4. Transportability of data for risk assessment of living modified organisms

Thank you for the opportunity to contribute to this important discussion.
I would like to highlight that the current guiding questions on the transportability of data for the risk assessment of LMOs are weighted toward identifying risks and uncertainties — which is, of course, a crucial element of RA&M. However, this framing misses the opportunity to also consider the potential benefits and opportunities of improved data transportability, such as enhancing efficiency, reducing duplication of effort, supporting regulatory cooperation, and strengthening the management aspects of risk assessment and risk management.
A more balanced approach could support a broader and more constructive dialogue that reflects both the challenges and the practical benefits and opportunities in this area. This is particularly important to help optimize the use of scientific and regulatory capacity, especially in circumstances where data transportability can reduce duplication of effort without compromising biosafety.
Likewise, the management aspects of RA&M deserve greater attention. Most of the current guiding questions focus on the risk assessment, with less emphasis on risk management, which is equally critical.
A more balanced framing that includes these missed opportunities would enrich the discussion.
best regards, Lúcia

Many thanks to all participants and the moderators for the past weeks interactions on this forum. My response to this point of data portability which is a key aspect for regional science-based decision making on LMOs with potential impact on trade is as below-

From a regulatory science perspective, the governance of genetically modified organisms (GMOs) under the United Nations Convention on Biological Diversity (CBD) and the Cartagena Protocol on Biosafety presents significant challenges—particularly in terms of biosafety data accessibility, interoperability, and portability across jurisdictions. These challenges are increasingly relevant as national biosafety authorities strive to make informed, science-based decisions using unique case- and location-specific as well as shared and harmonized data resources in a weight of evidence approach.
The Cartagena Protocol recognizes the critical role of information exchange and international cooperation in the safe handling of living modified organisms (LMOs). Article 20 of the Protocol establishes the Biosafety Clearinghouse (BCH) as a mechanism to "facilitate the exchange of scientific, technical, environmental and legal information." The BCH mandates parties to share data on risk assessments, regulatory decisions, and other relevant documentation, which is an implicit endorsement of data portability and transparency.
This provision supports interoperability goals by:
• Providing structured data submission formats, which help standardize risk assessment reports.
• Encouraging common ontologies and taxonomies through shared fields and categories (e.g., trait identifiers, transformation methods, receiving environments).
• Promoting access to peer-reviewed scientific information, particularly from Parties of Export and Import, which supports comparative risk analysis.
However, there are structural and practical limitations within the Protocol and the BCH framework that hinder true data interoperability:
1. Inconsistent Data Quality and Formats: Despite standardized templates, Parties often submit data in inconsistent formats or incomplete fields. This limits the capacity of regional authorities to reuse data effectively for comparative risk assessment or regulatory benchmarking.
2. Lack of Interoperability with National Databases: The BCH functions largely as a central repository rather than a federated system. There is minimal integration with national biosafety information systems, many of which use divergent data models or are not machine-readable. As a result, data portability across jurisdictions remains manual and inefficient.
3. Variable Participation: Not all Parties contribute equally to the BCH. Countries with limited technical or institutional capacity may underreport or have delays in submissions. This limits regional harmonization efforts and can create information asymmetries.
4. Limited Legal Mandates for Data Standardization: The Protocol does not require Parties to adhere to any specific data interoperability standards beyond minimal reporting obligations. In the absence of binding standards (e.g., XML schema compliance, use of common trait ontologies), the practical interoperability of biosafety data remains voluntary and uneven.
To overcome these challenges, a shift toward regional data harmonization initiatives—complemented by updates to BCH infrastructure—could enhance scientific collaboration and regulatory efficiency:
• Promote Regional Data Platforms: Encourage the development of regional biosafety data-sharing platforms (e.g., within the African Union, ASEAN, or Mercosur) that align with BCH formats but enable more dynamic data exchange and real-time collaboration.
• Adopt Global Data Standards: Push for integration of established biosafety and biotechnology metadata standards (such as those developed by the OECD, FAO, or Codex) to ensure semantic and technical interoperability. This is currently a missed opportunity.
• Capacity Building and Infrastructure Investment: Invest in national digital infrastructure and training to ensure consistent and timely data submission to the BCH and regional nodes. There is a critical need for timely data and decision document input to the BCH.
• Enhance Machine Readability and APIs: Advocate for modernization of the BCH with Application Programming Interfaces (APIs) and structured data access protocols that allow national systems to interact programmatically with BCH records to update, query and retrieve in real time.
In conclusion, while the Cartagena Protocol lays a strong foundation for data exchange in biosafety, meaningful progress in data portability and interoperability will require a combination of regulatory commitment, technical investment, and multilateral coordination—particularly at the regional level where shared ecosystems and agricultural trade ties create overlapping biosafety concerns.


best wishes
Brinda Dass
Senior Technical Expert, FNIH, USA

Dear Ms. Anita Anthonysamy and dear colleagues

As I understand it, the request was for guidance on how to use data developed for environmental risk assessment in countries other than where the LMO was developed and tested. The guidance is sought to help countries develop more uniform approaches to gathering data that will be both necessary and sufficient in many places at once.

The request only described data transferability in the context of agrophenotypic characterisation and only referred to crops. And most if not all of the references were to plants. If I haven’t misunderstood, then the request is for guidance on conducting trials and tests of only crop plants (and no other kinds of plants or other organisms, and for no other purpose) that would generically replace an Annex III risk assessment in many places at once.
If that summary is about right, then below is my evaluation in accordance with paragraph 7 of CP-11/7. I am evaluating from the wording of Annex III “to identify and evaluate the potential adverse effects of living modified organisms on the conservation and sustainable use of biological diversity in the likely potential receiving environment, taking also into account risks to human health.”

Please note that my evaluation is the same regardless of whether the request is for data transferability for data only on M crop plants or for any kind of LMO.

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

The topic creates challenges to existing risk assessment frameworks because ERA is local. The fixed place is the likely intended receiving environment which will have specific protection goals, potential exposures, and assessment endpoints. The United States National Academies said this in their 2016 report on LM plants:

“One can imagine an argument being made by certain stakeholders, that if the U.S. government found a plant to be safe, that judgment should be good enough for a country without the resources to conduct its own environmental analysis. That would be wrong.” [1]

Annex III paragraph 9 a-f already provides a list of what data can be used anywhere. Paragraph 9 g-h may or does specify information about where the LMO will be. Guidance on applying Annex III cannot change this.

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

None that I can see. I am not aware that the Protocol prevents an importing country from considering the data developed in another jurisdiction, and taking that into account even for items in paragraph 9 g-h. It preserves the right for each country to determine for itself what is necessary and appropriate in the described scientific risk assessment. The requested guidance doesn’t go beyond what a country already knows that it may ask for.

If guidance were envisioned to somehow suggest that a country should not ask for information allowed in Annex III, then it would not be compatible with the text of the Protocol.

3. What are the specific issues concerning this topic?
(i) Is there the potential to cause adverse effects?

Relying on data that is inappropriate for Annex III could result in adverse effects on biodiversity, in particular those that are serious or irreversible, taking into account the urgent need to protect specific aspects of biodiversity, such as an endemic/rare species or a unique habitat or ecosystem, taking into account risks to human health and the value of biological diversity to indigenous peoples and local communities.

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

Yes, I think deliberate introduction this is the intention behind data transferability.

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

Yes, I think dissemination across national borders is the intention behind data transferability.

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

Annex III

I cannot foresee that data could be developed in one jurisdiction predetermined to automatically satisfy a risk assessment according to Annex III in another jurisdiction, especially for any kind of LMO. Guidance on data transportability/transferability is of very little value because it provides no new technical insights or capacities that would aid in the use of Annex III which already speaks to the need for information applicable to the likely potential receiving environment.

1. NASEM. (2016) Genetically Engineered Crops: Experiences and Prospects, The National Academies Press. https://nap.nationalacademies.org/catalog/23395/genetically-engineered-crops-experiences-and-prospects

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

Environmental and ecological variability (e.g., soil types, climate, native species) can affect the relevance of foreign data.

Differences in regulatory requirements and levels of detail required in risk assessment dossiers.

Lack of guidance on when and how foreign data can be accepted or adapted, leading to inconsistent decisions and duplication of efforts.

Solutions:

Use comparative risk assessment frameworks that include criteria for determining the relevance and reliability of foreign data.

Develop contextual bridging studies to supplement foreign data with local evidence where necessary.

Promote mutual recognition mechanisms or data transportability guidelines, such as those proposed by OECD and some regional biosafety networks.

2. What could be the specific challenges related to this issue?
Limited access to proprietary data from origin countries or developers.

Insufficient local expertise or capacity to evaluate the applicability of foreign data.

Regulatory mistrust or lack of harmonization, especially where risk perception or policy objectives differ.

Risk of overlooking local ecological or socio-economic factors not captured in external studies.

3. What are the specific issues concerning this topic?
(i) Potential to cause adverse effects on biodiversity:
Yes. If data from another country do not capture region-specific risks (e.g., to endemic species), adverse effects may be underestimated.

(ii) Potential for deliberate or accidental introduction into the environment:
Yes. Decisions based on non-local data could lead to premature approvals without adequate safeguards.

(iii) Potential to disseminate across national borders:
Yes. Regional coordination on data sharing and assessment is essential to manage LMOs that move across borders.

(iv) LMO commercialization and global use:
Yes. Many LMOs are developed and tested in specific regions (e.g., North America), but deployed globally, raising concerns about the extrapolation of data without adaptation.

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 Kamal Kumar Rai, Nepal Indigenous Biodiversity Forum (NIBF), Indigenous Knowledge and Peoples Network Society for Wetland Biodiversity Conservation Nepal
*****
For IPLCs, It is crucially important to have  a holistic and a dynamic inclusive Assessment and Management mechanism.   Non-state actors IPLCs are always happy to collective contribute to the process in a respectful manner.  Not well known, publicly not well understandable innovations can bring adverse impacts to the biodynamics of Nature, ecosystems, plants, animals and microbes and the diversity and indigenous values and their systems including Indigenous health and foods, traditional ways of life deeply interconnected with socio-economic, culture, ethics, spiritually, cosmological, lingual symbiotic relationship in reciprocal are the assists for biodiversity conservation.

Right based and Inclusive mechanisms for IPLCs are important with full and effective participation at all, recognize and respect the rights of IPLCs, take into account the Free, Prior and Informed Consent. As guardians and right holders, IPLCs require a safe guard enline with the human rights over the lands, waters and territories and resources including biodiversity, foods, health and the reciprocal relationship, tangible and intangible sentiments interconnection with the whole total environment.  Many of ways, IPLCs are facing a problem of desplance, killing and forceful removal from the traditional lands, waters and territoires. Apart from these, innovations also support the decision and not taking care of the sentiments of IPLCs. Therefore, LMO, EGD related innovations, activities or programmes of work must have clear guidelines, policies and a mechanism to work with IPLCs and vice-versa. 

Thanks with regards
Kamal Kumar Rai
IPLCs

Esteemed colleagues,

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

Transportability of data for risk assessment of Living Modified organisms (LMO) poses in my opinion three important challenges to current risk frameworks and guidelines to have in consideration when 

Local regulations may include specific requirements that hinder the transportability of data across regions. This issue is highlighted by Bachman et al (2021), who present an example where some Parties recognize locally conducted agronomic studies as valid scientific evidence for granting agricultural authorizations for LMO.

Specific environmental conditions, like climate, altitude, soil, ecosystems and biodiversity, can factor in determining if data can be of use between different Parties or even within regions of the same Country. 

Intellectual property and data confidentiality may pose significant restrictions on the access and use of information required for conducting risk assessments and granting regulatory approvals. In Colombia, for instance, this issue was encountered by one of the Competent Nacional Authorities in LMO regulation when evaluating an off-patent LMO event. Due to limitations related to ownership and data confidentiality, it was not possible to use certain pre-existing studies and data. Consequently, the new applicant was required to generate their own studies, even though the overall conclusions were consistent with those of the original event.

References

Bachman, P. M., Anderson, J. A., Burns, A., Chakravarthy, S., Goodwin, L., Privalle, L., Song, S., & Storer, N. (2021). Data transportability for studies performed to support an environmental risk assessment for genetically modified (GM) crops. Journal of Regulatory Science, 9(1), 38–44. https://doi.org/10.21423/jrs-v09i1bachman

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.

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

Data transportability represents a significant technical and regulatory challenge within risk assessment frameworks, especially when aiming to ensure that external data are relevant to the local context.

However, this challenge can be addressed through a structured approach based on clear risk hypotheses, which allows for the analysis of whether external studies adequately respond to the critical questions of the assessment.

The solution does not lie in automatically requiring locally generated data, but rather in applying clear scientific criteria to determine when a dataset is sufficiently representative, robust, and relevant to be extrapolated and used in our evaluation.

Only in cases where studies conducted in other countries do not adequately address the formulated risk hypothesis—and this justifies the need for local trials—should such trials be required.

Harmonizing these criteria for accepting studies conducted abroad would be an important step toward establishing specific requirements without creating a burden of redundant information.

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

Achieving environmental risk assessments within a solid framework requires the formulation of clear risk hypotheses and the identification of the pathway to harm.

The assessment should be based on a well-defined problem, consider realistic scenarios, and focus on the elements relevant to decision-making.

In this context, external data may be considered as long as the studies are technically robust, well designed, include appropriate controls, and the parameters assessed are relevant to the formulated hypotheses.

The key is to ensure that the data are sufficiently representative of the phenomenon under analysis and applicable to the context of the evaluating country, without requiring local replication unless technically justified.

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?

It is crucial to formulate specific risk hypotheses and assess whether the available data allow for their acceptance or rejection within the local context.

In the case of studies on non-target organisms, for example, the use of ecologically equivalent surrogate species may provide extrapolable information without the need for replicating local field studies.

Transported data (or conclusions from studies conducted in other countries) can only serve as support to answer the questions raised for the assessment.

Any risk assessment must consider this impact. We must also bear in mind that the release occurs within an agroecosystem (a system already altered by agricultural production). The analysis should be conducted considering these comparisons, along with the risk hypotheses formulated at the beginning of the assessment.

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

Every risk assessment requires consideration of release scenarios, and in this regard, transportable data may be sufficient to characterize the behavior of the GMO under comparable agricultural conditions, allowing for the evaluation of its performance without the need for local release.

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

The potential dissemination beyond national borders reinforces the need for harmonized frameworks that recognize the validity of data generated in other countries and used in local assessments.

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

Regulatory frameworks that use risk hypotheses and pathways to harm allow for structuring the assessment in such a way that external data can be integrated solidly.

There are numerous regulatory guidelines and experiences that can be adapted or used as a basis for developing criteria on data transportability.

Additionally, there are national experiences with established practices for accepting studies generated in other countries, provided they meet quality and relevance criteria.

Final Reflection:

Data transportability, when implemented with rigorous and well-defined technical criteria, is compatible with a solid and scientific environmental risk assessment. It does not imply a reduction in requirements, but rather an optimization of the evaluation process, allowing for the efficient use of resources and avoiding unnecessary duplications. This approach can strengthen regulatory cooperation and facilitate harmonization between countries, without compromising the objectives of environmental and biodiversity protection.

Best regards.

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

Data transportability can present certain limitations that may challenge existing environmental risk assessment frameworks. Some data may not be directly applicable due to differences in climate, soils and species composition (biodiversity). Yes, solutions do exist, Bachman et al 2021 in publication titled ‘Data Transportability for Studies Performed to Support an Environmental Risk Assessment for Genetically Modified (GM) Crops’’ provides information for conditions for data transportability.

2. What could be the specific challenges to related to this issue?
Environmental variability including factors such as weather pattern, soil type and soil composition can significantly affect the growth and behavior of the Living Modified Organism (LMO. These differences may affect the reliability results when data is transported from one region to another. 

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?

Data from different climatic zones may not accurately reflect the potential risks associated with LMOs in the target environment. This may increase uncertainties in the risk assessment and may have potential to cause adverse effect on biodiversity which may be serious or irreversible

The transportability of data presents both opportunities and challenges for existing risk assessment frameworks for living modified organisms (LMOs). Challenges may include the absence of harmonized criteria for accepting foreign data and concerns about the applicability of external studies to local ecological conditions. While transportability may not always be feasible, a growing body of scientific guidance and regulatory practice shows that data—particularly from laboratory and well-designed field studies—can be transportable, provided they meet certain standards of quality, relevance, and alignment with risk hypotheses.

I agree with the emphasis on hypothesis-driven environmental risk assessment (ERA). In this context, data transportability offers an important opportunity to improve the efficiency and scientific consistency of LMO risk assessments, while maintaining high standards of environmental protection.

Laboratory studies can be well-suited for data transportability due to their controlled conditions, provided they are based on robust study design, high data quality, and clear relevance to the formulated risk hypothesis. For example, Romeis et al. (2011, 2013) contribute to the discussion on transportability in non-target organism (NTO) risk assessment. Their work provides guidance on laboratory study design for genetically modified crops, including surrogate species selection, reproducibility, and test sensitivity. Romeis et al. (2011) suggest that high-exposure studies may offer a conservative basis for early-tier NTO assessments with potential applicability across regulatory contexts. Romeis et al. (2013) further propose that carefully selected surrogate species, representing key ecological functions, may support the relevance of such studies even in regions with different species compositions.

Field studies are generally more context-dependent than laboratory studies; however, data transportability may still be supported when certain conditions are met. As Bachman et al. (2021) emphasize, the goal of field studies in ERA is not to detect all differences between genetically modified (GM) plants and their conventional counterparts, but to identify biologically relevant differences with potential environmental implications.

Such trials are typically conducted at multiple sites that reflect a range of relevant environmental conditions. While no single study can encompass every possible scenario, the purpose of these trials is to evaluate whether the introduced trait leads to adverse effects under diverse, representative conditions. When the studies are well-designed and no biologically meaningful differences are observed across varying environments, the resulting data may—in appropriate contexts—be considered applicable beyond the original trial locations, including across agroclimatic zones.

Empirical evidence supports this approach. Examples include Horak et al. (2015), who assessed the agronomic performance and weediness potential of GM soybeans in both the U.S. and Argentina and found no biologically meaningful differences compared to conventional comparators. Corrales Madrid et al. (2018) demonstrated similar conclusions with non-target arthropod data collected across distinct Mexican ecoregions. More recently, Nakai et al. (2024) emphasized that confined field trial data from one country can inform risk assessments elsewhere when based on standardized protocols and sound risk hypotheses.

That said, certain situations may justify the need for local data. These include cases where the receiving environment hosts unique, protected, or endemic species, or where the GM trait may interact with local conditions in ways not captured by existing studies. Additionally, some regulatory systems may require data on specific endpoints not previously assessed. In such instances, the decision to request local trials should be based on a clearly formulated risk hypothesis.

Regulatory frameworks in several countries already provide examples of how data generated abroad can be integrated into ERA. Authorities in the European Union (EFSA), Japan, Australia, Brazil, and others have accepted foreign field and laboratory data when they meet defined criteria for quality, relevance, and scientific justification.

Data transportability plays an important role in reducing redundancy, supporting responsible innovation, and promoting robust, scientifically sound, and efficient risk assessment in line with the objectives of the Cartagena Protocol. As previously noted, when implemented with rigorous and well-defined technical criteria, data transportability is fully compatible with a solid, science-based environmental risk assessment. It does not imply a reduction in requirements, but rather an optimization of the evaluation process—enabling the efficient use of resources and avoiding unnecessary duplications.
References
Bachman, P. M., Anderson, J., Burns, A., Chakravarthy, S., Goodwin, L., Privalle, L., Song, S., & Storer, N. (2021). Data transportability for studies performed to support an environmental risk assessment for genetically modified (GM) crops. Journal of Regulatory Science, 9(1), 38–44. https://doi.org/10.21423/jrs-v09i1bachman
Corrales Madrid, J. L., Martínez Carrillo, J. L., Osuna Martínez, M. B., Durán Pompa, H. A., Alonso Escobedo, J., Quiñones, F. J., ... & Ahmad, A. (2018). Transportability of non-target arthropod field data for the use in environmental risk assessment of genetically modified maize in Northern Mexico. Journal of Applied Entomology, 142(5), 525–538. https://doi.org/10.1111/jen.12499
Horak, M. J., Rosenbaum, E. W., Kendrick, D. L., Sammons, B., Phillips, S. L., Nickson, T. E., Dobert, R. C., & Perez, T. (2015). Plant characterization of Roundup Ready 2 Yield® soybean, MON 89788, for use in ecological risk assessment. Transgenic Research, 24(2), 213–225. https://doi.org/10.1007/s11248-014-9839-3
Nakai, S., Hoshikawa, K., & Ohsawa, R. (2024). Scientific considerations for transportability of confined field trial data in the environmental risk assessment of genetically modified plants. Frontiers in Bioengineering and Biotechnology, 12, 1359388. https://doi.org/10.3389/fbioe.2024.1359388
Romeis, J., Hellmich, R. L., Candolfi, M. P., Carstens, K., De Schrijver, A., Gatehouse, A. M. R., Herman, R. A., Huesing, J. E., McLean, M. A., Raybould, A., Shelton, A. M., & Waggoner, A. (2011). Recommendations for the design of laboratory studies on non-target arthropods for risk assessment of genetically engineered plants. Transgenic Research, 20(1), 1–22. https://doi.org/10.1007/s11248-010-9446-x
Romeis, J., Raybould, A., Bigler, F., Candolfi, M. P., Hellmich, R. L., Huesing, J. E., & Shelton, A. M. (2013). Deriving criteria to select arthropod species for laboratory tests to assess the ecological risks from cultivating arthropod-resistant genetically engineered crops. Chemosphere, 90(3), 901–909. https://doi.org/10.1016/j.chemosphere.2012.09.035

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.

Data transportability involves using data from confined LMO field trials for environmental risk assessments (ERAs) in countries beyond where the trials occurred. This data primarily focuses on agrophenotypic characterization to identify unintended or harmful effects of genetic modification. The Protocol's scope and objectives support this concept, ensuring sufficient protection. However, with decades of experience in LMO ERAs and extensive knowledge, parties must update and evolve their regulatory frameworks to fully engage with the concept.

Existing LMO risk assessment frameworks frequently limit data transportability. Establishing clear guidelines on data requirements could help regulators determine whether data from prior confined trials can support an ERA in a new country. This could streamline regulatory reviews and accelerate the delivery of desired varieties to producers. Diverse LMO risk assessment criteria across countries hinder the use of data in cross-jurisdictional risk assessments, escalating technology costs, especially for public institutions and SMEs. This burdens regulators, developers, and society.

Adopting data transportability in ERAs requires a clear, evidence-based procedure that justifies using data from another country, enabling local regulators to make decisions.

In summary, the ongoing debate aims to balance fostering innovation with ensuring safety while streamlining data requirements. The proposed concept of data transportability seeks to inform environmental risk assessments (ERAs) through agrophenotypic characterization of LMOs.

Best regards,

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

Thank you very much to the moderators and participants for this topic,

In response to Q1:

I would like to raise a point I raised with regard to data transportability in a previous topic, and echo the post by Jack Heinemann, that Annex III specifies the need to assess potential adverse impacts on the receiving environment. As such, any proposal to implement data transportability poses fundamental challenges to the ability to meet the obligations under Annex III of the Protocol.

Q2: Data transportability may raise specific challenges due to implementation of obligations under Annex III.

Q3 (i): Data transportability increases risks and uncertainties of adverse impacts on biodiversity due to the reduction or even elimination of studies assessing environmental risks that are relevant to the local context and biodiversity, as previously raised by Lilian Chimphepo in post #12560.

Moreover, in my view, there is currently a weak evidence base from which to support the concept of data transportability. From my understanding, there appear to be very few studies showing its applicability, all of which have been referenced in this forum.

For example, the Bachmann et al. (2021) study, presents two case studies including one (Corrales Madrid et al., 2018) that only assessed abundance of arthropods in four regions within one a single country (Northern Mexico). No other aspects of the receiving environment was assessed. The other study refers to food feed and processing, which is of limited relevance to ERA for environmental releases (Nakai et al., 2018). Nakai (2024) does not present any novel data to assist further analysis.

It is thus my view that this data is not sufficient to extrapolate the relevance of international data transportability to comprehensively cover all potential risks to local biodiversity, as well as to broader aspects such as local farming and cultural practices with added socioeconomic implications, linking back to the post made by Kamal Kumar Rai #12540.

Q3 (ii & iii): data transportability may increase the potential for environmental release as well as transboundary movements by accelerating approvals without adequate safeguards for potential impacts on receiving environments.

As such, I would like to support the conclusions by Jack Heinemann that guidance on data transportability would not assist Parties in implementing Annex III due to its incompatibility with the obligations to assess potential impacts on receiving environments.  Moreover, the scientific rationale for its implementation is lacking.

Corrales Madrid, J. L., Martínez Carrillo, J. L., Osuna Martínez, M. B., Durán Pompa, H. A., Alonso Escobedo, J., Quiñones, F. J., ... & Ahmad, A. (2018). Transportability of non-target arthropod field data for the use in environmental risk assessment of genetically modified maize in Northern Mexico. Journal of Applied Entomology, 142(5), 525–538. https://doi.org/10.1111/jen.12499

Bachman, P. M., Anderson, J., Burns, A., Chakravarthy, S., Goodwin, L., Privalle, L., Song, S., & Storer, N. (2021). Data transportability for studies performed to support an environmental risk assessment for genetically modified (GM) crops. Journal of Regulatory Science, 9(1), 38–44. https://doi.org/10.21423/jrs-v09i1bachman

Nakai,  S.,  Hoshikawa,  K.,  Shimono,  A.,  & Ohsawa,  R. (2015). Trans-portability of confined field trial data from cultivation to import countriesfor environmental risk assessment of genetically modified crops.Trans-genic Research, 24(6), 929-944. doi: 10.1007/s11248-015-9892-6

Dear Anita Anthonysamy, dear colleagues,

I would like to add a few thoughts and some references to this interesting discussion on transportability of data for risk assessment of LMOs.

When re-reading the party submission to this topic I come to the same conclusion as Jack Heinemann (#12532), i.e. that it only covers agrophenotypic characterisation data, that this data is only from field trials and only from LM crop plants. In particular it expresses the wish to enable the general utilisation of such data produced in one country to be transportable and be the basis for ERAs and decision making in other countries. The proposal states for example: "Furthermore, data transportability could facilitate regulatory approvals in countries where the market might not justify the expenses with new field trials..."

I will look at the proposal in that light of interpretation.

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

I regard that some data is easily transportable/transferable – such as the detailed characterisation of the organism in question, the source of inserted DNA (should there be an insertion) – i.e. the donor organism(s), the vector, the methodology used, the detailed genomic characterisation as to where modifications have been made (locus), what they are and what the surrounding sequences are, the intended modified trait and the changed characteristics, etc.; In fact, the Protocol already caters for this in Annex III para 9.

However, I would regard it as a real challenge for ERA and existing risk assessment frameworks to rely on and be limited to data from other locations and environments. It would by definition not be an ERA, as an environmental risk assessment is very much specific to the “likely potential receiving environment” (Annex III, para 5)

It is well known that plants will be impacted by different stimulants and stressors and ‘behave’ differently, meaning they produce different compounds, grow differently etc.;
Liu et al. (2016) looked at the impact of different parameters in their paper: “Influence of Environmental Factors on the Active Substance Production and Antioxidant Activity in Potentilla fruticosa L. and Its Quality Assessment” – i.e. looking at the Rosaceae plant commonly called ‘shrubby cinquefoil’, home to the Northern hemisphere and used in traditional medicine in China. The authors investigate the impact of altitude, annual sunshine duration and annual mean temperature and report:

“Environmental factors may influence types and contents of active substances. This study investigated the influence of environmental factors on the active substance contents and antioxidant activity of Potentilla fruticosa L. from different regions of China. Also, HPLC fingerprint similarity analysis (SA) coupled with hierarchical cluster analysis (HCA) and discriminant analysis (DA) were further introduced for the accurate classification and quality assessment of P. fruticosa. The results showed that altitude was significantly and negatively correlated to the content of tannin (P < 0.05). Annual sunshine duration and altitude were significantly and positively correlated to the flavonoids content, rutin content and antioxidant activity (P < 0.05). Annual mean temperature was significantly and negatively correlated to the content of total phenolics, while altitude was significantly and positively correlated to the content of total phenolics (P < 0.05).”

Depending on different parameters, ecosystems clearly differ from one another and are consisting of different compositions and different interactive networks and feedback loops. And within this, plants will respond to different biotic and abiotic stressors, yet set within an ecosystem context and its interactions and dependencies.

In this context it is of interest that LM plants, when investigated for stress response, showed different reactions and metabolic responses as compared to their non-GM counterparts. Undertaking such a study, Benevenuto et al. (2021) reported: 

“ …  the aim of this study was to analyze the metabolic cost by assessing the proteomic profiles of GM soybean varieties under glyphosate spraying and water deficit conditions compared to their non-transgenic conventional counterparts. We found evidence of cumulative adverse effects that resulted in the reduction of enzymes involved in carbohydrate metabolism, along with the expression of amino acids and nitrogen metabolic enzymes.”

How such responses affect ecosystem interactions, for example with pest, beneficial insects, diseases, soil microorganisms etc is an open question that require further investigation.  Additionally, quite likely, altered stress responses, altered interactions and altered impacts are event specific, though I cannot recall seeing a study on this.

As ecosystems and environments differ from each other, ERAs are by necessity relying on locality specific experimental data in an event specific manner.

The issue that protection goals (and assessment endpoints) are different from country to country or even environment/locality specific and are thus requiring different investigations, is another aspect that runs counter to transportability of ERA data.

I would like to reiterate – as in a previous submission of mine – the provisions of the Protocol oblige Parties to ensure that the transport, use, transfer and release of any LMO are undertaken in a manner that prevents or reduces the risks to biological diversity, taking also into account human health. (Article 2.2)


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

Other than what already said above, perhaps an important point here would be to look at what would happen to scientific uncertainty, lack of data or knowledge. The suggested proposal seems to run counter the notion of the precautionary approach.
What is for example behind the suggestion of establishing a procedure aimed at enabling an “evidence-based process”. What happens about lack of evidence? Which type of evidence is referred to here? Often there is a spectrum. We all are aware that lack of evidence is not evidence of absence.

It seems in the same direction that Brinda Dass (#12531) is arguing when saying
“These challenges are increasingly relevant as national biosafety authorities strive to make informed, science-based decisions using unique case- and location-specific as well as shared and harmonized data resources in a weight of evidence approach.”
A weight of evidence approach, especially in context of harmonized data resources appears to shut down minority findings, i.e. those findings that might have been produced by independent research, but would be less in quantity due to lack of funding and resources. Thus such evidence would disappear in an “weight of evidence approach”. For me that is linked to heading in a direction away from the precautionary principle/approach as well as reducing scientific knowledge and understanding.

3) What are the specific issues concerning this topic?

The following is very much in line with Jack Heinemann’s submission, #12532, as we seem to come to the same conclusions:

(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, not focussing ERA on the likely potential receiving environments and ignoring the specificity of biodiversity in various regions and locations is counter the Protocol and will allow to expose biodiversity, its conservation and sustainable use, to serious risks.

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

Yes. The proposal is aimed at speeding up approvals and introductions of LM crops into the environement.

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

Yes, that seems to be the expressed intention.

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

Maybe. This is not aimed at a specific LMO, but any that either already exist or is yet to be developed.

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

From my perspective the Protocol with Annex III clearly sets a pathway, as how to approach and carry out risk assessment for an LMO.


With kind regards,
Ricarda


Benevenuto, R. F., Zanatta, C. B., Guerra, M. P., Nodari, R. O., & Agapito-Tenfen, S. Z. (2021). Proteomic Profile of Glyphosate-Resistant Soybean under Combined Herbicide and Drought Stress Conditions. Plants (Basel, Switzerland), 10(11), 2381. https://doi.org/10.3390/plants10112381

Liu, W., Yin, D., Li, N., Hou, X., Wang, D., Li, D., & Liu, J. (2016). Influence of Environmental Factors on the Active Substance Production and Antioxidant Activity in Potentilla fruticosa L. and Its Quality Assessment. Scientific reports, 6, 28591. https://doi.org/10.1038/srep28591

Dear participants,

Thank you again for the opportunity to participate in these discussions. I am representing developers of biotech crops that have experience with the regulatory requirements for commercialization.

Question 1
This topic presents a “solution” rather than a challenge for risk assessment frameworks, in terms of contributing to regulatory efficiency and harmonization, and promoting information and knowledge sharing amongst risk assessors that supports capacity development and may address capacity limitations.

In my initial post in these online discussions (week 1 topic 5 #12393) I mentioned that biotech crop developers seek a “global” registration. This process involves regulatory assessment and authorization not only in the jurisdictions where the crops are intended to be cultivated but also in those where the crop products will be used in food, feed, or processing. These assessments and authorizations are different and involve regulatory authorities from around the world. They also require the generation of regulatory data to address the requirements of many regulatory processes (see Keiper and Atanassova 2022 https://doi.org/10.3389/fgeed.2022.898950).

Data transportability enables a regulatory body of a country (or the regulatory bodies of a group of countries) to leverage existing regulatory data generated in another country or region in support of regulatory assessment and decision making (for detailed explanation see: Bachman et al 2021 https://doi.org/10.21423/jrs-v09i1bachman). This is complementary to the concept of mutual acceptance of data generated following internationally agreed protocols. This data acceptance occurs for biotech food and feed assessments and to an extent for environmental risk assessment. For example, regulatory studies conducted under Good Laboratory Practices (GLP) standards are accepted in many jurisdictions throughout the world. However, some regulatory authorities require additional local laboratory and/or field studies, and this can occur despite a lack of country-specific hypotheses of unique risks. 

From the perspective of a developer, regulatory requirements to repeat studies in different jurisdictions adds time, cost and complexity to the global registration, without providing additional information essential to the environmental risk assessment.

Questions 2 and 3
An important consideration for data transportability is the need for well-designed studies that test clear risk hypotheses and follow well-established methods that are reconstructable, interpretable, reliable, and include appropriate statistical analysis. Test systems and study design should follow standardized and internationally accepted guidelines or peer reviewed published methodologies, where available. Laboratory studies should be conducted under widely accepted quality standards (e.g., GLP, ISO17025) to ensure reproducibility.

For environmental risk assessment, ideally regulatory data is developed to inform science-based risk assessment that is driven by problem formulation and the identification of plausible pathways to harm. For biotech crops, problem formulation is based on knowledge of the receiving environment, biology of the crop, agronomic comparison of the LMO with the unmodified recipient/parental organism, and the characteristics of the introduced trait. Typically, there are three core areas for assessment and regulatory data generation: weediness/invasiveness potential, the potential for and effects of transgene flow, and the potential adverse effects on beneficial non-target organism populations. Any need for additional data to this “core” set should be considered on a case-by-case basis, guided by problem formulation and development of risk hypotheses based on the core data and trait interactions with the environment (Bachman et al 2021).

Previous posts in this thread have raised varying local environmental conditions as a limiting factor for data transportability (e.g. #12546, #12560). As explained by #12561, the aim is to evaluate the introduced trait(s) for biologically relevant differences under representative conditions. Where data has been collected across multiple locations representing a range of environmental conditions in one country or region, and no biologically relevant differences were observed between the LMO and non-modified recipient/parental organism, it can be used to support risk assessment in another country or region regardless of agroclimatic zone. Generating additional data in a different country or expanded regions is only warranted if specific hypotheses of risk remain after assessment of the existing data, and if the generation of additional field data would address this risk (Bachman et al 2021). Examples of data transportability in this context exist, with some regulatory authorities accepting field-based agronomic data from a country or a region with comparable production practices for the crop.

Question 4
A CropLife International publication detailing the principle of data transportability and its application to the three core areas of biotech crop environmental risk assessment is cited here and in other posts: Bachman et al 2021 https://doi.org/10.21423/jrs-v09i1bachman.

Additional resources:
Ahmad et al 2015 https://link.springer.com/article/10.1007/s11248-015-9907-3
Anderson et al 2021 https://doi.org/10.21423/JRS-V09I1ANDERSON
Chege et al 2024 https://doi.org/10.1080/21645698.2024.2376415
Corrales Madrid et al 2018 https://doi.org/10.1111/jen.12499
Garcia-Alonso et al 2014 https://link.springer.com/article/10.1007/s11248-014-9785-0
Kearns et al 2013 https://link.springer.com/article/10.1007/s11248-013-9766-8
Nakai et al 2024 https://doi.org/10.3389/fbioe.2024.1359388
Nakai et al 2015 https://link.springer.com/article/10.1007/s11248-015-9892-6
Storer et al 2024 https://doi.org/10.3389/fbioe.2024.1394704
Vesprini et al 2020 https://doi.org/10.3389/fbioe.2020.00815
Wolt et al 2010 https://link.springer.com/article/10.1007/s11248-009-9321-9

Daer participants,

As mentioned in previous posts (including #12569) data transportability presents challenges regarding the principles and methods presented in Annex 3 especially regarding para 8. that clearly mentions the "likely potential receiving environment…"  as well as in Annex II, para 5 as mentioned in post #12573. As shown in numerous studies the impact of biotic and abiotic factors and their interactions is indeed likely to affect the life-history traits on an organism and this is also valid for LMOs. In return this is also going to influence its receiving environment, an impact that needs to be evaluated in an ERA. An example could be the impact of GM plants on soil microbes for example (Guan et al. 2016) . Interestingly a number of studies on this topic have reported significantly different results, highlighting the challenges associated with the transportability of data for risk assessment.

Zheng-jun Guan, Shun-bao Lu, Yan-lin Huo, Zheng-Ping Guan, Biao Liu, Wei Wei. 2016. Do genetically modified plants affect adversely on soil microbial communities?, Agriculture, Ecosystems & Environment, 235, pp. 289-305, https://doi.org/10.1016/j.agee.2016.10.026.

Best regards,
Christophe Boëte

I would echo the points shared in comment #12576 that international standards exist for laboratory or contained testing (GLP and others) and are well accepted by countries across the globe. These standards ensure that data generated is reliable, robust and repeatable. There should not be any concerns about their acceptability outside of the country in which they were generated. Additionally, Environmental Risk Assessments that use the problem formulation approach standardly assess from the view point of the biology of the organism, the intended change to be introduced, and the method used to produce the change and lineage derived from progenitor(s) all of which should remain unaltered regardless of receiving environment for any LMO. Data related to these preliminary steps should be applicable in all jurisdictions except for particular legal restrictions such as confidentiality. Countries should consider Memoranda of Understanding or other avenues for sharing information to avoid unnecessary duplication of efforts.
For field trials that are designed typically to collect data in response to more location specific factors or regulatory requirements, data sets from similar areas would still be informative in a weight of evidence approach and should not be disregarded. If there are no new pathways to harm identified or unresolved uncertainties that need new risk management processes in place then field trial results and conclusions from other areas should still be relevant in supporting a decision. Subject matter experts should be provided all available data and information to make the most informed conclusions. In this regard my previous comment related to providing data and information in standard format via the BCH or an online platform in a timely fashion would be most expedient to countries especially those with budgetary and capacity constraints.
I support comment #12552 that placing data transportability in a space that looks to harmonize standards capable of supporting scientifically credible environmental risk assessments would allow efficiencies of resources, capacity and streamline decision making without compromising overall protection goals for ecosystem biodiversity, and human and animal health.
Finally, we should also be cognizant of the unnecessary cost to society of duplicative data requirements and repeating of research and studies due to inability to accept data from studies conducted in outside jurisdictions as highlighted in comment #12566 and 12576

many thanks
Brinda Dass
Senior Technical Expert, FNIH, US

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