2. Living modified organisms produced through new biotechnologies

I would like to thank Ana Laura Mello for moderating this discussion and the Secretariat for facilitating it.
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.
Having joined last week's discussion late and not fully following the moderator's instructions, I will now try to correct both failures by starting early and following the questions set out to structure the discussion.
1. How does this topic potentially pose challenges to the existing risk assessment frameworks, guidance and methodologies? Do solutions exist?
CP9/13 Annex I sets out a process for recommending specific issues for consideration. However, the issue at hand has not been clearly described or defined what is meant by new biotechnologies in this context. The issue therefore remains broad rather than specific. In the submissions to NTF-2025-017, only the example of gene drives was given. As guidance on the latter issue has just been welcomed by the Meeting of the Parties, this could hardly be the focus or even part of further guidance materials.
Another very important condition to be met according to CP9/13 Annex I (b) is that the issue falls within the scope of the Protocol. As the topic is broad and not sufficiently defined, it is not possible to positively verify whether the issue meets this condition.

2. What could be the specific challenges to related to this issue?
The question relates to condition CP9/13 Annex I (d) "The challenges in addressing the specific issue are clearly described". As the issue under discussion is not sufficiently defined and therefore unspecific, the challenges in addressing it have not been, and probably cannot be, clearly described. Therefore, I do not consider this condition to be met.

3. What are the specific issues concerning this topic?

4. Are there existing resources on similar issues that can address this issue or resources that could be adapted to address this need?
As mentioned above, guidance material is available for the one example given, gene drives. I am also sure that other aspects that might fall under this broad topic are covered by existing guidance material (s. #12404). I would therefore reiterate arguments made earlier (#12361, #12372) that duplication of guidance material should be avoided, for clarity and efficiency reasons.


On the basis of the above, I consider that this topic does not meet the criteria set out in decision CP-9/13 for the process of identifying and prioritising specific issues for risk assessment of living modified organisms.

Werner Schenkel

Dear colleagues,

My name is Anastasia Matthies and I work at Federal Office of Consumer Protection, where I am responsible for the risk assessment of LMOs. Firstly, I would like to express my gratitude to the moderators and all participants for the interesting and informative discussion.

In my view, this topic is too broad and not sufficiently defined to allow verification of whether it meets the criteria set out in decision CP-9/13. In general, existing risk assessment methodologies provide the means to address the challenges of risk assessment of living modified organisms produced by new biotechnologies.
As mentioned above in the contributions to the Forum on genome-edited mammals, resources and guidance developed for LMOs will generally be suitable in their core approach for the risk assessment of living modified organisms produced by new biotechnologies. The problem formulation approach, based on pathways to harm, provides a flexible and robust framework for framing and informing case-by-case risk assessments of all LMOs. The universality of this approach is based on the fact that it can be flexibly applied to any type of species and modification, because the focus is not on the technology or the organism, but on the process of hazard identification, taking into account all factors (trait, modification, organism, released environment, exposure, etc.) and the resulting pathway to harm. The only challenge (and it is not specific to this issue) is to thoroughly inform the resulting test hypotheses. In essence, the challenge lies in the practical application of the concept. Training and capacity building for interested parties should therefore be directed in this direction.

Best regards,
Anastasia Matthies

Dear Colleagues,

Firstly, thank you again Mr. Schenkel and Ms Matthies for providing inputs and views on the guiding questions related to the criteria in annex I to decision CP-9/13.

I would like to encourage you to contribute to the topic of LMOs produced through new biotechnologies before the close of the first week of discussions on Monday 5 May at 11 a.m. Montreal time.

Also, as a kind reminder, I would appreciate if you would be able to share the DOI or URL links when sharing references and resources.

I look forward to discussions,

Ana Laura Mello

Esteemed colleagues,

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

1. Most current guidelines and regulatory frameworks focus on living modified organisms developed through recombinant biotechnology, which are not always applicable to living modified organisms obtained through new biotechnologies. This situation arises due to ambiguity and lack of clarity regarding whether living modified organisms derived from new biotechnology should be regulated in the same way or differently from those produced using recombinant biotechnology.

Also worth mentioning, is new Biotechnologies can comprise a vast diversity of methodologies which can generate that risk assessment must deal with more intriguing and complex issues than risk assessments for living modified organisms obtained by recombinant biotechnology (Example: Off target Effects).

Additionally, regulatory inconsistencies between countries due to a lack of a harmonized scope regarding living modified organisms derived from new biotechnologies, lead to diverging approaches to risk assessment and create regulatory barriers to trade. This lack of alignment affects the development of universal frameworks to work with.

Finally I must say that the pace at which new biotechnology techniques emerge often outpaces the development and implementation of corresponding regulations and frameworks. This results in a regulatory lag that creates gaps in the approval process for living modified organisms obtained through these new biotechnologies, whether for confined research or commercial use.

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

Question 1
In comparison the LMOs derived from ‚older‘ technologies (such as transgenic crops) the rise of ‘New LMOs’ (obtained from genome editing or new genomic techniques) e. g. raise new challenges in regard to
- speed of the development
- the broad range of traits
- the broad range of species, also including those beyond the fields
- the broad range of ecological networks concerned
- the possible scale of releases (in terms of number of species and number of events)
- the potential for ‚outdoor genetic engineering‘ (which means LMOs organisms are released to transform natural populations directly in the environment without the possibilities for control as known from laboratories)
- the development of ‘paratransgenesis’
- the involvement of AI for generating LMOs without sufficient human control.

To give an overview on some of these developments we recently published a report (Testbiotech, 2024).


Question 2
In general, the international framework has to be strengthened to comply with the goals of the Protocol for notification and information as well as labeling requirements and risk assessment procedures and unintended transboundary movements.

More guidance will be needed how to identify unintended genetic changes caused by the processes of ‘New biotechnology’ that are of relevance for risk assessment.

More guidance may also be needed for New LMOs that are obtained by small genetic changes without the introduction of additional DNA but nevertheless are unlikely to be obtained from classical breeding. In this context, we just recently published a backgrounder on ‘technical tuning’ of LM plants Testbiotech 2025).

A specific guidance is needed for how to assess the risks of LMOs that intentionally or unintentionally may spread and propagate in wild populations.

Specific guidance will be needed how to assess, limit and control the risks of a combination of different and large scale releases of LMOs into shared environments and their accumulated impact.

Guidance will be necessary how to address interactions and emerging risks in regard to complex systems such as microbiomes, symbiosis, pollination, foodwebs, climate adaption, co-evolution and population dynamics.

Specific guidance is necessary how in case to address too many unknowns and uncertainties and how to define and apply cut-off criteria for a refusal of experimental releases or commercial authorisation.

Question 3
All four questions can be answered with yes.

Question 4
So far, discussions about risks of ‘New LMOs’ have been mostly focused on LM gene drive organisms. However, in regard to risks to the environment and unintended transboundary movements, the overall framework and the specific has to be developed further to comply with the actual challenges.


References
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) ‘Technical-tuning’ of NGT plants shows: There is no magic threshold for the number of mutations to conclude on risks, https://www.testbiotech.org/publikation/technical-tuning-of-ngt-plants/

Thank you Ms Mello for your moderation, enthusiasm, and encouragement of participants. I acknowledge and appreciate the earlier interventions made on this topic.

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

The original submission from Egypt clearly articulates the challenges for existing frameworks: “Currently, there appears to be no risk assessment frameworks developed for this emerging field, despite products being close to market or released into the environment.”

I am not of the thinking that this topic, as precisely described by Egypt, is unmanageable. In my reading of that submission what has become this topic and topic 3 (LMOs expressing genome machinery for pest or pathogen control) of the forum were not obviously separated into two and they could be easily merged, if necessary, avoiding the need for Parties to choose between topics 2 and 3. To the degree that this topic might stretch the capacity to address it only in mind reinforces the need to address it.

I am aware of suggested frameworks for this topic in the research literature. Guidance could help to evaluate and translate, and to identify additional gaps if any, for Parties to operationalise their risk assessments. This would be in accord with operational objective 1.3 referenced in Decision BS-VII/12.

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

The specific challenge was also described by Egypt: "CRISPR-based [genome editing reagents] live bacterial sprays for controlling agricultural pests, and CRISPR-based [genome editing reagents] live bacteria incorporated into animal feed … For the first time, such applications would involve the release of not just of an LMO, but would also intentionally or unintentionally generate an LMO directly in the field. Moreover, any exposed nontarget organism could additionally be modified, depending on the sequence similarity of the CRISPR targets."

The outcomes descried above are not limited to gene drives, nor are they limited to use of only live bacteria, as I describe in post #12410. New techniques include delivering DNA or RNA for expression in recipient cells or direct delivery of oligonucleotides for oligonucleotide directed mutagenesis or ribonucleoproteins for gene editing. The efficiencies achieved by advances in tools such as those for gene editing makes it possible to produce intended products of modern biotechnology outside of contained laboratories, but it does not eliminate the co-production of unintended and potentially undesirable products also [1-5].

Annex III of the Protocol is a recipe based on the presumption that a particular organism is in the assessor’s possession and can be described, along with the relevant protection goals, potential adverse effects, and exposures. It draws upon the framework such as presented by the US National Research Council all the way back in 1987. Their Figure 2.1 shows a series of steps going from ‘biological source material→genetic modification by classical or cellular/molecular methods←→selection of desired form→evaluation in laboratory and/or field tests→large scale introduction’ [6].

Annex III can only work if "evaluation in laboratory and/or field tests" precedes release into the environment. Without the constraint of confinement and verification prior to release into the environment, it is challenging to imagine how case-by-case assessment can be done. It may not be impossible to address this challenge. To do so though requires new Guidance.

3. What are the specific issues concerning this topic?
(i)
These can only be determined by case-by-case risk assessment. Moreover, there is a significant potential to undermine prior informed consent.

(ii) Is there the potential to have an introduction into the environment either deliberately or accidentally?

Yes

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

Yes

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

There are a number of descriptions of emerging products of this kind in the research and patent literature. For example, in "Compositions and methods for scalable production and delivery of biologicals", US 2024/0081325 A1, is a process to produce minicells for encapsulating biological material, including site-directed nucleases and guide oligonucleotides for genome editing. The cells can be derived from bacteria, fungi, plants, or animals.

"[M]inicells disclosed herein can be uptaken to target plants and translocated to target cells when the minicells encapsulating biologically active compounds are applied to leaves of target plants." (I will leave it to another forum – or to future guidance? - to debate whether minicells are “alive”. In any case, whereas the patent may be specific to minicells, the concept and applications described could use any kind of cell.)

And their potential use is not limited to plants.

"The present disclosure teaches that a target cell comprises a plant cell, an insect cell, a worm cell, a bacterial cell, a fungal cell, a virus and a cell of an aquatic animal, wherein said aquatic animal comprises a fish, a shellfish, and a crustacean."

And their use is not limited to one or a small number of exposure routes.

In addition to application to living organisms both inside and outside of a contained facility, the invention may be applied to "any surface that may contact harvested crops including harvesting equipment, packaging equipment and packaging material."

To some extent this topic also has a connection with Week 3 Topic 2 on operationalising protection goals into relevant endpoint assessments. Any risk assessment framework is dependent on information specific to the LMO(s). The developing new chemical and biological vectors for the new techniques are not specific to an intended organism and therefore some uses result in unintended and unknown exposures. Furthermore, it may not always be possible to both formulate plausible and testable hypotheses. The precautionary approach may be required if the ability to test a plausible hypothesis is beyond available technical capabilities.

1. Heinemann, J.A. et al. (2023) Are Null Segregants New Combinations of Heritable Material and Should They Be Regulated? Front Genome Ed 4, 1064103.
2. Heinemann, J.A. and Walker, S. (2019) Environmentally Applied Nucleic Acids and Proteins for Purposes of Engineering Changes to Genes and Other Genetic Material. Biosafety Health 1, 113-123.
3. Hoepers, A.M. et al. (2024) Predicted Multispecies Unintended Effects from Outdoor Genome Editing. Ecotox Environ Safety 282, 116707.
4. Li, J. et al. (2021) Advances in Synthetic Biology and Biosafety Governance. Front Bioeng Biotechnol 9, 598087.
5. Mueller, S. (2019) Are Market Gm Plants an Unrecognized Platform for Bioterrorism and Biocrime? Front Bioeng Biotechnol 7.
6. NRC. (1989) Field Testing Genetically Modified Organisms: Framework for Decisions. National Research Council (Us) Committee on Scientific Evaluation of the Introduction of Genetically Modified Microorganisms and Plants into the Environment, The National Academies Press.

1. How does this topic potentially pose challenges to existing risk assessment frameworks, guidance, and methodologies? Do solutions exist?
Challenges:
Regulatory ambiguity: Many LMOs created using techniques like CRISPR or base editing may lack foreign DNA, leading to regulatory uncertainty about whether they fall under the definition of LMOs in some jurisdictions.

Scientific complexity and novelty: New biotechnologies can result in complex traits (e.g., multiplex editing, gene drives) whose ecological interactions are difficult to predict or assess using conventional frameworks.

Detection and traceability: Genome-edited organisms may be indistinguishable from naturally occurring variants, complicating monitoring, detection, and compliance.

Lack of specific guidance: Current CBD risk assessment guidance was developed primarily for “classical” GMOs, and may not adequately capture the breadth and novelty of organisms derived from synthetic biology or other new techniques.

Possible Solutions:
Update or supplement risk assessment guidance: The CBD's Roadmap on Risk Assessment and AHTEG guidance documents could be adapted to better address new biotechnologies (as has been discussed in COP and SBSTTA processes).

Case-by-case assessments: Tailored assessments based on product characteristics, rather than the technique used, can allow for more proportional regulation.

Use of whole-genome sequencing and -omics tools: These can help characterize both intended and unintended changes.

International cooperation: Harmonized definitions and data-sharing can reduce regulatory fragmentation.

2. What could be the specific challenges related to this issue?
Risk uncertainty: New molecular tools may result in subtle or systemic changes that are hard to predict, assess, or model.

Transboundary impacts: Some organisms (e.g., those involving gene drive systems) are designed to spread, posing challenges to national sovereignty and international oversight.

Socioeconomic and ethical issues: Concerns arise about ownership, access, and use of biotechnologies, particularly in relation to Indigenous Peoples and Local Communities (IPLCs).

Regulatory divergence: Different national approaches to what constitutes an LMO complicate international trade and biosafety enforcement.

Cumulative effects and long-term monitoring: Continuous use of new biotech-derived LMOs without proper post-release monitoring could lead to unpredictable ecological effects.

3. What are the specific issues concerning this topic?
(i) Potential to cause adverse effects on biodiversity and human health:
Yes.

Gene drive organisms may alter entire wild populations, potentially eradicating species or altering ecosystem dynamics.

Synthetic biology organisms might introduce novel traits or biochemical pathways with unknown ecological interactions.

Impacts on IPLCs: New traits could threaten traditional species/breeds or affect access to culturally significant biodiversity.

(ii) Potential for deliberate or accidental environmental introduction:
Yes.

Many organisms are intended for agricultural, environmental, or public health release (e.g., disease-resistant crops, gene drive mosquitoes).

Lab or facility escapes could occur in cases where bio-containment is inadequate.

(iii) Potential to disseminate across national borders:
Yes.

Gene drive organisms, self-propagating organisms, or LMOs used in open field environments (e.g., insects, fish) could spread beyond intended areas and across borders without consent.

(iv) Commercialization or current use status:
Yes.

Several genome-edited plants (e.g., soy, tomato, rice) are already on the market or approved in countries like the U.S., Brazil, and Japan.

Gene-edited livestock (e.g., heat-tolerant cattle, disease-resistant pigs) and insects (e.g., Oxitec mosquitoes) are in advanced stages of development or experimental release.

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

Dear colleagues,

I would like to thank Ms Ana Laura Mello and the Secretariat for moderating and organizing this important discussion. I would also like to thank the colleagues for their insights and information shared.

Please kindly see my answers to the guiding questions under this topic:

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

New biotechnologies serve as an umbrella term to describe organisms that have been genetically modified using techniques other than the well-known and commercialized transgenic methods. The EU is attempting to regulate these technologies under the term “New Genomic Techniques (NGT)” for plants. Brazil has a specific resolution on Precision Breeding Innovation Techniques (Tecnologias Inovadoras de Melhoramento Genético - TIMP, in Portuguese). There appears to be some confusion regarding the terminology used for ‘techniques,’ ‘applications,’ and ‘products.’ The list of techniques is not extensive and can be clearly defined.

Most importantly, Parties have been submitting information on their needs and priorities concerning these types of techniques even before Decision CP-9/13, such as in SCBD/CPU/DC/MA/MW/87798 (2019-009), SCBD/SPS/DC/MPM/MW/86376 (2017-035), and SCBD/BS/MPM/DA/85215 (2015-138). Post-decision submissions include SCBD/CPU/DC/WM/MW/90762 (2023-129) and SCBD/CPU/DC/WM/MAQ/MW/90762 (2023-007). It is also relevant to note submissions concerning the Synthetic Biology topic under CBD.

Regarding challenges to existing risk assessment frameworks, I refer to the arguments presented by colleagues in #12424, #12429, #12410, and #12430, on the other thread titled ‘Living modified organisms expressing genome editing machinery for pest or pathogen control.’ I believe this topic could also be integrated with the current discussion.

There are no existing frameworks that specifically address LMOs obtained through new biotechnologies capable of creating other LMOs in the environment. An example of an already commercialized product is BiomElix One® Guided Biotic from Folium Science (https://foliumscience.com/products/). This product is a CRISPR-expressing E. coli strain designed to target Salmonella bacteria in the chicken gut. It is delivered to chickens as a dry feed additive. The CRISPR components are introduced to Salmonella via conjugation, where the CRISPR machinery modifies vital genes in Salmonella, leading to bacterial death. Data on modified-Salmonella escape and survival and reproducibility rates are currently unknown.

There are no dedicated frameworks for LMOs in which endogenous gene(s) are modified to express a new trait, for example. However, several gene-edited LMOs with modifications to endogenous genes have already been commercialized, such as SLICK-edited Angus cattle, FLT01-edited tilapia, CD163-edited pigs, drought-edited soybean, and waxy-edited corn.
In addition, the majority of these LMOs are in fact null-segregant individuals that were generated from transgenic cassette negative individuals. Dedicated guidance is needed with regards to the comparative approach and the choice of comparators as, in these cases, the parental line is also a LMO.

I understand that solutions to the challenges will be built within the work of the CBD and the CP such as the one being done now, and domestically, and that should culminate with robust regulation and risk assessment methodologies.

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

Existing risk assessment guidance primarily address transgene flow in plants and, to some extent, horizontal gene transfer in microorganisms. However, for LMOs obtained through new biotechnologies, there is the potential and/or intention to modify other organisms via different vertical and horizontal pathways.

These new routes are based on the fact that LMOs can, and in some cases will intentionally, deliver reagents (such as CRISPR, other enzymes, or oligonucleotides) to other organisms for genome editing. The genome editing modifications introduced in these organisms could then be transferred to other organisms through various vertical and horizontal routes. Such pathways are not currently anticipated or covered within existing frameworks.
The case for null-segregants has been explain in question #1.

3. What are the specific issues concerning this topic?

(i) Is there the potential to cause adverse effects on biodiversity, in particular those that are serious or irreversible, taking into account the urgent need to protect specific aspects of biodiversity, such as an endemic/rare species or a unique habitat or ecosystem, taking into account risks to human health and the value of biological diversity to indigenous peoples and local communities?
Yes, there is a risk of irreversible changes to the genomes of non-target species, as well as unintentional irreversible changes in target species that could impact entire populations and their ecological niches. Indigenous peoples and local communities could be particularly affected when LMOs are released into areas where they reside.
Three examples can be drawn from our recent study on pesticide products that have the potential to modify genes in agricultural pests. We investigated whether such products, inspired by commercialized RNAi pesticides and the emerging literature on this topic, could potentially target genes in humans. Our bioinformatic analysis showed concerning and positive results indicating possible gene targets within the human genome.
I also agree with #12433 that there is a significant potential to undermine prior informed consent in these cases.
Hoepers A M, et al. Predicted multispecies unintended effects from outdoor genome editing. Ecotoxicol Environ Saf. 2024 Sep 1;282:116707. doi: 10.1016/j.ecoenv.2024.116707. Epub 2024 Jul 12. PMID: 38996645.

(ii) Is there the potential to have an introduction into the environment either deliberately or accidentally?
Yes.
(iii) Is there the potential to disseminate across national borders?
Yes.

(iv) Is the LMO already, or are likely to be, commercialized or in use somewhere in the world?
Yes. In Heinemann et al (2019) there are several references to commercial products and also a patent analysis. But also products approved in the US and Brazil.
Heinemann, J.A. and Walker, S. (2019) Environmentally Applied Nucleic Acids and Proteins for Purposes of Engineering Changes to Genes and Other Genetic Material. Biosafety Health 1, 113-123.

4. Are there existing resources on similar issues that can address this issue or resources that could be adapted to address this need?
I am aware that methodologies in this area are scarce in the scientific literature. Nevertheless, I agree with #12433 that guidance from this Convention and Protocol is needed to translate these methodologies into potentially relevant frameworks that align with the Parties' needs and priorities, and that support the goals and objectives of the Convention and Protocol.

Some of our collaborative research work discuss these challenges and provide some way forward:

Hoepers A M, et al. Predicted multispecies unintended effects from outdoor genome editing. Ecotoxicol Environ Saf. 2024 Sep 1;282:116707. doi: 10.1016/j.ecoenv.2024.116707. Epub 2024 Jul 12. PMID: 38996645.
Heinemann JA, et al. Are null segregants new combinations of heritable material and should they be regulated? Front. Genome Ed. 2023 4:1064103.
Benevenuto, R. F., et al. Alterations in genetically modified crops assessed by omics studies: Systematic review and meta-analysis. Trends in Food Science & Technology 2022 120, 325–337. doi: 10.1016/j.tifs.2022.01.002
Chu, P.; Agapito-Tenfen, S.Z. Unintended Genomic Outcomes in Current and Next Generation GM Techniques: A Systematic Review. Plants 2022, 11, 2997. https://doi.org/10.3390/plants11212997
Agapito-Tenfen SZ, et al. Revisiting Risk Governance of GM Plants: The Need to Consider New and Emerging Gene-Editing Techniques. Front. Plant Sci. 2018 9:1874. doi: 10.3389/fpls.2018.01874

Dear participants,

My name is Luciana Ambrozevicius, I´m a regulator and a risk assessor at the Brazilian Biosafety Commission. Thank you for the opportunity to participate in the on line forum. For the proposed topic “Living modified organisms produced through new biotechnologies” 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 “Living modified organisms produced through new biotechnologiesis” is too broad, no specific challenges can be identified, only general considerations that do not add value for risk assessors. On the contrary, a guidance on this topic will probably present a list of concerns that are more related with decision-making and not reflect the scientific nature of the Cartagena Annex III.

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,

Thank you all very much for your contributions. I appreciate the exchange and the provision of references, which will undoubtedly be a very valuable contribution to the work of the AHTEG. For those who haven't yet participated, please remember that you have until 11 a.m. tomorrow (Montreal time).

Best regards,

Ana Laura

1. Potential Challenges to Existing Risk Assessment Frameworks:
Living Modified Organisms (LMOs) produced through new biotechnologies, such as gene editing and synthetic biology, challenge existing risk assessment frameworks by introducing novel traits and pathways that current methodologies may need to be expanded to capture accurately. Many frameworks are designed around first-generation GMOs, limiting their ability to evaluate complex, unintended consequences at genetic, ecological, and socio-cultural levels. Furthermore, these frameworks often exclude gender analysis and indigenous perspectives, vital for assessing broader societal impacts. Solutions include integrating transdisciplinary methods that combine scientific and traditional knowledge systems, and applying gender-responsive risk assessment protocols
2. Specific Challenges:
Key challenges include excluding indigenous knowledge systems and gendered data in scientific risk analysis, limited regulatory capacity in developing countries, lack of informed public engagement, and infrastructural imbalances in biotechnology development and deployment. Women and Indigenous communities are often primary stewards of biodiversity, yet their concerns and knowledge are overlooked.
3. Specific Issues Concerning LMOs:
 Transboundary dissemination: Gene flow across national borders varies within countries and affects ecosystems.
 Commercialization: Many LMOs are already in experimental or commercial use globally, necessitating the design of harmonized safeguards within countries
4. Existing Resources:
Resources such as the Cartagena Protocol, the AHTEG guidance on risk assessment, and indigenous protocols like the Nagoya Protocol offer entry points for integrating local knowledge and gender mainstreaming.

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

I would like to express my gratitude to the moderator for this important forum and to all participants for their valuable contributions. After reviewing the different interventions, I would like to offer some comments on the topic of living modified organisms produced through new biotechnologies.

I fully support the positions expressed in posts #12405 and #12413, which point out that this topic is too broad and not sufficiently defined to allow verification of whether it meets the criteria established in decision CP-9/13 for the process of identifying and prioritizing specific issues.

A fundamental point raised in posts #12405 and #12446 is that the issue at hand "has not been clearly described nor has what is understood by new biotechnologies in this context been defined." This vagueness makes it impossible to verify whether the topic falls within the scope of the Protocol, which is a critical condition that must be met according to CP9/13 Annex I (b).

Respectfully,
Ediner Fuentes-Campos

In my view, the topic of new biotechnologies, which encompass a vast array of techniques, is too broad and not sufficiently defined. This lack of a precise definition makes it difficult to determine what specific technologies, organisms or applications are being referred to. Without clear boundaries, the topic remains too general and ambiguous, making it difficult to verify whether it meets the criteria established in decision CP-9/13. This vagueness complicates the process of identifying and prioritising specific issues for risk assessment.

Because the topic is so broad, there is a risk that new guidance could overlap with existing materials. Guidance material is already available for certain aspects, such as engineered gene drives, and other aspects might be covered by existing documents. This could lead to duplication of efforts and reduce the clarity and efficiency of risk assessment processes.

Existing risk assessment methodologies provide reliable means to address the challenges posed by new biotechnologies. The problem formulation approach, based on pathways to harm, is flexible and robust enough to frame and inform case-by-case risk assessments of LMOs.

I wonder whether the challenge lies in the practical application of existing concepts rather than the need for new guidance. Therefore, training and capacity building for interested parties could focus on thoroughly informing test hypotheses and applying existing frameworks effectively.

Question 1: How does this topic potentially pose challenges to the existing risk assessment frameworks, guidance and methodologies? Do solutions exist?
Whereas the topic  of new biotechnologies may need clarity on the definition parameters, Living Modified Organisms developed through new biotechnologies especially utilising synthetic biology tools, may present technical and regulatory considerations, including but not limited to precision and speed of genetic modifications, unpredictable off-target effects and or de-novo risks. 
While these developments may introduce complexity, they do not undermine or invalidate the foundational relevancy  of the Cartagena Protocol’s risk assessment framework to handle the same. Annex III provides a solid structure—based on scientific soundness, transparency, and case-by-case analysis—which remains applicable and adaptable.
Solutions exist, including:
• Additional voluntary guidance materials, such as those on engineered gene drives,
• Contextualized capacity-building by AUDA-NEPAD
• Utilization of international best practices tailored to African ecosystems and regulatory contexts.
Question 2: What could be the specific challenges related to this issue?
Challenges specific to new biotechnologies in Africa include:
a.Technical capacity gaps: Many countries may have limited expertise to evaluate potential risks associated with the use of synthetic biology.
b. Lack of regulatory clarity
Whereas, some countries have some broad biosafety laws, there is need for specific implementation guidelines, to support implementation.

Question 3: What are the specific issues concerning this topic?
(i) Potential to cause serious or irreversible effects on biodiversity and human health
This is subject to risk assessment where this could be  approached on a  case by case basis.  

(ii) Potential to disseminate across national borders
Yes. Once introduced, LMO may  cross national boundaries, reinforcing the need for regional cooperation and harmonized biosafety oversight, shared technical capacity and information sharing.
(iii) Current or potential for commercialization
Yes. Products of new biotechnologies are being developed globally for food, agriculture, health and industrial purposes. Some African countries are engaging in early research and field testing, and must prepare regulatory pathways ahead of commercialization.
Question 4: Are there existing resources on similar issues that can address this issue or resources that could be adapted to address this need?
Yes. Several resources can be adapted or expanded to address the risk assessment needs for LMOs from new biotechnologies:
• Voluntary guidance on risk assessment for living modified organisms (LMOs) containing engineered gene drives.
• WHO-Guidance Framework for Testing Genetically Modified Mosquitoes
• Regional tools and protocols developed by AUDA-NEPAD including:
o Risk analysis frameworks,

In conclusion, LMOs produced through new biotechnologies may present both opportunities(benefits) and regulatory challenges(potential risks). AUDA-NEPAD supports the continued application and adaptation of existing risk assessment frameworks, backed by regional coordination, capacity building, and evidence-based policy tools. Africa’s biosafety systems must evolve to ensure that innovation proceeds safely, sustainably, and in alignment with public interest.

Dear All,

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

Firstly, it is necessary to clarify that the Cartagena Protocol does not mention "new biotechnologies." Instead, in Article 3, item "i," it refers specifically to "modern biotechnology," thereby restricting its application to in vitro nucleic acid manipulation techniques - including recombinant - or the fusion of cells from species that would not naturally interbreed.

Although the broad scope of the term "new biotechnologies" makes it impossible to delineate or identify the inherent challenges, it is important to remember that the criteria established in decision CP9/13 Annex I, item "b," require that the issue must fall within the scope of the Cartagena Protocol.

Based on the above, as I understand it, any new guidelines must add value - that is, the materials should focus on clearly defined and specific issues, which is not the case here. For this purpose, Annex III of the Cartagena Protocol has proven sufficient and adequate over the past 25 years.

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

Dear all,

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

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

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

If the final product is an LMO, it must comply with the relevant Argentine regulations for LMOs.

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

The challenge is for all countries to reach an agreement and harmonize their regulations under a common approach to LMOs.

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?

These are addressed through the local LMO regulations of each country and the criteria established in the Cartagena Protocol.

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

Yes, however, both national regulations and the Cartagena Protocol contain specific provisions regarding the transboundary movement of LMOs.

This is a vital topic that encompasses some of the more specific issues raised in other topics under discussion, and thus I think it provides a useful overarching theme for highlighting the challenges being raised to a wide variety of applications by newer techniques such as genome editing. I would like to fully support and echo previous comments #12429, #12433, #12435, #12436 that comprehensively highlight why this issue fits the criteria for further guidance.

Firstly I would like to again, post a link to our legal analysis on why genome edited organisms are not excluded from the definition of an LMO under the Cartagena Protocol. The definition does not limit LMOs to those carrying foreign genetic material, but also to those with edits or small deletions. As such, even for those organisms that are not designed to carry foreign DNA, they still fall within the definition of an LMO under the Protocol (Sirinathsinghji, 2020).
As detailed in our analysis, Annex III covers unintended changes that may occur as a result of the GE process, such as accidental insertion of genetic material during genome editing engineering. As such,  organisms with intended outcomes of SDN-1, -2 and -3 fall within the scope.

Q1. The range of applications and species being targeted for engineering is growing, along with potential scale of releases, challenging existing frameworks for applications. Applications are also broadening beyond crops, into other aspects of agriculture (e.g. livestock microbiomes, re-domestification of wild species), public health (e.g. precision guided sterile insects that carry CRISPR machinery) and conservation (de-extinction eradicating invasive species), challenging current frameworks and experiences.

Currently, some applications are progressing to field trials and even commercialisation, some of which are being caterogised as non-LMOs despite the concerns of risks raised extensively in this forum on the various topics.

Highlighting the range of applications I also will answer Q3 (iv) here with some examples in addition others already raised (e.g. edited tilapia, high GABA tomatoes, waxy corn, Folium sciences Guided Biotics CRISPR-expressing E.coli).

In the US, trials appear to already be going ahead for LMO flies carrying CRISPR machinery for pest population control (Agragene).  Synvect is also developing similar technology for mosquito applications to be applied to the EU and US.  The UK company Genus, has also developed edited mammals that are also undergoing/have undergone regulatory review. The products listed under Brazil’s CTNBio website is also illustrative of the range of applications and species being approved that have been produced with new biotechnologies: https://ctnbio.mctic.gov.br/documents/566529/2304555/Tabela+TIMP/8c4a7218-f810-405b-94bf-a352d849f3dc?version=1.18
INARI, a company currently approved for trials in the EU, is also combining genome editing with existing herbicide tolerant and insecticidal Bt traits, adding additional complexities and uncertainties. Their strategy for example, to introduce regulatory genetic elements or alter/edit genetic elements introduces additional level of molecular complexity (e.g. altered expression of hundreds of genes), that does not necessarily correlate with the extent of genetic alteration e.g. a small edited to an enhancer element could have profound molecular impacts on an organism.

For the precautionary approach to be adhered to,  it is my view that risk assessments cannot be based around presumed claims of precision and safety that is based on intended design, e.g. that foreign DNA is not intended to be introduced. It is well established that unintended insertions are a common outcome of the genome editing process, and thus produced designed to have SDN-1 or -2 outcomes also warrant checks for transgenic insertions and other unintended effects.

While the topic covers a range of applications and species, a common thread throughout many of the posts are the challenges these techniques pose to assessing unintended effects such as on- and off-target changes, accidental insertion of DNA, and the high degree of uncertainty of applications, including for those being applied into wild populations (e.g. insects, microorganisms, endangered animal species etc), raising risks of long term and evolutionary changes, high potential for long range dispersal, persistence and transboundary movements, and the potential for unforeseen ecological impacts, for example.

With regard to topic 3 on LMOs carrying CRISPR machinery, based on outdated presumptions of safety, we are rapidly advancing towards applications that even move beyond our ability to assess potential unintended effects of the GM process prior to release. This is due to the technology being the release of the GM machinery, not a final product. Such technologies warrant a high degree of precaution, rather than relying on untested assumptions that no unintended effects are possible, paving the way for potential live environmental engineering of wild population, both target and non—target, without the ability to assess.

Q4: I will also post here my comments from the edited animals topic, on the pathways to harm approach in existing guidance materials on gene drives. In my view, utilising this guidance would be insufficient in addressing such unintended effects of the GM process, and in covering all potential pathways to harm due to the selective assessment nature of the method.

Moreover, the method does not sufficiently address uncertainties. The ‘pathways to harm’ approach promotes asking specific questions that can “demonstrate safety” rather than asking open, unbiased questions. Such a method also gets around addressing ‘unknown unknowns’, and this risks falling out of line with the precautionary principle. Other alternative processes such as the introduction of cut-off criteria as proposed by Christoph Then in other posts, provides a means to operationalise the precautionary approach that is lacking from the gene drive guidance.

My comment on pathways to harm from edited animals topic:

With regard to the suggestion that the recent guidance materials for LMOs containing engineered gene drives could be used more widely for other LMOs, I would like to highlight that those materials are voluntary. In contrast, Article 15 obligations under the Protocol require risk assessments  to be “carried out in a scientific manner, in accordance with Annex III”, without specifying a type of methodology. In our view, the topic of genome edited mammals meets the criteria under CP9/13, and key to this is that the risk assessments must be in accordance with Annex III.

Reliance on the ‘pathways to harm’ approach as described in the gene drive guidance may fail to provide sufficient considerations of the specific risks and challenges raised by edited mammalian applications (as well as the other topics in this online forum).  Proposals to adopt this approach for all future LMOs focus only on unintended effects of the intended trait, risking missing out the abovementioned central risks of genome editing, which include the unintended effects of the process itself. Moreover, within the voluntary guidance itself, linkages back to specific risks of new technologies (in this case, gene drives) are generally restricted to the mosquito section of the guidance.

Such a narrow implementation of a problem formulation/pathways to harm approach, risks weakening assessments such that that unintended effects and the engineered organism as a whole are not systematically assessed unless they relate to the intended design. For example, if assessment of unintended effects is restricted to the introduced trait, and not the process, any assessment along these lines would not detect on- and off-target effects that include accidental insertion of genetic material, as well as small- and large-scale unintended changes to the genome as has occurred in the case of the hornless cattle. If claims of equivalency with conventionally-bred animals are assumed for edited animals with no intended insertions, then no pathways to harm would be selected to assess unintended genotypic and phenotypic changes such as this. The selective approach to testing also challenges alignment with the precautionary approach,  Another challenge to the precautionary approach is that this method requires the proof of harm in a causal chain of events, rather than risk.


Sirinathsinghji (2020) Why Genome Edited Organisms are not Excluded from the Cartagena Protocol on Biosafety. Third World Network/GeneWatch UK.  https://biosafety-info.net/new-publications/why-genome-edited-organisms-are-not-excluded-from-the-cartagena-protocol/

With my continued thanks to the CBD Secretariat and to Ms. Mello for providing this opportunity.

I would like to support the views expressed in posts 12405, 12413, 12446, 12476, 12477, 124583 and 12488 that this topic is both far to broad to ever be practically addressed, but also not appropriately scoped for consideration under the CBD at all.  As pointed out in post 12483, the Protocol addresses LMOs produced through modern biotechnology (as defined within the document).  It does not mention "new biotechnologies" or old biotechnologies or imagined biotechnologies.  As is the case with other discussions occurring in parallel with this one, the development of guidance is not only an inappropriate mechanism to attempt to address policy differences between Parties, the possibility of useful material being developed and endorsed by the Parties on such a subject is nil. 

Finally, we continue to see posts mischaracterizing the existing risk assessment framework, and what can be done with it.  This is quite a serious problem, as it appear people are incapable (or unwilling) to consider available guidance and how it might be appropriately applied to cases of novelty.  It holds up remarkably well - in part because Annex III of the Protocol did not arise out of nothing - it builds upon decades of experience in organismal and chemical risk assessment. 

Kind regards,
Andrew Roberts, PhD
Agriculture & Food Systems Institute

Dear All,

My warm thanks to Ana Laura Mello and Anita Anthonysamy for also moderating this second round of discussions.

My name is Piet van der Meer, and I am trained as a microbial ecologist and an environmental lawyer. Since 1986, I have conducted hundreds of risk assessments in regulatory context, and 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.

Following the reminders of the moderators, I have alerted some of my colleagues in academia that there was only a day left for this online debate. Although all those colleagues kindly responded, the thrust of their message was not very encouraging: they felt that there is little point in contributing to this debate, because it is just a repetition of views.

I am afraid that there is truth in that.

More precisely, we seem to be having a repetition of different replies to different questions: 

In response to the moderators’ opening question, some – me included - that the scientifically sound methodology of Annex III can be applied to all categories of LMOs, and that the mentioned categories of LMOs do not challenge that methodology. On the other hand, others replied to the opening question that the existing risk assessment methodology potentially pose challenges for some categories of LMOs.

These are different answers to different questions, be it they are not necessarily mutually exclusive in as far as they address aspects under the scope of this debate. (Notate bene: not all the aspects that were listed as potentially posing challenges for some categories of LMOs fall under the scope of risk assessment under the CPB).

In short, with a view to the follow-up work of the AHTEG: while none of the mentioned categories of LMOs challenge the methodology of Annex III, the application of the methodology Annex can be challenging in specific cases in terms of collecting and evaluating ERA-relevant data. Whether it is worth developing additional guidance documents for that, depends on a cost-benefit analysis that considers things as the availability of already existing guidance, the number of cases for which Parties have received, or are about to receive, notifications, et cetera.

In addition to the fact that the opening questions were interpreted differently, some of the categories of LMOs that are the subject of this debate are so broad that one cannot draw meaningful conclusions as to whether they pose challenges to the risk assessment methodology. This case of “LMOs produced through new biotechnologies” is a good example of that. The term “new biotechnologies” does not tell us anything about the type of resulting novel genetic characteristics that is the starting point for the risk assessment methodology of Annex III.

In short, with a view to the follow-up work of the AHTEG: it will be important to clearly define the categories of LMOs that are being considered.

Similar observations apply to the other topics of the second round of debate, but in the interest of avoiding duplication, I will not repeat them there.

Regards to all,

Piet van der Meer

Dear Moderator and Colleagues,

Thank you for facilitating this critical discussion. Building on insights from previous contributions (e.g., #12405, #12413, #12424, #12429, #12446, #12476), I propose the following approach to address challenges posed by the evolving definition of LMOs under the Cartagena Protocol:

1. Challenges with the Current LMO Definition
The existing definition of LMOs (“any living organism with a novel combination of genetic material from modern biotechnology”) faces ambiguities due to advancements in synthetic biology and genome editing. As noted by Germany (#12405, #12413), the rapid pace of technological innovation (e.g., plasmid-free editing, oligonucleotide-directed mutagenesis) has rendered traditional methods (e.g., Agrobacterium-mediated transformation) obsolete. This creates regulatory gaps, particularly for LMOs lacking foreign DNA or produced via novel pathways (e.g., gene drives, paratransgenesis).

2. Proposed Pathway for Risk Assessment and Regulation
To align with the precautionary approach and scientific evidence-based regulation, we recommend:
A. Focus on the LMO Product, Not the Technology
• Risk assessment should prioritize the outcome (novel traits, ecological interactions) rather than the technique used, as highlighted by Egypt (#12435) and Testbiotech (#12429).
• Case-by-case evaluations for ambiguous cases (e.g., null segregants, endogenous gene edits) to complement existing guidelines, as suggested by Brazil (#12446) and the EU (#12476).

B. Phased Implementation Over the Next Decade
1. Short term (0–5 years): Apply existing Annex III frameworks to LMOs clearly falling under the current definition.
2. Medium term (5–10 years): Develop supplemental guidance for borderline cases (e.g., CRISPR-edited organisms without transgenes) through iterative AHTEG consultations and pilot studies.
3. Long term (10+ years): Refine definitions and frameworks based on accumulated evidence, ensuring alignment with CBD objectives.
C. Harmonization and Data Sharing
• Strengthen the Biosafety Clearing-House (BCH): Share non-confidential risk assessment data (e.g., trait characterization, ecological impact studies) to foster international consistency, as urged by Colombia (#12424) and AUDA-NEPAD (#12477).
• Regional cooperation: Adopt harmonized protocols for detection, monitoring, and post-release evaluation, particularly for transboundary LMOs (e.g., gene drives), as emphasized by Panama (#12469).

3. Expected Outcomes
This approach would:
• Maintain regulatory clarity for “traditional” LMOs while addressing emerging technologies.
• Reduce duplication of efforts (e.g., overlapping guidance for gene drives and synthetic biology).
• Enhance transparency and trust through shared data and capacity building, as advocated by the African Union (#12477).

Ju Seok Lee,

Dear forum participants,

My name is Delphine Beeckman, and I am participating in the CBD online forum on Risk Assessment as representative of the Belgian Biosafety Professionals (BBP, https://www.ebsaweb.eu/bbp/bbp). As a biosafety officer, focusing on the use of regulated and non-regulated biological materials in containment (e.g. labs, greenhouses, animal facilities), I am following up on developments in risk assessment for different types of biological materials, including Living Modified Organisms.

I would like to thank the CBD Secretariat for organizing this forum, in addition to Ana Laura Mello & Anita Anthonysamy for moderating this second week of discussions.

As has been expressed more eloquently in other posts (e.g. #12405, #12413, #12446, #12469, #12476, #12477, #12483, #12488, #12500, #12501), this topic is not sufficiently defined to allow consideration against the CP-9/13 criteria. As also pointed out by others (e.g. #12413, #12476, #12487) existing methodologies for case-by-case risk assessment informed by a problem formulation approach consistent with Annex III, remain generally applicable, and a wide range of guidance documents is already existing (e.g. 12477).

Although only mentioned under topic 3 in week 2, I would like to support the clarifications given by Keith Hayes in post #12411, which is relevant for the discussions throughout this 3-week Open-ended Online Forum on Risk Assessment.

Kind regards, Delphine

Dear Colleagues and Ms Mello,
Thank you again for the opportunity to share comments, information and reflections on this forum.
I share the views of comments #12405, #12413 and others, on the fact that the topic of "new biotechnologies" has not been clearly defined in this context, and no definition of new biotechnologies is provided in the Cartagena Protocol on Biosafety (CPB). The term encompasses a very broad range of organisms, making it challenging to contribute meaningfully to the discussion in this forum or to assess whether it meets the criteria outlined in Annex I of Decision CP-9/13.
Finally, in my opinion is on the COP-MOP to discuss if a definition of new biotechnologies is needed

Dear participants,

Thank you again for the opportunity to contribute to these discussions. Having reviewed the submissions made by Parties, my comments will largely echo those before me (#12405, #12413, #12446, #12469, #12476) regarding the “topic” not being sufficiently defined to enable consideration against the CP-9/13 criteria, and therefore they cannot be met. Further, additional voluntary guidance materials have already been developed for the one discernible example provided of LMOs containing engineered gene drives. The contents of the latter are helpfully explained in #12411 (Topic 3), along with the applicability of case-by-case risk assessment (per Annex III) and the problem formulation approach to any type of LMO – with this reiterated throughout the threads of this online discussion (e.g. #12404, #12412, #12447, #12463, #12470, #12473, #12480, #12482, #12487, #12503, #12508). We further emphasize that these approaches are applicable irrespective of the technology used to develop the LMO. We agree with previous contributors that duplication of guidance materials should be avoided, and that training and capacity building would better assist where there are challenges with practical application (#12405, #12413, #12476).

Evaluation of “new technologies” presents similar challenges to the attempts to analyze “synthetic biology” as a new and emerging issue (parallel program of work under the Convention on Biological Diversity). There is no consensus on how these terms are defined, and it is not possible to evaluate a collection of technologies that might be considered “new” against the CP-9/13 criteria. The technology itself does not undergo risk assessment; the criteria can only be addressed where a specific application of a technology is defined, i.e. it must involve an LMO to be in scope, with an intended use and likely receiving environment. There are outcomes of “new” technologies (e.g. genome editing) that are not considered to be LMOs and are therefore not in scope (and discussed at length in the “synthetic biology” program of work) and cannot meet the CP-9/13 criteria.

In this online discussion, the contributions made thus far point to the specific application in the Topic 3 thread and raise other “issues” connected to genome editing that in our view are out of scope (and not meeting the CP-9/13 criteria), or can be addressed via case-by-case risk assessment applying a problem formulation approach, or are relevant to decision making rather than risk assessment, or seek to guide interpretation of “LMO”. The question of regulatory scope has been addressed by governments in many jurisdictions (many of which have not participated in this discussion), while developments are ongoing in others. Where this question has been resolved, it has typically resulted in exclusions of certain applications of genome editing from LMO regulatory scope or a sui generis regulatory process (e.g. Argentina #12488). It is misleading to state that all applications of genome editing result in LMOs within the scope of the Cartagena Protocol (#12499), as there has been no such decision. It should also be noted that certain applications of genome editing will fall with LMO regulatory scope and existing risk assessment approaches remain applicable on a case-by-case basis, consistent with the Cartagena Protocol.

Where certain genome editing applications have been excluded from LMO regulatory scope or a different regulatory process applies, this has been determined based on examination of scientific evidence and the recognized need for risk-proportionate regulation. This remains consistent with the principles of Annex III. Post #12435 mentions “[g]enome-edited organisms may be indistinguishable from naturally occurring variants, complicating monitoring, detection, and compliance” – such organisms have been excluded from LMO regulatory scope in many jurisdictions for the very reason that they are indistinguishable, meaning that they present equivalent risk. This then begs the question why an “indistinguishable” organism should require an international response to develop guidance on risk assessment or “monitoring, detection, and compliance”. Similarly, many jurisdictions have clarified that null segregants (raised in #12436) are not within LMO regulatory scope.

I find the contributions by Jack Heinemann (#12433), Sarah Agapito-Tenfen (#12436) and Eva Sirinathsinghji (#12499) much in line with my thinking and analysis and would like to support those contributions rather than provide a lengthy submission myself.

Briefly:

Q1:
I also find that Topic 2&3 are very closely related and could be merged into one voluntary guidance material. It is a highly relevant topic, as said in the party submission, and covers an emerging field with many product either already being deployed or being in the development pipeline. As the term “new biotechnologies” or “New genetic techniques” are frequently being used in policy documents or in the literature, it is valid, to take this as a block for investigation and guidance. It also constitutes a bridging link to the topic of Synthetic Biology.

A list of challenges is provided by Christoph Then (#12429), to which I would like to add cumulative effects of the use and release of many products at the same time, including those of genome editing. What would be the consequence of genome edited or otherwise achieved LMOs replacing conventional and traditional crops? How would it impact pollinators, agriculture, biodiversity? So in this the current topic also links to topic 4.

Whilst there are differences of opinion on whether SDN1 should or should not be considered LMOs and fall under the definition and scope of the protocol, they are clearly GMOs under the European regulation.  Given that SDN1s (genome edited plants produced through the non homologous enjoining repair pathway) can contain multiple modified genes set either in parallel or sequentially, even this pathway allows for deep intervention into a pant and its functions and mechanisms. Whilst of course there will be individual SDN1 GM plants that are not posing risks per se, this obviously cannot be said categorically for the whole group, nor for any subgroup. It would be down to testing and checking. 

It deems a bit fruitless to go on this journey, as at the end I believe an exclusion would have to be a MOP decision, thus our debate here is not really required.

Q2:
Additional to the submissions by colleagues mentioned above I would like to add
Challenges would be to understand
- the depth to which modifications can reach.
- The change in approach to agriculture and biodiversity that might result from wide use of these technologies.
- The extent of the modification of the wild, and the impact on and of conservation.

Q3: I would respond with Yes to all of these, in particular ii, iii, and iv. For (i) it obviously has the capacity to cause adverse effects, yet this would need to be assessed in a case by case step - except when looking at cumulative impacts, where it would need to look at the whole.

Q4:
I refer to others again.

I would like to also call on my submission for topic 1 to the extent it is relevant to this topic.

With kind regards,

Ricarda

Dear Participants,

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

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

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

Best regards,

The Secretariat