3. Living modified fish

Dear Colleagues,

I would like to gently encourage you to contribute to the topic of LM fish before the close of the first week of discussions on Monday 28 April at 11 a.m. Montreal time. I trust that my co-moderator and I can count on you to provide your insights and expertise on this topic.

Perhaps to start the discussions, I would like to remind the participants of the study that was commissioned by the Secretariat and reviewed by both the online forum and AHTEG 2020 (https://www.cbd.int/doc/c/71a2/866c/17c10d9ba2dc23ebbca43f44/cp-ra-ahteg-2020-01-03-en.pdf). I would be curious to know views on recent developments or key points that remain valid.

I look forward to the discussions,

Ana Laura Mello

Dear Colleagues,

I would like to gently encourage you to contribute to the topic of LM fish before the close of the first week of discussions on Monday 28 April at 11 a.m. Montreal time. I trust that my co-moderator and I can count on you to provide your insights and expertise on this topic.

Perhaps to start the discussions, I would like to remind the participants of the study that was commissioned by the Secretariat and reviewed by both the online forum and AHTEG 2020 (https://www.cbd.int/doc/c/71a2/866c/17c10d9ba2dc23ebbca43f44/cp-ra-ahteg-2020-01-03-en.pdf). I would be curious to know views on recent developments or key points that remain valid.

I look forward to the discussions,

Ana Laura Mello

Esteemed colleagues,

In contribution to discussion I would like to comment on the questions 1 and 2:

1. Given that there are already some reference frameworks, guidelines, and methodologies for this type of organism, as well as commercial approval, such as for salmon, it is considered that the main challenge is obtaining the reasons from Parties to revisit this topic, especially if it has already been addressed by the Ad Hoc Technical Expert Group on Risk Assessment and Risk Management, which produced inputs and a study in 2020.

2. Based on the premise outlined in point 1, specific challenges for revisiting the topic could include: 

- Need to update the previously analyzed information 

- The emergence of new biotechnological advances in living modified fish that warrant a new review process 

- It is possible that the previous process did not specifically consider certain species of interest.

Gabriel Mutis
Colombia

Greetings, esteemed colleagues,

My name is David Castro, and I work at the Directorate of Genetic Resources and Biosafety of the Ministry of the Environment of Peru. My contribution will focus on living modified (LM) fish for ornamental purposes, particularly GloFish® (bioengineered to express fluorescent proteins).

In theory, these fish are marketed exclusively as pets in the United States and Canada, where they have been authorized or deregulated by the respective regulatory agencies (1,2). These agencies have concluded that GloFish®, when used solely for ornamental purposes, do not pose significant safety concerns due to their low likelihood of accidental release, the existence of risk mitigation mechanisms, and the fact that the genetic modifications do not confer adaptive advantages for survival in the cold or temperate climates of those countries.

Regarding questions 1 and 2:

Although GloFish® have been evaluated and approved in the U.S. and Canada, there is a significant informal flow toward other markets, where they are neither assessed nor authorized. In Peru, they are readily available in pet stores, including recently released varieties such as corydoras (3) and pristellas (4).

Both species are native to South America and inhabit Amazonian freshwater systems. Additionally, other modified species such as Danio rerio, Epalzeorhynchos frenatum, and Puntius sp., of Asian origin, could also adapt to the environmental conditions found in the Amazon.

It has been documented that some owners, either due to lack of knowledge or unwillingness to continue caring for them, release these fish into natural water bodies, including areas near the native habitats of species such as corydoras and pristellas. This raises significant biosafety concerns, particularly because the control and oversight present in the country of origin do not exist in the markets where these organisms enter informally or illegally.

Regarding question 3:

In 2020, Brazilian researchers studied water bodies near fish farms in Muriaé (Minas Gerais), the largest ornamental fish production center in Brazil (5). They found fluorescent zebrafish surviving and reproducing, especially during the rainy season. Furthermore, dietary analysis revealed autochthonous dipteran and hemipteran larvae, indicating a generalist feeding behavior.

In Peru, numerous studies have been conducted on transgenic fish purchased from local markets, including in Amazonian cities. These studies have shown that genetic flow occurs easily between GloFish® and their non-modified counterparts (6,7). While fluorescence may not directly increase fitness, it could influence mating behavior or survival under specific environmental conditions that remain unevaluated.

Given the interconnected nature of aquatic ecosystems in the Amazon, accidental releases are not limited to a single country. Modified fish can spread and cross borders, affecting biologically sensitive regions with unique biodiversity. Moreover, the scarcity of natural predators could favor the survival of these exotic transgenic species.

Regarding question 4:

It is crucial to adapt risk assessment methodologies for transgenic ornamental fish to scenarios like the Amazon basin, where the probability of accidental or illegal release is high, and where the ecological sensitivity is exceptional.

Biosafety measures to limit gene flow—such as triploidy or male sterility—should be considered.

The potential for dispersal through shared river systems highlights the need for regional coordination, enabling the development of joint monitoring and surveillance protocols to detect and mitigate potential ecological impacts.

Current risk assessment methodologies, mostly developed in Global North countries, tend to focus on environments unsuitable for tropical ornamental species and assume formal commercialization systems. This approach may underestimate the invasive potential of these organisms by failing to incorporate critical variables such as temperature, habitat connectivity, lack of natural predators, and unanticipated ecological interactions.

Risk assessments require data on survival, reproduction, and dispersal in natural environments. In the case of GloFish®, such local data are lacking for Amazonian water bodies.

References:

1) FDA - Intentional Genomic Alterations (IGAs) in Animals: Risk-Reviewed IGAs https://www.fda.gov/animal-veterinary/intentional-genomic-alterations-igas-animals/intentional-genomic-alterations-igas-animals-risk-reviewed-igas
2) Consultations on certain living organisms new to Canada https://www.canada.ca/en/environment-climate-change/services/managing-pollution/evaluating-new-substances/voluntary-public-engagement-initiative.html
3) https://www.glofish.com/glofish/cory.aspx
4) https://www.glofish.com/glofish/pristella.aspx
5) Magalhães, A. L. B., Brito, M. F. G., & Silva, L. G. M. (2022). The fluorescent introduction has begun in the southern hemisphere: presence and life-history strategies of the transgenic zebrafish Danio rerio (Cypriniformes: Danionidae) in Brazil. Studies on Neotropical Fauna and Environment, 59(1), 1–13. https://doi.org/10.1080/01650521.2021.2024054
6) Scotto, C. (2018). Report of a second introduction of fluorescent transgenic ornamental fish to Peruvian territory: Skirt tetra fish case (Gymnocorymbus ternetzi; Boulenger, 1895). Scientia Agropecuaria, 9(1), 153–156. https://doi.org/10.17268/sci.agropecu.2018.01.16
7) Scotto, C., & Chuan, R. (2018). Crossing and gene flow of the transgens of the red fluorescent proteins (RFP) and green (GFP) in the zebrafish (Danio rerio) transgenic introduced to Peru. Scientia Agropecuaria, 9(3), 417–421. https://doi.org/10.17268/sci.agropecu.2018.03.13

Dear colleagues, first of all I would like to thank our moderator. Thinking about this issue, I will try to contribute to the discussion.

1. How does this topic potentially pose challenges to the existing risk assessment frameworks, guidance and methodologies? Do solutions exist?
The answer to the question will be very similar to the answer for GM microalgae and microorganisms intended for release to the environment. To what extent is their use and regulation limited to closed systems. In relation to GM fish, there is, naturally depending on the trait, the possibility of release into the environment, movement across borders and/or invasiveness. For example, for fish species whose cycle is impossible without seawater, even in the presence of biological barriers and physical barriers, the probability is not zero, and the triploidization procedure itself is not always an effective process. Limitations still exist with triploid applications in aquaculture, including that these techniques are not always effective and reduce the viability of triploids and therefore the use of this technique, as well as generally include difficulty obtaining 100% triploidy induction and occurrence of some gonadal development in triploid male fish:
Piferrer F, Beaumont A, Falguière JC, Flajšhans M, Haffray P, Colombo L. Polyploid fish and shellfish: production, biology and applications to aquaculture for performance improvement and genetic containment. Aquaculture. 2009; 293(3–4): 125-156. doi:10.1016/j.aquaculture.2009.04.036
Ten-Tsao Wong, Yonathan Zohar, Production of reproductively sterile fish: A mini-review of germ cell elimination technologies, General and Comparative Endocrinology, Volume 221, 2015, Pages 3-8,https://www.sciencedirect.com/science/article/abs/pii/S0016648014004754
Hu F, Fan J, Qin Q, Huo Y, Wang Y, Wu C, Liu Q, Li W, Chen X, Liu C, Tao M, Wang S, Zhao R, Luo K, Liu S. The Sterility of Allotriploid Fish and Fertility of Female Autotriploid Fish. Front Genet. 2019 Apr 26;10:377. doi: 10.3389/fgene.2019.00377. PMID: 31105746; PMCID: PMC6498098. https://pmc.ncbi.nlm.nih.gov/articles/PMC6498098/

Of course, the solution to this issue can be a thorough development of regulation and monitoring of such developments. But, unfortunately, even with such an approach it is not always possible to avoid the release of organisms with a high potential for reproduction, movement and invasiveness. It is not always possible to predict their behavior because we still lack knowledge for a number of species about their genetics, biology and physiology. In our country, two species of non-LMO fish have become invasive – the Perccottus glenii, which was released by aquarists, and the American catfish (Ameiurus nebulosus), as well as  Neogobius fluviatilis, fish that has crossed the borders and moved to us. Unfortunately, in light of the above, this can happen unintentionally with GM fish as well.
Given that since the 2020 report, not only salmon has been approved, but also other fish species, including those produced using new genome editing technologies (https://www.isaaa.org/animalbiotechdatabase/default.asp), this raises uncertainty. Of course, one can say that according to the legislation of a number of countries such organisms will not be subject to GMO regulation, but in other countries they will be.
2. What could be the specific challenges to related to this issue?
The challenges may be, firstly, that even with very good legislative regulation of GMO species with a high potential for spread, invasiveness and unlimited movement across borders (we are talking about fish and other organisms that we are discussing today – algae, microorganisms intended for release into the environment), in practice, genetic, physical and other barriers may be overcome. Monitoring and control procedures may not always work, which depends on the different factors, including human factor. A number of organisms may really be intended for large-scale release, and we do not always have sufficient complete data on their genetics, physiology and biology.
In this case, in my opinion, constant monitoring of new trends is necessary. But in addition, new guidance or procedures that would include approaches to control, monitoring, detection and best practices of countries in regulating such organisms in light of new organisms being developed in one, not in separate examples, would not be superfluous. Of course, some methodological recommendations were developed, they were listed in the 2000 report, but I believe that it is recommendations of this kind with a focus on environmental orientation, regulation, monitoring and control, a detailed description of how to do this, taking into account the above-mentioned risks, that are necessary, especially in light of new developments and the possibility of their movement across country borders.

3. What are the specific issues concerning this topic?
The particular concerns of such organisms include the substitution of ecological niches, unlimited movement between borders, overcoming sterility, invasive potential and the very difficult implementation of monitoring or its impossibility, as well as the lack of methods for detecting such LMOs implemented in countries, what can affect biodiversity, unique habitats and ecosystems.

Best regards,
Galina

Dear colleagues,

It's a pleasure to contribute to this forum.

In response to question 1

The topic of genetically modified living fishes has been addressed in considerable detail in many Risk Assessment and Risk Management Guidance Documents. The use of LMFs (Living Modified Fishes) has been important in research settings across various fields, showing great success and no expected danger due to the specificity of the work. On the other hand, their commercial use in the industry is currently limited to GloFish and AquAdvantage Salmon—cases in which concerns about potential environmental risks have been raised, and in the case of the salmon, where the risks and mitigation measures have been well assessed. The field of genetically modified salmon for consumption is an active area of research, with many more genetic variants aimed at reaching the market, making this a topic that will remain relevant in the years to come. 

In response to questions 2-3

The remarks made by our colleague regarding GloFish are particularly important, as they highlight a current problem with potentially unknown consequences. In hyperdiverse countries with limited capacity to regulate and control the ornamental fish market, it is crucial to prioritize biocontainment strategies that rely on the producer’s responsibility. The burden of developing and investing in effective biocontainment, such as making the animal unable to survive outside controlled environments, should fall on the companies producing these organisms, not on the countries where they might be sold, even if illegally, as the company is profiting from it. In many of these countries, buyers are often not well-informed, and national authorities usually lack the resources to ensure adequate containment or enforcement. These fish can be bred, and this is a problem that needs further inspection, as it has already created issues, as greatly stated by our colleague. 

So far, all the AquAdvantage Salmon breeding is being done in land-based facilities, where the risk of release into the environment is pretty unlikely. Currently, there is no major concern about this, but as new variants enter the market in the future, it will be important to maintain the same standards and remain vigilant.

Finally, there is a lack of understanding of how the introduction of LMF can affect local communities, especially those who depend on local species of fish as their food source or revenue. It’s important to point out that no such assessment has been made to date. This gains significant relevance given the information on GloFish that our colleague shared.

My colleagues have already pointed out some of the possible environmental risks of introducing these LMF into the wild. I would like to share two sources I found useful: one is a publication that came out after the last Ad Hoc Expert Group guidelines on genetically modified fish, and the other is a book that provides a comprehensive overview of the environmental dangers. Both documents address topics that have already been covered in the Ad Hoc Expert Group's documents, but with a greater focus on the risks and the new technologies employed.

https://www.nina.no/archive/nina/pppbasepdf/oppdragsmelding/215.pdf
https://onlinelibrary.wiley.com/doi/abs/10.1111/raq.12538

Sol Parra

Dear colleagues,

Thank you to the Secretariat and the Moderator, particularly for the 2020 AHTEG report. I wanted to contribute to question 4. Here are some additional references that might be helpful to this topic: 

i) Kapuscinski, A. R. (2007). Environmental risk assessment of genetically modified organisms (Vol. 3). CABI
ii) Bolland, J. D., Nunn, A. D., Kerins, G., Stein, J., Blackburn, J., Hart, A., ... & Peeler, E. (2010). Defining environmental risk assessment criteria for genetically modified fishes to be placed on the EU market. EFSA Supporting Publications, 7(11).
iii) Van Eenennaam, A. L., & Olin, P. G. (2006). Careful risk assessment needed to evaluate transgenic fish. California Agriculture, 60(3).
iv) McGinnity, P., Prodöhl, P., Ferguson, A., Hynes, R., Maoiléidigh, N. Ó., Baker, N., ... & Cross, T. (2003). Fitness reduction and potential extinction of wild populations of Atlantic salmon, Salmo salar, as a result of interactions with escaped farm salmon. Proceedings of the Royal Society of London. Series B: Biological Sciences, 270(1532), 2443-2450.
v) Fleming, I. A., Hindar, K., MjÖlnerÖd, I. B., Jonsson, B., Balstad, T., & Lamberg, A. (2000). Lifetime success and interactions of farm salmon invading a native population. Proceedings of the Royal Society of London. Series B: Biological Sciences, 267(1452), 1517-1523.

I look forward to the discussions. Thank you.


Kumitaa

My name is Christoph Then and I am a member of ENSSER (The European Network of Scientists for Social and Environmental Responsibility) and representing Testbiotech (http://www.testbiotch.org) in this discussion.

In our most recent report (Testbiotech 2025) we have been collecting cases of LMO fish. We identify risks associated with the processes of genome editing that result both from the processes (unintended effects) or their intended outcomes (desired traits). This can affect various aspects of including animal protection, animal welfare, animal health, animal breeding, the environment and also cause risks for consumers. We also mention some cases of LMO fish that entered the market already. We also would like to draw the attention to Miklau et al. (2024) which recently provided a review including LMO fish.

Based on this short introduction, I address the four questions put forward by the moderator:  

1. In LMO fish, there are specific challenges that concern the outcomes of the genetic engineering processes. Inter alia, these difficulties are caused by genetic mosaics, genetic variants and the size of the populations that are grown in aquaculture. It is plausible that in many cases the individuals within these populations are not homogeneous in regard to intended and unintended effects. This can raise major problems in risk assessment (see for example VKM, 2023).

2. The challenges can be exemlified in the case of an application for the experimental release of LMO salmon that was submitted in Norway (VKM, 2023). It was the first of this kind of application in Europe. In this case, CRISPR/Cas was used to switch off genes in fish which are important for the development of their reproductive organs. The aim was to use the sterile LMO salmon, for which also a patent application had been filed (WO2021198424) to be released into aquaculture ponds in the sea for fish farming.

However, after examining the application, the Norwegian Scientific Committee for Food and Environment (VKM, 2023) came to a negative conclusion because there were too many uncertainties in the environmental risk assessment. According to the VKM, it had not been shown that all genetically engineered fish were actually sterile. The problem lies in the lack of precision of new genetic engineering: in CRISPR salmon, there are considerable genetic differences in the altered genes between the individual animals. One reason for this is the widespread genetic mosaicism in fish (see above). This can cause hazardous genetic alterations to be introduced into gene pool of the breeding populations when selecting NGT animals for fattening, as only some of the NGT fish may inherit exactly the desired characteristics.

VKM also stated that it was unclear how the CRISPR salmon would behave in the environment: for example, they could become competitors for younger fish in natural populations living in rivers around the fish farms. If they were not completely sterile, they could pass on the artificial genetic defects, and thus further weaken natural populations. According to the VKM, there is also a risk that the CRISPR salmon are more susceptible to diseases and could, therefore, contribute to the spread of dangerous pathogens in the affected regions. In addition to the possible uncontrolled spread of genetically engineered animals, there are other environmental risks. For example, genetically engineered animals can also transmit pathogens and spread these via faeces, which would not otherwise be expected. The reason for this may be a weakened immune system or the emergence of pathogens specifically adapted to the NGT traits. In addition, many applications promote high-intensity farming which can be associated with greater environmental pollution.

3. In the light of the information above and the statements already made by our colleagues, all questions can be answered with yes

4. For LMO fish that may enter the environment (unintentionally) and may persist and propagate, specific guidance is necessary that is adapted to the specific risks for the receiving aquatic systems. Also the particular processes for transformation of fish and their biology is different from those of terrestrial vertebrate animals. In this context, also ‘cut-off’ criteria are needed that allow to reject a application if there are to many unknowns to derive to reliable conclusions (Then et al., 2020). What also should be included are guidelines for animal welfare (see Testbiotech 2025).

Miklau M, Burn S-J, Eckerstorfer M, Dolezel M, Greiter A, Heissenberger A, Hörtenhuber S,
Zollitsch W and Hagen K (2024), Horizon scanning of potential environmental applications of terrestrial animals, fish, algae and microorganisms produced by genetic modification, including the use of new genomic techniques. Front. Genome Ed. 6:1376927. doi: 10.3389/fgeed.2024.1376927

Testbiotech (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/

VKM (2023) Environmental risk assessment of genetically modified sterile VIRGIN® Atlantic salmon for use in research trials in aquaculture sea-cages, https://vkm.no/english/riskassessments/allpublications/geneticallymodifiedsterilesal-
monriskassessmentoffieldtrials.4.49914e7a18a5261030860bee.html

see also VKM (?2024) Response to the Norwegian Environment Agency from VKM
Your ref.: 2023/5243 Additional considerations on the environmental risk of genetically modified sterile VIRGIN® Atlantic salmon for use in research trials in aquaculture sea-cages, https://vkm.no/download/18.528094718f293591e4f027b/1714980721738/Response%20to%20the%20Norwegian%20Environment%20Agency%20about%20CRISPR%20salmon%20VKM%20.pdf

My name is Josephine Amedu, and I work with the National Biosafety Management Agency in Abuja, Nigeria. Thank you, Moderators, for coordinating these discussions, and thank you to all colleagues for very insightful deliberations.
Regarding Living Modified Fish (LMF), as you all may know, ornamental fish (e.g., zebrafish, barb-fish) and edible fish species (e.g., AquaAdvantage Salmon) have been commercialized in several countries with safety assessments conducted using Risk Assessment guidelines mostly developed for GM animals. These guidance resources include: Canada’s Risk Assessment Guidance of GM Animals, European Union: Guidance on the Environmental Risk Assessment of LM animals (including fish), USA: Risk Assessment Guidance for LM Animals and the United Kingdom of Great Britain and Northern Ireland’s Guidance on the Risk Assessment of LMOs for contained use.
In terms of environmental risks identified, the most notable is the escape of LMF to the aquatic environment where it can hybridize with the wild population In particular, the issue is whether the effects of hybridization and transgene introgression into wild fish populations can affect their overall fitness in terms of survival, migration, and reproduction. While the risk of escape is minimized by restricting production to facilities with physical containment situated inland, and the risk of hybridization minimized by creating LMF as triploid sterile females for biocontainment of the transgene, some reports show that the methods for inducing polyploidy in embryos can result in a small percentage remaining as diploid, with the ability to hybridize with the wildtype. An increase in production levels in the future is very likely to result in increased likelihood of escapes of such fertile LMF events with corresponding effects in the receiving aquatic environment. Some have argued for a full environmental impact statement (EIS) to adequately consider the risks and proffer appropriate management measures. The performance of such measures must be carefully monitored overtime for efficacy.
Further challenges to existing regulatory frameworks lies in the complex biology and behaviour of fish making it difficult to establish appropriate baselines for wildtype and cultivated varieties to which transgenic varieties can be compared to. And so, information on the survival characteristics in different aquatic environments, such as data on adaptation to river and marine environments, levels of predation and competition, presence of wild type or compatible species and comparative fitness of LM and non-LM fish in compatible environments is generally lacking. Further information gaps is the inadequate description of the critical or limiting environmental conditions controlling the survival and distribution of this species. Therefore, establishing baselines and meaningful comparisons may be difficult so that assessing the impacts of genetic modifications, which can alter behaviour as well as phenotype, may be problematic, resulting in uncertainty.

Josephine Amedu
Nigeria

Dear colleagues,

Thank you very much for all your contributions and the resources you have provided. As you have mentioned, I understand that there are already risk assessment guides on this topic, but some of you mention difficulties associated with risk management. I find it interesting that we can delve deeper into this aspect based on the guiding questions.

We still have one more day of discussion, so I encourage you to continue contributing and enriching the debate. I also appreciate your continued reference to the specific questions and adding resources that may be relevant to the work of the AHTEG.

Best regards,

Ana Laura

Good Afternoon colleagues,
Some thoughts on the topic of Risk assessment of Living modified fish
1. How does this topic potentially pose challenges to the existing risk assessment frameworks, guidance and methodologies? Do solutions exist?
Challenges:
- Frameworks Focused on Terrestrial LMOs:
Most existing risk assessment frameworks (e.g., under the Cartagena Protocol) were developed primarily for terrestrial plants and microorganisms, not aquatic animals.
- Aquatic Environment Complexity:
LM Fish can interact with highly dynamic aquatic ecosystems characterized by vast dispersal pathways (rivers, lakes, oceans), making containment and risk prediction very difficult.
- Hybridization and Gene Flow:
LM Fish can breed with wild relatives, leading to genetic introgression, possibly reducing the fitness of wild populations or causing ecological displacement (Devlin et al., 2004).
- Behavioral and Ecological Changes:
LM Fish may show altered behaviors (e.g., feeding, migration, reproduction) affecting ecosystem structure and food webs.
- Long-Term Monitoring Gaps:
Fish are often long-lived species; thus, multi-generational effects need assessment, which existing frameworks often under-address.

Existing Solutions:
Confinement Strategies:
Physical (e.g., land-based recirculating aquaculture systems) and biological containment (e.g., triploid sterility) methods have been developed and are increasingly recommended (Kapuscinski and Brister, 2001).
Risk Assessment Guidance Adaptation:
Adaptations to aquatic contexts are emerging (e.g., CBD AHTEG recommendations, FAO Guidelines on Aquatic GMOs).
Precautionary and Stepwise Approach:
Risk assessments are advised to follow phased testing — laboratory → confined field trial → conditional release.

2. What could be the specific challenges related to this issue?
- Escape and Establishment Risk: LM Fish could escape from aquaculture facilities due to floods, equipment failures, or human error, with potential to establish feral populations.
- Impact on Wild Populations: Gene flow could reduce genetic diversity, fitness, and adaptive potential of native fish stocks (the "Trojan gene effect" hypothesis; Muir and Howard, 1999).
- Ecosystem Disruption: Introduction of fast-growing or aggressive LM Fish could displace native species and alter nutrient cycling or habitat use.
- Transboundary Movement: Fish can migrate over long distances, crossing national borders naturally (e.g., via rivers, coastal currents).
- Public Acceptance and Socioeconomic Effects: Fisheries-dependent communities may face economic disruption or cultural loss if LM Fish affect wild fisheries.
- Regulatory and Liability Challenges: Lack of harmonized international guidelines specific to LM Fish complicates governance and redress mechanisms in case of adverse impacts.
Additional Key challenges include:
i. High dispersal potential through water currents and active migration
ii. Complex reproductive behaviors that may facilitate transgene spread
iii. Sensitivity to environmental changes that could alter expected trait expression
iv. Difficult containment in open water systems
v. Limited baseline data on many wild fish populations
3. Specific Issues Concerning LM Fish
(i) Potential to Cause Serious or Irreversible Adverse Effects on Biodiversity
- LM Fish could cause irreversible genetic pollution of wild populations, particularly if endemic/rare species hybridize with them.
- Unique ecosystems (e.g., isolated lakes, coral reef systems) could be especially vulnerable.
- Risks to indigenous peoples and local communities are significant where culturally important fisheries are impacted.
- Competition with wild stocks, Disruption of predator-prey dynamics and Alteration of ecosystem functions (e.g., nutrient cycling) are potential biodiversity risks


(ii) Potential for Introduction into the Environment
- Deliberate introductions might occur under aquaculture operations.
- Accidental releases are a serious risk due to storms, floods, or infrastructure failures.

(iii) Potential for Dissemination Across National Borders
High risk due to:
1. Natural migration patterns
2. Human-mediated transport (e.g., ballast water)
3. River systems spanning multiple jurisdictions
- Rivers and marine currents can facilitate the movement of LM Fish across political boundaries, complicating control efforts.


(iv) Commercialization or Current Use
AquAdvantage® salmon was approved for sale and consumption in the USA and Canada.
GloFish (ornamental, multiple countries)
Other LM fish (e.g., gene-edited tilapia and catfish) are under research and early regulatory review.

4. Existing Resources or Adaptable Frameworks
Existing Resources:
Cartagena Protocol on Biosafety (2000): Applies broadly to LMOs, including animals, but needs aquatic-specific interpretation.
- CBD AHTEG Recommendations: Specific work on synthetic biology organisms and gene drive applications provides transferable principles.
- FAO Technical Guidelines for Responsible Fisheries (Aquatic Biotechnology Chapter): Provide principles for managing risks of aquatic GMOs.
- OECD Reports on Aquatic Biotechnology: Discuss biosafety, containment, and risk assessment challenges related to aquatic genetically engineered organisms.

Best Practices from Aquaculture:
Physical containment measures (e.g., land-based closed containment) and biological barriers (e.g., sterile triploid fish) recommended by FAO and national regulators (e.g., FDA).

Relevant Frameworks includes:
Codex Alimentarius Food Safety Guidelines for Recombinant-DNA Animals (2008):
Food safety risk assessments for GM animals could be adapted to include environmental aspects.
ISO/TC 276 (Biotechnology Standards): Technical standards for biotechnology could inform LM Fish testing and monitoring protocols.

Conclusion
Living Modified Fish introduce unique and serious challenges to existing biosafety and risk assessment frameworks. Their high mobility, reproductive capacity, and potential for irreversible genetic and ecological impacts demand aquatic-specific risk assessment methodologies, rigorous containment strategies, and cross-border governance frameworks.
Although solutions such as physical containment and biological sterilization exist, long-term ecological monitoring and enhanced international cooperation are essential to ensure that the benefits of LM Fish can be realized without compromising biodiversity, ecosystem services, and cultural values.

References
Devlin, R. H., et al. (2004). "Population effects of growth hormone transgenic coho salmon depend on food availability and genotype by environment interactions." Proceedings of the National Academy of Sciences, 101(25), 9303–9308.
Kapuscinski, A. R., & Brister, D. J. (2001). "Genetically Modified Fish and Ethics: Genetic Engineering Meets Environmental Ethics." Science and Engineering Ethics, 7(1), 59–74.
Muir, W. M., & Howard, R. D. (1999). "Possible ecological risks of transgenic organism release when transgenes affect mating success: Sexual selection and the Trojan gene hypothesis." Proceedings of the National Academy of Sciences, 96(24), 13853–13856.
OECD (2019). Biosafety and Aquatic Biotechnology: Policy Considerations and Best Practices.
FAO (2011). Technical Guidelines for Responsible Fisheries: Aquaculture Development.
WHO/FAO Codex Alimentarius (2008). Guidelines for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Animals.

Ossama AbdelKawy
Egypt National Focal Point of the Cartagena Protocol
Microbiology and Biotechnology Professor, British University in Egypt
Research Professor, Egyptian Atomic Energy Authority
Science Advisor, Egyptian Ministry of Environment

Contributions to Discussion on Questions 1,2,3(iii,iv)
Greetings!
The discussion on LM fish is really important and timely, particularly in developing countries where misinformation and misconception is quite prevalent despite the potential LM fish offers in helping to reduce pressure on wild fish population arising from overfishing and habitat loss due to climate actions and other anthropogenic activities. However,more studies will be required to firmly establish its potential adverse effects on biodiversity due to risks such as invasiveness, transboundary movement,etc.
Some of the possible challenges associated with it include lack of established regulatory mechanisms in the area of LM species of animals in some developing at the moment and lack of harmonized regional regulatory procedures (and thresholds as the case may be.) A harmonized regional regulatory system would further foster trade in LM fish and its products when developed, adopted,and implemented,while ensuring over all biodiversity protection and conservation.
In addition, since some natural bodies of water are transnational,there exist a risk of escape into territorial waters of neighboring countries. This therefore, underscores the importance and need of a harmonized regional regulatory framework in the area of LM fish.

Hassan Aimas Zakayo
Nigeria.

https://www.nature.com/articles/s41541-025-01099-9#Sec7
https://doi.org/10.1038/s41541-025-01099-9

I would like to submit the following paper, on the reversion of a live attenuated viral vaccine for African swine fever, that highlights some of the risks and uncertainties already raised in this discussion. The study reported instability of the virus, with reversion back to virulence and increased virema, viral shedding to fetuses and unvaccinated sows, and high rates of foetal death.

Many thanks
Eva

Dear colleagues,

Regarding question 3.iv, the European Food Safety Authority (EFSA) published in 2023 a report which presents a review of the commercial and pre‐commercial stage applications of new genomic technologies applied to farm animals and their agri/food/feed products which is available here: https://www.efsa.europa.eu/en/supporting/pub/en-8311 .

EFSA is also preparing a scientific opinion, which will be published later this year, on new developments in biotechnology (including synthetic biology and new genomic techniques) applied to animals for food, feed and other agricultural uses.

Best regards,
Alexandre

Dear All,

First, I apologize for the delayed response.

My name is Eder Toppa, and I have been working at the Brazilian Ministry of Agriculture and Livestock for the past decade. I currently serve as the Head of the Biosafety Service and am a member of the National Biosafety Commission.

Regarding the possible new topics for drafting new voluntary risk assessment guides, in response to submissions received and arising from Notifications No. 2023-0077 and No. 2023-129, the AHTEG evaluated the four topics proposed by the Parties in relation to the criteria outlined in Annex I of Decision CP-9/13 and concluded that, for now, no additional topic should be prioritized for the development of further guides. It is worth noting that one of the evaluated topics, which did not meet the criteria described in Annex I of Decision CP-9/13, was limited to modified living aquatic organisms, such as algae, crustaceans, and fish. Therefore, this is the reason why the development of a guide for fish should not be pursued or insisted upon, meaning that the wishes of the Parties must be respected and not subverted.

Best Regards

Eder Victor Braganti Toppa
Federal Inspector
Head of the GMO Biosafety Service
Plant Health Department
Ministry of Agriculture and Livestock

Dear Colleagues,

Thank you to the Secretariat and the Moderator,

We submit this comment in collaboration with the Japan Citizens' Network for Sustainable Food and Agriculture (FA-Net).

We respectfully wish to submit the following comment to the Open-ended Online Forum on Risk Assessment (2025-2026) - Week 1: 21 to 28 April regarding Living Modified Fish.


General Comments Regarding Genome-edited LM Fish
Thank you for this opportunity to comment on the Risk Assessment of Living Modified (LM) fish. We strongly believe that genome editing, including deletion editing, in which part of a gene is deleted by genome editing, should be brought under the control of the Convention on Biological Diversity and the Cartagena Protocol, and regulations should be strengthened based on international standards.
Genome editing is associated with several problems that require Risk Assessment. Abnormalities can occur in brain function, reproductive behavior, and immune responses. Activity is also weakened, fear is enhanced, diurnal rhythms are altered, and color perception is reduced. In addition, the genome editing technology itself leads to off-targets that disrupt other genes as well as causing large-scale chromosome damage at locations where the DNA is altered. Risk Assessment is essential to avoid the many problems and hazards involved in such a powerful technology.
For example, living genome-edited fish whose genes have been partially disrupted by CRISPR/Cas9 are produced, bred and sold by Regional Fish Institute Ltd. in Japan. These living genome-edited fish are raised in land-based aquaculture facilities run by a venture company with no rules for open and peer-reviewed information. It is difficult to say that sufficient measures have been taken to prevent environmental leakage from the tanks.
The possibility cannot be ruled out that living genome-edited fish in captivity could be released into the environment if the breeding facilities are damaged by some accident or natural disaster. We suspect that the company’s facilities in Noto, central Japan were damaged by the 2024 earthquake, and have asked what happened to the genome-edited LM fish in question, but neither the company nor the government will provide answers to the public.
International regulations on genome-edited LM fish should be established by the Convention of Biological Diversity as soon as possible, based on the precautionary principle, in order to identify such risks and prevent irreversible environmental impacts in advance. Strict biosafety regulations are needed with regard to all living genetically modified fish, bearing in mind that they are bred, raised and sold and disposed of not only for research and ornamental purposes such as aquariums, but also for food use.

1) Genetically Modified Medaka Rice Fish (Oryzias latipes)
In 2006, unapproved living GM medaka rice fish was smuggled to Japan from Taiwan. The LM fish were sold illegally in pet shops to enthusiasts to be kept as ornamental fish. This transgenically modified, ‘glowing’ living organism was originally produced by the National University of Taiwan so that it would glow in such a way that specific genes would be more easily-viewable under the microscope. Such living GM fish are banned in the EU.
Source:
https://www.env.go.jp/press/6802.html
In 2023, living GM medaka rice fish bred by enthusiasts for research purposes were found to have been illegally removed from a lab room. In this case, they had released some of the living GM medaka rice fish they had bred into the environment by disposing of alive fish in a nearby river. Living GM medaka rice fish were bred and transferred in Tokyo, Japan without obtaining approval under the Law Concerning the Conservation of Biological Diversity through the Regulation of the Use of Living Modified Organisms and Other Measures. The case in which such living GM medaka rice fish was sold in Tokyo was referred by the Tokyo Metropolitan Police Department to the Ministry of the Environment regarding the arrest of persons involved with the living GM medaka rice fish in violation of the Cartagena Act.
Cases of such artificially bred LM ornamental fish has been found in natural waters within western Japan's Shiga Prefecture, near Kyoto, according to media reports. These genetically modified fish are considered a "third type of invasive species," following foreign and domestic invasive species, and pose a significant threat to the genetic integrity of native fish. A joint research group from Lake Biwa Museum and the Ryukoku University Center for Biodiversity Science is urging people not to release ornamental rice fish into natural water bodies.
Sources:
https://www.env.go.jp/press/press_01252.html
https://www.mext.go.jp/b_menu/houdou/mext_01197.html
https://mainichi.jp/english/articles/20240815/p2a/00m/0sc/020000c

2) Genetically Modified Red Sea Bream (Pagrus major)
The living GM red sea bream has had the myostatin gene, which suppresses muscle development, knocked out by genome-editing by researchers at Kyoto University, Japan. The increase of skeletal muscle mass and reduced body length was achieved by genome editing with CRISPR/Cas9.
However, genome-editing technology itself leads to off-targets that disrupt other genes as well as causing large-scale chromosome damage at locations where the DNA is spliced. These can result in great hindrances to life activities. With regards to the living GM red sea bream case, Testbiotech, the German group of scientists, noted that the reduced body length and abnormal positioning of vertebrae make it a skeletal anomaly possibly constituting "torture fish breeding” with its concomitant animal welfare issues.
Sources:
https://www.testbiotech.org/en/news/crispr-fish-suspected-torture-breeding/
https://www.sciencedirect.com/science/article/abs/pii/S0044848617324705

Farmdo Group, which sells agricultural products directly in Gunma Prefecture and Tokyo, purchased some 400 living genome-edited red sea bream juveniles from Regional Fish Institute, Ltd. in 2023 with the aim of cultivating and selling them. Many of them died while growing, leaving only about 20 remaining. However, the company plans to purchase about 600 more fish and sell them at its food stations and other direct sales outlets. No explanation why the LM fish died has been provided.
3) Other Genetically Modified Fish

In December 2022, Regional Fish began selling genome-edited puffer fish online. At the same time, Miyazu City, Kyoto Prefecture, where the fish farms are located, decided to use the genome-edited pufferfish as a return gift for hometown tax payments. Protests against Miyazu City have spread, with consumer groups and others criticizing the use of fish whose safety has not been confirmed.
NTT Aqua has signed a comprehensive partnership agreement with the Okinawan company Akajin, which has its own filtration technology, and plans to expand this Okinawan onshore aquaculture system nationwide. Since September 2023, the two companies have been conducting research on the cultivation of the leopard coralgrouper (Plectropomus leopardus) and redspotted grouper (Epinephelus akaara).
In 2023, living GM flatfish was engineered to be abnormally fat by disrupting the anorexigenic leptin gene, to suppress appetite. However, the leptin gene is so important to the living animal that disrupting it can cause a range of other problems.
Sources:
https://www5d.biglobe.ne.jp/~cbic/english/2021/journal2102.html
https://www5d.biglobe.ne.jp/~cbic/english/2025/journal2501.html

4) Overseas Developments
Attempts to export living genome-edited fish and fish breeding systems to Thailand, Indonesia and Cambodia have been reported. Japan External Trade Organization (JETRO) is involved in several projects together with Regional Fish Institute, Ltd. Any cross-border movement of LM fish must be strictly guided by the rules of the Cartagena Protocol. We are concerned that the commercial entities involved do not take such rules seriously.
Sources:
https://www.jetro.go.jp/ext_images/_News/announcement/2023/52933042979ca942/JPN_Fish1.pdf
https://www.jetro.go.jp/ext_images/_News/announcement/2022/0e80b8da931addc9/JPN_Others3.pdf

Dear colleagues,
My name is Anastasia Matthies and I am employed at German Federal Office of Consumer Protection and Food Safety (BVL), where I am responsible for the risk assessment of living modified organisms. Firstly, I would like to express my gratitude to the moderators and all participants for the interesting and informative discussion.

4. Are there existing resources on similar issues that can address this issue or resources that could be adapted to address this need?

Echoing the posts #12286, #12344, #12345 it is important to note that there are already some reference frameworks, guidelines and methodologies for living modified fish (LMF) that have been reviewed and evaluated by the AHTEG in relation to the criteria outlined in Annex I of Decision CP-9/13. In this regard, reference should also be made to the decision of Decision CP-10/10, which encourages the use of existing materials rather than the creation of additional resources for LMF guidance. In this decision, the Secretariat is requested to provide dedicated web pages in the Biosafety Clearing-House to facilitate easy access and raise awareness of available information relevant to the risk assessment of living modified organisms, including living modified fish.
It is regrettable to note that such pages have not yet been created. This would represent the initial, efficacious phase in the consolidation of all extant information. The vast majority of comments in this online forum on LMF concern the provision of specific data relevant to risk assessment (environmental behavior, persistence, distribution, etc.) and not the RA methods themselves. Therefore, it is important that all information deemed to be pertinent to the risk assessment is made available. This will ensure the dissemination of all extant guidance material, in addition to other information that supports risk assessment (relevant decisions, case studies etc.).
In my view, the existing risk assessment methodologies provide the means to address the challenges mentioned in this online forum with regard to the risk assessment of living modified fish. This is due to the fact that the particular issues under discussion can be addressed by the universal principles of environmental risk assessment, based on the principle of problem formulation, taking into account the protection goals. It is recommended that greater emphasis be placed on the active application of these principles like it done in the guidance materials to support case-by-case risk assessments of living modified organisms containing engineered gene drives (https://www.cbd.int/doc/c/175e/90b0/89c0c71660cccc1539adf34f/cp-mop-11-09-en.pdf).
Furthermore, training and capacity-building measures for interested parties should be directed in this direction.
Best regards,

Anastasia Matthies

My name is Samson Simon, I work for the German Federal Agency for Nature Conservation (BfN) as a biosafety expert.

The topic of living modified fish was discussed previously. However, I think that they are some valid points that have been raised before, as well as some recent arguments why LM fish are an important topic to be tackled under the Cartagena protocol. Here, I wish to especially echo the post [#12295] by Galina Mozgova.

Q1 and 2: There are certain challenges that are pronounced due to the nature of the receiving environment. As being relevant both for LM algae and LM fish knowledge about  aquatic ecosystems is small. Due to the potential interconnectivity of populations probability of gene flow can be increased. Additionally, invasiveness is a potential risk that deserves special attention. For LM fish monitoring and risk mitigation strategies need to be further developed, when considering applications in aqua culture, which bear the potential of accidental release in the environment. A special challenge is that LM fish will be very difficult to retrieve from the environment once they are released (on purpose or accidentally).

Q3: Horizon Scanning in the field of LMOs has identified LM fish as an important trend (Miklau et al . 2024). E.g., as of 2023 a comparable high number of applications in aquatic species were in the pre-commercial or commercial pipeline for agri/food/feed products as identified in an EFSA external report: According to this publication (Van Eenennaam 2023) those include: “Nile tilapia (18 [applications]), Atlantic salmon (7), Channel catfish (7), Common carp (4), Gibel carp (2), Sterlet (2), Olive flounder (2), Farmed carp (1), White crucian carp (1), Mozambique Tilapia (1), Loach (1), Southern catfish (1), Yellow catfish (2), Tiger pufferfish (1), Red sea bream (1), Blunt snout sea bream (1), Rainbow Trout (1), Redhead cichlid (1), Royal farlowella (1), Oyster (1)”.
These organisms thus represent a variety of aquatic animals spanning a wide geographic area and covering a variety of ecosystems potentially affected.

Question 3 also covers the potential of LM fish to be released into the environment and spread across national borders. The accidental environmental release of fish being farmed in open and semi-open aqua culture cannot be excluded and has to be assumed when performing environmental risk assessment. For conventional farming such incidents in open and semi-open aqua farms are frequent. Thus, it has to be assumed that i. accidental release of LM fish occurs and ii. that their spread will not be restricted by national borders if their natural (or newly invaded) ecosystems cover multiple jurisdictions (which can safely be assumed).

References:

Van Eenennaam, A.L. (2023). New Genomic Techniques (NGTs) Animals and their Agri/food/feed products. EFSA supporting publication 2023: EN-8311. 82 pp. doi:10.2903/sp.efsa.2023.EN-8311

Miklau M, Burn S-J, Eckerstorfer M, Dolezel M, Greiter A, Heissenberger A, Hörtenhuber S, Zollitsch W and Hagen K (2024) Horizon scanning of potential environmental applications of terrestrial animals, fish, algae and microorganisms produced by genetic modification, including the use of new genomic techniques. Front. Genome Ed. 6:1376927. doi: 10.3389/fgeed.2024.1376927

Best regards
Samson

Dear participants,

My name is Luciana Ambrozevicius, I´m a regulator and a risk assessor at the Brazilian Biosafety Commission. Thank you for the opportunity to participate in the on line forum. For the proposed topic “Living modified fish” I would like to make the following considerations regarding the criteria for new topics established in the annex I to decision CP-9/13:

1. How does this topic potentially pose challenges to the existing risk assessment frameworks, guidance and methodologies? Do solutions exist?

There are challenges (question 2) but also existing solutions for the RA of LM fish. The challenges and solutions were already an object of intense debate of experts during two mandates of the AHTEG and the conclusion was established in the parties decisions. At COP-MOP 10 the Parties decided not to proceed with the development of additional voluntary guidance materials for LM fish. At COP-MOP 11 the Parties again did not consider to elaborate further guidance on LM fish.

It’s important that, with a limited amount of resources, those resources are focused into new topics that were not subject to analysis and could fulfill the criteria of decision CP-9/13 for further guidance.

2. What could be the specific challenges to related to this issue?

The challenges related with changes in behavior, survival, adaptation, competitiveness, reproduction, interactions with wild type and other species in the range of potential receiving environment were extensively discussed in the last years since the “STUDY ON RISK ASSESSMENT: APPLICATION OF ANNEX I OF DECISION CP 9/13 TO LIVING MODIFIED FISH” was made available for the AHTEG discussions on 2020.

But there is also existing guidance material available and experience that can be used to address the potential challenges raised for the RA of LM fish, with scientific risk hypothesis formulated to address those risks and in accordance with annex III of Cartagena Protocol, and risk management measures to be established, if necessary.

4. Are there existing resources on similar issues that can address this issue or resources that could be adapted to address this need?
The study mentioned by the moderator (document CBD/CP/RA/AHTEG/2020/1/3) describes in the Section 6 “the risk assessments performed on living modified fish by Canada and the United States of America and the guidance documents relating to risk assessment of living modified animals available in those two countries. In addition, it discusses the guidance documents that are available, such as those produced by the European Food Safety Authority, the Organisation for Economic Co-operation and Development and the Convention on Biological Diversity. There are also guidance documents available in many countries for risk assessment of living modified animals for contained use and the United Kingdom risk assessment system is presented as an example.”

These means there is existing guidance material available and experience that can be used to address the RA of LM fish.

Based on the above, I consider that this topic does not fulfill the criteria established for the process for the identification and prioritization of specific issues regarding risk assessment of living modified organisms, according with decision CP-9/13.

Best regards,
Luciana P. Ambrozevicius

Dear All,

My thanks to the moderators for providing some clear questions to structure this exchange.

My name is Piet van der Meer. I am trained as a microbial ecologist and an environmental lawyer, and since 1986 I have conducted hundreds of risk assessments in regulatory context. Since the adoption of the CPB, I also provide training on risk assessment to government- and public research institutions, with the principles and methodology of Annex III as the starting- and endpoint.

Before following up on the questions posed by the moderators, it is good to note that several colleagues place their contributions in the broader context of the KM-GBF, as it is nicely summarized in the introduction to the Cartagena Protocol on Biosafety “The Protocol thus creates an enabling environment for the environmentally sound application of biotechnology, making it possible to derive maximum benefit from the potential that biotechnology has to offer, while minimizing the possible risks to the environment and to human health.”.

Given the COPMOP2024 decision CP-9/13, the opening question posed by the moderators for this debate (i.e. how LM algae, LM animals, LM fish, LM microorganisms, and LMOs containing stacked events potentially pose challenges to the existing risk assessment frameworks and methodologies), is a very pertinent one.

My response to this question is that these topics do not pose challenges to the Annex III risk assessment methodology as such. Unlike some colleagues suggest, Annex III is not primarily designed for terrestrial GMOs or for crop plants. Annex III is designed for all LMOs and can be applied to all categories LMOs, including LM algae, LM animals, LM fish, LM microorganisms, and LMOs containing stacked events.

What is true, however, is that we have more guidance on ways to collect relevant data for LM crop plants, than for LM algae et cetera. Whether or not it is worth developing additional guidance for those topics is a cost-benefit analysis for the COPMOP to make.

Regards to all,

Piet van der Meer

Ediner Fuentes-Campos, Director of Research and Development at the National Secretariat of Science, Technology and Innovation of Panama and Focal Point of the Cartagena Protocol in Panama, as well as a Risk Assessor.

Annex III of the Cartagena Protocol provides a comprehensive and adaptable framework for the risk assessment of genetically modified fish. This framework already establishes solid principles that adequately address the particularities of GM fish through case-by-case assessment, considering their specific characteristics and the receiving environment. I agree with position #12359 when it points out that there are guidance materials available and accumulated experience that can be used to address the risk assessment of GM fish "in accordance with Annex III of the Cartagena Protocol". The experience gained through risk assessments conducted in Panama, Argentina, Canada, and the United States provides valuable precedents that demonstrate the applicability of the existing framework. It is important to remember that the Parties already decided at COP-MOP 10 and COP-MOP 11 not to proceed with the development of additional materials for GM fish, recognizing the sufficiency of current frameworks. As Mr. Eder Toppa (#12345) correctly points out, "the wishes of the Parties must be respected and not subverted."

The challenges related to GM fish have been widely discussed and are well characterized in the scientific literature. These include considerations about behavior, survival, adaptation, competitiveness, reproduction, and interactions with wild populations. However, it is crucial to highlight that these challenges can be adequately addressed through: 1) The formulation of scientifically based risk hypotheses, 2) The rigorous application of Annex III of the Protocol, and 3) The implementation of appropriate risk management measures when necessary. Our experience in Panama with the development and evaluation of AquAdvantage salmon demonstrated that these considerations can be effectively managed within the current framework. The monitoring and oversight processes implemented were fully compatible with the principles of the Cartagena Protocol, showing that the existing framework is adequate when rigorously applied.

Scientific research has demonstrated that the potential risk of GM fish can be effectively mitigated through robust case-by-case assessments. Existing risk assessment methods are appropriate for evaluating the potential effects of transgenic fish on ecosystems, although specific information is required on the transgene construction, fish biology, and the receiving environment. This case-by-case approach is already incorporated in Annex III and has proven to be effective. In Panama, the research and development processes for AquAdvantage salmon included comprehensive assessments following precisely this methodology, with results that validated the safety of these organisms under appropriate controlled conditions.

Advances in biotechnology have allowed the development of effective containment strategies. For example, sterility induced through triploidy in AquAdvantage salmon has proven to be an effective measure to prevent reproduction in case of accidental release. These biosafety measures, when combined with adequate physical barriers, can significantly reduce the risks of unwanted introduction. The combination of biological and physical barriers can provide multiple levels of containment that make the risk of establishment extremely low. These considerations are already contemplated in existing risk assessment methodologies.

The aspect of transboundary movements is adequately covered by the Cartagena Protocol in its specific provisions. Experience has shown that with the implementation of appropriate risk management measures, the potential for transboundary dispersal can be effectively controlled. The experiences of evaluation and management of GM fish in Panama have demonstrated that it is possible to implement robust containment systems that minimize this risk, always in compliance with the principles of Annex III.

As #12359 has correctly pointed out, there are numerous resources and guidance documents available that can be applied to the assessment of GM fish. These include those produced by the European Food Safety Authority, the Organisation for Economic Co-operation and Development, and the Convention on Biological Diversity itself. The mentioned study (CBD/CP/RA/AHTEG/2020/1/3) already extensively documents the risk assessments carried out on modified fish by Canada and the United States, as well as the related guidance documents available in those countries. This material constitutes a solid basis that can be adapted to different national contexts. Additionally, the experience accumulated in Panama with the research and development processes of AquAdvantage salmon represents a valuable resource for other Parties, demonstrating the practical applicability of the Annex III framework in a Global South context.

In line with the positions of #12345 and #12359, I consider that the existing frameworks, methodologies, and guidance in the context of the Cartagena Protocol are sufficient to adequately address the potential risks associated with GM fish. The experience accumulated in various countries, including Panama, demonstrates that the case-by-case approach established in Annex III is robust and adaptable to the particularities of these organisms. Instead of developing new guidelines, which the Parties already agreed not to prioritize in previous COP-MOPs, efforts should be directed at strengthening the capacities of national regulatory agencies to effectively implement existing frameworks. This approach would allow leveraging the potential benefits of GM fish for food, health, and scientific development, while ensuring the protection of biodiversity through rigorous and scientifically based risk assessments.

Ediner Fuentes-Campos
Deputy Director of Research and Development
National Secretariat of Science, Technology and Innovation of Panama
Focal Point of the Cartagena Protocol in Panama

Dear Collegues,

My name is Ms Mutibo Chijikwa from the African Union Development Agency - New Partnership for Africa’s Development. I would like to add to the topic on LMF.

Question 1 and 2

Substantial work has been undertaken on the topic of Living Modified Fish, including the several discussions, studies, existing resources (inlcuding guidelines) from several countries and various methodological approaches contributed by national and international organisations. Notably, the Ad Hoc Technical Expert Group (AHTEG) on Risk Assessment and Risk Management convened in 2020 generated valuable insights into the challenges faced by Parties, particularly in conducting robust risk assessments. The framework provides comprehensive and practical guidance that can be adopted or adapted to conduct risk assessment for LMO fish. Furthermore AUDA – NEPAD has been working with African member states to build their capacity to setup functional biosafety regulatory system for regulating LMOs including LMF. Annex 3 of the Cartagena Protocol on Biosafety remains a useful tool, in addition to the other existing resources, for conducting risk assessment of LMF.

Question 3 and 4
The study reports comprehensively highlight the concern related to LMO fish, that have been re-echoed by various contributors to this topic. The report mentions challenges with the complexities of assessing environmental impacts, limited guidance beyond contained use, and a general lack of experience and expertise among Parties. Other concerns noted include insufficient data to fully evaluate potential effects, risks associated with contamination or uncontrolled transboundary movements, pleiotropic effects, and the absence of established regulatory frameworks in certain jurisdictions. All these critical issues, thoroughly documented in the report, require further discussions and capacity building to ensure that Parties are well equipped to address them and other emerging issues related to LMF. Valuable lessons can be drawn from regions such as North America, which leads in the development and regulation of LMF technologies, as well as from Western Europe’s experience in research and risk assessment.


Additional information

It is important to make a clarification on the case of non-genetically modified technologies that are constantly being presented as LMF in contradiction to the Cartagena Protocol on Biosafety. A notable example is the Genetically Improved Farmed Tilapia (GIFT), developed by WorldFish through conventional selective breeding techniques, not genetic engineering. Despite its name, GIFT is frequently misidentified as a genetically engineered fish, particularly in the developing world. This misconception can hinder informed discussions around LMF, especially in the context of biosafety regulation and public perception.

Dear Colleagues,

First, let me thank the moderators for their work in moderating the discussion, and the CBD Secretariat for hosting it and allowing me to contribute.

My name is Andrés Frankow. I am a biologist, and I have been working in risk assessment of genetically modified organisms since 2004. I am currently part of the Coordination of Innovation and Biotechnology in the Secretariat of Agriculture, Livestock, and Fisheries.

Regarding genetically modified fish, and referring to the discussion on genetically modified animals, no significant challenges are anticipated on this matter. This is because there is a solid regulatory framework in place, based on a case-by-case approach, which adequately addresses the evaluation of such cases. This framework ensures a thorough assessment, considering all relevant aspects such as animal health and welfare, potential environmental impacts, and risks to human health. Therefore, the evaluation of genetically modified fish follows the same principles established for other modified animals, ensuring proper management of potential risks.

Therefore, there is no evidence to support the need for developing a specific guide on this topic.

Best regards,

Andrés

Hello everyone, in my opinion, the problem formulation approach, which relies on pathways to harm (as presented in the additional voluntary guidance materials to support case-by-case risk assessments of living modified organisms (LMOs) containing engineered gene drives), provides a robust framework for framing and informing case-by-case risk assessments of LMOs, including fish. This approach is considered scientifically sound and transparent, aligning with contemporary best practices for implementing risk assessments as outlined in Annex III of the Cartagena Protocol on Biosafety. Additionally, it is sufficiently flexible to address the specificities of each LMO case (including fish) under assessment. Best regards, Yann Devos

Good day colleagues,

My name is Thato Mogapi from the Department of Forestry, Fisheries and the Environment in South Africa.

Thank you for the interesting discussions thus far. Without repeating the views already expressed in earlier contributions, please find our input on this topic in response to some of the questions, from a slightly different angle, linking to the work on invasive alien species.

South Africa has a huge problem of invasive species, including fish species, which, while offering some economic benefits in some areas, pose a threat to the environment. LMF may present such characteristics, where they may establish, spread and negatively impact our native species and ecosystems, not forgetting the potential to cross borders. South Africa has not approved any LMF for intentional release into the environment, however, there is potential, due to increasing demand for fish. Aquaculture (marine and freshwater) has been earmarked as a priority sector for further development as part of implementing an ocean economy programme to boost economic growth and job creation.

Furthermore, in addition to future applications for intentional introductions, aquarium pet shop trade has been shown to be one of the high-risk pathways for the introduction of alien invasive fish species into natural ecosystems. Illegal online sales of LMF such as the GloFish could present a risk of escape, further exacerbating the problem of biological invasions. This underscores the need for studies to understand the extent to which this is happening, and more importantly the invasion potential of such LMF to inform measures to prevent any escape to the environment and to minimize impact on native species and ecosystems.

In addition to the national work that has been done on risk assessment of LMOs, aligned to Annex III, (including the environmental risk assessment framework guidance document which focusses on LM crops, and the risk analysis guidance document for contained use research and development activities with LM aquatic organisms), South Africa has done significant work in the field of invasive species, including in the development of useful resources such as a risk analysis framework to inform the control and management of such species, which could be useful for the discussions on risk assessment of LMF, in particular, the gaps identified in the study on LMF.

Resources
Vezi, M.S., Downs, C.T. & Zengeya, T.A. Ornamental fish in the South African pet shop trade: potential risk to natural aquatic ecosystems. Biol Invasions 26, 3031–3047 (2024). https://doi.org/10.1007/s10530-024-03349-8

Sabrina Kumschick, John R. U. Wilson and Llewellyn C. Foxcroft. 2020 “A framework to support alien species regulation: the Risk Analysis for Alien Taxa (RAAT)”, NeoBiota, vol. 62.

Kumschick, S., Foxcroft, L.C., Wilson, J.R. (2020). Analysing the Risks Posed by Biological Invasions to South Africa. In: van Wilgen, B., Measey, J., Richardson, D., Wilson, J., Zengeya, T. (eds) Biological Invasions in South Africa. Invading Nature - Springer Series in Invasion Ecology, vol 14. Springer, Cham. https://doi.org/10.1007/978-3-030-32394-3_20

Marr, Sean M., Ellender, Bruce R., Woodford, Darragh J., Alexander, Mhairi E., Wasserman, Ryan J., Ivey, Philip, Zengeya, Tsungai, & Weyl, Olaf L.F.. (2017). Evaluating invasion risk for freshwater fishes in South Africa. Bothalia - African Biodiversity & Conservation , 47(2), 1-10. https://doi.org/10.4102/abc.v47i2.2177

dear all,

much has been said and it is evident to me that there are strong risk assessment challenges at hand.

I would like to refer to my comments in the section on LM algae here, as I think that an emphasis needs to be given to the general aspect of LMOs in aquatic systems, with not only their interconnectiveness (through water), but also aquatic systems being dynamic systems that keep changing and responding and where so much is not yet known. Reliable risk assesments would need to make that a major focus and not simply to look at a single LM fish species or event on its own.

with best wishes,
Ricarda

Dear Participants,

Thank you kindly for your valuable interventions and active engagement during the first week of discussions.

Week 1 of the Open-Ended Online Forum is now closed.

Please return for Week 2. The discussions will open in an hour (12 pm (noon) Montreal time).

Best regards,

The Secretariat