The terms ‘flowchart’ or ‘roadmaps’ are used in several documents of COPMOP, and in the terms of reference for the AHTEGs that will be organized before the next COPMOP. But what is meant by these terms?
We have agreed that under the Protocol, risk assessment of LMOs is done in accordance with Annex III <
http://bch.cbd.int/protocol/text/article.shtml?a=cpb-43> of the Protocol. There are two paragraphs in Annex III that are crucial for how to actually perform such a risk assessment: paragraphs 8 and 9, under the heading ‘methodology’.
Paragraph 8 specifies the steps of risk assessment, paragraph 9 specifies the points that have to be taken into consideration during risk assessment.
It is good to realize, as is also indicated in the introduction to this topic, that the methodology reflected in Annex III was not developed ‘de novo’ but rather it is based on the experience of over 20 years of risk assessment and on the general principles as laid down several documents of international organizations (for examples refer to the Introduction to this topic).
The ‘flowchart’ or ‘roadmap’ (I will further use the term ‘roadmap’) provides an integration of the steps and the points to consider of paragraphs 8 and 9, to show how to proceed from step to step in the risk assessment process. Points to consider are allocated to the steps where they are relevant. The importance of having a roadmap is to know and agree on what points need to be taken into account in the different steps.
In this way the roadmap can strengthen capacity building for risk assessment as well as contributing to international harmonization.
I present here an example for further discussion, of how we see that the roadmap could be set up.
The roadmap lists the points to consider that may be relevant in the different steps, based on the existing experience with the methodology of risk assessment, whereby some points to consider have been added (points to consider derived from paragraph 9 of Annex III are indicated as such).
For taking into account each point to consider in the road map, information is needed that is relevant for each point. In another contribution to the discussion I intend to show what type of information we think is relevant at each point to consider. In a third contribution I will try to make clear how the points to consider in each step can function in practice as ‘cross roads’ on the road map. These ‘crossroads can help to make the information that is available in databases like the Biosafety Information Resource Centre (BIRC) of the BCH, easier accessible.
Proposal for the Roadmap for risk assessment and risk management under the Cartagena Protocol on Biosafety
Step 1: An identification of any novel genotypic and phenotypic characteristics associated with the LMO that may have adverse effects on biological diversity in the likely potential receiving environment, taking also into account risks to human health.
Points to consider:
(a) The biological characteristics of the recipient organism (e.g. its taxonomic status, its origin, centres of origin and centres of genetic diversity, and a description of the habitat where the organisms may persist or proliferate) relevant for its interaction with the likely receiving environment (Annex III, 9a).
(b) Characteristics of the vector (its identity, and its source or origin, and its host range) if used, and in as far as present in the LMO (Annex III, 9c).
(c) Characterization of the insert(s), including, as appropriate, the gene products, their level of expression, their function and physiological effect on the recipient (Annex III, 9d).
(d) The biological characteristics of the donor organism(s) relevant for the characterization of the donor gene(s) and its genotypic and phenotypic effects in the recipient (Annex III, 9b).
(e) Characterization of the resulting LMO, with a focus on identifying differences in biological characteristics between the LMO and those of the recipient organism (Annex III, 9e).
(f) Conclusions regarding the living modified organism, and the differences between the biological characteristics of the living modified organism and those of the recipient organism.
Step 2: An evaluation of the likelihood of these adverse effects being realized, taking into account the level and kind of exposure of the likely potential receiving environment to the LMO.
Points consider:
(a) Information relating to the intended use of the LMO (e.g. confined field trial, or unconfined large scale cultivation) (Annex III, 9g).
(b) Likely potential receiving environment: information on the relevant characteristics (e.g. geographical, climatic and ecological characteristics) of the likely potential receiving environment (Annex III, 9h).
Step 3: An evaluation of the consequences should these adverse effects be realized.
Points to consider:
(a) Characteristics of the likely potential receiving environment (Annex III, 9h), and of experience with similar consequences of traditional practices (e.g. agricultural practices, pest management) as a baseline.
Step 4: An estimation of the overall risk posed by the LMO based on the evaluation of the likelihood and consequences of the identified adverse effects being realized.
Step 5: A recommendation as to whether or not the risks are acceptable or manageable, including, where necessary, identification of strategies to manage these risks.
Points consider:
With regard to acceptability of identified risks:
(a) Likely potential receiving environment (Annex III, 9h), and experience with similar consequences of traditional practices, as a baseline.
(b) Evaluation of the risk associated with the LMO in the context of the risks posed by the non-modified recipients in the likely potential receiving environment (Annex III, 9e).
With regard to manageability of identified risks:
(c) Relevant management practices that are in use for the non-modified recipients, or for other organisms that require comparable risk management.
(d) Relevant methods for detection and identification of the LMO and their specificity, sensitivity and reliability (Annex III, 9f).
Step 6: Where there is uncertainty regarding the level of risk, it may be addressed by requesting further information on the specific issues of concern or by implementing appropriate risk management strategies and/or monitoring the living modified organism in the receiving environment.
