Hans, thanks for your message.
While SWG is behind from providing the draft guidance document, as my personal opinion, I would like to post guidance info on abiotic stress tolerances as in the below.
The key points are phenotype and the the environment where LMOs are intended to be used.
Guiding document for considering risk assessment for abiotic stress tolerance(Watanabe personal)
Introduction
1. Abiotic stresses such as drought and salt tolerances are of interest for the use in water deficit or marginal lands to maintain vegetation and agriculture production and recover vegetation.
2. The needs of aboitic stress tolerances such as drought tolerance are supported by international organizations such as FAO and IFPRI, especially for sustainable agriculture.
3. Because of higher fitness in a harsh environment, LMOs with abiotic stress tolerances may make adverse effect to the environment by having invasiveness such by super-weedy traits.
4. However, with the Annex III of the Protocol, there are general elements cited for risk assessment which may cover enough also on abiotic stress tolerances.
5. Aim of this document is to examine whether RA on abiotic stress tolerance traits shall need further consideration to support the RA and RM roadmap.
Definition
Abiotic stresses: stresses caused by non-living factors such as extreme environmental conditions such as water-shortage (drought), excess amount of saline (salt stress), low temperature (freezing), polluted air, organic substance influences, metal contamination etc. (see such as Cherry JH et al. Plant Tolerance to Abiotic Stresses in Agriculture: Role of Genetic Engineering (NATO Science Partnership Sub-Series: 3:) , 2000, Springer. ISBN-13: 978-0792365662)
Risk Assessment
Roadmap of the risk assessment needs additional information if the abiotic stress tolerance traits have extra precaution.
Key elements of the evaluation process
1. What are abitic stress tolerances, drought tolerance, salt tolerance, freezing tolerance?
Rationale: A LMO shall be investigated at case by case and so far the context of the abiotic stresses are very broad, the trait shall be well defined for further consideration.
Point to consider:
How a phenotype expressed by the transgene would have specific advantage over the targeted environment? Is there invasiveness, super-weedy or damage to living creatures. This also shall be considered parallel way as a transgene x environment condition, and go to 2. To include consideration on the environment for the intended sues.
2. What are the intended uses, such as for environmental remediation etc?
Rationale: the abiotic stress tolerance is often considered to the environmental condition where already environment has damage or marginal condition which needs remediation. Purposes are often for bioremediation, combating water resources shortage in agriculture, saline damage in vegetation oriented to desertification or afforestration purposes where no vegetation is available.
Points to consider: Where are they used in a specific environment, such as a dried land with low water availability to maintain vegetation?
3. What would be potential adverse effect to the non-targeted environment?
Rationale: High fitness capacity of a LMO with abiotic stress tolerance may potentially overtake the ecosystem beyond the targeted area.
Points to consider: Dispersal of germplasm such as pollen and seeds and establishment of filial progeny using the non transgenic host individuals.
4. Typical reference example could be GM crops with abiotic stress tolerances for immediate practice cases.
Rationale: LMO crops with such traits are already in field trials. There are many plant species with these entities including major crops such as maize, wheat, cotton and trees such as poplar and eucalyptus.
Points to consider: would the risk assessment components be identical to ANNEX II I of the protocol but more options would be indicated in the risk managements.
References
http://www.isbr.info/http://www.gmo-safety.eu/en/news/654.docu.htmlhttp://www.landesbioscience.com/journals/gmcrops/abouthttp://www.pubresreg.org/index.php?option=com_docman&task=doc_download& gid=445 –
http://www.biosafety-info.net/file_dir/14859528524a1b5798b3c82.pdf -
http://www.fao.org/Biotech/C8doc.htmhttp://www.ifpri.org/pubs/articles/2005/naturebiotech.pdfisbgmo.info/programme/
http://www.absp2.cornell.edu/news/documents/25_Indo-US_conference1.pdfKazuo