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Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3881]
POSTED ON BEHALF OF HELMUT GAUGITSCH
___________________________________

Dear Participants of the Open-Ended Online Forum:

Welcome to the first round of discussions of the Open-Ended Online Forum on Risk Assessment and Risk Management!

As mentioned in the email sent out by the Secretariat on Wednesday, the discussion will focus on the topic of the appropriate methodology and approach to be taken with the view to develop 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 (see Decision BS-VI/12, annex, Terms of reference, paragraph 3 (b)).

The objective of this first round of discussions on this topic is to brainstorm a way forward for the development of the integrated training package.

In addition to the questions suggested as points of discussion, please find below some further guiding questions to help focus the discussion:

1. Who will be the target audience of this package:
          o   Trainers of RA?
          o   People learning how to carry out a RA?
          o   Risk assessors/ Practitioners?
2. How can the Guidance and Manual be integrated?
          o   Should the Manual or the Guidance be used as the basis for this exercise?
          o   Should the package also provide a step by step guide for risk assessors to use when conducting RA?
          o   Should the package also be aimed for usage as a reference and background text for RA?
3. With respect to the type of language used: which document will have priority as the reference to standardise the language between the two documents?
4. Do we integrate all of the guidance or just the roadmap section?
5. Do we include a section on the decision making process in this new package?
6. What (practical) experiences have people had with either/ both documents?
          o   Was one document easier to use/ understand than the other?
          o   What aspects of one or the other do you think will enhance a user’s understanding of RA?

I am looking forward to a fruitful discussion!
Best Regards
Helmut
(edited on 2012-12-03 03:33 UTC by Dina Abdelhakim)
posted on 2012-12-03 03:32 UTC by Dina Abdelhakim, SCBD
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3885]
Dear Helmut,

Thanks very much for volunteering as moderator for this discussion and thanks very much for posting these very clear questions that will focus our discussion for a start.

As participants may remember, I am working in the Netherlands GMO office, where we are, among other things, dealing with environmental risk assessments of LMOs. I have been involved in the discussions that we have had during the past years in the AHTEGs and in the Online Forums.

In the NL we have been giving some thoughts to the questions that you pose, and I would like to try and share these thoughts with you.

1. Who will be the target audience of this package:
o Trainers of RA?
o People learning how to carry out a RA?
o Risk assessors/ Practitioners?
I think the package is aimed at anybody involved in environmental risk assessment of LMOs in the wide context of the CPB (I mean, in any legislation, in particular the legislation of Parties of the CPB). Anybody: be it as trainers, novice risk assessors, or seasoned risk assessors with a lot of experience.
Everybody will read the guidance in the package from a different point of view, though. Experienced risk assessors will look at the guidance in an opinionated way, and they may agree with various issues, or have a (slightly) different view. I think that the present exercise should get those views on the table, for the purpose of mutual learning from each others experience. The basic methodology of the risk assessment is given in the CPB, in particular in Annex III, and that should be the point of departure for all discussions. Trainers will be, ideally, as involved in and knowledgeable about actual risk assessments that they can be involved in these discussions in the same way.
We should keep in mind, however, that such discussions will tend to be at a different level of complexity than what is most helpful for people learning how to do a risk assessment. They should first master the basics, before they get involved in the more complicated discussions.
So, although the guidance will be useful to people at all levels of experience, we should keep in mind that it is the movice risk assessor who should be able to understand the flow of thoughts and can use the guidance in the practice risk assessments.
In the discussion of the package, we should keep that in mind.


2. How can the Guidance and Manual be integrated?
o Should the Manual or the Guidance be used as the basis for this exercise?
o Should the package also provide a step by step guide for risk assessors to use when conducting RA?
o Should the package also be aimed for usage as a reference and background text for RA?
I think the package is very much already all of these, although maybe not as effective as it could be.
The Manual and the Guidance are basically talking about the same process, although the manual is meant to be much more basic and hands-on, while the Guidance tries to go into the details of the risk assessment process, including references to many background documents where the reader may find more information. Hopefully the Guidance provides copntext for all this information, taht is not always in agreement, but it is essential that a risk assessor learns how to deal with conflicting information, too.
Both the Manual as the Guidance (see for instance the flow chart) aim to provide basic information and a step-by-step approach, at different levels. Ideally, understanding the Manual is a prerequisite for understanding the discussion in the Guidance. As it is now, one cannot go without the other.
In the end, the package as whole should function as a starter (Manual) and an advanced course (Guidance) in risk assessment. Therefore the package should aim to be all of the items listed under 2.


3. With respect to the type of language used: which document will have priority as the reference to standardise the language between the two documents?
Given the difference between the two documents: basic and advanced, I am not sure that the language of the documents should be fully harmonised, as explained in the following.
Obviously, the same terms should be used with the same meaning.
Concepts explained in the Manual should coincide with the same concepts used in the Guidance. It may be, though, that a concept is explained basically and in a straightforward way in the Manual, while in the Guidance it may become clear that things can be more complicated – but this is inherent to any science course and scientific discussion, isn’t it?
Therefore, I don’t think there has to be a priority for one or the other document – there is a need for consistency between the two documents.


4. Do we integrate all of the guidance or just the roadmap section?
This, as many things in risk assessment, should, or could best, be done in a step-by-step manner.
The Roadmap was meant to be a general document, applicable to all types of organisms.
The other documents in the Guidance go much more into detail and explain how the Guidance applies to specific cases, or one aims to show how a specific iessue in the Guidance, i.e., monitoring, is understood in (various) current practice(s).
Therefore, there should be some order in the complexity of the language and the explanations, the Manual being in line with a first tutorial, the Roadmap being an advance course and the other guidance documents being an exercise for those that have mastered the Manual and the Roadmap.
I think that is the way that we have also understood it and taken care of it in the AHTEG – at least for the Roadmap and the other guidance documents.
This implies that all documents should be in agreement as to the basics of risk assessment, terminology and concepts, and in order not to be tedious or confusing, there should be minimum redundancy, or only such redundancy as is necessary.
Asd a practical proposal, I would suggest that we start with integrating the Manual and the Roadmap, and, once way have learned from that exercise, we start integrating the Roadmap and the other documents. Let’s also remember that the AHTEG has been aware already about the consistency between the Roadmap and the other documents, and I guess that the authors of the Manual have been similarly aware of the need for consistency. We don’t start from scratch, therefore.


5. Do we include a section on the decision making process in this new package?
Annex III states: “2. Risk assessment is, inter alia, used by competent authorities to make
informed decisions regarding living modified organisms.”
So, the conclusions and recommendations of the risk assessment will be used in decision making, but
a) This is not the only information that may be used, see for instance Article 26 on socio-economic considerations.
b) And, Annex III is not prescriptive how the informastion should be used.
In agreement with this, Annex III is talking about risk management (which is something that is decided upon in the decision making process) is treated in Annex III and in the Guidance. In the discussions in the AHTEG I think we have agreed that the issue of risk management is treated is a as a link, a window, to discussions on decision making.
Under the mandate of BS-VI/12 we are supposed to be working on risk assessment and risk management. From what I say above it would follow that we could provide some general views on that the risk assessment should aim to be useful in decision making, and we could talk about prerequisites for being useful. One important prerequisite is that risk assessment should be useful, but should not be prescriptive for decision making, i.e., decisions are not made in the risk assessment. But, then I am already starting to write my section on desicion making – that’s not what I should be doing here.


6. What (practical) experiences have people had with either/ both documents?
o Was one document easier to use/ understand than the other?
o What aspects of one or the other do you think will enhance a user’s understanding of RA?
These questions seem to be on a different topic: this is much more what we should be asking of the people involved in the testing.
These are very general questions, and yes or no answers will give us very little insight in the situation.

We should encourage people at all levels of experience to participate in the testing – but all should be aware of what the testing is meant for.
The Manual is pitched at the novice audience, and as such easier to understand, whereas the Guidance is right in the middle of an advanced level of disussions about risk assessment, without always remembering the audience (mind you, I have been responsible for that, too).
I think the step-by-step approach of further developing the package, described above, will very much enhance the usefulness for the understanding of risk assessment.

As a final remark, all of this is very much the opinion of somebody that has been involved already in all discussions. I would very much like to hear from others, especially people that struggle with the documents, so I can become aware of where I should be doing some more struggeling, too.

I attach a word copy of this file to this message
posted on 2012-12-04 16:00 UTC by Mr. Hans Bergmans, PRRI
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3887]
I think that Hans has made some significant points and I particularly want to endorse the comment on testing under point 6. It is my recollection at the working group and contact group meetings in Hyderabad that most wanted to see these documents, the roadmap and guidance, tested. The feedback from the testing would then be used to modify these documents appropriately. It seems to me that to start be reviewing training materials before the base documents are tested and finalised is putting the cart before the horse.

I note that in document BS-VI/12 that the Executive Secretary has two relevant tasks to perform. At 5(a) they are requested to develop appropriate tools to structure and focus the testing of the Guidance. Then at 9(b) to Cooperate with the open–ended online forum and AHTEG to develop 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, with the clear understanding that the Guidance is still being tested.
However, the task laid out for the open–ended online forum and AHTEG in 9(b) will be greatly influenced by the outcome of the completion of the testing in 5(a) but this will not be completed before the AHTEG is to complete its task!

My concern is the task of this open–ended online forum and AHTEG will be irrelevant because the Guidance document will need significant rewriting as a result of the testing and then the training materials will have to be redrafted to take these changes into account. Consequently “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” will need to be done again.

I am also concerned that in develop this package a momentum will be created that will negate the outcome of the testing because of the effort that went into its creation, i.e. the package will be kept despite the outcome of the testing. If the outcome of the testing is that the guidance needs revision the AHTEG needs to be prepared to throw the package away and start again.

I also note that in Executive Secretary notification 2012-140 the statement “The Secretariat is pleased to announce that the Open-ended Online Forum is scheduled to reconvene in December 2012 to contribute to the following tasks: (a) provide input to assist the Executive Secretary in his task to structure and focus the process of testing the guidance, and in the analysis of the results gathered from the testing”. Given the importance of the testing I wonder why we are not considering this first.

I am more than prepared to be involved in both the task of testing the guidance and developing the package but believe that we need to be aware of the difficulties the decision document (BS-VI/12) has created.
posted on 2012-12-05 03:41 UTC by Dr. Geoff Ridley, Environmental Protection Authority
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3888]
Dear colleagues,

Firstly I would like to congratuate the opening of this discussion. Secondly, I would express my disappoitment on that we only got a commend after fours years' works.That is ridiculous. I guess I know what those guys were thinking of.

Thirdly, I would say that decision making should base on risk assessment. I believe that one main task of risk assessment is to serve for policy and the decision making. In addition, decision making is one part of risk management. Thus the guidance document on risk assessment and management should include a section on decision making.

Thanks and best wishes for a fruitful discussion.

Wei
posted on 2012-12-05 04:17 UTC by Mr. Wei Wei, China
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3889]
Dear Members of the online forum
first let me thank Helmut for the carefully developed questions
and also Hans for the first input to the discussion.
I can agree with most of the points Hans made.
1. I also think that the target audience of the package are all three groups addressed in Helmuts question but they may comment on the package out of different perspectives and experiences.  Therefore the questions asked to these different groups about their perception and experience with the manual and the guidance documents during learning, use or testing should/ could be different.
2. Out of my perspective the guidance is the more elaborated description of RA based on Annex III especially complementing module II and III of the training manual. With the help of the background documents connected to the guidance there is further and wider dealing with special topics possible helping to develop the own approach. Having said that I would see the manual as the basis, the road map and the monitoring part as a further elaboration of how to conduct a RA and develop monitoring approaches. The guidance on special traits or organisms is a third layer or level dealing with special aspects.   
3. I do not see the need for a standardising of language. But I agree that the  terms should be 
defined and be used interchangeably and consistently within the manual and the guidance documents.
4. We should integrate all of the guidance. Manual and guidance are or could be a combined tool navigating the user from the more broader and introductory level to the more complex level and the specifics of certain organisms or traits.
5. As has been said by others a section on decision making may be useful.
6. there is no short or easy answer to these questions. And I think the same holds true for me than for Hans: having been involved during the last 4 years in developing the documents it would be very interesting to hear the opinion of others.

best regards
Beatrix Tappeser
posted on 2012-12-05 16:20 UTC by Beatrix Tappeser, Federal Agency for Nature Conservation
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3890]
Greetings to all members of this Open-ended Online Forum. 

First, I extend my thanks to Helmut for his continued willingness to do the "hard work" required to get the discussion started.

My first comment aligns with those who are questioning the wisdom of starting with the second priority that came out of the decision on RA/RM in Hyderabad.  This will lead to further confusion since testing of the guidance has neither been designed nor conducted: and as pointed out by Wei, it was not welcomed by the Parties. 

Nevertheless, having looked over the training materials in quite a bit of detail and having been witness to their development and use in training sessions, I wonder if the Module III could be replaced by a completed (tested) roadmap.  A good roadmap would make Module III unnecessary and would then allow the work of this online discussion to focus on integrating Models I, II and IV into a coherent training course. 

If the outcome of our discussions is that both a Module III and roadmap are necessary, I feel strongly that standardization is necessary to avoid linguistic and other uncertainties. We would have to be very careful to ensure that no confusion on terms, principles or processes described.  It would be concerning to create a hierarchy between the two that results in confusion and diminishes the value of both work products for their intended use.  The current version of Module III is noticably inconsistent with the roadmap as exemplified by its lengthy description of "case-by-case", which appears to be presented as an iterative process rather than a principle as described by OECD.

As others have commented, and having been involved in this process for the last 4 years, this work is not easy.  Let's not make it more difficult however by leapfrogging across priorities.  The first priority that clearly came from Hyderabad was to develop protocols for testing, conduct the testing and analyze the results. 

Thanks and best regards to all,
Tom Nickson
posted on 2012-12-05 17:14 UTC by Mr. Thomas Nickson, Consultant
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3891]
Dear Helmut, dear collegues.
There is certainly merit in discussing a proper alignment between the manual and the guidance, but as Tom pointed out, it would be better to focus on the Hyderabad priorities.
Kindly
Paulo Andrade
UFPE/ Brazil
posted on 2012-12-05 20:48 UTC by Mr. Paulo Paes de Andrade, Brazil
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3892]
Dear colleagues,

Thank you, Geoff and colleagues, for your comments and concerns. To clarify the situation a bit more, I would like to add that the present Forum is a brainstorming session to gather the necessary information to map out the best strategy on how to approach this complex integration exercise.

You are correct in saying that the issues of testing and producing the package are without doubt interrelated and interlinked. The details of the precise content of the aligned package will be discussed at a later date once we have the necessary data from the testing of the Guidance as you pointed out. For practical reasons however, we started with the discussion of the issue of the integration of the Training Manual and Guidance, without prejudice to later testing.

In order to achieve the outcomes as outlined in the Terms of Reference (Hyderabad decision BS-VI/12) within the time limits that we have at our disposal, it will mean that the various developments will have to be undertaken in parallel and through a carefully structured process that will be iterative and interlinked. The mandate given to the Open-Ended Online Forum is challenging and needs careful planning and flexibility by all participants. I hope for your understanding!
I thank you all for your valuable input so far and hope that you and more experts will contribute to the discussion over the next couple of days on integrating the training manual and the guidance. Next year we will continue with the discussion on the other issues as well. Thank you and best wishes
Helmut
posted on 2012-12-06 09:33 UTC by Mr. Helmut Gaugitsch, Austria
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3893]
Dear colleagues,

I extend my thanks to Helmut for facilitating the discussion on the methodology to align the Guidance and the Manual.

I see reasonable the Helmut’s proposal to go on in parallel and discuss the package development and the testing of Roadmap.

I can endorse many points of Hans comments.
1. I see the package should be addressed first to risk assessors, and also to all  other target audience as decision makers, trainers, people learning etc.
2. As to the hierarchy between the documents, I would support the Manual to be as the basic level and complemented with many examples and exercises, to provide explanatory to the Guide and to be understandable for the large audience (students, learning people ect).
The Roadmap is the key element of the Guidance on RA/RM and addresses large and comprehensive points for RA/RM in accordance with the Annex III of the Protocol.
The guidelines on specific traits or organisms are the third level of documents and should be treated as an advanced document to guide with the focused specific cases.  
I would keep the Module III as part of manual and would not replace with the tested Roadmap.
Manual should be recorded to the Guidance and improved after testing of Roadmap.  
3. I also support Beatrix and Wei proposal to integrate the decision making section   in the package, as the risk assessment facilitates the informed decision making and is part of it.
4. With respect to language used, the Guidance should have priority in standardization of language; the manual may use more explicit and understandable language for large audience.

best wishes,
Angela
posted on 2012-12-06 10:28 UTC by Angela Lozan
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3894]
POSTED OF BEHALF OF HIROSHI YOSHIKURA
--------------------------------------------

1. I agree with the view expressed by Dr. Hans Bergmans and Dr. Geoff Ridley.  It is important to note that MOP-6 agreed that “The guidance will be tested nationally and regionally for further improvement in actual cases of risk assessment and in the context of the Cartagena Protocol on Biosafety” (RISK ASSESSMENT AND RISK MANAGEMENT (ARTICLE 15 AND 16, I, Further guidance on specific aspects of risk assessment, 1. (b)).

2. It will not be appropriate to consider any training package, until “the guidance will be tested nationally and regionally”. Training should be based on the final guidelines agreed by all parties of CBD.

3. In my view, in the risk assessment document, sections of “Overarching Issues in the Risk Assessment” and “Planning phase of the risk assessment” are now better in shape, but the “Conducting the risk assessment”, Annex Flowchart and PART II are not. They need substantial revision if they have to be maintained.

4. The party needs to agree on definition of “key words” first. Formal agreement on definitions is crucial for usability of any guidelines. The current Annex “use of terms” at the end of the guideline has not been well discussed at least in my memory.

5. Relation between risk assessment and risk management is not clear in the present guidelines. The guideline should clearly state “risk management is a process distinct from science based risk assessment. Though interaction between risk managers and risk assessors is necessary, risk assessment should be independent of risk management, a process of weighing policy alternatives, other relevant factors, etc.

6. If it is our mandate to draft a training package from now (though I disagree), the training should be conducted as a part of testing of the present guidelines in “actual cases of risk assessment”. In that case, training should be done “on site” using some on-going risk assessment examples. Here, the training should include estimation of person power, field trial facilities for the risk assessment, and required cost for assessment. Note that “the preparation of a food safety dossier for a product derived from modern biotechnology, for example, is estimated to be around US$ 1 million” from Modern food biotechnology, human health and development: and evidence-based study, Food Safety Department WHO, 2005).

7. As not a few developing countries are cultivating LMOs now, training cooperation among developing countries will be of immense value for planning of realistic risk assessment in trainees’ own countries.

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
posted on 2012-12-06 11:34 UTC by Dina Abdelhakim, SCBD
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3895]
Dear Helmut, dear all,

Below is my view:
1) I agree with the view expressed by Han and Angela, that the package should aimed at anybody involved in risk assessment of LMOs.
2) I think it is fine to use the training manual as the basis for RA, the road map, though still can be improved or simplified, provides illustrative step-by-step guidance on RA according to Annex III of the Protocol. But the guidance on special traits or organisms deals with special aspects on specific GMO, but the list of these documents will keep growing and I foresee difficulty to integrate the manual with these documents. I agree with Angela that the guidelines on specific traits or organisms can be regarded as an advanced document for specific use.  Combining the manual with the roadmap is a way forward, with the guidance on special traits or organisms as complements or appendix.
3) I agree that standardisation of language is really necessary but I remained to be convinced which document can be used as priority. At the present stage, I feel that some of the terms used should be well defined according to the wider scientific community and Tom & Beatrix rightly pointed out that they should be consistent within the manual and the guidance documents.
4) I think it is agreeable to integrate the Manual and the Roadmap
5) It may be useful to include a section on the decision making process in the new package
6) For practical experience feedback, having been an AHTEG member for 4 years, I may have been looking at the "blind spots" over and over. Hence views from a wider audience is definitely a better option.

Before I end, my special thanks to Helmut for chairing as moderator for this online forum.

Thank you and best regards to all,

Kok Gan CHAN
University of Malaya
Malaysia
posted on 2012-12-06 13:41 UTC by Dr Kok Gan Chan, Malaysia
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3897]
Dear Helmuth Dear ALL
Thamks to Hans amd Beatrix for their sigmificamt comments I agree with the poimts mentionned
I think  as suggested by some colleagues that it is impotamt to integrate the Manual and the Roadmap This will improve  the new package
Best regards
posted on 2012-12-07 00:17 UTC by Mr. Mahaman Gado Zaki, Niger
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3898]
Dear colleagues,

I think that the target audience of this package are all mentioned groups (trainers of RA, people learning how to carry out a RA, risk assessors/ practitioners) because from the point of view of an inexperienced country like Croatia, one must firstly learn and practice to become trainer, so all categories are overlapping across the time of involving oneself in the process.
Furthermore, I don’t think there has to be a priority for one or the other document. I feel that the most practical way could be to somehow integrate the Manual into the Roadmap and have one useful document with, of course, clear defined terms that are consistent through the whole document. I agree with the idea of language standardization to avoid different uncertainties in understanding the terms and whole process described.

Kind regards,
Jelena Žafran Novak
posted on 2012-12-07 07:42 UTC by Jelena Žafran Novak, Croatia
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3900]
Greetings to All
Thank you, Helmut for moderating this session and for your patience.

Below are my views:
All three categories of people involved one way or the other in Risk Assessment should be able to use the training manual package as then it will show the utility, applicability and readability of these documents from different aspects.  But as Hans pointed out the novice risk assessors or regulators should be able to understand the concepts very clearly and be able to use the documents for their regulatory work. For this also we need the documents to be tested and feedback given.

Like what the other have thus far, the Manual and the Guidance cannot go without the other. But I like what Hans and Beatrix have suggested that the Manual be the starter or the basis and the Roadmap be the advance level in risk assessment. The feedback that I have received from the Malaysian regulators is that the Roadmap to be used as a basis for training is a bit overwhelming for those new to the "game" but they welcome the Roadmap for reference purposes. They also found the Flow Chart very useful. The package then should include a step by step guide for risk assessors to use when conducting a RA. So Hans suggestion will fit in very well for novice regulators and risk assessors.

It will be very difficult, as others have pointed out to harmonise the language in both the documents but it cannot be emphasized enough the importance of consistency in the use of the same terms for the same purpose or for the same concepts, principles or processes to avoid confusion as well as making RA seem so daunting (feedback received by trainees in a RA training course). 

On the question if we should integrate all of the guidance- I fully support what Hans has suggested - to do it in a logical and systematic way.

A section on decision making will be helpful.

Our local regulators would like to see some actual cases of risk assessment using the principles outlined in the Roadmap to be part of the package.
As emphasized by others, the testing of all the documents is very important and crucial for the improvement and overall utility and feedback and views from a wider audience would be a step forward towards this agenda.

Thank you and best wishes to all.

Vila
posted on 2012-12-07 09:53 UTC by Vilasini Pillai, Ministry of Science, Technology and Innovation - Chair real-time conference Asia
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3899]
Dear Helmut, dear all,

Recalling the discussion in the COP-MOP6, as mentioned by Geoff, Tom, Paulo and Yoshikura, I think the Open-ended Online Forum and AHTEG should follow the COP-MOP6 decision and start with the first priority, i.e. the discussion on the Testing of the Guidance.  Since the time and resources are limited as Helmut pointed out, the Open-ended Online Forum and AHTEG should concentrate on the task of the first priority and avoid complex process.

Isao TOJO
posted on 2012-12-07 08:27 UTC by ISAO TOJO, Ministry of Agriculture, Forestry and Fisheries
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3903]
Dear participants:

I would like to follow up on the statement of Dr. Geoff Ridley, New Zealand as I agree with many of the contents. Also I believe similar statements were made by Tom, Paulo, Prof. Yoshikura and Mr. Tojyo on the process issues.

“”Quote””:
Dr. Geoff Ridley, New Zealand
My concern is the task of this open–ended online forum and AHTEG will be irrelevant because the Guidance document will need significant rewriting as a result of the testing and then the training materials will have to be redrafted to take these changes into account. Consequently “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” will need to be done again.
“”Quote over.””

Watanabe comments:
It is yet quite challenge to go over the present guidance documents to use it. It took four years to reach the present status of guidance doc and generating any new activities and additional documents would be odd. Before entering into adding any documents including supplementary info as training manual, more should be considered on testing of the present docs.

There is no substantial agreement made from many numbers of parties. Also my understanding on the purposes of RA guidance docs, is not aimed at driving parties to use them exclusively but as references and it looks more like the starting comments of the chair imply more unidirectional rather than liberty of parties to what to do with the position of the guidance documents.

Furthermore, there are tool kits / guidance / manuals on RA & RM made by different organizations, and I do not see immediate needs of manuals and training efforts, and again limited number of experts over-stretch again to the different world of “”training””, is at a high risk to incomplete and insufficient work results.

The capacity building efforts under Cartagena Protocol also had done a lot of work on RA related documents, training, workshops and other modality such as formal education programs, and I do not see further needs of stand-alone training consideration on the issue. For example, Biodiplomacy group of Institute of Advanced Studies, United Nations University (IAS-UNU) had made a couple of comprehensive  summary documents on Cartagena Protocol related capacity building over  diverse aspects including RA&RM on different organizations. Coordination and governance consideration should be made among the implementation supporting stakeholders rather than the AHTEG of RA&RM starts from the square-one.

In views of the feedback survey made in the past by SCBD on the parities comments on the guidance docs, usefulness is not well addressed, but rather on improvement and also consideration of the simplification are addressed?  It is not the number of the parties to indicate the usefulness, but pay more attention to the parties indicating inconvenience with the guidance documents or silence.

Also we must remember that not much participation was made by parities in each of real time conference: the past RA AHTEG members confirmed own views in the occasions, but users (NFPS) had not joined in the active discussion.  It is taken as serious fraud to me that in spite of no real feedback in on-line especially on real time, but reports have been made in a different interpretation that real time conference had been done actively.

Practical uses of the guidance documents should be enhanced. Tests over different cases and parties should be promoted for a period. (Sub)regional collaboration on sharing their testing experiences and exchange of the opinions.

It should be reserved for future subjects on any of new further document development items on specific LMOs such as mentioned by the Executive Secretary of SCBD at the beginning of MOP-6 as the real AIA has not been taken place soon on such very new LMO entities.  Even in developed countries do not have immediate actions on field testing and use of such LMOs, not like intervention of ES of SCBD.

Inter-linkages with the specialized research agencies, must be established to incorporate actively their feedback and fair and sound-science comments rather than accommodating any voices from non-experts who do not have experiences on the subjects. Individual contribution by experts out from AHTEG, may be accommodated but promotion should be enhanced more with credible scientific organizations rather than individual credential.

Finally, we (The past RA AHTEG) should have been more modest on scientific specialty of each expert, and we should have not exceeded each experience on RA issues: Many proportion of the discussion at the RA AHTEG, was made by many of who never had experiences. However, party-driven process had taken,  which does not have science-sound approach and lack of explanation for scientific RA implementation. Even it is not party-dirven as only small proportion of individuals regarded as parties accommodated into the recommendation. Experience with vast LMO handling such by Japanese and Korean have not been considered as practical examples and Brazilian and Mexican experiences with real expert participation in AHTEG, were not used in elaboration processes of the real useful documents for practices.

RA AHTEG should have been more with science and experience based, but indeed it was more with political driven beyond procedure issues under TOR of RA&RM AHTEG.


Thanks for your attention,


Kazuo Watanabe
A former RA&RM AHTEG member, JAPAN
posted on 2012-12-09 10:07 UTC by Dr. Kazuo Watanabe, University of Tsukuba
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3904]
Dear colleagues,

In his posting of today, Kazuo Watanabe, refers to the contribution of Geoff Ridley and some others.
The issue under discussion is the relationship between the testing of the Guidance and the integration of the Training Manual and the Guidance. He agrees with a quote from Geoff: “My concern is the task of this open–ended online forum and AHTEG will be irrelevant because the Guidance document will need significant rewriting as a result of the testing and then the training materials will have to be redrafted to take these changes into account.”

I agree in general with Kazuo’s comments, also where he is critical of the past AHTEG (in which both he and I were among the participants). From the present discussion it would indeed seem that we run the risk of getting into a circular argument, that could paralyse progress in both the testing and the integration of the package.

Decision BS-VI/12 (see http://bch.cbd.int/mop6/advance_unedited_compilation_mop6_decisions.pdf, page 55, in particular the ToR on page 57), states that the mandate of the Open-ended Forum is to:
(a) Provide input, inter alia, to assist the Executive Secretary in his task to structure and focus the process of testing the guidance, and in the analysis of the results gathered from the testing;
(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.
So, COPMOP wants the Open-ended Forum to be both active in the testing and in the development of a package.
The order of (a) and (b) suggests some form of order of priority. The phrase “with the clear understanding that the Guidance is still being tested” suggests that the testing certainly does not come second after the development of the package, but also that both processes run parallel to some extent; it also implies that the package should clearly reflect the results from the testing.

Helmut has stated that “the issues of testing and producing the package are without doubt interrelated and interlinked. The details of the precise content of the aligned package will be discussed at a later date once we have the necessary data from the testing of the Guidance as you [i.e., Geoff] pointed out.”

I think Helmut is right, although ‘interrelated’ and ‘interlinked’ are maybe even not strong enough terms, in the light of what I have pointed out above.
But, in all fairness, the exercise that we are doing at present is a necessary step – and poses some necessary questions, as I tried to argue in my previous posting.
What causes concern, also for me, is that we don’t see the perspective of HOW and WHEN the testing will be organised, and how the results of the testing will be reflected in the package.

I would therefore respectfully like to urge the organisers of the Open-ended Forum not to wait for too long with opening a second and separate line of discussion on the testing process, and probably an overview discussion on how we see that items (a) and (b) will be interlinked in practice in the Open-ended Forum.

Scondly, I am very happy to introduce in this message my colleague Boet Glandorf, who will join our discussions next week. Boet and I have been colleagues in our GMO Office (sharing a room in the office) for many years, hence we have had already many discussions about the CPB, and I am very happy that she will be involved hands-on in this discussion too.

Best wishes,

Hans

(Hans Bergmans is Senior risk assessor in the GMO Office of the Natl. Institute of Public Health and the Environment in the Netherlands, and has been a member of the AHTEG on RA&RM)
posted on 2012-12-09 16:19 UTC by Mr. Hans Bergmans, PRRI
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3906]
Thanks! It is really interesting to know the order of 'a)' and 'b)'. I dont think there shall exist an order of importance/priority. I should say it is little bit tricky. The parties might or might not realize this trick and might intend to or not intend to use this trick during the conference. If we were aware of this order, I believe that at least China would question on this order during MOP meeting. However, the decision is there now and people can have their own view of this order. But we should go for scientific, as Kazuo suggested, and should not go for tricky. Perhaps the best way is to have the official opinion of SCBD on that order.
posted on 2012-12-09 17:25 UTC by Mr. Wei Wei, China
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3907]
I would refer to  Hiroshi  comments. In his 7. point there  were mentioned “ As not a few developing countries are cultivating LMOs now, training cooperation among developing countries will be of immense value for planning of realistic risk assessment in trainees’ own countries”. I welcome this approach and would say that during the Hyderabad regional meetings some of countries from Eastern Europe (former Soviet Union) we have agreed to initiate testing of Roadmap on RA in cooperation, taking into account the similarity of economic and agricultural development, common language  (Russian) and current limited capacities for risk assessment.  

The testing of Roadmap in these countries expected to be done involving local researchers (risk evaluators), and also decision makers via a substantial training process. For this purpose I am sure we need to have the training manual available and the package of Guidance and advanced guidelines as well. I have my convince that it would be more helpful to go on in  parallel with the a) and b) in time frame. Majority of colleagues supported the including the section of decision making into the package, that will be also very helpful to train decision makers.  At the same time, the training materials will be    “tested” and improved  and completed with useful examples during the training activities at this stage.

Referred to Cazuo comment: “RA AHTEG should have been more with science and experience based, but indeed it was more with political driven beyond procedure issues under TOR of RA&RM AHTEG”, I would say that majority of former AHTEG  members involved has a scientific background,   experience of years, and some of us participate in decision making in the countries, being involved in National Biosafety scientific commission and/or representing public authority. I do not see a discrepancy or nonconformity in this.  Scientific and political factors should be balanced thaking into account that RA and RM is part  and the final scope of decision making in every country.

I very much welcome the consistent proposals made by Tomas, Geoff, Hiroshi, Cazuo and other participants for a very critical, logic and scientific based testing of Roadmap by a large audience and countries. The quality of guidance will  increase and this will be helpful for everyone.

With respect,

Angela
posted on 2012-12-09 18:59 UTC by Angela Lozan
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3905]
Dear friends and colleagues

I believe that the target audience for the training package should be the 3 groups namely people learning how to carry out a RA, risk assessors as well as trainers of RA. The training package should be able, through its different components, to assist all the 3 targets groups; the manual is meant to be more basic and hands-on for those that are new to the process, while the road-map and other guidance documents try to go into the details of the risk assessment process, including references to many background documents where the reader may find more information. And I think that some sort of “introduction” to the training package highlighting those ideas would be very useful.

The manual and the other guidance documents are basically addressing the same issue with a different level of complexity. To avoid confusion, there is a need for consistency of “terms used” throughout the package as if it was written by the same group of people but targeting different audiences, I would say.

I think including a section on decision making in the training package would be very useful. And there might be also a need to include some sort of case study to assist in the training on RA.
posted on 2012-12-09 16:19 UTC by Mr. Ossama Abdelkawy, Syrian Arab Republic
Priority a or b [#3908]
After a slow start it is nice to see so much engagement in this forum.

I work for a government agency that is responsible for the risk assessment, risk management and decision making with respect to LMOs. As such I tried to read the guidance and training manual from the point of view of a party with capacity and a party lacking capacity, and from the view point of what would be required from a Party should the guidance be endorsed. This is what led to New Zealand’s concern and the basis for our interventions at Hyderabad.

I have a number of issues.

While I acknowledge that the guidance document has value I do not see that it is any more valuable than other guidance material that is available. It is one of the reasons I do not favour endorsing the guidance at a MOP and would rather simple see it tabled and made available to those who wish to use it. However, even if it is to be tabled I would like to see it tested by parties and non-parties as a way of validating it as a useful document.

I am also uncertain as to what was to be achieved with these documents. The only endpoint that I can find seems to be that a roadmap and guidance were to be produced and I gather that this was largely for Parties lacking capacity in risk assessment. As a Party with capacity in this area I am sceptical that the roadmap and guidance are of any value to Parties lacking capacity. They are simply too technically dense to be useful and I would not give it to a new employee in my own organisation without significant training and an apprenticeship with a practising risk assessor as a way to guide the new employee through them.

I am also of the same opinion of the training material (module 3) that it is too technically dense. What concerns me most with the use of the training material is that training sessions are being conducted and used to claim capacity building is being achieved. The only evaluation that I can see are end of training session questionnaires. I struggle with the concept that participants, whose only exposure to risk assessments is the training they have just undertaken, are being asked whether or not the course was useful! They will only know if it was useful once they try to implement it and if they are successful in doing so – that will be the measure usefulness and of increased capacity. Training material needs to be set at the level of the existing capacity of the Party involved. This may mean that there needs to be a step-wise set of modules that build on each other and the increasing experience of the trainees as they progress through the modules. The current modules do not do this.

So my position at the moment is that these documents are ‘not fit for purpose’ (largely because the purpose has not been sufficiently defined) and that we, the forum and future AHTEG, are embarking on a programme of work to make these ‘not fit for purpose’ document consistent with each other. My hope for the testing of the guidance was to show that it was ‘not fit for purpose’ and to give us the direction to make them fit for purpose.

I also take on board that we have a limited time in which to achieve the outputs required from the MOP6 decision I think the proverb ‘more haste, less speed’ could serve us well here.
I apologise if this seems harsh but it’s the process that I would have to go through to introduce such documents into my own organisation.

The other question I want to address is whether the material should cover decision making. Decision making generally sits in the complicated legislative and political space of individual parties and for that reason can be a very case-by-case consideration. Given that we need to be working on the basics of risk management and assessment the inclusion of decision making should be left to another forum.

Geoff Ridley
Environmental Protection Authority, New Zealand
posted on 2012-12-09 23:28 UTC by Dr. Geoff Ridley, Environmental Protection Authority
RE: Priority a or b [#3909]
I am truly pleased to see the both the level of engagement and substance increasing in this forum.  I wish to share a few thoughts that were not in my earlier contribution.

First, who is this guidance meant to serve?  The experienced risk assessor working within a Party's regulatory authority that has been doing risk assessments does not need this guidance (e.g., New Zealand, Japan, Brazil, etc).  Such people are already operating in compliance with the Protocol and local laws, policies and administrative processess that were implemented in order to comply with their counrty's obligations.  Importantly, it would be incorrect and inappropriate for experts in this forum to suggest otherwise. 

One stakeholder that, to the best of my knowledge, has not been mentioned in the 4 years that these documents have been under development is the small and medium enterprise developers from both the for profit and not-for-profit sectors.  Developers of small-holder focused projects underway in some developing countries that are Parties anxiously await resolution to the current regulatory uncertainties.  These stakeholders would welcome efforts that create more certainty.  A critical test of the utility of these guidance documents is whether or not they help create this regulatory certainty for these Parties where GM project could improve the situation of small-holders. As a representative of a developer that is also engaged in such projects, I assert this guidance in its current form is not useful.  Because it blends theory and practice in a way that a developer cannot determine what is need to know in a real-world situation it creates more uncertainty than certainty.  Again, testing should be developed that will direct needed improvements to the guidance first and then, if necessary, to the manuals.  However, I still contend that new guidance is unnecessary.  Rather, existing experience and guidance should be packaged in a way that is useful to these Parties that need help.  Such exchange of experience was envisioned by both the Convention and Protocole.

Second, the process being used remains unclear and ad hoc. It is concerning that the path forward is left to explanation by very view and extensive explanation is needed.  Confusion is evident by the fact that many have questioned the wisdom of doing step 2 ahead of step 1 while others are agreeing to "working in parallel".  Yet all acknowledge the urgent need for testing the guidance.  There is truth in the humorous quote, "if you don't know where you're going, you will wind up somewhere else". 

To conclude for now, I believe that the guidance under development is not needed by experienced risk assessors.  It should be developed to help create greater regulatory certainty for developers and Parties targeting small holder applications.  However, we seem to be unfocused with regard to the audience for this guidance as a whole and the process being used will lead to a very uncertain outcome.  I resubmit that we continue to head down an unproductive path toward further editions of chair's text that integrates irreconcilable ideas.  Furthermore, we have no process to reconcile discrepencies because the process allows comingling real-world risk assessment practice that is compliant with the Protocol and leads to decision-making with untested theory. Until this process is fixed, integration of any ultimate guidance with helpful manuals should wait.  Unfortunately, transfer and adoption of useful and sustainable technologies to the developing world will also wait.

Thanks to all contributors,
Tom Nickson
posted on 2012-12-10 02:13 UTC by Mr. Thomas Nickson, Consultant
RE: Priority a or b [#3910]
Dear all,

Allow me a brief comment. As mentioned rightly by Geoff Ridley and Tom Nickson, and supported by many others, there is a clear priority on testing the current guidance document in actual cases. Recognition of the importance of "improvement by testing" was also a bottom-line, or a core understanding, when the Parties were able to reach a difficult compromise in the working group and contact group meetings at COP-MOP6. The importance of this priority should therefore not be underestimated, although it is not my intention to interrupt the current brainstorming.

Best Regards,

Nobuyuki Fujita
National Institute of Technology and Evaluation (NITE), Japan
posted on 2012-12-10 08:03 UTC by Mr. Nobuyuki Fujita, Japan
RE: Priority a or b [#3920]
I work for Japanese Government, Ministry of Economy, Trade and Industry.

I support the opinion posted by Nobuyuki Fujita, which is supported by many others, we have a clear priority on testing the current guidance document in actual cases.
Recognition of the importance of "improvement by testing" was also a bottom line, or a core understanding, when the Parties were able to reach a difficult compromise in the working group and contact group meetings at COP-MOP6.
The importance of this priority should therefore not be underestimated, although it is not my intention to interrupt the current brainstorming.

Best Regards,

Hidekazu Nakazawa
Ministry of Economy, Trade and Industry (METI), Japan
posted on 2012-12-11 05:43 UTC by Hidekazu Nakazawa
RE: Priority a or b [#3924]
Dear all,

I support the opinion posted by Nobuyuki Fujita and Hidekazu Nakazawa. There is a clear priority on testing the current guidance document in actual cases, although it is not my intention to interrupt the current brainstorming.
Recognition of the importance of "improvement by testing" was a core understanding, when the Parties were able to reach a difficult compromise in the working group and contact group meetings at COP-MOP6.The importance of this priority should not be underestimated.

Thanks for your attention,

Naohiro Noda
posted on 2012-12-11 12:11 UTC by Naohiro Noda
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3911]
Dear all,

I have followed your discussion with great interest.  Since I am a new participant in this discussion, let me first introduce myself. As Hans already mentioned, I am his colleague and office roommate and involved in risk assessment of LMO’s for over 10 years at both national and European level.

After reading the manual and guidance afresh I would think that it is feasible to align these documents by taking the manual as a starting document with including background information and the guidance as a follow-up risk document.  As mentioned before, the basic terminology differs between the documents but would not be difficult to adjust.
I have noticed that in the discussion the term ‘aligning’ is used, for the manual and the guidance, but also the term ‘integrated package’. As I understand it, the end result will be separate documents, offered in one package. The integration should, to my mind, not mean merging the documents into one. That would be a much more difficult task. 

From my experience the documents do not seem readily applicable for less experienced risk assessors (also in our own office) in their present form. All the basic theory is included, but the link to how risk assessment works in practice and how the information is taken into account to assess potential hazards and actual risks is lacking. When testing the manual and guidance there will be a need to include practical examples. This could be done in the form of real (or maybe specially compiled) applications. It would also be helpful by referring, in the manual and Roadmap, to specific examples when explaining the (sometimes complicated) risk assessment terminology, such as protection goals, assessment endpoints and receiving environments.
Also in the guidance for the specific LMO’s one or more real life examples can be included to illustrate how the ‘points to consider’ are actually dealt with in practice.
posted on 2012-12-10 11:36 UTC by Ms. Boet Glandorf, Netherlands
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3912]
Dear open-ended online forum members, dear colleagues,

First of all I would like to thank you for a lively and constructive discussion over the first week of this online forum. This shows that the instrument of an online forum is appropriate for the purpose of brainstorming on the way forward based on the COPMOP6 decision on risk assessment and risk management. On this basis I am optimistic that we can make even more progress on the issue in the second week.

As a moderator of this first round of discussion I kindly ask you to allow me a few reflections on your interventions so far as well as a suggestion on how to proceed:

I would like to state that the terms of reference in decision BS-VI/12 are very clear, Hans Bergmans has kindly quoted pars of them and thereby reminded all of us about the contents in his last and very thoughtful intervention. The given order of priority has to guide the work of the online forum, the COPMOP and we all seem to agree that testing of the Guidance and analysis of the results is crucial in this respect. Prioritization involves the issues of timing, giving weight and focus and also has to consider issues of practicality.  Decision BS-VI/12 is also clear with respect to the collaboration between the Executive Secretary, Parties, other Governments and relevant organizations and the open-ended online forum and AHTEG to undertake the testing (see for example paragraphs 3 and 5 (a) of decision BS-VI/12, Paragraph 1 (a) of the terms of reference in the annex of BS-VI/12). In order to allow more time for preparing the appropriate tools to structure and focus testing of the Guidance, the first round of online discussion addresses as another important issue the alignment of the Guidance with the training manual. This has pure practical reasons in order to make best use of the time which we have available and in order to avoid the circular situation which Hans Bergmans has addressed in his very relevant posting. Due to the fact that the items of testing and the alignment of Guidance and Manual are interlinked and interrelated we have to work in parallel in order to avoid  a situation that we cannot discuss alignment as we have not tested and that we cannot start testing as we have not spend thoughts on the alignment of the package.

I fully share the argument put forward by many of you that we need to know where we want to go and what we want to achieve. I also understand that you are eager and anxious to know more on the planned overall structure and timing of the activities of the online forum. This is currently under consideration and I kindly ask you to have confidence that early next year the discussion on the other issues, in particular on testing will start off in an appropriate manner.

I respect that some of you are not satisfied with the order taken. Still I hope that my additional explanations have provided more clarity why this order has been chosen. I kindly ask for your understanding and patience. For this round of discussion I again invite you take into account that the purpose is a brainstorming activity to identify points to consider with respect to the future alignment, not concrete text proposals towards the alignment yet. I therefore invite those of you who have not done so yet to follow the example of many online forum experts to provide your input to my proposed guiding questions which are meant to stimulate such a brainstorming. I also invite you to provide comments to the answers provided by the other experts. More comments on the sequence of the discussion points or priorities are on the one hand interesting but on the other hand do not bring much added value with respect to the contents of the expected outcome of our discussions.

With that I am sure that by the end of the week we all will have a good picture and valuable basis for the future alignment activity. At the same time it will allow us to focus on testing the Guidance and the package from early next year onwards.

Thank you and best wishes

Helmut
posted on 2012-12-10 11:51 UTC by Mr. Helmut Gaugitsch, Austria
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3913]
Dear Colleagues,


Thanks very much to Helmut for starting this discussion with some good guiding questions and giving some further explanations on the process to help keep us on track.

I would like to share some perspectives on his initial points, and some reactions to the comments thus far, as a former member of the AHTEG.


First, on the discussion of the mandate and the priority/order of the process –

Decision BS-VI/12 states that the mandate of the Open-ended Forum is to:

“(a) Provide input, inter alia, to assist the Executive Secretary in his task to structure and focus the process of testing the guidance, and in the analysis of the results gathered from the testing;

(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.”

What seems important here that has been overlooked is in part (b) which states that the development of package is undertaken “with the clear understanding that the Guidance is still being tested”.

So by my reading it seems unequivocal that the Parties clearly understand that testing and the development of a package would necessarily take place in parallel.


Second, in relation to the guiding questions posted by Helmut:

1. Who will be the target audience of this package:

On audience, as with others, my perspective is that the package should target all these groups.

Ill also not that I would not take it for granted the notion that the information in the Guidance is of limited value to risk assessors that already have established guides –whether they are in “developing” or “developed” countries. The Roadmap Guidance contains a number of innovations that advances the concept of risk assessment in ways that may not be implemented in some frameworks but nonetheless offer potentially more scientifically more rigorous (e.g greater attention to criteria for quality data and greate acknolwedgement of uncertainty)and useful approaches than might current practice. I certaintly would not want to assume this is the case for others, or others to assume this is the case for me.


2. How can the Guidance and Manual be integrated?

Let me offer a bit of a different perspective here.

I do not endorse the view that the manual can be seen as a “beginner” type of RA guidance and the Roadmap is more for “advanced” users –as if they were the same thing but with two different degrees of information. This is not my understanding of the aim of these two documents.

A training manual and a guidance document and those under consideration here  do not have the same purpose. While the training manual is “basic” in the sense that it starts with the assumption that the user has very little if any understanding or experience with the issues and is need of providing a contextual backdrop, a training manual in my view a pedagogic tool – by providing background and contextual information, exercises, reflective questions, checklists, even real RA case examples, for example -  to better orient the user how RA is conducted in practice. The user of a training manual may or may not have the need or desire to actually conduct an RA, they might just want to understanding how such information is developed, evaluated or communicated within the context of a larger risk appraisal process. And as an educational tool, the training would necessarily give more comprehensive details about the was that  RA is, set in the context to other assessments and mechanisms that inform decision-making- This might include prior informational and administrative steps, risk management issues, socio economic considerations risk communication, and risk management strategies, and the like. The aim of the training is to orient, inform and educate, rather than an explict need to operationalize the RA.

The guidance, on the other hand, in my view is focused on best practice guidance for RA conduct, as an explanatory document compliant with the given framework (in this case the Cartagena Protocol). This requires the selection of options from among the various (often equally valid) normative and scientific choices for conducting the RA. It is not explicitly and educational tool.

With his in mind, it seems reasonable that both the manual, as an educational document, and the Guidance, a “best practice” operational document would merge together as complementary package, where the Guidance integrates into the Manual in a way that contextualizes the operalization of the RA in a step-by-step explanatory fashion within Module III.

3. With respect to the type of language used: which document will have priority as the reference to standardise the language between the two documents?


My thinking is similar to others here – harmonizing the terms seems a priority and much more important than the language, as stylistic differences are probably useful given the different aims of each document.

4. Do we integrate all of the guidance or just the roadmap section?


All of the guidance will be useful, where linkages between Parts I, II and III made in the manual at the appropriate places.

5. Do we include a section on the decision making process in this new package?

As indicated previously and by others, the inclusion of the other elements in the appraisal process would seem integral here. The RA process does not happen in a vacuum, afterall. How the RA informs on decisionmaking should be clear. The Roadmap guidance provides some of this context, but the manual could facilitate better understanding in order to be useful.

6. What (practical) experiences have people had with either/ both documents?


As with others, I too am keen to see how testing and experience gained can be practically analyzed for improving the Roadmap. What is clear is that improvements to either the guidance through testing or the manual through futher online work will not seriously challenge the validity or applicability of the other, as long as their development continue to be structured in a logical and systematic way as we have done with the Guidance.


Lastly,  I wish to briefly express my regret that a few participants have chosen to use this forum to digress into a criticism of the 4 years of difficult yet good work undertaken by the AHTEG members to produce the Guidance. Political statements to criticize the process as being too political (!) and not scientific is unhelpful, inappropriate, and certainly ironic. Hopefully we can stay away from these unconstructive interventions and unsubstantiated allegations in the future and stick to the task at hand.

Kind regards,


David Quist
posted on 2012-12-10 15:17 UTC by David Quist
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3914]
As an outsider to the process of developing these documents, it has been interesting to watch these discussions develop and I would like to echo others and thank everyone for their engagement with the forum so far. Since there have been specific calls for input from those outside the developmental process, I would like to add my thoughts to the discussion, as someone who is engaged in the training and capacity building of risk assessors.

I will focus my comments on the question of integrating the manual and guidance documents and achieving consistency in language.

Firstly let me say that I can understand the desire to integrate these documents into a single package and to have the relationship between them clarified. I also wholeheartedly support the development of consistent language across the two. However, what seems equally important to me is the development of consistent conceptual thinking. For example, I found the way the manual dealt with uncertainty, particularly in module IV, both disappointing and confusing. Presenting the consideration of (remaining) uncertainties after the descriptions of RA and RM stages seemed to misrepresent the important ways uncertainties both affect RA and can influence and shape RM. I therefore found the guidance document and particularly the roadmap's presentation of uncertainty and quality as overarching issues much more helpful and insightful in this regard. Therefore I think it is important that any integration considers not only how to achieve consistency in language, but also consistency in conceptualisation and presentation of important aspects.

While it may on some level intuitively make sense to see the manual as a basic introduction to the topic and the guidance as a more advanced course, I think that in thinking this way, there is a need to be careful that any basic document is not so simplified as to be inaccurate or misleading. I was provoked to think this when I saw figure 2 in module III of the manual which supposedly represents the process of gene splicing but which in fact is an oversimplification to the point of misrepresentation - as the descriptive text below it highlights. I therefore found the Roadmap to be a much more useful document  on risk assessment than the manual and could understand Thomas' suggestion that perhaps the roadmap could be integrated into the manual by replacing module III. After watching the discussions further though, I can also see that there is a pedagogic need to build knowledge and introduce ideas in a stepwise manner.

I may therefore suggest the following approach to integration as a possibility for discussion.
Perhaps the manual could be reworked as a basic introduction to RA&RM in an integrated package. The Roadmap could then be integrated as the more detailed guidance on RA, followed by the already developed case study examples. A section on RM could then follow these, with monitoring elaborated as a case study example of RM practice. Any possible new section on decision-making could then follow the two main parts on RA&RM. Meaning a document with 4 key parts: Basic Introduction (i.e. reworked manual), Risk Assessment (roadmap + case study examples), Risk Management (including monitoring as a case study example), Decision-making (broader context including factors beyond risk to be considered and taken into account).

Finally I think it is important to consider the language used to describe these documents and what this implies about their role. For me, manual means 'this is what you do' and is very rigid in a way, whereas guidance means 'this is something we would like you to do' and therefore opens more easily for the acceptance of other ways to do things. I think this is worth considering when determining what any final integrated document may be called and therefore what it's intended purpose is communicated as and perceived to be.
posted on 2012-12-10 16:10 UTC by Ms. Fern Wickson, GenØk Centre for Biosafety
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3915]
Dear All,

As others who have served for four years in the previous AHTEG, I too am very pleased to see the active participation in this online conference.

Looking at the charge as laid down in Decision BS-VI/12, I think that already very early on in this debate some key points have been raised, and I thank Helmut for moderating it and Hans for kicking off the discussion with some very pertinent observations.

As regards process, I believe that Tom Nickson made an important observation that deserves further thought: we need to be clear on the process we will follow in order to reconcile or reflect discrepancies in views and experiences. In this respect we can learn from the previous AHTEG process, because the way in which the ‘Party Driven Process’ was applied resulted in a dense patchwork that is considered by several participants in this on line forum as not helpful to novice risk assessors, which is a view I share.

I therefore propose that it be clarified from the beginning how to reconcile or reflect differences. I propose that we try to reach as much as possible consensus on scientific grounds (and not on the question whether certain views are brought forward by Party participants or not, because some non-Party and observer participants have very substantial relevant experience in risk assessment), and that in as far consensus cannot be reached, the differences are reflected.
A second point of process raised in this online conference is the concern whether we are jumping ahead too much. I share that concern.  The instruction of the MOP is to align the Guidance Document and the Training Manual. Alignment can take various forms, ranging from aligning terminology to complete integration. To what extent alignment is possible will depend on an assessment of the documents concerned. Yet, in his first guiding questions, Helmut already refers to ‘integration’, while only in his last question he asks the – pertinent – question what experiences people have had with either/ both documents.

I too propose that we defer a suggestion as to whether and to what extent the documents can be integrated be taken after a proper assessment and testing of both documents. I fully support the notion raised by Hans, Geoff, Tom, Paulo, Hiroshi, Isao, Kazuo and others that we should follow the instruction of the MOP and start with testing. I would submit that testing of the guidance document and manual be done by people with much experience and people without less or no experience, and on the basis of realistic cases. In this respect I am very weary of the notion of “parallel” processes, whereby the testing would be done while working on the documents.
As regards content: I fully agree with Geoff that experienced risk assessors would not need nor use the guidance documents, yet I do believe that experienced risk assessors are among the audience, if only to get ‘peer reviewed’ feedback.  In general, I believe that that the resulting document should understandable for beginners, i.e. that it is built up in a step wise fashion that starts with simple introductions, and gradually increases the level of detail, with clear, real life examples.

Looking forward to the remainder of this debate

Piet van der Meer, University of Ghent, Belgium / PRRI
posted on 2012-12-10 16:21 UTC by Mr. Piet van der Meer, Ghent University, Belgium
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3916]
Dear colleagues,

Greetings to all members.

I do agree with Thomas Nickson, Paulo Paes and others: we should start working on the first priority that came from Hyderabad - to develop protocols for testing, conduct the testing and analyze the results. I strongly support the idea of having a practical experience with the training manual and the guidance before new documents are elaborated. This “practical experience” can show how the training manual and the guidance can be integrated in the best way to be useful into the risk assessment process. Additionally the experience of countries with commercial approved LMOs can be incorporated into the package to align the Manual and the Guidance, during this test phase. Some results were already obtained testing the Guidance. The “questionnaire for the testing of the guidance” (Nov/2011) was answered by different countries and can show some cues if the right questions were made and if they can be used as an orientation to improve the Guidance in a more applicable way. The way the results from testing the documents will be analyzed and used to make the documents “fit on purpose” (quoting Dr. Geoff Ridley), in my opinion, is an essential part of the process.  

I also agree with Vilasini Pillai about presenting actual cases of RA as part of the package. I understand that based on the experience testing the Manual and the Guidance we can produce some “case studies” to illustrate the application of RA principles outlined in the documents.    

About the decision making, I´m not sure if it´s useful to include a section regarding to this subject in the new package. I understand that risk assessment is a rigorous science-driven process as described in the Manual and the Guidance while a decision-making process incorporates other formally and informally factors such as public concerns and opinions, existing policies, responsibilities under international agreements etc. To avoid confusion over the functions to be performed by risk assessors I think is better to keep the decision making apart from the documents being discussed at this moment.

Best regards,
Luciana P. Ambrozevicius
Ministry of Agriculture / Brasil
posted on 2012-12-10 17:11 UTC by Ms. Luciana Ambrozevicius, Brazil
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3917]
Dear Helmut,
Thanks for your clarifications, and since this is the first time I have posted to this particular forum I will take the opportunity to thank you for your work in organizing the session and also thank the Secretariat for the opportunity to provide input.

I will also start by recognizing that the task that was assigned to the AHTEG, and which is being continued here, is by no means an easy one.  Reaching consensus with such a diverse stakeholder group is a real challenge, and the breadth of topics being addressed is more than a little ambitious.  I think the AHTEG participants deserve credit for their hard work and dedication, and I don’t think anyone should disparage that effort.  At the same time, however, I don’t think that should preclude us from looking at the work products with a critical eye. 

Although I agree that politics and Party affiliation are not productive topics for the forum, I disagree with David Quist’s assertion that comments on the process used to generate the guidance documents are misplaced or not constructive.  I think we need to consider how the process might be improved, or else we will repeat past mistakes.  We also need to keep in mind what the practical limitations are of a forum such as this one.  As Dr. Watanabe points out, it took the AHTEG four years to produce the documents as they are. 

I would wholeheartedly agree with the assertions offered by Dr. Ridley and others that the order of our work is imperative.  I think the first priority must be to produce a plan for testing the guidance documents and collecting information from those tests and analyzing it.  Then, depending on what that tells us we can consider making changes to them.  Otherwise, we are just redrafting them using the same process as before.  I also think it is imperative that we have a well-developed plan of what we hope to accomplish.  One of the procedural difficulties in producing the guidance documents was the failure to reach a common understanding among participants (and observers) on what the AHTEG was supposed to achieve and how it would go about its work.  I understand that this may seem laborious to those who are concerned about the schedule, but how could we ever agree that we have accomplished our task if we don’t first agree on what our task is? 

Finally, I’d like to express my deep misgivings about the proposal for the development of material related to decision-making.  I’m at a loss as to what sort of guidance a technical experts group might provide on this subject, beyond unnecessary (and likely unwelcome) interference with national legislative and political priorities.  This is simply not an appropriate forum for this topic, and I think it would put an unnecessary focus on trying to generate guidance tailored to a specific outcome rather than guidance based on the best science and informed by practical experience with risk assessment.
(edited on 2012-12-10 18:31 UTC by Andrew Roberts)
posted on 2012-12-10 18:28 UTC by Mr. Andrew Roberts, International Life Sciences Institute Research Foundation
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3918]
Dear Colleagues

I have read all the postings to date with interest and believe that the discussions are meeting purpose of providing a forum for brainstorming the future path for the (continued) development of guidance, the establishment of training materials and the testing of both guidance and training materials.  One point that to my mind has not been made explicit (though all of you will be aware of it) is that as we learn more about the application of risk assessment and as new tools are developed and refined, the way in which we conduct a risk assessment will (should) change.  Therefore the guidance and training materials need to have explicit 'built-in' flexibility.

However, my main reason for entering the discussion at this point is to endorse the comments made by Luciana Ambrozevicius and  Andrew Roberts (along with their endorsements of Geoff Ridley and others).  Critically for the revised AHTEG to be effective it must have an agreed purpose and understanding of its role and tasks, and how it will interact with other groups such as this forum.  I am also strongly of the view that if the Guidance is to include any reference to decision making then it needs to be clear that 'decision making' refers solely to the input that risk assessment has to making decisions about managing risks, and does not attempt to go beyond this.

regards
Janet Gough
posted on 2012-12-10 23:00 UTC by Janet Gough, Environmental Protection Authority
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3919]
I am a new member on this forum, and it is an honour to be participating here.  My background is primarily technical, though I have been participating in risk assessment of GM in food safety evaluations and I have some experience in capacity building.

I see the wisdom of streamlining the information in the two documents for clarity and ease of use, but I also think that keeping them separate allows them to serve different purposes/target slightly different audiences. Is a person using them likely to need to switch constantly from one to the other, and thus become confused if they are not integrated? Or, is it likely that a user will go to one or the other depending on the task at hand, and the language of the document can account for this?  This may require explicitly identifying the intended function and target audience of each document. 

Regardless of the final level of integration, it is crucial that technical terms and concepts are consistent between the documents (as has been mentioned previously).  Furthermore, it seems to me that this important work can be done without additional testing of the documents’ efficacy.  Many people here are debating whether or not testing should be conducted before revising the documents.  It seems the most practical route would be to identify aspects of the documents that can be changed without this, and focus on these first.  This would allow action on both a and b of Decision BS-VI/12 concurrently.
posted on 2012-12-11 01:09 UTC by Dr Dorien Coray, University of Canterbury
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3921]
Dear Helmut, Dear members of the forum

As this is my first submission to the forum I would like to extend my greetings to all of you and my appreciation to Helmut for agreeing to moderate. I was also a member of the last AHTEG.

1. Who is the target audience of this package? Like many others, I believe that the package should be structured so as to be helpful to trainers, novice risk assessors and risk assessors of advanced experience.  (We may not reach everyone in these groups because for example, as Hans Bergmans said in his first post, some risk assessors may have already formed opinions that they do not wish to revise.) However, I would also suggest that there are additional dimensions to our audience. Our audience may be composed of those with different risk assessment backgrounds, such as those with more experience in human health than in environmental risk assessment, and those with more familiarity and experience say in ecology than in molecular biology. In which case, I would encourage the new AHTEG to be aware of the different views that may come from those who have different specialist experiences. This may in part be achieved through the way the AHTEG is composed, e.g., perhaps more emphasis on human health and ecological sciences would benefit the next AHTEG. These considerations may also be applicable at the guidance testing stage.

If indeed the Guidance will be found to require significant revision after testing, and that is at this stage a hypothetical possibility, then we should not waste an opportunity to involve the ecological and human health scientists to a greater extent than perhaps we already have.

While I see that reducing “regulatory uncertainties” (Tom Nickson) for LMO developers (of any description) may be valued by them, I do not think that either the Guidance or the Manual should be prioritized to their needs. Ultimately “regulatory uncertainties” are not created by non-binding Guidance or training, but by interpretations of law and policy made within the national framework. These documents are meant for countries and in particular Parties to the Protocol and the focus is on value to them. It is not for us to judge if perceived regulatory uncertainties are deemed necessary by decision-, law- or policy-makers, or to intervene at the level of national policy and national laws.

2. Like others posting in the forum (e.g., Angela Lozan, Hans Bergmans, Wei Wei) I do not find it problematic to consider how to align the documents before we actually align the documents and complete testing. This plan and a vision for achieving a package does not presuppose the content of the final product. I am inclined to agree with what Boet Glandorf saw as a package in which the Manual and Guidance were not merged into a single document but were brought together as a package. In which case, it might be that the Manual as a single document reproduces parts of the Guidance, but it does not replace the Guidance.

While we should avoid duplication of effort, I see this forum as having been useful in identifying a pathway to operate the testing and integration in parallel and to derive some benefits from doing so. Perhaps I have over interpreted some interventions, but I get the impression that some in the forum already believe they know what will be the outcome of testing. I will keep an open mind on this until testing is completed.

On this point, I would like to ask a naïve question. I did not participate in the process of developing the 2003 Codex documents for food safety assessments on plants and microbes produced through modern biotechnology, but I did participate through the subsequent submission process on the Codex document for animals produced through modern biotechnology. I don’t recall ‘testing’ phases for those or for the OECD documents mentioned earlier in this forum, but that might be because of my limited knowledge of those processes. Was there a similar ‘testing’ phase for those guidance documents and if there was, are there lessons for us from that experience that might help us in this brainstorming exercise?

3. I am persuaded by those others in the forum that a discussion of the place and time for risk assessment, risk management and decision-making is proper for the package. As Geoff Ridley has indicated, his agency performs all three roles. In some countries, the roles may be split between different agencies or officials. I see no danger in decision-makers not knowing that they are decision-makers or in risk assessors being deceived into thinking that they are decision-makers because they read the Guidance or the Manual, so I think that there is little possibility of the kind of trespassing that I interpret as concerning Janet Gough and Andrew Roberts. But the revisions should remain sensitive to these concerns.

4. Several in the forum have stated that the testing should include “actual cases of risk assessment” (e.g., Vila Pillai and Hiroshi Yoshikura). I presume that this means actual LMOs (rather than pre-existing examples of the outcome of a risk assessment done by someone else). In any case, the LMO or sample assessment that might be chosen could very well be one that is described in Part II of the Guidance, and thus Part II should not, in my view, be arbitrarily seen as “advanced RA” and beyond the scope of the Manual. My way of thinking on this is close to Fern Wickson’s who described in her intervention one possible and attractive organization of the Manual and the existing three parts of the Guidance where the Manual is seen as a curriculum (in the David Quist sense) and the Guidance as a reference for those doing RA and RM. So to be clear, I think that the entire Guidance suite (all 3 parts) should be part of this alignment.

Thank you for this opportunity to participate in the discussion and best wishes to all.
Jack
posted on 2012-12-11 05:46 UTC by Mr. Jack Heinemann, University of Canterbury
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3922]
Dear Helmut and Participants of the Open-Ended Online Forum:
Thank you all for a very interesting exchange of ideas.
I would like to start by supporting those views that stressed the importance of carefully considering how could be the best way to accomplish the mandate given by the MOP, bearing in mind how to best make use our time. I share the opinions posted by Dr. Geoff Ridley, Luciana P. Ambrozevicius, Andrew Roberts and others in the sense that the first priority must be to produce a plan for testing the guidance documents, proceed with the testing and collect the information from those tests and analyzing it.

Following the invitation to share our thoughts with respect to the future alignment and the development of the integrated training package, like Hans (and others after him) pointed out in his intervention I also think that the package could be useful to anybody involved in environmental risk assessment of LMOs, but not just for trainers, novice risk assessors, and risk assessors with a lot of experience, also as Tom Nixon mentioned, for developers (most likely small ones) and possibly public research institutions planning to submit applications for the release of LMOs (i.e field trials). Each audience will very likely use it in different ways. I think that as a result from the testing process we will have a better idea, about which audiences find the guidance documents useful and modify them accordingly, both to better target a particular audience and if possible, expand its reach and usefulness to other audiences. On this however I will agree once more with Hans and underline that we should  “keep in mind that it is the novice risk assessor who should be able to understand the flow of thoughts and can use the guidance -and the training package- in the practice risk assessments” so we could prioritise this kind of audience.

There is the interlink of the testing process and the development of a package, as some Members already commented the testing process should allow for the identification of different audiences.

I think that the Manual should be used as the basis for the future alignment and the development of the integrated training package, since the manual presents more information and background. Also depending how the guidance will be modified after the testing process, it could stay as an additional document or as an integrated part of the Manual.

With respect to the type of language used I think that we could aim to prioritise the Manual as the reference to standardise the package. I think this is just a practical approach since, to my understanding, what is going to be tested and modified is the guidance, so part of the changes could include modifying its language to make it congruent with the Manual (or when appropiate adjust the lengujae in the Manual). (The next logical question could be if this will be done before or after the testing process).

In relation to the question on what do we integrate, if all of the guidance or just the roadmap section, I agree with Hans:  we start with integrating the Manual and the Roadmap, and, once we have learned from that exercise, we consider the other parts of the guidance in a step wise fashion.

Finally for now, in relation to the question of including a section on the decision making process in this new package, I do not see a mandate from the MOP to do so, and as Andrew Roberts pointed out “This is simply not an appropriate forum for this topic”.

I look forward for the following interventions
(edited on 2012-12-14 07:53 UTC by Sol Ortiz García)
posted on 2012-12-11 07:33 UTC by Ms. Sol Ortiz García, Mexico
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3923]
Dear members of the forum,

Their is one question that I miss to answer on my first post and that is the question of including a section on the decision making process in this new package. I don't support that idea and agree with some others that we should focus on risk assessment and management and the inclusion of decision making should be left to another forum.

Thank you and best wishes to all,
Jelena Zafran Novak
posted on 2012-12-11 08:22 UTC by Jelena Žafran Novak, Croatia
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3927]
Dear Jack,

Thank you very much for your intervention.  Although it seems that we are still at the stage of presenting and suggesting ideas (and I would normally refrain from heavily commenting on others posts), you have posed some questions, so it seems appropriate to respond and perhaps broaden the dialogue.

I was not directly involved in the negotiations for the Codex guidelines, but to the best of my recollection there was not a testing phase for these.  Others will correct me if I am wrong.  Perhaps a case can be made that there should have been, however there are many differences between the way the Codex committees operate and the way the Parties to the Protocol have chosen to formulate the AHTEG and direct its work.  Probably the most pertinent is that the Parties have, in their decision (multiple decisions, in fact) asked the AHTEG to test and evaluate the guidance or to at least propose a mechanism for doing so.  Thus, that is the task we have been given.

Regarding your point 4, I share your interpretation that what is being suggested is applying the guidance to real (or at least realistic) LMOs and allowing assessors to proceed with an assessment.  However, I think that this will have to be considered very carefully and that there will not be a single universal solution.  A case study approach, using cases that are designed for the testers (i.e. simple case studies for novice assessors, more complicated case studies for more experienced assessors), seems like the best way to proceed.  But again, we need to be cognizant of the fact that we are not interested in evaluating the case studies (or in the outcomes of the risk assessments), but rather in evaluating the usefulness of the guidance to the assessors.  In the case of risk assessors who are experienced and have existing regulatory assessments to draw from it may be appropriate for them to go through the formal exercise of considering how the guidance would or would not impact their assessments and whether they find the guidance beneficial. 

Finally I would like to agree wholeheartedly with your suggestion that we should not be attempting to “intervene at the level of national policy, or national laws” or to interfere with Parties’ interpretations of these.  I will point out though, that while “regulatory uncertainty” can include uncertainty at these levels it also includes uncertainty due to a lack of clarity regarding regulatory requirements and how risk assessments are conducted.  This speaks to transparency, which is contained in the first general principle for risk assessment in Annex III (paragraph 3).   In light of our agreement on staying out of Parties' national affairs, I’m also confused by your suggestion that we should include a discussion of decision making.  I can’t imagine anything that this group could contribute to Parties’ decision making that could avoid being seen as (and being in fact) interfering at the level of national policy, or national law.

Best,
Andrew
posted on 2012-12-11 16:30 UTC by Mr. Andrew Roberts, International Life Sciences Institute Research Foundation
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3932]
Greetings again to the forum

Thank you Andrew for both your insights on the Codex and OECD processes and for pointing out where I may have been unclear.

(1) I am pleased that the Parties to the Protocol have increased the standards of review for international guidance documents through the testing requirements. Thus we can be confident when this Guidance might differ from OECD or others.

(2) I don’t see it as a contradiction to include a section on decision-making and to exclude “regulatory uncertainties”. Perceptions of what these are may be contested and will likely vary from country to country and thus don’t constitute a thing we can address. Moreover, the Guidance is not the cause of regulatory uncertainties. If they exist for some who are subject to regulation, then they exist because of national choices in legislation, policy and practice.

The Guidance on the other hand repeatedly refers to transparency of assessor process, so again I would argue that the Guidance is not the cause of regulatory uncertainty that arise from not being transparent. However, it is up to the country how they achieve transparency.

I don’t presume that the Guidance would suggest what decisions are to be made or how the decisions are to be made and therefore I don’t presume a section on decision-making would necessarily be prescriptive or presumptive. The decision-making section could be a discussion on the difference between the role of the risk assessment and risk assessor and the role of decision-making; it could be a discussion on where in the timeline decision-making sits between assessment and management. I just note that some Parties see value in some text on this issue, and some don’t, and some think that the text would be inappropriate. I don’t see all topics under decision-making as necessarily inappropriate and therefore support the idea of developing appropriate text that some Parties want and others may ignore if they wish.

best wishes to all
Jack
posted on 2012-12-11 21:40 UTC by Mr. Jack Heinemann, University of Canterbury
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3928]
Thank you Helmut and others for the hard work.

1. Who will be the target audience of this package:
These manuals should be available to all people who are concerned about the safety of biodiversity and the health of their country, not only for regulators. This would facilitate citizen oversight over decisions made by the authorities.

2. How can the Guidance and Manual be integrated?
Both proposals presented to us by the Secretariat are complementary instruments that they address different aspects of risk assessment and management, but probably it can be useful to integrate then into one, trying to avoid some repetitions present in bot documents.

I agree with another participant that states that some of the graphs oversimplify the complexity of splitting genes, and risk assessment, so probably they should not be included.

Both instruments should be taken as a reference to the minimum procedures to be followed by countries upon approval of a living modified organisms. Thereafter, the country has the power to raise the standards and levels of security for both the environment and the health of its population.

I do not think that should simplify the texts, as the fact that a country has no risk assessors experienced, opts not to the standards to be used by those countries are the highest, and the procedure to ensure that the population decisions are taken on the basis of risk assessment not endanger neither them nor to biodiversity.

If a country does not have that capability, then you should not admit to its country LMO and other alternatives to solve the problems they want to address through the adoption of GM crops or other LMO.

3. With respect to the type of language used: which document will have priority as the reference to standardise the language between the two documents?

I think the document UNEP/CBD/BS/COP-MOP/6/13/Add.1  

5. Do we include a section on the decision making process in this new package?

Risk assessment is only one part of the decision making process, is only one input to it, since most of the decision are taking based in other aspects such as economical and political priorities of the countries. The decision should also include a process of consultation with the society and each country has different regulations and political culture in relation with people’s participation.

So, probably this section is not necessary
posted on 2012-12-11 18:14 UTC by Dr. Elizabeth Bravo, Acción Ecológica, Ecuador
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3933]
Attempt should not be made to deviate from the task given by Parties to test and evaluate the guidance or to at least propose a mechanism for doing so for now. The AHTEG and various experts have made tremendous useful inputs into the guidance in identifying a pathway to operate the testing.
Appointed assessors and CNAs should go ahead and test the guidance.
Based on reactions from the testing  the guidance can then be significant revised to address any gap identified. Its important for Parties from African that are now becoming active in modern biotechnology and biosafety activities to test the guidance to ascertain its usefulness to them.
Rufus Ebegba,
Nigeria
posted on 2012-12-12 04:17 UTC by Dr. Rufus Eseoghene Ebegba, Nigeria
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3925]
POSTED ON BEHALF OF MS WADZANAYI MANDIVENYI

-----------------------------------------------------------------
SOUTH AFRICA INPUT ON RISK ASSESSMENT AND RISK MANAGEMENT ONLINE FORUM

1. Who will be the target audience of this package:
o Trainers of RA?
o People learning how to carry out a RA?
o Risk assessors/ Practitioners?

SA response:
The package should target all the categories noted above. Of particular importance would be the risk assessors and practitioners. In the developing country context, the people learning how to carry out a RA will in turn

2. How can the Guidance and Manual be integrated?
o Should the Manual or the Guidance be used as the basis for this exercise?
o Should the package also provide a step by step guide for risk assessors to use when conducting RA?
o Should the package also be aimed for usage as a reference and background text for RA?

SA response:
Given the complex nature of the work at hand, it is best that both documents be integrated in a manner that is mutually inclusive. As such, while the manual should provide a basic more hands-on practical approach, the Guidance should provide greater detail including appropriate references to the many background documents where the reader may find more information.
It is important for the package to provide a step by step guide for risk assessors and to be robust enough to function as both a

3. With respect to the type of language used: which document will have priority as the reference to standardize the language between the two documents?

SA response:
Given the difference in approaches between the two documents it is not possible to really standardize the language between the two documents. However, it is very important for the glossary of terms and definition of concepts to be consistent. Given the target audience as developing countries with limited capacity for risk assessments, the simpler language with minimum repetition may be more helpful.

4. Do we integrate all of the guidance or just the roadmap section?

SA response:
For the purposes of risk assessment training and capacity building the roadmap is the most appropriate section for integration as it supports the risk assessment process indicated in the manual. The further integration of the specific guidance can be undertaken at a later stage once the overall guidance has been agreed upon.


6. What (practical) experiences have people had with either/ both documents?
o Was one document easier to use/ understand than the other?
o What aspects of one or the other do you think will enhance a user’s understanding of RA?

SA response:
South Africa tested the guidance and found that:
• The Guidance Document is well written and thought out but difficult to apply because of the subjective nature of the assessments. It was even noted that no two people could come up with anything like a similar assessment for an application.
• An improvement in this direction would be a semi-quantitative approach as described by Morris, 2011. Transgenic Research DOI 10.1007/s11248-010-9480-8.
• * The 'approach' taken by this roadmap should be more clearly explained. The leap is too big from the framework/strategy that we are accustomed to.
posted on 2012-12-11 14:27 UTC by Dina Abdelhakim, SCBD
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3926]
Dear All
Many thanks for the current discussions that will allow to provide input in the process of testing guidance taking into account the less develloping countries where capacities of risk assessment and risk management are not available. I think that the development of package guidance on RA of LMOs must provide a simple and clear scientific ground and also focus on training risk assessors and regulators particularly from developping countries. Best practices for RA conduct , the expanation on how to use the roadmap and the regulatory systems of various parties must also be taking into account .
posted on 2012-12-11 16:24 UTC by Mr. Mahaman Gado Zaki, Niger
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3929]
Thank you Helmut and others for the hard work.

1. Who will be the target audience of this package:
These manuals should be available to all people who are concerned about the safety of biodiversity and the health of their country, not only for regulators. This would facilitate citizen oversight over decisions made by the authorities.

2. How can the Guidance and Manual be integrated?
Both proposals presented to us by the Secretariat are complementary instruments that they address different aspects of risk assessment and management, but probably it can be useful to integrate then into one, trying to avoid some repetitions present in bot documents.

I agree with another participant that states that some of the graphs oversimplify the complexity of splitting genes, and risk assessment, so probably they should not be included.

Both instruments should be taken as a reference to the minimum procedures to be followed by countries upon approval of a living modified organisms. Thereafter, the country has the power to raise the standards and levels of security for both the environment and the health of its population.

I do not think that should simplify the texts, as the fact that a country has no risk assessors experienced, opts not to the standards to be used by those countries are the highest, and the procedure to ensure that the population decisions are taken on the basis of risk assessment not endanger neither them nor to biodiversity.

If a country does not have that capability, then you should not admit to its country LMO and other alternatives to solve the problems they want to address through the adoption of GM crops or other LMO.

3. With respect to the type of language used: which document will have priority as the reference to standardise the language between the two documents?

I think the document UNEP/CBD/BS/COP-MOP/6/13/Add.1  

5. Do we include a section on the decision making process in this new package?

Risk assessment is only one part of the decision making process, is only one input to it, since most of the decision are taking based in other aspects such as economical and political priorities of the countries. The decision should also include a process of consultation with the society and each country has different regulations and political culture in relation with people’s participation.

So, probably this section is not necessary
posted on 2012-12-11 18:15 UTC by Dr. Elizabeth Bravo, Acción Ecológica, Ecuador
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3930]
Greetings to all members of this Open-ended Online Forum

I would just like to remind us that the roadmap and the other guidance documents are already at a very advanced stage. What we have today in hand is the result of several rounds of discussions, testing and scientific review. Perhaps I would ask Helmut to kindly reflect on that for the colleagues that are new to our discussions.

In addition to that, the guidance documents do not introduce any new exotic ideas on risk assessment to fear that they will be tremendously changed by any kind of testing.

With this in mind and noting the urgent need of developing countries especially the African ones for the package I think we should proceed with the 2 tasks simultaneously.

Warm regards to all
posted on 2012-12-11 18:28 UTC by Mr. Ossama Abdelkawy, Syrian Arab Republic
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3931]
I would like to comment on a couple of issues recently raised in this forum and how it relates to our modus operandi. 

First, Jack raised an interesting question about whether Codex or OECD guidance underwent testing.  To the best of my knowledge the answer is "no".  However, I would quickly add testing was irrelevant because these were concensus documents.  Documents from groups like OECD can only be published by agreement among all Parties.  Because these are consensus document they are widely used around the world.  Furthermore, my experience with OECD working groups is that observer input plays a material role in the consensus outcome.

Second, Ossama correctly notes the (very) advanced stage of the guidance, but in truth it is still not a consensus. 

We are now continuing the very difficult work of advancing the guidance through testing and integration of the guidance with training materials.  The task is further complicated by the fact that we have very advanced guidance in the form of chair's text (not a consensus) and manuals in some other state of development. 

One brainstroming suggestion is to examine the process being used to see if and how consensus could be achieved within the new AHTEG.  A good start would be developing a consensus interpretation of the Terms of Reference in BS IV/12.  I share the concerns shared by several colleagues from Japan recognizing that these Terms of Reference were the outcome of challenging negotiations within the working group and contact group.  This should not be overlooked in developing the path forward here.

With regard to process, can we go back to Helmut's original proposal and focus on items where better consensus might be achieved such as #1 target audience and likely users and #6 experience with use?  Many of the other questions seem to lead the online forum to topics that are irrelevant to the Terms of Reference - specifically, a section on decision making.

Thanks again to all for their constructive brainstorming.
posted on 2012-12-11 21:25 UTC by Mr. Thomas Nickson, Consultant
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3934]
I have been out of the office for the last two days so it has been daunting to come back to so much discussion in my absence.

In my consideration of the guidance and manual I am always thinking of Article 22 (1):
The Parties shall cooperate in the development and/or strengthening of human resources and institutional capacities in biosafety, including biotechnology to the extent that it is required for biosafety, for the purpose of the effective implementation of this Protocol, in developing country Parties, in particular the least developed and small island developing States among them, and in Parties with economies in transition, ….

We are constantly hearing of the lack of capacity of many of the parties despites much activity over the last few years to change this situation. This was the reason I said that the documents needed to be fit for purpose. That purpose is not just to increase capacity but also in many cases to begin the development of capacity. I am yet to be convinced either of these documents are fit for this purpose. My concern is that we are producing documents that are purest and are not of use to those who need them most. I supported the testing of the documents especially by those countries with limited capacity (especially those who had been to capacity building courses) to see whether or not the documents were fit for purpose. If they cannot successfully use these documents then we have gone off on an irrelevant tangent and we are failing Article 22.

As a group we have become somewhat bogged down in the testing of the document. Testing might be the wrong word for what we meant but it became the accepted vocabulary in Hyderabad. As I note above it is not so much testing as it is can the documents be used by those who need to use them. The consistency of the language seems unimportant to me if the documents are of no utility.

Geoff Ridley
Environmental Protection Authority, New Zealand.
posted on 2012-12-12 07:45 UTC by Dr. Geoff Ridley, Environmental Protection Authority
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3935]
Dear Helmut and all,

It might be considered various ways of discussion and one of which may be presented by Helmut.  It is, however, decided by the Parties in the COP-MOP6 that “the Guidance will be tested nationally and regionally for further improvement in actual cases of risk assessment and in the context of Cartagena Protocol on Biosafety”, in paragraph 1(b) UNEP/CBD/COP-MOP/6/18 and the first priority of our work is the testing of the Guidance in the TOR.

It is no doubt that the roadmap and the other guidance documents have been discussed after COP-MOP4.  I understand, however, there is no consensus that it is at a very advanced satage, especially, newly developed guidance documents, which are the special guidance on “Risk assessment of LM trees” and “Monitoring of LMOs released into the environment”. 

Also, the documents have actually been developed through the face-to-face discussion of AHTEG and the several online discussions.  It is shown, however, that the participants of the discussion have been extremely limited, as described in UNEP/CBD/BS/COP-MOP/6/INF/11.  For example, when the comments on the priority of new topics were requested during the On-line Forum from April 11 to April 18 in 2011, there were only 17 interventions (and yet 9 of them were from the member of AHTEG, and 3 of 9 were from the same person).  Also, in the Real time on-line conference of Asia and Pacific region on April 19 in 2012, the participants were only from two Parties (China, Japan), excluding Chair(Malaysia) and two individual observers.

Isao TOJO
posted on 2012-12-12 07:57 UTC by ISAO TOJO, Ministry of Agriculture, Forestry and Fisheries
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3936]
Dear all:

Thanking to the intervention of Mr. Tojyo as a member of the risk assessor and regulator of the LMOs-FFP both on EBR and Food safety with relevant experiences on handling applications and decision-making, at MAFF of GOJ, I would like to recall again that we should not deviate from the decisions of MOP-4 to MOP-6, and the mandate of the online forum is limited for assisting the implementation of the RA&RM based on ANNEX III of the Protocol with relevant flexibility to the parties for their own ways of processes, and forums should not overtake to make a new mini-protocol without having interlinking and also collaborating with existing efforts.  I agree with some of participants that this forum should not discuss and prioritize needs of further addition of the content nor adding new mandate such as training on RA planning and manuals for the potential users at developing countries. As mentioned previously also by many of participants, testing and promotion of implementation practices help more than addition of the any of documents.  Upon the testing, the present documents could be modified based on the feedback from the users in future. Key practice such as AIA should be implemented rather than making a document further.

Also many organizations provides references docs as also presented in this forum, and inter-linkage and collaborative arrangements should be enhanced rather than stand-alone and square-one discussion.

As for industry relationship, while use of the LMOs is upon each country, and as Tom Nickson commented, domestic industry participation where applicable from parties are cardinal to support healthy economic development considering the sustainability and conservation of the biodiversity. Private sector participation from the developing counties also help to meet with the reality of the RA processes.

So far I do not see much of interventions from the regulators risk assessors, decision-makers etc. from the different parties, especially from the developing countries, where actual need and feedback shall be indicated. It is rather discussion by by-standers, who do not engage directly in the processes in a country.


Regards,

Kazuo Watanabe
posted on 2012-12-12 09:17 UTC by Dr. Kazuo Watanabe, University of Tsukuba
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3937]
It is very interesting and in my view unproductive discussion. I have just a few comments to participants who try to convince us that the quality of the Roadmap and advanced guidance documents is not appropriate. 

Where the on-line forums organized in secret? I suppose that all National Focal points, as well as relevant organizations, NGOs, experts were invited to participate.  Those people who considered important the forum and the proposed topic, they have opportunity to take part in discussions and contribute to the quality of the documents. This is not an argument for lack of consensus. 

We may never get a consensus on the quality of Roadmap or training tool. I would remind to us again that the guidance in RA/RM is a recommendative and non- prescriptive paper, and not necessary to give it to students or new coming evaluators to follow it point by point.  The document involved the theoretical approach and is based on available knowledge and experience of the day.  I also find the documents of a good quality, involving all basic elements and steps of a general theory on risk assessment. The testing of guidance expects to provide us with some possible missed questions to be completed. Some light improvements might be useful in relation to language, I admit. But I am far from idea to return back, to start from zero, and revise cardinally the document. It is waste of time and efforts.

For my understanding, it seems that some colleagues from industrial countries not fully aware the reality and needs of the developing countries.The Guidance document is really needed by countries with limited capacities, whether to build national capacities for the RA procedures, or to examine the RA papers part of notification provided by importers/developers during decision making.  It is not expected that countries will be requested to approve the document at national level.  According to the country's available resources and capacities, the guidance might be adjusted and adapted for individual country's conditions at present.  It doesn’t mean that we need to develop a simplistic version of Guidance. 

So I would propose to go for a constructive discussion of how to make useful the package.

Angela Lozan
posted on 2012-12-12 09:40 UTC by Angela Lozan
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3938]
Thanks! Angela! I fully agree to you. I continue to hear that some colleages from developed economies repeated that they have good experience and do not need the guidance. I am really suprised to that. As a scientist I worked on risk assessment of GMOs for more than ten years and am aware of the advanced system in the inductrial countries. However, I never hear any goveronment says they do not want any improvement. Whenever I look into the guidance documents I feel really satisfied. During the four years' works I felt I always learn a lot from the discussion with our colleagues.

I recalled my theory of cigars; someones said they can tolerate one burn ciggrete in the meeing room but others insist on three. If we could set up a standard, then there would have been no argument. It is true that the situation varied in each nation. An idea/standard documents should be developed that can serve as an reference when people want to use it. This kind of documents should be universal and taking all factors on board. Each party can choose to use it with their own situation. If the party do not want omics then they do not use it. That does not necessarily prevent the inclusion of omics in the documents.

Decision making should be one part of the document, but regulatory uncertainty is not part of the risk assessment procedure.

Cheers!
posted on 2012-12-12 11:05 UTC by Mr. Wei Wei, China
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3957]
Dear Colleagues—
I am sorry that other matters have kept me from earlier adding to this useful discussion; I do want to make a few points to fold into our deliberations. Unfortunately, they overlap the 6 points set out originally by Helmut, so I have not tried to artificially segregate them.

Despite the implication in PhilipMacDonald’s posting that countries like Canada don’t really need guidance and manuals, I’d like to say clearly that the actual “assessments” being put forth by developed countries (including the US and the EU) are NOT adequate to protect biodiversity or  human health (nor economic and other social factors). These “existing approaches” (to use the term of Boet Glandorf and Hans Bergmans) will be further explored as we move into discussing “testing,” but the reality is that none of these real-world activities measure up to the expected actions embodied in the Guidance (nor, since most of the LMOs are foods, the procedures set forth in the relevant Codex guidance documents).

This statement may seem unduly provocative to some colleagues, but I want to suggest that several court cases in the US have thrown out such assessments as being partial and inadequate. In the EU, EFSA has apparently recognized that its procedures had been faulty and has tried to develop new ones, although their adequacy is also being questioned by some experts. And, yes, experiments such as Seralini’s recent peer-reviewed paper show that the data submitted by the industry for EU approval of that sort of LMO were obtained by reliance on research of inadequate design (animals observed for too short a time), and hence are untrustworthy. (Please let’s not get into a discussion of the politically motivated attacks on this work.) Not only are these faulty administrative approvals unable to keep faith with the requirements of international treaties governments have signed (although not Parties to the Protocol, the US and Canada are Codex members and voted to accept the Codex procedures which are far more exacting than their current practices), but these failures contribute to widespread skepticism on the part of civil society.

Assessments are part of a political process, of allocating the distribution of risks/costs/benefits among different sectors of society, and thus public acceptance is clearly one of their goals.  The bounds and procedures of any assessment are established by subjective political and social factors (as this forum exemplifies).   Thus, I am in some disagreement with the comments Yoshikura-san has submitted. The basic decision of whether country A should do an assessment or rely on one performed by country B is political; it was not so long ago that countries producing LMOs argued that acceptance of the LMO anywhere (i.e., by them) should allow it to be accepted everywhere –certainly a non-scientific “criterion” which would ignore such elemental factual bases as the differences between receiving environments. Although part of the (somewhat artificially distinguished) risk management portion of this work, the answer to the basic question of “how safe is ‘safe’ ”—i.e., what level of risk is acceptable to a society--is surely not a matter of science but of politics.  Hence, the link of risk assessment to decision-making must be indicated and explored, but without any prescriptive aspects.

My concerns about the Manual flow from the description of its genesis by Glandorf and Bergmans: it is “the manual that has been used in regional training workshops. The manual was to be submitted to ‘experts and other reviewers from Parties and other Governments for an assessment of its effectiveness’.”  Unfortunately, much capacity-building which has occurred in past years (often under auspices of the Secretariat) has relied on relatively few “experts” who have voiced largely uniform positions on the contentious issues surfacing during the whole long Protocol process.  Their approach has often been, in my opinion, limited, partial, and biased.  A Manual reflecting these exercises (who reviewed it?  I don’t recall seeing it come around for comments) will not be nearly as comprehensive and useful as the Guidance the ATHEG has developed.  Integration (of language, etc) should be attempted, but in places of incompatibility or omission by the Manual,. I believe that we need to go with the superior Guidance work.

The bottom line is that we should produce documents that  affirm the clear position of the Protocol:  in the absence of an adequate comprehensive risk assessment, a Party is completely justified in invoking the Precautionary Principle and denying importation of an LMO.

Phil Bereano
Professor Emeritus, Technology & Public Policy
University of Washington
and for the Washington Biotechniology Action Council
posted on 2012-12-13 18:33 UTC by Dr. Philip L. Bereano, University of Washington
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3976]
Thank you for your comments.  You have however missed my point.  The guidance developed by Canada and most others stems from our legislation and is built around our protection goals and values as a country.  The regulations underwent extensive consultation and our regulatory framework is the outcome of a number of years of extensive consultation at national and provincial levels and included a wide cross section of the stakeholder group, including scientists.  This is the reason why Canada is unique in the world in recognizing that products rather than the technologies that create them can be a potential source of harm to biodiversity.  Thus we regulate novel products rather than LMOs.  This means, for example, that a broad spectrum herbicide tolerant plant created by radiation or chemical mutagenesis falls under the same regulatory oversight as a roundup ready crop produced by genetic engineering. 

While all mature regulatory systems, including the US, Canada and the EU are in a continual process of improvement, they are at a very different stage than those struggling to decide how to structure a risk assessment process that fits with their own goals and legislation.  That was really my point and I feel that this can be where the document could be truly useful and where the focus should lie.  To imagine that mature regulatory systems like ours that have legal requirements as to how they operate and an environment where developers have clear expectations of process, will now take on guidance developed in an external process by a small expert group, seems unrealistic to me.

Contrary to your comment, I would argue that after 20 years, and more than 80 plants with novel traits approved for commercialization our regulatory approach has been shown to be quite effective at protecting biodiversity but that now takes us into the political area that is outside the scope of this discussion.

Best regards,
Phil Macdonald
posted on 2012-12-14 15:19 UTC by Mr. Phil Macdonald, Canada
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3939]
POSTED ON BEHALF OF HIROSHI YOSHIKURA
-----------------------------------------------------

The first comment relates to Dr. Jack Heinemann’s comment mentioning Codex Alimentarius Task Force on Foods Derived from Modern Biotechnology. I was actually the Chair of the Task Force.

“Testing phase” mentioned by Dr. Jack Heinemann is out of the Codex’s scope, in my view, because:
1. Codex’s responsibility is to make proposals to and to be consulted by the Director Generals of FAO and WHO.
[Note: “Codex Alimentarius Commission shall …. be responsible for making proposals to, and shall be consulted by, the Director General of FAO and WHO on all matters pertaining to the implementation of the Joint FAO/WHO Food Standards Programme, ..” (Article 1).]

2. Its mandate is to craft Guidelines and Standards. If “testing phase” is really needed, there will be little support for initiation of the work itself. Alternatively, codex may focus the work on agreement of the principles to which member countries can agree while avoiding becoming too prescriptive.
[Note: “The codex alimentarius is a collection of internationally adopted food standards and related texts presented in a uniform manner” (General Principles of the Codex Alimentarius, Purpose of Codex Alimentarius)]

The second comment relates to “actual case risk assessment” also touched upon by Dr. Jack Heinemann. It is important to know how the risk assessment is actually done in the world now, because it will be a baseline from which other countries may start. If my understanding is correct, the dossier of risk assessment is prepared by developers, which bears all the cost of the risk assessment. [As WHO notes, such cost is discouragingly high (see my previous posting)] Then, such a dossier is examined by a government committee. Preparing the dossier by developers and examining the dossier by regulatory authorities are processes different from each other but constitute a package of the risk assessment process.

I understand the agreed sentence, “The Guidance will be tested nationally and regionally ….”, refers to such a package. If so, usability of the Guidance may have to be tested also at two layers, preparation of risk assessment dossiers by developers and examination of dossiers by regulatory authorities. The persons involved are different in their missions between the two layers.

The content of guideline will strongly impact on cost, time, person power, etc. required for the risk assessment. In this sense, I believe, collaboration among developing countries will be very useful in arriving at more realistic guidelines.

Best regards,
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
posted on 2012-12-12 14:33 UTC by Dina Abdelhakim, SCBD
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3940]
Dear open-ended forum members, dear colleagues,

Once again thank you for active contributions to our discussion forum so far.

On the positive note, a lot of thoughts have gone into the reactions to my guiding questions. The purpose of this round of discussion is to brainstorm on a way forward to develop a package that aligns the Guidance with the training manual in a coherent and complimentary manner. For that purpose I have provided some guiding questions, which many of you have provided answers and suggestions to and I want to thank you very much that, this is very helpful.

However, I am a bit worried that our discussion is losing focus. Some of the points raised by members addressed many other issues in a slightly unstructured manner and thereby we run the risk of being neither productive nor effective with respect to our tasks. These interventions did not seem to provide reflections on the topic at hand. I must say that they are undoubtedly important but not for the current round of discussions. This is a pity because we will lack your valuable contributions to the current topic.

Topics which are currently not open for discussion are general issues with respect to the contents, quality etc. of the Guidance and the details of the group’s plan of work. There is no doubt that the Guidance should be tested or used to assess its utility as so many of you have stressed, and these issues will be dealt with very soon.

In order to use the remaining days of this discussion group, I kindly ask you to address the topic at hand and refrain from addressing other topics which are not yet open but will be addressed soon. Only if we follow such a structured approach we will be able to come up with meaningful results of our work and make progress on those issues we have been tasked with.

I am looking forward to reading interventions along these lines. Thank you and best wishes

Helmut
(Moderator of this online discussion)
posted on 2012-12-12 16:51 UTC by Mr. Helmut Gaugitsch, Austria
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3946]
Dear Helmut,

Thanks –

True, those of us who participated in the earlier on line conferences on RA have seen  that these on line discussions do indeed have a tendency of losing focus and getting all over the place. This is why there was a wide spread call to have the discussions moderated, to help keep the discussion focused.

I believe that what made the discussion in this particular case go in various directions is the way in which the discussion was structured. On the one hand a key element of the MOP decision, i.e. “testing”, was left out, and on the other hand new elements were introduced that were not in the MOP decision, e.g. whether or not to include  a section on decision making. (For the record, I believe there should be no section on decision making, as this is not in the mandate of this group.)

I have no problem discussing the MOP requested “testing” separately, provided it is clear that actual alignment, and certainly integration, can logically only start after proper testing, whereby we should realise that testing would be more in line with what Geoff said, i.e. “trying it out” and whereby we should remember the concern expressed by our South African colleagues that the guidance is difficult to apply because of the subjective nature of the assessments, and that it was even noted that no two people could come up with anything like a similar assessment for an application.

Accepting to discuss testing separately, I support Nobuyuki Fujita in requesting that we get an idea when the discussion on testing is scheduled to take place. Finally, the suggestion that we can test and align in parallel is not helpful, and reminds me of how my young daughter years ago helped me packing my suitcase for travel by already closing the zipper before I was done packing, so that “that part was already done”.

Following your request I turn to the task as outlined by the Secretariat, i.e. discussing the appropriate methodology and approach to be taken with the view to develop a package that aligns the guidance and the manual.

For me, “an appropriate methodology and approach” means first and foremost that we ensure that whatever the outcome, the text is consistent with the Cartagena Protocol on Biosafety. In this perspective, I am concerned to find statements in the manual that are not consistent with the CPB. To give an example: the manual states early on “An LMO is therefore an organism that results from (i) in vitro modification of nucleic acid (DNA or RNA) molecules; or (ii) cell fusion between organisms of different taxonomic families.” This is a misrepresentation of what the CPB says in the definitions, because two important qualifications are left out that we find in the CPB definitions, namely in the definition of LMO “a novel combination of genetic material” and in the definition of modern biotechnology “that overcome natural physiological reproductive or recombination barriers and that are not techniques used in traditional breeding and selection”. These are crucial qualifiers that were included after long negotiations and cannot simply be left out in a manual.

Summarising, in the process of aligning the two documents I propose we start with checking for compliance with the CPB.

Looking forward to the reminder of the debate

Piet
posted on 2012-12-13 04:09 UTC by Mr. Piet van der Meer, Ghent University, Belgium
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3973]
Dear Helmut,
Thank you for your clarification, and I will look forward to the opportunity to have an expanded discussion on the contents and quality of the guidance, as well as the mechanisms for testing in the near future.

There have been many good interventions related to the topic at hand, and I do not have much to add that is original.  I would just like to emphasize a few points made by others.  First, I would like to echo Hector Quemada's suggestion that the important alignment will be of both sets of documents (the training manual and the guidance) with Annex III.  As others have pointed out, Annex III is definitive with respect to compliance with the Protocol and the purpose of both the guidance and the training is to help people further understand and meet their obligations, not to redefine or modify those.

This ties very closely into the suggestion by Piet van der Meer and others that key terms and definitions are important, and that these should be first aligned with what is in the Protocol already.  Then terms should be consistently applied throughout the documents as much as possible.  This is not to suggest that the documents must be uniform in their descriptive language, because they are designed for different purposes, but in as much as possible terms should be harmonized to avoid creating confusion.  As Maria Rocha has pointed out, the use of terms and the impact on translation is often neglected so I think this might be worthwhile to consider.  Reaching agreement on key terms, their definitions and the appropriate translations would, to my mind, be a significant achievement.

Finally, I think the questions of how the guidance and training manual should be "aligned" is challenging for many of us (myself included), because we are still uncertain of what the "package" is intended to be and how it will be used.  Part of the question seems to be which set of documents takes precedence over the other.  I find that I am ambivalent on this question, mostly because Annex III clearly has precedent over both sets of documents.  If both are aligned with Annex III, they should be reasonably well aligned with each other.  I think it is also important to remember that both sets of documents are intended to be tools that are useful to Parties (and others) who wish to use them.  They are not obligatory, and therefore if there somehow remain substantial or perceived differences between the documents, Parties (and others) will be free to choose which document is most useful for them.

Thanks once again to the Secretariat for organizing the Forum and to Helmut for taking on the challenge of moderating it. 

Best Regards,
Andrew
posted on 2012-12-14 14:10 UTC by Mr. Andrew Roberts, International Life Sciences Institute Research Foundation
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3941]
POSTED ON BEHALF OF PHILIP MACDONALD
----------------------------------------

Thanks to Helmut for getting us started on this important discussion and to all of the participants for the well considered input thus far.

I have followed the discussion on the potential audience for this document with interest.  I fear that in order to suit all potential audiences, the documents will in the end have true value for none.

This may be at the root of some of the difficulty in advancing the Roadmap and the guidance documents during their development as the focus shifted back and forth between highlighting aspects of academic inquiry on LMOs and providing practical guidance to a novice risk assessor.  I feel that it may be better to have a specific purpose for these documents rather than to be a modern version of the flying car that was neither a very good car nor a good airplane. I certainly support the view that those with functioning regulatory systems and experience are very unlikely to make use of the documents.  In Canada, for example, our regulatory frameworks and guidance are the outcome of more than 20 years of multi-stakeholder consultation at the national and provincial level.

Like many other competent authorities we have developed specific formats and standard operating practices that are subject to national audits to ensure consistency between risk assessors and enhance knowledge transfer.  I would struggle, as would I am sure other experienced competent authorities, to find a reason or a mechanism to make use of the guidance created by the AHTEG. As part of our long established capacity building activities, both alone and in partnership with others, we have developed case studies and training materials that reflect our respective experiences and regulatory frameworks.  As such, we would regard the work of the AHTEG with interest but the overall value would be quite limited. I would echo Piet’s sentiment that as an audience the value would be peer review rather than as a prospective user.

With regard to the comments on the processes of the OECD and CODEX, I can speak to the OECD process.  I think Andrew touched on some key points but in addition I would add that in general, the documents themselves are more focussed on a particular topic.  In this way, they are more like the additional guidance than the Roadmap.  More importantly, reaching consensus on issues, advancing the document and incorporating text takes place in a highly structured way with broad input from a wide range of experts.  This can be quite a long and laborious process.  As an example, the recently declassified document on the molecular characterization of a transgenic plant took 7 years and extensive consultation to complete.  The final documents represent a consensus view and the “testing” takes place as part of the document development.

I think the process by which the documents were created is very germane to this discussion. As Dr. Wei pointed out, after the extensive work of the AHTEG the documents were acknowledged but not endorsed by the COP.

A clear message was sent that more work was required.  I think it is fair to presuppose that changes will result from taking advantage of the extensive expertise available or there will be no hope of endorsement in the future either.  It is fair to examine how best to achieve these improvements when the process of the previous 4 years has fallen short.
It is clear to me that, as others have said, that the testing and validation of the guidance should be the first priority

I look forward to seeing how this discussion evolves and how the range of views will be reconciled

Philip Macdonald
National Manager, Plant and Biotechnology Risk Assessment Unit, Canadian Food Inspection Agency Gestionnaire national, Unité d'évaluation des risques des végétaux et des produits de la biotechnologie,  Agence canadienne d'inspection des aliments
1400 Merivale Rd. | 1400, chemin Merivale, Ottawa, ON K1A 0Y9 Government of Canada | Gouvernement du Canada http://www.inspection.gc.ca
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posted on 2012-12-12 21:36 UTC by Dina Abdelhakim, SCBD
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3943]
Dear all,

As a newcomer to this forum, and also as an English non-native, I was so much impressed by the dense discussion made in the last two weeks, and the enthusiasm and dedication of all the participants. At the same time, it has been a bit hard to catch up and digest all the interventions.

I understand that the next discussion will be on the "testing" issue. However, to be well prepared for future discussions, it would be very much helpful, for me and probably for all of us, if the Secretariat could suggest the overall schedule (timing and order) of anticipated future discussions in the two-years' time frame at the earliest possible occasion.

Best Regards,

Nobuyuki Fujita
National Institute of Technology and Evaluation (NITE), Japan
posted on 2012-12-13 01:34 UTC by Mr. Nobuyuki Fujita, Japan
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3944]
Dear Helmut Gaugitsch and members of the forum

This is my first submission and I would really like to thank you for the opportunity to participate in this forum. My background is mainly technical, though I have been following/participating in RA and RM of several LMOs in Brazil. I am also an outsider to the process of developing these documents but my thoughts about them were already mentioned by some previous opinions as I will further describe.

As agreed by many of you, I share the opinion of Hans Bergmans that the package is aimed at anybody involved in RA of LMOs in the wide context of the CPB. However, as brought by Jack Heinemann, the new AHTEG should be aware of the different views that may come from those who have different specialist experiences and that these considerations may also be applicable at the guidance testing stage.

In regards to the question on how to integrate the documents; I would like to endorse the words of Boet Glandorf and Jack Heinemann in which the documents are not intended to be merged into a single one. It might be that the Manual as a single document reproduces parts of the Guidance, but it does not replace the Guidance. Out of my perspective, I envision all Guidance, and not only parts of it, being aligned to the Manual.

With respect to the type of language, I tend to think the same as Angela Lozan, in which the Guidance should have priority in standardization of language; the manual may use more explicit and understandable language for large audience.

I would like to agree with the suggestion made by Fern Wickson that we should integrate the docs by including a section on the decision making process as the last part of the package which would then consider factors beyond risk.

Finally, I would like to endorse Angela Lozan words on the real need of the Guidance document by developing countries with limited capacities; whether to build capacity itself or during decision making process.


Best,

Sarah Agapito
(edited on 2012-12-13 03:34 UTC by Sarah Agapito-Tenfen)
posted on 2012-12-13 03:33 UTC by Dr. Sarah Agapito-Tenfen, GenØk Centre for Biosafety
'our tasks' [#3945]
I assume ‘our tasks’ are limited to the questions posed by Helmut in the open email?
1. Who will be the target audience of this package:
Trainers of RA?
People learning how to carry out a RA?
Risk assessors/ Practitioners?

*Given Article 22 there is a need to target all these, probably as separate modules, otherwise we will not grow capacity. I would see at least 3 modules, one for each then additional modules for each to grow the capacity of that audience.

2. How can the Guidance and Manual be integrated?
Should the Manual or the Guidance be used as the basis for this exercise?
Should the package also provide a step by step guide for risk assessors to use when conducting RA?
Should the package also be aimed for usage as a reference and background text for RA?

*The first question does not make sense if we are considering consistent language etc.
*The second question does not make sense either – how can you have a step by step guide when each assessment is case by case?
*Again I am getting confused – a package of what? What does package mean here?
3. With respect to the type of language used: which document will have priority as the reference to standardise the language between the two documents?

*Can we have some clarity on the history of the manual – Who produced it? I am assuming it was not the AHTEC otherwise the language would be consistent. When did the parties formally accept this document? It seems to me that the guidance has priority as this is the document that is to be endorsed if it passes the test.

4. Do we integrate all of the guidance or just the roadmap section?

*Again I am confused. Integrated into what? The manual? The package?

5. Do we include a section on the decision making process in this new package?

*An emphatic no. This is not our place or mandate – decision making is not part of risk management or risk assessment.

6. What (practical) experiences have people had with either/ both documents?
Was one document easier to use/ understand than the other?
What aspects of one or the other do you think will enhance a user’s understanding of RA?

*This is an odd question as it will depend on the audience. If an inappropriate document was not matched with the level of knowledge of the audience then the results would be meaningless. These documents were not written for the same audiences.

Geoff Ridley
Environmental Protection Authority, New Zealand
posted on 2012-12-13 03:50 UTC by Dr. Geoff Ridley, Environmental Protection Authority
RE: 'our tasks' [#3959]
I would like to strongly concur with Geoff’s observations.  I would also add that we seem to be wavering from the strong charge form the COP to embark on testing of the guidance and straying into more peripheral issues.  In particular embarking on a discussion on whether to consider decision making, an aspect that was outside of the original charge of the AHTEG, seems to be an unnecessary diversion form some of the more pressing tasks at hand.  To me the integration of the guidance into training modules is quite secondary to whether it serves the purpose for which it is intended.  I would reiterate that in my opinion, the guidance wil have the highest utility if it is fit for a purpose rather than for use in whatvever scenario can be imagined.

I look forward to the resolution of  some of the issues raised here and embarking on the challenging work of reconciling views and elaborating a path forward.  This has certainly been one of the more enaging online discussions.

Phil
posted on 2012-12-13 22:30 UTC by Mr. Phil Macdonald, Canada
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3948]
Dear participants,

I am a new member on this online forum, and it is my pleasure to be participating. 

In my opinion as a scientist (microbiology, ecology), we will need more background data to test and to evaluate the effectiveness of the COP-MOP6 decisions.
As Piet van der Meer mentioned in his previous comment, we will be focused on the analysis of "testing of the guidance document and manual be done by people with much experience and people without less or no experience, and on the basis of realistic cases".
Taking and analyzing data with "scientifically transparent manner" is time-consuming and be a burden. Thus, from the sense of science, we may not have enough time and budget to handle several topics in parallel.

My comment may not fully fit the objectives of "brainstorming".
However, the guidance without testing data is not reliable for further field application.
The guidance documents need scientific proofs to sustain a quality of COP-MOP decisions.

If we have to handle several topics in parallel, a suggestion from Nobuyuki Fujita will be a effective way to move forward the discussion & brainstorming.

Thank you and best wishes,

Kazuaki Matsui
posted on 2012-12-13 05:23 UTC by Kazuaki Matsui
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3949]
Dear colleagues,

We would like to remind you of the Terms of Reference of the AHTEGs as they have been established by various  COPMOP decisions.

BS-II/9
http://bch.cbd.int/protocol/decisions/?decisionID=10787
An AHTEG was established with Terms of Reference, including:
“1. The Ad Hoc Technical Expert Group shall:
...
(b) Consider the nature and scope of existing approaches to risk assessment based on national experiences and existing guidance materials;
(c) Evaluate the relevance of existing approaches and guidance materials to risk assessment under the Protocol, and identify gaps in those existing approaches and guidance materials;
(d) Identify specific areas where limitations in capacity may be an impediment to effective implementation of the risk assessment provisions of the Protocol at national level, and where capacity-building activities may be particularly important,
...”

BS-III/11
http://bch.cbd.int/protocol/decisions/?decisionID=11067
The report of the AHTEG was welcomed, and no new AHTEG was established in this decision.

BS-IV/11
http://bch.cbd.int/protocol/decisions/?decisionID=11690
An AHTEG was established; its Terms of Reference included, basically, to:
(d) “(i) Develop a "roadmap", such as a flowchart, on the necessary steps to conduct a risk assessment in accordance with Annex III to the Protocol and, for each of these steps, provide examples of relevant guidance documents;
(ii) Taking into consideration the identified need for further guidance on specific aspects of risk assessment,
...”
BS-IV/11 also established an open-ended online forum, and the ToR state that the AHTEG was to base its deliberations on (among other sources) “contribution received through the open-ended online forum, ad hoc discussion groups and real-time online regional conferences”.

BS-V/12
http://bch.cbd.int/protocol/decisions/?decisionID=12325
BS-V/12 provides Terms of Reference for “the Open-ended Online Forum and Ad Hoc Technical Expert Group on Risk Assessment and Risk Management”.
Among their tasks was to:
“1. ... (i) revise and test the first version of the Guidance on the basis of the results of the scientific review process, the testing associated with capacity-building activities and any testing initiated by the Ad Hoc Technical Expert Group and organized by the Executive Secretary, and (ii) assess the overall applicability and utility of the Guidance to living modified organisms across different taxa and receiving environments ...”
“3.The open-ended online forum and the Ad Hoc Technical Expert Group on Risk Assessment and Risk Management shall work together with the view to developing and achieving the following: (a) A revised version of the "Guidance on Risk Assessment of Living Modified Organisms ..."

Our deliberations should acknowledge these decisions by COPMOP.

We would like to make the following comments:

1) The first AHTEG was established in 2005. Since then there has been a clear line: the AHTEG is to develop guidance that is, in the first place, useful for risk assessors that have relatively little experience. Of course, starting risk assessors are everywhere. For example, in our office we have more than 20 years of experience with environmental risk assessments of LMOs, but we have a steady inflow of new people starting as risk assessors, and they have to be brought up to speed with the practice of risk assessment and the underlying theory and concepts. And, even the most seasoned risk assessor will learn something from good guidance, if only expand the horizon of his ideas. From the start it has been clear that the guidance is meant to facilitate the hands-on approach to risk assessment.

2) The training manual is mentioned first in BS-V/12, as the manual that has been used in regional training workshops. The manual was to be submitted to “experts and other reviewers from Parties and other Governments for an assessment of its effectiveness”. The revised training manual is acknowledged in BS-VI/12, and as we have discussed before, it is to be aligned with the guidance into one package.

3) The present discussion in this Online Forum was meant to provide an outline of the modalities for such an alignment. There have been various contributions on that issue, and we would be grateful to the Secretariat if they could provide a compilation of those comments.

4) Inevitably, the discussion has also gone into questions about the testing of the guidance.
The decision that the guidance should be reviewed scientifically and tested was already taken by COPMOP/5. BS-VI/12 now adds that “the guidance will be tested nationally and regionally for further improvement in actual cases of risk assessment and in the context of the Cartagena Protocol on Biosafety”. There is therefore no question whether there should be testing done, COPMOP simply has given us this task.
Some expectations have been uttered, prematurely we think, that the testing will not lead to large changes. It is clear that the guidance is an advanced document. But the document itself states that “it is intended to be a “living document” that may be updated and improved as appropriate and when mandated by the Parties to the Cartagena Protocol on Biosafety”. We have received such a mandate.

5) We think that the key for alignment of the manual and the guidance lies in the words “in actual cases of risk assessment” in BS-VI/12. We have already stated this, but we would like very much to draw your attention again to this crucial point. The testing will require a hands-on approach, and indeed any future reader will require the package for his or her hands-on approach of LMO risk assessment. It would be very good if the alignment process already takes this into account very carefully. The questions are: first, what information does anybody interested in performing (or evaluating) a risk assessment need, and second, how can we make clear what is meant by the theoretical answer to the first question, i.e., can we give practical information, preferably from “actual cases of risk assessment”.

Boet Glandorf
Hans Bergmans
Senior risk assessors at the GMO Office of the Natl. Institute of Health and the Environment, the Netherlands
posted on 2012-12-13 07:41 UTC by Ms. Boet Glandorf, Netherlands
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3950]
Dear all

Thank you for the opportunity to participate in these discussions. While I have not been a previous participant of this particular online forum, I have benefited from one of the several training workshops on risk assessment and risk management that had been organized at the request of Parties, and have had occasion to familiarize with both the Guidance and Manual in various scenarios (as training material, in evaluating a risk assessment).

1. Who will be the target audience of this package?

I agree with many commentators who point out that the package would be useful to all who are involved in risk assessment, whether as trainers, or novice or experienced risk assessors.

2. How can the Guidance and Manual be integrated?

Like others, I do not necessarily see the outcome of this exercise to be one document, but as a package that brings the two together. The Guidance and Manual may have different purposes e.g. to guide the risk assessor and to enable training and as an education tool for risk assessment, respectively, but what is important is that they are aligned and integrated to be complementary.

Let’s also not forget that the Guidance is a product of 4 years of work, several rounds of review and encompasses the further and specific development of Annex III of the Protocol. It thus seems to me that it would be important that the Manual takes on board the Guidance and the concepts it forwards. This might be most appropriate in Module 3 of the Manual.

3. With respect to the type of language used: which document will have priority as the reference to standardise the language between the two documents?

It would be important to standardize the terms between the two documents, that is part of the alignment process.

4. Do we integrate all of the guidance or just the roadmap section?

In my opinion, all of the guidance is useful, not just the roadmap section. Where relevant, there could be specific reproduction of parts of the Guidance in the Manual, but it would be important to add that the documents are not mutually exclusive, and that the Manual does not replace the Guidance.

5. Do we include a section on the decision making process in this new package?

As long as such a proposed section is not prescriptive. I think that where something useful could be said would be with regard to how and at what stage the risk assessment informs the decision making process (elements of these appear already in both the Guidance and Manual). We should of course recognize that decision making may, or has to, take into account various other elements such as socio-economic considerations, public consultation etc., as stipulated in the Protocol.

Kind regards,

Lim Li Ching
Third World Network
posted on 2012-12-13 08:05 UTC by Ms. Li Ching Lim, Third World Network
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3955]
Thank you very much to Boet and Hans for this factual and clear analysis.  In particular the references to previous MOP decisions is helpful to clarify the task(s) before us.  It also should provide the Secretariat with a basis to start organizing the contributions from this forum.  Building on the message from our colleagues from the Netherlands, we can get more concrete ideas on the "appropriate methodology and approach" to take to examine the any final guidance and manual "in actual cases of risk assessment". 

Paragraph #2 notes a concerning uncertainty which is the history of the manual.  Was this a mandate of Parties?  Perhaps the Secretariat could clarify for us this history and provide text as to what purpose Parties assigned to this manual.

Finally, and I note that we have one more problematic matter to deal with, which is the glossary in the current guidance.  This section was not addressed in a substantive manner within the former AHTEG; it has undergone no qualified technical review, and it could create an inaccurate perception that the all terms contained and definitions proposed are agreed to by consensus.  I propose that this section should be addressed very soon in a separate manner, but somehow within the scope of our tasks.

Thanks again to Boet and Hans for getting the discussion on a good trajectory.
posted on 2012-12-13 16:58 UTC by Mr. Thomas Nickson, Consultant
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3966]
Dear All,
Thanks very much to Hans and Boet for the overview of COP/MOP decisions relevant to our work, and I support their request that the Secretariat provides a compilation of the comments relevant to alignment for the benefit of future steps. I also support the suggestion of Geoff, Esther and others to address the use of terms (as Tom explained, the glossary of terms in the guidance was not discussed in a substantive manner in the AHTEG). As I mentioned earlier, it is very important that key terms are first and foremost aligned with the CPB and in particular with Annex III.
Another important aspect that should be kept in mind while looking at ways to align the documents is the need for flexibility to either further fine tune or to reduce information requirements based on gained experience.
Lastly, looking ahead at future moderated on line conferences, let me support something Wei-Wei said: the importance of attitude. In this context I urge the moderators of these conferences to remind the participants to stay on the scientific and technical level and not to resort to inappropriate political statements, as happened this time with reference to “, faulty administrative approvals” of certain regions or countries.
Wishing you all a good last day of the conference and a good weekend

Piet
posted on 2012-12-14 04:08 UTC by Mr. Piet van der Meer, Ghent University, Belgium
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3953]
Dear participants of the open-ended forum, colleagues and Helmut:

As this is my first posting, I would like to congratulate the Secretariat for allowing us to provide our points of view on this issue and Helmut for the work in organizing the forum.

I have been working in the GMO Unit of the Spanish Ministry of Agriculture, Food and Environment, for the last four years, dealing with the supervision of Risk Assessment both of national and regional level. However this is the first time I participate in an on line forum of the CPB.

From my point of view, The Manual and the Guidance should not be merged into one single document. Both documents seem to deal with the same process but tackle different objectives. Therefore, I would support the idea of having a package with 2 independent document booklet preceded by an introduction in which there would be an explanation about the processes that led to their final versions and which are the objectives of the Manual and the Guidance.

Furthermore, I would include a glossary in the package in order to provide the equivalence of terms between both documents (Guidance and training Manual) and in that way have a more consistent document.

Eventual weaknesses of the document may be detected after putting it into practice, and from that experience it can be improved taking into account the comments of the final users. As some participants have already mentioned, I consider that the guidance is difficult to apply mainly due to the subjective nature of the assessments and the multidisciplinary aspects that covers.

Also, I do not think that the ‘package’ should include a decision-making section since risk assessment is a process that ends in a science based technical document which provides detailed information on the analysis done on a LMO and it is one the multiple tools that feed the decision making process. Therefore, I would maintain both processes independent as they are.

Sincerely yours,

Esther Esteban Rodrigo
Ministry for Agriculture, Food and the Environment
Spain
posted on 2012-12-13 12:42 UTC by Dr. Esther Esteban Rodrigo, Spain
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3956]
Good day to all!
I am just now getting involved in the discussions and have been struggling to read all input made since the forum opened early December. I apologize for this but couldn´t get involved earlier.
I will first answer the questions posed by Helmut Gaugitsch and then make some general comments that I have reading everybodies thoughts over the past days in the forum:

1. Who will be the target audience of this package:
         It must be helpful and understandable to all audiences (probably for different purposes).........but a key Q is: What is the package going to be? (I know it is not part of this discussion, but it must beclarified further on).
2. How can the Guidance and Manual be integrated?
          o   Should the Manual or the Guidance be used as the basis for this exercise?
They sould both be used as the basis, again, the key Q is : What does integration mean? ( to me integration means NOT developing a "single integrated doc" but making sure the different doc´s (that have different purposes altogether) are not contradictory between them but share   enough common ground.
          o   Should the package also provide a step by step guide for risk assessors to use when conducting RA?
I am not sure we are ready to answer this Q yet, we need to look into the two doc´s i.e. roadmap of the guidance (being to me the priority over the whole "guidance") and the manual and figure out if this is really needed.
          o   Should the package also be aimed for usage as a reference and background text for RA?
I think this is irrelevant. The documents under discussion have different purposes, one is for capacity building on how to go about the task of understanding and then "doing"  Risk Assessment (the manual) and the other is a "explanation" of what annex III is all about, i.e. what the Cartagena Protocol thinks is relevant to be considered in Risk Assessment.
3. With respect to the type of language used: which document will have priority as the reference to standardise the language between the two documents?
Again, my answer is "both".....I do not believe we necessarily have to aim in having common "language" in both documents, what is surely necessary is that a "mapping of terms and concepts" is done so that people can understand what each term and concept in one document means in relation to the other. It might be useful to do this mapping first, and then decide if some of the terms or concepts must be changed (only if really necessary).
4. Do we integrate all of the guidance or just the roadmap section?
My suggestion is to start with the "roadmap", see how it works and then follow up on the other documents if relevant........
5. Do we include a section on the decision making process in this new package?
I think it is not necessary to go into depth on this issue, but it might be interesting to include clear ideas with respect on to how "risk assessment fits into the bigger picture of decision making", or put in a different way: "how decision making takes into account the results of the risk assessment process"...........
6. What (practical) experiences have people had with either/ both documents?
          o   Was one document easier to use/ understand than the other?
          o   What aspects of one or the other do you think will enhance a user’s understanding of RA?

We haven´t had experience with either but we are planning to try both, roadmap and manual.....see what happens......


After answering the Q´s posed by Helmut, I share some general comments:
i.-I would expect that testing the roadmap and the manual should help us understand if these two documents are well structured in relation to risk assessment or not to fullfill their different purposes. Testing should be done with practical, "real-case  scenarios" (simple and complex ones)....and if the two documents are well structured, then they should give us similar results (considering a given case and a given risk assessor) and therefore "common elements" that would later on feed the decision making process. What needs to be seen is if these two documents are either complementary or contradictory in nature.
ii.- I expect the roadmap and the manual to be in constant change due to the nature of change of modern biotechnology developments, this implies both documents must be flexible. What matters is identifying the common and absolutely necessary points between both documents that need to be coherent (to me this is "integration").
iii.- Both documents (manual and roadmap) should not be merged into something else, they must be kept separately, but need to share coherence, meaning, simplicity, interconnection, reference each other.
iv.- It would be very desirable to have a little section in both documents refering to the other and explaining their different purposes/function and relation between each other.
v.- In my personal opinion, the roadmap would benefit enormously if real life examples illustrate the "points to consider"......this could be a result of the testing process......
vi.- I strongly agree with the fact that the roadmap is innovative.....brings concepts together into discussion that might have been scattered and used by some in different contexts but that have not been envisioned as a "whole". In this order of ideas, I believe we should be open in trying it out (the unexperienced and the very experienced).
vii.- I see that the "task", the "how to get about it" and the "when" are really not clear. It would certainly be useful if this is made clear from the start so that peopole don´t waste time on this issue. This should be up to the Secretariat and those who are leading the discussion (moderators).

¡Un abrazo a todos!
Francisca Acevedo
posted on 2012-12-13 17:21 UTC by Ms. Francisca Acevedo, Mexico
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3958]
I’d like to thank Boet for the summary of document it was very useful.

I particularly note:
BS-IV/11
http://bch.cbd.int/protocol/decisions/?decisionID=11690
An AHTEG was established; its Terms of Reference included, basically, to:
(d) “(i) Develop a "roadmap", such as a flowchart, on the necessary steps to conduct a risk assessment in accordance with Annex III to the Protocol and, for each of these steps, provide examples of relevant guidance documents;
(ii) Taking into consideration the identified need for further guidance on specific aspects of risk assessment,
...”

So a roadmap (such as a flowchart) with the necessary step to be taken to do a risk assessment in accordance with Appendix III was to be produced. Each step was to be illustrated with reference to existing guidance documents. If no guidance was available then the mandate was to take into consideration the need for further guidance on specific aspects of RA. It strikes me that the guidance material goes well beyond this mandate? I don’t see any reference to decision making.

It is interesting how the need for a simple flowchart became a 65 page document.

At this stage, given that we have to do something and that the chair/moderator is adamant that the testing will occur in parallel to this process, I suggest that we should focus on the language and ensure that it is consistent between the guidance/roadmap (including use of terms) and the training manual.

Geoff Ridley
Environmental Protection Authority, New Zealand
posted on 2012-12-13 21:48 UTC by Dr. Geoff Ridley, Environmental Protection Authority
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3960]
Dear open-ended forum members,

I regret that I have not been able to offer an intervention sooner, but I have found the comments thus far very interesting.  I am pleased to see the level of participation, and I welcome the use of a moderator to keep us on a constructive path.  In my twenty years of doing risk assessments for recDNA organisms as part of a regulatory agency in the US Department of Agriculture, I have found similar dialogs with colleagues in other countries to be very stimulating, and I look forward to the discussions in this forum.

I welcome the brainstorming approach that the Secretariat has chosen for this first online forum, and I think it was likewise useful for the Secretariat to even offer “suggested topics” so that we could react to these suggestions and yet still have the flexibility to offer our own suggestions to address the work that the Parties have decided upon for the online experts forum and the new AHTEG. 

Recognizing that brainstorming is typically designed to get many ideas onto the table, I look forward to the clarification of the scope of work as the discussions progress.  I am particularly interested that the work of the group will stay on the risk assessment and risk management mandate, and not try to extend our work to the realm of decision making – a topic that is clearly beyond the tasks the Parties have set before us. 

Let me now turn to the decision of the Parties at MOP 6 in Hyderabad and how these decisions seem to offer a logical order of work, albeit different from the outline our moderator is advocating.  I think that the extensive discussions of the contact group on risk assessment in Hyderabad, as well as the decision of the Parties regarding risk assessment, have emphasized that the Guidance (Roadmap) needs further evaluation or testing before it can be accepted.  The decision also calls for aligning the Guidance with the Draft Training Manual. 

In light of the decisions of the Parties, it seems logical that the testing of the Guidance document will serve to identify those parts of the Guidance that are most relevant to be brought into the Training Manual, either in parts or by referring to those sections of the Guidance that are found to be truly useful and meaningful. By “useful and meaningful” I mean in the context of a risk assessor who must use the best available scientific information to reach scientifically valid conclusions in order to provide a recommendation to a government’s decision makers regarding an environmental release of an LMO. 

As we know, the request of the Parties at MOP4 for a flowchart or roadmap to provide guidance in applying the methodology of Annex III of the Protocol has resulted in the current version of Guidance that the Parties considered in MOP6.  Part of the mandate from MOP4 was to test the resulting roadmap guidance, and this was reiterated in the decision of MOP6.  In considering testing of the guidance, it has been inferred that it should serve the needs of Parties that requested it, namely those that had little or no practical experience in the risk assessment of LMOs.  As we move forward in response to the decisions of MOP6, it seems that in essence we are trying to identify the parts of the Guidance that are useful to the Parties that have asked for further guidance, then finding a suitable way to incorporate or reference them in the existing draft Training Manual.

We are reassured by the moderator of this session, Helmut  Gaugitsch, that we will take up the issue of testing the Guidance in greater detail in future online forums, so I will offer only brief comments on this issue for now in the full spirit of brainstorming at this stage.  It seems clear from the decision of the Parties that some of the Guidance is likely to be less worthy of endorsement and inclusion in the Training Manual.  In order to avoid duplication of effort, it seems that the testing of the Guidance should precede detailed consideration of alignment with the Training Manual.  I can envision that a thorough testing of the Guidance will enable the AHTEG and online experts group to identify which parts of the Guidance can be cited in the references of the Training Manual.

For our next iteration of discussions on testing the Guidance, let me suggest an approach that might address some of the concerns that Parties have shared with me in conversations in Hyderabad.  First, the testing should be based as much as possible on realistic scenarios that reflect our worldwide experience to date.  This type of approach would enable the testing exercises to use dossier materials that are already in  the public domain – a great advantage when looking at real-world circumstances.  Many people commented to me that the Guidance gives only brief mention of the differences that may arise when looking at requests for limited or confined environmental releases versus the types of unconfined environmental releases that are more common in production agriculture or in the control of mammalian diseases (the recombinant rabies vaccine control programs are an example here).

It seems that the Training Manual and Guidance both are viewed by some as having too little information to help risk assessors with a credible and practical approach to doing risk assessments for environmental releases which are confined (either physically, temporally, or biologically) versus those which are unconfined.  The previous AHTEG recognized this distinction, but mentioned it only briefly in the Guidance.  This is only one aspect that is likely to get more extensive feedback in a thorough testing of the Guidance document.

Before closing my comments, I should respond to Helmut’s most recent comment urging us to keep focused on the questions that were offered as suggestions to us when the forum was opened.  As I said at the outset, I think that it was useful for the Secretariat to offer suggestions, yet give us the freedom to address the full scope of the work that the Parties have decided for the online forum and the AHTEG.  Based on the comments I have seen thus far, I think that this has been constructive to allow the experts in the forum offer their views on the priority areas for the work that the Parties have asked us to do.  This is no time for a moderator's views to be seen as an adamant position that can not be influenced by the logic or reason of experts who have been asked to contribute.

David Heron
Biotechnology Regulatory Services
US Department of Agriculture
posted on 2012-12-13 22:44 UTC by David Heron, United States of America
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3962]
Good night!
I would like to just comment on two issues raised by Dave Heron.

I am not convinced that it is the Parties with less experience the ones that asked for the roadmap and the guidance on risk assessment, I believe many Parties were interested in going into developing such material (not just the least experienced ones).....personally I wanted to see development of clear ideas related to what annex III really is aiming for.....the roadmap does the job.....it points out what is meant to be considered in the risk assessment process.

Un abrazo,
Francisca
posted on 2012-12-14 02:12 UTC by Ms. Francisca Acevedo, Mexico
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3963]
Gracias!Francisca!

I have the same feeling but I hesitate to repeat it again. Some colleagues said they do not need the documents. While we can see their hard works in this forum, which I appreciate very much. I can not understand this point. It did not convince me that they are here to make the rules for the rest of world other than for themselves.

Apology to the Chair Helmut. I know I might distract the attention of this brainstorming. But this is a question of attitude. Chinese says that the attitude will decide everything. No correct attitude there will be no good output. We should be alerted on the wrong direction caused by any incorrect attitude.

Please forgive me if there is any incorrrect understanding.

Wei
posted on 2012-12-14 03:09 UTC by Mr. Wei Wei, China
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3964]
I would like to support Francesca's view about the importance of the Roadmap in clarifying the aim of Annex III.  I am not sure that the Roadmap does do this as well as it might at present, but it is certainly a very good start.  It might be valuable to include clear statements to the effect that this is the purpose, and what the Roadmap does not do.

I realise that this is heading too much into the specifics of the documents, but in the current discussion I see too many peripheral issues being raised (e.g. inclusion of sections on decision making in the guidance).

regards
janet gough
posted on 2012-12-14 03:16 UTC by Janet Gough, Environmental Protection Authority
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3961]
Dear all,

I agree with recent posts by Geoff Ridley in this and the other threads about the priority between two documents, the guidance and the training manual. I think that the guidance, next to the Annex III of course, should have the priority because it was welcomed in COP-MOP5, its progress was commended in COP-MOP6, and it could be approved in future COP-MOP, while the other is not. We don't even know by WHOM and HOW the training manual was made and revised (maybe within capacity-building activities). Apologies if I am missing or misunderstanding something.

Having said that, I fully understand the importance of and the need for such hands-on training manual for capacity-building purposes. I would therefore suggest that we should go straight to the testing and improvement of the guidance, especially the roadmap. Once the guidance is tested and improved accordingly, it will be rather straightforward to revise the training manual to be consistent with the guidance both in its contents and the language. In this context I would like to quote a Japanese word "isogaba maware" meaning that "if one tries to achieve something too fast, it will eventually take more time".

I also agree with Geoff that the manual will have separate modules each of which aims at different audience.

Best Regards,

Nobuyuki Fujita
National Institute of Technology and Evaluation (NITE), Japan
posted on 2012-12-14 01:36 UTC by Mr. Nobuyuki Fujita, Japan
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3969]
Dear Helmut and Participants of the Open-Ended Online Forum:
I like to thank Boet Glandorf and Hans Bergmans, for their brief and clear assemblage of the decisions that we need to keep in mind and understand very clearly since those give the context for our current  work. 
In particular I want to react to point five in their posting, which deals with the testing and the alignment of the manual and the guidance. I agree with the key questions identified for how to deal with this, but as far as I understand how the process will go, the hands-on testing is mandated only for the guidance. Does the sentence “The testing will require a hands-on approach, and indeed any future reader will require the package for his or her hands-on approach of LMO risk assessment.” implies that the testing will include the whole package (manual and guidance)?. I do not see this as useful since as stated by others these documents have different proposes.

I would also like to support the suggestion by Nobuyuki Fujita “we should go straight to the testing and improvement of the guidance, especially the roadmap. Once the guidance is tested and improved accordingly, it will be rather straightforward to revise the training manual to be consistent with the guidance both in its contents and the language”, according the annex III. Although this seems to me the logic way to work, we just need to be a bit more precise. To my understanding we will be contributing to the Secretariat on how to plan and do the testing and after the testing, we will contribute with the analysis of the results, but the Open ended online forum is not doing the actual testing of the guidance.
Kind regards
posted on 2012-12-14 08:01 UTC by Ms. Sol Ortiz García, Mexico
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3970]
Dear Forum Participants and Helmut
I hope that I can seek your indulgence to bear with me as I would like to point out some of the decisions in the document BS-VI/12 and seek some clarification (being a non-native English speaker) for some understanding on the whole process that is expected of the participants of the Open Ended on Line Forum. Helmut, apologies for deviating from the main topic of discussion. As requested by Isao Tojo, some clarity or background information is needed for some of the sentences in the document BS-VI-12.

In the document BS-VI/12, under the section Further Guidance on Specific Aspects of Risk Assessment it requests the Executive Secretary to: 
5(a) Develop appropriate tools to structure and focus the testing of the Guidance; 

(b) Gather and analyse, in a transparent manner, feedback provided as a result of testing on the practicality, usefulness and utility of the Guidance, (i) with respect to consistency with the Cartagena Protocol on Biosafety; and (ii) taking into account past and present experiences with living modified organisms; and 

(c) Provide a report on possible improvements to the Guidance for consideration by the Conference of the Parties serving as the meeting of the Parties to the Protocol at its seventh meeting;

Correct me if I am wrong but it does not say anywhere that we need to change or modify the guidance documents based on the analysis of the feedback received but requests the ES to provide a report on possible improvements to the guidance for consideration by the COP/MOP at its seventh meeting.
Hence Hans' concern in one of his earlier threads of discussion on how the results of the testing will be reflected in the package.

Then again in BS-VI/12,
9 (b) Cooperate with the open-ended online forum and AHTEG to develop 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, with the clear understanding that the Guidance is still being tested;
 
As Hans had earlier stated and also my understanding, the phrase "with the clear understanding that the Guidance is still being tested" suggests that both the testing and the development of the package run parallel to some extent, as what Helmut also pointed out.  And so the package is to be developed without further improvement to the Guidance on RA of LMO? Am I misunderstanding something here? Would really appreciate clarification on this from the Secretariat. This also brings me back to an earlier statement by Geoff Ridley when he stated the need to be aware of the difficulties the decision document (BS-VI/12) has created.

If this is what it means, I would like to support Geoff Ridley's suggestion that we should focus on the language and ensure it is consistent between the guidance/roadmap (including use of terms to have it aligned with the CPB and of course to Annex III as also suggested by Geoff, Esther, Piet and others) and the training manual.

As Wei had said, the right attitude is needed to get the best output and outcome of this whole process. In order to do that a clear understanding of the document BS-IV/12 is also needed.

Thank you for your patience and kind regards to all.
Vila
posted on 2012-12-14 08:16 UTC by Vilasini Pillai, Ministry of Science, Technology and Innovation - Chair real-time conference Asia
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3972]
I have been following the forum with great interest, but have not yet contributed to it. 

First, I would like to thank the people who authored the two documents under discussion for what looks like a considerable amount of hard work. 

I refer to Dr. Helmut Gaugitsch's comment on December 12: “ There is no doubt that the Guidance should be tested or used to assess its utility as so many of you have stressed.” We have since had some further discussion about testing one or both of the documents.  I wanted to add my voice to those who support testing the documents against real live scenarios, real life LMOs, because testing should find any problems or issues in the documents that can be sorted-out before the documents become “official”.  However, when doing this, I believe that it is vitally important that at least some of those involved in the testing have skills and experience in assessing risks to biosafety.  In particular, I believe that it is important to include scientists with training and experience in areas such as ecology, environmental science, toxicology and human health assessments; and scientists with hands-on research experience assessing the risks of LMOs to health and the environment.
posted on 2012-12-14 12:25 UTC by Dr Judy Carman, Institute of Health and Environmental Research
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3974]
Dear participants,
Thank you for the opportunity to contribute to this lively and stimulating discussion. But apologies for the late intervention as I have been distracted with revising our own national guidance on risk assessment.
I would like to comment on just a few of the points raised by Helmut.
1. Who will be the target audience of this package?
Although it would be ideal to produce guidance material for all possible audiences, this can be rather hard to achieve in practice. It may be more productive in the short term to have a narrower target audience. The Protocol operates at the level of government decision-making. Therefore it would seem that the primary target audience should be biosafety risk assessors from government regulatory agencies or their proxies. An appropriate secondary target audience could be the regulated community to assist with compliance in providing risk assessment information to a regulatory agency. This could include small developers, as mentioned by Sol, and research organisations with an interest in participating in this technology. As suggested by Geoff and Janet it may be more useful to generate different modules for different audiences.
As to whether experienced or inexperienced assessors should be targeted, I would like to support comments of Hans, Sol and others that most value would be gained by “the novice risk assessor”, that is, those associated with new developed or developing regulatory systems. The primary purpose of the guidance material is to shed light on Annex III. As well established regulatory agencies from Parties and non-Parties (such as Australia) are already compliant with Annex III; it would seem of limited value to replace typically much more comprehensive national guidance.
Although still eager to learn more about risk analysis, I am somewhat nervous when David Quist states that “[t]he Roadmap Guidance contains a number of innovations”.
Firstly, as an old-fashioned scientist I would prefer to work with scientifically validated risk assessment methodologies where the number of false positives and negatives have been quantified relative to true positives and negatives. In the absence of scientifically validated studies, these “innovations” have yet to be shown to produce risk assessments with greater statistical power or sensitivity. Nor is it clear that they will necessarily result in better decisions. In this regard I support Jack’s comments that we should involve experts who have real world experience with organisms that have observable, testable adverse effects. One example is weeds, which cause more than $8 billion of damage to health and the environment in Australia. It has given rise to an extensively tested and scientifically validated risk assessment methodology that could be most instructive for risk assessment of LM plants.
Secondly, as a conservative regulatory bureaucrat, I have reservations about “innovations” in international guidance material that has not achieved widespread consensus. I believe that Kazuo Watanabe was giving expression to the contentious nature of the guidance material, which remains unresolved amongst Parties on the AHTEG.
Thirdly, I have reservations from a social equity perspective. Having lived and worked in West Africa for some years I am acutely sensitive to the well-known Ghanaian quote “An African should not be made to suffer the loss of an arm from a gunshot in Europe”. To use novice African risk assessors as guineapigs for these “innovations” continues this paternalistic trend. There is also the mistaken notion that more complicated risk assessments with difficult to understand terminology are somehow superior. This is not the case with weed risk assessment methods, which were developed in consultation with a broad cross section of society and is very much in the fir for purpose mode advocated by Geoff.
Finally these “innovations” are open to mis-interpretation as representing consensus, see Georgina’s post “If the documents currently under discussion would not be consensus documents, they would not have been presented to the MOP, in the fi[r]st place” or as representing some minimum standard, see Elizabeth’s post “Both instruments [Guidance and Manual] should be taken as a reference to the minimum procedures to be followed by countries upon approval of a living modified organisms.”
3. With respect to the type of language used: which document will have priority as the reference to standardise the language between the two documents?
I support all the posts that advocate consistency of terms and meanings, but concur most strongly with Maria Mercedes and Tom that we need to carefully consider and agree on definitions.
5. Do we include a section on the decision making process in this new package?
This is most problematic as this is unclear on what authority this has been mandated, the current group does not appear to have the required expertise, and it is highly country specific. For example, in Australia the [single, independent] decision-maker is also the risk assessor and risk manager. This model seems to be unlike any other country that I am aware of.
Best regards
Paul
posted on 2012-12-14 14:20 UTC by Paul Keese, Australia
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3981]
Dear Forum Participants,

First, I wish to thank everyone for what has become in my opinion a useful and productive exchange.  My learning from this is that there are two distinct views as to the need for and purpose of the package (guidance with complementary manual).  There are some like myself who wish to see a package that targets those regulatory systems (authorities and developers) that seek help in developing a system that will ensure the safe transboundary movement, transit, handling and use of LMOs compliant with the Protocol.  It appears to me that other forum participants view this also as a mechanism to fix/change/improve regulatory systems broadly.  These would include systems that some developers and regualtors would call "functioning".  As we go forward, it will be necessary to understand how narrow and expanded objectives comply with the terms of reference for the online forum and future AHTEG.  I believe this forum has improved understanding has been quite helpful in this regard.

Second, at the risk of repeating myself, I strongly support the interventions of Geoff, Vila, Paul and others who see our immediate priority (accepting that testing will be done) as focusing on language and terms to ensure consistency within the package.  Paul and Maria pointed out definitions and ability to translate into other languages is critical to effectively communicating and ensure understanding.  As a brief aside, this forum has been a good example of misunderstanding and confusion about the basic terms "our task" and "our mandate".  Clearly these terms were viewed very differently, and the confusion was exacerbated by what may have been an assumption on the part of our moderator that we all shared his understanding.  I go back to an earlier comment and Vila's important observation that we must have a common understanding of what the Terms of Reference meant for our work and how they will guide it.

Finally, and having been a member of the AHTEG since its inception, I must correct any potential misunderstanding that Georgina may have created about the guidance being a consensus.  The only place you will find the word "consensus" in UNEP/CBD/BS/COP-MOP/6/INF/10 is on page 5 where the preface quotes from the Protocol.  This fact in no way disparages the hard work the AHTEG (including myself) did over this time.  However, I feel strongly that expert groups should work toward and achieve consensus, which to date has not occurred. 

I look forward to reviewing the summary of this forum.
posted on 2012-12-14 17:11 UTC by Mr. Thomas Nickson, Consultant
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3967]
Dear Helmut and all;

Followings are my responses to the questions;
1. Who will be the target audience of this package:
          o   Trainers of RA?
          o   People learning how to carry out a RA?
          o   Risk assessors/ Practitioners?

Before answering these questions, it would be better to have the image of a package and to know the reason why such kind of a package is needed.  This issue may be originated from the following description in UNEP/CBD/BS/COP-MOP/6/INF/11.

“During the Third Series of Regional Real-time Online Conferences, experts of the Open-ended Online Forum made a number of recommendations for consideration by the Parties at their sixth meeting with regard future activities related to the Guidance. These include:
---
(d)Integrating the Guidance and the “Training Manual on Risk Assessment of Living Modified Organisms” developed by the Secretariat in collaboration with other United Nations bodies and international organizations for the purpose of developing a coherent and complementary material to be used in capacity-building activities;”

Since this issue has not been discussed in detail in COP-MOP6, explanation of background of this work will help enhancing our common understanding.

The objective of the Guidance is “to provide a reference that may assist Parties and other Governments in implementing the provisions of the Protocol with regards to risk assessment, in particular its Annex III”(BS-V/12).  On the other hand, as for the Manual, “the purpose of this material is to provide basic training for environmental risk assessment, taking into account the provisions of the Cartagena Protocol on Biosafety and in particular Annex III of the Protocol.”(Training manual, Preamble)  

I think these purposes may indicate users of each document.  Also users of a package may be indicated by its purpose.  Is it a revised Guidance, or an advanced Manual?

2. How can the Guidance and Manual be integrated?
   o   Should the Manual or the Guidance be used as the basis for this exercise?
   o   Should the package also provide a step by step guide for risk assessors to use when conducting RA?
   o   Should the package also be aimed for usage as a reference and background text for RA?

The image of a package might be integration of two documents.  Answers to these questions would also depend on the purpose of a package. 

3. With respect to the type of language used: which document will have priority as the reference to standardise the language between the two documents?

Of course the language had better be consistent.  It is obvious that the consistency with the Protocol, and its Annex III is a basic requirement.

4. Do we integrate all of the guidance or just the roadmap section?

It would also depend on the purpose of a package.

5. Do we include a section on the decision making process in this new package?

To be consistent with Annex III, could it be included?  Again, what is the purpose of a new package?
Also it may help enhancing our common understanding if someone could provide the background information of the following sentence in BS-VI-12.

“Conduct workshops on risk assessment and risk management at international, regional and/or subregional levels, using the package to carry out training courses for risk assessors, taking into consideration real case studies in risk assessment and how to apply the Guidance in the context of the decision-making process under the procedures of the Protocol.”

6. What (practical) experiences have people had with either/ both documents?
o   Was one document easier to use/ understand than the other?
o   What aspects of one or the other do you think will enhance a user’s understanding of RA?

With reading those documents, my impression is that it had better be carefully checked in detail whether it is consistent with the Protocol and its Annex III.  If the documents contain the contents beyond the Protocol and Annex III, such contents had better be treated as an option, or just an example, in order to improve the flexibility of the documents.

Sincerely yours

Isao TOJO
posted on 2012-12-14 04:23 UTC by ISAO TOJO, Ministry of Agriculture, Forestry and Fisheries
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3968]
Dear all,

The number of comments posted and differing views shared on several issues under this forum proves the relevance of risk assessment (RA), and the need to keep working on it in the context of the Cartagena Protocol on Biosafety (CPB).

Several comments made are good substance for interesting and intense discussions. This post will not target several of them to avoid moving too far away from the scope of this forum. However, some of them are worthwhile to comment before providing the answers to the questions posted.

First of all, it seems that remains the old and repetitive tendency of going back to old issues (almost expired) already discussed when drafting the CPB and deciding on the establishment of the AHTEG (a good number of year ago). This repetitive practice certainly is far from being proactive in relation to the effective implementation of the CPB decisions. With the purpose of refreshing memories and encourage to move ahead in a more straightforward fashion, it is important to keep in mind that the already existing RA guidelines do not deal with the scope and objective of the CPB. This is the basis for keep working in the development of a common risk assessment and risk management (RA&RM) package of LMOs.

Second, it will be very important - in further discussions - not to disregard the long process already walked, and avoiding statements such as “we have very advanced guidance in the form of chair's text (not a consensus).” If the documents currently under discussion would not be consensus documents, they would not have been presented to the MOP, in the fist place. Additionally, such a comments are to certain extent disrespectful to the time and work of the AHTEG members and countries (especially the ones with limited biosafety personnel) that are putting effort for participating in a joint process. The current documents, regardless their MOP recognition/adoption status, are CPB documents and it is important to work constructively on them.

Finally, the current discussion is a preparatory work to the forthcoming activities such as testing the Guidelines. By providing useful insights on the WHO and HOW the testing will be done, and how the testing package can be improved before testing it (including testing it in capacity building activities), we are going in the right path.

Now to the questions posted:


1. Who will be the target audience of this package:

          o   Trainers of RA?
          o   People learning how to carry out a RA?
          o   Risk assessors/ Practitioners?

Certainly all the audiences mentioned above and others missing should be targeted by the RA package. However, if a specific audience should be prioritized, then they are “risk assessors and practitioners” since they are already doing the job.

In relation to this question and previous comments, some additional issues are worthwhile to point out:

- We need to be cautions and not pretend that the package will act by itself as a capacity-building course on LMO risk assessment. Doing this may result in a misleading testing of the package. The Guidance does not target novice (starting from scratch) on biosafety of LMOs, but people who already have enough background on biosafety of LMOs.

- As rightly pointed by others, “Experienced risk assessor” do not necessarily assess potential adverse effects of LMOs in line with the CPB objectives. Accordingly, they could also have room for further improvement of their skills and RA approaches, particularly to carry them out in a more rigorous and transparent way.

- Similar to the previous applies to “experienced” countries on RA. Several “experienced” countries carry out incomplete RA when, for instance, do not appropriately take “into account human health” in their RA processes. Hence, the package should be useful for all CPB Parties, developed and developing countries, as well as experienced and less experienced ones.


2. How can the Guidance and Manual be integrated?

          o   Should the Manual or the Guidance be used as the basis for this exercise?
          o   Should the package also provide a step by step guide for risk assessors to use when conducting RA?
          o   Should the package also be aimed for usage as a reference and background text for RA?

As others have mentioned, the Manual and Guidance should not be integrated in a single document since they fulfill different purposes and probably audiences as well. The important issue is that they are consistent in terms of content and integrated in a complementary fashion.


3. With respect to the type of language used: which document will have priority as the reference to standardise the language between the two documents?

In agreement with previous posts, the most important aspect is content consistency. For achieving this, the Guidance needs to be the basic document and not the Manual, since the former results from several years of work and discussions in different CPB fora.

In relation to this question and previous comments, it is important to mention that:

- The content of the package on RA is complex because of the complexity of the issue it deals with. Probably the Manual could be simplified for pedagogical purposes; however this simplification may reach only certain extent when consider the technical level that a proper RA of LMOs requires.

- “Realistic guidelines” should not mean realistic in economic terms, only; but realistic in relation to what needs to be protected according to the CPB: “Conservation and sustainable use of biological diversity, also taking into account human health”.


4. Do we integrate all of the guidance or just the roadmap section?

Is it important to integrate in the package both Guidelines and Road Map in a complementary fashion.


5. Do we include a section on the decision making process in this new package?

A section on decision-making in the package will be very useful if it makes explicit the following:

- The decision-making guidance focuses on evaluating “how” the risk assessment was conducted.

- The risk assessor should not take part in the decision-making.

- The environmental risk assessment provides only part of the information that a Party could take into account when reaching a decision on import of LMOs. Other aspects such as socio-economic, legal, etc. need to be considered in accordance to the CPB or the domestic biosafety regulation.

Additionally, in relation to a previous comments it is important to point out that the risk assessment cannot be unrelated from the risk management since the latter is designed according to the findings of the previous. Moreover, in the process of risk management, new information relevant to monitoring and updating the risk assessment may emerge.


6. What (practical) experiences have people had with either/ both documents?
          o   Was one document easier to use/ understand than the other?
          o  What aspects of one or the other do you think will enhance a user’s understanding of RA?

This should be the focus of another forum. Just in response to a previous post, it should be mentioned that including in this discussion the “experience of countries with commercial approved LMOs” in the testing of the package and “align the Manual and the Guidance” in relation to it, is likely to result in a misleading outcome. RA is essentially an ex-ante evaluation. Accordingly, testing in countries with no-approvals of LMO will provide highly useful information for evaluating the usefulness of the packages as tool for anticipatory assessments of adverse effects of LMOs.

Kind regards,

Georgina Catacora-Vargas
posted on 2012-12-14 05:18 UTC by Sra. Georgina M. Catacora-Vargas, Bolivia (Plurinational State of)
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3971]
POSTED ON BEHALF OF MARIA MERCEDES ROCA
------------------------------------------------------------

My name is Maria Mercedes Roca  from the National Biosafety Committee of Honduras. It is a privilege to participate in this forum and learn from the valuable  experiences of other regions and countries. I have received  training in Risk Assessment for Genetically Modified Organisms in Brazil, Argentina and the US  and have been active in training activities in  my region in Central America.  It is an understatement  to say that good,   clear teaching material greatly enhances our work.  It is also very important to clearly define the audiences receiving the training, so as to not waste valuable time and resources training people who will not be actively involved in risk assessment and management activities in their countries.  The definition of target audiences  in each country also needs careful consideration by national committees.

I am writing from  the annual meeting of the Society of Risk Analysis in San Francisco (12 December), and  participating in the biotechnology sessions   (and now also being discussed  is  synthetic biology), so it is very timely but  also daunting to keep up with the specific  discussion of the on-line forum. I want to thank and congratulate all the members of the AHTEG  for their great dedication and commitment in preparing the guidance and manual  documents, especially for use in developing countries that have a clear need to train regulators, to adopt  sustainable, modern agricultural technologies.

It is clear that the field  of Risk Assessment and Risk Management   is developing and there are great opportunities for  collaboration with countries  that have a lot of accumulated practical experience in this field. We are lucky in Latin America to have a lot of such accumulated practical experience. Although there is wide agreement that the  guidance and manual documents are in an advance stage,   I feel there is still lack of consensus among parties and experts in some areas. Such lack of consensus includes the technical language and the terminology  used, as pointed by Piet and Tom.  Language  matters a great deal to define concepts and terminology  with clarity and precision and to avoid ambiguity in an already complex subject. I invite the next group of AHTEG experts to look at this issue carefully, especially when translating documents for testing and  training purposes. 

To illustrate, the problem gets very complex when documents are translated from English into languages like Spanish, where some terms don’t even exist. For example in English we use “ Risk Analysis” as an umbrella for Risk Assessment, Management and Communication. In Spanish, the words “assessment” or “hazard” do not exist, so we loosely use terms like “evaluación ” to mean assessment. To illustrate further,   “management”  is defined as “gestión” or the word “peligro ”(danger!)  is used to mean “hazard”. To English speakers,   there are clear distinctions and weights of meaning in the  words “danger” or “hazard” associated with LMOs.  When documents get translated into other languages (especially by professional translators not trained in Risk sciences)  inexperienced regulators may get a different meaning of the original intended one and confussion in the process may arise. Thus, “not one size fits all” in terms of guidance and manuals for all regions in the world. 
To contribute to solve  this issue, a group  of Latin American regulators with wide  practical experience in the field of Risk Assessment of Genetically Modified Organisms, have recently  developed a guide that  includes practical case studies from  many countries in Latin  America. The document  is currently being translated into English and in the second  Spanish edition, it will include a glossary of  technical terms in both Spanish and English,  widely used in risk Analysis  (with guidance from members of the  Society of Risk Analysis). We hope this  “regionalized” document complements and  adds to the other excellent resources  already available or being currently developed,  like the present guidance and manual documents discussed in this forum.  

I join Francisca from Mexico in sending you warm regards from Latin America.
Maria Mercedes Roca
posted on 2012-12-14 11:09 UTC by Dina Abdelhakim, SCBD
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3975]
Dear All,

my additional comment to inclusion the decision making segment in the package.

The decision making sector would be relevant to risk management when a decision maker make decision whether the risk is acceptable and if it can be managed. This will be in connection with the step V of the Roadmap and selection of relevant risk management strategy and options.  I hope this decision making part will contribute to better understanding what are the operational steps need to undertaken by authorities before giving permission, which may take into consideration some other issues as socio-economic, ethical, legal or other domestic circumstances or aspects.

Although the related decision making sector might be non prescriptive, and countries may be free to decide if they want ti include it in their national RA operational system.

I am align to the comments made by Lim Ching, Georgina, Wei  and other participants who consider inclusion or the decision making. It would be very helpful.

Thank you.

Angela
posted on 2012-12-14 14:49 UTC by Angela Lozan
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3979]
POSTED ON BEHALF OF RYOSUKE FUDOU
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This is my first comments, and I would like to express my respects for all the participants who made valuables comments on this complex process.

In my notion, the current guidance book, although I admire the laborious tasks to make it, is not necessarily practical, and not yet fully fit to the people who need the guidance in developing country.

In addition to the technological issue, the cost of RA should also be taken into consideration.  For instance, the cost for RA of GM crops is assumed to range from 0.1 - 15 million US$ depending on the crops, genetic traits and countries etc (see,AgBioForum,13(1)53(2010), NatureBiotech,25(5)509(2007)etc).    Immense cost derived from inadequate or over-regulated guidelines would hamper the proper implementation of the RA especially in the developing countries.

In this regard, as pointed out by many members, we should get back to the decision made in the COP-MOP6 that “the Guidance will be tested nationally and regionally for further improvement in actual cases of risk assessment and in the context of Cartagena Protocol on Biosafety”. Based on the outcomes from testing in the actual sites, the guidance will be significantly improved both technologically and socio-economically.

Best regards
R.Fudou
Japan Bioindustry Association
posted on 2012-12-14 16:34 UTC by Dina Abdelhakim, SCBD
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3980]
Dear All,

It is good to see such active participation in this forum – by now reading all your posts is a challenge in itself and I will not pretend to have entirely kept up! This is the problem of waiting until the last day, and apologies for this. As I am sure is the case for many others, it has been difficult to set the time aside to contribute.

My first comment is that it important that the review of the guidance and training manual is well structured. I agree with those who consider that order is important and that we should avoid running processes in parallel as this is likely to result in duplication of effort. The Annex to Decision BS-VI/12 states that the open-ended on-line forum and AHTEG should work “on the following issues in the given order of priority.” And so should begin by developing a framework for testing the guidance. This discussion has, however, been useful in focussing on what is needed from the guidance and training manual.

1. Who will be the target audience of this package?
I agree that it is useful to take a step back and consider who the target audience is and most importantly to consider the question: what are these documents for and who needs these documents? The BCH could be effectively used at this point to collect further information from the Parties on this now that both the guidance and training manual are available.

I think there is a general audience and a more specific audience. The general audience is all Parties to the protocol. For this audience it should be possible to develop a framework for risk assessment/risk management which translates the requirements of the protocol into guidance adhering to principles which are acceptable to all Parties. Where issues are contentious and cannot be resolved it seems the guidance should not attempt to provide a solution, but could refer to the existence of different approaches. I believe this was the goal in drafting the guidance. To a large extent the roadmap section of the guidance achieves this, but the MOP illustrated that there are issues which continue to be contentious.

The specific audience is those in need of training (i.e. those new to risk assessment) and their trainers. For this audience a more discursive narrative would be useful. This could more fully explore different approaches, provide case studies and set the roadmap in context. The training manual already goes some way towards achieving this, but it would need to be revised to be based more clearly on an agreed roadmap.

2. How can the Guidance and Manual be integrated?
As others have noted, the Decision refers to alignment rather than integration and there is likely to be value in maintaining separate documents for different audiences. I agree with suggestions that Module III of the training manual could be replaced with a tested and revised version of the roadmap. At present Module III uses language and headings which differs from that used in the guidance. As pointed out by others in places there are even conceptual differences. Simply replacing Module III with a revised roadmap would provide a solution to this. This could be supplemented, if necessary, by boxes (a tool already used effectively in the training manual) providing diagrams, examples or case studies. The manual can be more effectively revised once the guidance has been tested and views collected from Parties as to their needs regarding guidance and training.

3. With respect to the type of language used: which document will have priority as the reference to standardize the language between the two documents?
A strength of the training manual is that in general it uses shorter sentences and simpler language than the guidance. Irrespective of the purpose of the documents it is important that every effort is made to communicate clearly. I also agree with others that it is important to harmonise terms.

4. Do we integrate all of the guidance or just the roadmap section?
The roadmap should be sufficiently developed so that it can be applied to any GMO in any circumstances. The current guidance on specific topics illustrates the challenge of providing concise, generic guidance on specific topics for an area requiring a case-by-case risk assessment. A better place for information on specific topics may be the training manual where a more discursive approach, backed by case-studies could be used.

5. Do we include a section on the decision making process in this new package?
It is important that the guidance notes that the process of risk assessment/risk management does not in itself result in a decision. Providing advice on how this decision should be made is not, however, explicitly required by Annex III and beyond the remit of an AHTEG on risk assessment/risk management. Decision-making could be an appropriate topic for discussion in the training manual as it is important for risk assessors to understand the context in which their recommendations will be used.

6. What (practical) experiences have people had with either/ both documents?
Our advisory committee has tested previous drafts of the guidance and this has informed input from myself and my colleague, Louise Ball, on previous consultations.

To conclude, the work which has gone into the risk assessment and risk management guidance and training manual has been substantial. This can now be capitalised upon if these documents are evaluated and tested in such a way as enables Parties to determine whether they correspond to their needs. The most important audience will be Parties with capacity building needs and it is important that their views well are captured in the testing process.
posted on 2012-12-14 16:47 UTC by Dr Katherine Bainbridge, Department for the Environment, Food and Rural Affairs
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3982]
Dear collegues
there is a wealth of input and proposals. Some of these are quite contradictory. Therefore I like to underline Katherine Bainbridge´s comment where issues are contentious and cannot be resolved the guidance (and our task) should not attempt to provide a single solution but should refer to the existence of different approaches. We all know that different concepts and approaches exist with for example among others a different understanding of the receiving environment, environmental characteristics to be taken into account etc. Especially for the "newcomer" it may be very valuable to learn about the different concepts and approaches to get the whole picture. With this in mind we should approach the use and testing task and try to align manual and the guidance package.
thanks and best regards
Beatrix
posted on 2012-12-14 17:33 UTC by Beatrix Tappeser, Federal Agency for Nature Conservation
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3984]
Dear colleagues

As this discussion draws to a close I would like to make comment on the original questions posed by Helmut (noting that subsequently we have been asked to concentrate on questions 1 and 5.

1. Who will be the target audience of this package:
          o   Trainers of RA?
          o   People learning how to carry out a RA?
          o   Risk assessors/ Practitioners?
My view is that the target audience will include all of the listed people (and I am assuming that this includes regulators).  In addition, I believe that the community at large will also be part of the target audience since regulators are working on behalf of their communities.  Therefore the processes need to be as transparent and 'de-mystified' as possible.

2. How can the Guidance and Manual be integrated?
          o   Should the Manual or the Guidance be used as the basis for this exercise?
          o   Should the package also provide a step by step guide for risk assessors to use when conducting RA?
          o   Should the package also be aimed for usage as a reference and background text for RA?
As a number of contributors have already stated the Manual and the Guidance were developed using different processes and my view is that given the lack of transparency involved in the development of the Manual it would be preferable to use the guidance as the 'lead' document (since it is clearly based on Annex III).  Having said that, the Manual is the document that will probably get the most use (?) and therefore an initial step should be be ensure consistency - or perhaps more accurately, to ensure that there is no inconsistency.
I would assume that a 'step by step' guide would be of value as long as it was not presented as being prescriptive.

I don't believe that the package should be aimed for use as a reference and background text for RA as it is too specific.


3. With respect to the type of language used: which document will have priority as the reference to standardise the language between the two documents?
I am confused - is there a lack of standardisation? If so, then this raised serious concerns about the process that was used to develop the manual.   As above, if there is any inconsistency the language must be standardised on the Guidance rather than the Manual. 
The language of Annex III is not the same as that used in some other areas of risk analysis and it would be useful to include a commentary about this (see that table used in the Australian and New Zealand Standard handbook 'Managing environment-related risk' which provides an alignment between different international terminology).


4. Do we integrate all of the guidance or just the roadmap section?
I don't understand this question.  I have serious concerns about some of the guidance documents attached to the Roadmap as they were developed by small groups and require broader peer review.


5. Do we include a section on the decision making process in this new package?
No.  For reasons outlined in earlier posts.  Decision making is an important separate topic.

6. What (practical) experiences have people had with either/ both documents?
          o   Was one document easier to use/ understand than the other?
          o   What aspects of one or the other do you think will enhance a user’s understanding of RA?
No comment.

Finally, as regards the priorities for 'what next', I would like to add my voice to those who are suggesting that testing is the critical bit.  Can I suggest that country representatives get together and propose how they might best test the materials and provide feedback to the AHTEG when it is formed.

regards
Janet Gough
posted on 2012-12-14 20:08 UTC by Janet Gough, Environmental Protection Authority
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3987]
POSTED ON BEHALF OF GAMAL MEDANI
-------------------------------------------------

Dear Forum Participants,

First of all I would like to express my respects for all the participants who made valuables comments on this complex process.

Simply, I’d like to stress upon five points as following
1- type of language used
In regarding to the type of language used, which document will have priority as the reference to standardize the language between the two documents (training manual and guidance)?
It is important for the training manual to use shorter sentences and simpler language than the guidance. Irrespective of the purpose of the documents it is important that every effort is made to communicate clearly. I also agree with others that it is important to harmonize terms.

2- Decision making.
I wish that decision making part will contribute to better understanding what are the operational steps need to undertake by authorities before giving permission, which may take into consideration some other issues as socio-economic, ethical, legal or other domestic circumstances or aspects.

3- Capacity building

It should be addressed as an important issue for the stakeholders and the authorized personnel.

4- I want to add my voice to those who support testing the documents against real live scenarios, real life LMOs, because testing should find any problems or issues in the documents that can be sorted-out before the documents become “official”. However, when doing this, I believe that it is very important that at least some of those involved in the testing have experience in assessing risks to biosafety. I believe that it is important to include scientists with training and experience in areas such as wildlife, ecology, environmental science, toxicology and human health assessments; and scientists with hands-on research experience assessing the risks of LMOs to health and the environment.

5- Finally, I would like to raise up a request to expand the discussion on the quality of the guidance and the mechanisms for testing in the near future.

Thanks a lot and best regards
Gamal
posted on 2012-12-14 20:52 UTC by Dina Abdelhakim, SCBD
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3988]
Hello All,

It is good to see so much participation in this discussion, and I appreciate the opportunity to add my comments.  I work for an organization that provides capacity building for the regulation for biotechnology in developing countries, and my comments are based on observations from my work.

I have participated in online discussions on the guidance in the past, but I am entering this discussion with some question about the manual and where it came from.  Regardless, I have the following thoughts to answer Helmut’s questions, taking into consideration what I have read from others in this discussion.

1. Who will be the target audience of this package?
There have been different opinions in this discussion so far about who should be the target audience.  These documents could be/and should be useful to many different categories of audience, including risk assessors, decision-makers, trainers, and developers.  Some of you have said ‘anybody’.   Hwoever, I would echo the posting of many who have cited the need to be very clear about the specific purpose of these documents, and in my opinion the audience should be defined by the specific purpose.  I believe the specific purpose of these documents should be to provide practical guidance to novice risk assessors.

However, the the participants, in the ‘testing’ of the guidance document could include experienced and inexperienced risk assessors, trainees, trainers, decision-makers, developers, as all of these groups can contribute to improving the documents based on their experience and expertise.

2. How can the Guidance and Manual be integrated?
I concur with the observation of others that the Decision refers to alignment rather than integration in the training, and these documents should not be merged, that the roadmap (after revision) could take the place of Module III in the manual, both documents should be aligned not only with each other, but first and foremost with the protocol and with Annex III of the protocol particularly with regards to the terminology, and that alignment can be accomplished most effectively if it takes place after the Guidance has been tested and revised.

3. Do we integrate all of the guidance or just the roadmap section?
I agree with those who have suggested that the initial effort should be to align the roadmap with the manual.

4. Do we include a section on the decision making process in this new package?
I agree with the many participants who have observed that decision-making should not be included as part of the package at all.  It is not within the mandate of the AHTEG to develop guidance on decision-making.  Although decision-making is an important part of the regulatory process and it is important to understand how risk assessment/risk management fit into the decision-making process, decision-making is separate from risk assessment.  Given the controversy reflected in the discussion of the guidance and manual for risk assessment and management which ARE within the mandate of the AHTEG and the amount of work that remains to test and revise these documents, it does not seem wise to broaden the scope of the AHTEG’s responsibility to introduce guidance on the additional difficult topic of decision-making at this time.

6. What (practical) experiences have people had with either/ both documents?
I have attempted to use the guidance documents in trainings and I have found what others have also noted, that it is not readily useful to novice risk assessors in its current form.  It will be very important, as the methodology for testing is developed, that the purpose of the testing (to test the usefulness of the guidance for novice risk assessors?) and the criteria for determining the outcome of those tests are clearly established.  For example, I also found it telling that our colleagues from South Africa concluded that no two assessors were able to produce a similar assessment by following the guidance.  Shouldn't we expect that a science based risk assessment lead to similar outcomes from different assessors?

At any rate, I look forward to more discussion along these lines when the next discussion on the topic of testing opens.

Regards,
Karen Hokanson
posted on 2012-12-14 22:02 UTC by Ms. Karen Hokanson, University of Minnesota
Moving forward [#3989]
I was greatly concerned by Georgina’s comment “Second, it will be very important - in further discussions - not to disregard the long process already walked, and avoiding statements such as “we have very advanced guidance in the form of chair's text (not a consensus).” If the documents currently under discussion would not be consensus documents, they would not have been presented to the MOP, in the fist place. Additionally, such a comments are to certain extent disrespectful to the time and work of the AHTEG members and countries (especially the ones with limited biosafety personnel) that are putting effort for participating in a joint process. The current documents, regardless their MOP recognition/adoption status, are CPB documents and it is important to work constructively on them”.

As a party to the Protocol I do not believe that we have yet in anyway formally accepted either the guidance or the training manual. At MOP6 the guidance was put up for consideration and the parties have asked for further work to be done and for it to be reconsidered at MOP7. I cannot second guess what will happen at MOP7 but I would expect that the parties will consider the guidance seriously and if it is not what was expected that it be rejected and not simply approved because it has some perceived mana as a CPD document. I also do not accept that robust discussion is “disrespectful to the time and work of the AHTEG members and countries”. It is our job to create a robust roadmap and not to be sycophantic to those who went before us. We need to accept what is good and reject what is not – that is our job.

As for the training manual – this was a document I believe, and please correct me if I am wrong, developed/commission by the secretariat to achieve capacity building under Article 22. I do not believe the parties have ever been asked to ‘endorse’ the training manual. It is my belief that if the training manual is increasing capacity then it should be used. If it is not increasing capacity then it should be rejected. At this stage I have not seen any evidence one way or the other.

I am also concerned about the way guidance is being used in this discussion. Guidance means – “advice or information aimed at resolving a problem or difficulty, especially as given by someone in authority” (Oxford English Dictionary). The original task was to produce a flow chart indicating the steps in a risk assessment and to direct the reader to existing material that would help them to deal with that step in their own risk assessment. At this stage it is my concern that this document is too big and too complex to act as guidance – this is the reason that New Zealand sought to have it rigorously tested before the MOP ‘endorsed’ it.

I noted in my earlier posts that I was concerned that if too much work was done on the existing documents in bring the language into alignment and creating a ‘package’ that there would be a reluctance to initiate any changes indicated by the testing of the guidance. I am still of that opinion. However, I do believe we can work on the language and especially the list of terms at the end of the guidance as a starter.

Geoff Ridley
Environmental Protection Authority, New Zealand
posted on 2012-12-14 22:06 UTC by Dr. Geoff Ridley, Environmental Protection Authority
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3991]
POSTED ON BEHALF OF MARJA ROUHONEN-LEHTO
-------------------------------------------------------------
Dear Helmut, dear all,

Due to travel and other obligations, I am only able to join now, during the last day and last hour. I have carefully read almost all the comments received by 6 pm (GMT+1h) and find the discussion very interesting and certainly useful for our further work and way forward. I am very glad that we are monitored and kept on focus; I would also otherwise be easily tempted to make comments not related to our first task. So thanks Helmut for keeping us on the track. And thanks Boet and Hans for reminding us of our earlier decisions related to RA&RM and the development of a road map and guidance on risk assessment. We need it, we have agreed to develop it and that’s what we should do.

Thanks to Hans, Beatrix, Angela, Kathrine and others that have made good suggestions how to move forward. I do not have much to add – just a few points.

1.      As others, I also see all three groups mentioned by Helmut in his opening statement as the target groups for the package. They will provide valuable input from different angels. As stated by others, these groups should probably be approached a little differently and e.g. questions posed to each group could be formulated differently.

2.      I see the package containing three parts; the manual as the basis to start with, the roadmap and monitoring guidance as a more detailed and advanced description on the different issues/steps of the RA. The specific guidance further adds to this, as the “third tear”. All parts complementing each other and guiding through the RA.

3.      I think we need a “glossary” of the main terms and they should be the same throughout the package. I do not see a need to strictly standardize the text/language. The text has to flow well in the whole package but there may even be a need to keep the manual text very easy to read while the learning process starts there.

4.       Aligning or integrating. I do not see a need to integrate all the existing documents into one document and I do not think that this was either meant in the decision. To me aligning means that these documents “talk to each other”. After having read/used/learned how to use the manual, it should be easy to move to the road map and monitoring guidance (this process can be parallel but that is for our further discussion how to test …). And further to the specific guidance. So yes, aligning all documents into a package; maybe stepwise, first the manual and the road map.

5.      A section on decision making could be useful. As has been pointed out by some of you. I guess we’ll give a little more thought to that.

6.      My colleagues and I have mainly used the road map, the monitoring guidance and the specific guidance (especially the one on trees). To us, having already quite a lot of experience on RA, they have provided new insight on some specific issues, in a very concise manner. They have also been helpful in situations where we have explained basic and specific issues of RA to people not so involved in LMO RA.

That’s all for now. Looking forward to further discussions on this important issues and task. Let’s stay focused and constructive and let’s keep in mind what has been decided in COPs and what we have been asked to do.

Marja RL
Finland
posted on 2012-12-14 22:59 UTC by Dina Abdelhakim, SCBD
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3992]
POSTED ON BEHALF OF HELMUT GAUGITSCH
-------------------------------------------------------

Dear Participants of the Open-Ended Online Forum:

I would like to thank everyone who participated in this vibrant first round of discussions and for your valuable contributions. The opinions expressed and the broad sets of experiences are vital aspects of the success of these online discussions.

While the current forum is closed, I will attempt to summarise the main points that were made during the exchanges  which I will send to all participants before the holiday season begins.

Once again I would like to thank all the participants for this fruitful discussion and I hope this level of engagement and enthusiasm will continue throughout the upcoming discussions.

Best regards,
Helmut
posted on 2012-12-14 23:51 UTC by Dina Abdelhakim, SCBD
RE: Opening of the discussion group on developing a package that aligns the Guidance and Training Manual [#3994]
POSTED ON BEHALF OF HELMUT GAUGITSCH
---------------------------------------------------
Dear Participants of the Open-Ended Online Forum,

Once again, I would like to thank you all for participating in the first round of discussions in the forum and for your views and comments.

The discussion focused on the topic of the appropriate methodology and approach to be taken with the view to develop a package that aligns the “Guidance on Risk Assessment of LMOs” (e.g. the Roadmap) with the training manual “Risk Assessment of Living Modified Organisms” in a coherent and complementary manner (see Decision BS-VI/12, annex, Terms of Reference, paragraph 3(b).

In spite of the challenge of keeping participants focused on the topic at hand, there were many concrete and useful suggestions made with regard to the topic of aligning the Guidance and training manual.

I will attempt to summarise the main points that were made during the discussions. Please note that this summary will focus only on the portion of the contributions that were relevant to the topic of aligning the Manual and Guidance. Many points were raised which were of a different, and to some extent more general, nature. These comments were useful in order to achieve a more common understanding of different lines of thinking on the topic among experts, as well as on the tasks of the Open-Ended Online Forum and the AHTEG in the context of decision BS-VI/12 including the terms of reference of the group. I hope for your understanding that this summary at this stage will not provide an explanation or interpretation of the terms of reference.

There will be an opportunity for specific discussions on the testing of the Guidance in the upcoming forum starting January 14th 2013 (see information note by the SCBD on 17 December 2012).

Question 1 - On the issue of the target audience of this package: There seemed to be a common understanding that the target audience depends on the purpose of the package to be developed. The main purpose is practical guidance to risk assessors and different modules may be needed for different audiences. The majority of participants agreed that the package should aim to be structured with a progressive level of complexity such that at all three groups of people (i.e. trainers, novice risk assessors and current practitioners, with a primary focus on novice risk assessors) are possible target groups.  It was also noted that the target audience of the package can also include other stakeholders such as developers of LMOs.

There was disagreement as to whether or not the primary focus should be on novice risk assessors and if experienced risk assessors/ practitioners should be considered as a target audience as well. This is due to the consideration that the experienced risk assessors already have several years of practical experience conducting risk assessments and may not be in need of guidance on the matter. Thus this can be a point for further consideration.

Question 2 - On the issue of how the Guidance and Manual should be aligned: Several excellent interventions with concrete suggestions were made with respect to this question and I commend you all for the thought and debate that went into this key issue. Several contributors introduced their suggestions with the observation that the way the package is presented depends largely on the perceived purpose of the final document and the audience the package will be targeting.  Below is a summary of the key suggestions that were made:

• A number of participants were of the view that the package can be structured in such a way that the Manual serves as a beginner level portion of the package and the Guidance, and possibly the section on specific LMOs and traits, serves as a section for more advanced users. A concern was raised that there are risks to using this model since it could imply that there is vital information that is missing from the “beginner” document and is thus incomplete.
• Another model suggested that the two documents remain independent but that the manual be restructured in such a way that its content is used as an explanatory guide to the Guidance, since from some users’ experiences the Guidance alone is not fully accessible to novice risk assessors. This would also allow room for the addition of sections for case studies and, possibly, decision making.
• Finally there was the proposal to replace module III of the Manual with the Guidance.

There were calls to ensure that regardless of which alignment model is chosen, the text needs to be in line with the Protocol and Annex III, have consistent conceptual thinking within the documents, has the flexibility to accommodate changes due to advances in the field and allow for the material to be used in different contexts while striving to provide options for contentious issues.

Question 3 - On the point of aligning the language between the two documents: There was agreement amongst participants that the use of terms between the two documents, with preference given to the terms in the guidance, needs to be consistent in such a way that the same terms are used with the same meaning in both documents in order to ensure that the communication of ideas is as clear as possible. Some interventions went a step further and stressed that additionally the flow of concepts between the two documents also needs to be considered for alignment. There was a strong call for a particular focus to be made on aligning the “Use of Terms” section in the Guidance both with the manual and with the text of the Protocol.

Question 4 - On the issue of either integrating all of the guidance or just the roadmap section: The majority of the colleagues who commented on this topic agree that we should focus on aligning the content of the Roadmap and the manual. However, there were some suggestions also proposing ways that Parts II and III of the Guidance could be aligned into the package, so this needs to be discussed further in the future process.

Question 5 - On the point of including a section on decision making in the package: Views were most divergent amongst participants on this issue. On the one hand, some participants supported the addition of such a section on decision making because conducting a risk assessment does not occur in a vacuum. Views were expressed that it depends on the purpose and focus of a possible section on decision-making but such a section could help inform the decision making process without confusing the roles of each player. There were proposals that the addition of such a section can be done with the understanding that it is not prescriptive and that there are defined prerequisites that a decision maker must keep in mind when using the risk assessment as a tool, amongst others, in the decision making process.

On the other hand those who were against the inclusion of such a section feel that this is simply beyond the scope of what the forum was mandated to do and it will shift focus away from key issues that should be the primary goals. Additionally the decision making process includes several non-scientific aspects, such as legal, socio-economic considerations and public consultations that are considered beyond the scope of a risk assessment. Lastly, it was also noted that discussing decision making in a risk assessment document may blur the lines between the functions of the risk assessor and the decision maker.

Question 6 - On the issue of experience with the documents and enhancing the understanding of the risk assessment process: Some participants shared their different experiences with using the documents in particular cases. Others felt that this question is more appropriate for the upcoming testing phase. Several participants suggested that it would be of use to include case studies in this package.

Once again I would like to thank all the participants for their contributions and I wish you all the best for the upcoming holiday season as well as the year 2013. I am looking forward to keeping in touch with you.

Best regards,

Helmut Gaugitsch, Environment Agency Austria
(Moderator of the first online discussion round)
posted on 2012-12-20 16:53 UTC by Dina Abdelhakim, SCBD