Dear all,

The discussion group on "Revision of the Guidance on Risk Assessment of Living Modified Organisms" is now open for comments at http://bch.cbd.int/onlineconferences/discussiongroups_ra.shtml .

This discussion will take place from 28 March to 11 April 2011 (1:00am GMT).

You may post comments in this discussion group by going to the website above and by either creating a new thread or replying to this posting. Alternatively, you may also reply to this message via email and your comment will be automatically posted in the discussion group.

Thank you and best regards,
Manoela

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Introduction to the discussion:

With the view to improving the Guidance on Risk Assessment of LMOs, participants of the Open-ended Group and the AHTEG are invited to make proposals as to ways of revising the current version of the Guidance on the basis of the results of the scientific review process, ie. the comments received from the Parties, other governments and organizations available at http://bch.cbd.int/onlineconferences/guidance_ra/review.shtml .

Participants are encouraged to make their recommendations on improving the Guidance by working directly on the text of the current version of the Guidance (in English). Please provide your recommendations in "track changes" mode and collated in one MS Word file that should be attached to a message posted in the discussion group.

Dear all,

Good morning and thank you for an exciting discussion! As Chair of the AHTEG, I am very pleased to see such a high level of engagement in the online discussions and I am happy about the excellent atmosphere for the exchange of views and ideas.

As you may know, during this and next year, we will have to  produce three main outcomes: (i) a revised version of the Guidance, (ii) a mechanism to update the background documents, and (iii) further guidance on new topics of risk assessment. Our current discussion focuses on the revision of the Guidance. The other two outcomes will be the focus of the discussions starting in two weeks’ time.

Since the AHTEG will only meet twice face-to-face during this and the next year, we rely mostly on the work done online, together with the Open-ended Online Group, to fulfil the mandate entrusted to us by the COP-MOP. While it is important that we discuss the various issues until a common understanding can be reached, we also need to be mindful of the time that is available to us for fulfilling our daunting tasks. The extent of our success will be largely influenced by how we make the best use of our limited time.

The AHTEG will meet next from 30 May to 3 June 2011. At that time, we will work on the basis of your concrete recommendations on how to improve and revise the Guidance.

With that in mind, I would like to recall the introductory message sent by the Secretariat at the opening of this discussion, and invite you to focus on the comments submitted by Parties, non-Parties and organizations through the scientific review process, and to make your recommendations on how to improve the Guidance by working directly on its text. Please provide concrete proposals on the changes you would like to see in the text! The results of the review process and current version of the Guidance are available in this page (in the right corner above this discussion).

I am confident that together we, the Open-ended Group and AHTEG, will successfully achieve our mandate and count on your continued support and valuable contributions.

Thank you very much and kind regards

Helmut Gaugitsch
Chair of the AHTEG

Dear Helmut:
Responding to the urge for us to center in concrete reccomendations, I would like to propose that at least one of the issues that the AHTEG should focus on during its next meeting face to face would be what Hans rescued from the discussions in the "coexistence thread" which are as follows (I am literally "copy-pasting"):

"- One aspect that deserves further discussion in the context of the Roadmap is the potential of the LMO to exchange genetic material with other (sexually) compatible organisms (this is tentative wording, meant to cover exchange between all types of organisms including micro-organisms). For (crop) plants this is the issue of outcrossing and introgression, that is mentioned in the Roadmap.
It should be clear that genetic exchange in general may result in the presence of a modification in another host than the host of the original LMO, i.e., it may result in a new LMO, that may be present in another receiving environment. This situation would require a new risk assessment for the new LMO in the new receiving environment. This may be made clearer in the Roadmap.
- This discussion in the Roadmap would deal with the issue of potential adverse effects on biodiversity as it covers introgression of new traits into compatible wild species, as well as the issue of 'contamination' in coexistence, as it covers genetic exchange/outcrossing from an LMO to organisms of the same species.

I propose that we ask the AHTEG to take these issues into account when they discuss a revised text of the Roadmap."

Kind regrads,
Francisca Acevedo

Dear participants,

Based on my experience as a risk assessor in Canada, I have provided in the attached document some suggested changes to the Roadmap and additional guidance documents for your consideration. I hope that these changes help to improve the clarity of the text and in some cases provide additional context. I have very much enjoyed following the discussion in the forum over the past two weeks and I appreciate the opportunity to participate.

Thank you,
Jaimie Schnell

Dear All,

I wish to thank all who have shared ideas and opinions on this important topic.  In particular, it is encouraging to see the active participation of "new members" of this on-line forum.  New inputs from Parties that have experience with risk assessment of LMOs like Brazil and the Philippines will be extremely valuable to the AHTEG as we do our work.

One of the first thing that I noted when reviewing all 31 submissions was the challenge of putting them into a format that could help extract specific recommendations.  As such, an Excel workbook was created that I share with you (attached).  While this workbook is incomplete due to time, it is a collation of the submissions from almost all governments (Parties and nonParties).  Apologies to Belgium, China and UAE because their submissions were either in a language that time has not yet allowed for translation, or in the case of Belgium, the format of their submission did not lend itself to ready extraction for this table.  The table also does not contain submissions from Observers, again because time was too short. 

In summary, the attached file contains the comments from 14 Parties and 2 nonParties for questions 6 through 24 dealing solely with the Roadmap.  Column B for Questions 6, 7 and 8 contains a short synthesis statement that might be helpful in proposing specific edits to the Roadmap.  Again and with apologies, time did not allow to produce similar synthesis statements for the rest of the questions.

I hope the AHTEG will find this complition helpful as it attempts to take the information from the organization and online submissions to develop a Roadmap meeting the needs of Parties.

Regards to all,
Tom Nickson

Note:  I am having problems uploading the workbook and will ask the Secretariat for help.

Note by the Secretariat: file uploaded (xls and xlsx formats).

Tom, the table is great! Thanks, it will be most useful, be sure.
Paulo Andrade

Dear all,

First of all, on behalf of the Plurinational State of Bolivia, I would like to thank to the Secretariat for the opportunity of commenting on the RA Guidelines. Also, we would like to stress their usefulness to the Parties to the CPB (clearly reflected in the results of the review from Parties).

Our general comment is related to the inclusion of concrete examples in some parts of the Guidelines, since it will also serve for capacity building purposes. In addition, we are suggesting the inclusion of a glossary of terms that may give place to different interpretations and impact the quality of the risk assessment process. Other more specific suggestions and comments are included in the attached document.

Best regards,
Georgina


NOTE BY THE SECRETARIAT: This message has been edited to attach the document BOLIVIA-RARM_Guidance.doc

Dear Manoela , Dear all
I would appreciate if the possibility to send comments to the discussion group on "Revision of the Guidance on Risk Assessment of Living Modified Organisms” would be extended for one more week; some of us were totally absorbed by the Coordination mechanism and the liaison group meetings held by the Secretariat and did not have time to send their comments. Of course other topics on the agenda can start in time but I was hoping if you keep the door open for sending comments on this specific issue a little bit of time.

Dear colleagues,

We are arriving to the end of this on line forum. I have followed the different contributions with great interest. Some discussions like the discussions on coexistence or socio-economic considerations show clearly that some aspects of the process are so important for some of us that one want absolutely to have them included in the document. However, as it was mentioned several times, the document focuses only on risk assessment and not on the most general process of risk analysis, that is described in other documents like those elaborated by Codex. However the comparison with Codex must be carefully done because Codex addresses food safety and in the present case environment is concerned.

I strongly concur with the point that those aspects – socio economic considerations, coexistence - do not find their place in the risk assessment sensu stricto. This statement does not mean that those aspects are not important, it only means that it would be highly confusing mentioning them in a document dedicated to risk assessment otherwise we will continue maintaining the confusion.

It would be, therefore, helpful to develop a parallel document that would remind the different stages of the process that will lead to decisions concerning the use in the environment of LMOs, especially the preliminary steps prior to the risk assessment itself:
1- Establishing National Policies that will set the basis for defining environmental protection goals. The work done in forums like the FAO conferences “Agricultural Biotechnologies for Developing Countries” (see attachment)or in some  OECD Working Parties, could help understanding this first step, which is often underestimated.
2- Based on those policies defining the protection goals. A clear definition of the protection goals is necessary not only for defining the assessment endpoints but also, when the risk assessment is completed, for allowing the decision maker/ risk manager to conclude on the acceptability of the assessed risk.
If those two preliminary steps are not done, any environmental risk assessment is vain. Anyhow I fear that this document falls out of the mission of the AHTEG
Best regards,

Jean-François Sarrazin

Dear colleagues,

I am one of those AHTEG members who, as Kazuo Watanabe assumed in a previous posting, prefer to mostly listen during these online conference allowing more opportunities for debate to those who have not participated in the AHTEG discussions.

In fact, everything that I would have wanted to say having read the debates in the early submissions was
already said by Hans Bergmans, chair of the sub-working group that has drafted the Roadmap, when he:
• urged participants not to reopen again the debate as to whether topics as socio-economic considerations and co-existence should be included in risk assessment, and
• urged participants to focus on our task, i.e. how to improve and enhance the guidance documents.

I fully endorse Hans’s calls on both accounts.

As Hans and others have said, socio-economic considerations and co-existence (which is not a safety issue but indeed an economic issue) are by their very nature not part of the environmental risk assessment in accordance with Annex III. Referring to the posting of Andrew Roberts: there is a reason why after long negotiations, socio-economic considerations are only mentioned in the CPB in relation to decision making (article 26) and not in relation to risk assessment. Finally, while I see the elegance of Didier’s observation that this could possibly be solved by mentioning these aspects under the “context and scoping of risk assessment”, such a move would need to be explored with great care and great attention to the exact wording of article  26.

I also fully endorse Hans’s call to focus on how to improve and enhance the guidance documents. I was originally discouraged to note how little debate was spent on the topics that Hans extracted from the peer review as needing “either be included or be further elaborated in the Roadmap” (see his posting of 5 April 2011), such as the tiered approaches, how to take into account human and animal health, how to take into account the intended scale and duration of the environmental release, how to define the various levels of likelihood and consequences, etc. etc.

Yet, the last couple of days I got encouraged again by several postings such as those from Paulo Paes de Andrade, who addressed some of these topics with quite some detail and clearly enormous scientific baggage, and by the active way how Kok Gan Chan and Lucette Flandroy carried the debate forward, even over their weekend. 

Before responding to some of the substantive points in a next posting before closure of this debate, let me first support Ossama El Kawy’s request to allow for some extra time of this part of the debate, since it clearly seems to be gaining momentum.

Piet van der Meer

Dear All,

following up on my previous posting, and building on some of the substantive points made by others: I believe that the for the clarity and usefulness of the guidance documents, it is important that in any case the following points be strengthened:

• Further clarification of the comparative character of risk assessment, underlining that variations are nothing unusual when working with organisms, that not every difference is significant, that not every significant difference is biologically relevant in terms of risk, that the risk assessment should aim at identifying whether differences resulting from a genetic modification are significant and relevant, and that the question of what is relevant can be guided by the ‘problem formulation’;
• Guidance about the choice of appropriate comparators, acknowledging that the appropriate comparators will be different for the different stages of the risk assessment, e.g. in the first stages of the risk assessment when we look at genotypic and phenotypic differences, appropriate comparators are near isogenic lines and possibly negative segregants, and that in later stages the variation in a certain crop is an appropriate comparator;
• clear identification of which parts of the guidance documents apply to confined field trials and which parts to unconfined releases;
• Practical guidance to decide whether a particular uncertainty is relevant and how such uncertainty can be dealt with; acknowledging that uncertainty in life sciences is nothing unusual;
• Include some concrete examples
• Provide access to background and additional guidance materials relevant to risk assessment; over the last 30 years a massive number of useful background and guidance documents has been developed for a large variety of topics.

Good night to all,

Piet van der Meer

Sorry but we have not yet received the said Table (from Tom). Hope The
Secretariat will kindly send it to us? ..................helen

Dear forum participants,

I wish to thank all of you for sharing ideas and opinions in the forum during the past two weeks. I think that the AHTEG will have a clearer view on where the Guidance can be improved. I have very much enjoyed following the discussions. Since I am also a Member of the AHTEG I also preferred just to follow the discussion, leaving the debate to those experts that will be involved mostly during this stage of our work.
From the last postings I share the views of Peter Van deer Meer and the points to be strengthened. From the beginning and in several of the threads of the discussions I found very useful suggestions and reviews from Paulo Paes de Andrade in particular on uncertainty and the coexistence not being a part of the roadmap. Also I appreciate inputs by Janet Gough and her analysis of the responses received by the Secretariat, and comments by Carmen Sílvia Pires, among many others. In this sense I think that the summary sent by Tom Nickson will be useful for looking at the inputs received.
Hans Bergmans comments posted 2011-04-05 13:30, clarify clearly the points where we need to focus more and I share most of them.
I would also like to thank  Dr. Jaimie Schnell, who presented her very valuable recommendations directly on the text of the current version of the Guidance in "track changes" as we were encouraged to do by the Secretariat.
HAve a good week.

Dear members of the Open-ended Online Group and AHTEG,

Thank you very much to all who have participated in the discussion on the “Revision of the Guidance on Risk Assessment of Living Modified Organisms” for your excellent input. A total of 115 messages were posted during the two weeks of this discussion showing an excellent level of engagement.

The discussion on this topic is now closed. A synthesis of the online discussions will be prepared by the Secretariat in teh coming weeks. The discussions on the two remaining expected outcomes will start shortly. 

Once again, thank you for your comments. Please keep up the good work!

Best regards,
Manoela

THIS MESSAGE WAS SUBMITTED SHORTLY AFTER THE CLOSING OF THIS DISCUSSION AND IS BEING POSTED ON BEHALF OF MARK BENEDICT
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Dear Manoela,

I just completed a second revision of the document that includes some of the recommendations made by the Belgian delegation. I hope you can still use this. I did not realize that the discussion closed before midnight.

Mark Q. Benedict
Atlanta, GA USA

THIS MESSAGE WAS SUBMITTED SHORTLY AFTER THE CLOSING OF THIS DISCUSSION AND IS BEING POSTED ON BEHALF OF MARIA MERCEDES ROCA, HONDURAS

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Dear colleagues,

I have been following this discussion closely and I am  making a comment for the first time.  I am a practicing plant pathologist working on Integrated Pest Management  in Central America. I have received good training in Risk Assessment during a recent  period of study at Texas A & M University and in other capacity building activities in several countries in Latin America  and have been able to develop a good  network of other ERA experts for the last decade.

Universities and other academic and research institutions have the mandate to educate, contribute to capacity building  and conduct research that addresses important issues in society,  such as the safe use of biotechnology.  As an educator and researcher,  I have to undertake  capacity building  activities in my region and I find the  current Roadmap for Risk Assessment  a little  complicated and confusing .

Very respectfully, I would like to ask the AHTEG and the Secretariat  to consider the reasons why I make these comments:

1. Establishing a context before conducting a Risk Assessment is crucial. Megadiverse countries in biological diversity  also have “megadiverse problems”:  pests, diseases and weeds that severely limit agricultural productivity are more prevalent  in tropical than temperate countries. Alternatives  to the highly contaminating present agricultural  practices  have to be adopted. The potential benefits of the new technology have  to be considered in the decision making process. The current Roadmap, largely ignores this fact and concentrates almost exclusively on the potential  risks. We don´t adopt risk technologies (air travel, electricity, etc) unless they have a benefit.

2. To have the  same  Roadmap for all countries, regardless of context and needs is not very helpful. The  resources and needs of developed countries  are very different to those of economies in transition, and to those of small developing  countries. Establishing a  biosafety system  has a cost that has to be considered by policy makers.  The cost does not end with training and continues well into implementation and beyond. Excessive bioregulation could hamper the agricultural productivity  of many developing countries with high consequences.

3. It would be helpful to have a Roadmap that addressed Risk Assessment at 3 different levels of capacity building, as suggested by Andrea Sissons from IPPC and by Hiroshi Yashikura:

• Training for professionals who will conduct  a Risk Assessment process (scientists and experts with appropriate credentials)

• Training for professionals who will evaluate the Risk Assessment process (regulators in Biosafety committees)

• Training for decision makers (Risk Management),  who ultimately decide, based on the RA done and evaluated  by experts and consulting with stakeholders.  As pointed out by many colleagues in this discussion, it is at this  stage of the process, and not during the Risk Assessment process, that other considerations (socio- economic, etc) have to be taken into account.


The present complex Roadmap, addresses mainly the capacity training needs for  the first  two categories.  It is developed for a very technical audience, and  mainly helpful  for countries that have trained regulators and who  can develop a solid  biosafety system at a high financial cost.

My humble view, is that the present Roadmap  will intimidate more inexperienced “budding”  regulators in smaller countries  that may lead them  not to comment  and participate in these discussions  and thus to “Paralysis by analysis” (to quote a colleague  from New Zealand).  It is noteworthy, that very few  small developing countries  are participating in this debate, with the notable exception of Bolivia and Costa Rica in our region. Our region, is not properly represented in this discussion.

Congratulations and apologies to the many people who have worked so hard to prepare the present Roadmap. These are  constructive comments “from the trenches” by the trainers that need access to useful guidelines to train others in small developing countries to develop their Biosafety systems.

Maria Mercedes Roca