Dear participants to the Open-ended Online Forum and AHTEG,

The online discussion for editorial improvements of the draft guidance on "Monitoring of LMOs Released into the Environment" is now open at http://bch.cbd.int/onlineconferences/discussiongroups_ra.shtml. This discussion follows an extensive revision of this draft guidance during the face-to-face meeting of the AHTEG Sub-working Groups held in Bonn, Germany, 13-15 February 2012.

Participants of the Open-ended Group and the AHTEG are invited to suggest ways to improve the readability and user friendliness of this document. Please make your suggestions for improvements directly to the text of the draft guidance (version of 22 Feb 2012; available in the attachment and through link above) in the "track changes" mode.

As per the revised tentative calendar of activities (see http://bch.cbd.int/onlineconferences/calendar_ra.shtml), please note that this is the last round of online discussion prior to the regional real-time online conferences and fourth meeting of the AHTEG.

//This discussion will be open from 27 February till 11 March 2012 (1:00 a.m. GMT). //

Your feedback on this document during this final round of online discussion is very important. Please do not hesitate to contact me (manoela.miranda@cbd.int) if you have any question or encounter problems when posting comments.

Best regards,
Manoela

POSTED ON BEHALF OF HIROSHI YOSHIKURA

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General comments to monitoring

1. I really appreciate AHTEG member for further improvement of the text. It is remarkable improvement compared with the previous one.

2. Though I understand the present version is the product of intense face-to-face discussion in AHTEG and it is already in a final step of editorial amendments, however, I think we should still reflect on the “purpose of monitoring” taking actual monitoring practices into account.

3. Monitoring, particularly, post-release monitoring, in my view, is to check whether LMOs are used (or are behaving) as intended or not. It is not necessarily only for detecting adverse events. Monitoring may reveal events that are unfavorable to the environments but may detect those that are favorable, too. If use of LMOs is proved to be useless even if they do not cause any harmful events, the use should be stopped. Unexpected events may be sometimes unexpectedly beneficial, which sometimes occur in science. Monitoring during risk assessment is for collection of data, which is again very neutral and scientific. I proposed to modify the text taking such a reality more into account (see attached file).

4. Parameters for monitoring are not always living organisms. In bioremediation, level of pollutants in the environment is an important remediation marker (which is sometimes reflected on soil microbial diversity). Therefore, possible use of parameters other than living organisms should be taken into account (see attached file).

5. Other comments related to uncertainty, specificity of monitored events, baseline monitoring and other items are also found in the attached file.

Best regards,
Hiroshi

Dear Participants, dear AHTEG group, dear Manoela,

Thank you for the new document, I really welcome this new version.

The stringency and readebility is considerably improved.

It seems to me that your face to face meeting was probably exhaustive but very successfull.


There is one argument of Hiroshi I would like to support.
Parameters or indicators for monitoring are not always living organisms.
Depending on the effect or process to be monitored, e.g. pollen deposition or hybridisation rates can be appropriate parameters/monitoring objectives.

Best wishes
Wiebke

Dr. Wiebke Züghart, Federal Agency for Nature Conservation, Germany

Dear participants,

I would like to speak highly of the great effort of the experts concerned to review fundamentally the document within a short period.
It would be good that the revised draft, in general, is compactly rearranged and easy to read, especially for the person whose native language is not English.

However the draft still seems to include some issues to be discussed.  One of the issues is related to the two types of CSM.  Even though the word of “GS” is not used in the current draft, the similar thing seems to be included in one type of CSM.  This might be caused by the confusion of the concept of “monitoring”.  Similarly, the understanding of “monitoring” in the Annex III of the protocol might also be confused.

Since this document is to be developed for the guidance to inexperienced persons, the important terms used in the document should be clearly defined and explained.  From this point of view, I would like to make following comments.

Yet the current forth draft, which is altered largely from the third draft, must be, so to speak, the first draft. Therefore, it might be needed a longer time schedule to discuss those issues than that is proposed by the secretariat.

1.Confusion of the terminology of  “monitoring”
The terminology of “monitoring” used in the document might be, in my view, somewhat confused.

IPCS(International Programme on Chemical Safety), co-established by UNEP, ILO and WHO developed a report ,“Risk Assessment Terminology”, on the harmonization of the terminology in risk assessment in 2004.  In the report, “Risk monitoring” is defined as “Process of following up the decisions and actions within risk management in order to ascertain that risk containment or reduction with respect to a particular hazard is assured.  Risk monitoring is an element of risk management.”  Namely, in case where “hazard” is not identified, any monitoring activities could not be included in “monitoring” of risk assessment.

Looking at the current draft, CSM includes two types of monitoring.  One of those addresses the uncertainties regarding the level of risk of LMOs “that were not identified in the risk assessment and, therefore, related to unanticipated adverse effects.”  According to the above mentioned harmonization report, such kind of “monitoring”, in which a particular hazard has not been identified, could not be included in “monitoring” of risk assessment.  The definition of “monitoring” in risk assessment might be different from that in, so-called, “environmental monitoring”.  (See, for example, OECD Glossary of Statistical Terms; Monitoring (environmental) “refers to the continuous or frequent standardized measurement and observation of the environment (air, water, land/soil, biota), often used for warning and control.”)

As the document, we are discussing, is to be a guidance of Annex III of the Protocol, which is on the risk assessment of LMOs, the terminology in the document had better be consistent with those described in the harmonization report mentioned above.
In order to avoid confusion within readers in the terminology of “monitoring”, the sentences which relate to the “monitoring” of unanticipated effects should be deleted.

2.“What to monitor?”
The draft explains “what to monitor?” in “2. Choice of indicators and parameters for monitoring”.  However,　if reading carefully 8(f) of Annex III of the Protocol, which is described as “by monitoring the living modified organisms in the receiving environment”, it is obvious that the object of the “monitoring” is LMOs.

Nonetheless, the object of the “monitoring” in the current draft is broadly interpreted as various indicators and parameters.  Such confusion might also be caused by the introduction of the concept of “monitoring” in “Environmental Monitoring” to the field of risk assessment.  Namely, “monitoring” in “Environment Monitoring” monitors changes in environment by various indicators and parameters.  On the other hand, “monitoring” in the field of risk assessment monitors hazards, including LMOs, which are identified as hazards in risk assessment.

In view of the objective of this document, which intelligibly explains the 8(f) of the Annex III of the Protocol, the terminology of “monitoring” had better be consistent with that in the harmonization report.

In order to reflect above mentioned clarification of terminology, the entire revision of the document might be recommended.  The minimum amendments that, I would think, had better be revised are shown in the attached file.

3.Terms of reference of AHTEG
In the introduction of the draft, it is explained that the current work is based on the terms of reference agreed in annex of BS-IV/11.  However, as far as I understand, the current work of AHTEG and On-line Forum is based on the annex of BS-V/12, where states that new topics are “selected on the basis of the priorities and needs by the Parties and taking into account the topics identified in the previous intersessional period”.  Even though the topic of “monitoring” might be “taking into account the topics identified in the previous intersessional period”, it is still not clear whether it is “selected on the basis of the priorities and needs by the Parties”.

4.The word of “cumulative”
During the previous On-line Forum on the monitoring guidance document, an expert defines cumulative effects “as those that arise from combinations of LMOs in the same receiving environment”.  And the other says “super-weeds and super-pests, which are widely reported in the scientific literature, provide examples of cumulative effects.  Similarly, the multiple cases of cancer, leukemia, lupus, endocrine diseases related to the technological package associated with GM crops (especially with herbicides tolerant crops) are cumulative.”  Thus, even experts might have the different image on the word of “cumulative”.  The word might cause confusion or misunderstanding to the readers.

In the regulation of EU, Directive 2001/18/EC, the term of “cumulative long-term effects” is included in ANNEX II, “Principles for the Environmental Risk Assessment”.  However, the EFSA Guidance Document in which explains “cumulative long-term effects” does not use the word of “cumulative”, but Category I (delayed effects) and Category II (widely grown effects).

In order to avoid confusion and misunderstanding, it had better not use the word of “cumulative”.  I would suggest the deletion of the word of “cumulative” from the document.

sincerely yours,

Isao TOJO

Dear participants.

As a member of the online forum I have actively participated in the first discussion (on contents) of most of the AHTEG documents. Unfortunately, in many cases I could not see real improvements on contents, although the form was sometimes improved.
This is the case of the document on monitoring. As you possibly already know, Brazil (the second largest GM plant producer, after USA) has a new system to monitor GMOs (whether they are plants or not), which is the result of a concentrated effort of the National Biosafety Agency. It is not based on baselines but on damage detection and it was designed to be of practical use. Its results may contribute, in the future, to the risk assessment of new GMOs, but monitoring is nevertheless a risk management activity, not to be mixed up with risk assessment.
I hope you may indulge me for not having contributed to the AHTEG text on monitoring and, instead, to challenge the whole idea presented in the text with the technical post you may read on
http://genpeace.blogspot.com/2012/03/comments-on-monitoring-of-lmos-released.html.
And I hope the Secretariat will allow this posting to be hanged on this pannel.
As stated before, this is a technical post that presents my analysis of the AHTEG text. It is not a government position and not even an official CTNBio position, although it certainly reflects the majority voice in this institution.
Kindly
Paulo Andrade
Paulo Andrade

Dear participants,

My comments on the fourth draft of the “Monitoring of LMOs Released into the Environment" guidance are as follows:

This version of the guidance has been greatly modified relative to the previous version. Although many experts commented on this in previous discussions, the concepts of case-specific monitoring and general surveillance have not been separated in this fourth version of the guidance. The term general surveillance no longer features, but much of the description still relates to monitoring for unanticipated effects where there is no risk hypothesis. This is general surveillance and not case specific monitoring. The current version of the guidance does not clearly establish that case specific monitoring should be designed to test specific hypotheses based on the outcomes of the environmental risk assessment. The definition of case specific monitoring has also been extended to include monitoring of experimental trials, which does not help in clearly defining what case specific monitoring should involve.  Because of these changes to the guidance it is now difficult to follow the logic of what monitoring is intended to achieve and so it is difficult to offer more specific comments on the text.

Best regards,
Kath

Dear all,
I am submitting the draft with some more than editorial improvements.
I hope this could be somehow useful.
Sincerely
Adriana Otero

Dear all,

My apologies for not posting this earlier. The website and I are cooperating well with each other now, and I would like to offer my comments and suggested text changes in the attached file.

Overall, I think the document is improving, but there is still substantial opportunity to clarify concepts in the choice of words and text organization so that readers can follow guidance that is consistent with Annex III of the Protocol and in agreement with the terms of reference for this AHTEG.

There will a number of places where the text can more consistently make clear that Annex III, states the reason and purpose for monitoring.  It will be most helpful for readers to find the same language used when restating this, namely that monitoring is to address uncertainties identified in the risk assessment regarding the level of risks associated with the environmental release of the LMO. It does become repetitive reading, but it is preferable over paraphrases that begin to give unclear indications of the meaning in Annex III.

The issue of general surveillance is only partially eliminated in this Feb 22 version, and the attached file offers additional comments and suggested text changes to address this.  The notion of some generalized monitoring is not consistent with the use of monitoring in the Protocol, even if some countries conduct a variety of environmental monitoring for other purposes.

In light of the discussions of the sub-working groups in Bonn last month, I think it was wise of the chair to omit the figure formerly in Annex I of this guidance document. 

The table in Annex II, however, is only slightly changed from its previous guise. As my comments indicate, I found that the information in the table lacks sufficient detail to really evaluate what points it is intending to convey.  It seems that if the authors of this document have specific examples to illustrate concepts in this guidance document on monitoring, the examples would be most helpful to the reader if they are portrayed in the body of the document in sufficient detail to support the text and provide relevant guidance.

Best regards,

David Heron

Dear colleagues,

Reading the comments that have been posted, I think there is ample praiseworthy advice that can be taken into account in further drafting of the document.

There is also one point where clearly the text does not meet its goal, i.e., in the following paragraph:
“Broader environmental monitoring for unanticipated adverse effects that were not identified in the risk assessment may be conducted to address more general questions related to the conservation and sustainable use of biological diversity, taking into account risks to human health. Monitoring for unanticipated effects starts with general observations of changes in indicators and parameters, which are often defined within national protection goals, and that could be related to adverse effects. Should monitoring for unanticipated adverse effects that were not identified in the risk assessment detect changes that could be related to an adverse effect, a more specific hypothesis may be formulated to establish a causal relationship between the LMO(s) and the adverse effect, and be followed up by case-specific monitoring or further research. When monitoring for unanticipated adverse effects that were not identified in the risk assessment, programmes already established for the surveillance of broader protection goals may be used in order for the monitoring to be more cost-effective.”

Clearly this text is taken by a number of readers as a further elaboration of the concept of CSM, which is not what is meant here.But, I can see that it is read in that way.
I would therefore propose that the text is amended to state that this type of monitoring is performed ‘in addition to CSM’. I have the feeling that, as was discussed in the Bonn meeting, it could be a good idea to hook up this type of monitoring, conceptually, to the monitoring that is described in Article 7 of the CBD.

But then, it is also clear that there is quite some opposition, both from Parties and from non-Parties and observers, against having a description of this monitoring process (which is more or less equivalent to what is called 'General Surveillance' in the EU system) in this document, as it is felt that this is not part of the monitoring described in the CPB, and, even more importantly, it is not a type of monitoring that they feel should be implemented.
Given this lack of consensus between Parties (as well as non-Parties and observers), I feel that this paragraph should still be discussed further before it can be decided to keep it, even in an amended form, in the document.

Best regards,

Hans

Dear All,

I have often wondered why the closing time for the online debates is 1 am GMT (2 am Brussels time).

I still don’t know why that time is chosen, but today I was grateful for the extra time, because when I took my daughter’s dog out tonight, to get some fresh air before finalising my comments, the dog raced off into the forest and I have spent hours looking for her. I got her back and am pleased I still had some time.

I believe that the text has been cleaned up and improved quite a bit, but I am also very aware that still a lot of work needs to be done to turn this text into a document that is of practical use.

Like Hans and others, one of main concerns is still the way in which general monitoring is addressed, and in particular how it confuses CSM and general monitoring.

I have therefore suggested in my attached comments to replace the paragraph that Hans referred to, by the following text:

“In addition to case specific monitoring for LMOs, where the trigger for monitoring lies in the result of the  risk assessment, some countries may also have existing environmental monitoring practices conducted in the context of article 7 of the CBD.  This kind of general monitoring is conducted unrelated to the release of an LMO, but addresses more general questions related to the conservation and sustainable use of biological diversity.  Data collected through these monitoring activities may be taken into account.

In this approach, the trigger for further action is an observed adverse phenomenon in the environment, for example a significant reduction of a protected species. When such a phenomenon has been identified, authorities typically explore the possible causes of the observed phenomenon.

The next step is to identify changes in the environment that are correlated in time and place with the phenomenon and that could plausibly be its cause. These changes could for example be in agricultural management, such as change in pesticide use.

If one of the identified correlated changes in the environment is the introduction of an LMO that could plausibly lead to the observed phenomenon, a specific hypothesis will need to be developed and tested in order to establish a scientifically valid causal relationship.  Data for establishing such a relationship may be obtained from a scientifically valid study designed to test the hypothesis, or through case specific monitoring”


Wishing you all a good remainder of the weekend

Piet  


Public Research and Regulation Initiative (PRRI) / Ghent University

Hi Piet

No matter what the deadline, it would be 1am somewhere! ;) Good that you found it useful this time.

Best wishes
Jack

True - and now - 6 hours later I see that we can still submit - I could have saved myself the stress

good weekend!

Piet

Hi, All, I still have problem with the choice of monitoring sites. I cannot understand why the site selection should depend on the parameters and indicators. I admit that monitoring of different sites may result in different choice of parameters. In general, however, a site should be chosen to monitor if it is liable to environmental change and/or invasion of alien species/disturbance. In any case, parameters and indicators should not be put on the first place when thinking of the site to monitor. I believe that people will agree to me.
In addition, implementation of safety measurement should also be monitored (‘what to monitor’), especially in countries that have less enforcement of biosafety regulation.

Dear Manoela, dear all
kindly find attached my comments on the document
warm regards
O.A.ElKAWY

Dear members of the open-ended online expert group,

Let me take the opportunity, near the closing time of this forum to thank all of those who provided comments to the 22 February version of the monitoring draft.

As pointed out, this draft represents improvements from what are sometimes long but nonetheless extremely important and detailed discussions that took place in Bonn, particularly on the major substantive issues of the draft, and improvements made capture a broad spectrum of concerns and issues.

As clearly indicated by Manoela at the beginning of the online forum, the scope of this round of discussion is focused on improvements to the readability and user-friendliness of the document. Thus the suggested improvements of this type received here will be the main focus of the next draft revision.

Lastly, it is with some regret that the Annexes have not progressed in parallel with the draft. It seems not possible to produce a graphic (Annex I) at this advanced stage in our timeline, and thus efforts will made a on improving Annex II along the lines of the many useful comments received here and in Bonn.

Again, I thank you for your continued attention and contributions to monitoring draft.

Kind regards from snowy northern Norway,

David Quist

Dear participants,

Thanks to all for your continued work on this document.  I am attaching my suggestions for improvement of the draft guidance.

I attach comments made in text to the current draft.

Several commentators to the forum are commenting on the inclusion of some of the different monitoring approaches described in the document. That argument has been long and I believe a valuable compromise has been reached in the current draft.

From my point of view, guidance documents should provide guidance in the form of “how to”, as in “how to monitor” when a risk assessor (e.g., regulator) or decision maker have decided that it is important. Trying to eliminate various ways in which monitoring is perceived, implemented or valued in different jurisdictions based on a priori value judgments against some monitoring approaches will not make them disappear from the world, only at most from this document. And then we will not have given guidance on how and when to implement these different approaches where a country has decided, as is its right, that such monitoring was important.

It does not help readability of the document to cloak already recognised concepts in convoluted phrases in order to disguise the underlying concept. The point of this intervention is thus to build on the rationale for including the two primary forms of monitoring under discussion, because clarity of the concepts is needed to find acceptable language, and then to suggest a language that I hope might improve the organization, flow and effectiveness of this guidance document.

There are to my current knowledge four legitimate reasons for choosing monitoring:
1. to determine if risks identified in the RA are real (i.e., possible harms caused by the LMO can/do become real harms);
2. to assess whether risks identified in the RA are likely or unlikely, or capable of causing severe or little harm, should they exist at all;
3. to identify, eliminate or mitigate risks of unanticipated adverse effects of the LMO, such as may arise in the long term and from interactions in the environment, if there is concern for such risks;
4. where risk management is recommended as part of the RA, monitoring may be used to inform the effectiveness of RA (independently of monitoring compliance with risk mitigation requirements), since the potential adverse effect of risk management is that it might fail to do what was anticipated it would do.

These are carefully incorporated into the current draft.

Different monitoring approaches are better suited to meeting the goals expressed by the above rationales, and for different ‘steps’ along the way to full release and including full release.

We all seem to be comfortable using the term “case specific monitoring” (CSM) to mean the process whereby a plausible potential adverse effect, likelihood of a potential adverse effect, or determination of severity of a potential adverse effect links to a causative agent (e.g., the LMO) in a way that can be tested using monitoring. Despite not discussing what a hypothesis is, or what a good hypothesis is, or how influential the vested and implied null hypothesis is in circles of power, the consensus in Bonn as I understood it was to equate case-specific with 'hypothesis-driven' monitoring.

CSM is no more inherently likely to deliver good results than any other method, and no more likely to be based on uniformly agreed hypotheses or criteria for identifying good hypotheses than any other method. All monitoring and RA activities are based on the “best available science”, which is based on the best available understanding of the science by the user. It is fanatasy to assume that there exists in contemporary time uniform views of the meaning of scientific observations even if some views ultimately settle as dominant over time. In other words, what I'm saying is that any CSM activity is only as good as those who do it and thus is not the pulpit from which to pummel other approaches.

The approach that some seem to want to pummel is the one described as “broader environmental monitoring for unanticipated adverse effects that were not identified in the risk assessment” (post #3099). At the very least, after saying this mouthful once we should invent a shorthand for the rest of the document. I have a suggestion below.

Many scientific and public-good activities operate a good deal of time within this broader framework. As we discussed in Bonn, surveillance of trends in prescriptions and reports from clinics and doctors help public health officials to identify, eliminate or mitigate the impacts of adverse effects to human health that can arise from any source, without necessarily having identified the causative agent through the initial monitoring activity. This is just one example.

In the EU, “broader environmental monitoring for unanticipated adverse effects that were not identified in the risk assessment” is called general surveillance. Resistance to the term seems to me to come in part from resistance to vindicate the EU for having this option rather than the term being flawed. But in any case, perhaps a new jargon would help us progress the issue and improve readability.

If case-specific monitoring means testing whether an LMO is the cause of known potential adverse effects (if that is what we come to think “case-specific” means) then perhaps this other approach is a form of ‘environment-specific monitoring” (ESM). In this framework, the monitoring is directed to either known or unanticipated potential adverse effects that may arise due to factors that create high uncertainty (time, cumulative effects, little science) in the context of the specific environment in which the LMO is found. The key distinguishing features of ESM are:
1. it includes a capacity to detect adverse effects in the environment regardless of cause (e.g., in the same way has epidemiologists monitor the ‘health environment’ for evidence of unanticipated new diseases or unanticipated outbreaks of known diseases);
2. it addresses uncertainties that cannot be effectively addressed by the RA or any subsequent CSM activity.

ESM should never be implied to link harm causation with the LMO. Once an adverse effect is found, CSM or other option might be used to test causation.

Best to all
Jack