Comments to the Roadmap
[#1317]
Dear all,
I am sorry to be able to contribute this late to the discussions. I find the discussions very good and helpful. I am sure they will contribute to the further development of the Roadmap. I will first make some comments to the text and then answer to the questions made by Hans (only those where I think I have something still to contribute).
First of all, very good work Hans and others!
General considerations/Chapeau:
1) Annex III (Risk assessment) includes a clear reference to risk management (when risks are not acceptable or manageable or there is uncertainty regarding the level of risk) and monitoring (there is uncertainty regarding the level of risk). All these issues must be included in the Roadmap. We should not go into theoretical dispute on what is meant by RA - different legislation look at these issues differently and our obligation is to look at the Protocol.
2) The issue of field trials and commercial release. The principles of RA are the same for both. But it is clear that we may ask different questions, may demand different kinds of data and get different kinds of answers depending on the scale of the release. I guess the Roadmap has to convey this in some way. But I definitely think that the Roadmap is for all releases. Some people have pointed out familiarity (see the OECD definition) and the experience the assessor has from previous, similar cases. For me this is self-evident but if needed it can be highlighted more clearly in the Roadmap.
3) Point h) under context of the RA process. I just do not understand what is meant here! Sorry! What goal of RA are you referring to? Scientifically sound manner, identification and evaluation of the possible adverse effects? Methodological and analytical requirements? Should take into account recognized RA techniques. Please clarify this point!
Step 1:
You could add to the first sentence "… that will assist in identifying the particular potential adverse effects arising from the genetic modification. I am a little confused by the reference to "credible causal pathways" here. Please give examples what you mean – do you mean the different mechanisms through which adverse effects may occur (the spread of the LMO(s) in the environment, the transfer of the inserted genetic material to other organisms, interactions with other organisms)? Please clarify!
Step 2:
I would restructure a little the rationale. "In step 1 the (potential) adverse effects of the LMO(s) have been identified. These adverse effects may/could result in risk and in order to determine …".
I must confess that I am a little confused with the discussion around the wording "potential" adverse effects. Article 15 refers to "possible", Annex III refers to "potential" or just adverse effects. I guess in a RA we identify adverse effects and then the examples we give are possible/potential adverse effects (disease, population displacement, disturbances in population dynamics etc.). I think we should add to important aspects: potential to spread and establish, possibility to affect the dynamics of populations of species in the receiving environment (not only displacement!).
What is meant in points to consider (d) … "(including levels of expression, as appropriate)"? Please clarify!
Step 5:
I think the rational is not in full-agreement with the Protocol text. I would refrase: "If the risks are not acceptable, strategies to manage these risks should be identified." The logics behind the text in Annex III, 8 (e) must be as follows. Either a recommendation is given stating that estimated risks are acceptable and no management strategies needs to be identified or the recommendation states that estimated risks are not acceptable and management strategies must be and are identified. I would continue the rational as follows: "Management strategies lead to reduction … "
What is meant by residual uncertainty in this context? The Protocol states: "Where there is uncertainty of the level of risk …" I do not like the reference of uncertainty to the acceptability of risk(s). Uncertainty of course affects our ability to estimate the risk and thus (may) indirectly have an effect on our recommendation on the acceptability of risk. Moreover, monitoring does not directly reduce uncertainty - it will, hopefully, in the long run give us information/data that will allow us to revisit the RA. It also allows us to confirm the estimations that we have done in the RA.
Discussion items:
1) Yes, we do need a glossary (co-existence, non-target organisms etc.) – maybe with synonyms like adverse effects/hazards …
2) I would be doubtful to discuss the issues "subjective". I think it is correct to say that assessment conclusions are, at least sometimes, value laden and qualitative for sure but subjective has an other meaning.
6) I would agree with Hans. All steps of RA are carried out – the level of detail varies.
7) I also think that this is important text and will clarify this specific step in RA – that is not always easy and straight forward. I think we need to see the next version of the Roadmap before we can decide where to put this text
13) Co-existence issues. I would agree with Hans (2.7.2009). I would mention co-existence in related issues but also under point 5. And definitely explain it in the glossary. However, I do understand the concerns of some people in relation to RA. However, these should be taken up in describing receiving environment and describing pathways for adverse effects to occur.
Marja Ruohonen-Lehto
posted on 2009-07-12 22:07 UTC by Marja Ruohonen-Lehto
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