3. Living modified organisms expressing genome editing machinery for pest or pathogen control

Thank you Ms Anthonysamy for moderating this session and greetings to colleagues.

I believe that there is need for guidance on this topic.

1. How does this topic potentially pose challenges to the existing risk assessment frameworks, guidance and methodologies?
Annex III of the Protocol provides high level structure for informing a scientific risk assessment, but it could not have anticipated the development of a category of organisms that might one day be self-driven creators of gene edited organisms.

Guidance on gene drive organisms partially addresses this problem. But that guidance was specific to the kinds of organisms that mainly or exclusively reproduce via meiosis, limiting the usefulness of the guidance to meiotic gene drives. This specific category of LMO, one that is engineered to express a genome editor, could be a microorganism, fungus, plant, or animal. In some cases meiosis is neither obligate, nor even used, for reproduction.

Moreover, the guidance was limited to gene drives. LMOs expressing genome editing machinery may be used for a variety of purposes, including inter alia pesticides through to the intended or unintended production of “null/negative segregants”.

This kind of LMO is both a product of modern biotechnology and a genetic engineer. The context, exposures, and intended receiving environments may not be under the control of those making such organisms and therefore challenge the idea that unintended outcomes could be known, much less assessed for risk, prior to release into the environment.

For example, an LM plant might express a CRISPR/Cas complex directed toward a viral pathogen, in similar fashion to the papaya plants that are engineered to express an RNAi response to a virus infection. An LM plant producing a site-directed nuclease (e.g. Cas9) and guide RNA/RNAs designed for a particular virus might inactivate the intended target virus, create derivative target viruses post damage repair, and/or mutagenise non-target viruses. The latter two products may even be thought of as unintended negative segregants [1].

The guide oligonucleotides may have been designed using the latest bioinformatic tools and the world’s largest genome databases, but even this would not be enough. Genome databases are highly biased to the genomes of the relatively few organism and virus genomes that have been sequenced, and the number of individuals of each of these species which have been sequenced [2, 3]. A third to a half of all bacteria species are completely unrepresented in databases [4].  Therefore, when attempting to design guides, it is impossible to know how limited they will be. Even in the comparatively low diversity of human genomes, off-target frequencies can vary between individuals [5].

Viral genome databases are particularly sparse. Viruses are ubiquitous and the Earth’s virome dwarfs all other biodiversity [6-8]. Because they often reside in cells, viruses may also be unintentionally modified simultaneously with another intended organism. Indeed, there is commercial interest in using genome editing as an antiviral therapeutic [9]. Damage specifically to the virus genome may even be unnecessary because the damage caused by the genome editor alone can stimulate viral reproduction and recombination [10].

The above is just one of many examples of plausible RA challenges. It is conceivable that exposure analyses will grow in complexity when gene editing complexes become better designed for transmission via inhalation and ingestion, as have dsRNA pesticides and LMOs expressing pesticidal dsRNAs. Guidance is needed to help with the assessment of a large number of uncertainties that arise from the release of this kind of LMO.

Do solutions exist?
There are no “solutions”, but proper guidance to assist risk assessment would make it possible for assessors to determine what information they require for release of an LMO in a particular environment.

2. What could be the specific challenges to related to this issue?
Annex III does not provide guidance for a risk assessor faced with the risk of organisms not intended to be modified and/or which have been modified outside of a containment facility. Annex III assumes that the LMO will be known and contained and therefore able to be assessed prior to release.

3. What are the specific issues concerning this topic?
These specific questions have been addressed above. In short, yes.


1. Heinemann, J.A. et al. (2023) Are Null Segregants New Combinations of Heritable Material and Should They Be Regulated? Front Genome Ed 4, 1064103.
2. Hoepers, A.M. et al. (2024) Predicted Multispecies Unintended Effects from Outdoor Genome Editing. Ecotox Environ Safety 282, 116707.
3. Lema, M.A. (2021) Regulatory Assessment of Off-Target Changes and Spurious DNA Insertions in Gene-Edited Organisms for Agri-Food Use. J. Regul. Sci. 9, 1-15.
4. Wu, D. et al. (2025) A Metagenomic Perspective on the Microbial Prokaryotic Genome Census. Sci Adv 11 (3), eadq2166.
5. Cancellieri, S. et al. (2023) Human Genetic Diversity Alters Off-Target Outcomes of Therapeutic Gene Editing. Nat Genet 55 (1), 34-43.
6. Roossinck, M.J. (2012) Plant Virus Metagenomics: Biodiversity and Ecology. Ann Rev Genet 46 (Volume 46, 2012), 359-369.
7. Mushegian, A.R. (2020) Are There 10e31 Virus Particles on Earth, or More, or Fewer? J Bacteriol., 202 (9), 10.1128/jb.00052-20.
8. Rivarez, M.P.S. et al. (2023) In-Depth Study of Tomato and Weed Viromes Reveals Undiscovered Plant Virus Diversity in an Agroecosystem. Microbiome 11 (1), 60.
9. Gersbach, C.A. et al. 30 April 2024. Genome Engineering with Type I Crispr Systems in Eukaryotic Cells. US11970710B2 https://patents.google.com/patent/US11970710B2/en?q=(nuclease+inhalation)&oq=nuclease+inhalation&page=5
10. Martin, D.P. et al. (2011) Recombination in Eukaryotic Single Stranded DNA Viruses. Viruses 3 (9), 1699-1738.

Thank you Anita for moderating this session. My name is Keith Hayes, I am a senior research scientist within Australia’s national science agency, the Commonwealth Science and Industrial Research Organisation (CSIRO). I lead a team that specialize in quantitative, probabilistic ecological risk assessment and was a member of the AHTEG that produced the recent Additional voluntary guidance materials to support case-by-case risk assessments of living modified organisms containing engineered gene drives.

A previous post on this thread (#12410) stated that this additional guidance is “specific to the kinds of organisms that mainly or exclusively reproduce via meiosis, limiting the usefulness of the guidance to meiotic gene drives”. I would like to respectfully disagree. The guidance contains the following sections and Annexes:

1. Objective and scope
2. Introduction
3. Engineered gene drives
4. General risk assessment guidelines for living modified organisms containing engineered gene drives
5. Recommendations of acceptability of risk and identification of risk management strategies
6. Monitoring
7. Related issues

Annex I: Further information on modelling
Annex II: Further information on uncertainty
Annex III: WHO guidance framework for testing genetically modified mosquitoes
Annex IV: Taxonomic classification of the Culicidae
Annex V: Non-exhaustive list of mosquito vectors of disease
Annex VI: Current landscape for development of LMMOs containing EGDs for disease vector control
Annex VII Engineered gene drives
Annex VIII List of terms.

Section 1, 2, 4, 6 and 7, together with Annexes I and II provide guidance that, on the understanding that all risk assessments should be conducted on a case-by-case basis, is applicable to any gene edited organism. Hence I would argue that most of the document (about 60% based on the number of relevant pages, excluding references and preamble) is pertinent and useful.

I think it is important to acknowledge that it is the risk assessments, not the guidance documents, that need to be case-specific, recognize the general applicability of the problem formulation approach to risk assessment, and be careful of dismissing existing guidance as irrelevant if it does not specifically mention a particular LMO.

Dear Esteemed Colleagues,

A sincere thank you to Dr. Jack Heinemann and Dr. Keith Hayes for sparking a thoughtful and engaging start to our discussion on Living Modified Organisms (LMOs) expressing genome editing machinery for pest or pathogen control.

As we continue exploring this important and evolving topic, I warmly encourage more of you to share your insights and experiences before the discussion closes on Monday, 5 May at 11:00 a.m. (Montreal time). Your perspectives are invaluable in shaping a deeper understanding of the implications and opportunities in this field.

Also, a kind reminder: when referencing studies or resources, please include the DOI or URL to make it easier for others to access and explore the material.

My co-moderator and I are looking forward to hearing your voices and continuing this vibrant exchange.

Best regards
Anita Anthonysamy

Posted on behalf of Kamal Kumar Rai, Nepal Indigenous Biodiversity Forum (NIBF), Indigenous Knowledge and Peoples Network Society for Wetland Biodiversity Conservation Nepal
*******
On the behalf of IPLCs, I heartily to thank a lot for sections on a case-by-case basis,  socio-economic, culture and ethical on the right based approaches are important that could be considered that are relevant for Indigenous Peoples, local communities, women, youth and persons with disabilities, non state actors. These groups of Peoples are the custodians and rights holders for biodiversity, species, genetic resources,  lands, waters, ecosystems and territories. Their knowledge systems play a vital role for the three objectives of the convention.

Yet we dont have any information about the LMO, containing EGDs social-behaviour within and out of the communities in ecological niches and interaction with nature and impacts on food chains. Many other issues must be assess under risk assessment and take care of them on Risk management

Therefore, we like to purpose something right based approach

Thanks with regards
Kamal Kumar Rai
IPLCs

Esteemed colleagues,

In contribution to discussion I would like to comment on the suggested questions 3:

3. Regarding i), the introduction of a living modified organisms expressing genome editing machinery for pest or pathogen control may alter pre-existing ecological dynamics by competing with native species, modifying trophic networks, or affecting essential symbiotic relationships. It could also create adaptative advantages directly or indirectly to certain organisms, which in turn could displace other species, thereby reducing biological diversity. Additionally, gene transfer could occur and create unforeseen consequences which could drastically alter the ecology and diversity.

Now, addressing point ii), depending on the end-use and the type of organism, there is a potential for environmental introduction either deliberate or accidental. Given that these types of modifications through gene editing are relatively recent and our understanding is still evolving, there is legitimate concern regarding both the short-term and long-term effects they may cause.  

On the other hand, regarding point iii), like I stated previously the week before, the use of any living modified organism intended for environmental release carries the risk of unintentional transboundary movement. Once released, these organisms can disperse through various biological mechanisms and external agents—such as wind, water, wildlife, or human activities—which do not adhere to geographic or jurisdictional boundaries.

My name is Christoph Then. For my affiliations please see the first round of questions. In the following, I try to answer to the questions raised by the moderator.

Question 1:
The most well known LMO expressing genome editing machinery for pest or pathogen control are gene drives. However, my input is focusing on other applications.

LMOs expressing genome editing machinery for pest or pathogen control were developed for animal feeding purposes, controlling specific species of pathogenic bacteria in the gut of swine and poultry (see for example patent application WO2016177682). Feed additives incorporating products derived from such LMOs were authorised for Brasil without being registered as LMOs. These organisms were developed by a company based in UK (Folium), using patented technology of a Danish company (SNIPR Biome). There are further development underway by company SNIPR Biome to interfere with the microbiome of humans and animals that use synthetic phages to deliver synthetic nucleases into target cells to kill them (see for example patent applications WO2024063986 and WO2022063986).

Other microbial LMOs expressing the genome editing machinery for pest or pathogen control are purposed for the protection of surfaces, substrates and fluids or contaminations (see, for example, patent application WO2016177682).

Being aware of experts warning about the potential harmful effects of genetically engineered microorganisms (GEMs) on the intestinal microbiome and public health (Lerner et al., 2024), these application definitely deserve a high degree of precaution. It should be acknowledged that introducing genome editing machineries into target living cells such as bacteria or archaea will cause the occurrence of an LMO that is supposed to kill itself (‘suicidal LMO’). In the case of LM microbes, the target cells will incorporate DNA to produce a synthetic nuclease that is supposed to kill the cell in a second step. Since these techniques are not 100 percent effective, some of the suicidal cells may be able survive and spread new gene combinations and transgenes within the natural cell populations. Such LMOs may also be involved in transboundary movements.

Another application of LMOs expressing genome editing machinery for pest or pathogen control are plants for agriculture usage. For example, Luo et al. (2025) established  an synthetic ‘immune system’  conferring DNA and RNA virus resistance in plants using CRISPR/Cas12a multiplex gene editing. Similar approaches have been followed by Aman et al. 2018; Yu et al. 2022; Zhang et al. 2019 and Yu et al. 2020. This may cause harm to the environment if for example viruses would acquire resistance and start to replicate in the cells of the transgenic plants. Such long term consequences are hard to predict and to prevent damage to the environment even if noticed.

Question 2
Specific pathways to harm may evolve if for example viruses would acquire resistance to the synthetic immune system and start to replicate in the cells of the transgenic plants. As shown in the case of the papaya ringspot virus, this may foster the development of spreading the resistance or even may support other viruses to adapt (Yang et al., 2024).

Also LM microorganisms meant to express genome editing machinery for pest or pathogen control and the resulting LM suicidal cells may contaminate spread in the environment, potentially establishing new pathways of harm.


Question 3
All three questions can be answered with yes.


Question 4.
As far as we know, no focused discussion has taken place on these issues despite first products already entered the market.

References
Aman R, Ali Z, Butt H, Mahas A, Aljedaani F, Khan MZ, Ding S, Mahfouz M. (2018) RNA virus interference via CRISPR/Cas13a system in plants. Genome Biol. 19(1):1. doi: 10.1186/s13059-017-1381-1.

Hoepers AM, Heinemann JA, Zanatta CB, Chu P, Hiscox TC, Agapito-Tenfen SZ. (2024) Predicted multispecies unintended effects from outdoor genome editing. Ecotoxicol Environ Saf. 282:116707. doi: 10.1016/j.ecoenv.2024.116707.

Lerner A, Benzvi C, Vojdani A. The Potential Harmful Effects of Genetically Engineered Microorganisms (GEMs) on the Intestinal Microbiome and Public Health (2024). Microorganisms. 12(2):238. doi: 10.3390/microorganisms12020238.

Luo, L., Miao, L., Ma, X., Hu, J., Li, S., Yang, W., Ma, S., Chen, R. and Liu, X. (2025), Establishing an Immune System Conferring DNA and RNA Virus Resistance in Plants Using CRISPR/Cas12a Multiplex Gene Editing. Plant Direct, 9: e70070. https://doi.org/10.1002/pld3.70070

Yang MZ, Hao ZG, Ren ZT, Tang R, Wu QH, Zhou LY, Hu YJ, Guo JY, Chen Y, Guo YL, Liu B, Liu LP, Xue K, Jia RZ. (2024) Genetic Variability and Evolutionary Dynamics of Papaya Ringspot Virus and Papaya Leaf Distortion Mosaic Virus Infecting Feral Papaya in Hainan Island. Phytopathology. 114(11):2442-2452. doi: 10.1094/PHYTO-01-24-0022-R.

Yu Y, Pan Z, Wang X, Bian X, Wang W, Liang Q, Kou M, Ji H, Li Y, Ma D, Li Z, Sun J. (2022) Targeting of SPCSV-RNase3 via CRISPR-Cas13 confers resistance against sweet potato virus disease. Mol Plant Pathol. 104-117. doi: 10.1111/mpp.13146.

Yu Y, Wang X, Sun H, Liang Q, Wang W, Zhang C, Bian X, Cao Q, Li Q, Xie Y, Ma D, Li Z, Sun J. (2020) Improving CRISPR-Cas-mediated RNA targeting and gene editing using SPLCV replicon-based expression vectors in Nicotiana benthamiana. Plant Biotechnol J. 18(10):1993-1995. doi: 10.1111/pbi.13384.

Zhang T, Zhao Y, Ye J, Cao X, Xu C, Chen B, An H, Jiao Y, Zhang F, Yang X, Zhou G. (2019) Establishing CRISPR/Cas13a immune system conferring RNA virus resistance in both dicot and monocot plants. Plant Biotechnol J. 17(7):1185-1187. doi: 10.1111/pbi.13095.

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

Key Challenges:
Active Genome Editing in the Environment
These LMOs are engineered not only to express a trait but to actively edit the genomes of other organisms in the environment post-release. This represents a paradigm shift in biosafety assessment, where the LMO becomes a vector of genetic modification beyond its own genome.

Unpredictability and Irreversibility
Self-propagating systems, such as gene drives, can spread through wild populations in unintended ways, undermining traditional containment strategies and posing a challenge to the precautionary principle due to potential long-term, irreversible ecological effects.

Horizontal Transfer Risks
The genome-editing machinery (e.g., nucleases, guide RNAs) expressed by these LMOs may transfer horizontally to non-target species or microbial communities, potentially inducing unintended genetic modifications in untargeted organisms.

Blurred Assessment Boundaries
The risk envelope extends beyond the LMO itself. Since these organisms are designed to edit other populations in situ, risk assessment must account for second-order effects—including genetic changes in target and non-target populations, ecological cascades, and evolutionary responses.

Detection and Monitoring Difficulties
Genetic changes induced in wild organisms may resemble naturally occurring mutations. This complicates detection, traceability, and compliance monitoring, particularly in jurisdictions with limited biosurveillance infrastructure.

Regulatory Ambiguity
Many existing national and international biosafety frameworks were not designed for organisms that autonomously alter other organisms' genomes, creating gaps in legal definitions, consent mechanisms, and liability provisions.

Potential Solutions:
Case-by-Case and Tiered Risk Assessment
Risk should be assessed based on intended function, ecological exposure, and dispersal potential.

Phased Testing and Confinement Strategies
A stepwise approach—including laboratory research, confined field trials, and containment methods such as molecular confinement (e.g., split or self-limiting drives)—can help manage uncertainties.

Real-Time Environmental Biosurveillance
Deployment of environmental DNA (eDNA) tools and biosensors capable of detecting genome-editing elements in wild populations can aid early detection of unintended spread or effects.


2. What could be the specific challenges related to this issue?
Ecological Tipping Points
Altering or suppressing entire populations of pest or vector species may trigger cascading ecosystem effects, particularly if the species plays a role in pollination, seed dispersal, or the food web.

Horizontal and Vertical Gene Transfer
Expressed gene-editing components may transfer across species barriers or persist in the environment in microbial reservoirs, amplifying ecological uncertainty.

Ethical, Social, and Cultural Dimensions
Releases could affect species or ecosystems that hold cultural, spiritual, or economic significance for Indigenous Peoples and Local Communities (IPLCs), raising questions of equity, consent, and justice.

Regulatory Fragmentation
With divergent national stances on gene editing, cross-border risks may emerge if LMOs are tested or deployed in some jurisdictions while others prohibit them.

3. What are the specific issues concerning this topic?
(i) Potential to Cause Adverse Effects on Biodiversity and Human Health?
Yes.

Gene drives targeting invasive species may inadvertently affect dependent predators or competitors, disrupting ecosystem balance.

Off-target genome editing or hybridization may impact closely related non-target species or beneficial organisms (e.g., pollinators).

Pathogens modified via genome-editing LMOs may evolve resistance mechanisms or unintended traits, posing human or animal health risks.

Loss of culturally significant species could impact the livelihoods, diets, or spiritual values of IPLCs.

(ii) Potential for Deliberate or Accidental Environmental Introduction?
High.

Environmental release is typically the intended outcome for these LMOs.

Accidental escape during laboratory research or confined trials is a known possibility, particularly where containment protocols are inadequate.

(iii) Potential to Disseminate Across National Borders?
Very high.

Mobile organisms (e.g., insects, aquatic species) can migrate naturally across boundaries.

Human activity (e.g., trade, travel) can unintentionally aid in transboundary movement.

(iv) Commercialization or Likely Use?
Emerging.

Several genome-edited pest-control organisms are undergoing advanced field testing, with growing private-sector interest in agricultural and vector-borne disease applications.

Commercial deployment may be imminent, depending on national regulatory approvals and public acceptance.

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 Esteemed colleagues,

I would like to contribute to this group discussion. My name is Norliza, I am a senior principal research scientist with MARDI involved in genome editing and omics studies of plant -pathogen interactions and also a member of the National Genetic Modification Advisory committee in Malaysia.

One of the greatest challenges for modern agricultural is to improve yield through the development of superior varieties. The increasing numbers of infectious plant diseases that are caused by plant-pathogens make it ever more necessary to develop new strategies for plant disease resistance breeding as it is the major factor for yield reduction. Genome editing is a powerful tool for revolutionize breeding by enabling precise and multiplex genome editing to improve resistance to phytopathogens.

Currently, genome edited plants to obtain plants resistance to certain pathogen are mainly carried out by targeting susceptibility (S) genes, editing resistance (R) genes, or enhancing immune responses whereby the data comes from extensive omics and plant-pathogen interaction studies.Genome-editing holds great potential to combat a wide range of pathogens including bacteria, fungi, viruses, and nematodes. And with the advancement of technology, genome editing tools continues to evolve with the introduction of editing tools like base and prime editing, along with advances in delivery systems (e.g., RNPs, viral vectors) which promises more efficient and targeted strategies for enhancing pathogen disease resistance in plants.

In regards with this I agree with #12404 and #12423] which has expressed their thoughts,  there was a challenge in reaching a consensus between Parties if genome edited organisms fall within the scope of the Cartagena Protocol. This will create different perspectives and methodologies to carry out risk assessment related to this topic if genome edited products are regulated. Furthermore, there is a need for Guidance on Genome-Edited Products Expressing Genome Editing Machinery as the Cartagena Protocol on Biosafety (CPB), specifically as the Annex III framework was developed at a time when the concept of genome edited organisms was not foreseen and there is still limited Existing Guidance on Gene Drives that primarily focuses on organisms that undergo meiotic reproduction.


Currently, there is evolving understanding of genome-edited organism and it can be extremely challenging to fully assess the potential risks associated with their release into the environment as genome editing can be quite similar to natural selection and even be more advantages due to its specificity. Furthermore, there are still challenges that need to be highlighted which includes off target effects particularly with CRISPR/Cas9 which may unintentionally modify DNA at sites other than the intended target, regulatory uncertainty whereby different countries regulate genome-edited organisms differently; causing trade barriers and uncertainty for developers, significant ethical debates which are also taken into account in many countries during the risk assessment of genome edited research applications, potential risks to ecosystems if they are released into the wild; such as disrupting biodiversity, the misuse of genome editing to create harmful organisms that may poses risks for biosecurity. Moreover, effectively controlling and mitigating these risks, as well as monitoring, would present significant challenges and potential considerable consequences. Another challenges that need to be  taken into account are organisms are both products and tools of genetic engineering that are engineered to carry editing components (e.g., Cas9, gRNAs) where they act as editing agents, potentially altering themselves or other organisms in the environment. These diverse applications challenge the scope and specificity of existing biosafety frameworks, which are often application-blind and organism-centered, rather than function-aware.

To aid the novel risk assessment of genome edited products that go beyond static, species-specific evaluations, it is advisable for future guidance to include:

i. Consider function- and interaction-based assessments,

ii. Address non-meiotic organisms and mobile genome editors,

iii. Account for ecological uncertainty and viral interactions,

iv. And incorporate bioinformatics limitations and off-target analysis.



References
Andolfo G, Iovieno P, Frusciante L, Ercolano MR. Genome-Editing Technologies for Enhancing Plant Disease Resistance. Front Plant Sci. 2016 Dec 1;7:1813. doi: 10.3389/fpls.2016.01813. PMID: 27990151; PMCID: PMC5130979.
National Academies of Sciences, Engineering, and Medicine. (2018). Biodefense in the Age of Synthetic Biology. https://doi.org/10.17226/24890
Sherkow, J.S. (2017). The CRISPR Patent Landscape: Past, Present, and Future. The CRISPR Journal, 1(1), 5–9. https://doi.org/10.1089/crispr.2017.0003

Heinemann, J.A., et al. (2021). Biosafety implications of genome editing technologies in agriculture. Frontiers in Bioengineering and Biotechnology, 9, 668–681. https://doi.org/10.3389/fbioe.2021.668482
Lin, Y.T., et al. (2020). CRISPR-induced DNA damage promotes recombination between divergent bacteriophages. Nature Communications, 11(1), 1–12. https://doi.org/10.1038/s41467-020-15637-8

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 organisms expressing genome editing machinery for pest or pathogen control” 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?

I agree with #12411, acknowledging that it is the risk assessments, not the guidance documents, that need to be case-specific, recognize the general applicability of the problem formulation approach. I do not think we should spend scarce resources elaborating guidance for each new technology or new organism we are facing. Instead, the criteria of decision CP-9/13 make us to look on the experience and material available in different parts of the world that can help risk assessors to evaluate new issues.

dsRNA (#12410), for example, have a huge potential to be part of the solution to reduce the use of chemical pesticides, part of the GBF Target 7, but are not in the scope of “living organims” of Cartagena Protocol. The dsRNA pesticides are specific sequences to target mRNA encoding, for example, a protein that may be essential for the survival, reproduction, or growth of a pest and are evaluate under pesticide RA frameworks as a pest control product.

Based on the above, I consider that this topic does not fulfill the criteria of decision CP-9/13, and can duplicate existing risk assessment frameworks of other areas.


Best regards,
Luciana P. Ambrozevicius

Living Modified Organisms (LMOs) expressing genome editing machinery for pest or pathogen control present innovative opportunities for disease and pest management, especially in agriculture and public health. However, they also introduce complex ecological, ethical, and sociocultural risks that current risk assessment and management systems may not adequately address. To ensure safe, ethical, and inclusive deployment, it is critical to incorporate indigenous knowledge systems, gender-responsive approaches, and community-based capacity-building tools such as gamification and localized learning.

Integration of Indigenous Knowledge:
Indigenous communities possess deep, place-based knowledge of local ecosystems and biodiversity dynamics. Their historical understanding of natural pest control methods and ecological balance offers essential insights into the unintended consequences of genome editing on non-target species and ecosystem functions. Including indigenous knowledge in LMO governance can support more context-specific, culturally relevant, and ecologically sound decision-making.

Capacity building strategies
Populations that constitute indigenous people and local communities' women lack access to formal scientific education and risk communication tools. Gamification and interactive capacity-building approaches can bridge this gap. Tools like community storytelling, and participatory mapping can simplify complex genetic concepts and make risk assessment processes more inclusive, especially for populations with low literacy or limited access to scientific discourse.

Localization and gender responsiveness:
Localizing information ensures that risk communication materials are tailored to community languages, customs, and contexts. Gender-responsive strategies recognize that women often carry the primary responsibility for food production and natural resource management. Ensuring their participation in LMO governance is critical for equitable decision-making and for identifying risks that disproportionately affect them. Together, the integrated strategies promote informed community consent, enhance social oversight, and support ethical innovation in biotechnology, aligning with the precautionary principle, the goals of the Cartagena Protocol, and the Kunming-Montreal Global Biodiversity Framework.

Dear colleagues, I’m Cinthia Soberanes-Gutiérrez. I am a researcher “Investigador por México”, at the Executive Secretariat of the Intersecretarial Commission on the Biosafety of Genetically Modified Organisms (CIBIOGEM), Mexico.
Below, I present our position in response to the questions posed:

1) How could this topic pose challenges to existing risk assessment frameworks, guidelines, and methodologies?
Living Modified Organisms (LMOs) expressing gene editing machinery, such as CRISPR/Cas9, present significant challenges to current risk assessment frameworks, which were primarily designed for genetically modified organisms with stable and known modifications. The ability of these LMOs to edit genomes in non-target organisms in open environments introduces uncertainties that are difficult to predict and assess. For instance, the study by Hoepers et al. (2024) demonstrated that the use of genome-edited LMOs in uncontrolled agricultural settings—via irrigation, fumigation, or fertilization—can lead to off-target effects in multiple species within the agroecosystem, including humans (42% of the organisms evaluated). Using bioinformatics tools, the authors predicted that these alterations could impact critical functions such as the development of the nervous and respiratory systems. These findings underscore the urgent need to apply the precautionary principle and reinforce biosafety measures to protect human health and biodiversity. Furthermore, the lack of genomic representation for a significant portion of microbial diversity in current databases limits the ability to predict off-target effects (Wu et al., 2025).
Are there solutions? To address these challenges, it is necessary to develop specific guidelines that consider the unique characteristics of these LMOs, including their capacity to edit non-target organisms and their potential to spread in the environment. These guidelines should incorporate risk assessment approaches that consider the complexity and uncertainty associated with these new types of LMOs. 1) Develop risk assessment approaches that incorporate uncertainties and the fundamental state of "unknowns" regarding the potential implications of releasing LMOs with gene drives. 2) Broaden decision-making processes to incorporate the range of factors that may be affected by the release of LMOs with gene drives, with implications extending beyond direct effects on biodiversity and human health. 3) Create capacity-building programs in developing countries, with an emphasis on those that are centers of origin.

2) What could be the specific challenges related to this topic?
The spread of LMOs with gene drives can alter the ecological and genetic dynamics of wild populations, with unpredictable consequences. Their ability to edit genomes in non-target organisms complicates the detection and monitoring of their effects in the environment. The lack of comprehensive genomic data for many species limits the ability to predict and assess off-target effects of gene editing (Wu et al., 2025). The production of organisms that have lost the gene editing machinery but may have undergone genetic changes raises questions about their regulation and risk assessment (Heinemann et al., 2023). The absence of effective mechanisms for free, prior, and informed consent for Indigenous Peoples and Local Communities (IPLCs), despite these groups being most impacted by biodiversity and territory (Kormos et al., 2022). Additionally, many developing countries lack the necessary infrastructure to conduct adequate risk assessments and monitor the effects of LMOs with gene drives, as well as regulatory capacity, epistemic inequality, and governance. There is also concern about the absence of clear mechanisms to assess ethical, biocultural, and socioeconomic risks related to potential impacts on species of spiritual, nutritional, or medicinal value for IPLCs.

3) What are the particular problems posed by this topic?
(i) Is there a possibility of adverse effects on biodiversity? Yes. As demonstrated by van der Vlugt et al. (2018), even the release of a small number of organisms with CRISPR-based gene drives, even under containment conditions, can lead to the invasion of local populations and subsequently other populations connected by minimal gene flow. These findings indicate that gene drive technology presents substantial risks of uncontrolled dispersion that have not been fully addressed by current frameworks. Therefore, allowing their release in megadiverse countries or centers of origin without rigorous, independent, and contextualized risk assessment poses a serious threat to biodiversity and biocultural heritage. It is imperative to apply the precautionary principle and prohibit any environmental release until robust regulatory frameworks and adequate national capacities for their assessment are in place.

(ii) Is there a possibility of introduction into the environment? Yes. Studies like that of Noble et al. (2018) have shown that even the least efficient CRISPR-based gene drive systems reported to date have a high probability of being invasive. Through mathematical models based on empirical data, it was demonstrated that, although resistant alleles can prevent the complete fixation of the gene drive, their release into wild populations still carries a high probability of uncontrolled dispersion. This indicates that LMOs with gene drives can spread beyond their initial target even without total success, highlighting the urgent need to apply the precautionary principle and prohibit any environmental release in countries with high biodiversity and limited containment capacity.

(iii) Is there a possibility of dissemination across national borders? Yes. For example, population genetics models reviewed by de Jong (2017) show that gene drive elements based on homing endonucleases can effectively spread in natural populations by converting heterozygotes into homozygotes, even when they have little or no effect on fitness. This means that, in the absence of evolutionary resistance, the drive can reach fixation. However, when the gene significantly reduces viability, its expansion may require overcoming a minimum presence threshold. Additionally, it is noted that systems with meiotic drive have a higher probability of dissemination than those activated in embryonic stages, which should be critically considered in environmental risk assessment. The DRAQUE model proposed by Courtier-Orgogozo et al. (2020) demonstrates how a gene drive element could contaminate non-target species through horizontal transfer or hybridization, and then spread within the new population, including scenarios where geographic dispersion cannot be contained by political borders. If the gene drive is successfully inserted and not eliminated by the new host's immune system, it could establish and expand in the population, crossing ecosystems and countries via biological vectors (such as insects, birds, or rodents) or indirect means.

(iv) Is the LMO already, or is it likely to be soon, commercialized or in use somewhere in the world? Yes. These organisms are already in experimental use in various countries and could enter the commercial phase without adequate frameworks (van der Vlugt et al., 2018).

4) Are there resources available on similar issues that can address this topic, or resources that can be adapted to meet this need? Yes. We agree with the contributions that point out that the Cartagena Protocol needs to be updated with specific guidelines on LMOs with active editing. Mexico proposes taking the following sources as references: Kelsey et al. (2020) address gaps in global governance on gene drives and suggest institutional strategies that allow for more robust, coordinated, and ethical regulation. They argue that this governance should be developed in parallel with research to prevent regulatory inequalities and protect the interests of developing countries. Kormos et al. (2022) explore how the development of gene drive technologies has largely excluded local actors from decisions. They propose the creation of ethical frameworks, principles of fair participation, and community co-development mechanisms. This approach is essential for building international guidelines with sociocultural relevance, especially for megadiverse and multiethnic countries like Mexico.
The post-release monitoring of LMOs with gene drives proposed by Ogoyi et al. (2024) offers recommendations on how to monitor the effects of LMOs with gene drives after their release into the environment. Finally, Undheim (2024) reviews emerging governance frameworks that could be adapted or inspire new guidelines to address the risks of highly dynamic technologies like LMOs with active gene editing. For example, he highlights governance approaches ranging from regulated control to social co-responsibility models. This diversity of approaches is key to thinking about adaptable frameworks in diverse national contexts.
In conclusion, the release of LMOs expressing gene editing machinery for pest or pathogen control poses significant challenges to existing risk assessment frameworks, especially in megadiverse countries like Mexico. It is essential to adopt a precautionary approach, consider the rights of Indigenous Peoples and Local Communities, and develop regulatory frameworks tailored to address the ecological, social, and ethical risks associated with this emerging technology. We concur with other contributions in this forum: #12410, #12425, #12430, and #12438, which highlight the great need for regulatory frameworks to accompany the exponential growth of this technology, especially in regions with less regulatory development. Particularly, contribution #12420 emphasizes the need to propose a rights-based approach.

References:
Courtier‐Orgogozo, V., Danchin, A., Gouyon, P. H., & Boëte, C. (2020). Evaluating the probability of CRISPR‐based gene drive contaminating another species. Evolutionary Applications, 13(8), 1888-1905. https://onlinelibrary.wiley.com/doi/full/10.1111/eva.12939
de Jong, T. J. (2017). Gene drives do not always increase in frequency: from genetic models to risk assessment. Journal of Consumer Protection and Food Safety, 12(4), 299-307. https://link.springer.com/article/10.1007/s00003-017-1131-z
Heinemann, J. A., Clark, K., Hiscox, T. C., McCabe, A. W., & Agapito-Tenfen, S. Z. (2023). Are null segregants new combinations of heritable material and should they be regulated?. Frontiers in Genome Editing, 4, 1064103. https://www.frontiersin.org/journals/genome-editing/articles/10.3389/fgeed.2022.1064103/full
Hoepers, A. M., Heinemann, J. A., Zanatta, C. B., Chu, P., Hiscox, T. C., & Agapito-Tenfen, S. Z. (2024). Predicted multispecies unintended effects from outdoor genome editing. Ecotoxicology and Environmental Safety, 282, 116707. https://www.sciencedirect.com/science/article/pii/S0147651324007838
Kelsey, A., Stillinger, D., Pham, T. B., Murphy, J., Firth, S., & Carballar-Lejarazú, R. (2020). Global governing bodies: a pathway for gene drive governance for vector mosquito control. The American Journal of Tropical Medicine and Hygiene, 103(3), 976. https://pmc.ncbi.nlm.nih.gov/articles/PMC7470596/
Kormos, A., Lanzaro, G. C., Bier, E., Santos, V., Nazaré, L., Pinto, J., ... & James, A. A. (2022). Ethical considerations for gene drive: challenges of balancing inclusion, power and perspectives. Frontiers in Bioengineering and Biotechnology, 10, 826727. https://www.frontiersin.org/journals/bioengineering-and-biotechnology/articles/10.3389/fbioe.2022.826727/full
Noble, C., Adlam, B., Church, G. M., Esvelt, K. M., & Nowak, M. A. (2018). Current CRISPR gene drive systems are likely to be highly invasive in wild populations. Elife, 7, e33423. https://elifesciences.org/articles/33423
Ogoyi, D. O., Njagi, J., Tonui, W., Dass, B., Quemada, H., & James, S. (2024). Post-release monitoring pathway for the deployment of gene drive-modified mosquitoes for malaria control in Africa. Malaria Journal, 23(1), 351. https://link.springer.com/article/10.1186/s12936-024-05179-4
Undheim, T. A. (2024). The whack-a-mole governance challenge for AI-enabled synthetic biology: literature review and emerging frameworks. Frontiers in Bioengineering and Biotechnology, 12, 1359768. https://www.frontiersin.org/journals/bioengineering-and-biotechnology/articles/10.3389/fbioe.2024.1359768/full
van der Vlugt, C. J., Brown, D. D., Lehmann, K., Leunda, A., & Willemarck, N. (2018). A framework for the risk assessment and management of gene drive technology in contained use. Applied Biosafety, 23(1), 25-31. https://www.liebertpub.com/doi/full/10.1177/1535676018755117
Wu, D., Seshadri, R., Kyrpides, N. C., & Ivanova, N. N. (2025). A metagenomic perspective on the microbial prokaryotic genome census. Science Advances, 11(3), eadq2166. https://www.science.org/doi/full/10.1126/sciadv.adq2166

Dear colleagues, dear moderator

I have a question about the proceedings that I'm hoping the Secretariat can answer for me.

I have seen a number of posts both in this thread and other threads that say or suggest that a specific issue nominated by a Party (and sometimes an issue not under discussion) does not meet the threshold that it does or will fall within the scope and objective of the Cartagena Protocol, my paraphrase of a criterion described in Annex 1 of Decision 9/13 and referred to in Annex (1c) of Decision CP-11/7. Annex 1 describes the obligations of Parties who were invited to submit information regarding their needs and priorities for guidance. On review of the submissions, I see that all submitting Parties have taken Annex 1 into account when they submitted their requests for guidance. None left blank the box describing how the specific issue fell within the scope of the Protocol, and therefore the nominations meet this qualifying condition for a specific issue to be discussed in the Online Forum and AHTEG.

Paragraphs 7-10 of Decision 11/7 describe the process through which the Online Forum and AHTEG will do their work. Decision CP-9/13 (6) and paragraphs 7-10 of CP-11/7 say that the work of the Online Forum and AHTEG is to recommend and prioritise, or to not recommend, specific issues identified by Parties for guidance. It is left to Parties in the submission process to follow the criteria in Annex I of CP-9/13, including the criterion of stating why they believe that the specific issue is in scope. Nowhere does it say that the AHTEG should contest the reason Parties provided to consider that the special issue was within scope or presume that any individual or individual Party view of scope is the view, or will be the future view, of the COPMOP, or using this as part of their analysis for recommending and prioritising guidance requested by Parties.

I personally think that this interpretation would be the case because, first, our list of questions does not include a response to the scoping question in CP-9/13. And second, my understanding is that only the COPMOP can determine how a specific issue is to be researched and discussed in the context of a scoping decision, and only it has the power to adjudicate on matters of scope.

So I am asking for clarification of this point from the Secretariat please, so that Parties, the AHTEG, and I are clear on what is the work of this Online Forum.

Thank you
Jack

Dear colleagues,
My name is Ediner Fuentes-Campos, Deputy Director of Research and Development at the Secretariat of Sciences of Panama. I have been working as a risk assessor at the National Biosafety Commission for GMOs and as a public researcher.

I would like to express my gratitude to the moderator for this important forum and to all participants for their valuable contributions. I fully support the position expressed in post #12411, which emphasizes that it is the risk assessments, not the guidance documents, that need to be case-specific, and which recognizes the general applicability of the problem formulation approach to risk assessment. The additional voluntary guidance materials for LMOs containing engineered gene drives provide a framework that is largely applicable to other genetically edited organisms as well.
I also agree with post #12447 that we should not allocate limited resources to the development of guidance for each new technology or organism. Instead, as established in decision CP-9/13, we should leverage existing experiences and materials available worldwide that can help risk assessors evaluate new issues.

From a practical regulatory perspective, I believe that case-by-case assessment remains the most effective approach. Existing frameworks, when properly implemented, can adequately address the risks associated with LMOs expressing genome editing machinery for pest or pathogen control. Rather than developing new guidance, efforts should be directed toward strengthening capacity building for the application of existing frameworks in different national contexts.

Respectfully,
Ediner Fuentes-Campos

Dear colleagues--

I am Bob Friedman, with the J. Craig Venter Institute, a genomics and synthetic biology research institute in the United States.  My thanks to our co-moderators for guiding this session and to all the participants for their perspectives. 

I would like to voice my support for the views expressed in #12411, #12447, and #12470 in that “it is the risk assessments, not the guidance documents, that need to be case-specific” and to “recognize the general applicability of the problem formulation approach.”  Post #12411 points out the relevance of the Additional Voluntary Guidance for LMOs Containing Engineered Gene Drives, in general and specifically for this topic.  (These points respond to questions 1 and 4.)

I’ve carefully read the responses of colleagues to questions 2 and 3 (asking for specific challenges or issues) looking for reasons why the COP might prioritize development of guidance on this vague topic, especially given the availability of the clear and direct Additional Voluntary Guidance developed by the previous AHTEG. Noting that funding is clearly limited, I give great weight to evidence of 3(iv), “LMOs already, or are likely to be, commercialized?” with 3(i) “serious or irreversible” “adverse effects on biodiversity”.  Seeing no evidence of such products close to commercialization, I like #12447 and #12470, would not include this as a priority topic for further guidance.     

Regards to all,
Bob

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

Notably, the main current strategies that use gene-editing machinery (CRISPR) for pathogen control involve a 'delivery bacterium,' which serves to deliver the plasmid through conjugation, for example, to the target bacterium. This process does not involve or contain recombinant DNA/RNA and, therefore, does not result in transgenic organisms, as both the CRISPR system and the conjugation machinery naturally occur in the donor organism itself.

Being precise, regarding the reference to Folium Science’s Guided Biotics platform in the Egypt submission, I would like to clarify: The product is a dry additive for poultry feed or water, composed of naturally non-toxic, non-allergenic, and non-virulent Escherichia coli, free of antibiotic resistance genes, designed to control all serotypes of Salmonella enterica, the causative agent of a significant poultry disease; the product does not contain recombinant DNA/RNA – the CRISPR system and the conjugation machinery required to mobilize the plasmid occur naturally in Escherichia coli.

As it does not meet the criteria outlined in decision CP9/13 Annex I, item "b," I consider that this topic should not be deemed relevant for the development of guidelines.

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

I believe the additional voluntary guidance materials for LMOs containing engineered gene drives are largely applicable to LMOs expressing genome editing machinery. Existing risk assessment frameworks, such as the problem formulation approach based on pathways to harm, are flexible and robust enough to frame and inform case-by-case risk assessments for these LMOs. These frameworks can be applied to new contexts on a case-by-case basis without the need for new guidance. Therefore, efforts should be directed towards leveraging existing materials and experiences globally to help risk assessors evaluate new issues.
Additionally, the challenge may lie in the practical application of existing concepts rather than the need for new guidance. Thus, training and capacity building for interested parties should focus on thoroughly effectively applying existing frameworks, especially the problem formulation steps.

Dear all,

Contributing to the discussion, I would like to share the perspective of what is done in Argentina.

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

In many producer and agro-exporting countries, such as Argentina, products obtained through NBTs, including those produced by gene editing, are addressed under specific regulations that allow for a determination process to establish whether the new product is a GMO or not.
This determination process is conducted on a case-by-case basis, and if the product is determined not to be a GMO, it is regulated in the same manner as a product obtained through conventional breeding techniques.
In this regard, and for the purpose of addressing organisms expressing genome editing machinery for pest or pathogen control, Argentina sees no obstacle in addressing them under the current regulations and guidelines available.

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

The challenge is to harmonize regulations and achieve a consistent approach across all countries for products obtained through NBTs.

3. What are the specific issues concerning this topic?

(i) Is there the potential to cause adverse effects on biodiversity, in particular those that are serious or irreversible, taking into account the urgent need to protect specific aspects of biodiversity, such as an endemic/rare species or a unique habitat or ecosystem, taking into account risks to human health and the value of biological diversity to indigenous peoples and local communities?

No potential adverse effects have been identified.

(iii) Is there the potential to disseminate across national borders?

Yes, but if the NBT product has been evaluated by the Argentine regulatory agency and determined not to be a GMO, it will follow the conventional regulatory pathways for any product entering the country.

(iv) Is the LMO already, or are likely to be, commercialized or in use somewhere in the world?

If the product obtained through NBTs is analyzed and considered conventional, it is not an LMO.

Thanks again to the Secretariat and to Ms. Anthonysamy for moderating the discussions and providing me with this opportunity.

I would like to support the views expressed in posts 12411, 12447, 12470, 12473, 12487 and 12489 that guidance on this subject would not be beneficial to pursue.  As has been mentioned, the recent gene drive guidance covers quite well issues associated with gene editing machinery.  It also remains clear that, if a risk assessment is deemed necessary, that the existing broad guidance documents and framework for risk assessment provided by Annex III remains robust, and more than capable of dealing with any issues identified during case specific problem formulation.  In this regard, I would like to once again support Dr. Keith Hayes in post 12411 for his contributions in providing clarity to the risk assessment process.

Regards,
Andrew Roberts, PhD
Agriculture & Food Systems Institute

Thank you very much for this topic,

I would like to echo previous comments, who have provide information that illustrate how this topic meets criteria for further guidance, particularly posts #12438, #12410, #12459 and #12430.

Q1 Such technologies are broadening the scale and scope of genetic modification, and increasing the potential to modify non-target organisms via exposure to editing machinery in the open environment. As previously stated, such technologies open up new routes of gene flow no longer limited by species barriers, instead being limited only be levels of exposure to the editing machinery. With potential delivery methods including spraying, the ability to protect non-target species from exposure is a challenge.

Q2. Fundamental to this topic is the inability to assess the LMO prior to release, due to the technology being the release of the GM process into the environment, where organisms are modified directly in the field. This raises direct challenges to the ability to perform a risk assessment. Moreover, such technologies raise additional specific challenges where the technology involves not just one LMO e.g. a bacterial species engineered to express CRISPR, but also of generating a second LMO in the environment, that is targeted by the CRISPR machinery.


(3(iv) As mentioned by others, some products are already being approved including those by the UK based company Folium Sciences that involve E. coli that express CRISPR machinery to target pathogens in the gut microbiome.

Other technologies may not involve the release of an LMO expressing living organisms, but just the machinery itself,  raising challenges to current experiences. For example, novel genome editing technical applications are being developed that could be applied to microorganisms directly in their native environments. A recent publication (Rubin et al., 2021) in the US has reported the development of ‘species-specific editing’ that “provides the first broadly applicable strategy for organism- and locus-specific genetic manipulation within a microbial community, hinting at new emergent properties of member organisms and methods for controlling microorganisms within their native environments.” Moreover, this work is being envisaged for a variety of applications inclusive of “agricultural, industrial, and health-relevant microbiomes”.

Q4. There are no existing guidelines to deal with the complexities and uncertainties of such an approach currently, and the existing guidance on gene drives is not suitable due to an absence of guidance on risk considerations outside of mosquito applications.
Rubin, B. E., Diamond, S., Cress, B. F., Crits-Christoph, A., Lou, Y. C., Borges, A. L., Shivram, H., He, C., Xu, M., Zhou, Z., Smith, S. J., Rovinsky, R., Smock, D. C. J., Tang, K., Owens, T. K., Krishnappa, N., Sachdeva, R., Barrangou, R., Deutschbauer, A. M., ... Doudna, J. A. (2021). Species- and site-specific genome editing in complex bacterial communities. Nature Microbiology, 7(1), 34–47. https://doi.org/10.1038/s41564-021-01014-7

Dear Participants,

Thank you kindly for your insights and your continued active engagement during the second week of discussions.

Week 2 of the Open-Ended Online Forum is now closed.

The online forum remains open for the Week 3 topics. Kindly refer to the ongoing discussions at https://bch.cbd.int/en/portals/risk-assessment/forum/week-3.

Best regards,

The Secretariat

I would like to refer to my contributions on Topic 1 and Topic 2, in particular as topic 2 could be merged with this topic.

An additional point to consider might be the impact of not striving towards sustainable and biodiversity based supportive systems, but rather to resort to means that could undermine other approaches. Thus it could result in an indirect adverse effect.

with best wishes,
Ricarda

I am Nicolas DEFARGE (ENSSER)
1. How does this topic potentially pose challenges to the existing risk assessment frameworks, guidance and methodologies?
The narrow comparators in use in current guidelines, and even more in the pathway to harm approach are not sufficient to the various and continuous genetic modifications generated by a genetic machinery.
Do solutions exist? A broader approach is needed
2. What could be the specific challenges to related to this issue?
3. What are the specific issues concerning this topic?
(i) Is there the potential to cause adverse effects on biodiversity, in particular those that are serious or irreversible, taking into account the urgent need to protect specific aspects of biodiversity, such as an endemic/rare species or a unique habitat or ecosystem, taking into account risks to human health and the value of biological diversity to indigenous peoples and local communities?
YES
(ii) Is there the potential to have an introduction into the environment either deliberately or accidentally?
YES
(iii) Is there the potential to disseminate across national borders?
YES
(iv) Is the LMO already, or are likely to be, commercialized or in use somewhere in the world?
YES
4. Are there existing resources on similar issues that can address this issue or resources that could be adapted to address this need?
NO

Thank you Anita for moderating the session. My name is Josephine Amedu, serving as an Assistant Chief Scientific Officer at the National Biosafety Management Agency, Abuja-Nigeria. I was a member of the AHTEG that developed the additional voluntary guidance materials for Risk Assessment of LMOs containing gene drives that enjoyed wide acceptance at the recent COPMOP11.

I fully support the submissions by Keith Hayes(12411), Yann Devos (12487) and Andrew Roberts (12502), that the document is useful for any gene editing machinery, provided all risk assessments are conducted on a case by case basis.

Efforts should now be tailored to developing strategies for capacity building and training activities on domesticating the Guidance document for Parties' peculiar needs.

Thank you.