| | english | español | français |
  Home|RARM Portal|AHTEG|Past Activities of the AHTEG|Online Discussions|SWG Post-release Monitoring   Printer-friendly version

SGW on Monitoring of LMOs Released into the Environment

Return to the list of threads...
Forum closed. No more comments will be accepted on this forum.
Item 6: The distinction between Case-Specific Monitoring CSM and General Surveillance (GS) [#2599]
Item 6: The distinction between Case-Specific Monitoring CSM and General Surveillance (GS)

Several commentors noted this distinction needs to be made more clearly in the guidance, and this is duely noted.

However, there seems to be a class of possible effects that donot fit neatly into either CSM or GS as they are generally understood, and hence an overlap between these two types of monitoring may occur: Adverse effects that can be identified, yet where the predictability of effects is low or particularly difficult (e.g. combinatorial or interactive effects), or are anticipated yet not scrutinized in the formal risk assessment because their effects are difficult or impossible to predict in a singular risk assessment.

One approach to resolve this follows that taken by  the British Advisory Committee on Reslease to the Environment (ACRE) who, beyond anticipated effects (CSM) and unanticipated effects (GS) found reason to cite another category “interactive or cumulative effects”, effects which by their nature are difficult (maybe impossible) to anticipate in an singular RA.

Question: How do you feel the monitoring guidance should handle such cases?
posted on 2011-08-11 20:08 UTC by David Quist
RE: Item 6: The distinction between Case-Specific Monitoring CSM and General Surveillance (GS) (Reply of Hans Bergmans) [#2612]
GS is there to try and answer questions that are left after CSM, and that cannot be answered by CSM. That is what we call GS, and from that it follows that GS is complementary in concepts, and therefore fundamentally different from CSM.

The questions that GS has to answer all stem from the fact that there will always be an argument that risk assessment, and hence CS monitoring, may not have covered all sources of adverse effects brought about by LMOs.
GS aims at: 1) finding unexpected effects in the environment (mind you, because we are asking about unexpected ones, we have no idea of what they might be or where they might occur (we have to leave open all possibilities, for instance all possible ways of exposure); starting from any hypothesis may make us biased  blind for some effects); 2) finding out whether these are related to (an) LMO(s), that is: finding correlations; 3) finding out about the causal relationships for these correlations (finding a correlation between an adverse effect and an LMO does not automatically imply that the LMO is the cause of the adverse effect); 4) and that leads you to further considerations for CSM: you have turned your GS into a case of CSM.
In other words: what we are doing in GS is a) taking care of a question that cannot be approached by CSM and b) make it amenable for further testing by CSM by finding the hypotheses behind the effects.
In summary: GS is a way to approach cases where we do not have a hypothesis. It is aimed at finding the effects (if they are there) and the underlying hypotheses. If you have a hypothesis you can approach it by risk assessment and CSM.
The example of ACRE contains aspects of CSM as well of GS. It is not an example that needs another approach to monitoring. It needs to be addressed both by CSM and GS.
In their example they talk about unexpected effects: these will be typically addressed by the GS that will be done for the LMOs in question. If there unexpected effects that are due to interactive or cumulative effects, this will be found in step 3 of the GS. But, the GS should not start focusing on interactive or cumulative effects, because this would introduce bias and would or could lead to wrong results.
The question of interactive or cumulative effects between one specific LMO and other LMOs that are grown next to it typically asks for a hypothesis driven approach, that is open to CSM. This question in general is specific to the market phase, and to PMEM: that is when LMOs from different provenance will ‘meet’ and the interactive and cumulative effects may occur. Similarly, effects that will only become apparent at very large scale applications, for instance because you can calculate that they will occur at very low frequencies, can only be approached in PMEM.
posted on 2011-08-18 15:12 UTC by Mr. Hans Bergmans, PRRI
RE: Item 6: The distinction between Case-Specific Monitoring CSM and General Surveillance (GS) (Reply of Hans Bergmans) [#2625]
I think all considerations can be taken care of by the two monitoring strategies: CSM and GS
posted on 2011-08-18 22:00 UTC by Ms. Esmeralda Prat, CLI representation
RE: Item 6: The distinction between Case-Specific Monitoring CSM and General Surveillance (GS) [#2635]
CSM and GS are complementary and can cover the whole area - adding another category would not add anything and only confuse

Piet
posted on 2011-08-18 22:27 UTC by Mr. Piet van der Meer, Ghent University, Belgium
RE: Item 6: The distinction between Case-Specific Monitoring CSM and General Surveillance (GS) [#2654]
I think that the guidance should clearly separate CSM and GS, and not include another strategy since as Hans pointed out the effects you mention will be already consider in either.
posted on 2011-08-19 05:08 UTC by Ms. Sol Ortiz García, Mexico