2. Operationalizing protection goals into relevant assessment and measurement endpoints

How does this topic potentially challenge existing risk assessment frameworks, guidance, and methodologies? Do solutions exist?

Risk assessment frameworks ought to be designed to include technical and ecological risks to incorporate social dimensions like gender mainstreaming. Operationalizing gender-mainstreamed goals challenges frameworks to go beyond biophysical endpoints and consider intersectional vulnerabilities. Solutions exist through integrated assessment models, inclusive socio-ecological indicators, and participatory approaches that embed gender-responsive evaluation.
What could be the specific challenges related to this issue?
• Lack of gender-disaggregated data in environmental contexts.
• Limited institutional capacity to translate protection goals into measurable, gender-sensitive endpoints.
Specific issues:
 Potential for transboundary dissemination:. Gender roles in cross-border assessments, especially during labor migration, may influence exposure and response capacities.
 Commercialization and use: Many LMOs are in use or trial stages globally; however, commercial oversight rarely includes gendered risk impact assessments.
3. Existing or adaptable resources:
 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
 FAO’s Gender and Rural Advisory Services Assessment Tool (GRAST) https://openknowledge.fao.org/items/acf2f90e-18f6-48ba-a9b8-431c99bc6382
 UNEP's Global Gender and Environment Outlook https://www.genevaenvironmentnetwork.org/wp-content/uploads/2020/05/gender_and_environment_outlook_opt.pdf
 OECD’s Toolkit for Mainstreaming and Implementing Gender Equality 2023: https://www.oecd.org/en/publications/toolkit-for-mainstreaming-and-implementing-gender-equality-2023_3ddef555-en.html

Dear Moderators and colleagues,

Thank you for the opportunity to participate on this forum. My name is Thato Mogapi, from the Department of Forestry, Fisheries and the Environment in South Africa. I have a background in microbiology and biotechnology. My role at the Department includes reviewing applications for release of LMOs to ensure compliance with our national biodiversity legislation, which entails conducting risk assessments and developing guidance documents on environment risk assessment and related topics; and also, currently serve as the national focal point for the Cartagena Protocol.

Please find our views on this topic, further to our submission.

1. How does this topic potentially challenge existing risk assessment frameworks, guidance, and methodologies? Do solutions exist?

Several guidance documents effectively articulate the role of assessment and measurement endpoints in the risk assessment of living modified organisms (LMOs), including their derivation from protection goals and their use during problem formulation to define the scope of assessment. It is widely recognised that approaches for translating protection goals into measurable endpoints vary across countries due to differing national priorities, policies, and legal frameworks.

However, in many countries, the explicit process of translating protection goals into measurable endpoints for LMO risk assessment remains either undocumented or embedded within national procedures without clear articulation. Where such processes exist, they are often not transparently recorded. This lack of documentation represents a missed opportunity to demonstrate national contributions to the objectives of the Cartagena Protocol on Biosafety and the Convention on Biological Diversity, particularly in safeguarding biodiversity through robust LMO risk assessment and long-term monitoring.

Clearly defined assessment endpoints help identify and prioritise species and ecosystems of conservation concern that may intersect with LMO cultivation areas and should be integrated into broader biodiversity monitoring frameworks. For example, South Africa’s National Biodiversity Assessment includes information on LMO impacts. There is also a process underway to develop a database of assessment and measurement endpoints used in LMO regulation. This initiative aims to track endpoint status, identify knowledge gaps, and support future regulatory decisions.

The key gap lies in the practical application: how the guidance on translating protection goals into assessment endpoints is implemented at the national level. A compilation of best practices, case studies, and lessons learned would be a valuable resource, potentially as part of a Biosafety Technical Series or similar supplementary material.

2. What are the specific challenges related to this issue?

Protection goals and assessment endpoints differ across countries due to varying biosafety frameworks, legislation, and policy contexts. Consequently, risk assessment methodologies also diverge. Additional resources, such as guidance documents or technical series using case studies, could help illustrate diverse approaches and criteria for developing and testing protection goals and endpoints.

3. What are the specific issues concerning this topic?

Protection goals and assessment endpoints are broadly applicable to all LMOs. Strengthening the explicit definition of protection goals and their subsequent translation into assessment and measurement endpoints will enhance both risk evaluation and monitoring in the context of biodiversity components that require protection.

4. Are there existing resources that could address or be adapted to this issue?
Several existing resources can inform the development of best practices for translating protection goals into assessment endpoints, including peer-reviewed publications and the Voluntary Guidance on Risk Assessment of Living Modified Organisms and Monitoring in the Context of Risk Assessment developed under the Cartagena Protocol.

Dear All,

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

My name is Piet van der Meer. I am trained as a microbial ecologist and an environmental lawyer, and since 1986 I have conducted hundreds of risk assessments in regulatory context. Since the adoption of the CPB, I also provide training on risk assessment to government- and public research institutions, with the principles and methodology of Annex III as the starting- and endpoint.

Protection goals are an important part of risk assessments, and I echo the observation by Thato Mogapi (#12474) that consideration of protection goals is often an implicit process that largely remains undocumented.

Below I add some further observations, based on my work with biosafety systems in over 50 countries.

Consideration of protection goals is relevant at various stages of risks assessments.

First, as part of the preparation of the risk assessment, it is always helpful to (in addition to collecting the relevant date about host, molecular characterisation, et cetera) look at the overall protection goal of the legislation under which the risk assessment is conducted. That overall protection goal can typically be found in the ‘Objective’ article or in the preamble. An example of such an objective is given in article 1 of the CPB: “ ….the objective of this Protocol is to contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of LMOs …...”. For Parties that do not yet have a domestic regulatory framework in place that is consistent with the CPB, the above overall objective/protection goal gives the context of their decisions under the CPB for transboundary movements to their territory. For Parties that have a domestic regulatory framework in place that is consistent with the CPB, the overall objective/protection goal domestic regulatory framework applies. Although these domestic regulatory frameworks should be consistent with the CPB, the reality is that there is quite some variety in objectives/overall protection goals, and it is therefore always good to carefully read those provisions in the domestic frameworks.

Next, turning to the stepwise methodology of Annex III: in cases for which scientifically plausible pathways for adverse effects have been identified in the first step of the Annex III methodology, the above overall protection goals are operationalized into relevant assessment and measurement endpoints for the subsequent steps of Annex III, e.g.
- the evaluation of the likelihood of these pathways/adverse effects being realized in a specific case at hand (e.g. in identifying relevant indicator species),
- the evaluation of the consequences should these adverse effects be realized in a particular regulatory context (e.g. the magnitude the consequence of a potential effect on certain species or ecosystems can be influenced by the regulatory status of those species or ecosystems, e.g. are these species protected or considered pests);
- the recommendation as to whether or not the identified risks are acceptable or manageable.

As Thato Mogapi rightly noted, the translation of overall protection goals into measurable endpoints varies across countries. It would be interesting to conduct a survey among countries about their approaches.

Regards to all,

Piet van der Meer

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

Abstract protection goals (e.g. “protect biodiversity”) are often too broad or vague to be directly used in risk assessments.

There is often no clear link between policy-level goals and measurable biological indicators, making it difficult to determine what to monitor or how to evaluate risk.

Inconsistent interpretation across countries regarding which endpoints are most relevant (e.g. population size, reproductive success, gene flow).

Solutions:

Use conceptual models or pathways to harm to translate protection goals into operational assessment endpoints (e.g. from “protect pollinators” to “assess effects on honeybee colony health”).

Develop guidance on endpoint selection, tailored to specific ecological contexts and types of LMOs.

Promote stakeholder engagement to identify socio-ecologically relevant endpoints, including those important to Indigenous Peoples and Local Communities.

2. What could be the specific challenges related to this issue?
Lack of harmonization in how protection goals are set and translated into endpoints across jurisdictions.

Data gaps on background variability or baseline conditions for many ecological endpoints.

Difficulty in quantifying values that are culturally or spiritually important to local communities.

Resource constraints in monitoring complex ecological indicators over time.

3. What are the specific issues concerning this topic?
(i) Potential to cause adverse effects on biodiversity:
Yes. Without appropriate assessment endpoints, subtle or cumulative impacts on ecosystems (e.g. pollinator decline, disruption of microbial communities) may be missed or underestimated.

(ii) Potential for deliberate or accidental introduction into the environment:
Yes. If endpoints are not well defined, monitoring may not detect unintended persistence or spread of LMOs in the environment.

(iii) Potential to disseminate across national borders:
Yes. Without harmonized endpoints, transboundary movement may result in inconsistent assessments of the same LMO across regions.

(iv) LMO commercialization and global use:
Yes. Widely-used LMOs (e.g. GM crops, gene-edited organisms) highlight the urgency of operationalizing protection goals consistently to ensure robust and comparable assessments worldwide.

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

Esteemed colleagues,

Regarding the topic I consider the protection goals and specific assessment points are defined in a general manner, which may lead to varying interpretations among Parties. It remains unclear whether this issue should be addressed through an AHTEG or if it requires an additional definition to enhance risk assessment processes. Moreover, limited technical capacities and resources may pose a significant challenge to effectively addressing this matter

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.

The challenges posed by this issue include, first and foremost, the need to clearly define protection goals (the values to be protected). Based on these, it is essential to formulate specific, plausible, and relevant risk hypotheses that can be addressed through concrete studies. This allows for the mapping of the "pathway to harm," that is, the establishment of a causal chain linking the introduction of a modified organism to a potential adverse effect.

A study with a robust design, aligned with the hypothesis being assessed, can generate solid evidence to determine whether the risk is real, likely, or negligible. This approach is key to ensuring assessments that are based on scientific evidence and focused on elements that truly require protection.

Any regulatory framework that includes problem formulation is equipped to address these challenges. This is the case in Argentina, where regulations and the assessment approach are based on problem formulation.

Best regards.

This is to  acknowledge, that while the translation of broad protection goals into specific, measurable assessment and measurement endpoints may present logistical and contextual challenges, it is not inherently a complex or insurmountable task.

In fact, the process is well-supported by existing international biosafety literature, particularly the scientifically grounded framework provided in Annex III of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity.
1. Annex III of the Cartagena protocol as a robust foundation
Annex III outlines a structured and stepwise risk assessment framework that emphasizes scientific rigor, case-by-case evaluation, and the use of comparative approaches. It already incorporates the key conceptual pillars required for operationalizing protection goals:
a. Problem Formulation : The first step in risk assessment already calls for the clear articulation of protection goals, identification of assessment endpoints, and formulation of testable risk hypotheses.
b. Case-by-case analysis and contextualization: The Protocol promotes tailoring the risk assessment to the specific environment where the LMO is to be released, allowing for local biodiversity considerations to be factored in.
c. Scientific and transparent evaluation: The Protocol mandates that risk assessments be based on scientific and technical information, which aligns well with the objective of developing measurable and defensible endpoints.
In this regard, Annex III provides a globally accepted scientific framework that, when appropriately applied, naturally leads to the development of context-specific and measurable endpoints aligned with national and regional protection goals pursuant to national or regional frameworks.
In Africa, where data availability may be limited and institutional capacity varies, there ought to be a few considerations,
Solutions exist, such as:
a) Tiered and problem formulation-based frameworks, which help tailor RA to the specific context and organism.
b) Use of ecological modelling and scenario analysis to predict potential impacts in data-poor environments.
c) Leveraging regional platforms and resources

2. What could be the specific challenges related to this issue?
a) Limited data sets availability presents a critical obstacle to translating broad protection goals into measurable and actionable endpoints.
b) Limited access to high-quality interoperable data hampering the ability to operationalize broad protection goals and measure environmental endpoints usually arising out of potentially unavailable datasets, fragmented data sources, inconsistent metadata standards hence limited data sharing necessary for reproducibility, and comprehensiveness of environmental assessments.
c) Challenges with data quality affecting clarity on goal definitions and leading to inconsistent endpoints, hence undermining  reliability and comparability of environmental assessments.
d) Non-adherence to agreed common technical stands for definitions for measurable endpoints and data collection methods
e) Capacity constraints in applying advanced RA methodologies at the national levels.
What are the specific issues concerning this topic?
(i) Potential to cause adverse effects on biodiversity:

Yes, subject to affirmation of risk assessments, implications of gene flow if there are no management strategies
(ii) Potential for introduction into the environment:

Deliberate introduction of LMOs in field trials and potential for accidental release.

(iii)Potential to disseminate across national borders:
Given shared ecosystems and porous borders within regional economic communities (RECs), there is a  likelihood of transboundary movement. This underscores the need for regional cooperation and harmonized RA frameworks.
(iv) Commercialization or use of LMOs:
Yes, some LMOs are under trial or in use within African countries.
4. Are there existing resources on similar issues that can address this issue or resources that could be adapted to address this need?
OECD’s consensus documents
Additional voluntary guidance materials to support case-by-case risk assessments of living modified organisms containing engineered gene drives

Thus, this issue is not primarily a matter of scientific difficulty but one of structured application and capacity building, both for which are actively being addressed across the continent.

Therefore with the use of Annex III of the Cartagena Protocol and existing biosafety literature, the operationalization of protection goals into relevant assessment and measurement endpoints can be further strengthened through continuous capacity development and regional cooperation including data sharing strengthening.

Parties and stakeholders are encouraged to focus on enhancing implementation using the tools already available, while strengthening institutional capacity, improving stakeholder engagement, and applying existing methodologies consistently and transparently.

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

My name is Samson Simon, I work for the German Federal Agency for Nature Conservation (BfN) as a biosafety expert.

When discussing the operationalisation of protection goals, two important aspects should be kept in mind: to be operationalized the aim of the goal is important and has to be attributed to the different aims or areas of concern: i) human health, ii) animal health, iii) agri-food production, i) environment and nature conservation. The risk assessment has to be carried out for each of these areas independently by identifying relevant risk areas and risk hypothesis. Each area of concern has its own protection goals. However, “various sectorial legislations/international protocols provide vague descriptions of protection goals” (EFSA 2016). While problem formulation can be readily carried out, problem formulation also should identify the entities to be protected, the endpoints which relate to these entities and deviations from the measurement endpoints which may indicate harm or, more exactly, a non-acceptable harm.

From this the specific challenges for operationalization of protection goals can be inferred. In the EU the proposed way to operationalize protection goals is via so called specific protection goals (SPGs) (EFSA 2016). But although the approach is meant to be applied in an overreaching way (i.e. usable for the assessment of pharmaceuticals, pesticides or GMO) it has hardly been applied. One reason for this might be that for operationalisation harm has to be defined for every measurement endpoint.

While for the areas of concern of human health, animal health, and plant production methods and tests have been established to prevent harm this is less so for environmental protection and especially for nature conservation (including biodiversity). So, there is a deficit of agreed methods and specific protection goals to protect biodiversity.

The difference to specific protection goals is important to notice. General protection goals are easier to identify and have a general character. The translation into specific protection goals is much harder. This is also due to the fact that the number of standardized tests to quantify the effects of LMOs on biodiversity, that have been developed so far, is low. Without being able to test the influence of an LMO on a general and/or specific protection goal it remains impossible to specify a limit of concern for this protection goal.

So, Piet van de Meer has already brought up the point. Maybe to ask more specifically: does any country have specific protection goals for nature conservation implemented and agreed on which magnitude of effect will harm the SPG? How did they get there? And if not: what is a practicable way forward to reach that goal?

Best Regards

Samson

Reference:
EFSA (European Food Safety Authority) (EFSA) (2016): Guidance to develop specific protection goals options for environmental risk assessment at EFSA, in relation to biodiversity and ecosystem services. In: EFSA Journal 14 (6), S. 4499. DOI: 10.2903/j.efsa.2016.4499.

Dear colleagues,

my warm thanks to our moderators, the Secretariat for facilitating it and the participants for 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.

I just wanted to mention that this issue has been addressed in the recently welcomed guidance on living modified organisms containing engineered gene drives. The guidance clearly states, and it was confirmed here (#12533), that it is a crucial step in problem formulation to identify protection goals and make them operational for use in risk assessment. However, due to a different focus, the issue was dealt with in a rather short section, highlighting the importance without really going into the practical implementation.
Although it is difficult for a subject that does not focus on a specific group of LMOs to relate to the conditions set out in decision CP 9/13 or the relevant questions in this discussion, Thato Mogapi (#12474) has done a great job and I largely agree with her assessment.
With this in mind, I think that risk assessors could benefit from additional guidance on the practical implementation of this issue when carrying out their task.
I do also agree that practical implementation can and should be supported through capacity building and regional cooperation (#12553).

Kind regards

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

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 and support the inputs in post #12564.

As for a practical example, I would mention the following article:
Angelika Hilbeck, Gabriele Weiss, Bernadette Oehen, Jörg Römbke, Stephan Jänsch, Hanka Teichmann, Andreas Lang, Mathias Otto, Beatrix Tappeser,
Ranking matrices as operational tools for the environmental risk assessment of genetically modified crops on non-target organisms,
Ecological Indicators,
Volume 36,
2014,
Pages 367-381,
ISSN 1470-160X,
https://doi.org/10.1016/j.ecolind.2013.07.016.
(https://www.sciencedirect.com/science/article/pii/S1470160X13002781)
Abstract: For the operationalization of the structured, stepwise selection procedure for non-target testing organisms integrated into the new EFSA guidelines for environmental risk assessment of GM plants practical tools – i.e. ranking matrices – were developed. These tools – some of them are new and some are refined from older ones – were tested using the GM case crop of TC 1507 maize. The selection procedure consists of six steps. The strategy builds on identifying the important ecological functions for the particular cropping system and compiling a species lists according to their ecological functions and presence in the specific receiving environments. Subsequently, the species numbers are reduced in a systematic, stepwise fashion to a relevant and practical number of testing organisms and/or processes. Four ecological functional categories were selected: herbivory, pollination, natural enemies and soil organisms/processes. Based on these categories, the relevant species were chosen and subjected to the selection steps. Out of a total of 33 herbivores, 73 pollinators/pollen feeders, 48 natural enemies and 77 soil organisms/processes we started with in Step 1, 15 herbivores, 10 pollinators 17 natural enemy species and 9 soil organisms/processes were selected as relevant and suited for a testing program at the end of the selection procedure in Step 4. Although the ranking tools will continue to need further refinement, we could demonstrate that this procedure allows to swiftly select the most important suite of species and processes from a large number of organisms. This expert-driven process increases ecological realism and transparency in risk assessment and tailors it to the particular receiving environment, thus, overcoming important deficiencies of the current approach that has attracted persistent criticism. We recommend balancing ecological requirements with practicability criteria and realism in the test strategy. At present, the ranking is abundance-oriented and, thus, excludes rare and/or endangered species that are sensitive to disturbances. We suggest additional selection criteria to strengthen nature conservation and off-field aspects.
Keywords: Bt toxin; TC 1507 maize; Bacillus thuringiensis; Genetically modified plant; Bt maize; Environmental risk assessment; Selection procedure; Non-target organisms; Ecotoxicological test species

Warm regards to everyone
Nicolas Defarge