POSTED ON BEHALF OF WADZI MANDIVENYI
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Dear Members of the Open-Ended Online Forum,

Welcome to the continued discussion on the development of a package that aligns the "Guidance on Risk Assessment of Living Modified Organisms" (e.g. the Roadmap) with the training manual “Risk Assessment of Living Modified Organisms”.

In line with the calendar of activities, this round of discussion will focus on the Use of Terms between the Guidance and the Training Manual. To assist in this discussion the Secretariat provided a resource document outlining an initial comparison between the terminology in the “Use of Terms” section of the Guidance and the corresponding definition and/or use of the term in the Manual.

Further to the introduction provided by the Secretariat, I would like to emphasise to participants a few key questions and issues to help focus our efforts:

- Are there additional key terms and concepts either in the Guidance and/or the Manual that need to be aligned? In reading the Guidance and Manual, I invite participants to highlight any additional terms that may have been overlooked but need to be aligned between the two documents.

- Do the notes in the comparison prepared by the Secretariat accurately reflect the use of the term in the Guidance and Manual? Participants are further invited to comment on the notes provided for each term used, focusing on whether or not the notes accurately reflect the consistency between the terms. Suggestions on how to improve the explanatory notes are welcome.

- What is the way forward? Where there is inconsistency in the way a term is used in the Guidance and Manual, participants are invited to provide recommendations on how to best proceed with the process of improving the consistency between the Guidance and the Manual. These recommendations will be collated and put forward to the consideration of the COP-MOP at its seventh meeting.

Once again, thank you for your time and efforts.
Best regards,
Wadzi Mandivenyi

POSTED OF BEHALF OF HIROSHI YOSHIKURA
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As interpretation of any documents depends on definition of terms, the present work is indispensable before going further. I really appreciate the Chair’s proposal to work on terminology. My comments are following:

1.     Comparison of the Manual with the Guidelines will be useful, but more important thing could be consistency of these documents with Cartagena Protocol and related documents agreed by UN and other international organizations (e.g. OIE and OECD, where appropriate). Therefore, the reference to “Other International Biosafety-Related Bodies” in pages 15-18 of the Manual is crucially important. For this, the secretariat of CBD will be encouraged to make contact with the secretariats of these agencies to check the appropriateness of the description and references.
For example, as for CODEX (where I chaired the GM Task Force), the list of GM guidelines is not complete; Risk assessment guidelines on GM plants, microbes and animals that are not listed will be useful when “taking also into account risks to human health”. The manner of referencing is curious. See CODEX (2003) Principles for the Risk Analysis of Foods Derived from Modern Biotechnology Organisation for the Economic Coopration and Development (OECD). Available at …..).
I recommend adding the CODEX Procedural manual (20th Ed.) to the list, which contains CODEX definitions, such as risk analysis, risk assessment, risk management, risk communication, etc..

2.     After that, we can identify the terms that need drafting afresh. The definition of such terms should be agreed on in the Plenary of MOP, not in the electronic working group, because the definition is so important for interpretation of not only guidelines/ manuals but Cartagena Protocol itself. We may need negotiations and compromises.

3.     We should avoid re-interpretation of the Cartagena Protocol, as it was agreed on negotiations and compromises. For example, look at lines 273-277 of the Manual, which explains what LMO is. The explanation completely neglects an important clause that qualifies the preceding bullet points i and ii.
The clause reads “that overcome natural physiological reproductive or recombination barriers and that are not techniques used in traditional breeding”.
It is important to note that the word “overcome” is not in singular but in plural, which means the clause qualifies the both i and ii. The definition with the qualification and the one without the qualification are entirely different.

4.     No guidelines or manuals should override the original agreements. We should maintain “precautionary approach” even in drafting.

Sincerely yours,
Hiroshi

Hiroshi Yoshikura
Adviser, Food Safety Division,
Ministry of Health Labour and Welfare
1-2-2　Kasumigaseki Chiyoda-ku, Tokyo　１００－８９１６
FAX:+81-3-3503-7965
Tel: +81-3-3595-2142/+-81-3-5253-1111 (2409)
E-mail:yoshikura-hiroshi@mhlw.go.jp

Dear colleagues
I want to thank the Secretariat and the chair for the proposal of working on terminology to allow an easy interpretation of guidance and training manual.
I join  Dr Hiroshi to suggest adding the CODEX Procedural manual ( 20 th Edition) definitions to the list .
Best regards
Gado

Dear Members of the Open-Ended Online Forum,

As you may be aware, the AHTEG, which I have the honour to chair, has initiated its activities and concluded a round of discussions on the development of tools to assist the Secretariat in their task to structure and focus the process of testing the Guidance. The questionnaire and concept note achieved through our collective efforts and forwarded to the Secretariat may be found at http://bch.cbd.int/onlineconferences/ahteg_ra.shtml?threadid=5346#5352. I thank all who have participated in the discussions under the Open-ended Online Forum because your contributions played a key role in highlighting relevant issues and helping the AHTEG to focus its work.

We, the Open-ended Online Forum and AHTEG, now have at hand the second task mandated by the COP-MOP in decision BS-VI/12, annex paragraph 1(b):

“Coordinate, in collaboration with the Secretariat, the development of a package that aligns the Guidance on Risk Assessment of Living Modified Organisms (e.g. the Roadmap) with the training manual “Risk Assessment of Living Modified Organisms” in a coherent and complementary manner, for further consideration of the Parties, with the clear understanding that the Guidance is still being tested;” 

This is no small task. Both the Guidance and the Manual were developed to assist risk assessors in conducting risk assessments of LMOs in the context of the Cartagena Protocol but the Guidance and Manual differ in their level of detail. As pointed out in the previous round of discussion on the alignment (http://bch.cbd.int/onlineconferences/forum_ra/discussion.shtml?threadid=3881#3885), the manual covers the more general and basic aspects of risk assessment, whereas the Guidance goes into more detail of the risk assessment process. And this is good because these two documents can indeed be used in a complementary manner, provided that they are coherent and properly aligned.  

I would like to thank the Secretariat and Ms. Mandivenyi for structuring this round of discussion in such a way that we can concentrate on aligning the terminology of the Guidance and Manual. In line with Ms. Mandivenyi`s opening statement, the task at hand can be tackled on the basis of the draft terminology alignment prepared by the Secretariat by indicating if there are other terms in the Guidance and Manual that need alignment, and by commenting on whether or not the explanatory notes provided in the draft terminology alignment provide an accurate and full comparative analysis of the terms in the Guidance and Manual. Moreover, we can also provide recommendations to the COP-MOP on how to deal with terms that need better alignment. 

In line with our calendar of activities, we will have six subsequent discussions on the alignment of the Guidance and Manual. The discussions are all interlinked and incremental so that comments on the terminology will lead the way towards the discussions on the alignment of the remaining modules of the Manual and sections of the Guidance.

I therefore echo the intervention by our moderator Ms. Mandivenyi and invite colleagues of the Open-ended Online Forum and AHTEG to share your input on this important topic before the discussion closes on Sunday, 9 June at 1:00 a.m. GMT.

I will soon provide my own reflections on the alignment of terms once I have had a chance to complete my assessment of the draft terminology alignment.

Best regards,
Helmut
Chair of the AHTEG

Dear colleagues,

The present round of discussion is focusing on the alignment of the terminology between the Guidance and the Manual. I am very grateful to the Secretariat for making available an initial comparison between the terminology in the “Use of Terms” section of the Guidance and the corresponding use of the term in the Manual. This shows by and large a reasonable agreement between the two documents. It also shows a number of issues that should be given some thought and probably a lot of discussion.
The task that has been given to this forum is vast. I apologize that I have no opportunity to take all request to the online forum into consideration. What I have been able to do until now is to go through part (about half) of the list of terms, and make a number of comments (see attached document). My comments are however fairly consistent, and from what I have done you will probably get a general picture.

My conclusions so far are:
• There are many terms that are used in the Guidance but not in the manual. This is probably (also) due to the fact that the manual is much more introductory and general than the Guidance. There is probably no reason to be alarmed by this.
• The Guidance uses terms, whereas the Manual explains risk assessment. Therefore it is only to be expected that the Manual has broader explanations of terms, as is the case now. So, no reason for alarm, either.
• In a number of cases descriptions of terms are open to discussion, and I would say, improvement.
• Descriptions for some terms have been taken from other documents. It is not clear why these documents were chosen. Descriptions found on the internet often quote different sources, shich may give a more complete picture.
• There should be a discussion what the status of these descriptions is. In principle, these should not be taken as ‘definitions’ or ‘standards’. That is why we speak of the ‘use of terms’ and ‘a working glossary’ in the Guidance.

This is just an initial attempt, I would need more time to complete the picture.

Best regards,

Hans Bergmans

Dear colleagues,

Even if I agree that there is no reason to be alarmed for the fact that there are many terms used in the guidance that do not appear in the Manual, I think that in some cases the Manual uses terminology that it does not specify properly. For example, I find significant that in the point 4.3 of the Manual “Establishing the appropriate comparator (s)”, you can not find a “short explanation” of the term (I do not use the term “definition” because I agree with Hans Bergmans (#5367)).
I understand that both documents should be independent and comprehensive. So I would suggest including in the Manual those terms that, according to the Secretary review, are “not defined in the Manual, but used in the same context”. That could be done adding a Glossary to the Manual (I think that it is even more needed here that in the Guidance) or adding the terms to the main text of the Manual, in the same way that the examples. This could also be helpful for those readers that jump from the Manual to the Guidance.

I also would like to point out that the review distributed by the Secretary is based on the glossary taken from the Guidance, but a similar table should be done comparing some terms used along the Manual that do not appear in the Glossary but are used in the Guidance.

Best regards,

Victoria Colombo

POSTED ON BEHALF OF WADZI MANDIVENYI
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Dear Members of the Open-Ended Online Forum,

I would like to thank the participants for their contributions thus far.

The COP-MOP mandated us to coordinate, in collaboration with the Secretariat, the development of a package that aligns the Guidance on Risk Assessment of Living Modified Organisms (e.g. the Roadmap) with the training manual “Risk Assessment of Living Modified Organisms” in a coherent and complementary manner.

This is the first in a series of discussions focusing on specific parts of the Guidance and Manual after the initial brainstorming discussion on this topic that took place at the end of last year. As indicated by Mr Gaugitsch, Chair of the AHTEG, the discussions on the alignment of the Guidance and Manual are interlinked and incremental with a view to providing the COP-MOP, at its seventh meeting, with a package that aligns the Guidance and Manual in a coherent and complementary manner.

I therefore further encourage participants to provide their input on the initial draft alignment of the terminology produced by the Secretariat, in particular focusing on whether there is a need to align additional terms between the Guidance and Manual, making comments on the accuracy of the initial alignment and notes provided by the Secretariat and suggesting recommendations on a way forward.

Your contributions to this discussion are an essential part of this process as they will lead the way towards the discussions on the alignment of the remaining modules of the Manual and sections of the Guidance.

I look forward to reading your interventions.

Thank you and best regards,
Wadzi Mandivenyi

Considering the different purposes and possibly different audiences of the two documents, I have the impression that thorough "literal" alignment of definitions between these two documents is not necessarily an important issue, provided that the same term is used in the same context, two definitions are conceptually consistent, or one definition is inclusive of the other. In that sense, I don't see any critical inconsistency in the current draft terminology alignment compiled by the Secretariat.

I noticed cases where different but related terms (e.g., horizontal gene transfer, gene flow, and introgression) are defined independently. Some alignment among them would be helpful.

Please see the attachment for additional comments. In particular, I oppose to use following terms in the Guidance. They are not used in the Protocol, and should not be used in the Guidance under its own definition.

1. Combinatorial effects
Any combination of genes, either introduced or innate to the organism, can potentially exert antagonistic, additive or synergistic effects. In other words, any biological effect can be a result of interaction of multiple genes or gene products. Use of this term in the context of LMO risk assessment is therefore not informative in any practical sense and will only result in confusions.

2. Cumulative effects
Any combination of organisms, either LMO or not, can potentially interact with each other to exert an additional effect. I don't see any rationale for putting particular emphasis on the interaction between LMOs. It is also not informative at all and will result in confusions.

regards,

Nobuyuki Fujita
National Institute of Technology and Evaluation (NITE), Japan

POSTED ON BEHALF OF MAHAMANE GADO

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Dear colleagues
I want to thank the Secretariat,the chair and Helmut for structaring these discussions.Initial comparison between the terminology in the Guidance and Manual  shows a synergy between the two documents.the current draft terminology alignment compiled by the Secretariat is consensual.
Best regards
Dr Gado

POSTED ON BEHALF OF MARIA ANTONIETTA TOSCANO

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This round of discussion finalized on the alignment of the terminology between the Guidance and the Manual is very intyeresting, and I am very grateful to the Secretariat for detailed documents useful for comparison between the "Use of Terms” section of the Guidance and the corresponding use of the terms in the Manual.

But I think that agreement between the two documents could be realized in a better way because I note a lot of small terms that may be changed to the aim to realize more facility in reading and interpreting the different issues.

Here, some points that may explain my message.

1) in more than 20 issues, terms are not used in Training manual.

2) in almost other 20 cases, terms are not defined in Training manual

3) in other issues, in Guidance and Manual there are two different definitions of the same concept, while, sometimes, Guidance and Manual provide two definitions not consistent or not entirely consistent

4) In explanatory notes is often remarked that " Definition in the Guidance is specific to the risk assessment of LMOs whereas the one in the Manual applies to environmental risk assessment in general". I agree with these notes but I think that Training Manual is strictly based on risk assessment of LMOS, as proved by the name of this Manual.

5) I think that Guidance and Training Manual may be utilized for differents uses but they have to be consistent to ensure an easy lecture in daily use.
So i think that terms have to be strictly similar and, if possible,also concepts have to be explained in the same matter.

6) I think that ecological aspects of LMOs should have a prioritary interest in context of Guidance and Training manual: so, in particular way, terms regarding "hazard", exposure"," risk" (risk assessment, risk characterization, risk management ....) have to be reviewed with the same definition, and surely not as "specific" in the Guidance and "in general" in Manual, beccause the aim of Training manual is based "on risk assessment of Living Modified Organisms" .

My best regards

Maria Antonietta Toscano

POSTED ON BEHALF OF WADZI MANDIVENYI
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Dear All,

I would like to invite you, once again, to share your views on the draft terminology alignment prepared by the Secretariat containing an initial comparison between terms used in the Guidance and Manual, primarily by indicating any additional terms that needs alignment, commenting on the explanatory notes and suggesting a way forward.

Please note that at this point in time the Guidance will not be changed, but rather any suggestions for improvements will be forwarded for consideration by the COP-MOP at its seventh meeting.

I look forward to reading your interventions.

Thank you and best regards,
Wadzi Mandivenyi

I want to thank Dr Hans Bergmans for big work in terms revising direction. I think the comments are very important.
I also see (as the other participants) that the terms in the Guidance and Training Manual have to be similar, for better understanding some explanations could be added to terms of the two Texts taking into account their specificity.
It seems to me that one of the problems is that the terms were taken from different sources and now they need to be formulated equally. From my point of view especially the key terms refer to the risk assessment process (and the other terms taking into account the possible broad audience of this two Documents) have to be clear and as simple as possible. It also will help for correct interpretation of the text to the other languages and to eliminate ambiguities and misunderstandings.
And it seems to me that for better understanding the links to the documents that we see in some terms definitions could be removed and it could be pointed from which sources they were taken at the beginning or at the end of the «Use of Term» chapter.
I suggest to add to the Terms:
Stacked genes,
Abiotic stress,
Vitality,
Invasiveness.
May be it would be useful to decipher in the Use of Term Chapter the main practical methods using for risk assessment, but the point of view is arguing as it may seem to someone prescriptive.

Dear Ms. Mandivenyi, Secretariat, and members of the Forum

I have carefully gone through the document prepared by the Secretariat called “terminology alignment”. Thanks to the Secretariat for this careful and helpful tool!

I attach to this post my term-by-term comments. I use shading to indicate where I have a preference for the Manual or Guidance and have added a column of explanation to indicate my reasoning. For the most part, I defer to the Guidance.

Ms. Mandivenyi has asked a few questions that I’d like to answer directly and in brief:
-Are there additional key terms and concepts either in the Guidance and/or the Manual that need to be aligned?

Some have suggested simply attaching the Codex terms. I am sympathetic to this request. But as it has been argued that Codex is food safety, and Annex III is environmental risk assessment, a carte blanche approach may not be appropriate. Perhaps those that wish definitions from Codex that would be unique additions or revisions of definitions in the Guidance can provide a specific list?

At the moment, the above withstanding, I have no other terms to nominate for the definitions section.

- Do the notes in the comparison prepared by the Secretariat accurately reflect the use of the term in the Guidance and Manual?

I have a made a case-by-case reply in the attached.

- What is the way forward? Where there is inconsistency in the way a term is used in the Guidance and Manual, participants are invited to provide recommendations on how to best proceed with the process of improving the consistency between the Guidance and the Manual.

I have made a case-by-case reply in the attached.

With best wishes
Jack

Thanks to all who have provided helpful ideas and comments to this second priority work of the interim session.  I believe that Hans' contribution was extremely helpful and points us in a productive direction - harmonization of terms.  His table provides concrete directions for the Secretariat to conduct the alignment process once the guidance is tested and changes are made that are relevant to the goals. 

Like others have stated, certain terms need not be used identically between the two work guidance and manual.  However, terms like "comparator", "risk", "hazard", etc, that are universal to risk assessment should be identical.  Also, as others have stated, certain terms in the glossary must not be used unless and until they are thoroughly vetted using a consensus process as is done when standards are set.  Descriptions for terms associated with various types of effects like "unintentional" and "combinatorial" have not been through this process.  I remind everyone (as I have done in the past) that the current glossary in the guidance was not discussed in detail within the AHTEG and many of the definitions are unclear and even lean toward a prejudgement of of LMO novelty. 

I also note that harmonization of terms may be more applicable to certain volumes of the manual.  For example, volume 3 on the risk assessment should be tightly aligned.

In conclusion, I think that testing the guidance should include close attention to the glossary with the idea that many of these terms will be aligned in the manual.  Terms like "risk assessment" have been through standards setting processes and their adoption should be straightforward with attribution through citation.  Other terms in the glossary were hastily constructed by a few hard working members of the AHTEG (to meet tight timelines), but have not benefitted from a rigorous review and revision process.  Successful testing of the guidance with specific attention to the glossary will provide valuable input to the Secretariat for this alignment work.

Thanks,
Tom