RA&RM of Living Modified Crops Resistant or Tolerant to Abiotic Stress

Dear all,
The draft outline of the guidance document on “RA&RM of living modified crops with resistance or tolerance to abiotic stress” has been posted and attached to this message for your comments and input.
Thanks and regards,
Manoela

Thanks Manoela and all:

Now we have more visibility for the discussion on the consideration on the risk assessment components on abiotic stress tolerances.
Yet, I feel that important aspect is the intended use at a specific environment such as environmental remediation or complement agriculture production under extreme water deficiency/drought, and the association with non-targeted environment.


Would you please feed us back on the point?

Kind regards,

Kazuo Watanabe

Dear All,

Thank you, Kazuo for providing this outline and draft text for comment.  It is very helpful to getting this important discussion started.  I have some questions and comments.

First, it might be helpful to restrict this guidance to abiotic stress tolerance in plants.  The draft was clearly written with plants in mind, and it may not be relevant to other LMOs in the future.

Second, the definition of abiotic stresses is overstated and could be recalibrated based on experience with traditionally bred crops.  It should acknowledge that plants are under stress constantly - the morning may be cold, the afternoon may be hot, it might rain too much or too little, and plants cannot amend soils or move to a better location.  Stress is a fact of life.  In the context of LMOs and this SWG's work, abiotic stress is (more simply) suboptimal environmental conditions for the plant to perform its  anthropogenic activity (produce food, feed and/or fiber or perform environmental remediation in the case of plants for bioremediation that are also stress tolerant).  The source of the suboptimal conditions (stress) are non-living in the case of abiotic stress.  Breeders have been modifying plants to tolerate abiotic stress for as long as there has been breeding.  I believe that the current definition is too vague and not helpful in providing guidance.  The word extreme should be deleted and we should be cautious about imprecise terms like "drought", "heat" and "cold".  These terms are descriptive, but may not be descriptive or precise enough to conduct a risk assessment.  

There is a particular point that should be made in Points to Consider.  My experience with conducting a risk assessment for Monsanto's drought maize highlighted the importance of carefully constructing hypotheses that account for the intended differences.  This is a very different situation than we had with HT and Bt crops.  For this drought maize we had to test the hypothesis that the GM maize would be phenotypically unchanged compared to the non-GM maize when water was limited and when water was optimal.  In my opinion and my experience this is a key element that should be reflected in the guidance.  Testing these hypotheses is not trivial, and a risk assessor will see this as a challenge.

Finally, I caution the SWG to keep concepts like "fitness" in perspective for risk assessment. There is much coming out in the literature about how stress traits enhance fitness.  However, the question for the risk assessment is not whether a plant is more fit, but whether it is a weed/pest, unacceptably invasive, etc.  We do not want to give guidance that is interpreted as studying fitness is the same as harm.

Please consider adding the publication Nickson (2008) Plant Phys vol 147: 494-502 to your list of references (submitted earlier by Esmeralda).

Thanks,
Tom

First of all, I appreciate SWG and comment by Tom which is based on real development and assessment of drought tolerant crop.

I agree with Tom that it is essentially important to test not only intended differences but also phenotypically unchaged compared to the non-GM host plant. I’d like to add to these basic points to consider, the importance of scoping which phenotypes to be checked because there are too many phenotypes to be test all.

To put it concretely, I think it important to scope which phenotype to be assessed and to check any other phenotypical difference except for intended differences, based on the mode of introduced genes action, especially when relationship between introduced genes and intended differences is not clear.


And I agree that socio-economic issue is important in some cases/area when LMOs are introduced, but in my opinion, we should not mix up risk assessment for biosafety and socio-economic consideration. They are to be considered separately.

Thanks,

Kazu

Kazu

Thanks to you and the others who have posted on this topic. I hope to be a more faithful contributor too now that my first semester courses have finished. I attach my comments using "track changes" in your document.

I tried to both capture what I thought Tom was saying and to introduce issues that I think are important.

All the best

Jack H

Thank you for the provided document, as the starting step for this discussion.
The SW group is going to deal with crops resistant or tolerant to abiotic stress, if I understand correctly Tom's comment we could focus not only on crops but also consider other plants that not being for uses as food or feed, could have a resistant or tolerance trait for use in remediation. With this I agree, but I also think that this approach might not the useful for LMOs others than plants.

I also think that the SWG should focus on identifying differences on the risk assessment and risk management of these particular group of LMOs; in relation to others LMOs that Annex III and the Roadmap already deal with.

Dear Kazuo, dear all,
thank you very much Kazuo for your additional suggestions, posted on 29 June. In my point of view the guidance document on abiotic stress tolerance should focus on LM crop plants, define and describe the various abiotic stress tolerances and then focus on the risk assessment of such LMOs in the structure as agreed by the AHTEG and as outlined by you in your draft (points to consider, rationale and relevant bibliography). At the AHTEG meting in April he topic chosen for the SWG was "RA&RM of living modified crops resistant or tolerant to abiotic stress". This topic is already quite vast considering all possible types of abiotic stress. The Terms of Reference for the AHTEG in the COP-MOP decision state that the development of the guidance documents should take into consideration the availability of scientific data. The guidance document on abiotic stress may certainly include general considerations on resistance to different types of abiotic stress in crops. Nevertheless, it would be useful to go into more depth on those types of abiotic stress for which more scientific information is already available.
I think that the specific subjects identified by Kazuo(environmental remediation, agricultural production under extreme condition) could be covered in the introductory section of the draft dealing with the definitions and description of various abiotic stress tolerance traits. The issue of “Association/interaction with non-target environments” should appear in the “points to consider” section of the risk assessment part. I am looking forward to further discussion and to the further development of the Draft Guidance Document. Thank you and best wishes
Helmut

Dear Helmut and all:

Thanks for the comments.
Indeed, the further discussion shall employ a specific example such as drought tolerance on a crop like  maize, to examine whether any additional consideration on LMO itself and the associated environments.  General points have been already addressed and concepts and  precaution ARE already in the  ANNEX of the Protocol, and it is cardinal to have a guidance doc with practicality.

Especially to the SWG members, please provide your view on the points.

Kind regards,

Kazuo Watanabe

Thanks to the SWG for their efforts to address risk assessment of plants engineered for abiotic stress tolerance.

I think there is a need to distinguish abiotic stress tolerance from bioremediation, because the intended use of these differs, and this should factor into the risk assessment.  ABIOTIC STRESS TOLERANCE is introduced into plants so that they can be grown on land where their productivity is otherwise limited because of the stressor that is present there. The intention of engineering plants for BIOREMEDIATION is not to improve the productivity of the plants in stressed conditions, but to facilitate the removal of a contaminant from the environment.

While some of the potential adverse effects associated with these modifications are the same, others will be different.  Since the first step in any risk assessment is to identify the potential adverse effects, it would be best to consider these as separate categories.

I believe the risks associated with abiotic stress tolerance can be assessed in the same way as other types of genetically engineered crop plants, following the steps for risk assessment in Annex III in the protocol. 

The first step is to identify adverse effects that may be associated with any novel genotypic and phenotypic changes associated with the abiotic stress tolerant LMO.  By comparing the LMO to its traditional counterpart, any novel changes associated with the abiotic stress tolerance can be identified, including any changes to the biology of the crop plant (e.g., if the genes may alter multiple characteristics of the plant) or to the potential receiving environment (e.g., if the plant can grow where it has not been grown before).  After the adverse effects associated with these changes have been identified, then the likelihood and consequences can be considered together to determine the risk and the need for any additional risk management.

There isn’t additional information in the ‘Guiding document for considering abiotic stress tolerance’ so far that would not be covered by the steps currently described in Annex III and in the roadmap.
 
It would be helpful if the roadmap that is being developed as part of this AHTEG’s efforts could use an abiotic stress tolerant plant to demonstrate how the risk assessment process can be applied to this type of LMO.

Whether or not the adverse effects identified in Step 1 of the risk assessment should include socio-economic impacts is not a question unique to abiotic stress tolerance.  Other commenters have suggested, and I agree, that socio-economic considerations should be included as part of the decision process, and not as part of the risk assessment process as described in Annex III.

First, I would like to thank Dr. Watanabe for his work in leading this discussion.  I think the questions he has posed are quite relevant for undertaking our work on living modified plants that have been developed to tolerate abiotic stresses.  

It is important to keep in mind that with this SWG we are not attempting to craft a new standard or even a new guide to conducting risk assessments under the Protocol.  The work of the AHTEG is not intended to produce a new obligation for Parties but to help those who wish to perform risk assessments in accordance with Annex III.  This greatly simplifies the task before us. 

Reading the posts on this thread and referencing Annex III, I am reminded that the Annex is a well-crafted and generally applicable document.  What is needed to support risk assessments, then, is not a set of specific instructions for reviewing a particular abiotic stress trait (which would seem contrary to the general principle of case-by-case assessments from paragraph 6 of Annex III), but rather a useful collection of available information that can help risk assessors obtain what information they need and guidance on how to use that information when performing an assessment.

The first step in this process is to assemble a solid baseline of available information on abiotic stress tolerance in plants of all kinds.  For this purpose I have pulled a few references together – there are many more and I will continue to look through my files while encouraging others to do the same.

There are many variations on the definition of abiotic stress, but in general they include the idea that it is a non-living stress on a living organism in a specific environment.  For our purposes here, there has been some discussion on which types of abiotic stresses to include in our work.  I think we should first look at what information is available information from “conventional” (non- GE) research into abiotic stress resistance and then what research is available for GE stress tolerance.  Our primary focus should be on developing useful information to help risk assessors examine the abiotic stress traits they are likely to see first.

For example, water stress has long been an area of research by plant scientists (e.g., osmotic regulation in the face of both too much and too little water).  Tolerance to heat, cold, and salinity have also been the subject of considerable research. Thirty years ago, a great deal of research focus was placed on air pollution stressors such as ozone and nitrous oxides that are common components of smog. In more recent years, scientists have pressed forward to develop crops that can better withstand these stressors, so we should concentrate our efforts in making some of these resources more readily accessible to people who will do risk assessments of plants engineered to tolerate abiotic stresses.  Then we can look at the research into GE abiotic stress tolerance and the products under development to see how it relates to this earlier work. In this way we can develop a foundation for our discussion as well as addressing the most pressing risk assessment needs.

On-line resources

National Plant Germplasm System   http://www.ars-grin.gov/npgs/
Germplasm Resources Information Network (GRIN) http://www.ars-grin.gov/
This is a very useful resource to see the broad phenotypic diversity available in germplasm accession lines.  Many plant breeders will be familiar with the GRIN database.

Selected Literature: Stress tolerance in plants
Most of these are review articles that can provide an entry to other research in abiotic stress in plants.

M.A.J. Parry, J. Flexas & H. Medrano. Prospects for crop production under drought: research priorities and future directions  Ann Appl Biol 147 (2005) 211–226

Basia Vinocur and Arie Altman.  Recent advances in engineering plant tolerance to abiotic stress: achievements and limitations.  Current Opinion in Biotechnology 2005, 16:123–132

M. M. Chaves and M. M. Oliveira.  Mechanisms underlying plant resilience to water deficits: prospects for water-saving agriculture.  Journal of Experimental Botany, Vol. 55, No. 407, Water-Saving in Agriculture Special Issue, pp. 2365–2384, November 2004

N. Sreenivasulu, S.K. Sopory, P.B. Kavi Kishor. 2007.  Deciphering the regulatory mechanisms of abiotic stress tolerance in plants by genomic approaches. Gene 388:1–13

Applications of Molecular Biology and Genomics to Genetic Enhancement of Crop Tolerance to Abiotic Stress:  A Discussion Document.  interim SCIENCE COUNCIL SECRETARIAT FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS. September 2003. 
This document comprises:
(a) Applications of Molecular Biology and Genomics to Genetic Enhancement of Crop Tolerance to Abiotic Stress - A Discussion Document,
(b) Status of Breeding for Tolerance of Abiotic Stresses and Prospects for Use of Molecular Techniques (Annex I),
(c) Genetic Engineering for Abiotic Stress Tolerance in Plants (Annex II)

Bidhan Roy & Asit Kumar Basu.  2009. Abiotic Stress Tolerance in Crop Plants : Breeding and Biotechnology.  ISBN: 9788189422943 / 8189422944

Thank you all for fruitful discussion. I hope the position of my reply is appropriate.

“Fitness” is “the ultimate measure of a plant’s performance which is the number of its offspring which reproduce in future generations”. And fitness is the one of the assessment items of “adaptability to abiotic stressed condition” here.

Abiotic stress includes not only draught and heat, but also contaminated soil with heavy metal and POPs (Persistent Organic Pollutants).
We have to consider the following items and to clarify the characteristics of LMO in abiotic stress. Therefore the comparative studies with Null crop are much more important in abiotic stress than the other LMO.
a)Phenotypic trait of LMO
b)Difference in such phenotypic trait between stressed and non-stressed (good) condition
c)Difference in internal change between stressed and non-stressed (good) condition
d)How do LMO adapt in stressed condition? Is there any difference due to the intensity of the stress?　Intensity of the stress means not only optimal and suboptimal condition, but also the range of stress.

We should also consider the following points for effect of LMO on biodiversity under abiotic stress.
a)Whether the transgenic gene act only under stressed condition or not? It means 1) Switch ON/OFF by stress or 2) constantly expressed.
b)Mode of action should be clarified in order to consider unexpected condition other than target stressed condition.
c)From the viewpoint of crop import, import countries basically assess the LMO under their own environment (condition). They had better know how the LMO performs under abiotic stress condition, however, they do not need to conduct the trial under such conditions, when they do not have such conditions.

Best regards,

dear All:


First of all, I than  Jack to polish the draft guiding document which was attached to his statement.
However, after Jack's elaboration on the draft document, there are further points raised by colleagues

Tom N.:  ""I believe that the current definition is too vague and not helpful in providing guidance.  The word extreme should be deleted and we should be cautious about imprecise terms like "drought", "heat" and "cold".  These terms are descriptive, but may not be descriptive or precise enough to conduct a risk assessment. """

Together with the message of David H,
I think it is true that there is need to define in a descriptive way of what is each of abiotic stresses.
Also now on I would be suggesting on focusing on starting defining ""drought tolerance"" and further discuss using drought tolerant plants for further discussion as I recommended using maize to test whether existing elements at the ANNEX together with the guiding doc draft would support.

Dr. Yogo:
As in the very early discussion, there were indication of wide range of LMO applications against abiotic stresses associated with bio-remediation purposes but again, to integrate and focus on the present discussion, there shall be specific example to be tested.

Kind regards,

Kazuo Watanabe