SWG on Risk Assessment of LM Trees

dear All
After the first round of online dicussions there was quite a number of diverging comments and valuable proposals for change. Thank you very much. On that basis I tried to write a next draft. I worked with the track change document of Les Pearson and accepted most of the proposed changes.
To live up to our timeframe I would like to ask for a next round of comments until 17.10. 1:00 am GMT.
Thanks to all of you
Beatrix

Dear Beatrix,
I admire your discipline in keeping pace with the deadlines.
Yet, this round of commenting underlines the general concern that I expressed in the earlier online conference, i.e. we are embarking on too many new documents without properly finalising earlier documents such as the roadmap.
For the outside world the AHTEG seems to aim at quantity rather than quality, and although this is surely not the intention, it will be the result if we continue like this.
I therefore repeat my suggestion to 1) take a pause with the GM tree document (as well as with the Monitoring document) until some key issues in the roadmap are sufficiently clarified,  and 2) when we pick up the work again, please involve outside GM Tree experts as well.
I expand on these points below.
1) A pause with this document until the main issues in the roadmap are sufficiently clarified,
There are parts in this revised text that are connected to general discussions that we had under the roadmap, and given the interpretations that are given in this draft GM Tree document, it is clear that we have not yet sufficiently clarified those issues. As those issues are of a general nature, we must clarify those first in the roadmap.
Some examples:
Lines 90-95: the text confuses the definition of living organism (capability of the biological entity to transfer or replicate genetic material), with the ability of trees to reproduce. Reproducing and replicating genetic material are two different things. To avoid confusion we need to address this in the roadmap.
Lines 127 and further (Transformation and propagation methods): we should further explore the question to what extent propagation methods are relevant for the risk assessment. Since this is not specific for GM trees, we should do this in the roadmap context. 
Lines 143 and further (Genetic and phenotypic characterisation and stability): the genetic stability is described as of key importance to the RA. However, as we discussed under the roadmap, stability is of relevance where the inserted trait is of relevance to risk management, e.g. male sterility. Otherwise, genetic instability is of relevance to performance, which is an agronomic issue.
Lines 172 (Receiving environment(s), points to consider). We should clarify under which circumstances those points to consider are relevant. For example, the fact that a habitat is protected because of the presence of a rare species of lizards is of no relevance to the assessment of GM trees.
More in general I must say that for many of the points to consider in this draft listed I don’t see a logic for them to be included, nor are they particularly helpful or understandable to an inexperienced risk assessor.  Listing points to consider will only be helpful to an inexperienced risk assessor if we clarify in which types of situations they may be relevant and what to do with the information requested.
This comes back to the different approaches towards this guidance document that we have observed in the discussions on the roadmap.  If we were at a stage where there was general agreement on the overall approach, then to seek comments in just 7 days might be reasonable, but at this stage and with these differences, this pace cannot result in a helpful document.

2) Involve outside experts.
Few, if any, of the members of the SWG are on a day to day involved in research pertaining to GM trees. Involvement of outside experts in such specialised fields is therefore appropriate. Scientists who are on a day to day involved in GM trees include: Prof. Steve Strauss, Oregon State University, USA; Prof. Wout Boerjan, Department of Plant Systems Biology, Belgium; Dr. Lorenzo Burgos, Consejo Superior de Investigaciones Científicas, Spain ;. Kevan Gartland, Glasgow Caledonian University, UK; Dr. David Harry, Oregon State University, USA; Dr. Richard Meilan, Purdue University, USA; Dr. Ralph Scorza, Agricultural Research Service, USA.

Regards

Piet

POSTED ON BEHALF OF KAZUO WATANABE

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Dear all:


Good morning from Asia!


I have two major comments again: sorry for coming back the same issues.

1) language is not concomitant with protocol such as "GM" use instaed of LMOs, but some members insisted to correspond with CBD.
Since the AHTEG under the Cartagena Protocol on Biosafety, any language should be followed under Protocol, and if there is contradiction of the language with CBD, it is between protocol and CBD, not AHTEG transforms without MOP authorization.

2) AHTEG has no eminent expert in trees with proven professional records  in the members except me as GM tree researcher, risk assessor and user,
I strongly urge guest participation of the industry (Les Pierson at Arbogen), Academia (such as Prof. Zander Myburg at South Africa, Prof. Meng-Zhu Lu, Chinese Academy of Forestry (and IUFOR senior member),  Prof. Taku Demura at NAIST, Japan), public sector (Dr. Eun Woon Noh, Korean Forest Research Institute, Suwon, Korea,  ),  International Research Organization (ICRAF or CIFOR) and Industry organization (ITTO). Also UNCCD representation may be invited for the reference of the user aspect of LMO trees.  Forest geneticists/ecologists who may have balance of understanding international forums would be Prof. Rene Valliancourt, Univ. of Tasmania, Australia, & Prof. Steven Strauss, Oregon State Univ.). An forest economist may be added then Prof. Ryo Kosaka of Nagoya City Univ. who has quite familiarity with CBD.


Kind regards,


Kazuo Watanabe

My congratulations to the primary writing team. I think that this document is shaping up to be both useful and appropriately balanced for providing risk evaluators/assessors with a framing of the issues for consideration. In the attached I have made specific suggestions for amendments to the text.

My conceptualization of the role of the AHTEG is to guide those evaluating the scientific evidence provided in support of the safety of an LM tree (or in the case of some regulatory authorities the scientists conducting or confirming the science) by providing a comprehensive list of possible risk pathways that are special to, or especially important for, LM trees. There will no doubt be some redundancy with the Roadmap but that in my mind is not a particularly important issue.

I’ve read the comments so far posted by others. I don’t have the same anxiety about the LM tree document being developed in parallel with the review and fine tuning of the Roadmap. The latter is sufficiently mature that we are capable of working from it for the purpose of identifying issues specific to, or particularly important for, trees.

I have said before and it remains my point of view that our intended audience is full of experts on their environments, but they may be inexperienced with the technology, product, impacts special to commercialization or why risk pathways may be relevant to their jurisdiction/home. Or they may not lack experience at all, but just hadn’t considered certain pathways that they may now wish to consider. The important qualitative value of guidance is to alert them to these risk pathways, especially in this case those special to LM trees, so that they do consider them before coming to a conclusion, one way or the other, about the potential for an adverse effect on their receiving environments. This guidance is not binding and thus does not force them to work on issues that they do not consider relevant.

Regarding the inclusion of other experts, I am wondering if these folks were able or willing to participate in the online forum to express their points of view? Is this not the way we harvest views beyond the writing team? As Kazuo indicates his status as a GM tree specialist, how is the voice of that community not brought to the table or adequately represented already?

Before we all start nominating our special experts in all things we may deem to be relevant, perhaps it would be helpful to know: 1. what special risk pathway has been overlooked in the document so far?; 2. how the nominee will help us to formulate that pathway and contextualise it for consideration by the intended audience of the guidance; 3. why a special involvement is warranted and why participation through the online forum or other existing means was not possible or practical.

With best wishes

Fully recognizing that this response is after the deadline suggested by Beatrix, I feel it important to restate some points I've made throughout this process and support the simple, but cogent suggestions of Kazuo.

First, any introductory text linking this guidance to other activities under the CBD is inappropriate and should be deleted. 

Second, The current draft fails to recognize both the letter and spirit of a great many comments gathered  during the online period.  A clear message from the on-line forum was that rather than editing and refining the existing text, more fundamental changes to how the information is structured and presented are needed to provide risk assessors with specific tangible questions and background that would assist them in completing a meaningful assessment. 

As several comments indicated, many of the characteristics listed for trees are really not unique.  Where some of these characteristics (for example vegetative propagation) may be unfamiliar to risk assessors who may have only dealt with the major row crops previously it is important to highlight these.  In fact, the document could be more broadly useful if instead of focusing on characteristics of trees that differentiate them from annual plants as a specific group, it serves as a springboard to alert risk assessors to characteristics they may not have considered, with trees simply being more immediate examples of where these may apply.  Still missing for example is that in some cases where a specific variety is already well established, the primary transformation event of the variety would be developed regardless of whether backcrossing was possible or not. 

Finally, I strongly suggest the AHTEG consider how to effectively engage with tree experts to really focus in on what risk assessment should consider, over and above what is already captured in the Roadmap.  As this is not intended to be a stand-alone but to be used in conjunction with the Roadmap a much shorter, more precise and to the point document would be of greatest value to risk assessors, with minimal overlap to the Roadmap itself.  Furthermore, the voice of the community of experienced tree experts has not been brought to the table of discussion.  If it had been, Kazuo would not have suggested this step and the input from these experts that was received during the online forum would be reflected in the current draft. 

The issue before this working group now is how to take the next step and engage experts on the working group as the rules of the AHTEG allow.

Regards,
Tom

dear Members of the Subworking Group
Thanks for your comments and proposals.
I like to state two things at this point of time:
the revised version is based on the track change document of Les Pearson, an expert observer of the online forum and acknowledged LM tree specialist from Arborgen. Most of the proposed changes ( which were in addition in line with other comments) were accepted.
Throughout the whole document only the term "LM" tree is used and not "GM" tree. Only a very short citation (half a line) refering to COP decisions is in the much shortened background section with the whole citation now in the foot note. I hope with that I met Kazuos intervention to stick to the language of the Cartagena protocol.
Best regards to all of you.
Beatrix