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SGW on Monitoring of LMOs Released into the Environment

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Item 2: The scope of our monitoring guidance [#2595]
Item 2: The scope of our monitoring guidance

Here we have 3 issues to comment on.

a) Is our guidance only referring to Post-Market Environmental Monitoring (PMEM) in the concept of “post-release monitoring”?

b) Does our guidance cover unintended or illegal releases, and what to do once these “releases” take place?

c) How to best capture the concept of “long-term effects” in our guidance?

I invite your view on any of these points here.
posted on 2011-08-11 20:04 UTC by David Quist
RE: Item 2: The scope of our monitoring guidance (reply of Hans Bergmans) [#2608]
Your three questions:

a) Is our guidance only referring to Post-Market Environmental Monitoring (PMEM) in the concept of “post-release monitoring”?
Yes, see Item 1.

b) Does our guidance cover unintended or illegal releases, and what to do once these “releases” take place?
Monitoring may be needed in all minds of situations, but our guidance should be on the specific issue of Post Market Environmental Monitoring, as this is a coherent package of concepts.
Illegal releases, or in general unintended releases, may need monitoring as one of the contingency measures, and our guidance will be useful there. We may mention this, but the guidance will not specifically cover these issues.

c) How to best capture the concept of “long-term effects” in our guidance?
Long term effects are also an issue in the environmental risk assessment that is been done for the placing on the market. Most probably, the data used in this risk assessment are not derived from direct observation, because that would take more time than your risk assessment procedure allows. Monitoring would then be a way to get more empirical data on a longer time scale on the suppositions that have been made in the risk assessment about long term effects.
posted on 2011-08-18 15:08 UTC by Mr. Hans Bergmans, PRRI
RE: Item 2: The scope of our monitoring guidance (reply of Hans Bergmans) [#2620]
a) I think this guidance should refer only to Post-Marker Environmental Monitoring (PMEM)

b) I believe this guidance should address an established process and not potential illegal releases, otherwise it becomes a "witch hunt" If there is reason to believe that there has been an accidental, unintended or illegal release, a country may use some of the principles of this guidance to monitor, but it should not bepart of the focus of the document.

c) long term effects would be part of the decision case by case on the monitoring to be done, if needed
posted on 2011-08-18 16:35 UTC by Ms. Esmeralda Prat, CLI representation
RE: Item 2: The scope of our monitoring guidance [#2631]
In relpy to the three questions:
a) Is our guidance only referring to Post-Market Environmental Monitoring (PMEM) in the concept of “post-release monitoring”?

>> Focus on PMEM

b) Does our guidance cover unintended or illegal releases, and what to do once these “releases” take place?

>> While the guidance should focus on PMEM,we can add a para that some elements can - mutatis mutandis - apply to certain aspects of unintended releases and illegal releases, although for illegal releases we are more talking about enforcement.  

c) How to best capture the concept of “long-term effects” in our guidance?

Analogues to the way we do that in the RA

>>
posted on 2011-08-18 22:17 UTC by Mr. Piet van der Meer, Ghent University, Belgium
RE: Item 2: The scope of our monitoring guidance [#2655]
I agree here with Hans and Piet. The guidance should focuss on post market environmental monitoring of LMOs. The use of the guidance for other monitoring activities could be mention when apropiate.
posted on 2011-08-19 05:17 UTC by Ms. Sol Ortiz García, Mexico
RE: Item 2: The scope of our monitoring guidance [#2657]
Colleagues
I Plea for the inclusion of guidance for monitoring of trials in the document. For those developing countries where they may be no post marketing release yet, monitoring of trials will be the first step where the Competent authorities will need sound guidance
Michael
posted on 2011-08-19 18:06 UTC by Michael DeShield