Dear colleagues,

First of all, I would like to thank those who contributed to the preparation of this draft version of the guidance on RA of LM Trees. This is a good basis for discussion. Nevertheless, I think that this first version can be largely improved and I will start the discussion by providing a few general comments.

Background
I recognize that the current information provided in the background section is useful to illustrate the context in which this guidance is produced. However, I would suggest to focus the guidance on issues directly associated with the risk assessment itself and to limit general considerations to a minimum. In that respect, the current text of the background section should be condensed to one or two general statements with references to the relevant COP decisions (where people will find detailed information).

Introduction - lines 47 to 67
I am wondering whether this part of the introduction is really necessary and has any added-value in this kind of guidance. Firstly, it focuses on socio-economic aspects which are outside the scope of the guidance. Secondly, this kind of introduction is not found in the other risk assessment guidance documents developed so far under the Cartagena Protocol (namely guidance on LM plants with stacked traits, on LM mosquitoes and on LM plants with tolerance to abiotic stress). I would suggest to delete this part and keep only information focusing on what makes LM trees specific in terms of risk assessment.

"Unintentional transboundary movement" - lines 126 to 137
The current wording is unclear in explaining why GM trees display some specific challenge as regards the application of the provisions of the Protocol concerning unintentional transboundary movements (e.g. in terms of "overlap in the relation between "intentional transboundary movement for intentional introduction into the environment" (Art 7) and "unintentional transboundary movements" (Art. 17)").

Risk assessment elements
Beside describing specific points to consider related to Step 1 of the risk assessment, it is important to underline that points relating to steps 2 and 3 of the RA process will be crucial in determining the biological significance of any specific characteristics identified in step 1. This is something that, in my view, should be better dealt with in the document.

Kind regards,
Didier Breyer, Ph.D
Scientific Institute of Public Health, Belgium

I am attaching my comments to the draft document on Post Released Monitoring.

Regards

Elizabeth Bravo