1. Living modified algae

In contribution to discussion on Question 3-

Indeed the discussion on Living Modified Algae (LMA) is generating deeper biosafety reflections as several studies have showed it's beneficial effect and sustainability for biofuel production. However, more studies will be required to understand potential adverse effects on biodiversity especially the potentials for LMA to proliferate uncontrollably in natural ecosystem (invasiveness), and outcompeting native species, altering ecological balances and food webs. Surely, there are insufficient and limited studies on this as most research focuses on laboratory settings and controlled environment, with few large scale ecological studies.
One of the challenges might be the complexity of aquatic systems as predicting invasiveness in such dynamic ecosystem remains may be challenging. This therefore underscores the need for more horizon scanning on LMA, support for more targeted ecological research, and availability of data of environmental risk assessment before environmental release.

Furthermore, in the release of LMA, their maybe possibilities of deliberate or unintentional introduction into natural water bodies. Therefore, risk assessment can also be tailored to prioritize - if when introduced to natural water bodies, could it be regarded as "contamination"? Could it affect affect drinking water especially in developing countries where several natural water bodies are source of drinking water. Also these natural water bodies are cross-borders of some nations, therefore risk management plans will be tailored for cross-boarder control.

Onyeka Nwosu
Nigeria.

1. How does this topic potentially pose challenges to the existing risk assessment frameworks, guidance and methodologies? Do solutions exist?
Living modified algae (LMA), due to their potential for rapid reproduction, dispersal in aquatic environments, and genetic modification traits, present unique challenges to existing risk assessment frameworks. Traditional methods under the Cartagena Protocol often focus on terrestrial LMOs like crops, and may not sufficiently account for the mobility, ecosystem interactions, and horizontal gene transfer risks specific to aquatic environments. Additionally, social dimensions, particularly gender-responsive risk assessment, ought to be integrated. Solutions lie in adapting existing tools such as the AHTEG guidance, incorporating case-specific aquatic models, and embedding participatory and gender-sensitive assessments that reflect diverse knowledge systems, including those of Indigenous Peoples and local communities (IPLCs).

2. What could be the specific challenges related to this issue?
 The ecological complexity of aquatic systems makes it challenging to predict the potential impacts of LMA on biodiversity.
 Lack of harmonized data and precedent on long-term ecological interactions or containment of algae in open environments.
 Cross-border spread due to water connectivity, which makes it complex for national-level regulatory control.
 Limited engagement of women and IPLCs in biotechnology-related decision-making, leading to gender-blind risk assessments.
 Commercial pressure from biotech sectors may override community concerns or environmental caution.

4. Are there existing resources on similar issues that can address this issue or resources that could be adapted to address this need?
Existing resources include:
 CBD’s Cartagena Protocol on Biosafety and its supplementary guidance documents on risk assessment.
 AHTEG reports (Ad Hoc Technical Expert Group) which provide relevant guidance on aquatic LMOs and their trans boundary implications.
 Gender mainstreaming toolkits from UN Women and CBD’s Gender Plan of Action can be used to ensure inclusive risk governance.

Dear Colleagues,

Thank you Mr. Nwosu and Ms. Marangu for ‘breaking the ice’ on the topic of LM algae and providing value inputs towards questions. You highlighted some important considerations related to the unique biology and ecology of these organisms and aquatic ecosystems.

I would like to encourage all participants to continue contributing and provide insights into this topic before this topic closes on Monday 28 April.

I look forward to the continued discussions,

Ana Laura Mello

Dear esteemed participants.

Here are a few thoughts and contributions that I hope can lead to the fruitful discussion:

Genetically modified (GM) algae are getting more attention and are commonly used to make biofuels, controlling pests (biocontrol) and cleaning up pollution (bioremediation). This are also common uses for GM microorganisms. Genetically modified algae (GM algae) fall within the scope and objective of the Cartagena Protocol on Biosafety as they are living modified organisms (LMOs) resulting from modern biotechnology. GM algae, particularly those intended for environmental release or large-scale cultivation, are relevant to the protocol due to their potential impact on ecosystems and biodiversity. However, there is currently limited experience and scientific knowledge in this area and it may lead to difficulty for risk assessors and regulatory authorities to evaluate these risks. Existing risk assessment frameworks may not fully address the unique biological characteristics of GM algae, such as their microscopic size, rapid reproduction rates, and potential for wide dispersal in aquatic environments. These features pose methodological challenges, including the difficulty of tracking algae populations, assessing their ecological interactions, and evaluating potential gene flow to wild relatives. Additionally, the adaptation of traditional risk assessment methodologies to account for the effects of GM algae on microbial communities and trophic interactions requires further attention. Therefore, it’s important that we start preparing now.

Among challenges that can be addressed for the GM algae includes
i. Limited baseline data on natural algal populations and their ecological roles.
ii. Lack of standardized methods for detecting and monitoring GM algae in aquatic environments.
iii. Complexity in assessing horizontal gene transfer and its ecological consequences.
iv. Predicting the long-term persistence and evolution of GM algae in natural ecosystems.
v. Ethical and regulatory challenges related to large-scale releases in open aquatic systems.

I am attaching here a list of references that might be of interest for this topic:

1. Miklau M, Burn SJ, Eckerstorfer M, Dolezel M, Greiter A, Heissenberger A, Hörtenhuber S, Zollitsch W, Hagen K. 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. 2024 Jun 13;6:1376927. doi: 10.3389/fgeed.2024.1376927. PMID: 38938511; PMCID: PMC11208717.
2. Henley et al. (2013), "Genetically Modified Algae: Perceptions and Risks," BioScience, https://doi.org/10.1525/bio.2013.63.9.4
3.Snow et al. (2015), "Risks of GM Algae for Biofuels: Ecological Considerations," Environmental Science & Technology, https://doi.org/10.1021/es505116b
4. Carney et al. (2016), "Ecological Risk Assessment of Genetically Modified Microalgae: Framework and Challenges," Journal of Applied Phycology, https://doi.org/10.1007/s10811-016-0816-2
5.Wang et al. (2019), "Genetic Engineering of Algae for Environmental Applications: Risks and Considerations," Environmental Biotechnology, https://doi.org/10.1007/s00253-019-09782-4

Greetings Colleagues,

I am Leocris S. Batucan Jr., from the National Committee on Biosafety of the Philippines.

Living modified algae (LMAs) challenge existing risk assessment frameworks due to their rapid proliferation and ecological adaptability, which are not adequately addressed by frameworks primarily designed for terrestrial GMOs. For instance, studies highlight that certain microalgae, like <i>Picochlorum renovo</i>, grows quickly enabling swift biomass accumulation which could disrupt aquatic ecosystems. This specific species is already being examined for potential industrial applications as it has high growth rate and high thermal tolerance (Dahlin et al, 2019).

It seems nuance in regulation is needed especially with with micro and macro algae.


Dahlin, L.R., Gerritsen, A.T., Henard, C.A. et al. Development of a high-productivity, halophilic, thermotolerant microalga Picochlorum renovo. Commun Biol 2, 388 (2019). https://doi.org/10.1038/s42003-019-0620-2 / https://www.nature.com/articles/s42003-019-0620-2

Esteemed colleagues,

In contribution to discussion I would like to comment on the 4 suggested questions:

1. A key challenge faced by the guidelines and frameworks for the risk assessment of living modified algae is that most of these resources are based on terrestrial organisms rather than aquatic ones, which exhibit distinct ecological and biological dynamics. An additional challenge is there is a lack of regulatory and methodological precedents that could serve as a baseline.

2. Among specific challenges worth mentioning are:

- There is a wide diversity of species with specific biological characteristics within what are collectively referred to as “algae”. These characteristics include aspects such as cell structure, reproductive mechanisms, metabolism, adaptability, and survival in different environments, as well as their potential to interact with native microbial communities. It is estimated that by the end of 2023 there were around 50,000 reported algal live species (Guiry, 2024; López & García, 2022; Sazanova et al., 2023).

- The variability in the different end-use applications of living modified algae (such as bioremediation, biofuel, and protein production for pharmaceutical use) creates a challenge in establishing a single reference framework on which to base a risk assessment process (Grama & Li, 2022).

- The assessment of geographical and temporal variables in an open system use such as in the case of bioremediation, represents a significant challenge for establishing clear boundaries regarding monitoring, containment, and long-term risk evaluation.

3. Issues i), ii), and iii) may be considered of importance in relation to genetically modified algae. The fact that some uses of living modified algae may involve deliberate (e.g., bioremediation) or accidental (e.g. biofuel production) release into the environment, suggests that their interaction with and potential impact on biodiversity must be considered such as the alteration of pre-existing ecological dynamics and the possibility of horizontal gene transfer (OGTR, 2020) to other microorganisms. Additionally, if the final use of the living modified organism involves an environmental release, it may disseminate across national borders through various biological mechanisms and external agents, such as wind, water, wildlife, or even human activities, which do not recognize geographic or jurisdictional boundaries

4. It may be helpful to contact the regulatory authority in Australia, the Office of the Gene Technology Regulator (OGTR), as they appear to have specific guidelines and interesting knowledge related to this specific topic (OGTR,2020)

REFERENCES

Grama, Liu & Li (2022), Emerging Trends in Genetic Engineering of Microalgae for Commercial Applications, Marine Drugs, 10.3390/md20050285.

Guiry (2012), How many species of algae are there? A reprise. Four kingdoms, 14 phyla, 63 classes and still growing, Journal of Phycology, 10.1111/j.1529-8817.2012.01222.x.

López, A., & García, M. C. (2022), Engineered microalgae in bioremediation, Journal of Applied Phycology, 10.1007/s10811-022-02645-7

OGTR. Office of the Gene Technology Regulator (2020), DIR 169 – Risk Assessment and Risk Management Plan: Commercial release of genetically modified Nannochloropsis oceanica for production of omega-3 long chain polyunsaturated fatty acids, OGTR, https://www.ogtr.gov.au/sites/default/files/2021-06/dir169-full_risk_assessment_and_risk_management_plan.pdf.

Sazanova, K., Dos Santos, F. B., & Silva, F. T. (2023), Genetically engineered microorganisms for environmental remediation, Chemosphere, 10.1016/j.chemosphere.2022.136751

Gabriel Mutis
Colombia

Dear all
My name is Mathurin ROUAMBA from National Biosafety Agency of Burkina Faso. Thank Secretariat of CBD and all moderators for this opportunity.
In term of the Q1, Living modified algae are mainly used in industrial processes to produce biofuels and medicines. This particular use of LM Algae promote a certain level of containment of the LM organism, thus reducing the risks associated with its exposure to humans, animals and the environment. However, unintentional dissemination or escape of these organisms to the outside world could lead to greater risks. Indeed, Sebesta et al, (2022) and Tracey et al, (2017) have shown that the release of microalgae into the environment could have negative ecological effects such as altered food webs, displacement of native phytoplankton, local extinctions, the formation of hazardous algal blooms (HABs) and serious societal effects when harmful/toxic strains are involved. Kamir (2015), also highlighted that ongoing work on cyanobacteria can pose risks of horizontal gene transfer due to the high receptivity of cyanobacteria to the incorporation of foreign genes. These risks are mainly linked to the types of traits and genes selected, and to the type of modification. Although the authors also point out that control methods exist to manage the risks associated with unintentional release, it would be interesting to have international harmonization through guidelines. These guidelines should focus on cases of release or commercial production of algae in unconfined environments.


1. Sebesta J., Xiong W., Guarnieri M. T., Yu J. (2022). Biocontainment of Genetically Engineered Algae. Frontiers in Plant Science. Volume 13 – 2022. ISSN=1664-462X https://www.frontiersin.org/journals/plantscience/articles/10.3389/fpls.2022.839446. DOI=10.3389/fpls.2022.839446

2. Tracey A. Beacham, Jeremy B. Sweet, Michael J. Allen. (2017). Large scale cultivation of genetically modified microalgae: A new era for environmental risk assessment. Algal Research. Volume 25. Pages 90-100. ISSN 2211-9264. https://doi.org/10.1016/j.algal.2017.04.028.

2. Shashi Kumar. (2015). GM Algae for Biofuel Production: Biosafety and Risk Assessment. Collection of Biosafety Reviews Vol. 9 (2015): 52-75. International Centre for Genetic Engineering and Biotechnology (ICGEB) Padriciano, 99, 34149 Trieste, Italy. http://www.icgeb.org/biosafety/publications/collections.html

Dear colleagues,
I have already touched on the issue of LMO algae in my post on LM fish. There are a number of overlapping issues here, and we have even previously suggested that aquatic organisms with a high potential for movement, invasiveness, high ability to pass through water boundaries, which are very difficult to monitor and control if they are released into aquatic ecosystems, be considered as a single entity for developing risk assessment guidelines. But of course, approaches may differ.

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

The colleagues above expressed the risks and I fully support them. In addition, there is an uncertainty and risks in the case of a large-scale release, how LM algae will behave in different environments. It seems to me that here it is necessary to change the generally accepted approaches to risk assessment, and include regulatory issues of control and issues of monitoring and detection. True, how to implement such monitoring with existing methods in case of the large-scale release is also a difficult question. But in any case, since there are developments in bioremediation (and this includes not only algae, but microorganisms) and the use of algae for the production of biofuels (e.g. https://www.cbd.int/doc/publications/cbd-ts-100-en.pdf), it is important to develop guidance before they are released. That release is possible is indicated by environmental testing.
We once discussed risk assessment in the online forum a few years ago, and some participants said that the development of monitoring plans and recommendations for regulation are not the subject of the risk assessment guideliness. At the same time, I think that for GM algae these are simply necessary chapters.
1. What could be the specific challenges to related to this issue?
Lack of data on behavior in different ecosystems, control, monitoring including detection, development of emergency response mechanisms.
2. What are the specific issues concerning this topic?
This is in addition to what colleagues have said, there is a large uncertainty around such organisms in a large-scale release that may not be captured by existing risk assessment methods.
3. (ii) (iii)  Even with a well-developed regulatory system, there is  the potential for unintentional release or movement across borders to another country.
(iv) Yes, commercialization is possible, as environmental testing shows:

Shawn J. Szyjka, Shovon Mandal, Nathan G. Schoepp, Briana M. Tyler, Christopher B. Yohn, Yan S. Poon, Steven Villareal, Michael D. Burkart, Jonathan B. Shurin, Stephen P. Mayfield, Evaluation of phenotype stability and ecological risk of a genetically engineered alga in open pond production, Algal Research, Volume 24, Part A, 2017, Pages 378-386 https://www.sciencedirect.com/science/article/abs/pii/S2211926417300024;

https://insights.globalspec.com/article/4977/field-trials-with-genetically-modified-algae-deemed-successful

https://www.aiche.org/chenected/2017/05/genetically-engineered-algae-passes-first-epa-approved-outdoor-field-test#:~:text=Researchers%20at%20the%20University%20of,outdoors%20while%20maintaining%20engineered%20traits.


4. Are there existing resources on similar issues that could be adapted to address this need?
Some helpful materials:

Sebesta J, Xiong W, Guarnieri MT and Yu J (2022) Biocontainment of Genetically Engineered Algae. Front. Plant Sci. 13:839446. doi: 10.3389/fpls.2022.839446

Tracey A. Beacham, Jeremy B. Sweet, Michael J. Allen, Large scale cultivation of genetically modified microalgae: A new era for environmental risk assessment, Algal Research, Volume 25, 2017,
Pages 90-100, https://www.sciencedirect.com/science/article/abs/pii/S2211926416305021

ENVIRONMENTAL RELEASE OF GENETICALLY ENGINEERED MICROORGANISMS (GEM): REGULATORY REQUIREMENTS FOR RISK
ASSESSMENT AND APPROVAL IN INDIA https://dbtindia.gov.in/sites/default/files/uploadfiles/Draft-Environment.pdf

Eckerstorfer, M.F.; Dolezel, M.; Miklau, M.; Greiter, A.; Heissenberger, A.; Kastenhofer, K.; Schulz, F.; Hagen, K.; Otto, M.; Engelhard, M. Environmental Applications of GM Microorganisms: Tiny Critters Posing Huge Challenges for Risk Assessment and Governance. Int. J. Mol. Sci. 2025, 26, 3174. https://doi.org/10.3390/ijms26073174  https://www.mdpi.com/1422-0067/26/7/3174

Best regards,

Galina

Dear colleagues,

Thank you, Ms. Ana Laura Mello, for moderating this discussion.
I would like to express my appreciation to the colleagues who have shared insights on risk assessment considerations for Living Modified Algae (LMA). I agree with the concerns raised and recognize the various challenges in assessing their safety under existing regulatory frameworks.

With regard to question #1, and in addition to the issues already mentioned by others, I would like to add the following points:
Considerations for Scale: The release of LMA into aquatic systems can reach scales that cannot be easily predicted or anticipated within current risk assessment methodologies.
Intentional Environmental Changes: There is a lack of risk assessment methodologies for intentional ecological changes (not for food or feed purposes). This is closely linked to biodiversity protection goals in each country, making harmonization and standardization an additional challenge.
Detection and Monitoring: Once LMA cross with other strains, modified DNA sequences can miss target detection regions, leading to false negative results. The lack of proper detection tools may pose challenges in monitoring the invasiveness potential of LMA.

Reference: Heinemann, JA, Paull, DJ, Walker, S, Kurenbach, B. 2021. Differentiated impacts of human interventions on nature: Scaling the conversation on the regulation of gene technologies. Elementa Science of the Anthropocene. 9: 1. DOI: https://doi.org/10.1525/elementa.2021.00086.

Regarding questions #2 and #3, key challenges include:
Invasiveness and Ecological Impact: LMA have the potential to proliferate uncontrollably in natural ecosystems, possibly leading to the displacement of native species, alterations in ecological balances, and disruption of food webs.
Limited Research: Most current studies are conducted in controlled laboratory settings rather than in large-scale ecological environments, which limits our understanding of LMA's long-term effects on biodiversity.
Complexity of Aquatic Systems: Predicting the invasiveness and ecological interactions of LMA in aquatic environments is difficult due to the complexity and variability of these ecosystems.
Regulatory Gaps: Existing risk assessment frameworks primarily focus on terrestrial organisms and may not adequately account for the unique behaviors and characteristics of aquatic organisms like LMA.
Lack of Harmonized Data: There is a shortage of standardized data regarding the long-term ecological interactions of LMA, complicating accurate risk evaluation.
Cross-Border Spread: The potential for LMA to propagate across national borders through interconnected water bodies complicates regulatory control and risk management.
Social Considerations: Limited engagement from women, indigenous peoples, and local communities in biotechnology-related decision-making processes can contribute to gender-blind risk assessments that fail to incorporate diverse perspectives and knowledge systems.
Methodological Challenges: Assessing horizontal gene transfer and its ecological consequences is difficult, particularly as LMA can interact with various microorganisms within ecosystems.
Emergency Response Mechanisms: There is a pressing need to develop effective monitoring and emergency response strategies in case of unintentional dissemination into natural water bodies.

Regarding question #4, the scientific literature on this subject is scarce. Here are a few references that may be relevant:
Eckerstorfer, M.F.; Dolezel, M.; Miklau, M.; Greiter, A.; Heissenberger, A.; Kastenhofer, K.; Schulz, F.; Hagen, K.; Otto, M.; Engelhard, M. Environmental Applications of GM Microorganisms: Tiny Critters Posing Huge Challenges for Risk Assessment and Governance. Int. J. Mol. Sci. 2025, 26, 3174. https://doi.org/10.3390/ijms26073174
Onn, S., Koh, G., Yap, W. et al. Recent Advances in Genetic Engineering of Microalgae: Bioengineering Strategies, Regulatory Challenges and Future Perspectives. J Appl Phycology 37, 247–264 (2025). https://doi.org/10.1007/s10811-024-03367-y

Best regards,

Sarah Agapito

Ediner Fuentes-Campos, Panama - National Secretariat of Science, Technology and Innovation of Panama
Thank you, Ms. Ana Laura Mello, for moderating this discussion.
I would like to extend my gratitude to the colleagues who preceded me and shared their considerations.

Microalgae constitute a biological resource with biotechnological potential to contribute to various contemporary challenges, including aspects of food security, energy diversification, and possible strategies for climate change mitigation. Their biotechnological application has increased their scientific relevance in the last decade, especially in research on biofuel production, functional food development, and bioactive compound obtention (Wang et al., 2024). The development of genetic engineering technologies applied to microalgae presents potential biotechnological applications that must be analyzed from a rigorous scientific perspective regarding their evaluation under the framework of the Cartagena Protocol.

Technologies based on microalgae present distinctive characteristics compared to other conventional crops. These include their capacity for cultivation in reduced spaces, continuous production without seasonality, specific nutritional requirements, utilization of spaces not destined for conventional agriculture, and lower dependence on pesticides (Medeiros et al., 2021). These properties constitute relevant technical elements for their consideration as biotechnological platforms.

The cultivation systems represent a determining technical factor in the scientific evaluation of GM microalgae. Closed systems such as photobioreactors provide physical containment characteristics that differ substantially from open systems (Wang et al., 2024). The determination of risk mitigation measures for each system should be based on rigorous scientific evaluations in accordance with the provisions of Annex III of the Cartagena Protocol, with each Party determining the specific criteria according to their particular national contexts.

The potential dispersion of GM microalgae is determined by specific biological parameters of each organism, including their physiological requirements and environmental adaptability. A relevant aspect from the scientific perspective is that numerous microalgae strains used in biotechnological applications require optimized cultivation conditions, which would potentially limit their ability to establish in natural environments (Patel et al., 2021). This factor should be evaluated case by case according to the specific characteristics of each genetic modification and recipient organism.
Various species of microalgae and their derived products have been subject to regulatory evaluations in different jurisdictions. For example, the FDA has classified species such as Chlorella vulgaris, Arthrospira platensis, and Chlamydomonas reinhardtii, among others, as "generally recognized as safe" (GRAS) (Medeiros et al., 2021). Research on GM microalgae has intensified in recent years, particularly oriented towards optimization of metabolic pathways for lipid production destined for biofuels. Technical analyses suggest that the application of genetic engineering technologies could contribute to reducing production costs of microalgal biofuels by 15-20% (Wang et al., 2024).

The scientific evaluation of technologies based on GM microalgae requires an objective analysis of both their potential applications and their biosafety considerations. From the perspective of applications, these organisms present biochemical characteristics of interest, such as their protein content (55-70% in Spirulina platensis) with amino acid profiles that differ from animal-origin products (Medeiros et al., 2021). Studies on their metabolism show CO₂ fixation capacity approximately 90% higher than conventional terrestrial plants, which could have relevance in research contexts on climate change mitigation (Nethravathy et al., 2019).

Biotechnological applications of microalgae as raw material for biofuels present distinctive biological characteristics related to productivity, photosynthetic efficiency, and adaptability to different cultivation conditions (Wang et al., 2024). Additionally, they constitute sources of specific bioactive compounds such as certain polysaccharides, carotenoids, and polyunsaturated fatty acids that could have applications in biomedical research (Patel et al., 2021).

The scientific evaluation of GM microalgae is framed within the Cartagena Protocol, which establishes fundamental principles for risk assessment. This framework provides a methodological structure that allows specific case-by-case evaluations according to the particular characteristics of each organism, genetic modification, and proposed application. The specific implementation of this regulatory framework will correspond to each Party according to their national contexts and priorities. A fundamental element in this process is the establishment of adequate biological and physical containment systems, particularly for organisms destined for open cultivation systems.

The scientific analysis of technologies based on GM microalgae suggests that:

-They represent a field of research with potential applications in various biotechnological sectors.
-The regulatory framework established by the Cartagena Protocol provides a methodological basis for case-by-case evaluation, with each Party determining specific criteria according to their national contexts.
-The specific biological characteristics of each organism, genetic modification, and proposed cultivation system are fundamental elements that should be considered in each evaluation.
-The development of adequate containment and monitoring measures constitutes an essential technical element, particularly for open cultivation systems.

A scientifically based approach requires rigorous and objective evaluations that consider both the technical aspects of each application and the biosafety elements relevant to the specific contexts of each Party.


Medeiros, V. P., Almeida da Costa, W. K., Tavares da Silva, R., Colombo Pimentel, T., & Magnani, M. (2021). Microalgae as source of functional ingredients in new-generation foods: challenges, technological effects, biological activity, and regulatory issues. Critical Reviews in Food Science and Nutrition. https://doi.org/10.1080/10408398.2021.1879729
Nethravathy M. U., Jitendra G. Mehar, Sandeep N. Mudliar, & Ajam Y. Shekh. (2019). Recent Advances in Microalgal Bioactives for Food, Feed, and Healthcare Products: Commercial Potential, Market Space, and Sustainability. Comprehensive Reviews in Food Science and Food Safety. https://doi.org/10.1111/1541-4337.12500
Patel, A.K., Singhania, R.R., Awasthi, M.K., Varjani, S., Bhatia, S.K., Tsai, M.L., Hsieh, S.L., Chen, C.W. & Dong, C.D. (2021). Emerging prospects of macro-and microalgae as prebiotic. Microbial Cell Factories, 20(1), 1-16. https://doi.org/10.1186/s12934-021-01596-1
Siddiqui, S. A., Ucak, İ., Afreen, M., Sasidharan, A., Yunusa, B. M., Bhowmik, S., Pandiselvam, R., Ambartsumov, T. G., & Shah, M. A. (2024). Microalgae as a potential raw material for plant-based seafood alternatives: A comprehensive review. Food Science & Nutrition, 12, 8559–8593. https://doi.org/10.1002/fsn3.4313
Wang, M., Ye, X., Bi, H. & Shen, Z. (2024). Microalgae biofuels: illuminating the path to a sustainable future amidst challenges and opportunities. Biotechnology for Biofuels and Bioproducts, 17(10), 1-24. https://doi.org/10.1186/s13068-024-02458-9

Thank you, Ana for coordinating these discussions, and thank you to all colleagues for very insightful deliberations.

I do echo the submissions of Ms. Galina (Belarus) and Mr. Mathurin (Birkina Faso) on the need for appropriate guidance documents to be developed before LM algae is commercialized.

Josephine Amedu
Nigeria

Dear participants, it has been a pleasure to read the diverse perspectives from around the world, each with unique priorities and expectations, yet united in the ambition to advance the CBD objectives and leverage biotechnological applications.

I am Patrick Rüdelsheim, Belgian, holding a PhD in Biology and lecturing at the University of Ghent and the University of Antwerp. My main professional activity is assisting researchers and developers in risk assessment and management of biologicals as well as compliance with biotechnology regulations.

In 2021, we completed a study for the advisory Commission on Genetic Modification (COGEM) of the Netherlands. This study reviewed available risk-related information to classify wild-type algae based on their potential adverse effects on human and animal health and the environment. We compiled a comprehensive reference framework, classifying 7191 genera across 800 families, 267 orders, 60 classes, and 13 phyla/divisions.

Further focus was on algal genera/species currently in use or expected to be used soon, such as for biofuel production or high-value components. For approximately 500 selected species, key elements relevant to assessing risks related to human and animal health, as well as ecological impacts, were described. This information can serve as a reference for developers and regulators when considering applications for genetic modification of these or closely related species.

In 2022, an additional report commissioned by the COGEM focussed on the establishment and proliferation potential of cyanobacteria. It contains information about the characteristics that play a role in dispersal, establishment and bloom formation of cyanobacteria, and the tests and assays that could provide information on the establishment and bloom potential of GM cyanobacteria.

We hope the information collected for COGEM can provide useful insights for other risk assessors facing similar challenges. Based on our findings, I would like to emphasize:
- As others have noted, the term "algae" encompasses such a diverse range of organisms that addressing them in general terms is impractical. Developing meaningful guidance for a single algae-specific risk assessment is challenging.
- While information on many algae species and strains is limited, some species are well-documented.
- Most concerns raised in this forum relate to the general behaviour of algae, which are considered potentially problematic primarily when genetic modification is involved. Should the same level of risk assessment be required for non-modified algae, given that they can also lead to toxin production, algal blooms, cross-border impacts, etc.?

I look forward to the continuation of this and upcoming exchanges,
Patrick

P. Van Rooij, G. Smets & P. Rüdelsheim (2021) CGM 2021-01 Taxonomy and risk classification of algae; Informing the risk classification of a dynamic taxonomic group https://cogem.net/en/publication/taxonomy-and-risk-classification-of-algae-informing-the-risk-classification-of-a-dynamic-taxonomic-group/

G. Smets, P. Van Rooij & P. Rüdelsheim (2022) CGM 2022-03 Establishment and proliferation potential of cyanobacteria; properties that can inform the risk assessment https://cogem.net/en/publication/establishment-and-proliferation-potential-of-cyanobacteria-properties-that-can-inform-the-risk-assessment/

Dear colleagues,

Thank you very much for all your contributions. I am very pleased to see contributions from different Parties and regions, as well as from the Women's Caucus.
I also thank you for addressing the specific questions and for providing several resources that will undoubtedly be relevant input for the AHTEG. I encourage you to follow the discussions, as we still have one more day of discussion on this topic.

Best regards,

Ana Laura

Dear esteemed participants.

Here are a few thoughts that I would like to contribute to this fruitful discussion:

1. Challenges to Existing Risk Assessment Frameworks
Living Modified Algae (LMAs) present unique challenges to current biosafety frameworks, which were primarily designed for terrestrial genetically modified organisms (GMOs). Unlike crops, algae thrive in dynamic aquatic environments where dispersal is rapid and difficult to control. Existing guidelines under the Cartagena Protocol and OECD standards lack specific provisions for aquatic ecosystems, leading to gaps in assessing risks such as horizontal gene transfer (HGT), unintended ecological interactions, and long-term persistence. Algal species can spread via water currents, migratory birds, and human activities like shipping, complicating containment efforts. The microscopic nature of algae makes detection challenging, requiring advanced tools like environmental DNA (eDNA) tracking.

To address these challenges, adaptive risk assessment models—such as ecological niche modeling and hydrodynamic dispersal simulations—should be integrated into regulatory frameworks. Enhanced containment strategies, including auxotrophic strains, could mitigate unintended releases. Early warning systems using molecular monitoring tools must also be standardized. Without these updates, current frameworks will remain inadequate for assessing LMA risks.

2. Specific Challenges Related to LMAs

LMAs introduce several distinct risks that demand careful consideration. Their potential for environmental persistence is concerning, as many algal species can reproduce asexually and adapt to diverse conditions. Gene flow to wild relatives is another critical issue, as modified traits could spread to natural populations. The risk of bioaccumulation raises concerns, as LMAs entering food chains may affect aquatic organisms and human health through contaminated seafood.

Unlike terrestrial GMOs, LMAs released into open water systems are nearly impossible to recall. Another serious concern is their potential to contribute to harmful algal blooms (HABs), which can devastate marine life and coastal economies. Regulatory approaches must prioritize strict containment measures and robust monitoring protocols.

3. Key Issues Concerning LMAs

(i) Biodiversity and Human Health Risks
LMAs could cause serious harm to biodiversity, particularly in sensitive ecosystems. Engineered traits might outcompete native species, leading to ecological imbalances. Human health risks may arise if modified algae contaminate drinking water. Indigenous communities relying on aquatic resources could face socio-economic disruptions.

(ii) Potential for Environmental Release
Both deliberate and accidental releases are plausible. Deliberate introductions may occur for carbon sequestration or biofuel production. Accidental releases could result from industrial spills or laboratory leaks.

(iii) Cross-Border Dissemination Risks
The transboundary nature of water systems means LMAs can spread across borders via ocean currents or ship ballast water, requiring international cooperation.

(iv) Current Commercialization Status
While full-scale release remains rare, companies are advancing applications in biofuels (Synthetic Genomics), nutraceuticals (DSM), and carbon capture (Brilliant Planet). Most deployments are still in pilot stages.

4. Existing and Adaptable Resources
Several frameworks can address LMA risks:
- OECD Guidance on Microalgae Risk Assessment (OECD, 2015)
- FAO's Responsible Use of GMOs in Aquaculture (FAO, 2008)
- ICES Code of Practice (ICES, 2005)
- U.S. EPA eDNA monitoring tools (U.S. EPA, 2021)

Conclusion and Recommendations
Key recommendations include:
1. Developing aquatic-specific risk assessment guidelines
2. Strengthening international collaboration
3. Investing in containment technologies
4. Implementing phased release testing

A precautionary approach is essential to balance innovation with environmental protection.

Useful References
Barrett, L.T., Swearer, S.E. and Dempster, T. (2021) 'Environmental risks of genetically engineered algae for biofuel production', Aquatic Biosystems, 17(1), p. 12.
Beal, C.M., Archibald, I., Huntley, M.E. and Greene, C.H. (2022) 'Integrating algae with bioenergy carbon capture and storage (ABECCS) increases sustainability', Nature Sustainability, 5, pp. 205-214.
Fu, W., Nelson, D.R., Mystikou, A., Daakour, S. and Salehi-Ashtiani, K. (2020) 'Advances in microalgal research and engineering development', Nature Biotechnology, 38(5), pp. 512-515.
Gressel, J., van der Vlugt, C.J.B. and Bergmans, H.E.N. (2023) 'Containment strategies for genetically modified algae', Trends in Biotechnology, 41(2), pp. 89-102.
Hallegraeff, G.M. (2021) 'Harmful algal blooms: A global overview', Manual on Harmful Marine Microalgae, 2nd ed. Paris: UNESCO Publishing, pp. 25-49.
Heinemann, J.A., Walker, S. and Thaler, D.S. (2021) 'Risk assessment of genetically engineered algae in biofuels production', Frontiers in Bioengineering and Biotechnology, 9, p. 612344.
Huesemann, M.H., Crowe, B. and Waller, P. (2020) 'A validated model to predict microalgae growth in outdoor pond cultures subjected to fluctuating light intensities and water temperatures', Algal Research, 51, p. 102032.
Keeling, P.J., Burki, F. and Wilcox, H.M. (2021) 'The Marine Microbial Eukaryote Transcriptome Sequencing Project (MMETSP): illuminating the functional diversity of eukaryotic life in the oceans through transcriptome sequencing', Current Biology, 31(15), pp. R906-R909.
Khan, M.I., Shin, J.H. and Kim, J.D. (2023) 'The promising future of microalgae: current status, challenges, and optimization of a sustainable and renewable industry for biofuels, feed, and other products', Biotechnology Advances, 62, p. 108075.
Tump, L.S., Verschoor, A.M. and van der Meer, J. (2022) 'Ecological risk assessment of microalgal biofuels: comparing closed and open system production', Ecological Applications, 32(1), p. e02489.
Visser, P.M., Ibelings, B.W. and Mur, L.R. (2022) 'Artificial mixing to control cyanobacterial blooms: a review', Harmful Algae, 113, p. 102187.

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

Dear colleagues,

I’m Emmanuel González-Ortega. I have a PhD in Biotechnology, and expertise in molecular biology, genetic engineering, GMO monitoring, risk assessment of GMO, and synthetic biology. I am a researcher “Investigador por México”, at the Metropolitan Autonomous University Xochimilco, in Mexico City.

First, I’d like to thank to the moderators of this online forum.

I recognize and appreciate the information shared by the colleagues on risk assessment issues and particularities for living modified algae, which I support.

Regarding Question 1, and additionally to what was previously mentioned on the issue that most of the guidance and risk assessment procedures were previously designed for the assessment of modified plants, I would like to point that, in a context of climate change, the potential behavior of marine ecosystems and organisms which are at the base of the trophic chain (i.e. species o algae) is also changing. This in complement of comment #12304. These changes are turning species which inhabit in determine ecosystems in potential invasive species, with consequences yet to fully determine (i.e. Sargassum in the Caribbean). From an integral perspective, the addition of artificial (human provoked), with potential changes in the composition (genetic, proteomic, metabolic, physiologic, etc.) poses additional challenges to risk assessment protocols and guidance.

https://doi.org/10.3390/w12102908

https://doi.org/10.1016/j.hal.2025.102838

http://www.jstor.org/stable/24861895.

https://doi.org/10.3390/plants11212997

https://doi.org/10.1016/j.marpolbul.2017.06.057



Regarding Questions 2 and 3.

Some specific challenges to risk assessment are the procedures for monitoring the grow rates of LMA through the seasons of the year, the movement of the populations in open water, and of course the genetic behavior of LMA populations, genetic flow between species (genetically modified or not). Regarding the socioeconomic considerations, there are challenges to determine potential risk to coastal, island and fisher communities and peoples, which could be profoundly endangered their way of living and even to evolve in a public health issue.

https://doi.org/10.1016/j.scitotenv.2018.04.013

https://doi.org/10.1016/j.envsci.2008.10.001

https://doi.org/10.1016/0044-8486(95)01095-5

https://doi.org/10.1007/s10530-012-0391-x

https://doi.org/10.1007/978-3-642-53971-8_13

https://doi.org/10.1080/26395916.2023.2253317

https://doi.org/10.1016/j.marpol.2024.106214

https://doi.org/10.1007/s11356-022-20300-3

https://doi.org/10.1590/2675-2824072.23089

https://doi.org/10.1016/B978-0-443-29240-8.00023-7

https://www.diva-portal.org/smash/record.jsf?pid=diva2%3A1812615&dswid=-6840

Looking forward to continue the interesting exchanges,
Best regards,

Emmanuel González-Ortega

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 Question 4:
Given the existence of several frameworks addressing risk assessment for genetically modified (GM) algae — such as the OECD Guidance on Microalgae Risk Assessment (OECD, 2015), FAO’s Responsible Use of GMOs in Aquaculture (FAO, 2008), and the U.S. EPA’s eDNA monitoring tools (U.S. EPA, 2021), alongside numerous scientific articles — limited financial resources should be allocated to other pressing priorities, for instance, the implementation of the KM-GBF.

Best Regards

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

Dear colleagues,

apologies for my late contribution.  Having just read through the whole thread, much has been covered and not much remains to be said. Let me just support a few arguments made and offer some additional aspects regarding dispersal.

From the start I found myself in agreement with Mr Nwosu (#12271), pointing to the challenges arising from “the complexity of aquatic systems” in particular re “predicting invasiveness in such dynamic ecosystem”.  The issue of complexity and challenges born out of the point it being an “aquatic system” seems to be made out as a major challenge by many participants of this forum.

Not much is known of all the interactions and contributions of all the different organisms within aquatic systems, in fact, many species have not yet been found or identified nor their role being understood.

So risk assessing aquatic organisms, here algae, becomes a challenge at multiple levels: that of knowledge (or lack of knowledge) of the ecosystem as such, and its components and interactions, and of how the LM algae would fit or interact or pose risks in this context, either directly or indirectly, and what the consequences would be should the LM algae reach these ecosystems and either spread as an organism or pass on its modified genes.

Risk assessment for aquatic organisms are also becoming much more challenging given that ecosystems – such as those within ocean settings -  are experiencing already vast challenges due to the presence and impacts of inter alia: climate change, micro- and nano plastics, increasing load of for-ever chemicals (e.g. PFAS) with often hormonal capacities, change of convection and nutrient streams, the impacts of sea bed mining and their multilayered disturbances, including the spread of underwater “clouds” of sand and dust and pollutants.

As said by many, much more targeted ecological research would be needed, and I believe it would need to ask the upfront question of what are the changing and dynamic factors over time and space, and how can they and their consequences be predicted and how in this can the LMO be properly and reliably assessed?

A challenge is also that containment might not be possible, given current (and often sudden) weather extremes with severe floods, tornados, gale-force winds, all of which can result in breach or destruction of containment facilities and the spread of the LMO algae into the wider environment. If facilities are inland but in the open, both wind and drought can also become agents of transport. It has, for example, been detailed that not only can microalgae be airborne and transported by wind currents - as listed by Tesson et al. 2016, but that there are also mechanisms that protect airborne microalgae during long distance dispersal (e.g. Chiu et al. 2020).

In order to anticipate risks and potential negative impacts it is necessary to understand the context where such either direct or indirect impact could take place, and what the given ecological conditions are in those places, including presence of other organisms, interactions and interdependencies, dynamics, currents, temperatures, nutrients, light conditions etc. Such points have been raised by many on this discussion.

I appreciate the raising of the issue of both “rapid proliferation” and especially that of “ecological adaptability” by Mr Batucan (#12282).

Given the pivotal ecological role of macro- and microalgae in aquatic systems (other than being food or an energy source), such as being pivotal for nutrient cycling and aquatic oxygen production, but also in providing shelter and habitats, the designing of a comprehensive catalogue of critical issues of assessment question seems vital.

In submission (#12300) Galina Mozgova highlights the overlap of aspects with that of LM fish and the general aspect of LMOs in/of aquatic environments. I very much support this approach of understanding the specific risk component that is derived from LMOs being aquatic organisms.

Both submissions (#12300) and (#12304) bring in the issue of scale, though touching different aspects. I support the inclusion of this aspect, as scale will be very much of importance if applications of genetic modification (including genome editing) of algae is expanding, including for contained use.

With thanks and warm regards,

Ricarda




References:
Tesson, S. V. M., Skjøth, C. A., Šantl-Temkiv, T., & Löndahl, J. (2016). Airborne Microalgae: Insights, Opportunities, and Challenges. Applied and environmental microbiology, 82(7), 1978–1991. https://doi.org/10.1128/AEM.03333-15

Chiu, C. S., Chiu, P. H., Yong, T. C., Tsai, H. P., Soong, K., Huang, H. E., & Chen, C. N. (2020). Mechanisms protect airborne green microalgae during long distance dispersal. Scientific reports, 10(1), 13984. https://doi.org/10.1038/s41598-020-71004-y

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 algae” 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 always challenges when new organisms, new traits or new receiving environments are brought into the RA frameworks, but those challenges can be addressed using the sequential five-step RA process under Cartagena annex III. For the LM algae the same procedure used for other organisms can be applied, always defining clear pathways between the LM algae and possible adverse effects in order to focus on generating information that will be useful in the decision-making.

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

The Office of Gene Technology Regulator (OGTR) from Australia is a concrete example of the development of credible pathways to potential harm (DIR 169 - Limited and controlled release of microalgae genetically modified for increased production of fatty acids - https://www.ogtr.gov.au/sites/default/files/2021-06/dir169-full_risk_assessment_and_risk_management_plan.pdf). In this document potential harms from GM microalgae are based on those used to assess the weed risk from aquatic and land-based plants (Virtue, 2008; Keese et al., 2014), and those specifically proposed for microalgae (Henley et al., 2013), including:

- harm to the health of people or other desirable organisms, including toxicity/allergenicity
- reduced biodiversity through harm to other organisms or ecosystems
- reduced ecosystem services (e.g. degradation of drinking water sources or recreational waters, negative effects on fisheries)
- reduced quality of the biotic environment (e.g. harmful algal blooms, providing food for pests or pathogens) or abiotic environment (e.g. negative effects on nutrient levels).

Algae is a far more diverse group of organisms than crop plants and any RA will have to consider a deep understanding of the recipient species. Also a species of algae may pose a different risk to different environments, such as an algae farm; a marine environment, mining or oyster farming; or a marine park. But those “challenges” will not be solved by a Guidance, a trained risk assessor can use the case-by-case nature of the RA to consider those specifics and formulate the adequate risk scenarios.



4. Are there existing resources on similar issues that can address this issue or resources that could be adapted to address this need?
The example in the question 2 shows that existing resources can adequately address the RA of LM algae. The formulation of risk scenarios for LM algae based on risks posed by GM crop plants is considered a valid approach, as risk evaluation for GM crop plants is well established (Henley et al., 2013 - https://www.sciencedirect.com/science/article/abs/pii/S2211926412000549).

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 Colleagues,

While genetically modified (GM) algae hold significant promise for biofuel production, pharmaceutical applications, agricultural supplements, and bioremediation, their unintended release into marine ecosystems poses unresolved ecological risks that demand rigorous precaution. Current understanding of marine ecological interactions and long-term impacts remains insufficient to mitigate potential cascading effects, such as:
- Disruption of trophic dynamics through competitive exclusion of native species
- Horizontal gene transfer to wild algal populations, altering ecosystem resilience
- Hypoxia amplification via accelerated biomass decay, exacerbating existing dead zones

Recent advances in biocontainment strategies-including synthetic auxotrophy, CO₂-concentrating mechanism (CCM) knockout, and toxin-inducible lethal switches-show promise but require further validation under ecologically realistic conditions. The NIH's 10⁻⁸ escape probability benchmark, while scientifically rigorous, lacks field-tested verification across diverse marine biomes.

Until failsafe biocontainment is demonstrably achieved through peer-reviewed ecological trials, open-ocean applications should remain restricted to small-scale, geographically isolated test beds with continuous genomic surveillance. The precautionary principle must prevail over commercial deployment timelines to prevent irreversible marine biosystem perturbation.

Ju Seok Lee,

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

New challenges to ERA arise from the convergence of artificial intelligence and Synthetic biology, where large language models are used to design, redesign and newly design genes, regulatory elements and organisms. In many cases they are new to nature with no or limited history of safe use and a lack of a suitable comparator. In this respect a per se risk assessment need to be developed. In addition, a problem formulation and pathways to harm approach may not be applicable straightforward, because of the high level of uncertainties and lack of knowledge.

In the case of microalgae, but also microorganisms this point is of special importance, because the convergence of AI and synthetic biology is especially strong in these areas. In addition, microalgae and microorganisms are not retrievable and therefore a step by step approach needs to include in depth step before any release for example in a contained microcosm.

Besides the development of per se risk assessment, a in-depth step by step approach also the monitoring methods are not adapted for this area.

Best regards
Samson

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

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 algae, whether macro or microalgae, existing regulatory frameworks (for genetically modified organisms, both macro and micro) adequately address the issues and challenges associated with their evaluation. These frameworks, which have been developed and updated over time, include a science-based approach and case-by-case assessment. There are also guidelines for the risk assessment of microalgae, the responsible use of GMOs in aquaculture, and monitoring tools.

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 algae. 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 algae) under assessment. Best regards, Yann Devos

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