Dear all,

Thank you very much for the lively discussion and active participation.

This is a gentle reminder that the discussion on the “Revision of the Guidance” will close on **11 April 2011 (1:00am GMT)**. If you are still planning on making suggestions on how to improve the Guidance on Risk Assessment of LMOs, please do so before the closing of this discussion.

Immediately after closing the discussion on the “Revision of the Guidance”, two other topics will be open for discussion:

• Topic 2: Possible mechanisms, including criteria, for future updates of the lists of background materials
• Topic 3: New specific topics of risk assessment for the development of further guidance

Information on these upcoming discussions is available in the main page of the discussion groups (http://bch.cbd.int/onlineconferences/discussiongroups_ra.shtml). Please note that the discussion on these two topics will remain open for one week, from 11 to 18 April 2011 (1am GMT).

Thank you and best regards,
Manoela

Dear forum participants,

Few messages have been posted on the specific part of the guidance for
RA of LM crops tolerant to abiotic stress.
This is however a group of LMOs in extended development.

This specifice guidance surely pinpoints several pecularities of these
plants.
But, generally speaking, I agree with the comments of our Belgian
Biosafety Advisory Committee on this issue, saying that the roadmap
suffers of some redundancies and some lack of clarity and of coherence
concerning the successive steps to follow in the course of the RA and on
specific aspects to consider.

In particular, the complexity of the issue regarding the finding of
adequate comparators and adequate situations for comparative testing (
cf. section on "Challenges with respect to experimental design" p. 29 of
the final report of the AHTEG)  could be more clearly explicited for
unexperimented users of the RA guidance ( see for some details the
comments of the Belgian Biosafety Advisory Committee sent to and posted
by the SCBD ).

Our experts also consider that a clear definition of "tolerance" could
be useful, to highlight the distinction between the wording "stress
tolerance" and "stress resistance"

This issue of GM plants tolerant to abiotic stresses is, with this of LM
mosquitoes, an issue that will particularly have to benefit from the
"living" aspect of the guidance and the necessity for further reflexion,
knowledge, experience, and methodologies development.

Presently, I notice that there is some discrepancy among expert opinions
concerning the potential higher ability of this type of LM plants to be
persistant and invasive.
A previous message ( from Paulo Paes de Andrade ) mentionned that the
concerned transgenic traits would give very limited tolerance, and would
not not allow the GM plants to propagate in a new environment , taking
moreover into account that most of cultivated plants cannot easily
propagate without our direct help.
By contrast, experts underline in the relevant comments of our Belgian
Biosafety Advisory Council that " there are significant connections
between both signalling pathways and the genes and molecules involved in
diverse abiotic stresses" and thus " it is likely that some modified
traits will cause increased tolerance to more than one abiotic stress".
This would rather suggest a larger potentiality of persistance and maybe
invasivity. In any case, it should be clear in the course of the RA what
are the intended effects of the transgenesis. Any other effects of
increased tolerance or other advantage or disadvantage given
simultaneaously or indirectly by the concerned transgenes should be
tested among "unintended" effects and looked at for their potential
safety concerns.
It would be good to give still some more attention in the guidance
concerning the pecularity in the general physiology/resistance/tolerance
changes of  the plant that could induce a tolerance trait to a specific
abiotic stress.
Attention should also be given to the constitutivity or signal-induced
tolerance(s).   

With best regards.

Lucette Flandroy





Disclaimer : http://www.health.belgium.be/eportal/disclaimer/index.htm

Dear Participants,

RA (risk assessments) consider if introduced trait makes a LM crop or LMOs more invasive into natural habitats. Special attention is given in cases when an introduced trait is expected to improve competitiveness in natural habitats, this include abiotic tolerance among others. Modern conventionally bred cultivars already exhibit a significantly enhanced tolerance to abiotic stresses, such as drought, or were adapted to survive on local temperature in comparison to the original crop varieties that were used a few decades ago. They already give an interesting baseline to consider the possible effects an abiotic stress tolerant crop obtained through modern biotechnology can have on the environment. Weediness, for instance, arises from several different characteristics and the introduction of one is unlike to make a crop with very few weedy characteristics turn into a weed. In the many cases that the crop has lost the ability to survive without the human help given within the agricultural setting (consequence of domestication) even if occasional volunteers appear it´s unlikely that they will invade natural habitats. If the crop is weedy or has weedy sexually compatible relatives in the environment and all the needed aspects to make it a threat, it will not pass through the RA, unless risk management strategies are put in place (these can include the different possibilities that modern biotech offers). I don´t intend to make here precise judgements about the, for example, persistence or invasiveness in the environment of the many possibilities and types of GM crops, the many possibilities of abiotic resistance, the many possible ways of risk management, etc. (that´s why we still consider on a case by case assessment). I think that perhaps is more useful, if we first concentrate on making an excellent guidance (general roadmap). In addition we can have a few cases considered of general interest (LM mosquitoes, abiotic stress tolerant, etc) as examples on how the RA is conducted (explaining the steps and rational - like case studies) for better understanding and support for the less experienced risk assessors. The reasons for that include:
- The general guidance (roadmap) is already a big challenge that needs to be very well thought and thus it is time consuming. If we disperse we might end up with several guidances of not the best and desired quality for much too long. That will not be the best way to meet the objectives of the protocol, including protect natural biodiversity while improving socio-economic aspects.
- I suspect that if we manage to have an excellent general guidance, the questions to be asked for let´s say abiotic stress tolerance/resistance will be there anyway, the added emphasis/detail of a guidance to the more specific case should be useful but basically it will actually be repeating what´s already being said in the general one.

I very much appreciated participating at this forum and I also sincerely hope that my comments are somehow useful for improving the quality/usefulness of the roadmap.
my best regards,
Lúcia

Dear Lucette.

I fully agree with the experts from the Belgian Biosafety Advisory Council that " there are significant connections between both signalling pathways and the genes and molecules involved in diverse abiotic stresses" and thus " it is likely that some modified traits will cause increased tolerance to more than one abiotic stress". Even if a single transgene could trigger a couple of different pathways, I still doubt that this would transform a stress tolerant plant in a stress resistant one, able to grow in new, radically different habitats and displaying some invasive behavior. This would be a concern for the regulator, interactions per se obviously not (although they can be intriguing and enlightening in science). Moreover, using the SuperSAGE technology, we observed in our lab that among more than 30,000 genes identified by 2 million tags, many hundreds are up- or downregulated in response to stress in plants. Therefore, I strongly doubt if a single transgene could be able to orchestrate more than a timid (although economically useful) stress response. My position is also partially supported by Lucia de Souza, who recently posted in this forum the following remarks: “Weediness, for instance, arises from several different characteristics and the introduction of one is unlike to make a crop with very few weedy characteristics turn into a weed. In the many cases that the crop has lost the ability to survive without the human help given within the agricultural setting (consequence of domestication) even if occasional volunteers appear it´s unlikely that they will invade natural habitats. “

In conclusion, I still do not see how slight changes in tolerance (either to drought, temperature, etc.), even for a couple of traits, would increase persistence and invasiveness. On the other hand, to investigate unanticipated interactions using molecular techniques will be both very expensive and will have scarce applications: for all high throughput techniques no baseline is available for common non-transgenic crops and we are still far from building up a sturdy databank to start a meaningful baseline (see Doerrer et al., 2010 - Evaluating biological variation in non-transgenic crops: Executive summary from the ILSI Health and Environmental Sciences Institute workshop, November 16–17, 2009, Paris, France. Regulatory Toxicology and Pharmacology 58: S2–S7). In my opinion, we should keep our attention focused on measurable parameters from likely biological outcomes due to transgenesis. The inclusion of unlikely hypothesis for the problem formulation in risk assessment will not improve the results and will transform the whole risk analysis in a cumbersome, expensive exercise.

My gratitude to all of you for such an exciting discussion.
Kindly
Paulo Andrade