Summary of comments
NOTE: The summary below was prepared by the CBD Secretariat with the aim to provide a snapshot of the most prominent views expressed in the submissions. It is strongly recommended that the discussions on how to revise and improve the Guidance be based on the original submissions themselves, rather than on the summary below.
A total of 31 submissions were received by the Secretariat following an invitation to Parties, other Governments and relevant organizations to undertake a scientific review of the Guidance on Risk Assessment of Living Modified Organisms. Of the reviews submitted, 17 were submitted by Parties, 2 by other Governments and 12 by relevant organizations.
The results of the scientific review process show a divergence in the assessment of the quality and usefulness of the Guidance among the respondents. In general, Parties scored high on the overall quality assessment of the Guidance, whereas the quality assessment by other Governments was very low and, by organizations, medium.
There was a high level of agreement among Parties that the Guidance is consistent with the Protocol and is a useful tool for assisting countries in conducting LMO risk assessments.
There was also a high level of agreement among the Parties that the concepts throughout the Guidance are relevant and accurate from a scientific point of view. However, many Parties pointed out that there are still relevant concepts that need to be included in the various sections of the Guidance and submitted recommendations in this regard (Please refer to comments below and the original submissions for more details).
The review process provided a clear indication that the language of the Guidance may not be easily understood by the target users. It was recommended that the language of the Guidance needs to be improved with the view to making it simpler and more concise.
With the view to improving the usefulness of the Guidance, some Parties recommended the inclusion of a (i) glossary of key terms, (ii) practical examples, and (iii) additional explanation on various concepts mentioned in the Guidance.
It was also recommended that a statement be included that the Guidance is not a standalone manual for risk assessment of LMOs and, as such, should be used together with relevant background documents and other risk assessment tools.
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Roadmap for Risk Assessment of LMOs
Seventy-eight percent of respondent Parties agreed that the overall quality of the Roadmap is good. However, only 12.5% of the respondent other Governments and 27.5% among relevant organizations agreed that the overall quality of the Roadmap is good. The level of agreement among all three respondent groups combined was 54%.
The majority of respondent Parties indicated that the Roadmap is consistent with the Cartagena Protocol and a useful tool to assist countries in conducting and reviewing risk assessments (i) in a scientifically sound and case-by-case manner, and (ii) of LMOs introduced into various receiving environments.
On the other hand, when asked if the Roadmap is applicable to the risk assessment of LMOs of different taxa, many respondent Parties shared the view that although the Roadmap is meant to give guidance on the risk assessment process for all types of LMOs this aim is not entirely met. It was noted that there was a bias towards crop plants in the terminology used and in many aspects of the Roadmap. For example, it was noted that several aspects which are relevant to LM micro-organisms are not included in the Roadmap. To address this issue, it was recommended that there is a need to include examples related to non-crop LMOs in the Roadmap or further develop guidance on other types of LMOs such as fish, trees, insects, microorganisms and viruses.
With regard to the completeness of the Roadmap, a number of issues were identified that should either be included or be further elaborated in the Roadmap. These issues included guidance on:
- The use of tiered approaches in the risk assessment process;
- The use sound statistical tests in the risk assessment process and the importance of describing these tests in the risk assessment report;
- How to deal with conflicting scientific data, especially data from publications and how to inform the decision makers of the difficulties encountered during the risk assessment such as high degrees of uncertainties, ambiguities or contradictory information;
- How to take into account human and animal health during the risk assessment in addition to environmental issues;
- How to take into account the intended scale and duration of the environmental release, in particular of releases whose objective is to generate information for further risk assessments, such as field trials;
- How to take into account the intended use of the LMO during the risk assessment (e.g. for cultivation vs. for import and processing);
- How to define the various levels of likelihood and consequences;
- How to implement monitoring as a means to address assumptions made during the risk assessment or to validate conclusions of the risk assessment on a wider (e.g. commercial) level of application.
It was also recommend that a number of terms be included in a glossary; for example terms such as: “protection goals”, “assessment end-points”, “risk thresholds”, “gene product”, “intended and unintented effects”, “cumulative effects”, “combinatorial effects”, “cumulative vs. aggregate effects”, “unmanaged ecosystem", “epistasis”, “gene function”, “gene products”, “co-existence”, “receiving environment”, “EC50”, “LD50”, etc.
Examples of concepts that were noted for further clarification are: “acceptable scientific quality”, “methodological and analytical requirements”, “management strategies” “manageability and acceptability of risks”.
Some Parties recommended improvements to the flowchart of the Roadmap (Please refer to submissions by Austria, Bolivia, Malaysia and Mexico).
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Risk Assessment of LMOs with Stacked Genes or Traits
Seventy-three percent of respondent Parties agreed that the overall quality of the section on LMOs with stacked genes or traits is good. However, none of the respondent other Governments and 30% among relevant organizations agreed that the overall quality of the section on LMOs with stacked genes or traits is good. The level of agreement among all three respondent groups combined was 52%.
The majority of respondent Parties were in agreement that the concepts expressed in this section of the Guidance are relevant and accurate from a scientific point of view.
A large number of respondents were of the view that a number of issues should either be included or be further developed in this section of the Guidance. Such issues included highlighting that risk assessment of stacked events:
- Should be conducted according to the principles outlined in the Roadmap, while taking into account the specific issues outlined in this section;
- Should address the possibility that LMOs with different combinations of transgenes (i.e. also stacked) might arise in the environment upon propagation of the stacked LMO in question;
- May be influenced by the regulatory framework of the country carrying out the risk assessment, for example, with regard to the using the stacked LMO itself to generate data for the risk assessment.
Only half of the respondent Parties were of the view that the language of this section is easily understood. Recommendations were made to simplify the language and include definitions to terms such as “combinatorial effects” and “cumulative effects”.
A recommendation was made to change the title of this section to "Risk assessment of LM crops with stacked genes or traits" since it deals exclusively with this type of LMOs.
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Risk Assessment of LM Crops with Tolerance to Abiotic Stress
Seventy-three percent of respondent Parties agreed that the overall quality of the section on LMOs with tolerance to abiotic stress is good. However, none of the respondent other Governments and 33% among relevant organizations agreed that the overall quality of the section on LMOs with tolerance to abiotic stress is good. The level of agreement among all three respondent groups combined was 53%.
The majority of Parties were of the view that all the issues included in this section of the Guidance are relevant and accurate from a scientific point of view. Nevertheless, about half of the Parties indicated that some issues are not sufficiently addressed. Among the issues to be given further explanation are:
- The “problem formulation” step, including how to identify protection goals, assessment end-points (a valued ecological entity and its measurable attributes) and risk hypotheses supported by science;
- How to address the difficulties in (i) controlling/measuring the environmental conditions in field experiments for studying the plant phenotype and (ii) describing the plant phenotype itself, which results from a complex relationship between external and physiological parameters.
- How the comparative approach with a non-LMO should be performed for LM crops with tolerance to abiotic stress;
- How to carry out the comparative approach including further details and clearer text on the use of the comparators, in particular on how to adjust the risk assessment when a comparative analysis with a non-modified organism is not possible;
- How to assess the cross talk between different stress responses of the plant and when this information must be considered relevant from a safety point of view;
- The importance of conducting field trials in regions with the same range of agricultural, plant health and environmental conditions as the likely receiving environment where the LMO may be commercially cultivated;
- How to distinguish between the potential for increased persistence in agricultural lands and invasiveness in natural habitats;
- Considerations about gene flow between feral and wild relatives under “Increased persistency in agricultural areas and invasiveness” since the introduction of stress-tolerant traits could result in an increase in crop ferality.
The respondents indicated that the language in this section of the Guidance also needs improvement. Recommendations were made as to which terms could be included in a glossary. Some of these terms included: “transcriptomics”, “metabolomics”, “non-modified comparator”, “stress tolerance” and “stress resistance”.
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Risk Assessment of LM Mosquitoes
Seventy-four percent of respondent Parties agreed that the overall quality of the section on LMOs Mosquitoes is good. However, none of the respondent other Governments and 47% among relevant organizations agreed that the overall quality of the section on LMOs with tolerance to abiotic stress is good. The level of agreement among all three respondent groups combined was 58%.
As noted in the previous sections of the Guidance, the majority of respondent Parties considered all the concepts contained in the section on LM mosquitoes relevant and accurate from a scientific point of view. On the other hand, more than half of the respondent Parties noted that this section of the Guidance lacks relevant issues that should have been included and that its language may not be easily understood by the target users.
Issues identified that can improve this section of the Guidance include the following:
- The importance of a complete taxonomic characterization of the non-modified mosquito strain used for the transformation as the first step of the risk assessment, including the description of its biogeographic origins and reliable molecular markers;
- A clear differentiation between the two types of strategies currently used to develop LM mosquitoes, i.e. self-limiting and self-propagating, and the different biological risks that these strategies may impose;
- Considerations on unintentional transboundary movement of the LM mosquitoes which are likely to occur due, for instance, to the broad dissemination spectra of these organisms or to anthropogenic activities;
- Considerations that the fitness (dis)advantage of the trait on the LM mosquito will affect the rate of spread of the transgenes;
- Considerations on possible new genetic mutations of the mosquito vector leading to unknown results, and negative impacts on other organisms and the food chain;
- Considerations on paratransgenic techniques to modify mosquito symbionts.
It was also noted whether there exist mechanisms for recalling LM mosquitoes; as such, it was recommended that the guidance should avoid mentioning that a recall of the LM mosquitoes would be possible.
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