POSTED ON BEHALF OF LUCETTE FLANDROY (MODERATOR)

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Dear Members of the Open Ended Online Forum,

Welcome back to our online discussions. I hope most of you were able to take some time off during the past few weeks.

It is a pleasure for me to continue moderating the discussions on the development of a package that aligns the “Guidance on Risk Assessment of LMOs” (e.g. the Roadmap) with the training manual “Risk Assessment of LMOs”.

As per our calendar of activities and the email sent by the Secretariat on 9 September, this discussion will focus on the alignment of the restructured version of Module 3 of the Training Manual with the relevant sections of the Guidance.

Recalling the positive reactions (summarized at http://bch.cbd.int/onlineconferences/forum_ra/discussion.shtml?threadid=5426) to the restructuring of the Training Manual proposed by the Secretariat on the basis of comments in the discussion session of early July, the Secretariat has kindly made available the restructured Training Manual at http://bch.cbd.int/onlineconferences/forum_ra/discussion.shtml, as well as the Guidance for your ease of reference.

Recalling also the concrete way forward that was proposed during the discussions held between 30 June - 14 July to help guide the alignment process (and summarized at http://bch.cbd.int/onlineconferences/forum_ra/discussion.shtml?threadid=5424), I invite all participants to:

i) Map the corresponding sections between the Manual, in particular its restructured Module 3 and the Guidance;

ii) Identify if there are sections or concepts contained in the Guidance that are missing in the Manual, in particular Module 3, and vice-versa, for which users would benefit from more introductory explanation (i.e. in the Manual) or more in-depth analysis (i.e. in the Guidance), taking into account the different scopes of the documents.

I encourage you to share your views and comments as soon as possible in order to allow time for others to respond/comment and, thereby, setting the scene for a vibrant discussion.

I am looking forward to reading your comments and suggestions!

Best regards,
Lucette

Dear All,

Many thanks for  the secretariat for the hard works in achieving such a helpful and very interesting manual.

I have a quick look and just provide a quick comment. Perhaps more will come after careful reading. In the clear version line 1242-1243, it seems that this sentence will provide a wrong impression that some kind of risk assessments can be finished without further investigation. I would propose to delete the word 'alone' and replace it with a phrase'taking current situation into consideration'. Then the whole sentence would be read 'Some risks can be assessed based on existing scientific literature and previously available information, taking current situation into consideration'. In this way, I think it will correctly express the right nature of risk assessment. I look forward to any comment from our colleagues on this aspect.

Tomorrow will be the Mid-Autumn Festival in China, I wish all you a happy life wherever you live on the earth.

Thank you!

Wei

dear Wei, dear All
First I like to convey my thanks to the Secreteriat for the thorough work on the documents and to Lucette for chairing this discussion. And many thanks to Wei for his heartful wishes.

as a quick response to Wei´s point I fully agree with him and appreciate his proposal of rewording. I would further add "As a starting point " at the start of the sentence, to clearly underline that a desk analysis alone does not fulfill the requirements of a RA and does not adequately consider the receiving environment. It would read then: As a starting point some risks can  be assessed based on existing scientific literature and previously available information, taking current situation into consideration.

best regards
Beatrix

Dear colleagues,

Thanks to the Secretariat and to Lucette for allowing us a further round of discussion on the training manual. I intend to post more comments, but I would like to start with a reaction to the discussion that Wei and Beatrix strated with their comments.

The original text starting at line 1242 is: "Some risks can be assessed based on existing scientific literature and previously available information alone. Others may require laboratory experiments (e.g. early tier toxicology testing), confined field experiments or other scientific observations.”

Wei states that “this sentence will provide a wrong impression that some kind of risk assessments can be finished without further investigation”. However, it is clear that some risk assessments can be finished without further investigation, for instance in the case of a market application. Please read the original sentence carefully: “Some risks can be assessed based on existing scientific literature and previously available information alone.” For a market application this would mean that one takes into account ALL available information: for instance scientific literature as well as the information that an applicant provides, which would be part of the “previously available information”, and which should in the ideal case be sufficient.
In that way, Wei’s proposal does make perfect sense: his text proposal is “Some risks can be assessed based on existing scientific literature and previously available information, taking the current situation into consideration”.
I think that Beatrix’ proposal to add “As a starting point” is based on an uneasy feeling that I also get from the language of “Some risks” in the first sentence  vs. “Others”, i.e., “other risks” in the second sentence. This creates an antithesis between two “types” of risks, which I think does not exist and which certainly does not help the discussion. I think we do not need the “some” and “others”, and we would not need “as a starting point”, if we phrase the point we want to make as follows:

and this is my TEXT PROPOSAL: “In general, risks can be assessed based on existing scientific literature and previously available information, taking the current situation into consideration. The assessment may require further information made available through laboratory experiments (e.g. early tier toxicology testing), confined field experiments or other scientific observations.”

One thing more about “In general risks can be assessed …”: I would argue that ANY risk assessment can be done on the basis of “existing scientific literature and previously available information, taking the current situation into consideration”. The outcome of the risk assessment may then be: the risk is difficult to assess because of existing uncertainty. The uncertainty may be tackled by providing more information, or by taking risk management measures, or by concluding that the estimated risks are too high to allow the LMO activity.

Best wishes,

Hans

POSTED ON BEHALF OF MARIA ANTONIETTA TOSCANO

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Dear All,

I agree with point of view of Wei and of Beatrix , but I think that, taking into consideration the different scopes of the documents, the restructured Training Manual text is complete and very easy to read and to apply.

I thank the Secretariat for the difficult work on the document and because has kindly made available the restructured Training Manual for other ours comment about its correspondence to the Guidance.

Moreover, taking into account the different scopes of the documents my personal opinion is that analysis in the Guidance is wide and complete and that introductory explanations in the Manual are well described and may be easily applied.

My best regards, while I am looking forward to reading other comments about Module 3 and other questions.

Maria Antonietta Toscano

Dear all,

Despite the busy schedule and many other responsibilities in our everyday  jobs, it is good to hear from you again. Congratulations to Wei Wei and all our Chinese colleagues  for the Mid-Autumn festival in China. I also hope our European colleagues have just returned from a well earned holiday.

Our National Biosafety Committee (Honduras) had a very long, but  fruitful session last week and testing of the Guidance was discussed by the group.  The discussion spread to other countries in Central America (Panamá, Costa Rica, Nicaragua, Honduras, El Salvador, Belize  and  Guatemala) thorough our  newly formed association – the ICABB  (March 2013 - Iniciativa Centroamericana de Biotecnología y Bioseguridad) endorsed by all our Ministers of Environment and Agriculture.

Maybe, mainly because  the text of the Guidance is in English, our Spanish-speaking regulators did not find the documents either easy to understand and less so, easy to apply, as some colleagues have suggested in previous postings on this forum. 

As an experienced teacher, I also know  that what may be very clear  and obvious to you - the teacher preparing and explaining  the subject matter - may  be very confusing and baffling to your students,  who lack a lot of the information and perspective that the teacher has and may take for granted.

Spending time and effort polishing the English prose of the current  text here and there, and not putting a serious effort into translating the text  properly (by professional translators and professional risk analysts) will distract the real problems of  “usability" or utility of the Guidance and the Training Manual  for member parties who are not native English speakers.

I apologize for sounding a dissonant note in this group,  on behalf of my Spanish speaking colleagues in Central America, but I agreed in our last meeting that  I would convey their message to the AHTEG, as their voted representative.   It would be far easier to keep silent and don’t get involved at all, as many parties chose to do. But we are all aware that unless we respectfuly  share our opinion with you, the AHTEG and the Secretariat may get a false sense that all is well and clear with the documents we are preparing.

I look forward to your wise opinions to the best way to move forward on this issue.

Best regards to all,

Maria Mercedes Roca, PhD.
(on behalf of the National Biosafety Committee of Honduras and the ICABB of Central America)

Dear colleagues,

Coming back to the issues suggested for the moderator, I have compared the module 3 of the Training Manual and the Part I of the Guidance.
In my opinion, both use the terms in the same sense, and both are comprehensive documents. I do not miss any term / concept in either of them.
I find this part of the Manual easier to understand for a no-expert user, due to the use of examples. However, I do not find a “more in-depth analysis” in the Guidance (regarding just to Part I). For me, the Module 3 of the Training Manual and the Part I of the Guidance have the same level of analysis, and now the same structure. The only difference is the presence of examples in the Manual. I think this approach is correct, provided that the rest of the Guidance reaches a level of analysis enough to help in the assessment of actual cases of LMOs.

Kind regards,

Victoria Colombo

Dear colleagues,

Coming back to the issues suggested for the moderator, I have compared the module 3 of the Training Manual and the Part I of the Guidance.
In my opinion, both use the terms in the same sense, and both are comprehensive documents. I do not miss any term / concept in either of them.
I find this part of the Manual easier to understand for a no-expert user, due to the use of examples. However, I do not find a "more in-depth analysis" in the Guidance (regarding just to Part I). For me, the Module 3 of the Training Manual and the Part I of the Guidance have the same level of analysis, and now the same structure. The only difference is the presence of examples in the Manual. I think this approach is correct, provided that the rest of the Guidance reaches a level of analysis enough to help in the assessment of actual cases of LMOs.

Kind regards,

Victoria Colombo

Dear all
Many thanks for the Secretariat and Lucette for this round of discussion.
The previous postings go, till now, in two directions: polishing/clarifying the English text; and proposing an effort to have a good translated document (Manual and Guidance).
Regarding the first approach, I took a look at both documents and found it clear enough. For sure, when I read it I tried to put myself in the position of a non-familiarized person with the topic – which, I had to say, is a very difficult task. And this put me in the context of the next approach: maybe saying it is clear and easy will not represent a reality for a "neonate" on this topic.
Saying so, I would like to leave the in-deep discussion of the English version to our colleagues of native-English spoken-members, just mentioning that I did read the Manual and corresponding topics in the Guidance, and could perfectly understand the purposes and examples.
And I would like to join the comments presented by Maria Mercedes (and her friends who endorsed her), mentioning the much appropriated proposal of a serious and urgent effort to get the translation of the texts, PROPERLY (emphasizing the properly, as she did in her post). For Brazil it could be much more important, since Portuguese is not included in the expected UN translations.
Finally, I would like to mention that next week a Brazilian Biosafety Congress will be held in Salvador, Bahia, and those members of the Forum that will be there could try to have a short meeting to discuss further steps to help in the proposal of a sound translation of the documents.

With my best regards

Deise Capalbo
Embrapa Environment, Brazil

POSTED ON BEHALF OF LUCETTE FLANDROY (MODERATOR)
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Dear participants to the forum,

I thank Wei, Beatrix, Hans, Maria Antonietta, Maria Mecedes, Victoria and Deise for starting a lively discussion.

While comments on the text of the documents are very pertinent and will be taken onboard at the appropriate time, we still have larger overarching issues to be resolved before we take up the task of editing and refining the text. In accordance with the way forward agreed upon in the previous discussion and reiterated in your opening message, I kindly invite you to focus on the task at hand, i.e. the “Alignment of the Guidance and Training Manual – Module 3” and, in particular:

“i) Map the corresponding sections between the Manual, in particular its restructured Module 3 and the Guidance;

ii) Identify if there are sections or concepts contained in the Guidance that are missing in the Manual, in particular Module 3, and vice-versa, for which users would benefit from more introductory explanation (i.e. in the Manual) or more in-depth analysis (i.e. in the Guidance), taking into account the different scopes of the documents.”

I look forward to further comments on the specific steps above.

Thanks already for your attentive re-reading and analysis of the two documents, and for your worth wile participation in the forum.

Lucette Flandroy

Dear colleagues,
First of all I would like to express appreciation to the Secretariat for the hard work. From my point of view now the two Documents are coordinated and it is become easy to navigate between the Guidance and Module 3 of the Manual. I have not identified to this time the sections or concepts contained in the Guidance that are missing in Module 3 of the Manual, and the explanations of the terms were clear. Almost all the terms. I tried to imagine that I read the Manual for the first time – and it seems to me (as not native speaker) that the terms «risk» and «hazard» (key terms) in the Part of the Manual «Overview of the Risk Assessment Methodology» were not clear enough, but below I think a good example is given, that helps to distinguish this two concepts. (Sorry, I can`t define the line numbers in the Text, because some problems with their numbering in the Documents when opening). And one more thing. When reading the Manual, I think it is a good explanation of the Steps of risk assessment, and all those important milestones that need to be taken into account at each Stage, but for the inexperienced reader it is hard to understand immediately all the varieties of the milestones he should take into consideration and in what cases it is necessary to do so. I lacked the Real example of risk assessment to understand this process (when I have presented myself reading the text for the first time). I think it would be good to insert into the text (Step «Сonducting the Risk Assessment») the relevant parts of the real case of the risk assessment decision making process as example. It can be inserted into each part, or possibly to the end of the Part «Conducting the Risk Assessment». I look forward to your views on this matter.
Sincerely yours, Galina Mozgova.

In regard to Dr Mozgova's confusion on terminology, in the English language literature: (a) "hazard" generally refers to the danger, the damage, (b) "risk" is usually the probability of that hazard occurring, and (c) "safety" is the ACCEPTABILITY of such a risk, made by a person or society, as appropriate.

Some observations.  (1) In casual discourse, "hazard' is sometimes used incorporating probability and then would be a synonuym for "risk"--EG, "Watch out driving on the icy road--conditions are hazardous" means that it is "risky".  (2) Note that "safety' is not an objective concept; you might think something is safe that I might think is too risky for me to do (I always have one student in class who does skydiving--the risk to each of the students would be the same; he--it is always a "he"--thinks it is safe, but the others do not.  (3) The schema above does not deal with the DISTRIBUTION of risks.  Since these often mean that some people are put at risk so others may benefit, it is ismossible to avoid the political aspects inherent in these risk analysis discussions.

Phil Bereano
Washington Biotechnology Action Council

Dear Members of the Open Ended Online Forum,



Few but interesting messages came on the forum end of last week and during the WE.



Among other, the message posted by Dr. Galina Mozgova was echoing the preceding message of Dr. Victoria Colombo: they both notice that one useful characteristic of the Manual is to provide examples that facilitate the understanding of somehow complex or delicate concepts linked to the process of risk assessment.



At this stage of the discussion, and taking into account some previous messages, I thus invite you in particular to :



a)      Identify if some section tackled in the Manual would be missing in the Guidance and would deserve a corresponding deeper analysis in the Guidance. By reverse, would some section in the Guidance miss a corresponding fluent introductory explanation in the Manual. (NB: these eventual missing sections could a.o. be identified just by looking at the titles of sub-chapters in both documents)



b)      Look if supplementary examples in addition to those proposed by Galina could be useful in the Manual to illustrate some concept that is still hard to capture with the present wording of the text . Besides, are all existing examples convenient or could some of them better be changed or completed ?



c)       Think if some example could also not be useful in some crucial part of the Guidance ?



d)      Examine if a deeper analysis could be useful in the Guidance in parts where both documents would have presently a comparative level of analysis ( this, to echo part of the comments of Victoria ); and if yes, what type of deeper analysis ?



e)      Examine if some supplementary displacement of sections would still be useful, despite the preceding restructuration of the Module 3, to make the navigation easier between the two  documents.



I wish us a second fruitful week of discussions, and a happy beginning of fall !



Best regards



Lucette


Disclaimer : http://www.health.belgium.be/eportal/disclaimer/

Dear Lucette, dear colleagues,

Regarding the point (d) of the post # 5483; when I said that, in my opinion, both the Module 3 of the Manual and the Part I of the Guidance have the same level of analysis, I was talking just about the part I of the Guidance, that deals with the “Roadmap for Risk Assessment of Living Modified Organisms”. I think it has a similar level of complexity that the Module 3 of the Manual. As I said, I think this is correct, as we all agree that both documents should be comprehensive, so it is not a problem if the Guidance comes back to the principles of risk assessment.
This Part I of the Guidance, as it is stated in the “Background”, it is based on living modified (LM) crop plants. My only concern is that, due that crop plants are used as a base for the introduction of general concepts of risk assessment, this could mean that the most frequent case does not have a specific chapter in Part II of the Guidance “Specific types of LMOs and Traits”. In my point of view, the Guidance gives more detailed instruction of how to conduct this “specific types”, that for crop plants expressing insect or herbicide resistance.
I did not want to enter now in this subject, as there are scheduled debates on the other parts of the Guidance, for the next months.

Kind regards,

Dear Lucette, Secretariat and all participantes to the online forum:
I apologize for not participating the first week, I only had a chance of reviewing module three yesterday (but I have been following the interventions  made up to now).

I would like to make a general comment first:

My impression from reading it was of clarity, precision, order......I felt comfortable while I browsed through the whole section....it was relatively easy to understand despite the complexity of the subject. In that sense I do not see it necessary to change the texto further, as it stands it is fine.

We in Mexico had the opportunity to participate already in a workshop to evaluate the guideline, so I had a chance to review the text a couple of times in past weeks..........comparing the roadmap and the manual with respect to module III, the two approaches are pretty much complimentary, I didn´t detect any contradictions or major blobs.

The only detail I feel is missing are real life examples in relation to particular ideas (for example, "dealing with the potential recieving environment") where the manual could direct the reader (x links) to specific clear cases in documents already up in the BCH to illustrate the "how did X or Y risk assessor go about the issue). I hope I made myself clear.

Un abrazo desde México!

Francisca

Dear Members of the Open Ended Online Forum,

I thank Dr. Victoria Colombo for the precision brought in her last message, that will be taken on board at due time.

But, beside the message of Victoria and Francisca, activity on the forum was rather sparse this week…….

I hope everyone had a chance to review the proposed alignment and you are satisfied with the present relationship in content and structure between Module 3 of the Manual and the Roadmap of the Guidance

I would like to remind you that this session of the forum will be closed on this Monday 30 September at 1am GMT.

Please, take the opportunity of these last days to feel free to post small or large comments on the subject of this discussion, especially on the basis of the questions I proposed on last Monday to guide your reflection.

With my best regards to all of you.

Lucette



Disclaimer : http://www.health.belgium.be/eportal/disclaimer/

Dear All,

My thanks to the Secretariat for restructuring the Manual in a way that makes it indeed easier to compare the structure of the Training Manual with the structure of the Guidance, and my thanks to Lucette for agreeing to moderate this session. 

Lucette, I can fully understand your disappointment that there are so few postings. I expect that the fact that people submit so late in these debates – this is certainly not the first time - is to a large extent because it does take quite some serious reading and reflection before being able to make meaningful comments about two documents that total well over 75 pages. Besides, many of us have to do this in the evenings and weekends (and I fully understand Maria’s concern of the additional complication for people who do not speak English on a daily basis have in examining these documents and formulating proposals).

Real online discussions are only possible on well focused topics, and that in the case  of open questions about long documents we should accept that input comes in at a later stage, and can be used in later stage by the AHTEG and MOP.

Turning to our task at hand, i.e. looking at the Training Manual with a view to alignment with the Guidance,  I offer the observations below.

Point of departure of my comments is that while the two documents have the same scope, i.e. ERA of LMOs in the context of the CPB, they have different objectives. The Training Manual is a tool to train novice risk assessors. As with any training manual, it is not a cookbook with fixed recipes, but  a manual to be used by trainers in training sessions. As with any training manual, the usefulness of this manual heavily depends on the experience that the trainers have with actual risk assessments. Fortunately, over the last decades, governments, public research institutes, companies and national and international organisations have accumulated a wealth of expertise and experience in this field.

Having compared Module 3 of the Training  Manual with the CPB and the Guidance, I share the following general observations: 

1. Several parts of the Manual need to be adjusted to align with the terminology, scope and approach of the Manual with the CPB and the Guidance. For example, on some places terminology is used that –is different from the terminology of the CPB. 

2. As others have also said, several parts of the Manual need to be further clarified to make them useful for training of novice risk assessors.
I note that some colleagues came to the conclusion (sometimes after “a quick look” or “while browsing through”)  that they felt that the manual was fine as it is and that it is not necessary to change it. I have some concerns with that approach. First, I think that a document as important as this manual, deserves more than just browsing through. Second, I believe that we should be in ‘peer review’ mode for these tasks, i.e. willing to take a critical look at such documents, also if it was produced by colleagues or with our own involvement. Third, and most important, the key question for me not whether this text is clear to me, but whether the text is clear to novice risk assessors.

3. The manual  contains on several places prescriptive langue and/or deals with regulatory aspects, a sit currently does.

4. The manual should does not clarify enough that biological concepts such as “Change”, “Outcrossing” , “introgression”, “resistance development” are natural phenomena that in themselves do not imply risk. The manual should on more places describe the context of the existing situation with non LMOs.

5. The manual does not clarify enough that uncertainty is a normal element of any biological process and in itself does not imply risk.

6. Examples and figures are not always clear, do not always have added value, and/or are not always based on up to date experiences with releases of LMOs.

7. The manual should underline the importance of mutual acceptability of data.
In this context I fully agree with Hans’s observations in response to a comment from Wei Wei.

8. The manual should on many places distinguish between ERA for confined field trials and for unconfined / commercial releases.


I will send later today some specific examples and text suggestions in relation to some of the above points.

Hope that this helps and wishing you all a good remainder of the Sunday !

Piet

Dear Lucette, dear colleagues,

Module 3 in the revised version of the Training manual on Risk assessment of LMOs is clearly better aligned with the Guidance in structure, in particular with the Roadmap. This was the first thing that the SCBD was asked to do, and I thank them very much for doing this.
But while I was reading this part of the manual I came across a lot more questions. In this reaction I would like to remind us of basic idea behind the Training manual, at least the way that I see it: the Manual should help the novice risk assessor and enable him or her to follow the more detailed discussion in the Guidance, and then to find their own way in the background documents.
Right now, the newly inserted texts in module 3 appear to be just a shortened version of the text in the Guidance, but not very helpful in explaining the issues. Over all, it would be a good idea to have a good look at the text of Module 3 and to try and give it a conscious look with the eyes of a novice risk assessor.

I can only give a few examples.

The treatment of the concept of uncertainty is a point is case.
The text is by and large a shorter version of what is in the Guidance. In the AHTEG we have spent hours of discussion and drafting on this subject, but somebody who is new in this discussion  will be baffled by this. He or she should be taken by the hand and guided through the argument. Uncertainty is a basic issue in science, in fact it’s the whole point of doing science: there are things we don’t yet know, and once we know them this will only lead to more things we don’t know. Despite this fundamental fact of life, we claim that we do know some things. But not with absolute certainty; and so the argument goes on, along the lines of the Manual, but some more explanatory text would be helpful. The example that is given: “There is no internationally agreed definition of ‘scientific uncertainty’, nor are there internationally agreed general rules or guidelines to determine its occurrence. Those matters are thus dealt with – sometimes differently – in each international instrument incorporating precautionary measures.” is not helpful at all: it just says “others probably struggled with the same problems and have not solved them very convincingly”.

There is a fundamnetal issue of consistency: the text has the word ‘should’ in many places, and it is questionable whether this prescriptive language is consistent with the BSP and the CBD in all cases. I stumbled over the following example: “Any request to conduct or review a risk assessment that does not follow the case-by-case principle should lead the regulatory framework to request a new risk assessment with a scope that is specific to the case under consideration (i.e. the LMO, its specific use and the likely potential receiving environment).” (line 1291)
This text prescribes what a regulatory framework should do. This is not in line with the Protocol. The Protocol only says: “Risk assessment should be carried out on a case-by-case basis. The required information may vary in nature and level of detail from case to case, depending on the living modified organism concerned, its intended use and the likely potential receiving environment.” This does not prescribe any regulatory framework how it should go about to get a risk assessment done, it just specifies that the risk assessment on which a decision under the Protocol is taken should be carried out on a case-by-case basis.

Another  example of an issue that remains confusing is the Comparator.
The text that is there in the Manual (line 1340) is a very short excerpt of what is said in the Guidance.
Again, the reader could be taken more by the hand, starting with the pivotal idea that risk assessment is done in a comparative manner. That means that a risk should be compared with a ‘standard’ situation. The ‘baseline’ can be explained in those terms. The ‘comparator’ can then be explained, as the standard to find out what has been changed, what is new, in the LMO. The isogenic line is the easiest comparator. But, it's not ideal; what if there is not just an isogenic line (when we are talking about crops that are populations). And, what if the isogenic line is a very a-typical plant in the different varieties that are in practical use. And, what if we want to compare other characteristics.
The manual does go into this, but it does not provide enough context, no connecting ideas that bind all these concepts together.

I have the uneasy feeling that I have only been able to scratch the surface of the issues. Probably a very general discussion like this online forum cannot do much more, and a more dedicated approach would be necessary.

Best regards,

Hans Bergmans

Dear All,

Following up on my earlier submission, I paste below some specific examples and text suggestions in relation to my comment that several parts of the Manual need to be adjusted to align with the terminology, scope and approach of the Manual with the CPB and the Guidance.


Wishing you all a good night

Piet





The line numbers refer to doc. ra_training_manual_rev9sep2013 placed on the CBD website


[line 1029] Title to read: “Environmental Risk Assessment of LMOs in the context of the Cartagena Protocol on Biosafety.”

[line 1133] After “methodology” add “as outlined in Annex III of the CPB”.

[line 1136] replace “source” by “quality” (see Guidance page 8)

[line 1136] add after “uncertainty” the wording “regarding the level of risk” as in the CPB 

[line 1149] replace “module” by “manual”

[line 1152] with reference to “LMOs”: Here and elsewhere, be consistent in using the abbreviation versus spelling it out once the abbreviation has been introduced in the text.
[line 1156 – 1163] replace this text by the text of line 1164 – 1167, which is directly taken from the CPB.

[line 1170] replace “certain use” by “a proposed transboundary movement” as in the CPB

[line 1175 – 1215]: This section uses terminology that is different from the CPB.
Propose to replace text, figures and examples from lines 1175 – 1215 by: “The terminology used for risk assessment in the Cartagena Protocol on Biosafety differs slightly from terminology used in other arenas of risk assessment.  The Protocol uses the term “adverse effect” instead of harm or hazard.  The Protocol uses the term ‘likelihood’ instead of the term exposure.  This manual will try to consistently use the terminology used in the Protocol to aid those who are doing risk assessments in the context of the Cartagena Protocol on Biosafety. “ (see also the Guidance lines 377-380).

[line 1216] delete “during the risk characterization step above” and replace “Harm from happening” by “identified risks” as in the CPB

[line 1221] add after “as to” “whether an identified risk is acceptable or” as in the CPB

[line 1223] figure 5 needs to be extensively revised or omitted.  It should use terms that are those used in CPB (adverse effect, likelihood, risk, risk management)
[line 1230] replace “years” by “decades”

[line 1234 - ] move this text up to where difference of terminology is discussed.

[line 1242]: add first a sentence about the most important information needed, namely knowledge of the range of phenotypes of the organism that has been chosen to modify via modern biotechnology.  If the LMO is a fish species, you will need knowledge of  that fish species, where it lives and the interactions it has with other organisms in its environments

[line 1248 -  Example 11] Delete example 11. This example from a document on chemicals assessment is unintelligible in the context of a manual for novice risk assessors.

[line 1238] add after “scope” the wording “of the risk assessment”

[line 1290 – 1294] this text is inconsistent with the CPB and in part contains prescriptive language regarding regulations. Text needs to be deleted.

[line 1366] replace “and” by “ taking also into account”  as in the CPB

[line 1402] replace  “theoretical” with the wording from the Guidance “Scientifically plausible” as in the Guidance , see for example line 407

[line 1541] the phrase “unintended receiving environments and uses” seems to renegotiate the language of the CPB, where the terminology “likely receiving environments” was agreed after long negotiations. Delete.

[line 1560] Replace “characterisation of” by the terminology of the CPB: ” the relevant technical and scientific details of”  as in the CPB.

[line 1579] better just use the annex of the CPB for the summing up that follows.

[1688 – 1689] This sentence seems to renegotiate the language of the CPB, where the terminology “likely receiving environments” was agreed after long negotiations. Delete.

[line 1951] replace “regarding the use of an LMO” by “in the context of the Protocol”.

[line 2015] replace “national regulatory framework” by “the Cartagena Protocol”.

Dear All,

I would like to thank the Secretariat for this opportunity to comment on the training manual and its alignment with the guidance in structure and in content.  As with others, it has taken me some time to go through the documents, and in fact I have run out of time.  So I will post a few thoughts that I have been able to collect now, and I hope that there will be more opportunities to discuss the documents further at another time.

I would also like to thank Lucette for moderating this session, and for redirecting the discussion midway.  Even though the initial postings were slightly off track from the purpose, I want to take this opportunity to say that I do strongly agree with Hans in his response to the comments of Wei.  There are some cases of risk assessment where new information is not needed.  Hans gave a few examples, and another would be in the case of confined field trials.  Without a question, some risks can be addressed based on the scientific literature and on previously existing information.  I support the text change suggested by Hans to say “In general, risks can be assessed’ this way. 

I agree with those who have noted that the training manual and the roadmap are now better and more clearly aligned structurally.  This is a significant improvement.

However, it is my general opinion that the training manual still has a long way to go before it can be useful.   There are still problems with the content of the manual, and some of these stem from problems in the content of the roadmap already.  I agree with the concerns noted by Hans specifically in his posting earlier today.  I also agree with the general comments noted by Piet Van der Meer.  I will not repeat the points Hans and Piet have made, but just support them.

I appreciate, and agree with, the specific changes to the text suggested by Piet, and I realize this is the type of clear suggestions hoped for in this discussion.  Therefore, in addition to the specific comments of Piet, I would like to add the following:

Re line 1425:  As presented here, this text gives the suggestion that gene flow only happens to LMOs and not non-LMOs, and that gene flow in and of itself is a risk.  This is misleading.  Gene flow is not a risk. 

Re line 1492, Example 17:  This example is not a helpful as it does not indicate risk, only change. Dynamic changes are part of nature.

Re line 1243: add after “other” the wording “risk assessments”

Re: line 1572  delete “commercialised”.  Many of these consensus documents have been produced for species that have not been commercialized LMOs yet.

I have run out of time to add more changes, but I feel that there could be more.

My biggest concern with the training manual has to do with the ‘examples’ that have been provided throughout.  As noted by Victoria, the biggest difference between the guidance and the manual is the presence of examples in the manual. I think this may mean that there will be significant emphasis placed on these examples when using the manual.  However, it is my observations that these examples have been randomly selected and inserted.  Where one example is given, it may be that there are several other, even contrasting examples, that have not been provided.  Furthermore, Francisca noted that ‘real life examples’ are missing from the manual.  And Galina also noted a lack of ‘real examples of risk assessment’.  I agree that the manual would be strengthened considerably if multiple ‘real life examples’ from risk assessments were used throughout.  And there should be examples for different kinds of risk assessments (ie confined field trials, general release, placing on the market, etc.) because these are different, as has been noted many times in the discussions of the guidance and again even in the current discussion.

In Lucette’s mid-session posting, she asked us to look for other examples to supplement those present and look for places where additional examples should be provided.  I agree that some serious effort needs to be given to this aspect of the manual.  Until the examples have been significantly improved, I would not support the use of the training manual.  The product is incomplete.  Unfortunately, there was not time to make this improvement in the course of this online discussion.

I look forward to discussing these and other comments in the next discussions and in the AHTEG.

Sincerely,
Karen

I also wish to thank the moderator and the secretariat for their hard work, and apologise for my reply so late in the process and near the deadline.

I just wanted to note that I do believe that 'gene flow' can be a risk whenever a potential adverse effect of gene flow has been identified. For example, gene flow from an agricultural crop planted annually and at large scales that could overwhelm a wild and protected relative, or which may result in the creation of a more competitive weed species. Like other risks, it is also possible to consider mitigation strategies and thus there has been lots of literature on techniques for mitigating the risks of adverse effects from the flow of particular genes.

with best wishes
jack

THIS MESSAGE WAS SUBMITTED SHORTLY AFTER THE CLOSING OF THIS DISCUSSION AND IS BEING POSTED ON BEHALF OF DAVID HERON
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Dear All,
I want to express my thanks to the Secretariat for providing us this opportunity to comment on the alignment of module 3 of the Manual with the text of the Guidance document.  I also appreciate Lucette’s recent message encouraging us to offer input, even as this session of the forum is drawing to a close.  Her words have spurred me to offer some comments of my own as I look over the many comments that have already been posted.  I also want to thank the stimulating comments of those who have commented before me – your words have caused me to think deeply about the Manual in light of the needs of the novice risk assessors for whom it is intended.

I recognize all of the work that has gone into the current version of the Manual, but overall I must agree with the previous comment of Karen Hokanson (#5492) that although the training manual and the roadmap are now better and more clearly aligned structurally, the manual still has a long way to go before it can be used to successfully train novice risk assessors.   The specific points she raised are all extremely relevant for improving the Manual, and I hope that future versions will take these concrete text proposals on board.  I would note special emphasis for the points she raised regarding how the Manual presents the issues of gene flow and change, both of which are merely phenomena, not indications of risk.
Karen picked up on a comment by Victoria that also bears emphasis for the revision of the Manual, namely providing more relevant and illustrative examples in the text.  In their current state, the examples are primarily dry and theoretical.  Some examples are even incorrect illustrations of the concept under discussion in the text.  The authors of the Manual have chosen an example drawn the Australian system for monitoring for compliance, rather than an example of monitoring for adverse effects on the environment – the concept that the Protocol uses when discussing monitoring.  It is clear to me that if the Manual is to be constructive tool for training people in conducting risk assessments in the context of the Cartagena Protocol on Biosafety, it will need real-life examples drawn from experiences worldwide over the past few decades of environmental risk assessments of LMOs.  In fact, it should be emphasized more clearly that our environmental risk assessments of LMOs is built upon our experience in the environmental risk assessment of organisms modified by means other than those described as modern biotechnology in the Protocol.

I agree with the points made by Hans (comment #5474), especially his text proposal: “In general, risks can be assessed based on existing scientific literature and previously available information, taking the current situation into consideration. The assessment may require further information made available through laboratory experiments (e.g. early tier toxicology testing), confined field experiments or other scientific observations.”  In its current form, the Manual repeatedly gives the impression that new experiments need to be done in order to do a risk assessment. This is definitely not the case, and I think the text proposed by Hans makes this point clearly.

I think that Piet van der Meer’s general comments earlier today strike me as being especially constructive and relevant to the task of aligning the Manual text with the Guidance, and I hope that subsequent work by the AHTEG are able to incorporate these ideas.  The main issues he raises in comment #5489 are similar to my impressions as I have been reviewing the two documents.  I think that the concrete text proposals he provided are very constructive ways to address these issues in the Manual text.  I also support the constructive text proposals he made subsequently in comment #5491.  These are quite appropriate in keeping the Manual well-aligned with the Protocol, something that is clearly essential.

For my additional comments below I have used the approach that others have done in their comments, namely to refer to the line numbers used in the document that was posted on the CBD website (ra_training_manual_rev9sep2013). 

I have used the general headings that Piet proposed in his earlier comment, so that the work of the AHTEG can more readily address the major areas that still need improvement.

1.   Clarify the Manual to make it more useful for training novice risk assessors.
Text proposals :
[lines 1284 – 1287]. These first sentences here are very convoluted and oriented toward specific regulation, rather than keeping the focus on the CPB. I propose to delete these sentences, and to start the next sentence with the working “In accordance with the Cartagena Protocol the elements of a risks assessment include...”.
[line 1345] Start this paragraph with the sentence “the choice of appropriate comparators will be different depending on the step in the risk assessment”.
[line 1348] Place after “comparator” the working “to identify novel characteristics of a genetically modified plant”. Then add a sentence next that states " Near-isogenic lines may work for some plant species, but not for turf and forage grass species and alfalfa, which are bulked populations.  Near-isogenic lines are not appropriate or perhaps even possible for animals and many other organisms that may be LMOs.”
[line 1442 – 1444] The suggested approach is not typical to evaluate the toxicity of an introduced gene product this way.  Direct toxicity testing needs to be explained here, too.  Only gene products that are likely to be toxic are tested.  Many gene products are widespread in nature and are unlikely to be toxic in ways that could be evaluated in the manner described here.  This section gives the impression that toxicity testing is more the rule, rather than the exception (it fails to take into account the scientific plausibility discussion previously covered).
[line 1444 – 1446] Soil ecosystems are not organisms, and why single out weeds (a term which is not defined)?   Suggest revising this or deleting.
[line 1465] What does this mean?  What variants would be produced in an LMO that would not be produced elsewhere?
[line 1491] Can the authors provide a relevant example of a biodiversity protection goal sensu CPB or CBD?
[line 1620-1621] Delete “which of the endogenous genes of the recipient or parental organism(s) may be affected by the genetic modification”. This is inconsistent with the CPB, it is not part of the genetic modification as such and it is unclear how that would be ascertained.
[line 1628 1634] This is unclear. Does this mean the same as the inserted genetic elements?  It is better to start with the actual language of the CPB, and then elaborate.
[line 1648] For clarity, the section on detection is best placed separate from RA (i.e., not in module 3 of the Manual).

2. The manual is a technical training tool, and should therefore - like the Guidance - not  contain prescriptive langue nor deal with regulatory aspects.
Text proposals :
Screen throughout the document for terms as “should” and replace by more appropriate terms. For example in line 1334, replace “should” by “is often”, in line 1705 replace “should” by “can”.
[line 1657] This manual is about the protocol, not about ‘some regulatory frameworks”.  Delete this phrase.

3. The manual should clarify that biological concepts such as “Change”, “Outcrossing” , “introgression”, “resistance development” are natural phenomena that in themselves do not imply risk.
Karen’s comments have already touched on this point, and I might add that the text also needs better description and discussion of the distinction between gene flow and introgression.  The current text seems to equate the two terms, but this is not correct.  The difference between the two concepts should be explained, as well as that these concepts do not only apply to plants.

4. The manual should clarify that uncertainty is a normal element of any biological process and in itself does not imply risk.
Text proposals :
[line 1229] Delete “in an attempt to increase the level of certainty” - this reference has nothing to do with new information coming available.
[line1256] as described in the CPB and in the text that follows, the uncertainty we look at is uncertainty ‘regarding the level of risk’, i.e. something that can therefore only be addressed towards the end of the process. Therefore the sentence “Considerations of uncertainty are undertaken throughout the whole risk assessment process” is incorrect and should be deleted.
[line 1261] add after “uncertainty” the wording “regarding the level of risk”, and replace “be often” by “in some cases be”
[line 1262] add after “uncertainties” the wording “regarding the level of risk”, as in the CPB.
[line 1262 – 1265] this notion is not consistent with Paragraph 7(f) of Annex III of the CPB.
[ line 1988] add after “uncertainties “regarding the level of identified risks” as in the CPB.
[line 2069] as described in the CPB and in the text that follows, the uncertainty we look at is uncertainty ‘regarding the level of risk’, i.e. something that can therefore only be addressed towards the end of the process. Therefore the sentence “at each step of the risk assessment process” is incorrect and should be deleted.
[line 2078 – 2089] same comment: this goes beyond the CPB. Delete.
[line 2117] add after “uncertainties “regarding the level of identified risks” as in the CPB.

5. Examples and figures should be clear, have added value, and based on up to date actual experiences with releases of LMOs.
Text proposals :
[line 1381, Example 15] Apart from the fact that this example cannot be found on the GMAC website, this example should be deleted as it is inconsistent with the CPB and the Guide as it, among other things, incorrectly suggests that outcrossing in itself is a risk. 
[line 1406, Example 16] This example need to be given a bit more detail to be understandable for novice risk assessors.
[line 1459, figure 7] another unclear and unhelpful cartoon. Delete or replace by something better.
[line 1474, Figure 8] this reference should be updated, as it suggests that targeted serum screening, animal models, etc are always applied. Such texts are only applied if the donor, homology and/or digestive tests give reason to look further. 
[line 1514, Example 18] This text contains text that is pejorative (e.g., genetic “pollution”), inaccurate (e.g., the suggestion that persistence of a gene in the environment is a risk  in itself). Delete and replace by a more objective and balanced examples.
[line 1550, Example 19] - Here and elsewhere, the examples are not real examples, but rather theoretical digressions from other texts. Replace by real-life examples that illustrate the concepts.
[line 2090 , Example 28] This is the wrong quotation of the precautionary approach cited by CPB.  See Rio Declaration text (also included correctly in the Guidance doc) for the actual statement of the precautionary approach.

6. The manual should clarify that the importance of mutual acceptability of data.
Text proposals :
[line 1242-1243]  As stated above, I fully supporting Hans Bergmans’ follow up on Wei’s comments, I propose to add after “ alone” the wording “including risk assessments done by others”.
[line 1243] add after “other” the wording “risk assessments”
[line 1572]  delete “commercialised”.  Most of these consensus documents have been produced for species which do not have commercialized LMOs yet.

7. The manual should more often describe the context of the existing situation with non LMOs.
Text proposals :
[line 1506] Context is needed for readers who may not know that these phenomena can – depending on their use - occur with conventionally produced crops as well as with LMOs. Proposal to start the paragraph with: ”As with conventionally produced crops, extensive use of ….”   The phrase “as with non-LMOs” may be an even better phrase to use consistently throughout the Manual to emphasize this point.

8. The manual should distinguish more between confined field trials and unconfined releases.
This is a point that Karen made briefly in her comment, and I believe this needs additional emphasis throughout the Manual.
Text proposals :
[Line 1388 – 1395]  For most field testing, extensive molecular characterization is not necessary, since the interactions of the LMO with the environment are limited in area and time. 
[Line 1389 ] Before “molecular analyses” add “ For requests for placing on the market of LMOs”, 
[line 1569] Add after “case” the wording “, whereby for placing on the market typically more detail is needed than for confined field trials”
[line 2020] Add after “environment” the wording “indicating whether this is for confined releases or for placing on the market”

Thanks again to all for a most stimulating online session.
Best regards,
Dave Heron