Dear participants to the Open-ended Group and AHTEG,

This is a kind reminder that the discussion on "monitoring" will be open till 31 January 2012 at 1:00 a.m. GMT.

In this discussion, participants to the Open-ended Group and AHTEG are invited to suggest ways to improve the third draft of the guidance on "Monitoring of LMOs Released into the Environment" (please see document attached to the message in the discussion page http://bch.cbd.int/onlineconferences/discussiongroups_ra.shtml).

Thank you and best regards,
Manoela

POSTED ON BEHALF OF LUCETTE FANDROY

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Dear participants, dear Manoela, dear members of the AHTEG,

I see very few enthusiam till now to participate in this new session of the online discussions on guidance elaborations in the context of the Cartagena Protocol.

I thus take the risk to open the discussion, after a look at the new version of the guidance draft on Monitoring, whereas I could understand that the lack of discussion would be linked to this new version reaching a good general approval.

I want indeed to thank the AHTEG for having taken very well into account the various remarks of the preceding session of discusssion, and offering here a new version of the document where the differences between, and the specific aims and basis of General Monitoring and of Case-specific Monitoring are well clarified.

I just put at this stage very few amendements in track-changes in the version of 16 January 2012.

As a general remark presently :

- I think that in the various " Points to consider ", it could be carefully looked at again when the word LMO could take a " s " or not, taking into account that indeed one of the purposes of GS could be to look at unforeseenable effects of the use of multiple LMOs or interaction between LMOs.

Not more for now.

Best regards.

Lucette Flandroy

POSTED ON BEHALF OF LUCETTE FLANDROY

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Dear participants,

I beg your pardon for quickly answering my own posting: I forgot the word " not " , which changes the meaning of the sentence, in the first amendement I made in the text of 16 january. It is now correct in the new amended joined document.

Kind regards

Lucette Flandroy

POSTED ON BEHALF OF HIROSHI YOSHIKURA

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My detailed comments to the document Monitoring of LMOs released into the environment are found in the attached file. Main concerns of mine are as follows;
1. Reference to several paragraphs in the Cartagena protocol and CBD in BACKGROUND, which is not precise in my interpretation. See the file for the detail.
2. Annex III considers “monitoring” as a risk management measure by saying “(f) Where there is uncertainty regarding the level of risk, it may be addressed by ….. or by implementing appropriate risk management strategies and/or monitoring the living modified organism in the receiving environment. The provision is for risk management, not for assessment. However, I note that “monitoring” is used routinely for obtaining data needed for risk assessment. Important is that monitoring as part of risk assessment is entirely different from post-release monitoring in scope and objectives. Therefore, I propose that this document treats the two types of monitoring as different practices.
3. The living organisms and physical environments are affecting each other. In addition, without LMOs, the environment is changing by climate change or anthropogenic reasons. It is important to take these into account when we consider the baseline.
4. GS should be done within the existing regulatory framework, such as environment protection law.
5. “Examples” should be kept to the minimum, because they are often cause of further confusion.

Yours sincerely,
Hiroshi

Dear Participants,
The persistence of the poorly received concept and predicted inability to implement General Surveillance (GS) is a troubling indicator of the process of producing The Guidance. While its dominance has been reduced in the text, it has blossomed in Annex 2. The protection goals of GS are laudable, but their relevance for creating a science-based and effective monitoring plan have not been demonstrated.

The indefinite nature of GS is clearly illustrated by the following statement:

“It is important to note that the GS strategy is undertaken independent of specific LMOs that are being used, or that have been used in the past. GS may be useful, for instance, in the monitoring of long-term, and cumulative effects, particularly those arising from the use of multiple LMOs or when the interaction between LMOs or other organisms could not have been predicted.”

This statement is admitting is that GS is recommended independently of the characteristics of LMOs. If GS cannot be linked directly to a specific LMO, it is clearly unfocused, inefficient and unproductive strategy to identify undesired effects from the release of any particular LMO. It is poor guidance to provide to those attempting to use LMOs safely.

Inclusion of GS is totally at odds with the recommendation that (emphasis mine)…

“…the description of a monitoring strategy should be transparent and presented in sufficient detail to ensure scientific quality and RELEVANCE of the data obtained.”

If the monitoring strategy is to be relevant, GS cannot be a part of it because it is defined as including factors whose relevance specifically cannot be determined. If they could be, it would then be the very reasonable case-specific monitoring.

The impossibility of implementing GS is evident in the following recommendation (emphasis mine):

“The establishment of RELEVANT baselines is a key element for determining whether there is a CAUSAL LINK of any detected changes to one or more LMOs. In practice, THE baseline is a measurement of the RELEVANT parameters and their indicators prior to the introduction of the LMO(s) to an environment that is the same as or similar to the likely potential receiving environment.”

Which baselines should be monitored in GS if we have not established any potential science-based link between an LMO and a protection goal? In fact, THE baseline cannot be defined in GS. There are literally thousands of baselines that could be considered, all of which necessarily have no conceivable link to any particular LMO: If they did, they would be addressed in CSM.

Annex II contains numerous items which one MIGHT consider monitoring under GS (more, in fact, than CSM). However, I’m sure that each of the discussion group participants could identify hundreds more. I suspect in each of our minds that when we examine the examples and think, “That seems reasonable.” we are conceptualizing some CAUSAL link between the LMO and the baseline to be monitored. To the extent that is true, the baseline then becomes a relevant case-specific indicator.

General surveillance is not science-based, efficient or likely to improve the safety or reduce the impacts of the release of LMOs. To the extent that REASONS can be presented to justify it, it becomes case-specific monitoring. CSM provides science-based, reasonable measures that will result in concrete and justifiable monitoring plans for users. This guidance should be limited to that.

Mark Q. Benedict

Dear participants,

My comments to the 3rd draft of "Monitoring of LMO" are as follows. 

1.Procedure of the discussion
While I have been taking part in the discussion of this online-forum since last July, I am not satisfied with the procedure of the discussion.

1)Disclose of the reason not to be adopted the comments: I have already submitted some comments so far, and some are reflected in the draft.  However, since the reasons have not been shown in case that the comments were not adopted, the further discussion/comments are impossible. In order to deepen the discussion, it must be necessary to show the reasons why the comments are not adopted on scientific and logical basis.

Especially it has been repeatedly commented from many experts that GS is not necessary, nevertheless GS still remains in the document.  I could not find the reason.  The development of the documents will not be advanced if this kind of procedure is repeated.

2)Clarification of the point of arguments: It becomes a heavy burden for me, whose native language is not English, that the documents have been changed largely every time.  In order to avoid this kind of problem, the discussion on the major points should be finished first, and followed by the details of the documents.

3)Reasons for selection two “Monitoring” and “LM tree”: Since it is not shown the reason why those two topics, such as “Post-released Monitoring” and “RA of LM Trees”, are selected, the decision of selecting topics itself does not seem to be transparent.  I could not find that it is selected fully on the basis of the priorities and needs by the Parties, as fixed in the terms of reference in BS-Ⅴ/12.

2.The objective and scope of the guidance of monitoring
1)As far as I understand, the development of the guidance of monitoring is based on BS-Ⅴ/12, the decision of MOP5.  According to the terms of reference in the annex of the decision, the open-ended online forum etc. shall work together with the view to developing and achieving “further guidance on new specific topics of risk assessment”.  Therefore, I understand the new topics are necessarily related to the risk assessment, i.e. AnnexⅢ of the Protocol.

Thus, the objective and scope of the guidance of monitoring should be to provide a guide to the 8(f) of the AnnexⅢ.  Therefore the GS, which observes the effects that were not anticipated in the risk scenarios, could not be included in the guidance, as I commented last time.

2)In the current draft, it is shown that the article 7 of CBD, which is defined as “parent treaty”, is related to the monitoring. However, the article 7 is not quoted in the preamble of the Protocol.  The “Identification and Monitoring” of CBD would be monitoring of the general biodiversity and would be qualitatively different from the monitoring of LMO stated in the AnnexⅢ, which is in the part of the risk assessment and management process.  As I understand the documents, which we are discussing, is a guidance of the Protocol, I think the quotation of the article 7 of CBD in the document would make confusion.

If included articles or provisions are not directly related to the monitoring, it should be written merely as a reference.

3)It is referred to “observation” in the article 16 of the Protocol in the document.  However, the article 16 states that the “observation” is performed “before it is put into its intended use”.  An attention should be paid that it is inconsistent with general definition of “monitoring” shown in the line73-line74, i.e. “once released into the environment”.

3.Use of the guidance to unintended environmental release
According to the article 17 of the Protocol, if an unintentional transboundary movement of LMO occurs, related information is sent to the Party, such that the Party could determine appropriate responses.  In those cases, the scientific risk assessment as shown in the AnnexⅢ could also be applied.  If so, 8(f) of AnnexⅢ, including “monitoring”, could be used in unintended environmental release.

Therefore, it is not necessary that unintentional/illegal transboundary movements are outside of the scope of this guidance as written in line 22–line 24 in “Objective and Scope”.

4.Cumulative effects
The words of “cumulative effects” are used in the document.  It would be understandable in case of chemical substances which are not easily decomposed.  However, it is not clear what kind of effects is imagined in case of LMO.  I would think that those kinds of effects have not been recognized through over 15 years of experience of cultivation in the U.S.?  This kind of words, which is vague and unsupported by the evidence, had better not be used.

Therefore the words of “cumulative effects” and related description should be deleted.

Sincerely,

Isao Tojo

Dear Participants,

My comments on the Monitoring of GMOs into the Environment are in the attached document.

To summarise:

The guidance is generally improved, however, the description of CSM and GS is still combined. As these are conceptually different, it is not possible to combine the description in this way and to do so will lead to confusion. It needs to be clear that CSM is to test specific hypotheses whereas GS is to check for unanticipated adverse effects and that different methodology will be appropriate in each case. The two need to be separated.

It would also be useful to state more clearly that although GS is required under EU legislation, there are limitations as to what GS can deliver. Regulatory authorities may wish to decide whether they consider it proportionate to implement monitoring for unanticipated effects following a pre-market risk assessment.

As written, the guidance might be interpreted as implying that regulators should design monitoring plans, whereas a more appropriate role for the regulator would be to provide guidance. This should be made clearer in the text.

Best regards,

Kath Bainbridge

Dear participants,

Thank you for the effort to provide the draft of the guidance on "Monitoring of LMOs Released into the Environment".

My concerns for the draft guidance are as follows:

1) According to the Cartagena Protocol and the Convention of Biological Diversity (CBD), monitoring is an option to be considered on a case-by-case basis (Cartagena Protocol Annex III #9; CBD article 7). However, the draft guidance just emphasizes the importance of monitoring. The paragraphs in the Cartagena protocol and CBD should not be skewed in the draft guidance (in the background section).

2) An ambiguous monitoring itself could be a risk. Evaluation that lacks reasonable considerations (testing hypothesis) will cause difficulties in reaching reliable conclusions. If unnecessary monitoring is conducted and the introduction of biotechnology to reduce the environmental impact (e.g. bioremediation for hazardous waste) is postponed, the biological diversity in such an area would be threatened by hazardous waste. To avoid this kind of situation, risk assessment should be carried out on a case-by-case basis, as stated in Annex III #6.

3) Specific comment
Line 20: “This guidance can be used for all types of LMOs”
This is contradicting the #6 in Annex III “Risk assessment should be carried out on a case-by-case basis.”

Sincerely,
Kazuaki Matsui

POSTED ON BEHALF OF MICHAEL ECKERSTORFER

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Dear participants, dear Manoela, dear members of the AHTEG and the sub-working group,

First I want to express my sincere thanks to the authors of the draft guidance document and the AHTEG for providing the updated Guidance Document at hands which in my opinion reflects the previous discussions – it is shorter and easier to digest for readers with a less elaborate background in monitoring, while still containing a lots of valuable guidance and information to consider.

I thus only include a few additional suggestions on the text in attachment, which are mostly editorial in nature and want to refer 2 points which seem important to me:

One point that is treated more concrete in the introduction at hands is the important difference between monitoring of small-scale trials which also serve the purpose to generate data for risk assessment of further larger scale releases and Post-marketing monitoring (e.g. after placing on the market of LMOs).

While both aspects should be mentioned in a document that is meant to address monitoring comprehensively, it is certainly good to refer to the different purposes as precisely as possible. In that respect I would support to mention as appropriate the specific requirements for both types of monitoring in the text of the rationale of later chapters, e.g. as suggested by Hiroshi Yoshikura for chapters (3) Duration and Scale and (6) Reporting.

Another point that should be clarified is the description of General Surveillance, specifically the notion that “the GS strategy is undertaken independent of specific LMOs”.

While GS is less targeted to specific hypotheses for adverse effects due to a single LMO, which were already established during the risk assessment, it should be designed with a view to the characteristics of an LMO or combinations of LMOs that are to be monitored. I hope my suggestion in the text addresses this point to avoid any confusion.

Supporting also the remarks and (updated) suggestion of Lucette, I am positive that with some minor revisions the document can proceed forward.

Best regards
Michael

POSTED ON BEHALF OF OSSAMA ABDEL-KAWY

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Dear Manoela, Dear all

Kindly find attached proposed few amendments in track-changes in the version of 16 January 2012.

Also find below a quick responses to some of the comments that were raised

- Article 32 of the Cartagena Protocol establishes the relation between the Protocol and the Convention, Moreover identification and monitoring are required for the purpose of article 8g of the convention; an aticle that  is recalled in the preamble of the protocol

-  Having a careful look at the language of article 7 and 8g of the convention “Party shall, as far as possible and as appropriate, in particular for the purposes of Articles 8 to 10 “ it is quite clear that identification and monitoring , in particularly for activities relevant to the use and release for LMOs, is mandatory for all CBD parties (193 parties till now).

- Setting appropriate baselines is essential for the detection of any damage, however those baselines need also to take into account any other human induced variation and natural variation.

Warm regards, 
O.A.ElKawy

Dear open ended online forum members,

I wish to add a few points and clarifications on the ongoing discussion.

1. Time constraints (particularly with most inputs coming in the final day or minutes of the discussion period!) do not permit a response to each point of comment provided by expert reviewers in the online forum. This was attempted in the SWG at earlier rounds, but was not sustainable. As previously noted, and in line with the procedure of previous specific guidance documents created under this AHTEG, every comment is taken into consideration in the amendement of the draft document regardless of source or affiliation of the contributor.

2. The document is based on input from a diversity of experts. While there is not consensus on many issues, the document should reflects points made on their merits, and not on their frequency of being repeated. I quite well understand the frustration of some that their positions do not find purchase in the document despite repeated requests. However, particularly for more contentious issues and differences of opinon lends itself to being more inclusive, rather than less, and letting the user decide what information may be relevant for their particular scenario. Such is the case in the GS discussion.

3. Mark Benedict raises the point that some of the information that is discussed in the monitoring strategy would be dealt with during the RA. While this may be the case, it cannot be assumed as such. I think the discussion here highlights that the information from an RA can be quite informative in the design of a monitoring strategy, to know what was convered, how it was done, and what questions remain for CSM.

Assuming that the RA would have covered some of the provisions discussed in the monitoring document seems to overstate what the risk assessment can accomplish, both on practical and epistemological grounds. That is, CSM or GS may be applied in relation to a decision for a release after the RA has taken place, and may take into account effects scenarios that were outside the scope of the specific RA case, or could not be sufficiently addressed in the RA due to uncertainty (scale-dependent effects, interactions with other LMOs in the enviornment, health impacts in direct users) but were deemed necessary to be undertaken within the decisonmaking process for approval. Then, monitoring observations then can provide more information that may reflexive the release decision or RA of the specific LMO.

4. The term “relevant” as discussed by Mark Benedict is of course quite open to various interpretations, and I thank him for bringing this up. Narrowly interpreted would lead to the conclusion that something is "relevant" if it can be shown to implicate the effect of an LMO (as I take his interpretation to be). A broader interpretation would lead to the conclusion that something is relevant if it further the objectives of the monitoring activity, or to the protection goals themselves. The latter is what was intended and can be clarified. Good that this was brought up to clarify any confusion over the use of the term.

5. I read with interest the arguments that GS is not science-based. The idea seems to be that only specific hypotheses, and not general ones, qualify as “science-based”. It seems to me that general hypotheses are equally valid (and often asked under GS), and often where one starts from in areas where complexity, uncertainty, or ignorance is high. Indeed, most “science-based” knowledge started from a position of ignorance or uncertainty, where further observations or experiementation allowed knowledge to move from general to more specific. This is illustrated in our example of GS starting with general hypotheses or protection goals and accruing data that may lead to more specific CSM.

6. I appreciate the discussion by Isao Tojo of unitentional transboundary releases. I think this merits further discussion – on a reading, I do not see how an unintentional release, and information from this, would channel into a risk assessment process, particularly for a country where the LMO unintentionally released has not been approved. It would seem a detection programme would be put in place the would observe for the presence, and potential impacts of the unintentional LMO release this would be a type of monitoring, true. That is, it seems difficult to see a procedure we can identify where the information provided in thiswould trigger an RA process. Looking forward to hearing other perspectives on this matter here or in future fora.


Kind regards,

David

Dear all,

I am surprised again that this third draft did not consider the strongly supported recommendations of the reviewers giving scientific arguments about the elimination of the GS, for first and second draft.  I do not know how to help to the development of the work if my comments are not reflected on the document without knowing the scientific or technical razon, I understand that is not frequency, but arguments that unfortunately are not being explained.

Expecting COP MOP 6 decide to create particular experts groups on each of the guidances that are presented as PART II on the road map, including this one, here there are some comments:

The background present a confusion between risk management and monitoring. The articule 16 and Anex III 8(e) of the Cartagena Protocol on Biosafety, and the article 8g of the Convention of Biological Diversity (CBD) made reference to  risk management, no to monitoring.

Risk management and monitoring are clearly separate activities, since Annex III 8(f) refers to them separately, in fact there are some Countries (like Mexico) where the autorities for manage and control risks identified in the risk assessment are different from the authorities in charge of monitoring.

Art 16.4 of the CBD Made reference to a period of observation PREVIOUS to its intented use, then it can not be reffered as monitoring.
Articule 7 of the CBD is related to monitoring just in in reference to risk assessment. Only 7c could be consider that made reference to RISK ASSESSMENT (for all kind of activities, not just in reference to GMOs) and from there the monitoring in relation to the release to the environment of LMO is only the one mentioned on Anex III, 8f of the Cartagena Protocol .

The hole Art 7 in CDB is about the obligation of the countries to know and monitoring their own diversity and to have it in databases. In Mexico we have done this for almost two decades, before of the release of the first GMO to the environment; because it is part of the knowledge of our natural capital and not in particular relation to GMOs, but to all human activities. We do not try to impose this kind of work to all the countries of the CBD, but in our view try to do GS as is proposed in this guidance will be irrelevant and incomplete, because it do not consider all the factors that affect positive and negatively the conservation of our biodiversity.

I have done other comments on the document, I hope it is useful.

Sincerely,

Adriana

Dear all,



First of all, we would like also to thank to the ones who wrote this new
draft of the monitoring guidance. As mentioned previously by others, this
new version is more succinct and contains the main issues relevant to
monitoring.



We would like to focus our brief comment on the issue of GS. As a country
that is part of the main target group for this guidance (re: countries
lacking expertise in monitoring of LMOs) we highly appreciate the inclusion
of GS as important type of monitoring of LMOs once introduced in a specific
environment. We think that in the previous and current discussion there are
no strong arguments that justify its deletion, or valid suggestions of
another type of monitoring that can fulfill its well stated purpose,
re: “*General
Surveillance (GS) *encompasses monitoring as observations for adverse
effects that were not identified or anticipated in the risk scenarios
evaluated in the risk assessment. GS, in contrast to CSM, thus tries to
address more general questions from 'unknown' risks that could lead to
adverse effects to biological diversity, taking into account risks to human
health.”


Moreover, we strongly disagree with the proposal of deleting GS in this
monitoring guidance under the argument that other regional specific
guidance addressed it (e.g. EFSA). As CPB guidance document, it should
contain the information relevant to all Parties, and not rely on other
regional specific guidance assuming that these are relevant to other
regions or that other Parties should be familiar with them.



We also think that with some minor changes for clarification e.g the ones
stated by Michel Eckerstorfer, the monitoring guidance document is ready to
move forward.



Greeting on behalf of the Vice-Ministry of Environment of Bolivia.



Georgina Catacora-Vargas

Dear particpants of the forum,

The new version of the ‘monitoring’ document shows a number of improvements, but I’m afraid that by and large there still is a lot of dicsussions needed.
In general, discussion is what has been lacking in the development of this document.
Although David is right that it is a cumbersome process to discuss in online forums, that is no reason to be satisfied with the outcome of a process where it is not clear, because of lack of discussions, why some proposals were followed and others not.

For that reason I feel that I have to resubmit my comments that I have made to the previous version of this document, that was circulated among the SWG. (guidance_monitoring_d3_22dec2011_comments_Hans_Bergmans). I also submit a new set of comments (draft_guidance_monitoring_16jan2012[1] comm HB), that may make some of my previous comments more clear. In my new comments I refer to some previous comments specifically, but my other previous comments also apply, as a whole.

I would like to make a few general comments:
The subject of GS is still mixed with CSM. I can see why a number of comments state that GS should not figure in this docuemnt at all. I think that GS can, and as a matter of fact should, figure in this document, because one of the regulatory systems, that of the EU, makes GS mandatory in PMEM. It would be good to explain in this document in a few short paragraphs what the EU concept of GS entails.

The text of the document is still extremely verbose.
Especially in the Points to consider, we try to capture anything that we can think of. That leads to considerations being repeated time and again in many of the paragraphs.
I would be willing to cooperate in an effort to make the points to consider more straightforward, putting them together in categories, like a set of points to consider that apply in general (and therefore don't have to be repeated), and those that are really particular to the specific paragraphs of the document.
Also, the text could be improved by discriminating between main points to consider and subsidiary points to consider, that could be presented as examples elucidating the main points.
If these ideas would be supported I would volunteer to provide a draft along these lines, for further discussion.

Hans Bergmans

POSTED ON BEHALF OF JANET GOUGH

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I would like to support Hans’ comments and also his suggestion of preparing a further draft based on these comments.

Regards
Janet Gough

Dear participants,

I have read the comments from others over the past few days with great interest.  It seems that others share my frustration that previous suggested revisions to the text have been ignored by the chair,and there has been no reason given to explain why. Those who are not members of the AHTEG may not realize that the comments from members of the AHTEG have met a similar fate of being ignored with no rationale provided by the chair.

As with the previous version of this document, I have started making track changes but soon stopped when I realized that it would require a complete revision of virtually every paragraph.  This would be almost impossible to read, so I have opted instead to try to summarize the main concepts in the paper that that are still inconsistent with the Protocol, the charge of the AHTEG, and the experience that has been gained worldwide in the environmental risk assessment of LMOs released into the environment. 

The current draft of this guidance, like the previous versions, i, for ease in communication I have put some of my thoughts here to share at this stage.  Like others, I think that many of these issues will be easier to resolve in face-to-face discussions.  I thank you, Manoela, and other members of the Secretariat for making the effort to make such a meeting possible.

My main concerns with the document in its current form have not been addressed since the previous version, namely:

1. Throughout the document the choice of words appears to be inconsistent with the term “monitoring” is actually used in the Protocol.  The term monitoring of LMOs is actually used only once in the Protocol – only where there is uncertainty regarding the level of risk, not all circumstances as the current draft text implies.  In addition, as the Protocol text below indicates, monitoring LMOs is only one of several approaches that might be used.  “Article 8(f)   Where there is uncertainty regarding the level of risk, it may be addressed by requesting further information on the specific issues of concern or by implementing appropriate risk management strategies and/or monitoring the living modified organism in the receiving environment."  

2.  There is a blurring of the Protocol and the Convention, especially in setting the background for the guidance.  According to the charge provided by the decision of the Parties to the Protocol, the work of the AHTEG is supposed to be with the Annex III of the Protocol and providing guidance to help Parties successfully conduct risk assessments. 

3.  Throughout the text the relationship of national legislation to the Protocol  is misleading.  If a Party has a national legal framework, the monitoring with respect to Party obligations under the Protocol are not removed.  Monitoring as an option in risk assessment may or may not be affected.

4.  This is not the charge from the Parties to develop a “living document”.  Here and elsewhere, the description of the documents as “living documents” should be removed.  They would be living documents only if adopted by the Parties as living documents (not done yet nor part of the original charge to the AHTEG).

5.  There is still a lot of confusion about the use of General Surveillance (GS) to draw scientifically valid conclusions about cause and effect.  GS is not used in other areas of risk assessment to draw such conclusions, and the current draft confuses this issue for the reader.  The guidance should make clear with examples when and where environmental monitoring has actually provided evidence upon which conclusions can be drawn.

Sincerely,

David Heron

Dear all,

Thank you to those who have worked on this to bring it this far.

As time is ticking on, here very briefly a few general points.

I find the guidance document developed to date very helpful, and fully support its inclusiveness and current structure/content.

As mentioned by others, the monitoring of field trials as well as large scale releases are both of importance - yet in a similar but not identical manner. This may be reflected in the different sections, as for example attempted/indicated by Michael Eckerstorfer.

Whilst the debate regarding GS might not have been satisfactory to all – and I am sorry this seems to be the case - I find that there is a strong argument for the full inclusion of GS.  As it is most likely not possible to predict or anticipate all adverse effects (and thus specifically monitor for them), yet negative impacts to biodiversity and impacts otherwise detailed in protection goals need to be avoided, ‘general surveillance’ is offering the right tool for this purpose. To fulfil our obligation to prevent substantial harm, we are – in my interpretation - required to monitor both specifically and under general surveillance methodologies.

To identify or get an understanding for the type of monitoring required in the context of various protection goals/objectives and linked to particular subjects/indicators – I find annex II is offering a real service. Maybe some further detail could be included or examples refined.   Annex I is all but a heading so far, I can see its importance though and look forward to its development.

With kind regards,

Ricarda

Dear Forum participants,

While reading the other contributions in this on line debate, I see various observations about process and about content with which I agree.

As regards process, I can fully understand the sentiments expressed by several colleagues who have concerns that it is unclear why certain comments were taken on board and others were not. 

David Quist explained that time constraints did not permit him to write a response to each point of comment provided by expert reviewers in the online forum, and I can understand that with the current pace and the number of documents under development this will indeed not be an easy task.

Having said that, let me share a few additional observations:
First, we need to better clarify the process and take away the misunderstanding that appears in some interventions that this version of the guidance was produced by the AHTEG itself or by the SWG. This version is produced by the chair of this SWG, David Quist, and is not the result of deliberations within the AHTEG or the SWG. As Hans said, in general, discussion is what has been lacking in the development of this document. I therefore very much look forward to the informal meeting of the SWGs from 13 to 15 February in Bonn, in which we will discuss this draft guidance document ‘face to face’.

Second, referring to Hans’s observation that although it is a cumbersome process to discuss in online forums, that is no reason to be satisfied with the outcome of a process where it is not clear, because of lack of discussions, why some proposals were followed and others not.

I believe that the AHTEG would do itself, as well as the SWGs, the chairs, the on line forum colleagues and indeed the MOP a favour if we list the criteria we use for inclusion of text in the draft guidance.

For me those criteria would include:
• Direct relevance to the task of the AHTEG: i.e. produce practical guidance on Annex III; i.e. topics outside that scope (e.g. topics under the CBD, see Hiroshi’s comments) should either not to be included or moved to a section “other related topics” as we did in the roadmap.
• The guidance should be practical, i.e. providing the main thoughts and offering access to further back ground information.
• Language should be clear, understandable and simple enough to be translated into other languages. 
• Content should be based on sound science and experience gained over the years – this is after all why experts are brought together in AHTEGs
• It should offer practical guidance and not prescriptive text – see also Katherine’s comments. 
• As much as  possible aiming for consensus text, but where diverging opinions remain, clearly outlining the different views.

With the above criteria in the back of my head I started commenting with track changes last week, as I did before, but like others I gave up after a while, because that it would result in large chunks of track changes, and I realise that we first need the face to face meeting to clarify a number of things

Let me end with some general points about the text itself:

1) General: Over the more than 25 year that I am involved in this field, I have seen many monitoring plans, most of which were straight forward, building logically on the RA. Yet, the current draft is still very difficult to read rather than practical. This is largely caused by the ‘bulky’ language and by including – especially in the ‘points to consider’ - everything people could think of, without offering guidance in which cases those points might be relevant and in which cases they would not be relevant.

2) GS: given that GS is included in some regulatory systems, I agree with Hans that it might be good to say a few words about GS under “other related topics”, explaining how GS is understood in certain systems, and how it is different from CSM, e.g. that it is not hypothesis based. Yet, as Adriana and others have argued, the document should focus on CSM.

3) Some concepts should be clearly distinguished: e.g. monitoring for confined field trials vs PMEM;  and risk management vs monitoring;

In short, I look forward to our discussions in Bonn

Greetings to all!

Piet van der Meer

Dear forum members, Dear David Heron, Dear Piet,


First, I refer you to my post from earlier today regarding the consideration of comments coming from the SWG and open ended online forums.

To iterate, all comments, regardless of the affilation or party status are considered in each version of the draft. The consolidation process is in line with that of previous special guidance documents before it.

I made early attempts (SWG members will recall the detailed point-by-point response to Esmerelda Prat’s early contribution towards the first draft) to provide greater depth to the discussion by detailed responses to concrete proposals. Yet I quickly realized (as you have yourself in providing comments), the large undertakings that would be involved with tight time constraints.

What I have done in its place is provide explanation on larger issues and how they are dealt with in the manner they have (particularly GS) in the draft. I refer you to the previous discussions that have led to significant revisions in the GS framing within the draft.

I very much hope that this point on consolidation is further clarified once again, and I thank you in advance for your continued constructive feedback so that this misunderstanding of the process can be addressed.

Second, I appreciate Piet’s intervention and some suggestions that may provide greater framing of what we might achieve with guidance documents. I do find that coming to terms with some some subjective language -- “relevance” “practicality” (especially when applied to “experience” to date with LMOs), guidance vs. descriptions of current practice -- these are all going to require quite possibly lengthy discussions and clarifications so that all are on the same page in how how these suggestions would be applied.

Third, regarding the level and depth of discussion possible for the development of the document, I note that many of the interventions—case in point Piets here -- is coming just minutes before the close of the discussion period – not really leaving time for the kind of discussion that is requested. I sincerely hope that forum members would can make use of the time given here to provide comments earlier in the discussion period so we may actually benefit from a timely exchange.

Fortunately we will have the benefit of the face-to-face meeting in a few weeks time to get into a greater depth of dicussion than achieved! I look forward to it.


Kind regards,

David Q

If I have captured the essence of the postings on GS accurately, there seem to be two threads to the argument against including GS.

1. GS has no scientific basis;.
2. GS has no place under the mandate of the Protocol (with some disagreement on whether the Convention or the Protocol has jurisdiction on this matter).

I would like to briefly address point 1. Mark’s posting in particular I found useful for organizing my own thoughts. So thanks for that Mark even though at the moment I come to different conclusions. As I understand the framing against inclusion of GS in the monitoring document it is that:
1. in any way that it is useful, that way is already captured by CSM;
2. in all other ways, it may be counterproductive because it distracts from CSM.

Presently I take the view that GS is legitimate and useful on a case by case basis. I think that a compelling reason for GS is that you cannot plan to detect the unanticipated potential adverse effect, especially if it comes from cumulative effects.

I don’t subscribe to the view that GS is not case by case as some commentators suggest. Each environment that is the subject of a risk assessment is a case, just as is each LMO being considered in the arbitrary order in which they are received by the regulator for consideration. This will be different for different countries and is a good reason to not substitute the US experience for risk assessment everywhere else. The Roadmap recognizes this, it seems to me, but defining ‘cumulative effects’ as those that arise from combinations of LMOs in the same receiving environment. While the last LMO to be considered can be considered in relation to all that preceded it, the first LMO to enter the environment is unlikely (usually not) re-considered in relation to all that come after it. Perhaps all cumulative effects might be anticipated just from considering the addition of the last LMO, but on this point I think we make an assumption too far. This consideration rightly resides with the regulator doing their assessment in their environment and with their particular combination of LMOs because that is the case that they are challenged with at that moment. This guidance addresses that case. Like all guidance, any particular regulator may ignore it. We aren’t writing guidance for that regulator, we are writing it to the regulator who thinks that there may be reason to monitor for unanticipated cumulative effects.

In the medical/epidemiological area there are precedents for general surveillance. One does not need to know the cause of a suddenly high absenteeism rate, reports to clinicians of vomiting, diarrhea, headache and lethargy in order to make the recording and reporting of this indicator data useful for tracking a cause. Likewise, general monitoring of the frequency of antibiotic resistance among bacteria in the community does not require that you have formed the hypothesis that medical use of one antibiotic, say kanamycin, is the cause (it might be agricultural use of animal growth promoters, hospital use of kanamycin or similar aminoglycoside antibiotics, linkage of the resistance gene to another antibiotic resistance gene that is being selected), but using this indicator is relevant to addressing the risk that antibiotic therapy will fail when a patient needs it.

CSM and GS may use the same or overlapping indicators, but that does not mean that whenever an indicator is held in common it is by default a CSM process. Again using the introduction of a compound into animal feed as an example, one might find that the compound has no direct toxicity to clinically important pathogens and thus the CS risk assessment might form no hypothesis that made use of monitoring for resistance. An unanticipated effect might be that the gene that allows soil bacteria to tolerate this compound produces a “synthetic” phenotype when in combination with another gene in clinically relevant bacteria. We see this in, for example, bacteria with a combination of resistance alleles to two fundamentally different antibiotics such as rifampicin and nalidixic acid because they display as resistant to a third fundamentally different antibiotic/chemotherapy agent mitomycin-C. Community surveillance of unrelated resistances in a target indicator population could reveal a potential risk pathway that CSM would not.

For these reasons I am at the moment hesitant to reject the idea that GS is not scientific. To replace the usefulness of GS would require suggestions of how CSM could be designed to detect the unanticipated.

I had carefully viewed the discussion on “Monitoring LMOs” as an RA AHTEG member to  encourage many folks to participate in on-line forum rather than commenting again which took place in AHTEG meetings.

But please allow me repeat and echo some points.

1) Task of RA AHTEG and Position of the “Monitoring LMOs” guidance doc
This shall be only the component within RA AHTEG and its associated on-line forums to make digestion of ANNEX III of the Cartagena Protocol.  Allowing me to recall the MOP-4 at Bonn, 2008 when activation of RA AHTEG was discussed, a sharp mandate was given to RA AHTEG on focused mandate to the ANNEX III. However, the topics outside that scope may be often indicated over the RA AHTEG and open-forums, and this dilutes the efforts and also the given tasks would not be attained. With the base consideration, the Monitoring LMOs” guidance doc is becoming self-propagating beyond ANNEX III?
Also RA AHTEG is under Protocol, but not directly under CBD. Anything discrepancy had happened between Protocol and CBD, or if there is need on the confirmation of consistency of the activities between Protocol and CBD, then first AHTEG shall consult with MOP of the Protocol, which reports to COP of CBD.

2) Guidance docs for beginners, not making dictionaries
AHTEG must assist to understand ANNEX III for the beginners. But present discussion is likely making more confusion than understanding. With the feedbacks of the NFP at the party countries of the Protocol over past several months on the draft docs, while the draft docs had been tested, it is yet cumbersome, and language cosmetics shall be minimum to avoid further complication. But different views off course should be respected to reflect a useful guidance doc.

3) Not imaginary precaution, but with the relevant experience for the practicality
Monitoring is a typical issue which should incorporate experience, but the present discussion seems lacking respecting of the contribution with the both long term monitoring in research and LMO crops uses in some countries. Scientific facts should be well considered based on practical experiences.

On the specific points on Monitoring of LMOs

a) GS, general surveillance
Recognizing EU legislation includes GS, but this should not be the central component, but as an optional element as not always possible. Also this may be deviation from ANNEX III of the Protocol? Science-based hypothesis and targets should be well defined.

b) Cumulative effects
How this could be explained as a term? What can be cumulated? There is so far no report on such an aspect by cultivating THE LMO crops, and yet imaginary rather than precautionary.

Furthermore, I have a comment to the last statement of David Q (#2940):

Quote”
Third, regarding the level and depth of discussion possible for the development of the document, I note that many of the interventions—case in point Piets here -- is coming just minutes before the close of the discussion period – not really leaving time for the kind of discussion that is requested. I sincerely hope that forum members would can make use of the time given here to provide comments earlier in the discussion period so we may actually benefit from a timely exchange.

Quote over.”

I have a concern to the statement: My understanding is how to provide statements, is liberty of the contributors, and they should not be blamed as slow submission within the given timelines. If submission is regarded as slow, so I am intimidated by such a message on my slow action while it is yet within the allowed timeline on the on-line forum.


But yet I might have taken wrongly of the comment, and the next face-to-face SWGs in Bonn may dissolve the issue.  But unfortunately, since I cannot attend the SWGS, I would request letting me in the meeting on-line as it had taken in Slovenia and Mexico meetings with some AHTEG members who could not attend.


Regards,


Kazuo Watanabe

Dear members of the online forum, AHTEG colleagues:
I agree with several of the comments related with the way some comments are included in the text and others discarted with no further explanation. This has been a very dificult process.
I started to look at the reviewed draft and all I can say this far (and this late) is to urge the chair to reconsider the file I sent in the first round of comments.
Thank you.

Dear Kazuo,

Thank you for raising this point. To respond to your response, my intention was to encourage earlier contributions to facilitate discussions between members so that we can have a useful exchange of ideas. Apologies if this was interpreted otherwise.

Kind regards,

David

POSTED ON BEHALF OF ELIZABETH BRAVO

----

Dear participant of the forum:

I would like to make some comments in relation with what have being said in relation with monitoring.

Several participants noted that it is not necessary to include the GS document, as there is enough experience, and it should be used only in case of uncertainty. It is nost uncertainty a constant in the case of GM crops?

There may be enough experience in some countries but not in most of the world. A very low percentage of countries worldwide have massively adopted GM crops, but these are expanded to countries with little technical and scientific capacity to adequately evaluate its impact. These countries, unlike those with industrialized agriculture, has a veru lively rural economy and biodiversity which can be seriuoly affected by GE crops, so that you can not extrapolate the experience of the former. In this case, monitoring and GS are a must if introduction of LN crops occurs. I believe that here is a lack of understanding of what happens in the rest of the world when one used the example of a few countries with extensive experience in industrial agriculture.

Regarding whether or not the cumulative effects should be included, I would ask whether the emergence of super-weeds and super-pests, which are widely reported in the scientific literature does not provide examples of cumulative effects caused by GM crops. Similarly, the multiple cases of cancer, leukemia, lupus, endocrine diseases related to the technological package associated with GM crops (specially with herbicides tolerant crops) are not cumulative. These and other aspects should be long-term monitored.

I will not be able to attend the meeting in Bonn because obtaining visa  takes long time, but I would like to participate via skype.

Sincerely
Elizabeth Bravo