General considerations/Chapeau
[#1267]
It is nicely mentioned in the General considerations/Chapeau - While the steps described in Annex III are distinct, they are also interlinked and iterative.
It is also nice to give thought on …”Some overarching issues that are relevant to the process as a whole should be taken into account in the scoping phase of the risk assessment. They are important for the quality and relevance of information available as it pertains to the risk assessment needs.”
I missed in the examples of issues the importance of making relevant questions, such as identifying the significant risks and deciding on how to test them before the second bullet on “How to interpret results from experimental trials accounting for specific ecological situations….”. A good assessment plan is essential for a straightforward and effective RA. The interpretation of results without considering first pertinent questions is tricky as one can easily get lost in research data that is fun to know but does not really help in the conclusions of a RA. Considering that are several really important issues within RA itself already exist, I suggest to take out other important points for decision-making that are not related to RA such as public awareness and treat them separately in the appropriate context.
posted on 2009-07-07 20:14 UTC by Ph.D. Lúcia de Souza, PRRI - Public Research and Regulation Initiative/ANBio (Associação Nacional de Biossegurança - Brazilian Biosafety Association)
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RE: General considerations/Chapeau
[#1270]
Following up on this comment from Lucia, the purpose of Step 1 in the roadmap should be made clear. The purpose should be to identify the adverse effects. It is not to compare the LMO to the recipient organisms and identify any differences.
The first step in any risk assessment must be to clearly identify the adverse effects. Without making this clear, the roadmap could encourage lengthy descriptions of the LMO, the crop plant, and the receiving environment, which may or may not be relevant.
In addition, the rationale and points to consider in Step 1 of the roadmap, as it was written, gives the impression that “differences” between the LMO and the recipient organism equate with “adverse effects”. That is a serious mistake, but one which is too easy to make and one I often hear in discussions of risks associated with LMOs. (There is evidence of this in some of the comments posted to the discussions of the the other Sub-Working Groups.)
Establishing a credible causal pathway for each adverse effect is an important part of the risk assessment as it relates to determining the likelihood in Step 2. Whether or not that pathway is likely to be followed determines the likelihood of the adverse effect.
This is not quite captured in the rationale for step 1 of the roadmap, as written. Perhaps it should be revised as follows:
Step 1 Rationale: This step identifies adverse effects that could result from the use of the plant. This step involves a comparison of the LMO with the recipient organism to determine any differences in the introduced trait, the biology, or the receiving environment that may cause an adverse effect. It then establishes a credible causal pathway whereby the genotypic and phenotypic changes … may give rise to each adverse effect…
Thanks,
Karen
posted on 2009-07-09 17:03 UTC by Dr. Karen Hokanson, Agriculture and Food Systems Institute
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RE: General considerations/Chapeau
[#1275]
I concur with Karen's comments about adverse effects (ie differences are not adverse effects). I previously noted that the Roadmap in current form does not include an explciit identification of risk. I would support Karen's proposed working if 'potential' were added before 'adverse effect'
posted on 2009-07-10 00:41 UTC by Janet Gough, Environmental Protection Authority
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RE: General considerations/Chapeau
[#1277]
I would like to echo Karen’s comments. If the road map is to help with the structured inquiry that leads to the identification of potential adverse effects that need to be considered rather than an exercise in data generation, then it is important to include the need to develop plausible mechanisms for an effect resulting from the change. In practice, that is exactly how experienced risk assessors operate since field data under review often reflects the inherent variability that crops display when grown under a variety of circumstances and under a variety of environments.
One key aspect that I still feel is missing from the chapeau is that the road map leaves the appearance that every risk assessment on an LMO is a new experience that requires strict adherence to each step. While some of the scientific discussion has been interesting from a theoretical perspective, in practice, risk assessors will benefit from their experience with similar traits in the same crop or the same gene in a different crop and this will form the context for the risk assessment.
posted on 2009-07-10 16:56 UTC by Mr. Phil Macdonald, Canada
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RE: General considerations/Chapeau
[#1283]
There has been some back and forth about whether there is a fundamental need to follow all steps of the Roadmap in all cases. The "correct" answer will probably be given on a case-by-case basis based on a Party's interpretation of "in accordance with" as stated in Article 15.1.
I believe that the Chapeau should highlight that Parties are obligated to post risk assessments, summaries and other relevant materials on the BCH according to Article 20 (information sharing). How a Party uses that information e.g., as an applicable final risk assessment is a decision to be made a Party. The Roadmap should not imply any requirement otherwise.
posted on 2009-07-10 17:55 UTC by Mr. Thomas Nickson, Consultant
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RE: General considerations/Chapeau
[#1287]
Thanks to all for the healthy discussion here, very useful.
I would like to address the issue of credible pathways. While I certainly see the value in establishing pathways as a basis for further understanding, particularly for risk management options, applying it as criteria for hazard ID, as proposed, is problematic, for at least two reasons.
First, the mode of action is not always known that leads to an adverse effect, nor is it necessarily the result of a linear causal chain of events (there are a plethora of examples from medicine and ecology that demonstrate this). Second, even if a credible causal pathway is established, it may not necessarily tell you anything about the likelihood of the event occurring—plausibility yes, likelihood no. For example, the mechanisms of horizontal gene transfer among bacteria are well described, yet do not give an appreciable estimate of transfer frequency—the likelihood question attended to in step 2.
Lastly, we should be careful that conditions for identifying hazards does not put undue burden of proof on the risk assessor to pioneer transgenic biology or systems biology to explain possible modes of action that are not already well defined or scientifically established. Certainly the guidance provided by the precautionary principle, as stated in the first Article of the Protocol, should be considered here.
posted on 2009-07-10 18:43 UTC by David Quist
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RE: General considerations/Chapeau
[#1290]
In the context of science-based risk assessment, the use of the word "plausible" has a very specific meaning. That is, that we are able to generate hypotheses that are testable in order to determine whether a particular observed difference (if that difference is judged to be significant enough biologically) leads to an adverse effect that is relevant, based on a country's protection goals. We can then use these hypotheses to determine which data in the points to consider (either in the roadmap or Annex III) are relevant to test the hypotheses. We are therefore not requiring risk assessors to know everything about everything in order to generate "plausible" hypotheses. The burden is not on them to do so. The protocol calls for risk assessment to be carried out "in a scientifically sound and transparent manner". To me this means application of the scientific method to as much of the process as we can. If we can't do that, we are not conducting science-based risk assessment.
posted on 2009-07-10 19:25 UTC by Hector Quemada
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RE: General considerations/Chapeau
[#1303]
I agree that we are discussing ‘potential’ adverse effects in risk assessment, and it is better to refer to them this way.
However, the list of potential adverse effects in any case could be endless. There has to be a way that potential adverse effects to be considered are separated from those that should not, on a case-by-case basis. Establishing credible plausible pathways, based on what is known about the introduced trait, the biology of the crop plant, and the receiving environment, is the way to do this. If this is not possible, then risk assessment becomes a ‘needle-in-a-haystack’ exercise.
If the steps in the pathway are determined, then it is possible to determine the likelihood of each of these steps. If any step in the pathway to an adverse effect is not likely, then the adverse effect is not likely. If it is not possible to determine the likelihood of any of the steps in the pathway to an adverse effect, then it is not possible to determine the likelihood of the adverse effect. In this case, more information is necessary, and it can be gathered by testing hypothesis about the likelihood of one or more of the steps in the pathway.
This does require the risk assessor (be it the party of import or the party of export) to explain possible modes of action that are well defined and scientifically established. A scientifically sound risk assessment can not be conducted otherwise.
This should be reflected in the roadmap.
posted on 2009-07-11 16:35 UTC by Dr. Karen Hokanson, Agriculture and Food Systems Institute
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RE: General considerations/Chapeau
[#1319]
I would strongly support what David says about establishing credible pathways and having them as criteria for hazards/adverse effects identification. This is not in agreement with the general principles of RA.
(edited on 2009-07-12 22:45 UTC by Marja Ruohonen-Lehto)
posted on 2009-07-12 22:38 UTC by Marja Ruohonen-Lehto
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