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SGW on Monitoring of LMOs Released into the Environment

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Opening of discussion for comments on the draft guidance on monitoring and long-term effects [#2481]
Dear members of the SWG on Monitoring,

I am pleased to inform that the first draft of the guidance on “Monitoring and long-term effects of LMOs released into the environment” is available at http://bch.cbd.int/onlineconferences/monitoring_swg_ahteg_ra.shtml (thanks David for developing the draft) and would like to invite all members of the SWG to provide comments on this draft. 

Your comments may focus, for instance, on:

i) Whether all issues relevant to this topic have been included in this draft and, if not, which ones should be added; and

ii) Suggestions for improvements to the current text and/or structure.

Please provide also suggestions for background documents to be included. Please do so by uploading the document you think is relevant or by providing its full reference, and indicate to which section(s) of the guidance the document is relevant.

Please send your comments as soon as possible but no later than 29 July 2011 (1:00GMT).

I look forward to your active participation.

Thank you and best regards,
Manoela
posted on 2011-07-11 20:41 UTC by Ms. Manoela Miranda, UNEP/SCBD
RE: Opening of discussion for comments on the draft guidance on monitoring and long-term effects [#2483]
Dear colleagues,

I am at this moment enjoying the vast nature of Namibia, and hence not able to spend more than a couple of minutes on the monitoring draft (thanks indeed, David). I will be back in the office by July 27, and I will react then in full.

Meanwhile, I would like to ask your attention for the reports that I have submitted previously, on GS. In order to understand monitoring, it is vital to understand the fundamental scientific differences between CSM and GS. I hope that the reports show our (the Netherlands) way of thinking on the subject.

I guess and I hope that the underlying documentation that people have sent previously is available to us somewhere?

Sorry, this is very much in haste, I hope you understand.

Best wishes,

Hans
posted on 2011-07-16 05:49 UTC by Mr. Hans Bergmans, PRRI
RE: Opening of discussion for comments on the draft guidance on monitoring and long-term effects [#2484]
Dear Hans and Colleages,

Thanks for your quick response on this despite the undoubtedly wonderful environment you must be enjoying in Namibia.

I also am away, and with unreliable internet connection at the moment, but please know that I intend to post to this forum all of the documents already submitted for consideration in the guidance from our prior email round in the end of June. I received documents from Esmerelda, Sol, Osama, Jack, and yourself.

Of course as indicated by Manoela there is now until the 29th the opportunity for further inputs of the type you indicated (particularly on the three areas outlined at the beginning of this thread), as we work together to further improve the existing draft.


Kind regards,
David Q
posted on 2011-07-16 09:31 UTC by David Quist
RE: Opening of discussion for comments on the draft guidance on monitoring and long-term effects [#2486]
Dear Monitoring SWG members,

Attached are the background documents received to date from SWG members for the development (and use as possible references) in the monitoring guidance.

Kind regards,
David Q
posted on 2011-07-18 10:02 UTC by David Quist
RE: Opening of discussion for comments on the draft guidance on monitoring and long-term effects [#2508]
And 2 others that I know you have but was not included in David's list
posted on 2011-07-26 04:52 UTC by Mr. Jack Heinemann, University of Canterbury
RE: Opening of discussion for comments on the draft guidance on monitoring and long-term effects [#2518]
Dear Daivid, and dear colleagues,

To my dismay I have had preciously little time to look at the draft that you made. I thank you very much for this first draft, that must have taken you quite some time and effort.

I have quite some comments, but I only had a few hours today to write them down. I hope my commemnts are clear from the attached word file (basically, your draft with comments and a few direct text proposals).

My basic comment is that, maybe even because of all the effort you put into it, your text may be overshooting its goal, if that is an English expression.
It already provides quite some detailed text, where I think we will first want to have some more discussion on the framework.
This is most evident in the section on the four elements in the Description of the proposed CSM and GS Monitoring Plan. There I think that we should first discuss a framework for this section, and then fill in the details.

As I have stated in my comments, we as a Party are having a different view here, or at least we seem to have a different approach and different experiences. I am disagreeing with your text here, but I can only give a sketchy idea of how we would like the text to be developed. Following a discussion on these ideas I will be fully prepared to take my responsibility as a dissenter and actively help drafting a new text.

Even more important, I hope all is well with you. We had the most wonderful holiday in beautiful Namibia, where internet was virtually (and happily) not available.

Very best regards,

Hans
posted on 2011-07-28 12:44 UTC by Mr. Hans Bergmans, PRRI
RE: Opening of discussion for comments on the draft guidance on monitoring and long-term effects [#2520]
Dear members of the Monitoring SWG,

Firstly, I want to thank those who have contributed with comments and inputs to the draft guidance thus far.

I further wish to give a gentle reminder that the period for comment will end very soon, on 29 July 2011 (1:00GMT). Therefore I encourage any further comments that you may have to be submitted in the remaining time available.

Particularly, you will see that Annex 1 and Annex 2 still needs to be developed. I would very much appreciate if there are any SWG members who would be willing to volunteer to help produce this important supporting information. If there are no volunteers, I likely will ask some members for their help in the development of these Annexes in the near future.

Again, thank you in advance for your continued contribution and support of this emerging specific guidance document.

David
posted on 2011-07-28 16:47 UTC by David Quist
RE: Opening of discussion for comments on the draft guidance on monitoring and long-term effects [#2521]
Thank you for your message David:
I would like to ask you if it would be possible to extend the time for receiving comments to this first draft, at least to next Monday (!rst of August), ideally to the 6th) . I think this is also an important part of the process where I would like to contribute but for different reasons I had not been able to revise the document yet, and I am guessing that several of us might be in the same circumstance.
Thank you in advance for considering this possibility.
Kind regards
Sol
posted on 2011-07-28 19:06 UTC by Ms. Sol Ortiz García, Mexico
RE: Opening of discussion for comments on the draft guidance on monitoring and long-term effects [#2522]
Dear Sol, dear all,

Following the request to extend this discussion, I will leave it open till Monday, 1 August at 1:00am GMT for those who still wish to provide comments.

Please note that "1 August at 1:00am GMT" is Sunday night in countries in the Western hemisphere.

Thanks and best regards,
Manoela
posted on 2011-07-28 20:42 UTC by Ms. Manoela Miranda, UNEP/SCBD
RE: Opening of discussion for comments on the draft guidance on monitoring and long-term effects [#2528]
POSTED ON BEHALF OF OSSAMA ABDEL-KAWY

----

Dear David
Many thanks for your wonderful efforts and appologies for my delayed response
kindly find attached my comments relevant to the proposed draft.
see u soon in Tromso
Ossama
posted on 2011-07-29 16:11 UTC by Ms. Manoela Miranda, UNEP/SCBD
RE: Opening of discussion for comments on the draft guidance on monitoring and long-term effects [#2524]
I would like to join with Hans in thanking David for this huge effort. And welcome back from Namibia, Hans!

The document may be long, but there is service in having a document with ‘too much’, in that we know what we want to discuss with greatest efficiency rather than having to raise new ideas.

Diverging just a bit from Hans (in his opening comments on the document itself), I take the view that in the vacuum of guidance from national regulatory authorities on post-release monitoring there is a clear and useful function for guidance of detail coming from this group. I disagree that we should wait for some hypothetical consensus, particularly the notion that we should wait until Europe has formed a view. Europe is just one (albeit big!) voice. If we were to apply this deference to every jurisdiction that might be discussing something, then there would be no reason for us to exist. But clearly there is because the Parties delegated their authority to the Secretariat for this topic.

Of course, wherever we can, we must show sensitivity to the discussions being had by other bodies and learn as much as is possible from them so that our document is both relevant and current.

With this in mind, I’ve tried to add to Hans’ draft indicating where I think minor modifications to text might present some options for agreement and where I think major discussions might still emerge.

Best wishes to all.
posted on 2011-07-28 23:40 UTC by Mr. Jack Heinemann, University of Canterbury
RE: Opening of discussion for comments on the draft guidance on monitoring and long-term effects [#2529]
Dear Sol, Manoela and all members of the Monitoring SWG,


Sincere thanks to Manoela for the prompt followup to address Sol’s request for extension of the online discussion. I think this additional time will be very valuable and I hope SWG members will take the opportunity of extra time to provide comments.

As you recall from the action plan, there is only until the 26th of August for consolidation of the comments and further work after the discussion session has ended. We must be mindful not to shrink this window for subsequent work by too much.
 
Therefore, lets make the August 1st extension (0100 GMT) as our final deadline for this round of discussions.

Kind regards,

David
posted on 2011-07-29 17:02 UTC by David Quist
RE: Opening of discussion for comments on the draft guidance on monitoring and long-term effects [#2534]
Dear colleagues,

I would like to add (and to be honest, repeat) a little bit to the comments that I posted previously, also in the light of comments that were made by others.

As to David's request for help with the Annexes 1 and 2: I will be glad to help in thinking and discussing on the drafting of both annexes.

Wei's question about monitoring in field experiments also surfaced with me when I was reading the draft text. We do have examples that could be called monitoring, in field experiments, for instance monitoring for volunteers (followed by inactivation). I think that this, however, is straightforward risk management, not monitoring as it is meant in this guidance. What do you think?

In reaction to Jack's general comments: I am convinced that the AHTEG can have a function of guidance on the topic of monitoring. I don't think that there is a vacuum of guidance from national or regional regulatory authorities: for instance there is guidance available from EFSA. Also we ourselves as Netherlands authorities have been working extensively on the issue, and are producing our own reports. These are just a few examples of the discussions that are ongoing. What I meant is that it will only be sensible, and also helpful for the readers, that our guidance will have an open eye for such developments and take these into consideration.

My central point for the discussion is that the guidance should explain the fundamental difference between CSM and GS. This cannot be made clear enough.

In simple words, CSM starts from the LMO and from expectations that one may have, let's call them hypotheses, based on the use of the LMO. These can be tested in monitoring and the way that these tests should be done follows the logic and the rules that are pointed out in the Roadmap for risk assessment. If we should find new rules in CSM, that are not in line with the Roadmap, I am convinced that this would indicate that we have missed something in the description of the risk assessment process in the Roadmap.

GS deals with aspects that we have not been able to foresee in the risk assessment. That does not mean that everything that we ACTUALLY have not foreseen in the risk assment, is in the realm of GS. We cannot exclude that we have missed a hypothesis, that is case specific, and such a hypothesis could be leading in CSM. In most cases, however, we in our regulatory system would say that this is new information (or as the case may be, new considerations) that should lead to a (partially) new risk assessment.
The cases that Jack mentions are interesting, because we would say (as far as I can judge from his short description) that they belong to the realm of CSM. Monitoring a new disease outbreak or antibiotic resistant bacteria would be CSM if the LMO is a modified virus, or a modified bacterium, and indeed, then you can make such hypotheses.

In our experience, GS deals with the unknown (and the hence unexpected). We think that a sensible approach of the unknown starts with looking at 'new things', 'things out of the ordinary',  that occur in the environment. It would also be sensible to look there where things need to be protected, and therefore a country's protection goals need to be the guiding principle here (and take the place of the hypothesis in CSM). Clearly, the protection goals that are important for GS have no direct relationship to the LMO (because then it would be a case for CSM). The major points in GS are: how to detect adverse effects against the baseline, how to analyze them statistically, and how to link them to their cause that may be the release of an LMO, but may also be any another cause.
In our point of view this can be done by using monitoring networks - and this would dictate many of the modalities of GS.

As I have argued before, the approaches of CSM and GS as we see them are fundamentaly different, and this should be clearly reflected in the guidance.

These comments and the comments that I posted earlier on are on the structure and the general content of the document. I expect that a next version will enable me to present more detailed textual comments.

Best wishes,

Hans
posted on 2011-07-31 20:32 UTC by Mr. Hans Bergmans, PRRI
RE: Opening of discussion for comments on the draft guidance on monitoring and long-term effects [#2531]
Thanks, David for your hard work. I did not have specific comments but I am wondering if we need to add the monitoring of field trials and if their safety requests are fulfilled. In addition, it could be also necessary to develop the ability to monitor and detect any illegal planting of unapproved LMOs.

Best wishes

Wei
posted on 2011-07-30 17:10 UTC by Mr. Wei Wei, China
RE: Opening of discussion for comments on the draft guidance on monitoring and long-term effects [#2535]
Dear colleagues

Enclosed are my comments adn some additional references

Regards,
Esmeralda
posted on 2011-07-31 22:33 UTC by Ms. Esmeralda Prat, CLI representation
RE: Opening of discussion for comments on the draft guidance on monitoring and long-term effects [#2539]
POSTED ON BEHALF OF SOL ORTIZ

----

Dear David and colleagues.
Here I am sending some comments and suggested changes to the document presented by the chair of the group  of  post release monitoring.
David, thank you for the firts draft.
Kind regars
Sol
posted on 2011-08-01 13:43 UTC by Ms. Manoela Miranda, UNEP/SCBD
RE: Opening of discussion for comments on the draft guidance on monitoring and long-term effects [#2540]
POSTED ON BEHALF OF PIET VAN DER MEER

----

Dear David,

Apologies for this late contribution.

Unfortunately this online commenting round fell just in a period in which I had much unexpected travel, of which the last four days in Armenia for an FAO project, and where I had very limited internet access.
I just returned to Belgium and I hereby share my comments with you through Manoela.,

I join Hans Bergmans and others in expressing appreciation for the many hours of work you have put in preparing this draft for guidance on post release monitoring.

Yet, I also join Hans in his concerns. I find the document too long, not easy to read and not easy to comprehend.

The document is unnecessary long, in part because various concepts are being repeated several times throughout the text, and in part because of the sometimes lengthy way of phrasing things.

To be useful, all our guidance should be as accurate, clear and succinct as possible.

Further, I am concerned about the undertone of the document.

Throughout the document the reader gets the impression that the risk assessment is inadequate, and that there must be adverse effects. This is illustrated with sentences such as “As LMOs are living organisms, their adverse effects may not be limited in time and space“. Similarly, the way in which the Precautionary Approach is used through the text suggests that with monitoring we are typically taking about cases of “ serious or irreversible damage” (see the language of the Precautionary Approach as laid down in Principle 15). This kind of language needs to be cleaned up in a next round of drafting, to ensure that the text is neutral and reflects current experience. 

As regards the content of the document I have the following concerns:

1) The concepts of Case Specific Monitoring and General Surveillance are clear and widely used concepts that are distinct yet complementary.  CSM is hypothesis driven, based on the RA, and GS is a form of “keeping our eyes open”, as is good practice in - for example - breeding and farming. Yet, the draft text mixes key concepts of CSM and GS and as a result the text causes confusion. This is illustrated with sentences such as “GS is of particular importance where there is uncertainty about the level of effects”, or  that GS looks at “Adverse effects identified in the RA but not included in the CSM plan”. 

2) The draft introduces several new terms. For example, in addition to the widely used term “monitoring plan” the draft introduces terms as “monitoring strategy” and “monitoring framework”.

3) The draft moves on several places from providing guidance to being prescriptive. For example, questionnaires to farmers can certainly be useful, but there is no reason to make those mandatory, as the text suggests.

4) The draft addresses issues that have no place in technical guidance on monitoring. I am referring to aspects such as decision making, public participation, socio-economic considerations, dissemination, etc. etc. These are all very important concepts, in particular the socio-economic considerations many farmers have had in using GM certain crops, but they are not suitable for technical guidance on monitoring.

Like Hans I have started trying to make proposals for text changes, but realised after a while that cleaning up the text requires much more time than now available.

I have therefore limited myself  to the first step: trying to reduce the text as much as possible by deleting or marking repetitions as well as matters that have no place in technical guidance on monitoring.

Having done that, I also believe that the SWG would be well advised to have conference call on these key issues CSM and GS before embarking on further(re)drafting.

In that conference call we should in my view also discuss whether the nature of this guidance should be conceptual, as the current suggests, or practical, as the Roadmap suggests.

I am pleased to report that I will not be travelling anywhere for the next two weeks, so I am available for a conference call if need be. 

Let me take this opportunity to thank the Secretariat for extending the deadline for comments on the overall guidance until 6 August.

Regards to all!

Piet
posted on 2011-08-01 15:44 UTC by Ms. Manoela Miranda, UNEP/SCBD