5. Use of living modified organisms in centres of origin and in traditional agricultural systems

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

Conventional risk assessments may not fully account for the unique ecological, genetic, and cultural sensitivities of centres of origin and traditional agricultural systems.

Gene flow from LMOs to wild relatives or landraces can lead to loss of genetic diversity and disruption of in situ conservation practices.

Socio-cultural impacts are often underrepresented in current methodologies, despite their importance in these regions.

Solutions:

Adopt case-specific, precautionary approaches where centres of origin and diversity are involved.

Include participatory assessments involving Indigenous Peoples and Local Communities (IPLCs) to capture traditional knowledge and cultural concerns.

Implement spatial and temporal restrictions or buffer zones to minimize gene flow risks.

2. What could be the specific challenges related to this issue?
Lack of baseline data on wild relatives and traditional varieties to monitor potential impacts.

Limited regulatory enforcement in remote rural areas.

Conflicts between commercial agriculture and traditional farming systems, potentially leading to marginalization of IPLCs.

Unclear liability and redress mechanisms in case of harm to traditional crops or practices.

3. What are the specific issues concerning this topic?
(i) Potential to cause adverse effects on biodiversity:
Yes. LMOs may introgress into native gene pools, threaten landrace integrity, and reduce agro-biodiversity, particularly where traditional seed systems are active.

(ii) Potential for deliberate or accidental introduction into the environment:
Yes. LMOs may be introduced via commercial or aid-based distribution channels, without full awareness of local consequences.

(iii) Potential to disseminate across national borders:
Yes. In border regions that are shared centres of origin, LMOs released in one country may impact traditional systems across national lines.

(iv) LMO commercialization and global use:
Yes. Some LMOs (e.g., maize, cotton, rice) have been introduced or proposed in their centres of origin, raising concerns among conservationists and local farmers.

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

Posted on behalf of Mr. Ahmed Al-Muqdad, ACSAD (Arab Center for the Studies of Arid Zones and Dry Lands)
*****
In the absence of precise regulations and legislation for dealing with genetically modified organisms based on specific experiments and tests, I see the need to be cautious when dealing with such genetically modified organisms, especially those intended for human consumption, since humans are the goal and path of life. If there are any results from previous experiments in this field, please provide them to us so we can convince citizens to use these organisms.

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

Previous experience and scientific evidence showed that the introduction in the environment of the first generation LMO (i.e. transgenics) in centers of origin and traditional agricultural systems poses risks to the conservation of native varieties of the crops (i.e. maize, cotton), and its parental wild relatives. Additionally, the traditional agricultural practices and knowledges of IPLCs are also at risks. These experiences should be considered in the risk assessment guidance of living modified organisms produced with genome edition.

Specifically, in the case of maize in Mexico, a crop of nutritional, ecological, economic, and cultural importance, and considering that Mexico and the Mesoamerican region are the center of origin and diversity of maize, the presence of recombinant sequences in Mexican maize has been published since 2001 (1). Subsequent monitoring efforts confirmed the presence of transgenes in different territories, at different frequencies in commercially distributed native and hybrid maize varieties. This, combined with other socioeconomic factors, has led rural sectors to abandon agricultural activity (based on maize), losing their seeds and associated ancestral knowledge. This, in addition to the fact that Mexico currently imports large quantities of genetically modified maize (i.e. transgenic), from the USA. Moreover, scientific evidence on the accumulation of transgenes in maize (in seed/grain, and food) has been published (2-4). However, given the lack of technical methodologies (and Risk Assessment guidance) for identifying stacked transgenic events, it has not yet been possible to determine which stacked events have arrived in Mexico from grain imports and importantly, how these events are dispersing to local, native maize varieties and possibly to the parental wild relatives of maize (5).

Scientific evidence has been published on off-target outcomes of genome editing in a variety of organisms (6-18). It has also been determined that the genetic modification techniques used to insert recombinant sequences (transgenesis) cause alterations at the proteomic and metabolomic levels in modified plants (19). Therefore, given that the genome modification systems are introduced into cells using largely the same methodologies, alterations in the modified organisms could be expected (20,21).

Additionally, there is no information on the possible interaction between transgenic sequences (and their associated regulatory elements) and the genome editing machinery, or on the possible synergistic or additive effects of the combined expression of genetic modifications (transgenes and expected and unexpected genetic modifications resulting from genome editing) and their effects on organisms. It is currently known that inserted recombinant sequences (i.e., T-DNA) cause alterations at the genomic and proteomic levels of organisms (22-25).

A very important characteristic of (native) crops derived from centers of origin and its diversity is the genomic plasticity of some crops, which exists, in part, due to gene flow between wild relatives and domesticated crops (26-32). In contexts such as climate change, genetic erosion of hybrid varieties, and adaptation and improvement to pests or abiotic stress, native varieties and wild relatives can be a reservoir of potentially useful genes for agriculture. The genomic plasticity of plants should be considered in the risk assessment guidance updates.



2.
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

References
1. Transgenic DNA introgressed into traditional maize landraces in Oaxaca, Mexico https://doi.org/10.1038/35107068

2. A data mining approach gives insights of causes related to the ongoing transgene presence in Mexican native maize populations https://doi.org/10.1080/21683565.2022.2146252

3. Local and Regional Dynamics of Native Maize Seed Lot Use by Small-Scale Producers and Their Impact on Transgene Presence in Three Mexican States https://doi.org/10.3390/plants12132514

4. Pervasive presence of transgenes and glyphosate in maize-derived food in Mexico https://doi.org/10.1080/21683565.2017.1372841

5. Genome editing with the HDR-enhancing DNA-PKcs inhibitor AZD7648 causes large-scale genomic alterations https://doi.org/10.1038/s41587-024-02488-6
6. Template plasmid integration in germline genome-edited cattle. Nat Biotechnol, 38(2): 163-164. https://doi.org/10.1038/s41587-019-0394-6 
7. Chromosomal Rearrangements and Chromothripsis: The Alternative End Generation Model https://doi.org/10.3390/ijms24010794

8. Leibowitz M.L., Papathanasiou S., Doerfler P.A., Blaine L.J., Sun L., Yao Y., Zhang C.-Z., Weiss M.J., Pellman D. (2021) Chromothripsis as an on-target consequence of CRISPR-Cas9 genome editing. Nat Genet, 53(6): 895-905. https://doi.org/10.1038/s41588-021-00838-7 
9. Generate a new crucian carp (Carassius auratus) strain without intermuscular bones by knocking out bmp6 https://doi.org/10.1016/j.aquaculture.2023.739407

10. Joint single-cell profiling of CRISPR-Cas9 edits and transcriptomes reveals widespread off-target events and their effects on gene expression https://doi.org/10.1101/2025.02.07.636966
11. The complex architecture and epigenomic impact of plant T-DNA insertions. https://journals.plos.org/plosgenetics/article?id=10.1371/journal.pgen.1007819
12. An Agrobacterium-delivered CRISPR/Cas9 system for high-frequency targeted mutagenesis in maize https://onlinelibrary.wiley.com/doi/10.1111/pbi.12611
13. Highly Efficient and Heritable Targeted Mutagenesis in Wheat via the Agrobacterium tumefaciens-Mediated CRISPR/Cas9 System https://www.mdpi.com/1422-0067/20/17/4257
14. Site-directed mutagenesis by biolistic transformation efficiently generates inheritable mutations in a targeted locus in soybean somatic embryos and transgene-free descendants in the T1 generation https://link.springer.com/article/10.1007/s11248-020-00229-4
15. Efficient DNA-free genome editing of bread wheat using CRISPR/Cas9 ribonucleoprotein complexes https://doi.org/10.1038/ncomms14261  
16. Off-target effects in CRISPR/Cas9 gene editing https://doi.org/10.3389/fbioe.2023.1143157

17. Precise editing of myostatin signal peptide by CRISPR/Cas9 increases the muscle mass of Liang Guang Small Spotted pigs. Transgenic Res, 29(1): 149-163. https://doi.org/10.1007/s11248-020-00188-w 

18. An integrated multi-omics analysis of the NK603 Roundup-tolerant GM maize reveals metabolism disturbances caused by the transformation process https://doi.org/10.1038/srep37855
19. Unintended Genomic Outcomes in Current and Next Generation GM Techniques: A Systematic Review https://doi.org/10.3390/plants11212997
20. On techno-fixes in the era of crises: genomic interventions in food crops https://doi.org/10.1080/21683565.2024.2429620
21. Developmental plasticity and the origin of species differences https://doi.org/10.1073/pnas.0501844102
22. On the evolutionary origin of discrete phenotypic plasticity. https://doi.org/10.1093/g3journal/jkae144

23. Plasticity and genetic adaptation as contributors to the evolutionary history of cultivated maize and its wild relatives https://theses.hal.science/tel-01763831/

24. Mapping the Diversity of Maize Races in Mexico https://doi.org/10.1371/journal.pone.0114657

25. Genetic erosion in maize’s center of origin https://doi.org/10.1073/pnas.1407033111

26. Geographical distribution and diversity of maize (Zea mays L. subsp. mays) races in Mexico https://doi.org/10.1007/s10722-016-0405-0

27. Population structure and genetic diversity of New World maize races assessed by DNA microsatellites https://doi.org/10.3732/ajb.0800097

Esteemed colleagues,

In contribution to discussion, I would like to comment on the suggested questions 1 and 2 

One important challenge is that general risk assessment frameworks and guidelines often do not incorporate local regulations or context-specific considerations. This omission can lead to conflicts with cultural and ethnic groups and may result in unintended impacts on the biodiversity of these areas. Furthermore, local regulations may contain specific provisions or even prohibitions that significantly alter the risk assessment process and end-result.

In terms of specific challenges, the following points may prove useful and relevant to incorporate into the broader discussion:

Conventional risk assessment approaches do not always incorporate ancestral and traditional knowledge systems. In the context of LMO used in centers of origin and traditional agricultural systems, it becomes crucial to ensure that scientific methodologies are harmonized with the cultural values and practices of local communities, when evaluating the risk, and always in accordance with the provisions of the Cartagena Protocol.

Assessing the potential impacts on wild relatives and traditional crop varieties adds a significant layer of complexity to the risk assessment process. This is particularly critical because any adverse effect on these populations could have far-reaching ecological, genetic, and cultural consequences.

Dear colleagues,

Thank you all very much for your contributions and active participation over the past three weeks. We have generated invaluable input for the work of the AHTEG. You can submit comments until 4 p.m. (Montreal time) today.

Best regards

Ana Laura

First of all my thanks to the moderators, here is my contribution to this topic.

3. What are the specific issues concerning this topic?
As my colleagues have stated in previous posts, there have been reports and studies that show how LMOs can hybridize with local varieties, jeopardizing the genetic diversity of traditional crops and affecting biodiversity and food sovereignty. This is especially worrisome in Indigenous and local communities whose traditional activities include the exchange of seeds. Additionally. the use of patented seeds also leads to a shift in traditional agricultural practices, where the best seeds from each season are  saved for the next without additional purchase/investment. Patented LMO seeds deplete the financial stability of traditional farmers and undermine cultural practices, especially in developing countries where most food is produced by smallholdings. All of these problems can especially affect local and Indigenous women, who have traditionally played a central role in safeguarding seeds and maintaining traditional farming practices. A gender-focused approach is therefore a necessity. For Latin American countries, cassava and potato are crucial crops to protect, since their origins lie in the Andes and Amazon respectively, and they are deeply embedded in cultural practices. There is local research being done to create varieties resistant to pathogens and those are tailored to specific social and environmental conditions, this type of LMOs need to be incentivize.

4. Are there existing resources on similar issues that can address this issue or resources that could be adapted to address this need?
The case of hybrid Bt cotton in India is well known for its negative outcomes for farmers’ finances. A recent study developed a bio-economic model to understand which social, economic, biological, and environmental factors affect cotton crops, and concluded that short-season, high-density cotton varieties would give better results for production yield and farmer income. It is unfortunate that such a study was done after the negative impact that the introduction of the LMO had on the finances of local farmers. If studies like this were conducted before the introduction of an LMO, that would have avoid the unexpected bad effects. Research like this shows how important it is to take into account the social, economic, and environmental conditions of a place before introducing any LMO ands shows a roadmap for methodologies to do so.

Because most commercial LMOs are produced and developed outside the countries where they are farmed, they are not tailored to local conditions and may end up having unexpected negative effects. That is why locally developed, non-patented LMOs should be encouraged, and while maintaining the same safety requirements, be considered a better option than patented LMOs from elsewhere.

Indian hybrid Bt cotton study- https://enveurope.springeropen.com/articles/10.1186/s12302-020-00406-6
LMOs  centres of origin and diversity- https://www.semillas.org.co/es/publicaciones/los-centros-de-origen-y-de-diversidad-deben-ser-regiones-libres-de-transgenicos

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Dear participants,

My name is Christophe Boëte, I am a research scientist at the IRD (Research Institue for Development) in France, based at the Institute of Evolutionary Science of Montpellier, France. Most of my research deals with the interactions between mosquito and their pathogens, the evaluation of novel approaches against vectors at the ecological and epidemiological levels as well as the aspects related to their acceptability and the related regulation. I was a member of the AHTEG that worked on the additional voluntary guidance materials to support case-by-case risk assessments of living modified organisms containing engineered gene drives.

As said in post #12558 and #12543, a critical issue is the hybridization of LMOs with local varieties or wild relatives. This does not only affect biodiversity but also food sovereignty and puts at risk the traditional practices based on seed exchange and classical selection base on the phenotypic characteristics. The case of maize in Mexico is a famous example of the genetic pollution of a transgenic DNA the adequate references have been cited earlier.

While not being a case of an LMOs being used in a centre of origin but in a traditional agricultural system, the use of Bt cotton in Burkina Faso is an example of a failure related to the use of LMOs. Indeed, while being often wrongly presented as a success story (Luna et Dowd-Uribe, 2020) the GM transformation of cotton to make it pest resistant (Bt cotton) has unexpectedly lead to a very low quality of lint. This biological issue has then been detrimental for the cotton producers in Burkina Faso and this has led Monsanto to pay compensation to the Burkinabes farmers and the end of Bt cotton growing in the country. This situation also highlight the importance of transparency and accountability in the reporting of data and knowledge production for an adequate evaluation of technologies.

Regards,

Christophe Boëte


Jessie K. Luna, Brian Dowd-Uribe,2020. Knowledge politics and the Bt cotton success narrative in Burkina Faso,  World Development,136, 2020, 105127, https://doi.org/10.1016/j.worlddev.2020.105127.

Dear moderator, dear colleagues,

Many important points have been made above to this topic thread and I particularly would like to support the inputs of (#12539), (#12543) and (#12558).

It appears to me that -in general- often there is too little understanding of the consequences of contamination of the centres of origin, the centres of diversity of a crop, or the areas of traditional use – other than seen as a living depositary of genetic diversity. The reliance on -and being able to rely on- traditional seeds and on land races is vital for local communities and indigenous peoples at multiple levels, which ultimately all interlink with sustainable use and conservation of biodiversity. We are at times of multiple and increasing crises, thus more attention needs to be given to resilience and self-reliance.

Where centres of origin are also also places of major consumption of the crop as a main staple food, contamination through LMOs could create yet an extra burden and challenge, as the effects could be across wide sections of society.  Much could be said. This will need attention.

As I am supporting the analysis and responses (to the set of four questions) made by the three contributions listed above, I only want to add an extra piece of I believe relevant information.

The routes and causes of contamination are or can be manyfold, and all of which will require attention, if we are to ensure the integrity of the landraces and their breadth of genetic diversity.

With cross-pollination being potentially a major source of contamination where LMO crops are grown in the centres of origin or diversity, the establishment of buffer zones is often suggested to prevent or reduce cross-pollination. However, what if the assumed distance required in underestimated?

I remember for example learning that rice will only outcross up to 2%. Yet I learned recently, that this is actually not the case, as the factor of flower opening times (FOT) is largely ignored when determining the cross-pollination frequency (CPF). Deb and  Bhattacharya (2021) found in fact that cross-pollination frequency of rice can be as high as 81%. Here the abstract of their paper:

“Cross-pollination in cultivated rice (Oryza sativa L.) is rarely reported to exceed 2%. This low cross-pollination frequency (CPF) is conducive to successfully maintaining the purity of rice landraces for many generations. We were therefore surprised to notice a dramatic loss of genetic purity in some of the pure line landraces in many farmers' fields. Having ruled out the possibility of mixing of seeds from different varieties, we surmised this rapid loss of genetic purity to be due to a somewhat higher degree of cross-pollination, and conducted a carefully designed experiment with suitably chosen pairs of landraces. We report here an unusually high (>81%) CPF seen in a pair of landraces whose flower opening times (FOTs) were coincident. Our control experiment on a pair of landraces with non-overlapping FOTs failed to detect any cross-pollination. This preliminary report suggests that the crucial importance of FOT diversity in landraces in determining CPF has not been recognized in designs of previous reports of crossing experiments, resulting in a severe underestimation of CPF in cultivated rice under natural conditions.” (Deb and Bhattacharya, 2021)

So what does that mean for the centres of origin and diversity of rice, when suggesting to introduce LM rice at a major scale, as is suggested for example for so-called golden rice?

It has been a pleasure reading all the contributions. Thank you all.

With kind regards,
Ricada


Deb, D., & Bhattacharya, D. (2021). Unusually high frequency of cross-pollination between rice landraces Shiuli and Kharah with coincident flower-opening times. Current Science, 121(1), 121–126. https://www.jstor.org/stable/27310558

Distinguished colleagues,

Allow me to begin by expressing my sincere appreciation to the moderators and organizers of this important forum for the opportunity to participate.

My name is Humberto Peraza Villarreal, and I belong to the Executive Secretariat of the Intersecretarial Commission on Biosafety of Genetically Modified Organisms (CIBIOGEM) in Mexico.

1. How does this topic potentially pose challenges to the existing risk assessment frameworks, guidance and methodologies? Do solutions exist? 
The use of genetically modified organisms, particularly GM maize in Mexico, poses challenges to existing risk assessment frameworks, which are often designed for homogeneous, industrial agricultural systems and fail to account for the ecological, cultural, and social complexity of centers of origin. Current international methodologies such as those applied under the USMCA dispute panel do not consider critical local variables, including the modes and frequency of maize consumption, nor the extensive dependence of the population on maize as a staple food, with annual per capita consumption reaching 123–196.4 kg, far above global averages (1,2). This oversight compromises the relevance and accuracy of risk evaluations when they are applied uniformly across diverse contexts.
Moreover, prevailing frameworks inadequately address the risk of gene flow from imported GM maize to native varieties cultivated in traditional agroecosystems, where more than 64 maize races are conserved, 59 of them native (3,4,5,6,7). This introgression threatens not only genetic diversity but also the cultural and food sovereignty of Indigenous people and local communities. The biological risks are compounded by socioeconomic and ethical implications, such as dependence on seeds sold by transnational companies and the erosion of biocultural heritage. Despite this, international frameworks often neglect these broader dimensions (6,7,8).
Yes, solutions exist. Risk assessment methodologies must be contextualized adapted to reflect the specific ecological, social, and cultural characteristics of each region.  Risk assessments must be aligned  with international commitments, such as the Cartagena Protocol on Biosafety. In this regard, there is a clear obligation to comply with Annex I(a) of document CP9/13, as well as Articles 15 and 16 of the Protocol, which call for rigorous, science-based, and context-specific risk assessments, along with appropriate and precautionary risk management measures (9,10). 

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

The risk of genetic contamination of native maize by transgene introgression from imported GM maize. 
The loss of genetic diversity and traditional knowledge, which undermines food sovereignty and cultural identity of Indigenous peoples and local communities
International trade agreements -e.g., USMCA-, may pressure megadiverse countries to weaken GMO biosafety measures (11). 
Inadequate consideration of local consumption patterns in global risk frameworks. 
Challenges in enforcing the precautionary principle due to legal and political pressures. 
Accidental contamination from GM maize used for industrial or livestock purposes, despite planting bans on. 

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...? 

Yes. There is a documented risk of serious and potentially irreversible genetic contamination of Mexico’s native maize varieties, which threatens biodiversity, food security, and the biocultural heritage of Indigenous people and local communities. Mexico is a center of origin and diversification of maize. Losing this genetic reservoir would have global consequences, especially in the context of the climate crisis (14).

(ii) Is there the potential to have an introduction into the environment either deliberately or accidentally? 
Yes. Although GM maize cultivation is judicially suspended in Mexico since 2013, the importation of GM maize for industrial and livestock use continues, creating risks of accidental environmental introduction and gene flow into traditional agroecosystems.

(iii) Is there the potential to disseminate across national borders? 
Yes. Gene flow does not respect political borders and given the trade and movement of maize across countries, there is potential for transboundary dissemination of genetically modified organisms, especially in regions with shared ecosystems or agricultural practices. 

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

Yes. GM maize is widely commercialized and used, particularly in the United States, which exports it to Mexico. The recent USMCA dispute ruling highlights the ongoing commercialization and trade of GM maize, which poses challenges for countries seeking to apply stricter biosafety measures.

References: 

1.Serna-Saldívar, S. R. O., & Amaya-Guerra, C. A. (2008). El papel de la tortilla nixtamalizada en la nutrición y la alimentación. En M. Rodríguez-García, S. O. Serna-Saldívar, & F. Sánchez-Senecio (Eds.), Nixtamalización del maíz a la tortilla. Aspectos nutrimentales y toxicológicos (pp. 59–74). UNAM. 
2. SIAP (Sistema de Información Agroalimentaria y Pesquera). (2018). Atlas agroalimentario 2012–2018. https://nube.siap.gob.mx/gobmx_publicaciones_siap/pag/2018/Atlas-Agroalimentario-2018
3. Turrent-Fernández, A., Serratos-Hernández, A., Mejía-Andrade, H., & Espinosa Calderón, A. (2009). Propuesta de cotejo de impacto de la acumulación de transgenes en el maíz nativo mexicano. Agrociencia, 43, 257–265. https://www.scielo.org.mx/scielo.php?pid=S1405-31952009000300005&script=sci_abstract
4. Kato, T. A., Mapes, C., Mera, L. M., Serratos, J. A., & Bye, R. A. (2009). Origen y diversificación del maíz (1ª ed.). Universidad Nacional Autónoma de México; Comisión Nacional para el Conocimiento y Uso de la Biodiversidad. 
5. CONABIO. (2011). Proyecto Global de Maíces Nativos. Comisión Nacional para el Conocimiento y Uso de la Biodiversidad; Instituto Nacional de Investigaciones Forestales, Agrícolas y Pecuarias; Instituto Nacional de Ecología y Cambio Climático. https://biodiversidad.gob.mx/diversidad/proyectoMaices
6. Altieri, M. A. (2003). The sociocultural and food security impacts of genetic pollution via transgenic crops of traditional varieties in Latin American centers of peasant agriculture. Bulletin of Science, Technology & Society, 23(5), 350–359. https://doi.org/10.1177/0270467603259774V 
7. Piñeyro-Nelson, A., Van Heerwaarden, J., Perales, H. R., Serratos-Hernández, J. A., Rangel, A., Hufford, M. B., & Álvarez-Buylla, E. R. (2009). Transgenes in Mexican maize: Molecular evidence and methodological considerations for GMO detection in landrace populations. Molecular Ecology, 18(4), 750–761. https://doi.org/10.1111/j.1365-294X.2008.03993.x 
8. Quist, D., & Chapela, I. H. (2001). Transgenic DNA introgressed into traditional maize landraces in Oaxaca, Mexico. Nature, 414(6863), 541–543. https://doi.org/10.1038/35107068 
9. Serratos-Hernández, J. A. (2009). Bioseguridad y dispersión de maíz transgénico en México. Revista Ciencias, 92–93, 46–55. 
10. Serratos-Hernández, J. A., Gómez-Olivares, J. L., & Salinas-Arreortua, N. (2007). Transgenic proteins in maize in the soil conservation area of Federal District, Mexico. Frontiers in Ecology and the Environment, 5(5), 247–252. https://doi.org/10.1890/1540-9295(2007)5[247:TPIMIT]2.0.CO;2
11. Secretariat of the Convention on Biological Diversity. (2000). Cartagena Protocol on Biosafety to the Convention on Biological Diversity: Text and annexes. United Nations. https://www.cbd.int/doc/legal/cartagena-protocol-en.pdf 
12. Secretariat of the Convention on Biological Diversity. (2018). Decision adopted by the Parties to the Cartagena Protocol on Biosafety: 9/13. Risk assessment and risk management (Articles 15 and 16). Ninth meeting of the Conference of the Parties serving as the meeting of the Parties to the Cartagena Protocol on Biosafety, Sharm El-Sheikh, Egypt, 17–29 November 2018. https://www.cbd.int/doc/decisions/cp-mop-09/cp-mop-09-dec-13-en.pdf
13. USMCA Panel established pursuant to Chapter 31. (2024, December 20). Mexico — Measures concerning genetically engineered corn (MEX-USA-2023-31-01). Final report. Agreement between the United States of America, the United Mexican States, and Canada. https://www.gob.mx/se/prensa/panel-del-t-mec-distribuye-informe-final-en-el-caso-mexico-medidas-relacionadas-con-el-maiz-geneticamente-modificado-mex-usa-2023-31-01 
14. Harlan, J. R. (1971). Agricultural origins: Centers and noncenters. Science, 174(4008), 468–474.

I am Dr. Nicolas Defarge, molecular biologist, representative of ENSSER (European Network of Scientists for a Socail and Environmental Responsability)

3. What are the specific issues concerning this topic?
As said in several posts, a critical issue is the hybridization of LMOs with local varieties or wild relatives, and I support the inputs in post #12539, #12543, #12558, #12578 and #12585.

(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, as identified in most of the posts quoted.

Warm regards to everyone.

Nicolas Defarge

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

Hello.  My name is Karen Hokanson and I work with the Agriculture & Food Systems Institute, a nonprofit scientific organization that among other things provides capacity building for risk assessment of LMOs.  As this is my first post during this online forum, I wish to thank the moderators and the secretariat for facilitating this discussion.

In response to question #1, I would like to say based on my experience that this topic of use of LMOs in centers of origin and in traditional agriculture does not pose challenges to existing frameworks for risk assessment, in the same way that algae, animals, fish, microorganisms, LMOS containing stacked events, long term and cumulative effects of LMOs, as well as genome edited organisms (if a party wishes to assess these).  As has been described by many in the posts of this forum already, and stated most simply by Yann Devos in his posts on algae, fish animals and microorganisms,, the problem formulation approach which relies on pathways to harm, applied in the context of Annex III, on a case by case basis, can be employed in the case of LMOs in centers of origin.

This is not to diminish the significance of considering potential impacts of LMOS in Centers of Origin. One challenge risk assessors face in this case is clearly identifying the protection goals and the assessment endpoints, and for this and other reasons I do see merit in considering the “operationalization of protection goals” as a general topic for further guidance.  It is also important to note that the decision to approve LMOs in centers of origin may extend to cultural and societal considerations, even when risks to the environment or human health are considered negligible.

As others have noted, what is needed for these topics is not additional guidance per se, but examples of how these topics can be assessed using existing frameworks and capacity building, and access to information that can help inform the plausible pathways to harm and the likelihood of their occurrence.

I refer here one publication that illustrates my point:
Hokanson, K.E., Ellstrand, N.C., Dixon, A.G.O., Kulembeka, H.P., Olsen, K.M., Raybould, A. 2016. Risk assessment of gene flow from genetically engineered virus resistant cassava to wild relatives in Africa: An expert panel report.  Transgenic Research 25(1):71-81. doi: 10.1007/s11248-015-9923-3
But also see:
Hokanson, K.E., Ellstrand, N.E., and Raybould, A.  2018. The integration of science and policy in regulatory decision-making: observations on scientific expert panels deliberating GM crops in centres of diversity.  Frontiers in Plant Science. 9:1157. Doi: 10.3389/fpls.2018.01157

Thanks,
Karen