, and systems. The politics of technology encourage us to ask more questions, like: Who decided we needed the technology? Who designed it? Who is the technology designed for? Where did the parts of the technology come from? Who gathered the raw materials needed to build it? What was the ecological impact of gathering those resources? Who built the technological object? Who implemented the technology? Who owns the intellectual property rights? Who has access to the technology, and who doesn’t? Who profits from the technology? What practices did it alter or displace?
In this way, we can begin to engage with technologies as processes by which social, economic, political, and ecological relationships are negotiated and transformed. The political roots of that transformation lie in the purpose for which a technology was created.
See https://www.etcgroup.org/sites/www.etcgroup.org/files/files/politics_of_technology_en_-_digital_0.pdf
Some of these questions (broader and structural like technological lock-inns, patents, narrow approaches, credulity in promises, neocolonial relations) have been raised in different comments in the forum (#3596, #3608, #3614, among others) which shed light on the underlying power relations involved in the discussion on the technological developments on synthetic biology.
For ETC it’s imperative to address technological developments on synthetic biology as political and, therefore, dig into those critical questions through a participatory multidisciplinary assessment of all their economic, social, cultural, ethical and human rights implications.

8) Imperative for a needs assessment

Among the most important questions when seeing technology as “political” is who decides that it’s needed. In ETC Group’s view, before any technological development in synthetic biology goes through a robust risk assessment, it is imperative that it passes through a formal, participatory “needs assessment” process, for all interested (and potentially impacted) actors to collectively assess beforehand whether it responds to their needs, rather being imposed upon them. This process must fully consider opportunity costs, alternatives, efficacy, and risks, among other parameters.

9) Precautionary approach towards microbial applications

ETC fully endorses comment #3593 and #3631 on the need to guarantee a precautionary approach towards microbial applications to fulfill the objectives of CBD, KMGBF targets and human rights obligations. As well expressed there, microorganism applications, particularly those aimed at environmental release, raise many potential negative impacts, due to their capacity for rapid replication, spread and persistence, and gene flow, making them impossible to predict and control, and added evolutionary dimensions.

10) Hype vs. reality

Many comments in the forum have called for the need to separate the hype from reality (notably #3596 and #3625, among others). As many comments in the discussion on “current benefits” point out, it’s almost impossible to find examples of current benefits of synthetic biology, and currently, as comment #3534 expresses, “there are no essential use benefits”. On the contrary, there are current and potential, real and possibly irreversible negative impacts of technological developments in synthetic biology that need to be given serious consideration in the AHTEG and other CBD spaces.

Hello, everyone.
I’m Kathleen Lehmann working at the Directorate-General for Health and Food Safety of the European Commission. I’m a member of this year’s AHTEG of synthetic biology (SynBio) and was also a member of the last multidisciplinary AHTEG, participating for the European Union. My general background is in biochemistry and I’m a specialist for regulation and risk assessment of genetically modified organisms, including for SynBio.

Since 2023, the role of Artificial Intelligence (AI) in SynBio has continued to grow, with general and domain-specific large language models, such as GPT-4, BioGPT, Evo, Evo 2 and BioMedLM, enabling advances, for example, in de novo protein design and genetic circuit development.

Hybrid AI – which integrates predictive, generative, and symbolic AI methods – offers a framework for advancing agricultural synthetic biology by being able to integrate a wide range of data sources and by considering structured relationships between genes, traits and environmental variables.

While these developments are new, it must be stated that organisms modified with or obtained by SynBio, with or without the help of AI tools, can have the same potential negative environmental impacts as established living modified organisms pertaining to persistence and invasiveness (KMGBF Target 6), gene transfer to wild relatives (KMGBF Target 4), interactions with non-target organisms (KMGBF Targets 10 and 13), resistance development (KMGBF Target 10), effects on biodiversity (KMGBF Targets 1 and 4) and cumulative and long-term effects (KMGF Targets 1, 4, 6, 8 and 10). A potential increase in the speed of developing new organisms with SynBio as promised through the use of AI does not per se aggravate these potential negative impacts.

The European Food Safety Authority (EFSA) has concluded that the requirements of the EU regulatory framework and existing EFSA guidelines are adequate for the molecular characterisation and environmental risk assessment of SynBio products to be developed up to 2030 (KMGBF Target 17). EFSA also acknowledges that as SynBio approaches evolve, a need may arise to adjust risk assessment guidelines to ensure that they remain adequate and sufficient (EFSA Panel on GMOs 2021. Evaluation of existing guidelines for their adequacy for the molecular characterisation and environmental risk assessment of genetically modified plants obtained through synthetic biology: EFSA Journal 20(7), https://doi.org/10.2903/j.efsa.2021.6301; EFSA GMO Panel , 2022. Scientific Opinion on the evaluation of existing guidelines for their adequacy for the food and feed risk assessment of genetically modified plants obtained through synthetic biology. EFSA Journal 2022;20(7):7410, 25 pp.; EFSA Scientific Committee, 2022. Scientific Opinion on the evaluation of existing guidelines for their adequacy for the food and feed risk assessment of microorganisms obtained through synthetic biology. EFSA Journal 2022;20(8):747; EFSA Scientific Committee, 2020. Scientific Opinion on the evaluation of existing guidelines for their adequacy for the microbial characterisation and environmental risk assessment of microorganisms obtained through synthetic biology. EFSA Journal 2020;18(10):6263). The work of EFSA has been supported by horizon scans of SynBio developments (Cécile J.B. van der Vlugt, 2020. Horizon Scan of Synthetic Biology Developments for Microorganisms with application in the Agri-Food sector. EFSA supporting publication 2020:EN-1664.22 pp. doi:10.2903/sp.efsa.2020.EN-1664; Katharina Unkel, Doerthe Krause, Thorben Sprink, Frank Hartung, Ralf Wilhelm, 2020. Mapping of plant SynBio developments in the agri-food sector. EFSA supporting publication 2020:EN-1687. 36 pp. doi:10.2903/sp.efsa.2020.EN-1687).

In addition, there is an intense debate about the possibility and feasibility of creating new organisms from scratch through SynBio and AI. In a recent book (On the Future of Species: Authoring Life by Means of Artificial Biological Intelligence, Adrian Woolfson Bloomsbury (2026)), the author considers that creating genomes from scratch is not inherently dangerous, but we are acquiring tools powerful enough to remake life while lacking the theoretical understanding needed to control the consequences (AI tools can design genomes. Will they upend how life evolves?).

References:
Brixi et al. (2025) Genome modeling and design across all domains of life with Evo 2. Nature. 2026 Mar 4. doi: 10.1038/s41586-026-10176-5. 

Goshisht, M.K. (2024) Machine Learning and Deep Learning in Synthetic Biology: Key Architectures, Applications, and Challenges, ACS Omega 9 (9), 9921-9945, https://pubs.acs.org/doi/10.1021/acsomega.3c05913

Najafabadi, M.Y. & Jackson, S.S. (forthcoming) Hybrid AI in synthetic biology: next era in agriculture. Trends in Plant Sciences, https://www.cell.com/trends/plant-science/fulltext/S1360-1385(25)00237-7.

Thank you, Martin, for raising this important question.
In my view, several recent technological developments since the previous forum in March 2023 deserve particular attention because they could increase the scale, speed, persistence or governance complexity of synthetic biology applications with possible implications for the three objectives of the Convention and the implementation of the KMGBF.
A first notable development is the continued technical progress in CRISPR-based gene drive systems. In 2024, researchers reported that a multiplexed, confinable CRISPR/Cas9 gene drive could propagate in caged Aedes aegypti populations, with the carrier frequency rising from 50% to as high as 89% in the cage trial. In the same period, researchers also reported gene drive and genetic sex conversion in the agricultural pest Ceratitis capitata (Mediterranean fruit fly). These developments are important because they move the discussion beyond theory and toward more operational gene drive designs in disease vectors and agricultural pests.
Anderson, M.A.E. et al. (2024) A multiplexed, confinable CRISPR/Cas9 gene drive can propagate in caged Aedes aegypti populations. Nature Communications. DOI: https://doi.org/10.1038/s41467-024-44956-2
Meccariello, A. et al. (2024) Gene drive and genetic sex conversion in the global agricultural pest Ceratitis capitata. Nature Communications. DOI: https://doi.org/10.1038/s41467-023-44399-1
A second development is the growing focus on engineered bacteria intended for environmental release, including proposed uses in agriculture, environmental cleanup, biosensing, biomining, self-repairing materials and anti-corrosion applications. Recent work has emphasized that such applications shift biosafety concerns from simple laboratory containment to the much harder question of how to control persistence, spread, and horizontal gene transfer in open environments. That is highly relevant for biodiversity because open-environment use creates the possibility of ecological persistence, unintended interactions with native microbiota, and movement of engineered genetic material beyond the intended setting.
Chemla, Y. et al. (2024) Engineering Bacteria for Environmental Release: Regulatory Challenges and Design Strategies. Preprint. DOI: https://doi.org/10.22541/au.171933709.97462270/v1
George, D.R. et al. (2024) A bumpy road ahead for genetic biocontainment. Nature Communications. DOI: https://doi.org/10.1038/s41467-023-44531-1
A third major development is the rapid convergence of artificial intelligence and synthetic biology, including AI systems that can interpret and generate genomic sequences at very large scale, and AI-assisted protein and genome-editor design. In 2024, the Evo model was presented as a multimodal model able to interpret and generate genomic sequences across the prokaryotic tree of life. In 2025, researchers also reported model-guided design of highly functional genome editors beyond naturally occurring diversity. These developments could lower technical barriers, accelerate design cycles, and increase dual-use concerns, including the possibility of faster design of organisms or biological components whose ecological and biosafety properties are not well understood.
Nguyen, E. et al. (2024) Sequence modeling and design from molecular to genome scale with Evo. Science. DOI: https://doi.org/10.1126/science.ado9336
Ruffolo, J.A. et al. (2025) Design of highly functional genome editors by modelling the universe of CRISPR systems. Nature. DOI: https://doi.org/10.1038/s41586-025-09298-z
Woolhouse, M. et al. (2024) Protein design meets biosecurity. Science. DOI: https://doi.org/10.1126/science.ado1671
Bloomfield, D. et al. (2024) AI and biosecurity: The need for governance. Science. DOI: https://doi.org/10.1126/science.adq1977
A fourth development, which in my view is especially important for the AHTEG to note, is the emergence of mirror life as an explicit synthetic biology governance issue. In late 2024, a large group of researchers published a warning in Science arguing that mirror bacteria and other mirror organisms should not be created unless compelling evidence emerges that they would not pose extraordinary dangers. Their concern is that self-replicating mirror organisms could interact with ecological and immunological systems in ways that are difficult to predict and potentially very harmful. Although mirror bacteria do not yet exist, the fact that this issue has now moved into a serious scientific risk discussion is itself a notable recent development in the field.
Adamala, K.P. et al. (2024) Confronting risks of mirror life. Science. DOI: https://doi.org/10.1126/science.ads9158
Technical Report on Mirror Bacteria: Feasibility and Risks (2024): https://stacks.stanford.edu/file/druid%3Acv716pj4036/Technical%20Report%20on%20Mirror%20Bacteria%20Feasibility%20and%20Risks.pdf (Science)
A fifth area is the continued advance of de-extinction and synthetically assisted conservation technologies, particularly through combinations of genome editing, cloning, stem-cell approaches and assisted reproduction. A 2025 review in the Journal of Heredity shows that these tools are increasingly being discussed not only for de-extinction narratives but also for conservation applications such as restoring traits or genetic variation. However, these approaches also raise concerns about ecological mismatch, invasive-like behavior, uncertain welfare outcomes, and diversion of resources and political attention away from habitat protection and the conservation of extant species.
Turner, S.D. et al. (2025) De-extinction technology and its application to conservation. Journal of Heredity. DOI: https://doi.org/10.1093/jhered/esaf069
Genovesi, P. & Simberloff, D. (2020) “De-extinction” in conservation: Assessing risks of releasing genetically modified organisms into the wild. Current Opinion in Environmental Science & Health. DOI: https://doi.org/10.1016/j.coesh.2020.03.004 (OUP Academic)
From the perspective of the three objectives of the Convention, the potential negative impacts of these developments could be substantial.
For the conservation of biodiversity, the main concerns include unintended spread across ecosystems or across borders, irreversible modification or suppression of wild populations, impacts on non-target organisms, disruption of food webs, horizontal gene transfer, and longer-term ecosystem effects that may be difficult to reverse once release occurs. These concerns are especially clear for gene drives, engineered organisms intended for environmental release, and any future mirror-life or de-extinction applications. In my assessment, the KMGBF targets that could be most directly negatively affected here are Target 4 on halting extinction and maintaining genetic diversity, and Target 6 on preventing the introduction and establishment of invasive alien species. This mapping is my inference from the target texts and the technologies noted above.
CBD Target 4: https://www.cbd.int/gbf/targets/4/
CBD Target 6: https://www.cbd.int/gbf/targets/6/ (Convention on Biological Diversity)
For the sustainable use of biodiversity, a key concern is that some applications could be deployed with a narrow production or technical objective while their broader ecological effects remain insufficiently understood. For example, engineered microbes or genetically altered pest-control systems might reduce one pressure while creating others, especially if persistence, gene flow, ecosystem interactions or cumulative effects are underestimated. In that sense, synthetic biology could also challenge implementation of Target 14, which calls for biodiversity to be integrated into planning, regulation, environmental impact assessment and decision-making across sectors.
CBD Target 14: https://www.cbd.int/gbf/targets/14/ (Convention on Biological Diversity)
For the fair and equitable sharing of benefits, the rapid expansion of AI-enabled design and synthetic genomics also sharpens existing concerns around digital sequence information (DSI), traceability, concentration of technological capacity, and the possibility that commercial value may be derived from biodiversity-related data without fair benefit-sharing, meaningful technology transfer, or adequate recognition of associated traditional knowledge. In that respect, Target 13 may also be negatively affected if governance does not keep pace with these developments.
CBD Target 13: https://www.cbd.int/gbf/targets/13/
IUCN (2024) Synthetic biology in relation to nature conservation, especially the sections noting the relevance of ABS and DSI: https://portals.iucn.org/library/sites/library/files/documents/2024-004-En.pdf (Convention on Biological Diversity)
In addition, several of these developments raise broader governance concerns relevant to Targets 21 and 22, particularly where scientific uncertainty is high, data and methods are not equally accessible, or affected communities and Indigenous Peoples and local communities are not meaningfully involved in decision-making. These targets are directly relevant because they concern access to knowledge, information, participation, and respect for traditional knowledge and rights.
CBD Target 21: https://www.cbd.int/gbf/targets/21/
CBD Target 22: https://www.cbd.int/gbf/targets/22/ (Convention on Biological Diversity)
Overall, I would suggest that the AHTEG pay particular attention to the following as notable post-March 2023 developments:
(1) more operational and scalable gene drive systems;
(2) the transition toward engineered microbes for environmental release;
(3) AI-accelerated biological design that lowers barriers and increases dual-use concerns;
(4) the emergence of mirror life as a serious biosafety and biosecurity concern; and
(5) increasingly sophisticated de-extinction / synthetically assisted conservation approaches. Taken together, these developments suggest that the main risks are no longer only hypothetical “synthetic biology in general,” but increasingly concern deployability, scalability, persistence, transboundary effects, and governance lag.
At the same time, I would underline that the evidence base is not equally mature across all of these examples. For mirror life, for example, the risk discussion is serious and scientifically grounded, but self-replicating mirror organisms have not been created; therefore any ecological impact remains a forward-looking risk assessment rather than an observed environmental outcome.

Dear All,

As raised in post  #3654, humans rights considerations are relevant to the CBD, Section C of the Kunming-Montreal Global Biodiversity Framework (KMGBF), which states: “Implementation of the Framework should follow a human-rights based approach, respecting, protecting, promoting and fulfilling human rights.”

Relevant to such consideration is the topic of eDNA collection, which is often described as a non-invasive approach. However, with regard to human rights risks, eDNA collection has the potential to be in fact, quite invasive. I would like to point to this recent Nature paper, where studies aiming at assessing eDNA from wildlife, also inadvertently caught human DNA, at sufficient levels for it to be identifiable to individuals.  It is increasingly apparent that human DNA presence is ubiquitous in environmental samples. This raises serious ethical concerns due to risks of an erosion privacy, surveillance, discrimination and other issues that are rightly recognised and regulated within human research. The Nature paper calls for novel regulation to ensure against human rights breaches of eDNA use. https://doi.org/10.1038/s41559-023-02056-2 Risks of evading consent during research using eDNA has also been raised. https://doi.org/10.1007/s44206-023-00077-9 

https://www.annualreviews.org/content/journals/10.1146/annurev-ecolsys-110617-062306 And while there are potential uses for eDNA, there are also challenges to the efficacy of eDNA that needs to also be considered, in order to protect against failures of the technology or opportunity costs.

Many thanks
Eva

Dear colleagues,

Thank you for sharing your reflections on this topic!

Some colleagues have mentioned synthetic biology as potentially beneficial for animal welfare or for breeding animals for organ transplants [#3590]. In my view, the latter aspect may fall outside the scope of our current discussion in relation to biodiversity. 

I would like to draw attention to a very interesting publication by Leonie Bossert and Thomas Potthast (https://doi.org/10.5840/enviroethics202442674), which provides valuable insights into the ethical dimensions of genetically engineering wild animals and its potentially negative impacts. They address the three main goals for engineering wild animals namely to protect them, to de-extinct them and to eradicate them. The authors look at development, rewilding challenges, moral responsibility (to engineer or not wild animals), human-animal relationship, the concept of wildness and the last resort argument. I can highly recommend. 

A recent report from New Zealand reviewing genetically engineered animal trials conducted between 2015 and 2024 at the AgResearch Ruakura facility offers relevant insights. Although these trials were carried out in the context of livestock farming and medical applications, they may nevertheless help illustrate some of the challenges that genetically engineered animals could raise in the context of nature protection. The report documents chronic health problems, deformities, high rates of abortion, premature deaths, and the routine euthanasia of animals due to suffering across all genetically engineered animal lines. These issues reportedly persisted despite technical developments from earlier transgenic techniques to newer gene-editing approaches. According to the report, most of these animal experiments have since been discontinued ( https://www.gefree.org.nz/assets/pdf/GE-Animals-in-New-Zealand.pdf).

Dear valued colleagues and moderator,

I am Oliver Ryder, a conservation scientist with the non-profit San Diego Zoo Wildlife Alliance and have worked in conservation genetics and genomics, ex situ population management, linking ex situ and in situ conservation, biobanking viable cell cultures, and genetic rescue.

One current example of the application synthetic biology relevant to KMGBF Target 4 is the successful cloning of the black-footed ferret, Mustela nigripes, to restore genetic variation no longer present in the living population (doi: 10.1093/jhered/esv041; doi: 10.1101/2024.04.17.589896). Three female black-footed ferrets have been cloned from cryopreserved cell cultures derived from a wild black-footed ferret that died in 1988. One of the clones has bred with a current-generation male and produced offspring. (https://www.fws.gov/carp/story/cloned-black-footed-ferret-kits-offer-hope-species) No cloned black-footed ferrets or their descendants have been released in the wild as careful assessments of the clones and their offspring are being conducted. This work has been authorized by the United Stated Fish and Wildlife Service and conducted through collaborations with San Diego Zoo Wildlife Alliance, Revive & Restore, Viagen Pets and Equine, and the Smithsonian Conservation Biology Institute.

The effort to recover the black-footed ferret from the last small population has involved many interested parties through a public-facing process.

The California condor (Gymnogyps californianus), the largest bird in North America, is recovering from a population bottleneck that reduced its numbers to 22 birds and the combined wild and managed population numbers more than 600 birds. However, challenges remain that constrain the growth of the reintroduced populations in the United States and Mexico, including introduced diseases. An outbreak of Highly Pathogenic Avian Influenza (HPAI)  occurred in 2023 that resulted in the deaths of at least 21 condors. A vaccine developed using synthetic biology methodologies that was developed for domestic chickens was trialed for producing immunity in California condors to HPAI (10.3201/eid3106.241558).
These examples speak to current applications of synthetic biology that address KMGBF Target 4.
With regards,
Oliver Ryder

Dear Forum Participants and Mr. Batič,  

My name is Ana Atanassova, and I represent the Global Industry Coalition (GIC) in this online forum. My input draws upon over 20 years of academic and biotech industry experience in research, development, and regulation of biotech crops, as well as advancements in agricultural biotechnology and pharmaceuticals. I have served as a participant in the AHTEG on Synthetic Biology 2017-2018 and have been contributing to the development of GIC materials and submission of information in response to SCBD Notifications. I look forward to contributing to the work of the AHTEG on Synthetic Biology 2026.  



For this topic, the moderator Mr. Batič has requested specific examples of potential negative impacts of the most recent technological developments (#3513, #3550), Generally the contributions present views debated at length in previous programs of work on synthetic biology and other programs of work under the Convention and Protocols (e.g. organisms containing engineered gene drives, transgenic/LM crops, genome-edited crops, herbicide tolerance traits in biotech crops, LM microbes, LM mosquitoes, de-extinction, benefit sharing, digital sequence information, artificial intelligence, traditional livelihoods, dual use). These examples are therefore not new, nor are they specific or unique to the most recent biotechnological developments (e.g. #3608) – and some assertions (particularly for crops) date back to the 1970s. We also note that some contributions are opinions concerning regulation/risk assessment inadequacy or absence, or disagreement with regulatory modernisation (e.g. #3566), and assumptions that other considerations (such as benefits) can override the outcomes of a risk assessment (addressed by #3618).

Many of the postulated negative impacts (provided they are plausible) are routinely addressed in environmental risk assessment. The topic of gene drives in particular has been deliberated at length by previous synthetic biology AHTEGs*, and due to the concerns raised having a basis in adequately informed risk assessment, it was referred to the risk assessment program of work under the Cartagena Protocol where AHTEGs** analysed the need for, and ultimately developed, the “Additional voluntary guidance materials to support case-by-case risk assessments of living modified organisms containing engineered gene drives” (Biosafety Technical Series 07 - https://bch.cbd.int/en/database/VLR/BCH-VLR-SCBD-280754). This resource was not developed due to inadequacies in the existing regulatory framework provided by Annex III of the Cartagena Protocol, rather it outlines current best practice for its implementation that can be applied to any type of LMO, including those labelled as “synthetic biology”.

It has already been established that most organisms developed using “synthetic biology” are LMOs (2017 AHTEG Report - https://www.cbd.int/doc/c/aa10/9160/6c3fcedf265dbee686715016/synbio-ahteg-2017-01-03-en.pdf), and as such, they remain within its regulatory scope and subject to applicable regulatory mechanisms. A wealth of evidence exists demonstrating the positive environmental impacts of LMOs released into the environment over more than three decades (#3669). The applicable regulatory mechanisms have thus proven effective, with established risk assessment and risk management processes preventing adverse environmental impacts attributable to the LMO. In our view, LMOs that are intended to be released into the environment in the foreseeable future do not require fundamental changes in regulatory approaches compared to LMOs developed to date. There are more recent regulatory assessments of LMOs that might be labelled “synthetic biology” in this forum, for example engineered microorganisms, and disagreement with such assessments and/or views on the adequacy of regulation is not evidence for international debate on potential negative impacts, not it supports evidence of such impacts.



* Reports of synthetic biology Ad Hoc Technical Expert Groups

2017: CBD/SYNBIO/AHTEG/2017/1/3, available at: https://www.cbd.int/doc/c/aa10/9160/6c3fcedf265dbee686715016/synbio-ahteg-2017-01-03-en.pdf 

2019: CBD/SYNBIO/AHTEG/2019/1/3, available at: https://www.cbd.int/doc/c/b2bb/cf58/b09729bb00be6abf72325a1a/synbio-ahteg-2019-01-03-en.pdf

2024: CBD/SYNBIO/AHTEG/2024/1/3

https://www.cbd.int/doc/c/a26e/a6dc/571dd825eb08eef3865f85de/synbio-ahteg-2024-01-03-en.pdf 



** Reports of risk assessment Ad Hoc Technical Expert Groups

2016: UNEP/CBD/BS/RARM/AHTEG/2016/1/6, available at: https://www.cbd.int/doc/meetings/bs/bsrarm-ahteg-2016-01/official/bsrarm-ahteg-2016-01-06-en.pdf

2020: CBD/CP/RA/AHTEG/2020/1/, available at:

https://www.cbd.int/doc/c/a763/e248/4fa326e03e3c126b9615e95d/cp-ra-ahteg-2020-01-05-en.pdf

2024: CBD/CP/RA/AHTEG/2024/1/3, available at:

https://www.cbd.int/doc/c/0e44/e702/e4783d74c9e6f262989fbcbc/cp-ra-ahteg-2024-01-03-en.pdf

Thank you for the opportunity to participate in this exchange, 

Kind regards

Thank you to colleagues for the insightful contributions. Several colleagues have also noted the growing convergence between synthetic biology and artificial intelligence (AI). Recent analyses highlight that AI is increasingly used to accelerate the design–build–test–learn cycle of synthetic biology, including predicting biological structures, designing genetic constructs and automating laboratory workflows. While these advances may expand innovation across sectors such as medicine, agriculture and environmental applications, they also raise new biosafety, biosecurity and governance challenges (Groff-Vindman et al., 2025; Hynek, 2026; O’Brien & Nelson, 2020).

One important consideration is that technological convergence can amplify risks that may not be fully captured when technologies are assessed in isolation. AI-assisted design tools can dramatically increase the speed and scale of biological engineering, potentially lowering the technical barriers for designing novel biological systems or generating large numbers of biological variants. This accelerated design capacity may challenge existing risk assessment and oversight systems developed for slower biotechnology innovation pathways and may complicate efforts to prevent or reduce threats to biodiversity from emerging technologies (Targets 7, 14) (Hynek, 2026; O’Brien & Nelson, 2020).

Another issue concerns the increasing automation and digitalisation of bioengineering processes. Highly automated or AI-guided design pipelines may reduce transparency and interpretability in biological design, particularly when complex machine-learning models function as “black boxes.” This can make it more difficult to understand the reasoning behind design outputs or to anticipate unintended ecological or biological consequences before environmental release or large-scale deployment, potentially affecting ecosystem integrity and biodiversity monitoring efforts (Targets 4, 21) (Groff-Vindman et al., 2025).

These developments suggest that assessments of potential impacts of synthetic biology may benefit from explicitly considering technology convergence and cross-sector governance. As synthetic biology increasingly interacts with AI, automation and digital bio-design tools, governance approaches may need to address these interconnected systems rather than evaluating each technological domain separately. Strengthening interdisciplinary collaboration between biosafety, biosecurity, digital governance and environmental risk assessment communities may therefore be increasingly important to support responsible innovation, risk management and international capacity-building (Targets 13, 20) (Groff-Vindman et al., 2025; Hynek, 2026).

Thank you very much for the discussions so far.

Best regards,
sarah

References
Groff-Vindman, C.S., Trump, B.D., Cummings, C.L. et al. The convergence of AI and synthetic biology: the looming deluge. npj Biomed. Innov. 2, 20 (2025). https://doi.org/10.1038/s44385-025-00021-1
Hynek, N. Synthetic biology/AI convergence (SynBioAI): security threats in frontier science and regulatory challenges. AI & Soc 41, 951–968 (2026). https://doi.org/10.1007/s00146-025-02576-4
O'Brien, J. T., & Nelson, C. (2020). Assessing the Risks Posed by the Convergence of Artificial Intelligence and Biotechnology. Health security, 18(3), 219–227. https://doi.org/10.1089/hs.2019.0122

Dear Participants,

In the last hours, I would like to express my appreciation for your time, active discussions on the online forum and considered interventions.
Thank you for sharing information regarding the new technological developments, including those that have attracted recent attention in the media and the interesting considerations regarding regulations. I would also like to thank you with performing the difficult task of looking at the targets of the KMGBF with respect to the potential negative impacts of these most recent technological developments. These discussions will also nicely complement the others under the potential positive impacts.
In the last hours, I encourage you to continue to look at the potential negative impacts of the developments on the targets of the KMGBF.
I am also certain that all of the resources (e.g. publications, reports, policy papers, patents) shared will support the work of the AHTEG.

I will work with the Secretariat to assist with ensuring the discussions have been captured.

Best,

Martin

Hello all,

There are several challenges associated with synthetic biology that may merit discussion in the context of the Convention on Biological Diversity (CBD) and the implementation of the Kunming–Montreal Global Biodiversity Framework (KMGBF). Here are some I think about a bit:

1) Parallel use of multiple LMOs in the same environment

If the benefits of synthetic biology materialize, it is plausible that multiple living modified organisms (LMOs) could eventually operate in the same ecological setting. In agricultural systems, for example, one could imagine modified crops (enhanced nutrition), insects (next generation SIT), and microbes (green fertilizer or carbon capture) being deployed within the same landscape.

This raises questions about how cumulative and combinatorial effects should be addressed within risk assessment frameworks. At present, many risk assessments focus primarily on individual products rather than complex multi-technology ecosystems (from a practical standpoint).
Addressing this challenge will require strengthening risk-assessment systems to evaluate interactions among multiple technologies simultaneously. Integration and standardization of AI in Risk assessment pathways is a potential solution [see post #3570]. Furthermore, improvements would directly support KMGBF Targets 6 (invasive species management), 11 (ecosystem restoration), and 20 (capacity building) while contributing to the CBD objective of conservation and sustainable use of biodiversity.

2) Monitoring LMOs that are not easily observable

Some synthetic biology applications, particularly those involving microorganisms, present monitoring challenges. Microbial organisms are often not readily visible, and processes such as horizontal gene transfer play an important role in microbial evolution and ecological adaptation (plenty of papers cited on this in the forum already).
However, advances in environmental monitoring technologies are expanding the ability to detect biological signals in complex environments. Environmental DNA (eDNA) sampling, including emerging techniques such as airborne eDNA monitoring, has demonstrated the ability to detect terrestrial species through DNA captured from air samples (https://doi.org/10.1016/j.cub.2021.11.064). These approaches could potentially be extended to monitoring synthetic biology applications through integrated environmental surveillance networks. When combined with automated sequencing platforms and AI-enabled data analysis, such monitoring systems could strengthen early detection, transparency, and long-term stewardship. Furthermore, genetic design elements that increase specificity and controllability as has been observed in the field of gene drives will be crucial for limiting persistence and spread of products of synthetic biology [see post #3570].

Investment in molecular monitoring infrastructure would support KMGBF Target 21 (knowledge and monitoring systems) and Target 7 (pollution and environmental risk reduction) while advancing the CBD objective of conservation and sustainable use of biodiversity through improved environmental monitoring.

3) Increasing accessibility of genetic engineering tools

As genetic engineering technologies become cheaper and easier to use, they are becoming more widely available across research institutions and industry. For example, CRISPR-based genome editing has dramatically reduced the technical and financial barriers associated with genetic modification.
This accessibility can be positive, as it allows more countries and institutions to participate in biotechnology innovation and develop solutions tailored to local environmental challenges. At the same time, wider accessibility raises governance and biosecurity questions if oversight mechanisms do not keep pace with technological capability.
This challenge can be addressed by strengthening governance infrastructure (see 1 & 2). Investments in biosafety capacity, monitoring systems, and international cooperation will help ensure that synthetic biology applications can be detected, evaluated, and managed appropriately.
Such efforts directly support KMGBF Targets 20 & 21 (capacity-building and knowledge sharing) and Target 19 (financial and technical resources) while advancing CBD objectives related to scientific cooperation and responsible biotechnology governance.

Historically, societies tend to respond to challenges through a combination of mitigation, adaptation, and innovation. In the case of synthetic biology, mitigation will be difficult without unanimity, adaptation would be sluggish/reactive, so innovation, specifically investing in the institutional and technical infrastructure necessary to support responsible development and deployment of biotechnology seems optimal. This includes improving the ability to conduct comprehensive risk assessments, expanding environmental monitoring capacity, and strengthening international cooperation around biosafety and biosecurity.

-Justin Overcash, FNIH

Dear Forum,

While the precise definition and scope of synthetic biology remain under active discussion, most current and near‑term applications are likely to fall within the existing definition of Living Modified Organisms (LMOs) under the Cartagena Protocol. Accordingly, Risk Assessment and Risk Management (RARM) for such applications should be primarily guided by the principles and methodology set out in Annex III, while remaining open to refinement as novel traits and use cases emerge. At the same time, the rapid evolution of synthetic biology is expected to generate cases in which the straightforward application of existing guidance becomes difficult, underscoring the need for periodic, science‑based review by specialized expert bodies such as the Ad Hoc Technical Expert Group (AHTEG) to keep governance adaptive and robust.

In the context of Targets 4 and 6 of the Kunming‑Montreal Global Biodiversity Framework (KMGBF), the environmental release of synthetic organisms may, under certain conditions, facilitate horizontal gene transfer to wild relatives or traditional crop varieties, with the potential to affect ecosystem functions and resilience. Engineered gene drives and living modified microorganisms, which can be self‑replicating and capable of dispersing beyond their initial release sites, raise particular concern because they may persist and spread in ways that are difficult to predict or reverse if not adequately assessed and managed. These characteristics call for especially stringent, case‑specific risk assessment, monitoring, and, where appropriate, the development of containment and recall strategies.

Conversely, in relation to Targets 7 and 10, plastic‑degrading microorganisms and enzymes, enhanced nitrogen‑fixing microbes, and artificial or bio‑hybrid photosynthetic systems illustrate how synthetic biology could contribute to reducing pollution and improving the efficiency of natural resource use. While these innovations hold promise as part of a broader portfolio of solutions to issues such as plastic accumulation, nutrient pollution, and inefficient land use, their deployment must be carefully managed to avoid creating new environmental risks or unintended ecological impacts. This reflects a dual‑use landscape in which the same underlying technologies can both mitigate and generate risks, depending on how and where they are applied.

In line with the precautionary approach under the Convention on Biological Diversity and the Cartagena Protocol, it is prudent to prioritize the use of synthetic biology applications in contained and controlled systems, especially when scientific uncertainty about environmental effects remains high. By emphasizing rigorous containment, minimizing unnecessary environmental releases, and preventing unintended interactions between synthetic organisms and natural ecosystems, the international community can better protect biodiversity while still exploring and harnessing the potential benefits of biological innovation.
Thanks
Dr. Ju Seok Lee

*** Posted on behalf of Tapsoba Ali de Goamma (Terre à Vie)***

Je m’appelle TAPSOBA Ali ; Je suis sociologue. Je suis président de Terre à Vie et porte-parole de la Coalition de Veille sur les Activités Biotechnologiques en Afrique.

la biologie de synthèse prétend créer la vie. Elle se distingue à la fois par des voies de recherche et technologiques originales et des positions épistémologiques et philosophiques particulières. L’engouement qu’elle suscite chez les uns n’a d’égal que le rejet qu’elle suscite chez les autres.
L’essor des biotechnologies durant le dernier quart du XXe siècle repose sur le paradigme selon lequel les gènes déterminent les caractères, en sont la cause principale, sinon unique, et que manipuler les gènes permet de modifier les caractères et les comportements.

Cependant, l’échec des OGM à exprimer des caractères complexes d’une part, et une série de découvertes successives montrant l’importance d’autres types de causalité d’autre part, ont fragilisé ce paradigme et abouti à une critique de plus en plus forte de ce qui a été appelé le « tout-génétique » et au développement d’un mode de pensée plus systémique prenant en compte la grande complexité des phénomènes biologiques.

La biologie de synthèse entend répondre aux difficultés rencontrées par les biotechnologies classiques en appliquant des stratégies issues des sciences de l’ingénieur. Pour elle, la complexité comporte deux composantes : l’une issue de l’histoire évolutive et l’autre intrinsèque au fonctionnement des êtres vivants. Il s’agirait de supprimer la première grâce à la conception de « cellules minimales » et de maîtriser la seconde par les méthodes de modélisation utilisées dans la construction des machines. Il ne s’agirait donc plus d’obéir aux processus naturels à l’origine des êtres vivants, considérés comme imparfaits du fait des contingences historiques liées à l’évolution, mais de les rationaliser, de les traduire en principes « ingéniériques » simples, de les penser comme un agencement (sur le mode par exemple d’un circuit électronique) de pièces détachées comme des machines vivantes.

Quel scandale
Plusieurs arguments mettent en doute la prétendue maîtrise associée à cette démarche :

Les génomes, même les plus simples, sont des entités complexes que les sciences biologiques commencent à peine à entrevoir. Être capable de synthétiser de longues séquences d’ADN, voire des génomes entiers (qui ne sont finalement que de longs polymères constitués de quatre entités chimiques que les appareils de synthèse sont capables aujourd’hui de fabriquer), ne signifie pas posséder la clé de leur fonctionnement. Celui-ci réside dans l’information contenue dans la séquence de ces quatre entités chimiques mais nous n’en comprenons aujourd’hui qu’une infirme partie. Le génome reste un constituant d’une grande complexité inaccessible à notre entendement. Penser que de sa séquence, l’organisme et son comportement pourraient être déduits, est une chimère.

La complexité des organismes n’est pas réductible à celle de leur génome et ne peut être appréhendée en dehors de l’organisme lui-même et des millions d’éléments divers qui le composent et qui interagissent entre eux et avec le génome selon des mécanismes dits non linéaires, en d’autres termes difficilement prévisibles par les méthodes actuelles.
Prétendre maîtriser tout cela apparaît donc aujourd’hui illusoire !
L’incertitude est aujourd’hui masquée par les discours enthousiastes des nouveaux synthétiseurs du vivant. Des recherches intenses dans le domaine de la médecine, de l’environnement, de l’énergie… risquent d’aboutir dès demain à la dissémination de super organismes modifiés, entourés de l’aura d’une technologie triomphante mais au comportement aussi incertain que nos OGM actuels.

A propos des OGM classiques il vous souviendra que le Burkina Faso a connu une expérience lamentablement échouée du Coton Bt. L’introduction du gène Bt dans le cotonnier Burkinabè avait engendré une réduction de la fibre et une baisse des rendements créant une chute de la filière avec des milliards de CFA en perte. Des millions de paysans se sont retrouvé endetté.
Après cette amer expérience, le Burkina Faso a encore mis fin au projet funeste de moustiques génétiquement modifié conduit par Target malaria et dénoncé fortement par la société civile. Des experts commis par le gouvernement ont démontré que la finalité de ce projet qui était le gène drive risquait de mettre en péril la biodiversité et créer un problème de santé publique.

Le rejet total des OGM dans mon pays montre que les populations réfutent leur réel succès. Ces OGM portent atteinte à la souveraineté alimentaire ,économique et sanitaire des Africains. Même des aspects socio-culturels sont menacés par les applications de la biotechnologies modernes.
Donc comment pouvons-nous accepter la biologie de synthèse tandis que même les OGM classiques ne sont pas maitrisés ?
Nul doute que la biologie de synthèse sera encore un outil de domination des masses par les firmes industrielles. Les savoirs endogènes fondements de la résilience des Africains risquent d’être détruits.
Ne nous leurrons pas, les futurs organismes synthétiques, s’ils apparaissent un jour, n’auront rien à voir avec les êtres vivants que nous connaissons, mais ressembleront essentiellement à des usines vivantes conçues pour assouvir nos besoins. Serons-nous alors prêts à intégrer au sein de notre planète un troisième monde aux côtés des mondes vivant et inanimé ? Un troisième monde dit vivant, mais tellement différent de celui que nous connaissons, que les ingénieurs du vivant pourraient construire, modifier et détruire à leur aise. Un monde dépourvu d’une histoire évolutive, façonné par et pour l’homme, disponible ou jetable à la demande ? Que savons-nous de la capacité qu’aurait ce monde-là de nous interpeller et de nous menacer dans notre humanité ? Le moment n’est-il pas venu de cesser d’espérer résoudre les problèmes essentiels auxquels nous confrontent les technologies actuelles par une fuite en avant vers l’illusion d’une maîtrise absolue de la nature ?
Quels sont les risques environnementaux, sanitaires et sociaux liés à ces systèmes biologiques ?
Un risque classique est souvent mis en avant, celui d’«  une utilisation négligente ou mal intentionnée ». Le risque de la biologie de synthèse serait donc principalement celui de son utilisation. Les colloques et autres rapports parlementaires consacrés à la biologie de synthèse reviennent sans cesse sur cette idée mais, en revanche, ne questionnent que rarement en amont cette discipline. Pour eux, la question majeure est d’en réguler les usages. Ainsi, il suffirait donc de mettre en place des garde-fous pour que cette discipline soit au service de l’Humanité et éviter qu’elle ne tombe dans les mains d’États voyous ou de groupes terroristes. Qui va décider que tel pays peut l’utiliser et pas tel autre ? Qui nous dit qu’un pays démocratique n’a pas d’intentions impérialistes pour sécuriser ses approvisionnements en matières premières ? Qui nous garantit qu’il est à l’abri d’un coup d’État ?

Michel Morange, professeur de biologie à l’ENS (École normale supérieure), dans un article souligne que « le risque avec les êtres vivants est leur extraordinaire pouvoir de multiplication qui peut perturber tous les écosystèmes dans lesquels ils se développeront. Probablement, les risques sont plus grands dans le cas des projets les plus « classiques » (des micro-organismes OGM en fermenteur) par rapport à des xénobactéries : moins on a modifié un organisme, plus il a de chance de rester compétitif. Il est cependant toujours difficile a priori d’évaluer les risques. Par contre il y a des mesures de protection bien connues : le confinement physique dans des locaux et, mieux encore, l’insertion de mutations ou de gènes dans l’organisme nouvellement créé le rendant dépendant d’une substance particulière, et donc incapable de pousser en dehors du laboratoire ».
François Kepès, de l’ISSB un chercheur pourtant très favorable à la biologie de synthèse, disait aussi « dans 10-15 ans, [cette bactérie] aura trouvé un autre moyen de s’alimenter par symbiose par exemple ». Une « nature » totalement artificielle, étanche à la nature telle qu’on la connaît, est un fantasme. Il y aura toujours interactions entre les deux mondes.
Un autre impact identifié de la biologie de synthèse, c’est la mise en concurrence entre production agricole et production industrielle. L’artémisine est une molécule utilisée dans la lutte contre le paludisme issue d’une plante, Artemisia annua. Amyris a mis au point l’artémisine synthétique, grâce notamment à une aide de 42,6 millions de dollars de la Fondation Gates.  Cette industrialisation prive des milliers d’agriculteurs de leur moyen de subsistance. D’autres plantes pourraient bientôt aussi devenir obsolètes et les communautés paysannes qui en ont pris soin depuis des millénaires en perdront les avantages et bénéfices liées à ces ressources génétiques. Des projets visent la vanille, la réglisse, les huiles essentielles, etc.

En 2002, DuPont déposait un brevet sur un micro-organisme génétiquement modifié pour produire « biologiquement »  un composé – l’isoprène – pour remplacer le caoutchouc. Cela met concrètement en péril les revenus de millions de familles qui dépendent de cette production agricole.
Par ailleurs, toutes ces bactéries synthétiques ne se nourrissent pas d’amour et d’eau fraîche. Quand on passe à l’échelle industrielle, il leur faut du sucre, et en grande quantité. Donc nous allons assisté à un accaparement des terres agricoles dans beaucoup de pays.
La biologie synthétique implique une dégradation des écosystèmes. La demande massive de matières agricoles et va faire exploser le prix de l’alimentation. Rappelons que les émeutes de la faim en 2008 ont été provoquées, en partie, par une augmentation spectaculaire du prix des matières premières, notamment suite à l’augmentation des quantités de maïs utilisé comme agrocarburant. Les savoirs endogènes seront détruits. Les communautés locales perdront leur souveraineté alimentaire, sanitaire, économique, culturelle et politique. Le monde sera dirigé à partir d’un Clic.

*** Posted on behalf of Ms. Annah Takombwa (Zimbabwe)***

My name is Annah Takombwa, I work for the National Biotechnology Authority in Zimbabwe.

While recognizing that, like all technologies, synthetic biology may pose potential negative impacts, each application should be evaluated on a case-by-case basis. Potential risks should not be generalized across all uses of the technology. Societies should be given the opportunity to benefit from the innovations and solutions that synthetic biology can offer. Regulators should therefore establish robust regulatory frameworks that enable comprehensive, risk assessments to ensure that potential risks are properly identified, managed, and mitigated.

Dear colleagues, thank you for organizing this forum and for the opportunity to participate in this important exchange of perspectives.

From the perspective of a megadiverse and pluricultural country, which also constitutes a center of origin, diversification, and domestication of numerous species of global importance for food, culture, and the economy, the assessment of synthetic biology should be conducted under a precautionary and biosafety approach, considering not only direct biological impacts but also its implications across social, economic, biocultural, ecological, and human health dimensions.

One of the most relevant aspects discussed in this forum relates to the potential risks associated with the environmental release of organisms such as gene drives. These technologies raise scientific questions, including the possible alteration of trophic networks and population dynamics, the spread to non-target species, and the difficulty of reversing their effects once released into the environment, as highlighted in several comments in this forum [#3531, #3542, and #3535].
On the other hand, the development of synthetic biology applications based on digital sequence information (DSI) poses challenges for the international governance of biodiversity. In particular, it is necessary to ensure that access to and use of DSI is consistent with the principles of the Convention on Biological Diversity (CBD), implying recognition of the historical contributions of megadiverse countries, as well as Indigenous Peoples and local communities, in the conservation of biodiversity and the generation of knowledge associated with it. Furthermore, the use of DSI raises socio-economic, biocultural, and global justice implications, as there is a risk that the economic value derived from biodiversity may become concentrated among technological actors, reproducing dynamics of biocolonialism and limiting the benefits for the countries and communities that have conserved these resources.  1,2

Given that proponents of gene editing argue that the mutations introduced through these techniques would not pose risks to the environment or to human health, and therefore that organisms or products derived from these technologies should be exempt from regulation, risk assessment, traceability, and labeling, it is necessary to promote robust regulatory and biosafety frameworks and rigorous risk assessments, particularly when organisms derived from these technologies may interact with natural ecosystems or enter food chains, which could also restrict the freedom of choice of farmers and consumers. In this regard, it is necessary to strengthen international risk-assessment frameworks, promote transparency and public participation in decision-making, and ensure that the development and application of synthetic biology are fully compatible with the objectives of the CBD. 3

Humberto Peraza Villarreal, Doctor en Ciencias Biológicas.
Subdrirector de vinculación Social e Investigación Socioeconómica, Secretaría Ejecutiva de la Comisión Intersecretarial de Bioseguridad de Organismos Genéticamente Modificados (SEj-Cibiogem), México.

1. Smyth, S. J., Macall, D. M., Phillips, P. W., & de Beer, J. (2020). Implications of biological information digitization: Access and benefit sharing of plant genetic resources. The Journal of World Intellectual Property, 23(3-4), 267-287. https://doi.org/10.1111/jwip.12151Digital Object Identifier
2.  Akpoviri, F.I., Baharum, S.N. & Zainol, Z.A. Digital Sequence Information and the Access and Benefit-Sharing Obligation of the Convention on Biological Diversity. Nanoethics 17, 1 (2023). https://doi.org/10.1007/s11569-023-00436-3
3. Martínez Debat, C., González-Ortega, E., & Piñeyro-Nelson, A. (2024). La edición génica y la agroecología en la “encrucijada”. Una pareja disfuncional y dispareja en el reino de las promesas de coexistencia. Tekoporá, 2024, 5 (2): 166-182.

Dear Colleagues, my name is Cicilia Githagia, an advocate (lawyer) at Wangari Githaiga & Co Advocates in Kenya and I was appointed to the last Multidisciplinary AHTEG by the Women Caucus. There are several points on this discussion which we wish to share as follows in addition to those raised by our colleagues (without mentioning all of them) and the previous statements of the women caucus. 

Definition of Synbio.
The legal challenges surrounding Synbio begin with lack of a clear definition of what Synbio is because if we do not have a definition that is acceptable to all then it is not clear which regime synbio should be regulated under and this would complicate regulation and enforcement. As such, the team should start by coming up with a definition that is acceptable so that it is understood the scope within which we must operate.


Embeding Synbio within the Three objectives of the Convention, the GBF and other multilateral agreements.
It is our submission that the work being done under synbio should fall within one or more of the  the three objectives of the CBD and must help towards achievement of those objectives and must also address at least one or several of the targets of the GBF and by extension the sustainable development goals. We must however not lose sight of the fact that some of the developments mentioned by several colleagues relate to other multilateral environmental agreements and regimes such as climate change and health meaning that we must have a broad view of the potentials and limitations of synbio. This therefore implies that we need to not only look within the CBD but also the United Nations Framework Convention on Climate Change (UNFCCC), the United Nations Convention to Combat Desertification (UNCCD) to make up the three RIO Conventions. In addition critical agreements such as the the United Nations Declaration on the Rights of Indigenous Peoples (UNDRIP) among others must also form part of the discussion towards protection of the rights of indigenous peoples and local communities.
It is our submission that in the spirit of multilateralism at a time when we are trying to ensure coordination and collaboration between multilateral agreements, the issue of synbio be considered with the context of other agreements and how a coordinated and harmonized approach towards its regulation can be achieved even as we locate the various work and activities of synbio within the three objectives of the CBD.
There are both positive and negative impacts of synbio and as we have heard from some of the submissions, there is cause to be concerned about the negative impacts because there are many unknown consequences and there may also be some unintended consequences. As such, there will be need to regulate synbio but to regulate the definition needs to be clear for us to achieve meaningful regulation. Indeed in the absence of clear definition enforcement of rights and responsibilities is almost impossible.  

Legal rights and legal obligations arising and resulting from the work on synbio.
The same way we have been advised by some colleagues that risks come with hazards, legal rights are also accompanied by legal obligations. Thus, with the ongoing research and the right to commercialize, innovate and make products and even release into the environment, what legal obligations must be in place?
In this regard, Definition of Synbio.
The legal challenges surrounding Synbio begin with lack of a clear definition of what Synbio is because if we do not have a definition that is acceptable to all then it is not clear which regime synbio should be regulated under and this would complicate regulation and enforcement. As such, the team should start by coming up with a definition that is acceptable so that it is understood the scope within which we must operate.

Embeding Synbio within the Three objectives of the Convention, the GBF and other multilateral agreements.
It is our submission that the work being done under synbio should fall within one or more of the  the three objectives of the CBD and must help towards achievement of those objectives and must also address at least one or several of the targets of the GBF and by extension the sustainable development goals. We must however not lose sight of the fact that some of the developments mentioned by several colleagues relate to other multilateral environmental agreements and regimes such as climate change and health meaning that we must have a broad view of the potentials and limitations of synbio. This therefore implies that we need to not only look within the CBD but also the United Nations Framework Convention on Climate Change (UNFCCC), the United Nations Convention to Combat Desertification (UNCCD) to make up the three RIO Conventions. In addition critical agreements such as the the United Nations Declaration on the Rights of Indigenous Peoples (UNDRIP) among others must also form part of the discussion towards protection of the rights of indigenous peoples and local communities.
It is our submission that in the spirit of multilateralism at a time when we are trying to ensure coordination and collaboration between multilateral agreements, the issue of synbio be considered with the context of other agreements and how a coordinated and harmonized approach towards its regulation can be achieved even as we locate the various work and activities of synbio within the three objectives of the CBD.
There are both positive and negative impacts of synbio and as we have heard from some of the submissions, there is cause to be concerned about the negative impacts because there are many unknown consequences and there may also be some unintended consequences. As such, there will be need to regulate synbio but to regulate the definition needs to be clear for us to achieve meaningful regulation. Indeed in the absence of clear definition enforcement of rights and responsibilities is almost impossible.  

Legal rights and legal obligations arising and resulting from the work on synbio.
The same way we have been advised by some colleagues that risks come with hazards, legal rights are also accompanied by legal obligations. Thus, with the ongoing research and the right to commercialize, innovate and make products and even release into the environment, what legal obligations must be in place?
In this regard, Hohfeld’s analysis of rights explains the relationship between and amongst rights, duties, privileges, powers and immunities which will be a helpful guide in deciding what rights, duties, powers privileges and liability accrue with every research, development or product.

The human right to a clean healthy and sustainable environment and why it is important in buttressing the need to center the precautionary principle in all the work on synbio.
There are certain normative rights that are fundamental to all including the human rights to a clean healthy and sustainable development.  A resolution of the United Nations General Assembly (UNGA) did reiterate that the right to a clean and healthy and sustainable environment is a human right and that too must be put in perspective when mediating rights between legal persons. That also invariably means that the research, development, innovation and or products that ultimately end up in the market or environment must ensure that they adhere to the prescription of this right in addition to the other normative human rights.
The precautionary principle is a principle of international Environmental Law that has also been prominently reiterated under article 14 of the CBD. It is therefore necessary that all actions and activities relating to synbio be approached with caution in line with this principle especially where there is likely to be access by the market or release into the environment.
This rights will also assist us achieve sustainable development goals seeing that it specifically mentions a sustainable environment.
The necessity of undertaking an assessment of what exists and how it has developed over time and of positive and negative impacts along with a periodic review of new and emerging technologies and innovations.
As some authors have pointed out, it is necessary to undertake an assessment and we support this position because it will help create legal certainty and will also help governments to put in place the relevant measures necessary to regulate and safeguard the rights of other legal persons and the environment as required under Article 14 of the CBD. Otherwise without a proper assessment and periodic review, it will be very difficult to know when to alter the law with the developments in technology and any new risks and hazards.
A regulatory and policy framework will work best where it is informed by data but this data will need to be updated periodically in synch with the developments in society and in law (Jurisprudence) hence the need for a periodic review of what is happening in the field of synthetic biology.   
Rights of indigenous peoples, women and youth (Targets 22 and 23 of the GBF).

The rights of indigenous peoples under the United Nations Declaration of the rights on Indigenous Peoples must also be taken into account with the right to FPIC being at the centre of access and use of their resources being properly governed in a manner that ensures that the benefits that accrue to indigenous peoples from use of their resources, data and information are negotiated and agreed. Amongst the indigenous peoples it is noteworthy that there are indigenous women and youth who make up the future generation whose rights to intergenerational equity must also be taken into account. Women also have within the GBF, target 23 which is also supported by the gender plan of action with clear objectives and actions towards its implementation. Amongst the women are indigenous women whose knowledge may also constitute separate knowledge compared to men which is typical of most indigenous communities but which also varies with context.
of rights explains the relationship between and amongst rights, duties, privileges, powers and immunities which will be a helpful guide in deciding what rights, duties, powers privileges and liability accrue with every research, development or product.

The human right to a clean healthy and sustainable environment and why it is important in buttressing the need to center the precautionary principle in all the work on synbio.
There are certain normative rights that are fundamental to all including the human rights to a clean healthy and sustainable development.  A resolution of the United Nations General Assembly (UNGA) did reiterate that the right to a clean and healthy and sustainable environment is a human right and that too must be put in perspective when mediating rights between legal persons. That also invariably means that the research, development, innovation and or products that ultimately end up in the market or environment must ensure that they adhere to the prescription of this right in addition to the other normative human rights.
The precautionary principle is a principle of international Environmental Law that has also been prominently reiterated under article 14 of the CBD. It is therefore necessary that all actions and activities relating to synbio be approached with caution in line with this principle especially where there is likely to be access by the market or release into the environment.
This rights will also assist us achieve sustainable development goals seeing that it specifically mentions a sustainable environment.
The necessity of undertaking an assessment of what exists and how it has developed over time and of positive and negative impacts along with a periodic review of new and emerging technologies and innovations.
As some authors have pointed out, it is necessary to undertake an assessment and we support this position because it will help create legal certainty and will also help governments to put in place the relevant measures necessary to regulate and safeguard the rights of other legal persons and the environment as required under Article 14 of the CBD. Otherwise without a proper assessment and periodic review, it will be very difficult to know when to alter the law with the developments in technology and any new risks and hazards.
A regulatory and policy framework will work best where it is informed by data but this data will need to be updated periodically in synch with the developments in society and in law (Jurisprudence) hence the need for a periodic review of what is happening in the field of synthetic biology.   
Rights of indigenous peoples, women and youth (Targets 22 and 23 of the GBF).
The rights of indigenous peoples under the United Nations Declaration of the rights on Indigenous Peoples must also be taken into account with the right to FPIC being at the centre of access and use of their resources being properly governed in a manner that ensures that the benefits that accrue to indigenous peoples from use of their resources, data and information are negotiated and agreed. Amongst the indigenous peoples it is noteworthy that there are indigenous women and youth who make up the future generation whose rights to intergenerational equity must also be taken into account. Women also have within the GBF, target 23 which is also supported by the gender plan of action with clear objectives and actions towards its implementation. Amongst the women are indigenous women whose knowledge may also constitute separate knowledge compared to men which is typical of most indigenous communities but which also varies with context.

Hello everyone, I am Raquel Sotomayor. On this occasion, I would like to mention that I agree with the contributions mentioned in the different developments in synthetic biology. On this occasion, I will comment on the possible negative impacts identified in three objectives of the CBD and the KMGF targets:
- Objective A CBD — Conservation of biological diversity
Risk of loss or alteration of wild populations due to accidental or intentional releases (e.g., gene drives, organisms with increased fitness, synthetic microorganisms that compete with native species).
Possible generation of invasive species or functional hybrids that displace endemic Andean and Amazonian species in Peru.
Potentially affected KMGF targets: Target 3 (protect and restore areas and species), Target 9 (management of invasive alien species), Target 2/Target 1 (integrity of ecosystems and protected areas).

- Objective B CBD  — Sustainable use of components of biological diversity
Displacement of local sustainable practices by corporate-controlled biotechnological solutions (e.g., replacement of agroecology by patented crops/consortia), with adverse socio-ecological effects.
Risk of technological dependence and loss of agricultural resilience to pests/climate if synthetic solutions do not consider local variability (Peruvian Andes and Amazon).
Potentially affected KMGF targets: Target 10 (sustainable production and consumption), Target 12 (sustainable agriculture and food security), Target 15 (restoration and sustainable management of agricultural land).
- Objective C CBD  — Fair and equitable sharing of benefits (ABS/rights and governance)
Biopiracy and inequitable use of genetic resources and traditional knowledge: easy sequencing and synthesis allow ex situ appropriation without complying with ABS or prior informed consent, affecting indigenous communities in Peru.
Commercialization of derivative products without clear benefit-sharing mechanisms and without recognition of collective rights.
Potentially affected KMGF targets: Target 13/Target 16 (fair and equitable benefits, community participation), and ABS obligations under the Nagoya Protocol
Based on this, the following is suggested: Strengthen national capacity for ecological risk and biosafety assessment, environmental genomic surveillance, and contained release protocols.
Implement ABS clauses and prior, informed, and mutually agreed consent processes for sequences and resources, with the effective participation of indigenous peoples.
Integrate socio-ecological risk assessment into authorizations for the environmental use of synthetic organisms; support independent research on impacts on Amazonian/Andean ecosystems.

Sincerely,
Raquel Sotomayor

Dear Participants,

Thank you kindly for your active participation and robust discussions.

The Open-Ended Online Forum is now closed.

Kind regards,

The Secretariat