1. Detection and monitoring of living modified organisms

Dear colleagues,

I would like to thank the moderators of this forum for their expertise and ability to bring us together to exchange our experiences. My name is Marvis Suárez Romero, and I am a specialist in Regulation, Control, and Safety. I work for the Office of Environmental Regulation and Safety, the Regulatory Authority for GMOs, among other topics. Our office belongs to the Ministry of Science, Technology, and Environment (CITMA) of Cuba. I have been part of the last Ad Hoc Technical Expert Group on Risk Assessment.

Regarding this topic, I would like to mention that in our country, the commercial release of genetically modified corn and soybeans has recently begun, and one of the main concerns is to protect the existing Cuban corn varieties in our fields and to prevent the introduction of undeclared and unauthorized genetic events in grain or seed shipments that may later be released into the environment, whether intentionally or not.

Currently, we only have two laboratories prepared with the personnel and equipment for the detection and identification of GMOs, which are in the process of accrediting their molecular techniques. This step has only been achieved thanks to a GEF-UNEP project. For developing countries, it is very difficult to obtain funding for the detection and monitoring of GMOs. Detection technologies and their equipment are becoming increasingly expensive and difficult to acquire in the market, even due to political issues, as well as achieving monitoring to assess potential adverse effects on the environment where GMOs have been released.

Currently, all genetically modified crop projects at a commercial scale involve a risk analysis prior to release, using existing guidelines and geographic information systems that include a database with the location of the Cuban varieties to be protected.

Best regards
Marvis

Ms. Anita Anthonysamy thank you for your moderation. Greetings again colleagues. I’ll renew my introductions. I’m Jack Heinemann, a professor of molecular biology and also am part of a biosafety research centre at the University of Canterbury.

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

I draw upon an analysis by Food Standards Australia New Zealand (FSANZ) for my response to this topic [1]. I attach this analysis to my post and mainly refer to Table 3: Summary of international approaches to NBT regulation.

According to the analysis, a relatively small minority of countries have acted to reduce their regulations on products of modern biotechnology (<20), and some of these are non-Parties to the Protocol. A slightly larger number are discussing doing so (~30). Combined they are still a minority of countries. In addition, the FSANZ report was written before the United States reversed its changes and reinstated its previous regulations [2,3].

Of the ~19 countries that have reduced regulation (and most still discussing their regulations), almost all exempt from GMO regulations those products made using described techniques (e.g. SDN-1, such as Australia) or outcomes that meet prescribed criteria (e.g. “Absence of a new combination of genetic material” or “Absence of foreign DNA”).

Only 2 countries, both non-parties to the Protocol, have no requirement to confirm that the LMOs meet the exemption criteria prior to release. These are Canada, but limited to only plants, and Australia, but limited to intended outcomes of SDN-1 techniques. (As I’ve mentioned before in week 2 topic 1 post #12440, even SDN-1 techniques routinely create unintended transgenic products and only verification can reduce the risk of releasing unintended SDN-1, 2, and 3 outcomes [2,4].)

Without prejudice to what the COPMOP might one day determine is within scope of the Protocol, and taking a “face value” reading of the definition of modern biotechnology (which does not say only inserts, transgenes, or foreign DNA), I believe that there are new challenges for monitoring and detection, including to prevent unnotified transboundary movement, since the guidance on this topic was written.

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

The patchwork of national laws and the maturing capacity to use some techniques of modern biotechnology outside of containment facilities - and thus without controls on unintended exposures resulting in creation of unintended LMOs (including transgenic LMOs) - will challenge the ability of both exporting countries to provide notifications to receiving countries and of receiving countries to confirm presence of unknown GMOs/LMOs.

Meanwhile, techniques for detecting products of modern biotechnology, including those made using SDN-1 type techniques or products that might have arisen by conventional breeding, are rapidly improving [5,6]. As they do, it is very likely that there will be more true and false positive detections. Unless and until such detections are confirmed and evaluated, especially in countries with zero tolerance for unknown/unauthorised GMOs, there will be potential trade disruptions, undermining one of the key utilities of the Protocol.

Under the task given to the Online Forum in paragraph 7 of CP-11/7, and limited to that task (“evaluation of the needs and priorities identified by Parties through the submission of the information requested in paragraph 8”) and not more, my suggestion is that new voluntary guidance designed to address the challenges for managing the monitoring and detection requirements would be useful. This guidance could be developed to provide inter alia technical advice on verifying and applying detection methods, and understanding limits of detection and how they relate to determinations of risk (ultimately, when to invoke the precautionary approach) when more unintentional LMOs will be admixed with known or authorised 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?

Yes

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

Yes

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

Yes

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

This topic is relevant to both LMOs intended for commercialisation and LMOs that are produced as a by-product or used in conservation.

References
1. FSANZ, Updated Compilation of Regulatory Approaches and Definitions, P1055 – Definitions for gene technology and new breeding techniques, 2024.
2. Heinemann, J.A. et al (2025) https://ir.canterbury.ac.nz/server/api/core/bitstreams/0e1aa118-5e68-4b43-b395-2a4487d90aa4/content
3. Heinemann, J.A. et al (2025) https://ir.canterbury.ac.nz/server/api/core/bitstreams/05dd6485-82e0-4f54-844b-8860e8548b68/content
4. Chu, P. and Agapito-Tenfen, S.Z. (2022) Unintended Genomic Outcomes in Current and Next Generation Gm Techniques: A Systematic Review. Plants 11 (21), 2997.
5. Chhalliyil, P.I., H.; Kazakov, S.A.; Howard, S.J.; Johnston, B.H.; Fagan, J. (2020) A Real-Time Quantitative PCR Method Specific for Detection and Quantification of the First Commercialized Genome-Edited Plant. Foods 9, 1245.
6. Saltykova, A. et al. (2022) Detection and Identification of Authorized and Unauthorized Gmos Using High-Throughput Sequencing with the Support of a Sequence-Based Gmo Database. Food Chem (Oxf) 4, 100096.

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

Temporal and spatial limitations: Traditional risk assessments are typically pre-release and may not sufficiently account for long-term or post-release impacts.

Detection limitations: Current detection methods (e.g., PCR-based assays) may not be applicable for all LMOs, especially those with small, undetectable genetic modifications or gene-edited traits.

Inadequate monitoring protocols: Risk assessment guidance under the Cartagena Protocol often lacks detailed, standardized post-release monitoring approaches.

Difficulty distinguishing LMOs from natural or conventionally bred organisms: This is particularly problematic with LMOs developed using new genomic techniques (NGTs), including cisgenesis or genome editing without foreign DNA.

Solutions:

Development of molecular detection tools: Including event-specific, construct-specific, or genome-wide screening approaches.

Use of environmental DNA (eDNA) and digital tools: Integration of AI and bioinformatics can enhance traceability and monitoring.

Adaptive risk assessment frameworks: Updating methodologies to include dynamic post-release evaluation and real-world monitoring.

Harmonized international standards: Promoting coherence across jurisdictions for detection protocols and data sharing.

2. What could be the specific challenges related to this issue?
Lack of accessible reference materials for new LMOs, especially for detection of proprietary or unpublished genetic constructs.

Inadequate laboratory infrastructure and capacity in many developing countries.

Unregulated or undocumented LMO releases, including illegal transboundary movements.

Integration of traditional ecological knowledge with molecular monitoring techniques remains limited.

Cost and technical complexity of high-throughput detection systems.

3. What are the specific issues concerning this topic?
(i) Potential to cause adverse effects on biodiversity:
Yes. Undetected or poorly monitored LMOs may:

Affect non-target species or ecosystems.

Interfere with pollinators or food webs.

Threaten species with limited ranges (e.g., endemic or rare species).

Impact cultural or livelihood values associated with biodiversity for Indigenous Peoples and Local Communities.

(ii) Potential for deliberate or accidental introduction into the environment:
Yes. LMOs may escape from confined field trials, gene banks, research facilities, or during transport and trade.

(iii) Potential to disseminate across national borders:
Yes. LMOs (especially plants, insects, or microorganisms) can spread via natural dispersion, trade, or human movement. Monitoring tools must be designed to detect such unintended transboundary movements.

(iv) LMO commercialization and global use:
Yes. Many LMOs are commercialized or under development globally (e.g., GM crops, gene-edited animals, sterile insects). This complicates global monitoring due to inconsistent transparency and regulatory approaches.

4. Are there existing resources on similar issues that can address or be adapted to address this need?
Yes. Existing and adaptable resources include:

OECD’s BioTrack Product Database: Contains detailed information on LMO products that can support detection.

CBD Biosafety Clearing-House (BCH): Provides access to detection protocols, risk assessments, and regulatory decisions.

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

I'd like to thank the online forum moderators again. I'm Emmanuel González-Ortega. I have experience in GMO detection and identification, socio-environmental analysis of GMO impacts, and GMO risk assessment.

Regarding Q1 & Q2.

As previously stated in post #12451, monitoring and detection of LMO is essential for risk assessment guidance, this including identification of the intended and unintended changes in genomic regions (indels, CRISPRtripsis) and punctual genetic modifications on LMOs produced by genome editing. Additionally, the delivery method of the genome editing machinery should be part of the risk assessment process of LMOs, since additional unintended outcomes may occur due to the insertion technique (12). There is no RA guidance for assessing the potential impact derived from off-target modifications on LMOs (proteomic, transcriptomic, metabolic, physiologic). Current and most used methodologies for monitoring LMO -transgenics (i.e. RT-PCR, digital PCR), may not detect subtle modifications, or INDELs in genome editing LMO.
  
Although several methods for detecting and monitoring genomic modifications have been developed (1-11), there is a gap between the advancement on technical protocols and the inclusion of them as part of biosafety governance in countries and/or as risk assessment guidance, i.e. Biosafety regulations in Mexico do not consider New Plant Breeding Techniques, therefore, protocols aimed to detect and identify genome editing or risk assessment of LMO are not considered.

1. Combined shRNA over CRISPR/cas9 as a methodology to detect off-target effects and a potential compensatory mechanism 10.1038/s41598-017-18551-z
2. Cas9 Cuts and Consequences; Detecting, Predicting, and Mitigating CRISPR/Cas9 On- and Off-Target Damage 10.1002/bies.202000047
3. OliTag-seq enhances in cellulo detection of CRISPR-Cas9 off-targets.  10.1038/s42003-024-06360-w
4. Genome-wide identification of CRISPR/Cas9 off-targets in human genome 10.1038/cr.2014.87
5. Biased and Unbiased Methods for the Detection of Off-Target Cleavage by CRISPR/Cas9: An Overview https://doi.org/10.3390/ijms17091507
6. Detection of on-target and off-target mutations generated by CRISPR/Cas9 and other sequence-specific nucleases 10.1016/j.biotechadv.2016.12.003
7. CIRCLE-seq: a highly sensitive in vitro screen for genome-wide CRISPR-Cas9 nuclease off-targets. 10.1038/nmeth.4278
8. Mapping the genomic landscape of CRISPR-Cas9 cleavage. 10.1038/nmeth.4284

9. Digenome-seq: genome-wide profiling of CRISPR-Cas9 off-target effects in human cells. 10.1038/nmeth.3284
10. A high-throughput screening strategy for detecting CRISPR-Cas9 induced mutations using next-generation sequencing 10.1186/1471-2164-15-1002
11. Unbiased detection of off-target cleavage by CRISPR-Cas9 and TALENs using integrase-defective lentiviral vectors 10.1038/nbt.3127ç
12. Revisiting Risk Governance of GM Plants: The Need to Consider New and Emerging Gene-Editing Techniques 10.3389/fpls.2018.01874

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

Since there are no risk assessment guidance related to monitoring of LMOs produced via genome edition, the risk of trans border movement is high, particularly in regions/countries that are centers of origin and diversity (i.e. Mexico), in which research and field tests (?) have already been performed (https://www-cimmyt-org.translate.goog/projects/mln-gene-editing-project/?_x_tr_sl=en&_x_tr_tl=es&_x_tr_hl=es&_x_tr_pto=tc ).


3. What are the specific issues concerning this topic?

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

Yes

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

Yes.

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

Yes.

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

Yes

Esteemed colleagues,

In contribution to the discussion, I would like to respectfully express that, while the propose topic is undoubtedly relevant, it may not warrant the development of additional voluntary guidance material or being the central topic at the Ad Hoc Technical Expert Group (AHTEG) on risk assessment, especially considering the presence of other pressing matters that require our full-on commitment, like they the ones in this same Open Ended Online Forum.

Furthermore, I would like to highlight that the broad nature of the topic poses challenges for effective technical dialogue, particularly in the absence of clarity regarding the specific types of organisms or the methodologies being addressed (e.g., are we referring to monitoring LMO of solely obtained through recombinant DNA technology, or does this also encompass LMO developed through New Biotechnology Techniques?). These uncertainties make it difficult to define a focused and structured framework for discussion.

It is also important to note that this topic was recently addressed within the framework of the COP-MOP (decision CP-11/8), and relevant actions are already underway, so we may be duplicating efforts by focusing solely on this topic.

In this context, I would kindly suggest that this issue may be considered as a component within a broader topic similar to how it was addressed in Chapter 6 of the “Additional voluntary guidance materials to support case-by-case risk assessments of living modified organisms containing engineered gene drives”, rather than being treated as a standalone subject.

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.

In reference to the proposed topic, we do not see challenges in this matter. Detection and monitoring systems are standardized and allow for accurate identification of LMOs. In Argentina, there are official detection laboratories that meet international requirements.

LMOs should not be confused with products obtained through NBTs, including gene editing, which are not LMOs and therefore do not require detection and monitoring (just as other products obtained through conventional breeding techniques, mutagenesis, etc.), do not.

This is in line with the Cartagena Protocol, which only calls for detection and monitoring in cases involving LMOs.

Greetings to the moderators and colleagues, it is a pleasure to be able to participate in this forum. In response to this subject:

Current guiding material for detection and monitoring is comprehensive enough and addresses the technical aspects of the problem. The main issue lies with capacity building, as mentioned in intervention #12526, particularly in developing countries where facilities may be limited and regular monitoring is difficult to implement. This poses a challenge to the safety of local and Indigenous communities, where LMOs can enter undetected. It is also important to recognize that women in these communities often lead efforts in seed preservation and local agriculture, making them especially vulnerable to the consequences of insufficient monitoring. That’s why any strategy to strengthen detection and monitoring should include a gender perspective transversely.

CBD’s Voluntary Guidelines on Gender-Responsive Biodiversity Action Plans: https://www.cbd.int/doc/c/f64f/e1b9/e8da56802bc2c458a56fcefa/cop-15-l-24-en.pdf

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, as far as I am concerned, the topic does not meet the criteria set out in Decision CP-9/13 Annex I. Additionally, recognizing the necessity of developing a guideline for it would be counterproductive to the very purpose of the "Training Manual on the Detection and Identification of Living Modified Organisms in the Context of the Cartagena Protocol on Biosafety (Biosafety Technical Series 05)", and would result in redundancy or duplication of efforts, since it was recently addressed in Decision CP-11/8.

I would like also to fully support what Mr. Frankow has said (#12550): 'LMOs should not be confused with products obtained through NBTs, including gene editing, which are not LMOs and therefore do not require detection and monitoring (just as other products obtained through conventional breeding techniques, mutagenesis, etc.)' and to stress that almost all the challenges previously stated can be addressed with a robust capacity-building initiative and not properly a new guideline.

Finally, I want to echo Mr. Namur (#12544) on his statement that 'there are other pressing matters that require our full commitment' and note that we also have limited financial resources.

Best regards,

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

Dear Colleagues,

In contribution to the discussion on this topic, I provide responses to questions 1, 2 and 4 as follows:

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

Detection and identification of LMOs are important for effective biosafety governance and risk assessment. While certain laboratories had experience with many tools and techniques, such as next-generation sequencing, digital PCR and isothermal amplification techniques, many laboratories in developing countries are constrained by outdated methodologies and limited adaptability to emerging technologies, such as genome editing, and only had experience with detecting a limited number of genetic elements using end point or real-time PCR and could thus potentially miss LMOs during screening, such as those that were newly developed or not authorized. The recent decision CP-11/8 recognizes these evolving needs and calls for integration of advanced tools like digital PCR and next-generation sequencing (NGS).
Solutions:
1. Adoption of advanced detection tools must be complemented with targeted capacity-building, especially in laboratory infrastructure and human resource development, through workshops, hands-on training and exchanges among others.
2. Regional centres of excellence and networks of laboratories, as encouraged under paragraph 4 of CP-11/8, will enable improved inter-laboratory and technical collaboration, knowledge-sharing and cost-efficiency.
3. Continued use and updating of the Training Manual on Detection and Identification of LMOs (Biosafety Technical Series 05) remains essential to guide laboratory practices. This should be complemented with the development of technical materials as appropriate.
4. To achieve the above listed solutions, increased financing cannot be overemphasized. Parties, and other Governments, donors and biosafety capacity-building initiatives, should endeavour to make resources available to support Parties in their efforts to strengthen capacities and enhance the implementation in this priority area of the detection and identification of LMO.
The above points underscore the continued relevance of the decisions outlined in CP-11/8, such as:
1. Establish and fund regional laboratory networks to implement standardized detection protocols and facilitate rapid sharing of analytical results (CP-11/8, para 4–5).
2. Leverage the Global Environment Facility (GEF) for financial and technical support in establishing and accrediting infrastructure and acquiring certified reference materials (CP-11/8, para 6).
3. Encourage Parties to share data, materials, and experiences via the Biosafety Clearing House in line with para 2–3 of CP-11/8.
4. Engage technology developers to disclose detection methods for new LMOs entering markets (CP-11/8, para 7).
5. Support the Secretariat’s role in hands-on training and multilingual technical resource dissemination (CP-11/8, para 8c).

Question 2. What could be the specific challenges to related to this issue? (especially in developing countries)

1. Many developing countries lack the laboratory infrastructure, trained personnel, and access to reagents and reference materials needed for reliable LMO detection (CP-11/8, para 5). Where laboratories do exist, many are not accredited, and as a result, their analytical results are often not recognized or accepted in other jurisdictions, undermining mutual confidence in regulatory decisions and limiting participation in international trade. There is an urgent need to address capacity gaps related to methodologies and techniques, infrastructural development, access to essential consumables, and the establishment of enabling legal agreements.
2. Informal seed markets and porous borders increase the risk of undetected unauthorized LMOs entering the environment.
3. While the Biosafety Clearing House provides a repository, many national authorities lack capacity to regularly contribute or access this data effectively.
4. Limited coordinated networks or harmonized protocols hinders data comparability and quality assurance across countries.

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

1. Network of Laboratories for Detection and Identification of LMOs, referenced in CP-11/8, offers a foundation for regional collaboration. There had been national and regional laboratory collaborations with several examples from Africa, Asia, Latin America and the Caribbean and Europe. The networks of laboratories had been successful at enabling cost efficiency, knowledge-sharing and addressing gaps in capacity, as well as harmonizing and standardizing methodologies. The establishment of these networks was largely facilitated through funded projects, enabling legal frameworks, and bilateral agreements. Membership structures were often diverse, comprising public institutions, academic organizations, and private laboratories. However, not all networks sustained their operations beyond the initial phase, with several becoming inactive following the conclusion of foundational support or project funding.
2. Biosafety Clearing House provides a platform for data sharing; national focal points are encouraged to upload and utilize the system more effectively.
3. Reference documents and methodologies in the Training Manual (BTS-05) remain relevant but require updates incorporating next-generation methods.

Thank you for the opportunity to participate in this open-ended forum.
Modupe Adeyemo
AUDA-NEPAD

Dear colleagues,

My name is Anita Greiter. I am an ecologist working at the Environment Agency Austria on biosafety issues since 2009. I am also BCH National Focal Point for Austria.
First, I would like to thank Anita Anthonysamy for moderating this discussion and the participants of this forum for the discussion and all the information provided.

There are challenges regarding the detection of LMOs, including those developed by new gene technologies, as already pointed out by others above. However, work is going on and in that respect I would like to point to the ongoing EU-funded projects DARWIN and DETECTIVE.
https://darwin-ngt.eu/
https://detective-ngt.eu/

The aim of the monitoring is to identify the occurrence of adverse effects of the LMO or its use, which were not anticipated in the ERA and to assess whether the conclusion from the ERA are correct. Monitoring of LMOs was in the past mostly discussed for crop plants. However, the current research and development of LMOs cover a variety of organisms, as also the topics of this forum show. In addition, novel LMOs may be released in a range of non-agricultural environments with potential implications for ecosystems and biodiversity. Thus, it needs to be discussed how monitoring concepts and methodological approaches need to be adapted for other organisms like animals, algae or microorganisms.

References:
Dolezel, M.; Lang, A.; Greiter, A.; Miklau, M.; Eckerstorfer, M.; Heissenberger, A.; Willée, E.; Züghart, W. Challenges for the Post-Market Environmental Monitoring in the European Union Imposed by Novel Applications of Genetically Modified and Genome-Edited Organisms. BioTech 2024, 13, 14. https://doi.org/10.3390/biotech13020014

Ribarits, A.; Narendja, F.; Stepanek, W.; Hochegger, R. Detection Methods Fit-for-Purpose in Enforcement Control of Genetically Modified Plants Produced with Novel Genomic Techniques (NGTs). Agronomy 2021, 11, 61. https://doi.org/10.3390/agronomy11010061

Ribarits, A.; Eckerstorfer, M.; Simon, S.; Stepanek, W. Genome-Edited Plants: Opportunities and Challenges for an Anticipatory Detection and Identification Framework. Foods 2021, 10, 430. https://doi.org/10.3390/foods10020430


Thank you very much for the discussion
Anita

Dear colleagues,

my warm thanks to Ms Anita Anthonysamy for moderating this discussion, the Secretariat for facilitating it and the participants for their valuable 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.

The topic „detection and monitoring of LMO“ is already addressed under COP MOP agenda item "Detection and identification of LMO". A guidance on this topic does exist: „Biosafety Technical Series 05: Training Manual on the Detection and Identification of Living Modified Organisms in the Context of the Cartagena Protocol on Biosafety“ (https://bch.cbd.int/en/database/VLR/BCH-VLR-SCBD-260177-3). Updating of this guidance is under discussion and will be conducted in case a need is identified and sufficient information is available. Furthermore, in the current intersessional period such information is gathered as decided with decision CP-11/8. Therefore, I do not see the need for a further voluntary guidance under the topic Risk assessment regarding challenges in detection and monitoring of LMO.

In my perspective and as mentioned before (#12528, #12535, #12559) the main challenge for detection and monitoring in many countries is not a lack of guidance but rather the need for capacity-building and resource allocation. In this regard, let me refer to a recent publication on the outcome of the „International Conference on GMO Analysis and New Genomic Techniques“ held in Berlin in March 2023 (https://doi.org/10.1007/s00003-025-01542-y). In addition, further resources provide information on trade and/or detection and monitoring of LMO (OECD´s BioTrack Product database: https://biotrackproductdatabase.oecd.org, EU-RL GMFF GMOMETHODS: https://gmo-crl.jrc.ec.europa.eu/gmomethods/, EUginius: https://euginius.eu/euginius/pages/home.jsf and via BCH).

Kind regards

Dear participants,

Thank you again for the opportunity to participate in these discussions. I am representing developers of biotech crops, and our activities include the development and provision of detection methods for commercial events, and as required by regulatory authorities in the implementation of their LMO regulatory frameworks.

For CropLife International member companies, who are the major biotech crop developers, full descriptions of validated DNA-based methods are provided for commercial events in a searchable database hosted by CropLife International: https://detection-methods.com/. This database is also available for use by non-member companies that develop biotech crops.

Question 1
An observation of this online discussion series is that “issues” are being raised that duplicate or extend other ongoing CBD/CP programs of work or the work of other international organizations where there is dedicated expertise. In our view this is not a risk assessment issue (in agreement with #12544, #12565). Relevant programs of work have been mandated by COP-MOP for Articles 18 (detection and identification of LMOs) and 17 (unintentional transboundary movements and emergency measures), supported by a long-standing Network of Laboratories. CropLife International member companies also contribute to the work of this group and have committed to sharing information on developments and demonstration of new techniques or processes for detection. We have also contributed to capacity building and training initiatives to support implementation.

Questions 2 and 3
It is widely recognized that there is a need for capacity building and training in this area for many Parties – it is in COP-MOP decisions on detection and identification of LMOs, unintentional transboundary movements and emergency measures, and capacity building, and it is reflected in goal A.8 of the current Cartagena Protocol Capacity-building Action Plan (CP-10/4, Annex https://bch.cbd.int/protocol/post2020/capacity-building/text.shtml). While this is a genuine concern, it would be better addressed via other dedicated programs rather than additional risk assessment guidance materials.

For some participants in this online discussion series, the impetus for work in this area appears to be risk assessment/management for organisms developed with the use of “new biotechnologies”. Here there is a divergence of views on whether the resulting organisms are within scope of the Cartagena Protocol and hence the need for risk assessment/management. In regard to genome editing, I have already stated our view that there are outcomes that are not within LMO regulatory scope (week 2 topic 2, #12513; in agreement with #12550 and #12565 in this thread), and these would include (but not be limited to) genome-edited organisms that are indistinguishable from organisms developed with the use of conventional tools, and organisms that do not contain foreign DNA (referred to in #12528 and #12535 in this thread).

Specific reference is made in this thread to products of genome editing of the “SDN-1” type (mentioned in #12528) and I would like to contribute our experience with detection methods for edits resulting from this approach and other genome editing approaches with comparable outcomes. SDN-1 is based on DNA cleavage by site-directed nucleases (SDN), with “edits” resulting from a natural occurring DNA repair mechanism known as non-homologous end joining (NHEJ). SDN-1 type edits are considered equivalent to spontaneous (naturally occurring) mutations and mutations resulting from conventional (non-biotech) methods in the jurisdictions that have excluded them from LMO regulatory scope. This includes outright exclusion (per Australia for SDN-1, as mentioned in #12528) and/or a new sui generis regulatory process to determine if the organism is in/out of LMO regulatory scope (e.g. Argentina, see #12488 week 2 topic 2). Where edits are of a category that is not within LMO regulatory scope, products are handled in the same manner as conventional material, including that they do not have regulatory detection/identification requirements like regulated LMOs do (e.g. Argentina, see #12550 in this thread).

The question about the detection and identification of SDN-1 type edits, and edits resulting from other genome editing approaches with comparable outcomes, has two distinct elements. One is related to the regulatory status of the resulting outcomes, as addressed above. The other is about the technical feasibility to detect and identify different changes in the genome of an organism. While it is technically possible to detect DNA sequence changes in plants using current DNA-based detection technologies, it remains challenging to uniquely and unequivocally identify a genome-edited product when it is equivalent to conventional material.

One challenge for such identification is linked to the fact that a specific DNA sequence change could have occurred through various means – and be either spontaneous (naturally occurring) or induced by the use of different tools. This challenge has been recognized by the European Commission Joint Research Center and the EU Network of GM Laboratories (https://gmo-crl.jrc.ec.europa.eu/doc/JRC116289-GE-report-ENGL.pdf).

Additional challenges arise from the sensitivity of the method, and the purity and homogeneity of the DNA sample. For example, DNA variation may be detectable in laboratory samples where the DNA is highly pure and homogenous. Difficulties arise when aiming to routinely and reliably detect the same types of DNA changes in bulk (mixed or heterogeneous) samples. Also, depending on the sample composition, non-DNA components may inhibit detection reactions.

The challenges described above indicate that fast, easily deployable detection methods that meet the same performance standards as current LMO detection methods are unlikely for certain genome-edited organisms. If methods were to be required for regulatory purposes, it is not clear, based on the current technical capacity and knowledge, what scalable solutions can be developed for routine and reliable use.

It should be noted that where a “new biotechnology” involves the creation of a sufficiently large and unique DNA sequence, this may allow for the development of a specific sequence-based detection method. For example, where a genome editing application involves the introduction of a transgene (e.g. of the SDN-3-type), the sensitivity and performance of a detection method would be similar to those currently used to detect LMOs.  However, even in such circumstances, whether there is a need for the development of regulatory detection and identification will be subject to the regulatory status of the given resulting organism.

Question 4
The Network of Laboratories has developed a “Training Manual on the Detection and Identification of Living Modified Organisms in the Context of the Cartagena Protocol on Biosafety” (Biosafety Technical Series 05 https://bch.cbd.int/en/database/VLR/BCH-VLR-SCBD-260177-3) which they consider to remain applicable in its current form (confirmed most recently by COP-MOP11 - CP-11/8 https://bch.cbd.int/protocol/decisions?decisionID=13924). Information sharing on new techniques for detection is ongoing in the work of that group and the Training Manual could be enhanced if the need is identified in the future.

Dear colleagues

My name is Christoph Lüthi, I work at the Swiss Federal Office for the Envronment and I am Switzerland's BCH and CBP National Focal Point. One of my main expertises in my current role is the ERA of LMO.

I would like to start with thanking Anita Anthonysamy for moderating the discussion and the CBD Secretariat for providing this opportunity.

Currently, the Swiss gouvernment is consulting the public on a draft legislation on plants derrived from new breeding techniques (NBT). The gouvenemnt intends to regulate NBT plants as LMO. This is in line with many other counries, as  pointed out in post #12528.

I would like to comment on questions 2 (What could be the specific challenges to related to this issue?) and 3 (What are the specific issues concerning this topic?):

An effective enforcement of any regulation on LMO according to the respective national definitions requires detection methods to ensure compliance. As pointed out by others (e.g. #12575), current detection methods are not fit for purpose in the light of new gene technologies. One important aspect to consider here is that the challenges to detecion are highly context-specific. In some cases, it is indeed  impossible to identify a specific modification as a result of genetic engineering. However, this is not necessary in many cases. In fact,it is sufficient to identify a specific organims as a known LMO. In cases where we are dealing with an entire organisms, e.g. at transboundary transport or monitoring, a detecion is already possible with current methods. A major challenge is the detection of LMO as ingredients procesed products or of the presence of unintended traces of LMO. As pointed out in post #12571, new and more powerful detection methods are in development. However, these methods will be more expensive, require special equipment and trained personal. This will likely limit the availability of these methods for some parties.

Thank you Ms. Anita Anthonysamy and the Secretariat for moderating and organizing these important discussions. Thanks to all colleagues who have shared their views and information on detection and monitoring of LMOs.

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

Analytical detection of LMOs requires prior information on DNA/RNA sequences or transgenic proteins expressed by LMOs. Some protocols enable simultaneous screening for multiple LMOs, while others are designed to identify specific LMO events. These detection methods are essential for establishing and implementing monitoring plans and strategies aimed at detecting unintended and illegal LMO releases. They are also critical for monitoring the long-term adverse effects of approved LMOs.
In cases where legislation on organisms obtained through new biotechnologies is asynchronous—reflecting a relatively small minority of countries as described in #12528—challenges will arise in the notification of transboundary movements. Such discrepancies would impact domestic activities related to monitoring unintended and illegal LMO releases, as well as the long-term assessment of adverse effects of approved LMOs.
This situation represents a novel challenge for Parties and global trade markets, as national legislation on LMOs have traditionally been harmonized among Parties. Currently, Parties lack experience in the surveillance of unintended and illegal LMOs that have not undergone risk assessment procedures or labeling schemes recognized by other Parties. This emerging divergence in legislative frameworks underscores the need for establishing new approaches to monitoring and managing LMOs across different jurisdictions.

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

While analytical methods have advanced in recent years, the capacity of developing countries to adopt these technologies and establish the necessary infrastructure remains limited. Detecting and monitoring organisms produced through new biotechnologies will require extensive research and investigation, which may not be fully compatible with existing rules and procedures enforced by domestic laws.
Additionally, some classical methods, such as real-time PCR techniques widely used globally, may not be sufficiently specific for certain LMOs created through novel biotechnologies. Consequently, new methods will need to be developed, implemented, and validated by Parties to ensure accurate detection and monitoring.

3. What are the specific issues concerning this topic?

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

Yes

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

Yes

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

Yes

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

Yes. Many are already commercialized by Parties. Several examples have been given under topic #2 of week #2 “Living modified organisms produced through new biotechnologies”.

While I agree with previous interventions on the need for capacity building and resource allocations for detection and monitoring, I also see the lack of updated technical guidance as a major need for developing countries. In addition, research needs have been also articulated by the European Commission with their recent funding for two large Horizon Europe projects fully dedicated to the development of new detection methodologies to cover LMOs obtained by new biotechnologies. This has been posted by another colleague too:

https://darwin-ngt.eu/
https://detective-ngt.eu/

Therefore, I also endorse the suggestions regarding the development of new voluntary guidance to address the challenges involved in monitoring and detection requirements. Such guidance could be valuable in offering technical advice on the verification and application of detection methods, clarifying the limits of detection, and explaining how these relate to risk assessments of unintentional, illegal LMOs and the long term adverse effects.

Thank you,
Sarah Agapito

Dear colleagues, I would like to thank the moderators and organizers of this forum. My name is Cinthia Valentina Soberanes Gutiérrez, of the Executive Secretariat of CIBIOGEM in Mexico. 

1) How could this topic pose challenges to existing risk assessment frameworks, guidance, and methodologies? Are there solutions to address this?
The detection and monitoring of Living Modified Organisms (LMOs), especially those developed through genome-editing techniques for open-environment use, represents a significant challenge for current risk assessment frameworks and guidelines. This is because these technologies can modify genomes in non-target organisms in an uncontrolled manner, generating unintended and potentially harmful genetic alterations within ecosystems.

A recent study demonstrated that genome-editing products for outdoor use, such as CRISPR/Cas-based pesticides, have the capacity to alter the genomes of non-target species through unintended editing mechanisms (Hoepers et al., 2024). Moreover, metabolic enrichment analysis confirmed that these alterations could trigger significant adverse effects in non-target organisms. Furthermore, SDN-1, SDN-2, and SDN-3 technologies can generate insertions and deletions in unintended genome regions (Chu & Agapito-Tenfen, 2022). In addition, a recent study by Chhalliyil et al. (2020) reported that detecting gene-edited plants is challenging since it is difficult to distinguish them from natural mutations. This increases the risk of unauthorized releases and their introduction into food chains without proper monitoring. This situation is exacerbated in megadiverse regions like Mexico, the center of origin and diversification of maize and other plants, where the loss of native varieties could be irreversible. It is worth remembering that native varieties are essential for addressing crucial problems arising from climate change, as they are sources of genetic variation, such as adaptation to environmental stress.

These findings highlight the urgent need to update risk assessment frameworks to include specific methodologies for detecting and monitoring unintended effects in non-target organisms. Furthermore, the development of capacities in developing countries is required to perform thorough monitoring and evaluate the associated risks before the environmental release of these LMO.

Therefore, we propose the following:

Implement a comprenhensive  risk assessment approach that considers the environmental and social characteristics of each region.
Integrate omics-based environmental monitoring methodologies, such as genomics, transcriptomics, proteomics, and metabolomics, to detect unforeseen molecular and physiological effects in non-target species. These advanced techniques allow for a deeper understanding of off-target impacts at the genetic, protein, and metabolic levels, improving the capacity for early detection and risk assessment.
Strengthen technical and regulatory capacities in megadiverse countries to ensure the protection of biodiversity and the rights of Indigenous people and local communities.
Apply the Precautionary Principle as a guiding axis to prevent irreversible damage.

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

The specific challenges include:

Lack of technical capacities: In developing countries, the infrastructure for monitoring and detecting LMOs is insufficient, making it difficult to trace their spread.
Monitoring of off-target effects: Studies by Leibowitz et al. (2021) have demonstrated that gene-editing techniques can cause off-target effects that are difficult to detect and quantify.
Risk to Indigenous Peoples and Local Communities: The loss of native varieties and genetic contamination impact not only biodiversity but also the biocultural rights of communities that depend on these species for their sustenance and culture (Kormos et al., 2022).
For this reason, we request the strengthening of human rights and the rights of Indigenous Peoples in decision-making processes regarding the use of LMO, as well as the integration of traditional and biocultural knowledge into risk assessment processes.

3) What are the particular problems posed by this issue?

(i) Is there a possibility of causing adverse effects on biodiversity, particularly those that are severe or irreversible?
Yes, there is a high risk of irreversible effects on biodiversity. Studies such as that of Noble et al. (2018) have shown that even the least efficient gene drive systems can spread invasively in wild populations. In the context of a megadiverse country like Mexico, this could result in the loss of native varieties and the deterioration of unique ecosystems.

(ii) Is there a possibility of introduction into the environment, either deliberately or accidentally?
Yes, various reports confirm that LMOs can be introduced into the environment both accidentally and deliberately. Mexico, as an importer of transgenic maize, has reported cases of introgression into native varieties.

(iii) Is there a possibility of dissemination across national borders?
Yes, transboundary spread is a demonstrated risk. As mentioned earlier in this forum, there is a lack of unified international guidelines, facilitating the unintended movement of LMOs between countries, especially in regions with shared ecosystems.

(iv) Is the LMO already, or is it likely to be soon, commercialized or in use somewhere in the world?
Yes, multiple LMOs are already in experimental phases, and some are in commercial production (Andolfo et al., 2016). This includes gene-edited crops for pest and disease resistance, which are undergoing trials in megadiverse countries.

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

Mexico proposes the following:
Update the Cartagena Protocol guidelines to include LMOs derived from new biotechnologies.
Strengthen post-release monitoring and regional cooperation for transboundary control.
Create a specific risk assessment framework for megadiverse countries with high genetic richness, such as Mexico.

References:
Andolfo, G., et al. (2016). Genome-editing technologies for enhancing plant disease resistance. Frontiers in Plant Science, 7, 1813. https://doi.org/10.3389/fpls.2016.01813
Chhalliyil, P., Ilves, H., Kazakov, S. A., Howard, S. J., Johnston, B. H., & Fagan, J. (2020). A real-time quantitative PCR method specific for detection and quantification of the first commercialized genome-edited plant. Foods, 9(9), 1245. https://doi.org/10.3390/foods9091245
Chu, P., & Agapito-Tenfen, S. Z. (2022). Unintended genomic outcomes in current and next generation gm techniques: a systematic review. Plants, 11(21), 2997. https://doi.org/10.3390/plants11212997
Hoepers, A. M., Heinemann, J. A., Zanatta, C. B., Chu, P., Hiscox, T. C., & Agapito-Tenfen, S. Z. (2024). Predicted multispecies unintended effects from outdoor genome editing. Ecotoxicology and Environmental Safety, 282, 116707. https://doi.org/10.1016/j.ecoenv.2024.116707 
Kormos, A., Lanzaro, G. C., Bier, E., Santos, V., Nazaré, L., Pinto, J., ... & James, A. A. (2022). Ethical considerations for gene drive: challenges of balancing inclusion, power and perspectives. Frontiers in Bioengineering and Biotechnology, 10, 826727.  https://doi.org/10.3389/fbioe.2022.826727
Leibowitz, M. L., Papathanasiou, S., Doerfler, P. A., Blaine, L. J., Sun, L., Yao, Y., ... & Pellman, D. (2021). Chromothripsis as an on-target consequence of CRISPR–Cas9 genome editing. Nature genetics, 53(6), 895-905. https://www.nature.com/articles/s41588-021-00838-7
Noble, C., et al. (2018). Current CRISPR gene drive systems are likely to be highly invasive in wild populations. Elife, 7, e33423. https://elifesciences.org/articles/33423

I am Dr. Nicolas Defarge, molecular biologist, representative of ENSSER (European Network of Scientists for a Social and Environmental Responsability).
I would like to thank all the experts of the forum for their highly valuable inputs.
To avoid repeating what was already mentionned, I support the inputs in post #12528, #12535, #12542, #12559, #12568, #12571, #12581 and #12590.

(i) Is there the potential to cause adverse effects on biodiversity, in particular those that are serious or irreversible, taking into account the urgent need to protect specific aspects of biodiversity, such as an endemic/rare species or a unique habitat or ecosystem, taking into account risks to human health and the value of biological diversity to indigenous peoples and local communities?
YES
(ii) Is there the potential to have an introduction into the environment either deliberately or accidentally?
YES
(iii) Is there the potential to disseminate across national borders?
YES
(iv) Is the LMO already, or are likely to be, commercialized or in use somewhere in the world?
YES

Warm regards to everyone.

Thank you kindly to Ms Anita Anthonysamy for moderating this discussion, and everyone involved in enabling the smooth running of the online forum for the whole three weeks.

Dear colleagues,

It appears that there are different issues with monitoring, including the issue of capacity and resources to carry out detection and monitoring (e.g. original Party submission, and also for example #12526 and #12568) as well as needing to adapt monitoring concepts methodological approached to organisms beyond plant crops, such as animals – including insects, algae or microorganisms (e.g. #1257) as well as for LMOs resulting from new genetic techniques (e.g. genome editing).

I recall discussions in the AHTEG on risk assessment of LMOs containing engineered gene drives on not only how to monitor gene drive organisms and their impacts across time and space, but also how to afford it and who would be funding it.

The capacity (both methodologically as well as financially and people wise) seems to be prerequisite for releasing organism into the wild that we have no long-term experience with or possibly little understanding of potential impacts.

Yet I also recall our discussion in an Risk Assessment AHTEG way back, when working on voluntary guidance material for Monitoring (see link at end of document). The debate was on whether to monitor a) for certain outcomes, but where data was missing so far or where there was uncertainty (some called it hypothesis derived monitoring), or b) for any unexpected outcomes (referred to as general monitoring), as forming a hypothesis or causal chain might miss those impacts and effects that could not be perceived based on current knowledge.

I assume that this will be an even stronger dichotomy now, as monitoring will have to cover such a broad spectrum of new LMOs where there is little experience or knowledge, as well as cumulative effects (scaling affects) from the sheer number of releases of different LM organisms, including genome edited organisms.

It is an urgent issue and fits the criteria, yet it would be helped my extra debate.

Thank you all.

With kind regards,
Ricarda


Guidance on Risk Assessment of Living Modified Organisms
PART III: Monitoring of Living Modified Organisms Released into the Environment
https://bch.cbd.int/protocol/guidance_risk_assessment  -or-  https://www.cbd.int/doc/meetings/bs/mop-08/official/bs-mop-08-08-add1-en.pdf

Dear Participants,

Thank you very much for your active engagement over the past weeks of the Open-Ended Online Forum on Risk Assessment. The Secretariat will work hard to synthesize your important insights and inputs for the Ad Hoc Technical Expert Group.

The final week of the online forum is now closed.

Kind regards,

The Secretariat

**** Posted on behalf of Jens Warrie, Belgium ****

Dear everyone, I am Jens Warrie, Cartagena Focal Point for Belgium. My background is ecology and GMO policy and I will share my views based on these contexts.



How does this topic potentially pose challenges to the existing risk assessment frameworks, guidance and methodologies? Do solutions exist?
Challenges regarding detection and identification to risk assessment frameworks were already addressed by others in this Online Forum, but I’d like to focus on the role of risk management instead. Especially monitoring is a key measure to follow up on the environmental risk certain LMOs would pose. A high cost or the lack of molecular tools for monitoring will influence decision making by public authorities, as certain risks identified during the risk assessment will prove harder to manage without the possibility to easily keep tabs on them.

A solution to explore is to reinvigorate the AI Handling, transport, packaging and identification (Article 18), last dealt with at COP MOP 7 in Pyeongchang via decision VII/8 as this gives another take on this topic, focusing on traceability via documentation and an efficient usage of costly molecular techniques.


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

I support the assessment of other contributors to this forum how challenges mainly relate to a capacity issue at one hand and an increasing complexity to detect and identify certain LMOs at the other.


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?
The main risks to biodiversity relate to reactions from policy to the challenges listed above, already apparent in different Cartagena Parties around the globe. Issues in detectability and identification are sometimes raised to motivate a softer approach to those LMOs, often coupled with a differentiated approach to risk assessment as well. We stress the specific issue of how detection issue influence national legislation is of course very dependent on national circumstances. Discussions in this direction can be found under different topics of this Online Forum and are therefore more appropriately handled under those or – even more fitting - the Compliance AI.


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

Undoubtedly, which would make it very interesting to reestablish a workstream to identify these resources as a complementary resource to the Training Manual for Detection and Identification.



Final remark is how this Online Forum was set up to evaluate the submissions of Parties for the development of additional guidance in accordance with the criteria in Annex 1 of Decision CP 9/13. For clarity, we have some reservations if this topic is in line with those criteria, but leave this to the AHTEG to analyze more in depth. We do however feel the concerns raised by different Parties need to be addressed one way or another and leave it to the AHTEG and Secretariat to find the most appropriate approach to bring this to the agenda of COP-MOP 12.



Kind regards

Jens