Modalities for cooperation in identifying LMOs or specific traits that may have adverse effects

Dear all,

Since the topic on “Modalities for cooperation on the identification of LMOs or specific traits that may have adverse effects” is new to our online discussions, I thought it would be useful to provide some additional information on this issue.

According to the terms of reference of the Ad Hoc Technical Expert Group (AHTEG) on Risk Assessment and Risk Management, as defined by Parties to the Protocol, at its second meeting, the AHTEG should “consider possible modalities for cooperation in identifying living modified organisms or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health”.

The Discussion Groups under the Open-ended Online Forum aim at providing a platform where a wide number of experts can share views on specific topics of risk assessment with the view to assisting the AHTEG in its deliberations.

Therefore, the objective of this Discussion Group is to assist the AHTEG by sharing views on a process for cooperation or potential mechanisms by which cooperation may be established by the Parties to the Protocol to identify LMOs or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health.

A synthesis of submissions received on a related issue is attached to this message.

Your views on this topic are welcome and very important. Thank you!

Best regards,
Manoela

In order to start the participation I would like to support the advice of the PRRI about split the question “which LMOs or specific traits may have adverse effects”? in a number of specific questions:
1. Are there LMOs or traits that have caused adverse effects?
2. Are there LMOs or traits of which experience shows that they are unlikely to cause adverse effects?
3. Are there LMOs or traits of which risks assessment has shown that they are likely to cause adverse
effects?
4. Are there LMOs or traits of which risks assessments suggest that they are unlikely to cause adverse
effects?

Suggestion that is in concordance with Norway submission “First, we wish to note to the CBD secretariat that it would also be useful to also request scientifically sound information that document not only adverse effects, but evidence of safety (as opposed to evidence no effects) for biodiversity and human health”

About the modalities for cooperation, one option could be regional workshops or on line discussion to answer these four questions.

I agree to the usefulness of workshops in solving such a qusetion. However, I am wondering if it is possible or necessary to have a joint-project to conduct research works on this topic. This project can be devided into several sub-topics and to work on identifying species and on certain traits that risk hugely. These topics could cover those target groups for which our colleagues are working for in the aspect of risk assessment guidlines, e.g. mosquito (insects), resistance to abiotic stresses. The final report will focus on the mechanisms and the levels of risk. Of course, the output might be several academic papers of high impact as well as the reports.

Regarding the request for evidence of safety:  the data submitted to support the safety of a transgenic is not intended to show "no effects" but rather to show that the transgenic is as safe as its comparator.  This comparative approach is explicit in Annex III, where risks "should be considered in the context of the risks posed by the non-modified recipients or parental organisms in the likely potential receiving environment."  Therefore the request for this type of evidence misunderstands the risk assessment process, and will not help clarify which LMO's fall within the scope of the protocol, namely those that are likely to have adverse effects on biodiversity.

Many thanks for including  “Modalities for cooperation on the identification of LMOs or specific traits that may have adverse effects” in our online discussions About the modalities of cooperation we are already the online discussions option, other tools should be sound documents, regional workshops and meetings
Best regards
Dr Gado

I do not think that the concept of identifying LMOs or specific traits that may have adverse effects is in keeping with the principles of case by case risk assessment. Recommendations about safety or otherwise should be based on scientifically sound assessments conducted in a transparent manner. However, it is useful to identify LMOs and traits that could pose a problem for risk assessment. For example, crops that produce non-food/feed products such as pharmaceuticals or plastics - how should a comparative risk assessment be carried out?

Therefore, in advising on 'which LMOs or specific traits may have adverse effects' I agree with PRRI's suggestion for splitting the question into parts. (And with the need to establish criteria for accepting evidence).

Many thanks for including the topic Modalities for cooperation on the identification of LMOs or specific traits that may have adverse effects” in our online discussions About modalities of cooperation, we are already using one option, the oneline discussions other tools should includesound documents, regional workshops and meetings
Best regards
Dr Gado

Dear All

To identify those LMOs with adverse effects – that is the task given to us – is not an easy one and has to reflect a number of different aspects and criteria. As pointed out the comparator or better a comparative management with the unmodified crop species is of great importance. But how to get a clear image? There exist a great number of different management ways depending on the region, climate, soil, crop rotation and other agricultural aspects. To my opinion there is the need for further discussion on appropriate comparisons and how to find these. One way of cooperation on this issue could be regional (online?) workshops to further explore contemporary agricultural practices and delineate what would be appropriate criteria for the comparison. May be also the proposition by Wei could be a way.
In addition, to have a scientifically sound basis for categorisations of LMOs with adverse effects we need good reliable data. Risk assessment is one pillar. Risk assessment is inter alia based on data of experimental field releases and in addition is somehow a forecast and modelling how the results of small scale will translate into large scale.  But we all know that scaling up may show qualitatively new aspects and statistics teach us that especially in interlinked systems with quite a number of influences impacts may only be statistically significant if they have a quite high probability because of background variation. To neutralize these short comings from short term small scale field releases we need verification with the help of scientific data gathered during commercial use – these we do not have yet. Therefore a second topic of discussion could be how to organize pilot monitoring projects to fill in this gap.
And last but not least there should be some discussions on basic data gaps or missing data in the context of the task.

best regards

Beatrix