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SGW on Monitoring of LMOs Released into the Environment

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Item 1: The title of our monitoring guidance [#2594]
Item 1: The title of our monitoring guidance

The original title of our guidance was “Post-release monitoring and long-term effects of LMOs released into the environment” and was changed in the initial dreft to“Monitoring and long-term effects of LMOs released into the environment”” in an attempt to improve readability. 

Question: In your view, were important elements lost or gained with this change?
posted on 2011-08-11 20:03 UTC by David Quist
RE: Item 1: The title of our monitoring guidance (reply of Hans Bergmans) [#2607]
I think that both titles are not correct. The document should at least and in the first place be concerned with monitoring after placing on the market of an LMO. I think that the issues in monitoring during field experiments is a subset of the considerations in a document on PMEM. We may want to say that somewhere, but only as minor explanatory point. The most straightforward title would be “Post-Market Environmental Monitoring of LMOs placed on the market; (monitoring for) long term effects of LMOs”. Or any other way that you think that monitoring and long term effects are related within the framework of this document. It is not clear to me why long term effects need to be mentioned in the title here, because they will be part of what is covered in monitoring, but monitoring is not just about long term effects.
In any case, a shorter title just saying ‘monitoring’ is not an improvement as far as I’m concerned.
posted on 2011-08-18 15:07 UTC by Mr. Hans Bergmans, PRRI
RE: Item 1: The title of our monitoring guidance (reply of Hans Bergmans) [#2619]
Post release monitoring is very broad, if treating all together you would need to distinguish between confined releases and post-market release, i would suggest that at this stage the document treats only the post-market environmental release.  I agree with Hans that long term effects do not need to be mentioned in the title, if there are, they will appear as the result of the monitoring, so I think a title that reads "Post-Market Environmental Monitoring of LMOs" may be sufficient.

Esmeralda
posted on 2011-08-18 16:21 UTC by Ms. Esmeralda Prat, CLI representation
RE: Item 1: The title of our monitoring guidance [#2628]
I agree with Hans and Esmeralda to keep the title focused on Post Market Monitoring and to keep it short and clear. Adding the long term effects in the title is unnecessary as it will become clear from the text itself that that is included as well.


I would suggest "Post Market Environmental Monitoring"

Piet
posted on 2011-08-18 22:09 UTC by Mr. Piet van der Meer, Ghent University, Belgium
RE: Item 1: The title of our monitoring guidance [#2634]
The issue that seems to make "Post-Market" problematic in the title is simply that pre-market risk assessments (e.g field trials) are also subject to an RA, including Step 5 of Annex III. Therefore our guidance on monitoring inevitably must be applicable in these cases as well. PMEM in the title would not accurately reflect this.

Kind regards,

David Q
posted on 2011-08-18 22:27 UTC by David Quist
RE: Item 1: The title of our monitoring guidance [#2643]
David,

In haste

It is true that field trials are also subject to monitoring, but I think that there are good reasons to keep monitoring for field trials out the guidance document, at least for now.

The reasons for that are that monitoring for field trials typically looks at parameters that are very specific for the individual case, such as the adequacy of confinement measures.

I therefore propose that for now we keep that out the document (in the same way as the GM trees discussed whether or not to address all GM trees) and discuss later whether or not to include it in the guidance documents.

Finally, let me also raise a point that I forgot to mention in my previous comments, and that is related to the question what we are monitoring for.

In some of your submissions you refer to “the anticipated effects”. This comes back to my earlier observation that your current draft gives the impression that there must be adverse effects.

With the term “anticipated effects” we give the strange impression that CAs would willingly approve a market release while actually expecting a certain adverse effect.

What we mean here are potential adverse effects that have been addressed in the risk assessment and whereby the conclusion is that they are not likely to occur, but for which there are reasons to have that conclusion confirmed – or falsified – with monitoring.

Piet
posted on 2011-08-19 00:20 UTC by Mr. Piet van der Meer, Ghent University, Belgium
RE: Item 1: The title of our monitoring guidance [#2646]
I think that this question is more related to what would be the best title we can come up with for the document that we are trying to produce, in a way that it represents the guidance on monitoring in the framework of the Protocol.
I agree with the comments of Hans, Esmeralda and Piet in the sense that we should use a short, concise and direct title something more in the lines of: “Post Market Environmental Monitoring of LMOs”.
posted on 2011-08-19 04:39 UTC by Ms. Sol Ortiz García, Mexico