2. Living modified animals
Mr Austein McLoughlin,
SCBD#12256
SCBD#12256
منذ عام واحدمنذ عام واحد
Posted on behalf of Ms. Anita Anthonysamy
Welcome to the first week of the Open-Ended Online Forum on Risk Assessment and Risk Management.
My name is Anita Anthonysamy. My educational background is Plant Biotechnology and Public Administration. I have been working with the Department of Biosafety in Malaysia for 15 years. I have participated in risk assessments and risk management conducted in Malaysia. I am the Biosafety Clearing House Focal Point and the FAO GM Foods Platform Focal Point for Malaysia.
I have the honour of being the co-moderator of this forum and I look forward to providing support and guidance to the discussions.
Parties have identified 15 topics in total as being priorities. My Co-moderator and I have worked with the Secretariat to compile the topics in a manner that facilitates our further reflections on the topics. Thus, to organize the forum discussions, we will discuss five topics for the period of a week. As such, I will be moderating the threads on LM animals, LM microorganisms and LMOs containing stacked events during this first week. Under this thread, we will be discussing LM animals.
To complement the information submitted by the Parties, I would like to focus the discussions around the following questions:
1. How does this topic potentially pose challenges to the existing risk assessment frameworks, guidance and methodologies? Do solutions exist?
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?
(ii) Is there the potential to have an introduction into the environment either deliberately or accidentally?
(iii) Is there the potential to disseminate across national borders?
(iv) Is the LMO already, or are likely to be, commercialized or in use somewhere in the world?
4. Are there existing resources on similar issues that can address this issue or resources that could be adapted to address this need?
When providing information and to support the synthesis, kindly indicate which of the questions information is provided for.
Given the volume of topics to be discussed, there will not be the possibility to extend the online forum. So, I kindly invite you to contribute before the close on Monday 28 April 2025 11 a.m. EDT.
I wish you all productive and fruitful discussions.
Anita Anthonysamy
Welcome to the first week of the Open-Ended Online Forum on Risk Assessment and Risk Management.
My name is Anita Anthonysamy. My educational background is Plant Biotechnology and Public Administration. I have been working with the Department of Biosafety in Malaysia for 15 years. I have participated in risk assessments and risk management conducted in Malaysia. I am the Biosafety Clearing House Focal Point and the FAO GM Foods Platform Focal Point for Malaysia.
I have the honour of being the co-moderator of this forum and I look forward to providing support and guidance to the discussions.
Parties have identified 15 topics in total as being priorities. My Co-moderator and I have worked with the Secretariat to compile the topics in a manner that facilitates our further reflections on the topics. Thus, to organize the forum discussions, we will discuss five topics for the period of a week. As such, I will be moderating the threads on LM animals, LM microorganisms and LMOs containing stacked events during this first week. Under this thread, we will be discussing LM animals.
To complement the information submitted by the Parties, I would like to focus the discussions around the following questions:
1. How does this topic potentially pose challenges to the existing risk assessment frameworks, guidance and methodologies? Do solutions exist?
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?
(ii) Is there the potential to have an introduction into the environment either deliberately or accidentally?
(iii) Is there the potential to disseminate across national borders?
(iv) Is the LMO already, or are likely to be, commercialized or in use somewhere in the world?
4. Are there existing resources on similar issues that can address this issue or resources that could be adapted to address this need?
When providing information and to support the synthesis, kindly indicate which of the questions information is provided for.
Given the volume of topics to be discussed, there will not be the possibility to extend the online forum. So, I kindly invite you to contribute before the close on Monday 28 April 2025 11 a.m. EDT.
I wish you all productive and fruitful discussions.
Anita Anthonysamy
Dear Colleagues,
I would like to encourage you to share your thoughts and expertise on the topic of Living Modified (LM) Animals before the first week of our discussions concludes on Monday, 28 April at 11:00 a.m. (Montreal time).
My co-moderator and I are looking forward to your valuable contributions and insights to enrich this important conversation.
Looking forward to engaging discussions!
Anita Anthonysamy
I would like to encourage you to share your thoughts and expertise on the topic of Living Modified (LM) Animals before the first week of our discussions concludes on Monday, 28 April at 11:00 a.m. (Montreal time).
My co-moderator and I are looking forward to your valuable contributions and insights to enrich this important conversation.
Looking forward to engaging discussions!
Anita Anthonysamy
1. How does this topic potentially pose challenges to existing risk assessment frameworks, guidance and methodologies? Do solutions exist?
Living Modified Animals (LMAs) challenge existing risk assessment frameworks because most protocols were designed with plant-based LMOs in mind. Animals especially those genetically engineered for disease resistance, growth enhancement, or environmental tolerance interact more dynamically with ecosystems and other species, making it difficult to model or predict their behavior. Furthermore, existing methodologies often overlook the gender-differentiated impacts and the roles of indigenous peoples and local communities (IPLCs) in animal husbandry and biodiversity stewardship.
Solutions exist in adapting the Cartagena Protocol’s risk assessment tools to include animal-specific parameters (e.g., behavior, reproduction, migration), and integrating participatory and gender-responsive frameworks to ensure inclusive governance.
What could be the specific challenges related to this issue?
• Unpredictable ecological interactions—such as gene flow to wild relatives or altered food chains.
• Ethical and cultural concerns, particularly in IPLC contexts where certain animal species have sacred or livelihood significance.
• Gender disparities since women often manage local breeds and may be disproportionately affected by changes in animal populations or access to traditional livestock.
• Regulatory gaps whereby many national biosafety frameworks ought to make provisions for LMAs.
• Lack of long-term data on ecological and socio-economic impacts.
3. What are the specific issues concerning this topic?
(i) Potential to disseminate across national borders:
Migratory LMAs (e.g., insects, fish, birds) can easily cross borders, challenging biosafety control and requiring regional cooperation for monitoring and regulation.
4. Are there existing resources on similar issues that can address this or be adapted?
Key resources include:
• Cartagena Protocol on Biosafety and its Risk Assessment Guidelines, which can be expanded for animals.
• CBD’s Voluntary Guidance on Risk Assessment and Guidance on Risk Management.
• Gender-responsive biodiversity assessments such as those developed under CBD’s Gender Plan of Action.
Living Modified Animals (LMAs) challenge existing risk assessment frameworks because most protocols were designed with plant-based LMOs in mind. Animals especially those genetically engineered for disease resistance, growth enhancement, or environmental tolerance interact more dynamically with ecosystems and other species, making it difficult to model or predict their behavior. Furthermore, existing methodologies often overlook the gender-differentiated impacts and the roles of indigenous peoples and local communities (IPLCs) in animal husbandry and biodiversity stewardship.
Solutions exist in adapting the Cartagena Protocol’s risk assessment tools to include animal-specific parameters (e.g., behavior, reproduction, migration), and integrating participatory and gender-responsive frameworks to ensure inclusive governance.
What could be the specific challenges related to this issue?
• Unpredictable ecological interactions—such as gene flow to wild relatives or altered food chains.
• Ethical and cultural concerns, particularly in IPLC contexts where certain animal species have sacred or livelihood significance.
• Gender disparities since women often manage local breeds and may be disproportionately affected by changes in animal populations or access to traditional livestock.
• Regulatory gaps whereby many national biosafety frameworks ought to make provisions for LMAs.
• Lack of long-term data on ecological and socio-economic impacts.
3. What are the specific issues concerning this topic?
(i) Potential to disseminate across national borders:
Migratory LMAs (e.g., insects, fish, birds) can easily cross borders, challenging biosafety control and requiring regional cooperation for monitoring and regulation.
4. Are there existing resources on similar issues that can address this or be adapted?
Key resources include:
• Cartagena Protocol on Biosafety and its Risk Assessment Guidelines, which can be expanded for animals.
• CBD’s Voluntary Guidance on Risk Assessment and Guidance on Risk Management.
• Gender-responsive biodiversity assessments such as those developed under CBD’s Gender Plan of Action.
Esteemed colleagues,
In contribution to discussion I would like to comment on question 2:
2. Considering that no specific type of living modified animal is defined, the following specific challenges may be considered:
Biological characteristics such as cell structure, reproductive mechanisms, metabolism, adaptability, among others vary greatly between different species of living modified animals. As a result, the associated risks and their management also differ significantly, making it difficult to establish a single risk assessment framework or study applicable across all living modified animal models.
The available information, both biological and regulatory, also varies between species of living modified animals, leading to an asymmetry in the knowledge available for each species.
Gabriel Mutis
Colombia
In contribution to discussion I would like to comment on question 2:
2. Considering that no specific type of living modified animal is defined, the following specific challenges may be considered:
Biological characteristics such as cell structure, reproductive mechanisms, metabolism, adaptability, among others vary greatly between different species of living modified animals. As a result, the associated risks and their management also differ significantly, making it difficult to establish a single risk assessment framework or study applicable across all living modified animal models.
The available information, both biological and regulatory, also varies between species of living modified animals, leading to an asymmetry in the knowledge available for each species.
Gabriel Mutis
Colombia
In contribution to the discussion on Question 1 and 2
One of the issues I wish to raise for further insights will be- considering some strict laws on animal welfare in some countries, among some of the challenges for existing risk assessment as it relates to LMA may be animal welfare concern. Some animal welfare experts will usually ask- Can gene modifications unintentionally cause suffering to animal- developmental defects, behavioral changes or metabolic disorders? The specific challenge here therefore lies in establishing causal or no-causal link of LMA under trial/research to violation of what animal welfarism may tag as "freedoms of animal welfare" which include freedom from discomfort, pain, fear and ability to express natural behavior.
Among the possible factors to this challenge may be the inadequate or lack of species-specific welfare data due to the novelty in LMA research, seeing LMA as uncommon species in the laboratory settings, thereby providing limited baseline welfare data. With this, it therefore becomes challenging to assess what constitutes "normal" health and cognitive behaviour, detect subtle welfare impairment and establish meaningful welfare benchmarks.
My personal question to arouse further insights will them be- How effective will it be to incorporate and enforce implementable animal welfare concerns into risk assessment protocols ensuring that animal welfare is assessed alongside ecological and health risks during trial.
It therefore calls for a deeper scanning, deeper discussion and analysis of outputs on tailoring welfare assessment protocols for each animal species and context, incorporating behavioral, physiological and environmental indicators.
The good thing in some jurisdiction where animal welfare laws are not strict, is that regulatory frameworks for LMA focusing on environmental and food safety assessment may scale through.
Scanning for resources and information for addressing animal welfare concerns in risk assessment, from countries where LMA containment and trial ongoing may be helpful for decision-making in this regard.
One of the issues I wish to raise for further insights will be- considering some strict laws on animal welfare in some countries, among some of the challenges for existing risk assessment as it relates to LMA may be animal welfare concern. Some animal welfare experts will usually ask- Can gene modifications unintentionally cause suffering to animal- developmental defects, behavioral changes or metabolic disorders? The specific challenge here therefore lies in establishing causal or no-causal link of LMA under trial/research to violation of what animal welfarism may tag as "freedoms of animal welfare" which include freedom from discomfort, pain, fear and ability to express natural behavior.
Among the possible factors to this challenge may be the inadequate or lack of species-specific welfare data due to the novelty in LMA research, seeing LMA as uncommon species in the laboratory settings, thereby providing limited baseline welfare data. With this, it therefore becomes challenging to assess what constitutes "normal" health and cognitive behaviour, detect subtle welfare impairment and establish meaningful welfare benchmarks.
My personal question to arouse further insights will them be- How effective will it be to incorporate and enforce implementable animal welfare concerns into risk assessment protocols ensuring that animal welfare is assessed alongside ecological and health risks during trial.
It therefore calls for a deeper scanning, deeper discussion and analysis of outputs on tailoring welfare assessment protocols for each animal species and context, incorporating behavioral, physiological and environmental indicators.
The good thing in some jurisdiction where animal welfare laws are not strict, is that regulatory frameworks for LMA focusing on environmental and food safety assessment may scale through.
Scanning for resources and information for addressing animal welfare concerns in risk assessment, from countries where LMA containment and trial ongoing may be helpful for decision-making in this regard.
Greetings colleagues
My present intervention is intended to draw attention the range of creatures we call animals (and some that don’t really fit neatly into any of the named groups for this forum). They include a large number of species that perhaps do not always get proportionate attention, but are very important sources of potential LMOs.
In addition to fish, which are a separate topic in this forum, are large animals and birds that are common livestock. Insects also receive considerable attention, but mainly those that are agricultural pests or are vectors for disease in people, eg, mosquitos.
1. Challenges to the existing risk assessment frameworks
A vast array of animals are invertebrates or microscopic. These are not only attractive to modify, they are vulnerable to unintended modification if they are inadvertently exposed during use of modern biotechnology techniques.
Hoepers, A.M. et al. (2024) Predicted Multispecies Unintended Effects from Outdoor Genome Editing. Ecotox Environ Safety 282, 116707.
The possibility of this happening is now imminent because of new techniques (Week Two topic 2) and because some countries are or may deregulate some techniques and allow them to be used outside of containment facilities. Existing frameworks rely upon a prototypical individual (or population) that may be characterised and evaluated prior to release, on a case-by-case basis. Guidance on unintended products of modern biotechnology developed outside of this paradigm is needed.
2. Specific challenges
A specific challenge is the scale of exposure. According to the United Nations Food and Agriculture Organization: “Over 1000 species of invertebrates may be found in a single m2 of forest soils. Many of the world’s terrestrial insect species are soil dwellers for at least some stage of their life-cycle. A single gram of soil may contain millions of individuals and several thousand species of bacteria. A typical, healthy soil might contain several species of vertebrate animals, several species of earthworms, 20-30 species of mites, 50-100 species of insects, tens of species of nematodes, hundreds of species of fungi and perhaps thousands of species of bacteria and actinomycetes.” FAO (2015) Liberation. http://www.fao.org/fileadmin/user_upload/soils-2015/images/EN/WSDPosters_Promotional_Material/En_IYS_food_Print.pdf, (accessed 2 September 2019).
While not technically “animals”, protists are “animal adjacent” and ubiquitous in outside environments and many of these organisms are still to be described. “Toward the end of the last millennium, there was an estimated 4,300 described free‐living ciliate species. In the new millennium, species of free‐living ciliates are being described at an average rate of ~50 per year” Warren, A. et al. (2017) Beyond the “Code": A Guide to the Description and Documentation of Biodiversity in Ciliated Protists (Alveolata, Ciliophora). J Eukaryot Microbiol 64 (4), 539-554..
Populations range from 1000s of protozoans per gram of agricultural soil, to 10s of thousands in prairie soils up to 100s of thousands in forest soils Fortuna, A.-M. (2012) The Soil Biota. Nat Educ. Knowledge 3, 1.
3. Specific issues
Small animals and protists provide critically important ecosystem services. “Heterotrophic microeukaryotes such as ciliates are thought to be of considerable importance in aquatic ecosystems, as they are major predators of bacteria and constitute a nutritional resource for other protozoa, invertebrates, and probably fish larvae. In addition, protozoan bacterivory contributes to enhanced decomposition of leaf detritus—a vital nutrient resource in streams—by increasing turnover of bacterial populations through predation” Dopheide, A. et al. (2009) Relative Diversity and Community Structure of Ciliates in Stream Biofilms According to Molecular and Microscopy Methods. Appl Environ Microbiol 75 (16), 5261-72.
This also allows them to potentially transfer effects up the trophic scale. While I am only aware of demonstrations of trophic effects with use of dsRNA for RNAi effects so far, they are a reasonable model of what might transpire with LMOs that produce biocidal dsRNA or emerging tools for delivery of vectors for spontaneous expression of gene editors and guides.
Zhang, H. et al. (2022) New Insights into Transmission Pathways and Possible Off-Target Effects of Insecticidal Dsrna Released by Treated Plants. Pest Biochem Physiol 188, 105281.
For a variety of reasons, then, I support the previous contributions of Ms. Marangu #12277 and Mr. Mutis Namur #12285 and add to the call for guidance on LMO animals and protists.
My present intervention is intended to draw attention the range of creatures we call animals (and some that don’t really fit neatly into any of the named groups for this forum). They include a large number of species that perhaps do not always get proportionate attention, but are very important sources of potential LMOs.
In addition to fish, which are a separate topic in this forum, are large animals and birds that are common livestock. Insects also receive considerable attention, but mainly those that are agricultural pests or are vectors for disease in people, eg, mosquitos.
1. Challenges to the existing risk assessment frameworks
A vast array of animals are invertebrates or microscopic. These are not only attractive to modify, they are vulnerable to unintended modification if they are inadvertently exposed during use of modern biotechnology techniques.
Hoepers, A.M. et al. (2024) Predicted Multispecies Unintended Effects from Outdoor Genome Editing. Ecotox Environ Safety 282, 116707.
The possibility of this happening is now imminent because of new techniques (Week Two topic 2) and because some countries are or may deregulate some techniques and allow them to be used outside of containment facilities. Existing frameworks rely upon a prototypical individual (or population) that may be characterised and evaluated prior to release, on a case-by-case basis. Guidance on unintended products of modern biotechnology developed outside of this paradigm is needed.
2. Specific challenges
A specific challenge is the scale of exposure. According to the United Nations Food and Agriculture Organization: “Over 1000 species of invertebrates may be found in a single m2 of forest soils. Many of the world’s terrestrial insect species are soil dwellers for at least some stage of their life-cycle. A single gram of soil may contain millions of individuals and several thousand species of bacteria. A typical, healthy soil might contain several species of vertebrate animals, several species of earthworms, 20-30 species of mites, 50-100 species of insects, tens of species of nematodes, hundreds of species of fungi and perhaps thousands of species of bacteria and actinomycetes.” FAO (2015) Liberation. http://www.fao.org/fileadmin/user_upload/soils-2015/images/EN/WSDPosters_Promotional_Material/En_IYS_food_Print.pdf, (accessed 2 September 2019).
While not technically “animals”, protists are “animal adjacent” and ubiquitous in outside environments and many of these organisms are still to be described. “Toward the end of the last millennium, there was an estimated 4,300 described free‐living ciliate species. In the new millennium, species of free‐living ciliates are being described at an average rate of ~50 per year” Warren, A. et al. (2017) Beyond the “Code": A Guide to the Description and Documentation of Biodiversity in Ciliated Protists (Alveolata, Ciliophora). J Eukaryot Microbiol 64 (4), 539-554..
Populations range from 1000s of protozoans per gram of agricultural soil, to 10s of thousands in prairie soils up to 100s of thousands in forest soils Fortuna, A.-M. (2012) The Soil Biota. Nat Educ. Knowledge 3, 1.
3. Specific issues
Small animals and protists provide critically important ecosystem services. “Heterotrophic microeukaryotes such as ciliates are thought to be of considerable importance in aquatic ecosystems, as they are major predators of bacteria and constitute a nutritional resource for other protozoa, invertebrates, and probably fish larvae. In addition, protozoan bacterivory contributes to enhanced decomposition of leaf detritus—a vital nutrient resource in streams—by increasing turnover of bacterial populations through predation” Dopheide, A. et al. (2009) Relative Diversity and Community Structure of Ciliates in Stream Biofilms According to Molecular and Microscopy Methods. Appl Environ Microbiol 75 (16), 5261-72.
This also allows them to potentially transfer effects up the trophic scale. While I am only aware of demonstrations of trophic effects with use of dsRNA for RNAi effects so far, they are a reasonable model of what might transpire with LMOs that produce biocidal dsRNA or emerging tools for delivery of vectors for spontaneous expression of gene editors and guides.
Zhang, H. et al. (2022) New Insights into Transmission Pathways and Possible Off-Target Effects of Insecticidal Dsrna Released by Treated Plants. Pest Biochem Physiol 188, 105281.
For a variety of reasons, then, I support the previous contributions of Ms. Marangu #12277 and Mr. Mutis Namur #12285 and add to the call for guidance on LMO animals and protists.
Dear colleagues, thank you very much for the opportunity to participate in this Forum and to share our experiences. My name is Marvis Suárez Romero, I am a specialist in Regulation, Control, and Safety, and I work for the Office of Environmental Regulation and Safety, Regulatory Authority for GMOs, among other topics. Our office belongs to the Ministry of Science, Technology, and Environment (CITMA) of Cuba.
It has been a great pleasure for me to read the opinions of dear colleagues with whom we have shared work sessions at some point in our lives, and I fully agree with what Gabriel from Colombia, Galina from Belarus, and others have mentioned. Since the online Forum in 2020, we have stated that the existing guidelines for risk assessments of GMOs generally explain how to proceed with a risk analysis that can be used for any species, but adapted to comply with the case-by-case principle outlined in the Cartagena Protocol in its Annex III. However, it is evident that there are still doubts and concerns in many of our countries, especially regarding animals, where there is no history of use as has been the case with crops that have global experiences. The issue of intentional or unintentional releases of species into the environment, with the possibility of losing our rich biodiversity, is always a concern.
I would like to draw attention to aspects that several authors have expressed regarding the behavior and the differences in the containment of terrestrial and aquatic animals, which is why the World Organisation for Animal Health establishes working codes for each group. In my opinion, we could consider developing guidelines with aspects to take into account for terrestrial and aquatic animals. For example, in fish, the containment in production facilities is not the same when they are in the fry stages as when they are close to reaching commercial size, thus alerting on strategic points that can help with better understanding.
All materials to be developed should exemplify each step for better understanding; a good example was the documents prepared by the group of experts on LMOs with gene drives applied to mosquitoes, which were very well received at the last COP in Colombia. It is impossible to create guidelines for every case, but some examples based on the applied technology could help.
Also, on several occasions, the need for training on how to use the guidelines and to consider hazards and estimate risks from the experimental phases, releases, and commercialization of these organisms, taking into account their specific characteristics, has been raised. The formation of multidisciplinary groups is essential, with the involvement of biotechnologists, specialists in different species, and the existence of regulatory biosecurity structures with solid legislation to establish controls and achieve safety. The development of science should not be denied, as long as it is to solve a problem, especially regarding health or food, but the phrase "Biosafety first" must be upheld.
I positively believe that these criteria are applicable to any species, whether they are algae, fish, GMOs with stacked genes, or animals in general.
Thank you very much.
Best wishes to all my colleagues.
It has been a great pleasure for me to read the opinions of dear colleagues with whom we have shared work sessions at some point in our lives, and I fully agree with what Gabriel from Colombia, Galina from Belarus, and others have mentioned. Since the online Forum in 2020, we have stated that the existing guidelines for risk assessments of GMOs generally explain how to proceed with a risk analysis that can be used for any species, but adapted to comply with the case-by-case principle outlined in the Cartagena Protocol in its Annex III. However, it is evident that there are still doubts and concerns in many of our countries, especially regarding animals, where there is no history of use as has been the case with crops that have global experiences. The issue of intentional or unintentional releases of species into the environment, with the possibility of losing our rich biodiversity, is always a concern.
I would like to draw attention to aspects that several authors have expressed regarding the behavior and the differences in the containment of terrestrial and aquatic animals, which is why the World Organisation for Animal Health establishes working codes for each group. In my opinion, we could consider developing guidelines with aspects to take into account for terrestrial and aquatic animals. For example, in fish, the containment in production facilities is not the same when they are in the fry stages as when they are close to reaching commercial size, thus alerting on strategic points that can help with better understanding.
All materials to be developed should exemplify each step for better understanding; a good example was the documents prepared by the group of experts on LMOs with gene drives applied to mosquitoes, which were very well received at the last COP in Colombia. It is impossible to create guidelines for every case, but some examples based on the applied technology could help.
Also, on several occasions, the need for training on how to use the guidelines and to consider hazards and estimate risks from the experimental phases, releases, and commercialization of these organisms, taking into account their specific characteristics, has been raised. The formation of multidisciplinary groups is essential, with the involvement of biotechnologists, specialists in different species, and the existence of regulatory biosecurity structures with solid legislation to establish controls and achieve safety. The development of science should not be denied, as long as it is to solve a problem, especially regarding health or food, but the phrase "Biosafety first" must be upheld.
I positively believe that these criteria are applicable to any species, whether they are algae, fish, GMOs with stacked genes, or animals in general.
Thank you very much.
Best wishes to all my colleagues.
My name is Christoph Then and I am a member of ENSSER (The European Network of Scientists for Social and Environmental Responsibility) and representing Testbiotech (http://www.testbiotch.org) in this discussion.
Before I refer to specific questions, I would like to raise the attention on the recent case of the ‘dire wolf’ and its implications for environmental risk assessment. As you all may know, the US company, Colossal Biosciences, is claiming to have brought back an extinct species of the ‘dire wolf’. This species (Canis dirus) became extinct over 10,000 years ago and is not directly related to the recent grey wolf. Ultimately, however, Colossal has created nothing more than a genetically engineered grey wolf whose genome has been altered at 20 target sites. Among other things, the genetically engineered wolf is larger and has a modified coat.
The Colossal business model is based on bringing extinct animals back to life, e.g. the woolly mammoth or the ‘dire wolf’. In reality, the company only adds new gene variants to the gene pool of existing species (Asian elephants, grey wolves). In result, these animals are ultimately ‘transgenic’, i.e. their genetic material contains characteristics that are foreign to the species. They can be considered as a new generation of transgenic animals that are completely new to the ecosystems.
If the genetically engineered wolves were to escape and mate with their wild counterparts, they could become a threat to the population of grey wolves. The genetically engineered wolves are said to be larger and stronger than their male competitors, and could therefore become dominant in the pack. Their offspring would be hybrids that could also possibly spread rapidly. The business model of resurrecting extinct species would thus endanger existing species. It also should be taken into account that e. g. hybrid offspring of NGT wolves and grey wolves may be able to perform transboundary movements.
In regard to risk assessment of LMOs, this case, as well as many others, show that LMOs that do not inherit additional genes, but e. g. result from just a limited number of changes in the regulation of its endogenous genes (as supposed in the case of the ‘dire wolf’), should undergo detailed risk assessment as foreseen under the Protocol.
Based on this introduction, I shortly try to address the questions. The topic ‘living modified animals’ is unclear, since risks for fish and animals used in agricultural production are handled as separated topics. So maybe, you want us to address other organisms such as insects? But maybe not gene drives? Hereby, I shortly address LMO insects that are meant to spread, mate an propagate in the environment, by taking into account the four questions:
Besides gene drives there are other applications for release into the environment especially of insects, meant to mate and propagate with in the native populations to propagate, for example, genes of infertility (see for example Ant T., et al., 2012; Evans et al., 2019; Kandul et al., 2019)
In our recent report (Testbiotech 2024) we consider these applications ‘outdoor genetic engineering’, which means that the genetic transformation takes place in the environment. The existing applications go beyond cultivated areas into ecosystems with high complexity and vulnerable biodiversity. Furthermore, some of these applications have a high potential for spontaneous transboundary movements and are concerning the protection of biodiversity in various aspects.
Risk assessment of such applications (‘outdoor genetic engineering’) is much more complicated than in previous cases, where the process of transformation was contained to the laboratory. Therefore, specific methodology in risk assessment and measures in risk management are needed, in addition to the specific applications of gene drives. For example, much more data will be needed about the receiving environment than for annual LMO crops that can not persist, spread and propagate in the environment. An other issue is the convergence of SynBIo and Artificial Intelligence (AI) as we notice it in the case of Colossal Biosciences. In addition, in the face of the uncertainties that go along with such LMOs, ‘cut-off’ criteria are needed that allow to reject a application if there are to many unknowns to derive to reliable conclusions (Then et al., 2020).
In our report from end of last year (Testbiotech 2024), we create a broader picture of the upcoming developments, including LMOs of all kingdoms, including animals and ‘outdoor genetic engineering’.
In our most recent report (Testbiotech 2025) we haven been collecting a broad range of LMO vertebrate animals. We identify risks associated with the processes of genome editing in livestock that can result both from the processes (unintended effects) or their intended outcomes (desired traits). This can affect various aspects of including animal protection, animal welfare, animal health, animal breeding, the environment and also risks for consumers. We also mention some cases of LMO animals that entered the market already. In addition we would like to draw the attention to Miklau et al., (2024) which recently provided a review.
Ant T., et al. (2012) Control of the olive fruit fly using genetics-enhanced sterile insect technique. https://doi.Org/10.1186/1741-7007-10-51
Evans B.R., et al. (2019) Transgenic Aedes aegypti Mosquitoes Transfer Genes into a Natural Population. https://doi.org/10.1038/s41598-019-49660-6
Kandul NP, Liu J, Sanchez C HM, Wu SL, Marshall JM, Akbari OS. (2019) Transforming insect population control with precision guided sterile males with demonstration in flies. Nat Commun. 10(1):84. doi: 10.1038/s41467-018-07964-7.
Miklau M, Burn S-J, Eckerstorfer M, Dolezel M, Greiter A, Heissenberger A, Hörtenhuber S,
Zollitsch W and Hagen K (2024), Horizon scanning of potential environmental applications of terrestrial animals, fish, algae and microorganisms produced by genetic modification, including the use of new genomic techniques. Front. Genome Ed. 6:1376927. doi: 10.3389/fgeed.2024.1376927
Testbiotech (2024) What is a mammoth doing on mars? Why we must protect our biosphere from genetic engineering. https://www.testbiotech.org/publikation/what-is-a-mammoth-doing-on-mars/
Testbiotech (2025) Use of new genetic engineering in farmed vertebrates: a critical assessment.
https://www.testbiotech.org/publikation/use-of-new-genetic-engineering-in-farmed-vertebrates-a-critical-assessment/
Then, C. Kawall, K., Valenzuela, N. (2020) Spatio-temporal controllability and environmental risk assessment of genetically engineered gene drive organisms from the perspective of EU GMO Regulation. Integr Environ Assess Manag, 16(5), 555-568. https://doi.org/10.1002/ieam.4278
Before I refer to specific questions, I would like to raise the attention on the recent case of the ‘dire wolf’ and its implications for environmental risk assessment. As you all may know, the US company, Colossal Biosciences, is claiming to have brought back an extinct species of the ‘dire wolf’. This species (Canis dirus) became extinct over 10,000 years ago and is not directly related to the recent grey wolf. Ultimately, however, Colossal has created nothing more than a genetically engineered grey wolf whose genome has been altered at 20 target sites. Among other things, the genetically engineered wolf is larger and has a modified coat.
The Colossal business model is based on bringing extinct animals back to life, e.g. the woolly mammoth or the ‘dire wolf’. In reality, the company only adds new gene variants to the gene pool of existing species (Asian elephants, grey wolves). In result, these animals are ultimately ‘transgenic’, i.e. their genetic material contains characteristics that are foreign to the species. They can be considered as a new generation of transgenic animals that are completely new to the ecosystems.
If the genetically engineered wolves were to escape and mate with their wild counterparts, they could become a threat to the population of grey wolves. The genetically engineered wolves are said to be larger and stronger than their male competitors, and could therefore become dominant in the pack. Their offspring would be hybrids that could also possibly spread rapidly. The business model of resurrecting extinct species would thus endanger existing species. It also should be taken into account that e. g. hybrid offspring of NGT wolves and grey wolves may be able to perform transboundary movements.
In regard to risk assessment of LMOs, this case, as well as many others, show that LMOs that do not inherit additional genes, but e. g. result from just a limited number of changes in the regulation of its endogenous genes (as supposed in the case of the ‘dire wolf’), should undergo detailed risk assessment as foreseen under the Protocol.
Based on this introduction, I shortly try to address the questions. The topic ‘living modified animals’ is unclear, since risks for fish and animals used in agricultural production are handled as separated topics. So maybe, you want us to address other organisms such as insects? But maybe not gene drives? Hereby, I shortly address LMO insects that are meant to spread, mate an propagate in the environment, by taking into account the four questions:
Besides gene drives there are other applications for release into the environment especially of insects, meant to mate and propagate with in the native populations to propagate, for example, genes of infertility (see for example Ant T., et al., 2012; Evans et al., 2019; Kandul et al., 2019)
In our recent report (Testbiotech 2024) we consider these applications ‘outdoor genetic engineering’, which means that the genetic transformation takes place in the environment. The existing applications go beyond cultivated areas into ecosystems with high complexity and vulnerable biodiversity. Furthermore, some of these applications have a high potential for spontaneous transboundary movements and are concerning the protection of biodiversity in various aspects.
Risk assessment of such applications (‘outdoor genetic engineering’) is much more complicated than in previous cases, where the process of transformation was contained to the laboratory. Therefore, specific methodology in risk assessment and measures in risk management are needed, in addition to the specific applications of gene drives. For example, much more data will be needed about the receiving environment than for annual LMO crops that can not persist, spread and propagate in the environment. An other issue is the convergence of SynBIo and Artificial Intelligence (AI) as we notice it in the case of Colossal Biosciences. In addition, in the face of the uncertainties that go along with such LMOs, ‘cut-off’ criteria are needed that allow to reject a application if there are to many unknowns to derive to reliable conclusions (Then et al., 2020).
In our report from end of last year (Testbiotech 2024), we create a broader picture of the upcoming developments, including LMOs of all kingdoms, including animals and ‘outdoor genetic engineering’.
In our most recent report (Testbiotech 2025) we haven been collecting a broad range of LMO vertebrate animals. We identify risks associated with the processes of genome editing in livestock that can result both from the processes (unintended effects) or their intended outcomes (desired traits). This can affect various aspects of including animal protection, animal welfare, animal health, animal breeding, the environment and also risks for consumers. We also mention some cases of LMO animals that entered the market already. In addition we would like to draw the attention to Miklau et al., (2024) which recently provided a review.
Ant T., et al. (2012) Control of the olive fruit fly using genetics-enhanced sterile insect technique. https://doi.Org/10.1186/1741-7007-10-51
Evans B.R., et al. (2019) Transgenic Aedes aegypti Mosquitoes Transfer Genes into a Natural Population. https://doi.org/10.1038/s41598-019-49660-6
Kandul NP, Liu J, Sanchez C HM, Wu SL, Marshall JM, Akbari OS. (2019) Transforming insect population control with precision guided sterile males with demonstration in flies. Nat Commun. 10(1):84. doi: 10.1038/s41467-018-07964-7.
Miklau M, Burn S-J, Eckerstorfer M, Dolezel M, Greiter A, Heissenberger A, Hörtenhuber S,
Zollitsch W and Hagen K (2024), Horizon scanning of potential environmental applications of terrestrial animals, fish, algae and microorganisms produced by genetic modification, including the use of new genomic techniques. Front. Genome Ed. 6:1376927. doi: 10.3389/fgeed.2024.1376927
Testbiotech (2024) What is a mammoth doing on mars? Why we must protect our biosphere from genetic engineering. https://www.testbiotech.org/publikation/what-is-a-mammoth-doing-on-mars/
Testbiotech (2025) Use of new genetic engineering in farmed vertebrates: a critical assessment.
https://www.testbiotech.org/publikation/use-of-new-genetic-engineering-in-farmed-vertebrates-a-critical-assessment/
Then, C. Kawall, K., Valenzuela, N. (2020) Spatio-temporal controllability and environmental risk assessment of genetically engineered gene drive organisms from the perspective of EU GMO Regulation. Integr Environ Assess Manag, 16(5), 555-568. https://doi.org/10.1002/ieam.4278
Dear Esteemed Participants,
Allow me to offer a few reflections and insights that I hope will further enrich this valuable discussion.
1. Challenges to Existing Risk Assessment Frameworks
Current biosafety frameworks face significant limitations in assessing LM animals due to their fundamental biological differences from plants and microbes. Traditional risk assessment models under the Cartagena Protocol and national GMO regulations were primarily designed for stationary organisms, failing to account for animal mobility, complex behaviors, and long-life cycles. The introduction of traits like disease resistance or reproductive manipulation in animals creates unpredictable ecological interactions that existing methodologies cannot adequately address. Furthermore, ethical considerations surrounding animal welfare remain underdeveloped in current frameworks, despite being crucial for public acceptance and regulatory decisions.
Emerging solutions include the development of animal-specific guidance through the Cartagena Protocol's AHTEG, which recommends incorporating evolutionary ecology and gene flow modeling into assessments (CBD/SBSTTA/24/5). Adaptive approaches such as phased releases and confined field trials are being proposed for high-risk applications like gene drives, while new monitoring technologies like environmental DNA tracking offer improved surveillance capabilities.
2. Specific Challenges of LM Animals
The ecological risks posed by LM animals are multifaceted and potentially severe. These include:
• Gene Flow to Wild Populations: LM animals may interbreed with wild relatives, leading to introgression of modified genes, potentially affecting natural populations' fitness or survival.
• Disruption of Ecosystem Dynamics: Introduction of LM animals could affect predator-prey relationships, food webs, or ecosystem services.
• Socioeconomic and Cultural Impacts: LM animals could impact traditional farming, fisheries, and livelihoods of indigenous and local communities, particularly if they displace native species or local breeds valued for cultural reasons.
• Regulatory Uncertainty: Many countries lack clear regulatory categories for LM animals (particularly synthetic biology animals, such as gene-edited livestock).
• Animal Welfare and Ethical Concerns: Traits engineered into animals (e.g., disease resistance, growth acceleration) may inadvertently cause pain, distress, or unintended health issues in the animals themselves.
3. Critical Issues in LM Animal Applications
The biodiversity impacts of LM animals could be profound and irreversible. Modified species may outcompete or genetically swamp endemic populations, particularly in sensitive ecosystems. The case of AquAdvantage Salmon demonstrates these concerns, where escapees could threaten wild Atlantic salmon populations already under conservation pressure. Such scenarios raise important questions about protecting the rights and resources of indigenous communities whose cultural practices depend on native species.
Both deliberate and accidental environmental releases present significant risks. While planned releases for biocontrol (e.g., GM mosquitoes) undergo some scrutiny, containment failures in research or production facilities remain a worrying possibility. The cross-border mobility of many animal species creates international governance challenges, as seen in debates over jurisdiction for gene drive organisms.
Commercialization of LM animals is advancing despite these uncertainties. Gene-edited livestock for disease resistance are nearing market readiness. These developments outpace the establishment of robust international standards, creating a patchwork of national regulations with varying rigor.
4. Available Resources and Adaptation Needs
Specialized guidance is currently lacking. The OECD's work on novel traits in livestock provides some valuable risk assessment methodologies that could be relevant.
Moving forward, several key adaptations are needed:
1) Development of standardized ecological risk assessment protocols for LM animals
2) Enhanced international cooperation on monitoring and containment
3) Integration of Indigenous knowledge and ethical frameworks into decision-making
4) Establishment of global registries for LM animal research and releases
Conclusion
The emergence of LM animals presents significant biosafety challenges that current frameworks are unprepared to address comprehensively. Their unique biological characteristics, potential for ecosystem disruption, and ethical implications demand urgent development of specialized assessment methodologies. A precautionary approach combining robust science, adaptive governance, and inclusive stakeholder engagement will be essential to harness benefits while minimizing risks. International cooperation through existing agreements like the Cartagena Protocol must be strengthened to address the transboundary nature of these challenges.
Useful References
Browning, H. & Veit, W. (2022). "The welfare of farmed animals with genetic modifications." Nature Food, 3(10), 805-810.
- Esvelt, K.M. & Gemmell, N.J. (2017). "Conservation demands safe gene drive." PLOS Biology, 15(11), -e2003850.
- López-Delgado, J. et al. (2023). "Ecological impacts of genetically modified terrestrial species." Trends in Biotechnology, 41(3), 324-337.
- NASEM (2016). Gene Drives on the Horizon. National Academies Press.
- OECD (2022). Biotechnology in Livestock: Novel Traits and Risk Assessment.
- Thomsen, P.F. & Willerslev, E. (2015). "Environmental DNA - An emerging tool in conservation." Biological Conservation, 183, 4-18.
- UNEP (2021). Indigenous Peoples and Synthetic Biology.
- WHO (2021). Framework for Biological Containment of Modified Organisms.
Ossama AbdelKawy
Egypt National Focal Point of the Cartagena Protocol
Microbiology and Biotechnology Professor, British University in Egypt
Research Professor, Egyptian Atomic Energy Authority
Science Advisor, Egyptian Ministry of Environment
Allow me to offer a few reflections and insights that I hope will further enrich this valuable discussion.
1. Challenges to Existing Risk Assessment Frameworks
Current biosafety frameworks face significant limitations in assessing LM animals due to their fundamental biological differences from plants and microbes. Traditional risk assessment models under the Cartagena Protocol and national GMO regulations were primarily designed for stationary organisms, failing to account for animal mobility, complex behaviors, and long-life cycles. The introduction of traits like disease resistance or reproductive manipulation in animals creates unpredictable ecological interactions that existing methodologies cannot adequately address. Furthermore, ethical considerations surrounding animal welfare remain underdeveloped in current frameworks, despite being crucial for public acceptance and regulatory decisions.
Emerging solutions include the development of animal-specific guidance through the Cartagena Protocol's AHTEG, which recommends incorporating evolutionary ecology and gene flow modeling into assessments (CBD/SBSTTA/24/5). Adaptive approaches such as phased releases and confined field trials are being proposed for high-risk applications like gene drives, while new monitoring technologies like environmental DNA tracking offer improved surveillance capabilities.
2. Specific Challenges of LM Animals
The ecological risks posed by LM animals are multifaceted and potentially severe. These include:
• Gene Flow to Wild Populations: LM animals may interbreed with wild relatives, leading to introgression of modified genes, potentially affecting natural populations' fitness or survival.
• Disruption of Ecosystem Dynamics: Introduction of LM animals could affect predator-prey relationships, food webs, or ecosystem services.
• Socioeconomic and Cultural Impacts: LM animals could impact traditional farming, fisheries, and livelihoods of indigenous and local communities, particularly if they displace native species or local breeds valued for cultural reasons.
• Regulatory Uncertainty: Many countries lack clear regulatory categories for LM animals (particularly synthetic biology animals, such as gene-edited livestock).
• Animal Welfare and Ethical Concerns: Traits engineered into animals (e.g., disease resistance, growth acceleration) may inadvertently cause pain, distress, or unintended health issues in the animals themselves.
3. Critical Issues in LM Animal Applications
The biodiversity impacts of LM animals could be profound and irreversible. Modified species may outcompete or genetically swamp endemic populations, particularly in sensitive ecosystems. The case of AquAdvantage Salmon demonstrates these concerns, where escapees could threaten wild Atlantic salmon populations already under conservation pressure. Such scenarios raise important questions about protecting the rights and resources of indigenous communities whose cultural practices depend on native species.
Both deliberate and accidental environmental releases present significant risks. While planned releases for biocontrol (e.g., GM mosquitoes) undergo some scrutiny, containment failures in research or production facilities remain a worrying possibility. The cross-border mobility of many animal species creates international governance challenges, as seen in debates over jurisdiction for gene drive organisms.
Commercialization of LM animals is advancing despite these uncertainties. Gene-edited livestock for disease resistance are nearing market readiness. These developments outpace the establishment of robust international standards, creating a patchwork of national regulations with varying rigor.
4. Available Resources and Adaptation Needs
Specialized guidance is currently lacking. The OECD's work on novel traits in livestock provides some valuable risk assessment methodologies that could be relevant.
Moving forward, several key adaptations are needed:
1) Development of standardized ecological risk assessment protocols for LM animals
2) Enhanced international cooperation on monitoring and containment
3) Integration of Indigenous knowledge and ethical frameworks into decision-making
4) Establishment of global registries for LM animal research and releases
Conclusion
The emergence of LM animals presents significant biosafety challenges that current frameworks are unprepared to address comprehensively. Their unique biological characteristics, potential for ecosystem disruption, and ethical implications demand urgent development of specialized assessment methodologies. A precautionary approach combining robust science, adaptive governance, and inclusive stakeholder engagement will be essential to harness benefits while minimizing risks. International cooperation through existing agreements like the Cartagena Protocol must be strengthened to address the transboundary nature of these challenges.
Useful References
Browning, H. & Veit, W. (2022). "The welfare of farmed animals with genetic modifications." Nature Food, 3(10), 805-810.
- Esvelt, K.M. & Gemmell, N.J. (2017). "Conservation demands safe gene drive." PLOS Biology, 15(11), -e2003850.
- López-Delgado, J. et al. (2023). "Ecological impacts of genetically modified terrestrial species." Trends in Biotechnology, 41(3), 324-337.
- NASEM (2016). Gene Drives on the Horizon. National Academies Press.
- OECD (2022). Biotechnology in Livestock: Novel Traits and Risk Assessment.
- Thomsen, P.F. & Willerslev, E. (2015). "Environmental DNA - An emerging tool in conservation." Biological Conservation, 183, 4-18.
- UNEP (2021). Indigenous Peoples and Synthetic Biology.
- WHO (2021). Framework for Biological Containment of Modified Organisms.
Ossama AbdelKawy
Egypt National Focal Point of the Cartagena Protocol
Microbiology and Biotechnology Professor, British University in Egypt
Research Professor, Egyptian Atomic Energy Authority
Science Advisor, Egyptian Ministry of Environment
Dear colleagues,
I coincide with comments #12285 #12292, regarding the issue on determining the concept of “animal” and boundaries for the discussion.
Since current risk assessment protocols were originally designed for GM plants, there is a knowledge gap and in consequence, great challenges for updating the current risk assessment frameworks.
I would like to point some topics that should be considered while updating the risk assessment guidance and methodologies for LM animals:
“Animals” are complex organisms, with complex ecological functions and behaviors (migration, breeding with wild relatives, change in behavior patterns according to seasons of the year, etc). It has been documented that one of the possible causes of the recent pandemics (SARS-CoV2) and other epidemics, was the continued loss of natural ecosystems in which species inhabit. Para domestic species could be part of the chain that ignited the zoonotic spillage to humans through domesticated farm animals.
The risk assessment guidance update should take in consideration that LM animals for industrial porpoises could be genetically homogeneous and since there is no previous history of safe use of LM animals, there is no evidence of the behavior of the genetic, epigenetic, proteomic, and metabolomic landscape of the industrial LM animals. In the plausible case of a zoonotic spillage, the potential viral clade could provoke effects on industrial LM animals that could derive in risks to human health and to the environment.
Additionally, beyond the technical, medical difficulties, there are relevant ethical and medical concerns regarding the use of LM animals for xenotransplants of human organs. For this topics there are no a previous frameworks of risk assessment, nor biosafety governance.
Below, some references accounting the research on the effect of viral infection to the expression of genes, proteins and metabolism in farm animals.
Transcriptome profiling in swine macrophages infected with African swine fever virus at single-cell resolution https://doi.org/10.1073/pnas.220128811
Mechanism of interaction between virus and host is inferred from the changes of gene expression in macrophages infected with African swine fever virus CN/GS/2018 strain https://doi.org/10.1186/s12985-021-01637-6
Temporal Proteome and Lipidome Profiles Reveal Hepatitis C Virus-Associated Reprogramming of Hepatocellular Metabolism and Bioenergetics https://doi.org/10.1371/journal.ppat.1000719
SARS-CoV-2 viremia is associated with distinct proteomic pathways and predicts COVID-19 outcomes 10.1172/JCI148635
Update on Proteomic approaches to uncovering virus-induced protein alterations and virus –host protein interactions during the progression of viral infection https://doi.org/10.1080/14789450.2020.1821656
Differential proteome response to H5N1 highly pathogenic avian influenza (HPAI) viruses infection in duck https://doi.org/10.3389/fimmu.2022.965454
The Effects of Swine Coronaviruses on ER Stress, Autophagy, Apoptosis, and Alterations in Cell Morphology https://doi.org/10.3390/pathogens11080940
Genomic Divergence Characterization and Quantitative Proteomics Exploration of Type 4 Porcine Astrovirus https://doi.org/10.3390/v14071383
Here some literature on the xenotransplantation issue:
The Dilemma of Ethical Recipients of Xenotransplantation under the Biopsychosocialmedical Model. 0.23977/phpm.2024.040116
Animal engineering for xenotransplantation. DOI: 10.57603/EJT-307
Ethical and Societal Issues Occasioned by Xenotransplantation. https://doi.org/10.3390/ani10091695
Genetically Modified Porcine-to-Human Cardiac Xenotransplantation DOI: 10.1056/NEJMoa2201422
Pig organs in humans: a forum on xenotransplantation https://doi.org/10.1093/nsr/nwae208
I coincide with comments #12285 #12292, regarding the issue on determining the concept of “animal” and boundaries for the discussion.
Since current risk assessment protocols were originally designed for GM plants, there is a knowledge gap and in consequence, great challenges for updating the current risk assessment frameworks.
I would like to point some topics that should be considered while updating the risk assessment guidance and methodologies for LM animals:
“Animals” are complex organisms, with complex ecological functions and behaviors (migration, breeding with wild relatives, change in behavior patterns according to seasons of the year, etc). It has been documented that one of the possible causes of the recent pandemics (SARS-CoV2) and other epidemics, was the continued loss of natural ecosystems in which species inhabit. Para domestic species could be part of the chain that ignited the zoonotic spillage to humans through domesticated farm animals.
The risk assessment guidance update should take in consideration that LM animals for industrial porpoises could be genetically homogeneous and since there is no previous history of safe use of LM animals, there is no evidence of the behavior of the genetic, epigenetic, proteomic, and metabolomic landscape of the industrial LM animals. In the plausible case of a zoonotic spillage, the potential viral clade could provoke effects on industrial LM animals that could derive in risks to human health and to the environment.
Additionally, beyond the technical, medical difficulties, there are relevant ethical and medical concerns regarding the use of LM animals for xenotransplants of human organs. For this topics there are no a previous frameworks of risk assessment, nor biosafety governance.
Below, some references accounting the research on the effect of viral infection to the expression of genes, proteins and metabolism in farm animals.
Transcriptome profiling in swine macrophages infected with African swine fever virus at single-cell resolution https://doi.org/10.1073/pnas.220128811
Mechanism of interaction between virus and host is inferred from the changes of gene expression in macrophages infected with African swine fever virus CN/GS/2018 strain https://doi.org/10.1186/s12985-021-01637-6
Temporal Proteome and Lipidome Profiles Reveal Hepatitis C Virus-Associated Reprogramming of Hepatocellular Metabolism and Bioenergetics https://doi.org/10.1371/journal.ppat.1000719
SARS-CoV-2 viremia is associated with distinct proteomic pathways and predicts COVID-19 outcomes 10.1172/JCI148635
Update on Proteomic approaches to uncovering virus-induced protein alterations and virus –host protein interactions during the progression of viral infection https://doi.org/10.1080/14789450.2020.1821656
Differential proteome response to H5N1 highly pathogenic avian influenza (HPAI) viruses infection in duck https://doi.org/10.3389/fimmu.2022.965454
The Effects of Swine Coronaviruses on ER Stress, Autophagy, Apoptosis, and Alterations in Cell Morphology https://doi.org/10.3390/pathogens11080940
Genomic Divergence Characterization and Quantitative Proteomics Exploration of Type 4 Porcine Astrovirus https://doi.org/10.3390/v14071383
Here some literature on the xenotransplantation issue:
The Dilemma of Ethical Recipients of Xenotransplantation under the Biopsychosocialmedical Model. 0.23977/phpm.2024.040116
Animal engineering for xenotransplantation. DOI: 10.57603/EJT-307
Ethical and Societal Issues Occasioned by Xenotransplantation. https://doi.org/10.3390/ani10091695
Genetically Modified Porcine-to-Human Cardiac Xenotransplantation DOI: 10.1056/NEJMoa2201422
Pig organs in humans: a forum on xenotransplantation https://doi.org/10.1093/nsr/nwae208
Dear colleagues,
I coincide with comments #12285 #12292, regarding the issue on determining the concept of “animal” and boundaries for the discussion.
Since current risk assessment protocols were originally designed for GM plants, there is a knowledge gap and in consequence, great challenges for updating the current risk assessment frameworks.
I would like to point some topics that should be considered while updating the risk assessment guidance and methodologies for LM animals:
“Animals” are complex organisms, with complex ecological functions and behaviors (migration, breeding with wild relatives, change in behavior patterns according to seasons of the year, etc). It has been documented that one of the possible causes of the recent pandemics (SARS-CoV2) and other epidemics, was the continued loss of natural ecosystems in which species inhabit. Para domestic species could be part of the chain that ignited the zoonotic spillage to humans through domesticated farm animals.
The risk assessment guidance update should take in consideration that LM animals for industrial porpoises could be genetically homogeneous and since there is no previous history of safe use of LM animals, there is no evidence of the behavior of the genetic, epigenetic, proteomic, and metabolomic landscape of the industrial LM animals. In the plausible case of a zoonotic spillage, the potential viral clade could provoke effects on industrial LM animals that could derive in risks to human health and to the environment.
Additionally, beyond the technical, medical difficulties, there are relevant ethical and medical concerns regarding the use of LM animals for xenotransplants of human organs. For this topics there are no a previous frameworks of risk assessment, nor biosafety governance.
Below, some references accounting the research on the effect of viral infection to the expression of genes, proteins and metabolism in farm animals.
Transcriptome profiling in swine macrophages infected with African swine fever virus at single-cell resolution https://doi.org/10.1073/pnas.220128811
Mechanism of interaction between virus and host is inferred from the changes of gene expression in macrophages infected with African swine fever virus CN/GS/2018 strain https://doi.org/10.1186/s12985-021-01637-6
Temporal Proteome and Lipidome Profiles Reveal Hepatitis C Virus-Associated Reprogramming of Hepatocellular Metabolism and Bioenergetics https://doi.org/10.1371/journal.ppat.1000719
SARS-CoV-2 viremia is associated with distinct proteomic pathways and predicts COVID-19 outcomes 10.1172/JCI148635
Update on Proteomic approaches to uncovering virus-induced protein alterations and virus –host protein interactions during the progression of viral infection https://doi.org/10.1080/14789450.2020.1821656
Differential proteome response to H5N1 highly pathogenic avian influenza (HPAI) viruses infection in duck https://doi.org/10.3389/fimmu.2022.965454
The Effects of Swine Coronaviruses on ER Stress, Autophagy, Apoptosis, and Alterations in Cell Morphology https://doi.org/10.3390/pathogens11080940
Genomic Divergence Characterization and Quantitative Proteomics Exploration of Type 4 Porcine Astrovirus https://doi.org/10.3390/v14071383
Here some literature on the xenotransplantation issue:
The Dilemma of Ethical Recipients of Xenotransplantation under the Biopsychosocialmedical Model. 0.23977/phpm.2024.040116
Animal engineering for xenotransplantation. DOI: 10.57603/EJT-307
Ethical and Societal Issues Occasioned by Xenotransplantation. https://doi.org/10.3390/ani10091695
Genetically Modified Porcine-to-Human Cardiac Xenotransplantation DOI: 10.1056/NEJMoa2201422
Pig organs in humans: a forum on xenotransplantation https://doi.org/10.1093/nsr/nwae208
I coincide with comments #12285 #12292, regarding the issue on determining the concept of “animal” and boundaries for the discussion.
Since current risk assessment protocols were originally designed for GM plants, there is a knowledge gap and in consequence, great challenges for updating the current risk assessment frameworks.
I would like to point some topics that should be considered while updating the risk assessment guidance and methodologies for LM animals:
“Animals” are complex organisms, with complex ecological functions and behaviors (migration, breeding with wild relatives, change in behavior patterns according to seasons of the year, etc). It has been documented that one of the possible causes of the recent pandemics (SARS-CoV2) and other epidemics, was the continued loss of natural ecosystems in which species inhabit. Para domestic species could be part of the chain that ignited the zoonotic spillage to humans through domesticated farm animals.
The risk assessment guidance update should take in consideration that LM animals for industrial porpoises could be genetically homogeneous and since there is no previous history of safe use of LM animals, there is no evidence of the behavior of the genetic, epigenetic, proteomic, and metabolomic landscape of the industrial LM animals. In the plausible case of a zoonotic spillage, the potential viral clade could provoke effects on industrial LM animals that could derive in risks to human health and to the environment.
Additionally, beyond the technical, medical difficulties, there are relevant ethical and medical concerns regarding the use of LM animals for xenotransplants of human organs. For this topics there are no a previous frameworks of risk assessment, nor biosafety governance.
Below, some references accounting the research on the effect of viral infection to the expression of genes, proteins and metabolism in farm animals.
Transcriptome profiling in swine macrophages infected with African swine fever virus at single-cell resolution https://doi.org/10.1073/pnas.220128811
Mechanism of interaction between virus and host is inferred from the changes of gene expression in macrophages infected with African swine fever virus CN/GS/2018 strain https://doi.org/10.1186/s12985-021-01637-6
Temporal Proteome and Lipidome Profiles Reveal Hepatitis C Virus-Associated Reprogramming of Hepatocellular Metabolism and Bioenergetics https://doi.org/10.1371/journal.ppat.1000719
SARS-CoV-2 viremia is associated with distinct proteomic pathways and predicts COVID-19 outcomes 10.1172/JCI148635
Update on Proteomic approaches to uncovering virus-induced protein alterations and virus –host protein interactions during the progression of viral infection https://doi.org/10.1080/14789450.2020.1821656
Differential proteome response to H5N1 highly pathogenic avian influenza (HPAI) viruses infection in duck https://doi.org/10.3389/fimmu.2022.965454
The Effects of Swine Coronaviruses on ER Stress, Autophagy, Apoptosis, and Alterations in Cell Morphology https://doi.org/10.3390/pathogens11080940
Genomic Divergence Characterization and Quantitative Proteomics Exploration of Type 4 Porcine Astrovirus https://doi.org/10.3390/v14071383
Here some literature on the xenotransplantation issue:
The Dilemma of Ethical Recipients of Xenotransplantation under the Biopsychosocialmedical Model. 0.23977/phpm.2024.040116
Animal engineering for xenotransplantation. DOI: 10.57603/EJT-307
Ethical and Societal Issues Occasioned by Xenotransplantation. https://doi.org/10.3390/ani10091695
Genetically Modified Porcine-to-Human Cardiac Xenotransplantation DOI: 10.1056/NEJMoa2201422
Pig organs in humans: a forum on xenotransplantation https://doi.org/10.1093/nsr/nwae208
Dear Colleagues,
Thank you for sharing your views and providing information on this topic. I look forward to contributing to the discussion.
On question 1.
I support #12285, #12292, #12321, #12329: indeed, LM animal is a very broad terminology that include vertebrate and invertebrate; mammals, birds, reptiles and insects; differences can be listed also for the reproductive time cycles (e.g.: cattle vs fish or insects) and mobile capability (sheep vs birds or fish or insects). For these reasons, and the other listed by previous comments, it would be extremely challenging to apply the existing risk assessment frameworks, guidance and methodologies. The existing frameworks, guidance and methodologies may doesn’t allow to correctly assess the latest developments in fields of biotechnologies; furthermore, most of them are not focused on environmental aspects.
Nevertheless, in my opinion, some of the approaches proposed in existing guidance could be applied (e.g. problem formulation, case by case and step wise approach).
The followings comments are mainly focused on LM mammals and birds.
On question 2.
- The mobile capability of animals, in particular of those animals like birds and insects, would increase the potential to have an introduction into the environment either deliberately or accidentally, together with a higher potential for an unintended transboundary movement.
- Unintended epigenetic modifications: In mammals, genetic modifications can either be introduced into a zygote-stage embryo or into somatic cells in culture followed by transfer of the modified diploid nucleus into an enucleated oocyte using the process of somatic cell nuclear transfer. In both technologies, the resultant embryos are then transferred into recipient dams to generate a live-born animal. Each approach requires the use of assisted reproductive technologies (e.g. generation of preimplantation embryos, artificial activation of embryo development, in vitro culture of embryos) that can produce unintended epigenetic modifications irrespective of the genetic alterations brought about by the genetic modification itself (De Waal, E., W. Mak, S. Calhoun, P. Stein, T. Ord, C. Krapp, C. Coutifaris, R.M. Schultz, and M.S. Bartolomei. 2014. In vitro culture increases the frequency of stochastic epigenetic errors at imprinted genes in placental tissues from mouse concepti produced through assisted reproductive technologies. Biology of Reproduction - 90(2):22 DOI: 10.1095/biolreprod.113.114785 and De Waal, E., L.A. Vrooman, E. Fischer, T. Ord, M.A. Mainigi, C. Coutifaris, R.M. Schultz, and M.S. Bartolomei. 2015. The cumulative effect of assisted reproduction procedures on placental development and epigenetic perturbations in a mouse model. Human Molecular Genetics 24(24):6975-6985.) doi: 10.1093/hmg/ddv400.). The potential unintended epigenetic modifications shall be considered during ERA. Methods to identify them and the related potential effects shall be further developed.
- Lack of standardized detection methods for unintended alterations:
For LM mammals various off-target detection methods are currently available, yet each has its own strengths and weaknesses (e.g., complex protocols, applicability across different cell types, associated costs, sensitivity, requirement of suitable controls, bias). Further empirical research is needed to benchmark and refine current
methods for genome sequencing and bioinformatic detection of unintended alterations. (National Academies of Sciences, Engineering, and Medicine. 2025. Heritable Genetic Modification in Food Animals. Washington, DC: The National Academies Press. https://doi.org/10.17226/27750)
On question 3(i)
A specific potential risk of disease-resistant LM livestock is the potential evolution of pathogens in both animal and human populations (Looi, F.Y., M.L. Baker, T. Townson, M. Richard, B. Novak, T.J. Doran, and K.R. Short. 2018. Creating disease resistant chickens: A viable solution to avian influenza? Viruses 10:561. https://doi.org/10.3390/v10100561). During ERA the hypothesis that pathogens might adapt to overcome resistance, potentially increasing their ability to infect new hosts, including wildlife and humans, or evade treatments should be analysed. Monitoring activities that combine disease surveillance in LM animals with wildlife monitoring to track pathogen changes and mitigate risks should be suggested (Gao, G.F. 2018. From “A”IV to “Z”IKV: Attacks from emerging and re-emerging pathogens. Cell 172(6):1157-1159, DOI: 10.1016/j.cell.2018.02.025; National Academies of Sciences, Engineering, and Medicine. 2025. Heritable Genetic Modification in Food Animals. Washington, DC: The National Academies Press. https://doi.org/10.17226/27750).
On question 3 (ii)
- To assess this issue the characteristics of the LM animal, considering also the associated management of the production systems, together with accessible ecosystem(s) (e.g. marine, fresh water, cultivated agricultural habitats, natural and semi-natural habitats, rural and urban areas) should be assessed in order to identify potential environmental exposure pathways.
Thank you for sharing your views and providing information on this topic. I look forward to contributing to the discussion.
On question 1.
I support #12285, #12292, #12321, #12329: indeed, LM animal is a very broad terminology that include vertebrate and invertebrate; mammals, birds, reptiles and insects; differences can be listed also for the reproductive time cycles (e.g.: cattle vs fish or insects) and mobile capability (sheep vs birds or fish or insects). For these reasons, and the other listed by previous comments, it would be extremely challenging to apply the existing risk assessment frameworks, guidance and methodologies. The existing frameworks, guidance and methodologies may doesn’t allow to correctly assess the latest developments in fields of biotechnologies; furthermore, most of them are not focused on environmental aspects.
Nevertheless, in my opinion, some of the approaches proposed in existing guidance could be applied (e.g. problem formulation, case by case and step wise approach).
The followings comments are mainly focused on LM mammals and birds.
On question 2.
- The mobile capability of animals, in particular of those animals like birds and insects, would increase the potential to have an introduction into the environment either deliberately or accidentally, together with a higher potential for an unintended transboundary movement.
- Unintended epigenetic modifications: In mammals, genetic modifications can either be introduced into a zygote-stage embryo or into somatic cells in culture followed by transfer of the modified diploid nucleus into an enucleated oocyte using the process of somatic cell nuclear transfer. In both technologies, the resultant embryos are then transferred into recipient dams to generate a live-born animal. Each approach requires the use of assisted reproductive technologies (e.g. generation of preimplantation embryos, artificial activation of embryo development, in vitro culture of embryos) that can produce unintended epigenetic modifications irrespective of the genetic alterations brought about by the genetic modification itself (De Waal, E., W. Mak, S. Calhoun, P. Stein, T. Ord, C. Krapp, C. Coutifaris, R.M. Schultz, and M.S. Bartolomei. 2014. In vitro culture increases the frequency of stochastic epigenetic errors at imprinted genes in placental tissues from mouse concepti produced through assisted reproductive technologies. Biology of Reproduction - 90(2):22 DOI: 10.1095/biolreprod.113.114785 and De Waal, E., L.A. Vrooman, E. Fischer, T. Ord, M.A. Mainigi, C. Coutifaris, R.M. Schultz, and M.S. Bartolomei. 2015. The cumulative effect of assisted reproduction procedures on placental development and epigenetic perturbations in a mouse model. Human Molecular Genetics 24(24):6975-6985.) doi: 10.1093/hmg/ddv400.). The potential unintended epigenetic modifications shall be considered during ERA. Methods to identify them and the related potential effects shall be further developed.
- Lack of standardized detection methods for unintended alterations:
For LM mammals various off-target detection methods are currently available, yet each has its own strengths and weaknesses (e.g., complex protocols, applicability across different cell types, associated costs, sensitivity, requirement of suitable controls, bias). Further empirical research is needed to benchmark and refine current
methods for genome sequencing and bioinformatic detection of unintended alterations. (National Academies of Sciences, Engineering, and Medicine. 2025. Heritable Genetic Modification in Food Animals. Washington, DC: The National Academies Press. https://doi.org/10.17226/27750)
On question 3(i)
A specific potential risk of disease-resistant LM livestock is the potential evolution of pathogens in both animal and human populations (Looi, F.Y., M.L. Baker, T. Townson, M. Richard, B. Novak, T.J. Doran, and K.R. Short. 2018. Creating disease resistant chickens: A viable solution to avian influenza? Viruses 10:561. https://doi.org/10.3390/v10100561). During ERA the hypothesis that pathogens might adapt to overcome resistance, potentially increasing their ability to infect new hosts, including wildlife and humans, or evade treatments should be analysed. Monitoring activities that combine disease surveillance in LM animals with wildlife monitoring to track pathogen changes and mitigate risks should be suggested (Gao, G.F. 2018. From “A”IV to “Z”IKV: Attacks from emerging and re-emerging pathogens. Cell 172(6):1157-1159, DOI: 10.1016/j.cell.2018.02.025; National Academies of Sciences, Engineering, and Medicine. 2025. Heritable Genetic Modification in Food Animals. Washington, DC: The National Academies Press. https://doi.org/10.17226/27750).
On question 3 (ii)
- To assess this issue the characteristics of the LM animal, considering also the associated management of the production systems, together with accessible ecosystem(s) (e.g. marine, fresh water, cultivated agricultural habitats, natural and semi-natural habitats, rural and urban areas) should be assessed in order to identify potential environmental exposure pathways.
Good day!
Contributing to Question 1 & 2:
Applications of biotechnology to animals build upon age-old animal breeding practices aimed towards genetic gains such as improved yield, agricultural sustainability, or animal welfare.
Risk assessment of living modified animals as compared to that of other living modified organisms maybe similar in some aspects, but very different in others. Environmental risk assessment and management is one of the aspects that would require a different approach. It’s important for example, to consider the fact that animals move and therefore their interactions with the environment are more dynamic.
Given that plants were the first living modified organisms to be approved and widely used, the risk assessment frameworks for most nations were designed with plants in mind. Most of the proposed containment or confinement measures, packaging and transportation methods are suitable for plants but not applicable to animals.
There’s also the question of animal welfare and ethical considerations. While it’s ok to accept unfavourable results such as developmental defects arising from genetic modifications in plants, because these would simply be selected out, such wouldn’t be so easily acceptable with animals. The question of causing unnecessary suffering to the living modified animals would have to be considered. How this animal welfare question integrates into the existing risk assessment framework is unclear.
Contributing to Question 3 & 4:
The potential to cause adverse effects on biodiversity would to a large extend depend on the species in question, so does the potential to disseminate across national borders. The potential for these risks increases with gene drive insects which can easily move across borders, mate and reproduce undetected. Accidental introduction into the environment, or moving across borders undetected is less of a risk with higher LMAs, and even less when it comes to livestock that require human intervention to thrive.
Many countries have biotechnology regulatory systems in place that cover animals. Most of these countries have laws and the processes were developed to regulate the products of genetic engineering, i.e., to regulate the incorporation of rDNA or transgenes into plants, animals, and other organisms. Some countries have experience making regulatory decisions for animals under these systems. Below are some resources with information on living modified animals that have been, or are likely to be commercialized; and best practices for regulation and oversight of genetically modified animals.
• https://www.isaaa.org/kc/proceedings/animalbiotechnology/default.asp
• https://www.isaaa.org/kc/proceedings/fish-shellfish/default.asp
• https://www.isaaa.org/animalbiotechdatabase/default.asp
Contributing to Question 1 & 2:
Applications of biotechnology to animals build upon age-old animal breeding practices aimed towards genetic gains such as improved yield, agricultural sustainability, or animal welfare.
Risk assessment of living modified animals as compared to that of other living modified organisms maybe similar in some aspects, but very different in others. Environmental risk assessment and management is one of the aspects that would require a different approach. It’s important for example, to consider the fact that animals move and therefore their interactions with the environment are more dynamic.
Given that plants were the first living modified organisms to be approved and widely used, the risk assessment frameworks for most nations were designed with plants in mind. Most of the proposed containment or confinement measures, packaging and transportation methods are suitable for plants but not applicable to animals.
There’s also the question of animal welfare and ethical considerations. While it’s ok to accept unfavourable results such as developmental defects arising from genetic modifications in plants, because these would simply be selected out, such wouldn’t be so easily acceptable with animals. The question of causing unnecessary suffering to the living modified animals would have to be considered. How this animal welfare question integrates into the existing risk assessment framework is unclear.
Contributing to Question 3 & 4:
The potential to cause adverse effects on biodiversity would to a large extend depend on the species in question, so does the potential to disseminate across national borders. The potential for these risks increases with gene drive insects which can easily move across borders, mate and reproduce undetected. Accidental introduction into the environment, or moving across borders undetected is less of a risk with higher LMAs, and even less when it comes to livestock that require human intervention to thrive.
Many countries have biotechnology regulatory systems in place that cover animals. Most of these countries have laws and the processes were developed to regulate the products of genetic engineering, i.e., to regulate the incorporation of rDNA or transgenes into plants, animals, and other organisms. Some countries have experience making regulatory decisions for animals under these systems. Below are some resources with information on living modified animals that have been, or are likely to be commercialized; and best practices for regulation and oversight of genetically modified animals.
• https://www.isaaa.org/kc/proceedings/animalbiotechnology/default.asp
• https://www.isaaa.org/kc/proceedings/fish-shellfish/default.asp
• https://www.isaaa.org/animalbiotechdatabase/default.asp
Dear colleagues,
Regarding question 3.iv, the European Food Safety Authority (EFSA) published in 2023 a report which presents a review of the commercial and pre‐commercial stage applications of new genomic technologies applied to farm animals and their agri/food/feed products which is available here: https://www.efsa.europa.eu/en/supporting/pub/en-8311.
EFSA is also preparing a scientific opinion, which will be published later this year, on new developments in biotechnology (including synthetic biology and new genomic techniques) applied to animals for food, feed and other agricultural uses.
Best regards,
Alexandre
Regarding question 3.iv, the European Food Safety Authority (EFSA) published in 2023 a report which presents a review of the commercial and pre‐commercial stage applications of new genomic technologies applied to farm animals and their agri/food/feed products which is available here: https://www.efsa.europa.eu/en/supporting/pub/en-8311.
EFSA is also preparing a scientific opinion, which will be published later this year, on new developments in biotechnology (including synthetic biology and new genomic techniques) applied to animals for food, feed and other agricultural uses.
Best regards,
Alexandre
Dear All,
First, I apologize for the delayed response.
My name is Eder Toppa, and I have been working at the Brazilian Ministry of Agriculture and Livestock for the past decade. I currently serve as the Head of the Biosafety Service and am a member of the National Biosafety Commission.
Regarding Question 4:
A significant number of countries have established regulatory frameworks for animal biotechnology. Additionally, the OECD has published key documents to guide risk assessment in this field, including consensus papers on the biology of Aedes aegypti mosquitoes (2018) and Atlantic salmon (2017), as well as a 2022 report on novel traits and risk assessment in livestock biotechnology. These documents offer valuable insights into risk assessment practices for animals.
Given the current situation, I believe that the limited financial resources available should be allocated to other priorities at this time.
Best Regards
Eder Victor Braganti Toppa
Federal Inspector
Head of the GMO Biosafety Service
Plant Health Department
Ministry of Agriculture and Livestock
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:
A significant number of countries have established regulatory frameworks for animal biotechnology. Additionally, the OECD has published key documents to guide risk assessment in this field, including consensus papers on the biology of Aedes aegypti mosquitoes (2018) and Atlantic salmon (2017), as well as a 2022 report on novel traits and risk assessment in livestock biotechnology. These documents offer valuable insights into risk assessment practices for animals.
Given the current situation, I believe that the limited financial resources available should be allocated to other priorities at this time.
Best Regards
Eder Victor Braganti Toppa
Federal Inspector
Head of the GMO Biosafety Service
Plant Health Department
Ministry of Agriculture and Livestock
My name is Samson Simon, I work for the German Federal Agency for Nature Conservation (BfN) as a biosafety expert.
I want to refer also to the recent example of living modified grey wolves, by the company referred to as dire wolves.
We know quite little about the molecular work that has been performed on the grey wolves. However, it is clear that even though those LM wolves have very little in common with dire wolves, it nonetheless shows the depth of intervention that genome editing can offer.
With as little as 20 changes in 14 genes, performed using CRISPR base editing (https://colossal.com/direwolf/science/), Colossal was able to significantly change multiple traits of the wolf, including its size and coat. Such multiplexing applications, which can be used to transfer traits between species, will probably be standard procedure in the future.
But in contrast to farm animals, we are looking at the genetic modification of wild living species, with the long-term goal of environmental release (as far as I understand this work). When following the approach of Colossal, we would run into the issue of gene transfer between LM wolves and native wolf populations, which belong to a protected species in the EU. We should take the time to prepare in order to be able to perform a sound risk assessment of this class of LMOs as well.
I want to refer also to the recent example of living modified grey wolves, by the company referred to as dire wolves.
We know quite little about the molecular work that has been performed on the grey wolves. However, it is clear that even though those LM wolves have very little in common with dire wolves, it nonetheless shows the depth of intervention that genome editing can offer.
With as little as 20 changes in 14 genes, performed using CRISPR base editing (https://colossal.com/direwolf/science/), Colossal was able to significantly change multiple traits of the wolf, including its size and coat. Such multiplexing applications, which can be used to transfer traits between species, will probably be standard procedure in the future.
But in contrast to farm animals, we are looking at the genetic modification of wild living species, with the long-term goal of environmental release (as far as I understand this work). When following the approach of Colossal, we would run into the issue of gene transfer between LM wolves and native wolf populations, which belong to a protected species in the EU. We should take the time to prepare in order to be able to perform a sound risk assessment of this class of LMOs as well.
Dear colleagues,
I am an independent regulatory consultant, who has been involved in genetic modification and regulation for over 30 years. More recently I have been following and supporting projects on living modified insects, both with and without gene drives.
I would like to contribute to Q4 regarding existing resources specifically in the context of LM mosquitoes and gene drives and support the comment #12344 from Mr Toppa.
There are existing resources on LM mosquitoes prepared under the AHTEG and previous risk assessment forums:
-Additional voluntary guidance materials on the risk assessment of living modified organisms containing gene drives from decision CP10/10
-CBD/CP/RA/AHTEG/2024/1/3
-CBD/CP/RA/AHTEG/2020/1/4
These documents outline the steps involved in risk assessment, along with Annex III, including problem formulation, development of an analysis plan, and the selection of appropriate comparators, all of which remain valid for living modified invertebrates such as mosquitoes. The additional voluntary guidance also included a case study of living modified Anopheles mosquitoes which also sought the risk assessor to consider unintentional transboundary movements as well as the persistence of the transgene in the ecosystem, placing it in the contest of the effectiveness and availability of existing mosquito control methods.
Therefore, I suggest that additional guidance on risk assessment for living modified mosquitoes would be duplicative and should be excluded from the topic of living modified animals.
I am an independent regulatory consultant, who has been involved in genetic modification and regulation for over 30 years. More recently I have been following and supporting projects on living modified insects, both with and without gene drives.
I would like to contribute to Q4 regarding existing resources specifically in the context of LM mosquitoes and gene drives and support the comment #12344 from Mr Toppa.
There are existing resources on LM mosquitoes prepared under the AHTEG and previous risk assessment forums:
-Additional voluntary guidance materials on the risk assessment of living modified organisms containing gene drives from decision CP10/10
-CBD/CP/RA/AHTEG/2024/1/3
-CBD/CP/RA/AHTEG/2020/1/4
These documents outline the steps involved in risk assessment, along with Annex III, including problem formulation, development of an analysis plan, and the selection of appropriate comparators, all of which remain valid for living modified invertebrates such as mosquitoes. The additional voluntary guidance also included a case study of living modified Anopheles mosquitoes which also sought the risk assessor to consider unintentional transboundary movements as well as the persistence of the transgene in the ecosystem, placing it in the contest of the effectiveness and availability of existing mosquito control methods.
Therefore, I suggest that additional guidance on risk assessment for living modified mosquitoes would be duplicative and should be excluded from the topic of living modified animals.
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 “LM animals” I would like to make the following considerations regarding the criteria for new topics established in the annex I to decision CP-9/13:
2. What could be the specific challenges to related to this issue?
3. What are the specific issues concerning this topic?
The topic “LM animals” is so broad that could comprise from mosquitoes till mammals, is not possible to identify any specific challenge or issues concerning. Such a broad topic will diminish the value of any further guidance and duplicate dozen RA guidance that already exists for specific organisms, including the recent guidance about LMO containing gene drive focusing on mosquitoes (CBD/CP/MOP/11/9). In my opinion, in this case the proposed topic does not fulfill the criteria according with the decision CP-9/13 and neither will be an outcome useful for Parties.
Best regards,
Luciana P. Ambrozevicius
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 “LM animals” I would like to make the following considerations regarding the criteria for new topics established in the annex I to decision CP-9/13:
2. What could be the specific challenges to related to this issue?
3. What are the specific issues concerning this topic?
The topic “LM animals” is so broad that could comprise from mosquitoes till mammals, is not possible to identify any specific challenge or issues concerning. Such a broad topic will diminish the value of any further guidance and duplicate dozen RA guidance that already exists for specific organisms, including the recent guidance about LMO containing gene drive focusing on mosquitoes (CBD/CP/MOP/11/9). In my opinion, in this case the proposed topic does not fulfill the criteria according with the decision CP-9/13 and neither will be an outcome useful for Parties.
Best regards,
Luciana P. Ambrozevicius
Dear Colleagues,
I have been working on environmental risk assessment for LMOs at a non-profit scientific organization since 2009. This includes work on risk assessment for GM animals. I see a lot of similar arguments being put forward in this thread as in all of the other threads. "Animals are complex, there are lots of different kinds of animals, the types of modifications and their uses may be different than for plants, etc." All of these points are true, and useful. But they don't reflect a need for additional guidance. They reflect the reality already acknowledged in Annex III to the Cartagena Protocol - that risk assessments should be case specific and consider the nature of the organism, its modification and its intended use.
The framework(s) for risk assessment that are in place across various Party and non-Party countries and international organizations, coupled with the availability of publications referenced in #12303 and #12345 provide an adequate basis to allow Parties to establish a framework for case specific risk assessment of LMO animals. It is difficult to see what benefit additional guidance would bring at this time. I therefore strongly support the conclusions of #12303, #12344 and #12345 that additional guidance on LMO animals should not be a priority at this time.
Regards,
Andrew Roberts, PhD
Agriculture & Food Systems Institute
I have been working on environmental risk assessment for LMOs at a non-profit scientific organization since 2009. This includes work on risk assessment for GM animals. I see a lot of similar arguments being put forward in this thread as in all of the other threads. "Animals are complex, there are lots of different kinds of animals, the types of modifications and their uses may be different than for plants, etc." All of these points are true, and useful. But they don't reflect a need for additional guidance. They reflect the reality already acknowledged in Annex III to the Cartagena Protocol - that risk assessments should be case specific and consider the nature of the organism, its modification and its intended use.
The framework(s) for risk assessment that are in place across various Party and non-Party countries and international organizations, coupled with the availability of publications referenced in #12303 and #12345 provide an adequate basis to allow Parties to establish a framework for case specific risk assessment of LMO animals. It is difficult to see what benefit additional guidance would bring at this time. I therefore strongly support the conclusions of #12303, #12344 and #12345 that additional guidance on LMO animals should not be a priority at this time.
Regards,
Andrew Roberts, PhD
Agriculture & Food Systems Institute
I would like to thank Ms Anita Anthonysamy for moderating this discussion, the Secretariat for facilitating it and especially the participants for their very informative contributions.
My name is Dr Werner Schenkel, I have been working as a risk assessor for the German Competent Authority for about 20 years and have been involved in Cartagena Protocol related issues since 2017.
I would like to support Ms. Marvis Suárez Romero mentioned (#12303) stating that the existing guidelines for risk assessments of GMOs generally explain how to proceed with a risk analysis that can be used for any species, but adapted to comply with the case-by-case principle outlined in Annex III of the Cartagena Protocol.
I see no evidence in the Cartagena Protocol, including Annex III, that the Protocol or the risk assessment methods it provides for are primarily designed or focused on plants. The same applies to the regulations implementing the Protocol in the EU, Germany and probably most other Parties.
We should also bear in mind Decision CP 9/13 Annex I, which asks whether there are specific issues that challenge existing risk assessment frameworks, guidance and methodologies. Many of the issues that have been mentioned here, such as potential for persistence, spread, horizontal or vertical transfer of genetic material, interaction with the ecosystem, or limited information, limited knowledge, limited baseline, receiving environment are in my view not specific to the group of genetically modified animals, but general issues with LMOs or general challenges in risk assessment. I think this is supported by the fact that very similar issues are mentioned for LM fish, LM algae or LM microorganism. So either the issue is not specific to the class or the class is not well chosen to address a specific issue. Other issues mentioned are in my view not in the scope of a risk assessment according to Annex III CP.
However, many of these fundamental challenges can be successfully addressed through a systematic but flexible and open approach, such as the problem formulation and pathways to harm approach exemplified in the recent and widely supported guidance on gene drives.
I would also like to support the view expressed in #12358 that more emphasis should be placed on the active application of these principles. Training and capacity building in this direction would better support interested parties and contribute more to biosafety than additional guidance material.
As LM animals are not a very new concept, guidance material is already available that can be used for risk assessment. One example is the EFSA Guidance on the environmental risk assessment of genetically modified animals (EFSA 2013), which is also available through the BCH. This guidance includes among others sections on GM fish, GM insects, the receiving environment and long-term effects.
Werner Schenkel
Germany
EFSA 2013: https://bch.cbd.int/en/database/BCH-LAW-EU-115260-1
My name is Dr Werner Schenkel, I have been working as a risk assessor for the German Competent Authority for about 20 years and have been involved in Cartagena Protocol related issues since 2017.
I would like to support Ms. Marvis Suárez Romero mentioned (#12303) stating that the existing guidelines for risk assessments of GMOs generally explain how to proceed with a risk analysis that can be used for any species, but adapted to comply with the case-by-case principle outlined in Annex III of the Cartagena Protocol.
I see no evidence in the Cartagena Protocol, including Annex III, that the Protocol or the risk assessment methods it provides for are primarily designed or focused on plants. The same applies to the regulations implementing the Protocol in the EU, Germany and probably most other Parties.
We should also bear in mind Decision CP 9/13 Annex I, which asks whether there are specific issues that challenge existing risk assessment frameworks, guidance and methodologies. Many of the issues that have been mentioned here, such as potential for persistence, spread, horizontal or vertical transfer of genetic material, interaction with the ecosystem, or limited information, limited knowledge, limited baseline, receiving environment are in my view not specific to the group of genetically modified animals, but general issues with LMOs or general challenges in risk assessment. I think this is supported by the fact that very similar issues are mentioned for LM fish, LM algae or LM microorganism. So either the issue is not specific to the class or the class is not well chosen to address a specific issue. Other issues mentioned are in my view not in the scope of a risk assessment according to Annex III CP.
However, many of these fundamental challenges can be successfully addressed through a systematic but flexible and open approach, such as the problem formulation and pathways to harm approach exemplified in the recent and widely supported guidance on gene drives.
I would also like to support the view expressed in #12358 that more emphasis should be placed on the active application of these principles. Training and capacity building in this direction would better support interested parties and contribute more to biosafety than additional guidance material.
As LM animals are not a very new concept, guidance material is already available that can be used for risk assessment. One example is the EFSA Guidance on the environmental risk assessment of genetically modified animals (EFSA 2013), which is also available through the BCH. This guidance includes among others sections on GM fish, GM insects, the receiving environment and long-term effects.
Werner Schenkel
Germany
EFSA 2013: https://bch.cbd.int/en/database/BCH-LAW-EU-115260-1
Thank you to the moderators and contributors for these interesting discussions.
The development of LM animals appears to be expanding in the range of species targeted for engineering, assisted by advances in GE methods (e.g. genome editing), and their accompanying supportive techniques.
(Q3 iv) As far as commercialisation, insect species are already undergoing environmental trials include Drosophila (utilising genome edited ‘precision guided sterile insect techniques (pgSIT) (Agragene), fall armyworm are being commercialised (Oxitec), and cattle tick projects are also under development Oxitec). There are also a wide variety of other insect proposals including the engineering of insecticide resistance into pollinator species (honeybees) using genome editing e.g. https://www.horticulture.com.au/globalassets/laserfiche/assets/project-reports/ph22000/ph22000-final-report.pdf
Several genome-edited LMO mammals have been approved or undergone regulatory review, including pigs resistant to Porcine Reproductive and Respiratory Syndrome, ‘heat-tolerant’ cows, and cows with ‘increased yield’, respectively.
Research is also advancing on engineering disease resistance, e.g. to develop genome edited chickens designed to be resistant to avian flu.
Q1: The advances in genome editing and their supportive techniques may also potentially expand the range of species being modified, challenging current RA experiences.
Q2 and 3: Specific challenges and issues may include
- Gene flow of undesirable traits to non-target organisms (e.g. pesticide resistance);
- Potential applications targeting pollinators for example, may result in unintended adverse impacts on wild pollinator species and function, with direct implications for biodiversity and food security.
- Unintended transboundary movements e.g. long range dispersal of insects, cross border movements of migrating mammalian/bird species, or the spread of pathogens that have evolved around disease-resistant traits
- generating pathogen reservoirs with biosecurity risks of pathogen evolution; novel spillover events. Eg. A recent paper (Ikoko-Akoh et al., 2023) on the development of genome edited chickens designed to be resistant to avian flu reported that the mutations in the bird flu virus unexpectedly allowed the virus, that is usually limited to birds, to use the two shorter proteins, which also occur in humans, and thus the virus partially adapted itself for replication in mammals (potentially including humans).
- A related concern is that a gene edited disease-resistant animals may be infected but not show symptoms of disease, perhaps benefitting the individual animal but putting other animals at increased risk. In animals, these problems are compounded by the difficulties described above in scaling up production to create large herds or flocks: this process is likely to be too slow to keep up with fast evolving pathogens. (see Genewatch, 2025 https://www.genewatch.org/uploads/f03c6d66a9b354535738483c1c3d49e4/gw-response-to-efsa-genetically-modified-animals-fin.pdf).
- unintended effects of GM process (e.g. on and off-target effects) resulting in novel hazards (e.g. transfer of antibiotic resistance genes in the hornless cattle (Norris et al., 2019), production of novel allergens/toxins with implications for food safety, food webs and wider ecological interactions.
- unintended effects and animal welfare issues associated with reproductive supportive techniques such as cloning, that may result in mosaicism, deformities, still births, miscarriages and early animal death. (Kirkden et al., 2012; Megraver et al., 2019; Salvesen et al., 2024; Sri
Repeated cloning may also be required (e.g. Mueller et al., 2019). Such risks also challenge the assertion that edited animals can be equivalent to conventional animals.
- adverse impacts may arise in mosquito or pest control applications, such as niche replacement with secondary pests (including disease vectors), or an alteration in disease epidemiologies.
- Socio-economic effects could adversely impact traditional and local farming systems, e.g. via unintended impacts such pathogen evolution, displacement of native farming species, divergence of economic resources away from proven or safer solutions (e.g. access to healthcare in the case of health applications).
Current guidance does not appear to cover the scope of potential unintended effects that can result from LM animal applications, warranting additional precautionary oversight. Moreover, testing should not be limited to following a pathways to harm under a problem formulation approach, on a case-by-case basis, due to the potential to miss the detection of unintended effects. It is not always possible to identify all 'pathways to harm' in advance, and thus
the assessment should not be narrowed in advance. Instead a precautionary approach should be adhered to, that would capture the full range of risks and potential harms and the associated uncertainties.
Many thanks.
Idoko-Akoh, A., Goldhill, D. H., Sheppard, C. M., Bialy, D., Quantrill, J. L., Sukhova, K., Brown, J. C., Richardson, S., Campbell, C., Taylor, L., Sherman, A., Nazki, S., Long, J. S., Skinner, M. A., Shelton, H., Sang, H. M., Barclay, W. S., & McGrew, M. J. (2023). Creating resistance to avian influenza infection through genome editing of the ANP32 gene family. Nature Communications, 14, 6136. https://doi.org/10.1038/s41467-023-41476-3
Kirkden, R. D., & Broom, D. M. (2012). Welfare of Genetically Modified and Cloned Animals Used for Food. Retrieved from Compassion in World Farming (CIWF) website: https://www.ciwf.org.uk/media/4237869/welfare_of_genetically_modified_and_cloned_an imals_used_in_food.pdf
Mehravar, M., Shirazi, A., Nazari, M., & Banan, M. (2019). Mosaicism in CRISPR/Cas9- mediated genome editing. Developmental Biology, 445(2), 156–162. https://doi.org/10.1016/j.ydbio.2018.10.008
Mueller, M. L., Cole, J. B., Sonstegard, T. S., & Van Eenennaam, A. L. (2019). Comparison of gene editing versus conventional breeding to introgress the POLLED allele into the US dairy cattle population. Journal of Dairy Science, 102(5), 4215–4226. https://doi.org/10.3168/jds.2018-15892
Salvesen, H. A., Grupen, C. G., & McFarlane, G. R. (2024). Tackling mosaicism in gene edited livestock. Frontiers in Animal Science, 5. https://doi.org/10.3389/fanim.2024.1368155
Srirattana, K., Kaneda, M., & Parnpai, R. (2022). Strategies to Improve the Efficiency of Somatic Cell Nuclear Transfer. International Journal of Molecular Sciences, 23(4), 1969. https://doi.org/10.3390/ijms23041969
Tan, W., Proudfoot, C., Lillico, S. G., & Whitelaw, C. B. A. (2016). Gene targeting, genome editing: from Dolly to editors. Transgenic Research, 25(3), 273–287. https://doi.org/10.1007/s11248-016-9932-x
The development of LM animals appears to be expanding in the range of species targeted for engineering, assisted by advances in GE methods (e.g. genome editing), and their accompanying supportive techniques.
(Q3 iv) As far as commercialisation, insect species are already undergoing environmental trials include Drosophila (utilising genome edited ‘precision guided sterile insect techniques (pgSIT) (Agragene), fall armyworm are being commercialised (Oxitec), and cattle tick projects are also under development Oxitec). There are also a wide variety of other insect proposals including the engineering of insecticide resistance into pollinator species (honeybees) using genome editing e.g. https://www.horticulture.com.au/globalassets/laserfiche/assets/project-reports/ph22000/ph22000-final-report.pdf
Several genome-edited LMO mammals have been approved or undergone regulatory review, including pigs resistant to Porcine Reproductive and Respiratory Syndrome, ‘heat-tolerant’ cows, and cows with ‘increased yield’, respectively.
Research is also advancing on engineering disease resistance, e.g. to develop genome edited chickens designed to be resistant to avian flu.
Q1: The advances in genome editing and their supportive techniques may also potentially expand the range of species being modified, challenging current RA experiences.
Q2 and 3: Specific challenges and issues may include
- Gene flow of undesirable traits to non-target organisms (e.g. pesticide resistance);
- Potential applications targeting pollinators for example, may result in unintended adverse impacts on wild pollinator species and function, with direct implications for biodiversity and food security.
- Unintended transboundary movements e.g. long range dispersal of insects, cross border movements of migrating mammalian/bird species, or the spread of pathogens that have evolved around disease-resistant traits
- generating pathogen reservoirs with biosecurity risks of pathogen evolution; novel spillover events. Eg. A recent paper (Ikoko-Akoh et al., 2023) on the development of genome edited chickens designed to be resistant to avian flu reported that the mutations in the bird flu virus unexpectedly allowed the virus, that is usually limited to birds, to use the two shorter proteins, which also occur in humans, and thus the virus partially adapted itself for replication in mammals (potentially including humans).
- A related concern is that a gene edited disease-resistant animals may be infected but not show symptoms of disease, perhaps benefitting the individual animal but putting other animals at increased risk. In animals, these problems are compounded by the difficulties described above in scaling up production to create large herds or flocks: this process is likely to be too slow to keep up with fast evolving pathogens. (see Genewatch, 2025 https://www.genewatch.org/uploads/f03c6d66a9b354535738483c1c3d49e4/gw-response-to-efsa-genetically-modified-animals-fin.pdf).
- unintended effects of GM process (e.g. on and off-target effects) resulting in novel hazards (e.g. transfer of antibiotic resistance genes in the hornless cattle (Norris et al., 2019), production of novel allergens/toxins with implications for food safety, food webs and wider ecological interactions.
- unintended effects and animal welfare issues associated with reproductive supportive techniques such as cloning, that may result in mosaicism, deformities, still births, miscarriages and early animal death. (Kirkden et al., 2012; Megraver et al., 2019; Salvesen et al., 2024; Sri
Repeated cloning may also be required (e.g. Mueller et al., 2019). Such risks also challenge the assertion that edited animals can be equivalent to conventional animals.
- adverse impacts may arise in mosquito or pest control applications, such as niche replacement with secondary pests (including disease vectors), or an alteration in disease epidemiologies.
- Socio-economic effects could adversely impact traditional and local farming systems, e.g. via unintended impacts such pathogen evolution, displacement of native farming species, divergence of economic resources away from proven or safer solutions (e.g. access to healthcare in the case of health applications).
Current guidance does not appear to cover the scope of potential unintended effects that can result from LM animal applications, warranting additional precautionary oversight. Moreover, testing should not be limited to following a pathways to harm under a problem formulation approach, on a case-by-case basis, due to the potential to miss the detection of unintended effects. It is not always possible to identify all 'pathways to harm' in advance, and thus
the assessment should not be narrowed in advance. Instead a precautionary approach should be adhered to, that would capture the full range of risks and potential harms and the associated uncertainties.
Many thanks.
Idoko-Akoh, A., Goldhill, D. H., Sheppard, C. M., Bialy, D., Quantrill, J. L., Sukhova, K., Brown, J. C., Richardson, S., Campbell, C., Taylor, L., Sherman, A., Nazki, S., Long, J. S., Skinner, M. A., Shelton, H., Sang, H. M., Barclay, W. S., & McGrew, M. J. (2023). Creating resistance to avian influenza infection through genome editing of the ANP32 gene family. Nature Communications, 14, 6136. https://doi.org/10.1038/s41467-023-41476-3
Kirkden, R. D., & Broom, D. M. (2012). Welfare of Genetically Modified and Cloned Animals Used for Food. Retrieved from Compassion in World Farming (CIWF) website: https://www.ciwf.org.uk/media/4237869/welfare_of_genetically_modified_and_cloned_an imals_used_in_food.pdf
Mehravar, M., Shirazi, A., Nazari, M., & Banan, M. (2019). Mosaicism in CRISPR/Cas9- mediated genome editing. Developmental Biology, 445(2), 156–162. https://doi.org/10.1016/j.ydbio.2018.10.008
Mueller, M. L., Cole, J. B., Sonstegard, T. S., & Van Eenennaam, A. L. (2019). Comparison of gene editing versus conventional breeding to introgress the POLLED allele into the US dairy cattle population. Journal of Dairy Science, 102(5), 4215–4226. https://doi.org/10.3168/jds.2018-15892
Salvesen, H. A., Grupen, C. G., & McFarlane, G. R. (2024). Tackling mosaicism in gene edited livestock. Frontiers in Animal Science, 5. https://doi.org/10.3389/fanim.2024.1368155
Srirattana, K., Kaneda, M., & Parnpai, R. (2022). Strategies to Improve the Efficiency of Somatic Cell Nuclear Transfer. International Journal of Molecular Sciences, 23(4), 1969. https://doi.org/10.3390/ijms23041969
Tan, W., Proudfoot, C., Lillico, S. G., & Whitelaw, C. B. A. (2016). Gene targeting, genome editing: from Dolly to editors. Transgenic Research, 25(3), 273–287. https://doi.org/10.1007/s11248-016-9932-x
Dear Moderator, CBD Secretariat and other esteemed participants,
I am John Connolly from Imperial College London and Target Malaria, developing potential solutions for malaria vector control using GM mosquitoes, and I would like to commend the contents of, and add to comments within, posts #12303, #12339, #12344, #12345, #12358, #12361 and #12369 on LM animals, as well as support germane sentiments expressed in posts #12336, #12351, and #12362 on stacked events.
1. How does this topic potentially pose challenges to the existing risk assessment frameworks, guidance and methodologies? Do solutions exist?
Adoption of a case-by-case approach to risk assessment, incorporating a range of issues such as technology platform, target organism, and receiving environment, has already successfully been developed and applied to the use of LM animals under a range of international fora (e.g. EFSA 2013, EFSA 2020, WHO 2021, AU 2022, CBD 2024) and specific applications (e.g. Connolly et al 2021, Connolly et al 2023; Kormos et al 2023, Hayes and Hosack 2025). These and many other examples establish tangible precedents for cogent risk assessment of a variety of approaches to the use of LM animals.
2. What could be the specific challenges to related to this issue?
Any challenges related to risk assessment frameworks, guidance and methodologies can and have been addressed on a case-by-case basis that is founded in problem formulation and scientific, evidence-based approach to risk analysis and management.
3. What are the specific issues concerning this topic?
Specific issues concerning this topic need to be addressed on a case-by-case basis in specific exercises of risk assessment of particular applications of LM animals. On policy and guidance levels, frameworks and methodologies are more than sufficient to facilitate thorough scientific, evidence-based approaches to risk assessment of LM animals, building on robust problem formulation. A specific example of a universally well-received piece of guidance on risk assessment of gene drive using this approach can be found in CBD 2024.
4. Are there existing resources on similar issues that can address this issue or resources that could be adapted to address this need?
The resources cited in this post can directly, or easily and sensibly be adapted to, address any complexities in risk assessment of LM animals, anchored as they are in robust and systematic approaches to problem formulation and pathways to harm analyses (e.g. Connolly et al 2021, CBD 2024, Hayes and Hosack 2025). In short, no new guidance is needed, and to do so would be a wasteful use of CBD resources, although further support for capacity building in current best practices in risk assessment for some Parties may be helpful and might be considered in the future.
References
AU (2022): https://www.nepad.org/publication/guidelines-risk-analysis-testing-and-deployment-of-genetically-modified
CBD (2024): https://www.cbd.int/doc/c/175e/90b0/89c0c71660cccc1539adf34f/cp-mop-11-09-en.pdf
EFSA (2013): https://bch.cbd.int/en/database/BCH-LAW-EU-115260-1
EFSA (2020): https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2020.6297
Hayes and Hosack (2025): https://www.tandfonline.com/doi/full/10.1080/10807039.2025.2484229#d1e1654
Kormos et al (2023): https://www.frontiersin.org/journals/bioengineering-and-biotechnology/articles/10.3389/fbioe.2023.1261123/full
WHO (2021): https://www.who.int/publications/i/item/9789240025233
I am John Connolly from Imperial College London and Target Malaria, developing potential solutions for malaria vector control using GM mosquitoes, and I would like to commend the contents of, and add to comments within, posts #12303, #12339, #12344, #12345, #12358, #12361 and #12369 on LM animals, as well as support germane sentiments expressed in posts #12336, #12351, and #12362 on stacked events.
1. How does this topic potentially pose challenges to the existing risk assessment frameworks, guidance and methodologies? Do solutions exist?
Adoption of a case-by-case approach to risk assessment, incorporating a range of issues such as technology platform, target organism, and receiving environment, has already successfully been developed and applied to the use of LM animals under a range of international fora (e.g. EFSA 2013, EFSA 2020, WHO 2021, AU 2022, CBD 2024) and specific applications (e.g. Connolly et al 2021, Connolly et al 2023; Kormos et al 2023, Hayes and Hosack 2025). These and many other examples establish tangible precedents for cogent risk assessment of a variety of approaches to the use of LM animals.
2. What could be the specific challenges to related to this issue?
Any challenges related to risk assessment frameworks, guidance and methodologies can and have been addressed on a case-by-case basis that is founded in problem formulation and scientific, evidence-based approach to risk analysis and management.
3. What are the specific issues concerning this topic?
Specific issues concerning this topic need to be addressed on a case-by-case basis in specific exercises of risk assessment of particular applications of LM animals. On policy and guidance levels, frameworks and methodologies are more than sufficient to facilitate thorough scientific, evidence-based approaches to risk assessment of LM animals, building on robust problem formulation. A specific example of a universally well-received piece of guidance on risk assessment of gene drive using this approach can be found in CBD 2024.
4. Are there existing resources on similar issues that can address this issue or resources that could be adapted to address this need?
The resources cited in this post can directly, or easily and sensibly be adapted to, address any complexities in risk assessment of LM animals, anchored as they are in robust and systematic approaches to problem formulation and pathways to harm analyses (e.g. Connolly et al 2021, CBD 2024, Hayes and Hosack 2025). In short, no new guidance is needed, and to do so would be a wasteful use of CBD resources, although further support for capacity building in current best practices in risk assessment for some Parties may be helpful and might be considered in the future.
References
AU (2022): https://www.nepad.org/publication/guidelines-risk-analysis-testing-and-deployment-of-genetically-modified
CBD (2024): https://www.cbd.int/doc/c/175e/90b0/89c0c71660cccc1539adf34f/cp-mop-11-09-en.pdf
EFSA (2013): https://bch.cbd.int/en/database/BCH-LAW-EU-115260-1
EFSA (2020): https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2020.6297
Hayes and Hosack (2025): https://www.tandfonline.com/doi/full/10.1080/10807039.2025.2484229#d1e1654
Kormos et al (2023): https://www.frontiersin.org/journals/bioengineering-and-biotechnology/articles/10.3389/fbioe.2023.1261123/full
WHO (2021): https://www.who.int/publications/i/item/9789240025233
Ediner Fuentes-Campos, Deputy Director of Research and Development at the National Secretariat of Science, Technology and Innovation of Panama, Focal Point for the Cartagena Protocol in Panama.
I would like to share some reflections on the topics raised by the moderators.
For centuries, breeders have intentionally selected the parents of each generation based on desirable characteristics. The marked differences observed in the appearance and productivity of different breeds demonstrate the power of this selection on genetic variations. Genetic modification simply represents a more precise and targeted extension of this historical process. Early applications of transgenic animals focused precisely on traits that favor sustainability, such as disease resistance and reduced environmental impact.
Annex III of the Cartagena Protocol already provides an adequate framework for risk assessment, recognizing that these assessments must be specific to each case, considering the nature of the organism, its modification, and intended use. It is important to highlight that there is already a significant history of safe use with animal genetic modification technologies that can be used as a reference within the Protocol framework.
I agree with the position of #12363 when he points out that arguments about the complexity of animals do not reflect a need for additional guidance. Rather, they reflect the reality already recognized in Annex III: that assessments must be specific and consider multiple particular factors. The case-by-case assessment concept is fundamental and already incorporated into the existing framework. Like #12361, I consider that the "GM Animals" topic is excessively broad, ranging from mosquitoes to mammals, which makes it difficult to identify specific problems. Such a general topic would diminish the value of any additional guidance and duplicate the multiple existing risk assessment guidelines for specific organisms.
I fully agree with #12354 when noting that a significant number of countries have established adequate regulatory frameworks for animal biotechnology. Additionally, the OECD has published key documents to guide risk assessment, including studies on the biology of Aedes aegypti mosquitoes (2018), Atlantic salmon (2017), and a 2022 report on novel traits and risk assessment in livestock biotechnology. I also support what was expressed by #12344 regarding existing resources related to GM mosquitoes, which include various voluntary guidance materials for risk assessment. The frameworks in force in several countries, together with the available publications, provide an adequate basis for establishing specific assessments. I agree that additional guidance on GM animals should not be a priority at this time. Always remembering that in the biomedical sector, this technology has been developing for many years with a demonstrated history of safe use. GM animals have contributed to the development of important pharmaceutical products.
I would like to specifically reaffirm Ms. Luciana Pimenta Ambrozevicius's position that additional guidance is not required on this topic. As she correctly pointed out in contribution #12361, the "GM Animals" theme is too broad to identify any specific challenge or related issue. This proposed topic does not meet the criteria according to CP-9/13 decision and would not be a useful outcome for the Parties. The existing risk assessment frameworks and guidance are sufficient for addressing case-by-case evaluations of GM animals within the current protocol structure.
Ediner Fuentes-Campos
I would like to share some reflections on the topics raised by the moderators.
For centuries, breeders have intentionally selected the parents of each generation based on desirable characteristics. The marked differences observed in the appearance and productivity of different breeds demonstrate the power of this selection on genetic variations. Genetic modification simply represents a more precise and targeted extension of this historical process. Early applications of transgenic animals focused precisely on traits that favor sustainability, such as disease resistance and reduced environmental impact.
Annex III of the Cartagena Protocol already provides an adequate framework for risk assessment, recognizing that these assessments must be specific to each case, considering the nature of the organism, its modification, and intended use. It is important to highlight that there is already a significant history of safe use with animal genetic modification technologies that can be used as a reference within the Protocol framework.
I agree with the position of #12363 when he points out that arguments about the complexity of animals do not reflect a need for additional guidance. Rather, they reflect the reality already recognized in Annex III: that assessments must be specific and consider multiple particular factors. The case-by-case assessment concept is fundamental and already incorporated into the existing framework. Like #12361, I consider that the "GM Animals" topic is excessively broad, ranging from mosquitoes to mammals, which makes it difficult to identify specific problems. Such a general topic would diminish the value of any additional guidance and duplicate the multiple existing risk assessment guidelines for specific organisms.
I fully agree with #12354 when noting that a significant number of countries have established adequate regulatory frameworks for animal biotechnology. Additionally, the OECD has published key documents to guide risk assessment, including studies on the biology of Aedes aegypti mosquitoes (2018), Atlantic salmon (2017), and a 2022 report on novel traits and risk assessment in livestock biotechnology. I also support what was expressed by #12344 regarding existing resources related to GM mosquitoes, which include various voluntary guidance materials for risk assessment. The frameworks in force in several countries, together with the available publications, provide an adequate basis for establishing specific assessments. I agree that additional guidance on GM animals should not be a priority at this time. Always remembering that in the biomedical sector, this technology has been developing for many years with a demonstrated history of safe use. GM animals have contributed to the development of important pharmaceutical products.
I would like to specifically reaffirm Ms. Luciana Pimenta Ambrozevicius's position that additional guidance is not required on this topic. As she correctly pointed out in contribution #12361, the "GM Animals" theme is too broad to identify any specific challenge or related issue. This proposed topic does not meet the criteria according to CP-9/13 decision and would not be a useful outcome for the Parties. The existing risk assessment frameworks and guidance are sufficient for addressing case-by-case evaluations of GM animals within the current protocol structure.
Ediner Fuentes-Campos
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
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
Thank you moderators,
Living Modified Animals (LMAs) represent an emerging frontier in modern biotechnology, with applications spanning public health animal agriculture, and conservation biology. The development and use of LMAs may raise distinct ecological, and regulatory considerations highlighting needs for scientific dialogue and capacity building. While some African Union (AU) Member States have initiated work in this area, comprehensive biosafety frameworks for LMAs remain underdeveloped in the majority of countries. Given the complexity of animal systems and the potential environmental considerations this topic has been identified as a priority area for evidence-based advisory support and continental guidance under AUDA-NEPAD’s biosafety initiatives, notably ABNE and the Integrated Vector Management (IVM) programme in addition to the ongoing CBD discussions. LMAs remain a priority for knowledge-based support, evidence-sharing, and strategic biosafety investment under the African Union’s Science, Technology, and Innovation (STI) agenda.
Living Modified Animals present both transformational opportunities and unprecedented challenges for Africa’s environmental governance and public health systems. Under the leadership of AUDA-NEPAD and its programs (ABNE and IVM), Africa has made critical strides toward developing a robust scientifically informed biosafety architecture. However, significant investments in capacity building, regional harmonization, ecological monitoring are still required.
Question 1.
How does this topic potentially pose challenges to the existing risk assessment frameworks, guidance and methodologies? Do solutions exist?
Living Modified animals may introduce unique considerations into risk assessment frameworks due to factors such as mobility, breeding behavior, potential for horizontal gene flow, and interactions with both ecological systems and communities. However, these complexities do not undermine the structure of the risk assessment framework under Annex III of the Cartagena Protocol on Biosafety. Instead, they reinforce the importance of a case-by-case, scientifically informed assessment, as envisioned in the Protocol. Risk assessment must be based on scientific and technical information. Risk assessment should be carried out in a scientifically sound and transparent manner, and may take into account expert advice of, and guidelines developed by, relevant international organizations
The current risk assessment process—comprising hazard identification, exposure assessment, risk characterization, and risk management—remains applicable to LMAs. However, the biological, behavioral, and reproductive characteristics of animals, especially species with long lifespans or wide-ranging habitats, may necessitate additional data collection and specialized modelling approaches to strengthen overall risk characterization.
In the African context, these considerations have prompted AUDA-NEPAD to develop contextualized tools and ethical guidelines, particularly for LMAs used in vector control, such as genetically modified mosquitoes. These frameworks emphasize both technical biosafety considerations. The Additional voluntary guidance materials to support case-by-case risk assessments of living modified organisms containing engineered gene drives serve as an important resource.
2. What could be the specific challenges to related to this issue?
The specific challenges related to LMAs in Africa may be to limitations in scientific and technical expertise however, this is being strengthened through AUDA-NEPAD capacity building initiatives. The case by case approach through risk analysis can handle any challenges related.
3.Are there existing resources on similar issues that can address this issue or resources that could be adapted to address this need?
AUDA-NEPAD has developed and continues to enhance a suite of resources relevant to the risk assessment and governance of LMAs, particularly within the Integrated Vector Management (IVM) programme including risk analysis frameworks and the recently adopted guidance on risk assessment of gene drive.
To bridge remaining gaps, Parties with experience in LMA governance should be encouraged to share data, regulatory protocols, and case studies. This could enable less-experienced countries to tailor international best practices to national contexts. Furthermore, Parties should report regulatory challenges to foster a collaborative, learning-based biosafety system at the continental level. Valuable lessons can be drawn from regions such as North America, which leads in the development and regulation especially EFSA.
Living Modified Animals (LMAs) represent an emerging frontier in modern biotechnology, with applications spanning public health animal agriculture, and conservation biology. The development and use of LMAs may raise distinct ecological, and regulatory considerations highlighting needs for scientific dialogue and capacity building. While some African Union (AU) Member States have initiated work in this area, comprehensive biosafety frameworks for LMAs remain underdeveloped in the majority of countries. Given the complexity of animal systems and the potential environmental considerations this topic has been identified as a priority area for evidence-based advisory support and continental guidance under AUDA-NEPAD’s biosafety initiatives, notably ABNE and the Integrated Vector Management (IVM) programme in addition to the ongoing CBD discussions. LMAs remain a priority for knowledge-based support, evidence-sharing, and strategic biosafety investment under the African Union’s Science, Technology, and Innovation (STI) agenda.
Living Modified Animals present both transformational opportunities and unprecedented challenges for Africa’s environmental governance and public health systems. Under the leadership of AUDA-NEPAD and its programs (ABNE and IVM), Africa has made critical strides toward developing a robust scientifically informed biosafety architecture. However, significant investments in capacity building, regional harmonization, ecological monitoring are still required.
Question 1.
How does this topic potentially pose challenges to the existing risk assessment frameworks, guidance and methodologies? Do solutions exist?
Living Modified animals may introduce unique considerations into risk assessment frameworks due to factors such as mobility, breeding behavior, potential for horizontal gene flow, and interactions with both ecological systems and communities. However, these complexities do not undermine the structure of the risk assessment framework under Annex III of the Cartagena Protocol on Biosafety. Instead, they reinforce the importance of a case-by-case, scientifically informed assessment, as envisioned in the Protocol. Risk assessment must be based on scientific and technical information. Risk assessment should be carried out in a scientifically sound and transparent manner, and may take into account expert advice of, and guidelines developed by, relevant international organizations
The current risk assessment process—comprising hazard identification, exposure assessment, risk characterization, and risk management—remains applicable to LMAs. However, the biological, behavioral, and reproductive characteristics of animals, especially species with long lifespans or wide-ranging habitats, may necessitate additional data collection and specialized modelling approaches to strengthen overall risk characterization.
In the African context, these considerations have prompted AUDA-NEPAD to develop contextualized tools and ethical guidelines, particularly for LMAs used in vector control, such as genetically modified mosquitoes. These frameworks emphasize both technical biosafety considerations. The Additional voluntary guidance materials to support case-by-case risk assessments of living modified organisms containing engineered gene drives serve as an important resource.
2. What could be the specific challenges to related to this issue?
The specific challenges related to LMAs in Africa may be to limitations in scientific and technical expertise however, this is being strengthened through AUDA-NEPAD capacity building initiatives. The case by case approach through risk analysis can handle any challenges related.
3.Are there existing resources on similar issues that can address this issue or resources that could be adapted to address this need?
AUDA-NEPAD has developed and continues to enhance a suite of resources relevant to the risk assessment and governance of LMAs, particularly within the Integrated Vector Management (IVM) programme including risk analysis frameworks and the recently adopted guidance on risk assessment of gene drive.
To bridge remaining gaps, Parties with experience in LMA governance should be encouraged to share data, regulatory protocols, and case studies. This could enable less-experienced countries to tailor international best practices to national contexts. Furthermore, Parties should report regulatory challenges to foster a collaborative, learning-based biosafety system at the continental level. Valuable lessons can be drawn from regions such as North America, which leads in the development and regulation especially EFSA.
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.
There are regulatory frameworks with more than 20 years of implementation, along with consolidated guidelines and methodologies that specifically address the evaluation of modified animals, ensuring a science-based and case-by-case approach. Therefore, no significant challenges have been identified regarding this topic.
Over the years, no issues have been reported by competent authorities indicating adverse impacts on ecosystems, human health, or animal health related to modified animals that have been evaluated and approved under these regulatory frameworks.
Risk assessment for modified animals is conducted by considering specific aspects such as animal health and welfare, potential environmental impact, and risks to human health, identifying the values to be protected and following a proper problem formulation and clear risk hypothesis development for case-by-case analysis.
This approach ensures thorough and science-based evaluations, contributing to the protection of biodiversity, human health, animal health, and the environment.
Therefore, there is no evidence to support the need for developing a specific guide on this topic.
Best regards,
Andrés
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.
There are regulatory frameworks with more than 20 years of implementation, along with consolidated guidelines and methodologies that specifically address the evaluation of modified animals, ensuring a science-based and case-by-case approach. Therefore, no significant challenges have been identified regarding this topic.
Over the years, no issues have been reported by competent authorities indicating adverse impacts on ecosystems, human health, or animal health related to modified animals that have been evaluated and approved under these regulatory frameworks.
Risk assessment for modified animals is conducted by considering specific aspects such as animal health and welfare, potential environmental impact, and risks to human health, identifying the values to be protected and following a proper problem formulation and clear risk hypothesis development for case-by-case analysis.
This approach ensures thorough and science-based evaluations, contributing to the protection of biodiversity, human health, animal health, and the environment.
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 animals. 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 animals) under assessment. Best regards, Yann Devos
Thank you for the opportunity to comment on the evolution of policy and guidance on the Risk Assessment and Management of LMO’s.
I have worked across government, industry and the university sectors in Canada and the UK, and specifically LMO regulatory issues for close to 20 years. In dealing with both plant and insect LMO regulatory issues from the perspective of both a national regulatory body including multilateral standard setting, and as a regulated party, I have observed that with emerging technologies there is often a reflex to develop more and more oversight mechanisms before taking stock of what may already be in the toolbox. I would like to strongly echo the comments of Dr Werner Shenkel (#12367), who supports those of Ms. Marvis Suárez Romero (~12303) of in that the existing risk assessment paradigm of problem formulation, hazard and exposure characterisation, risk characterisation etc, used in LMO regulation globally by parties and non-parties, is underpinned by Annex III principles and hold true for all LMOs. This is also highlighted by Ms. Camilla Beech (#12354) in identifying existing guidance, as well as Mr Andrew Roberts (#12363), both of whom reference other contributors to this forum as well.
The fundamentals of ERA remain sound and the principle of “case-by-case” must be fully appreciated in that technology and molecular tools will continue to advance and that we cannot expect new international guidance documents to come with every permutation and iteration of potential LMO animal applications. We risk having a more and more piecemeal approach by adding on more guidance and creating even more uncertainty for national regulatory bodies. Again, in echoing Dr. Werner Schenkel, (#12367), the active implementation and interpretation of existing guidance through training and capacity building would be efforts better spent. Active sharing through the BCH and communities of support between parties should be encouraged and facilitated in dealing with novel applications of LMOs on a case-by case basis. These foundations need to be strengthened and resilient to addressing new applications, before complicating the field with more guidance.
Geoff Turner
I have worked across government, industry and the university sectors in Canada and the UK, and specifically LMO regulatory issues for close to 20 years. In dealing with both plant and insect LMO regulatory issues from the perspective of both a national regulatory body including multilateral standard setting, and as a regulated party, I have observed that with emerging technologies there is often a reflex to develop more and more oversight mechanisms before taking stock of what may already be in the toolbox. I would like to strongly echo the comments of Dr Werner Shenkel (#12367), who supports those of Ms. Marvis Suárez Romero (~12303) of in that the existing risk assessment paradigm of problem formulation, hazard and exposure characterisation, risk characterisation etc, used in LMO regulation globally by parties and non-parties, is underpinned by Annex III principles and hold true for all LMOs. This is also highlighted by Ms. Camilla Beech (#12354) in identifying existing guidance, as well as Mr Andrew Roberts (#12363), both of whom reference other contributors to this forum as well.
The fundamentals of ERA remain sound and the principle of “case-by-case” must be fully appreciated in that technology and molecular tools will continue to advance and that we cannot expect new international guidance documents to come with every permutation and iteration of potential LMO animal applications. We risk having a more and more piecemeal approach by adding on more guidance and creating even more uncertainty for national regulatory bodies. Again, in echoing Dr. Werner Schenkel, (#12367), the active implementation and interpretation of existing guidance through training and capacity building would be efforts better spent. Active sharing through the BCH and communities of support between parties should be encouraged and facilitated in dealing with novel applications of LMOs on a case-by case basis. These foundations need to be strengthened and resilient to addressing new applications, before complicating the field with more guidance.
Geoff Turner
First my appreciation and thanks to the CBD Secretariat and also the moderators for this online forum to facilitate discussion on a global scale. My name is Brinda Dass and I am a Senior Technical Expert at GeneConvene Global Collaborative, FNIH, USA. I have led dossier evaluations of GM animals previously at the US Food and Drug Administration and served on the last two CBD AHTEG for RA/RM as well.
I would like to support those interventions that have highlighted that the term “animal” is quite broad and as such requesting for specific challenges to such a broad category is not practical or useful. Such challenges are obviated by the CBD and Cartagena Protocol’s stated need for all LMO Risk Assessments to be conducted on a case-by-case basis. Specific challenges will be clearer when considering the specific Target Organism and modifications along with their intended use and receiving environment. A broad blanket statement on challenges would not help us move forward in terms of generating specific guidance.
The points mentioned in question 3 on specific issues concerning this topic to my mind are more aligned with generating pathways to harm for a particular risk assessment. Again, this would vary on a case specific basis and when taking protection goals into account. Asking generic broad questions on potential pathways to plausible harms will not lead us to the need for specific guidance as the broadest guidance is already encapsulated more than adequately in Annex III of Cartagena Protocol.
The main gap that I see via the comments is a lack of technical expertise in the conduct of risk assessment which cannot be bridged by having more guidances. I believe that best way forward is for more specific capacity building either bilaterally with countries that have expertise in this area and those that do not or at a regional level again with a lead country that has experience and expertise in LMO assessment- ERA, EIA or ESHIA or all of the above. As others have stated the general Risk Assessment framework is well established and operationalizing it based on the specific use case is where the questions appear to be arising. I would strongly recommend looking to build networks for capacity building among regulators and decision makers. GeneConvene Global Collaborative is also happy to assist with capacity building and sharing data and information that is not confidential.
Also the BCH could highlight Risk Assessments on their website with the underlying baseline data that was provided to support decision making.
Best wishes
Brinda
I would like to support those interventions that have highlighted that the term “animal” is quite broad and as such requesting for specific challenges to such a broad category is not practical or useful. Such challenges are obviated by the CBD and Cartagena Protocol’s stated need for all LMO Risk Assessments to be conducted on a case-by-case basis. Specific challenges will be clearer when considering the specific Target Organism and modifications along with their intended use and receiving environment. A broad blanket statement on challenges would not help us move forward in terms of generating specific guidance.
The points mentioned in question 3 on specific issues concerning this topic to my mind are more aligned with generating pathways to harm for a particular risk assessment. Again, this would vary on a case specific basis and when taking protection goals into account. Asking generic broad questions on potential pathways to plausible harms will not lead us to the need for specific guidance as the broadest guidance is already encapsulated more than adequately in Annex III of Cartagena Protocol.
The main gap that I see via the comments is a lack of technical expertise in the conduct of risk assessment which cannot be bridged by having more guidances. I believe that best way forward is for more specific capacity building either bilaterally with countries that have expertise in this area and those that do not or at a regional level again with a lead country that has experience and expertise in LMO assessment- ERA, EIA or ESHIA or all of the above. As others have stated the general Risk Assessment framework is well established and operationalizing it based on the specific use case is where the questions appear to be arising. I would strongly recommend looking to build networks for capacity building among regulators and decision makers. GeneConvene Global Collaborative is also happy to assist with capacity building and sharing data and information that is not confidential.
Also the BCH could highlight Risk Assessments on their website with the underlying baseline data that was provided to support decision making.
Best wishes
Brinda
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
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
