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

I am pleased to invite you to take part in the discussion on the first draft of the guidance on "Post-release Monitoring and Long-term Effects of LMOs Released into the Environment" (available at https://bch.cbd.int/onlineconferences/discussiongroups_ra.shtml).

This discussion will be take place from 5 to 17 September 2011 (1:00am GMT) at the link above.

Your comments in this discussion may focus, for instance on:

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

- Suggestions for improvements to the current text and/or structure; and

- Suggestions for background documents to be included (please provide the full reference and indicate to which section(s) of the guidance the background material is relevant).

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

Dear David, Dear Manoela
Many thanks for your dedication

It is quite interesting to see that some scientists are still negotiating the CBD obligations under this forum saying that they are unpractical and costly.. But anyway

Following Quist’s invitation for me to contribute some text in relation to the relevance of CBD articles on monitoring to our guidance document, I propose the following text:

“Conscious of the tremendous value of biological diversity and its components and its importance for the evolution and for maintaining life sustaining system for the biosphere the Convention on Biological Diversity (CBD) was inspired.

Noting that the threats to species and ecosystems caused by human activities has never been so great as it is today, the CBD established a structured process (article 7, 8, 9 and 10 of the CBD) aiming for the in-situ conservation of ecosystems and natural habitats (article 8 of the CBD), the maintenance of recovery of viable populations of species in their natural surroundings and the sustainable use of components of biological diversity (article 10 of the CBD). Monitoring is at the core of this process. It is essential to start monitoring before starting any activity that may have potential adverse effect on the conservation and sustainable use of biological diversity including the use and release of LMOs, otherwise it would be impossible to establish a baseline.
The CBD structured process consists of the following steps:
   -Identifying and monitoring (GS) of components of biological diversity important for its conservation and sustainable use paying particular attention to those requiring urgent conservation and those which offer the greatest potential for sustainable use (article 7.a and 7.b of the CBD). Therefore, monitoring should start with an inventory of all our natural resources, cataloguing the local fauna, flora and the health status of humans and their animals. Without this information no data can be interpreted later. This is highly important specially with regards to liability and redress where the damage by definition should be measurable or otherwise observable taking into account, wherever available, scientifically-established baselines recognized by a competent authority that takes into account any other human induced variation and natural variation (article 2 of the Nagoya – Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety)
   - Monitoring, though sampling and other techniques, the effects of processes and categories of activities, including the use and release of LMOs, which may have adverse impacts on the conservation and sustainable use of biological diversity (article 7.c and 8.g of the CBD).  It is important in this step to pay due attention to all sites and locations where such activities (e.g . production, transportation, storage and release of LMOs) are taking place
   - Maintain and organize data derived from the identification and monitoring activities.
   - Establish or maintain means to regulate, manage or control the risks associated with the use and release of living modified organisms resulting from biotechnology which are likely to have adverse environmental impacts that could affect the conservation and sustainable use of biological diversity, taking into account the risk to human health (article 8.g of the CBD)”

I recommend that this text goes to the introduction section of the guidance document.
I also remain open for any other text that adequately capture those ideas

Regards,
O.A.El-Kawy

Firstly I would like to acknowledge the amount of work that the subgroup has put into this document. I understand the importance of generating a version quickly to determine whether the key elements have been incorporated and whether these have been clearly and accurately communicated. In its current state, I found the principles of LMO monitoring as described in the guidance difficult to understand because of the structure of the document, the drafting and the repetition. Therefore, I apologise if I have misunderstood some of the points I refer to in these comments.

I have made notes in the text of the guidance (please find attached). But my major concerns are that it:

- will be very difficult for competent authorities with little experience to follow this guidance without a significant revision;
- does not help competent authorities to adopt a systematic, proportionate, evidenced based approach to LMO monitoring;
- overstates what monitoring can achieve and understates the challenges.


In particular I found the presentation of the following key elements confusing:

Objectives
I was confused by the varying language that implied different objectives of monitoring. It is very important to establish what these objectives are before explaining the approaches for achieving them (and the associated challenges and limitations). Across the guidance I found at least 7 reasons for monitoring. Some of these objectives are discussed throughout the guidance – others appear more sporadically:

Pre-authorisation 
(i) to provide evidence in decisions to release LMOs (results from monitoring releases elsewhere or from previous trials in the importing country). There is a suggestion that applicants should generate monitoring data from smaller trials where there is a possibility that an application to release the LMO on a larger scale will follow (monitoring in early development). Presumably, this is something CA’s should consider recommending to applicants – they wouldn’t be able to establish requirements that are disproportionate to the risks of the trial in question?
(the monitoring plan can help design effective risk management measures?)
Post-authorisation
(ii) to substitute for missing elements in stage 1 of the RA. The guidance distinguishes between objectives (ii) and (vi). The latter deals with unanticipated effects whereas this point addresses adverse effects that could be anticipated if the hazard identification step in the RA had been incomplete.
(iii) to address uncertainties associated with stage 2 and 3 of the RA (i.e. to confirm conclusions) e.g. due the scale of the release, the relevance of data from other countries etc.
(iv) to check that any risk management measures are effective i.e. to confirm conclusions about the overall risk
(v) to repeat aspects of the RA – the text refers to prioritising these.
(vi) to identify unanticipated adverse effects (that could not be identified in the RA).
(vii) to evaluate ‘broader impacts’ of the GMO not addressed in the RA, as a valuable          science-based learning tool (sic).
(as a useful means of generating further scientific information! – this is not consistent with proportionate regulation)



If the suggestion in (ii) is that monitoring is being used to compensate for a lack of significant evidence that could be compiled pre-release by the applicant, there needs to be an acknowledgement that the alternatives are for CAs in the importing country to request further information prior to a decision being made or to stipulate risk management measures, including monitoring conditions (as appropriate).
I would not agree with objective iv (if it is one). As it is, the system appears self-perpetuating. I would also suggest that as socio-economic considerations are on-going the final point is referred to in this context, if it is at all.

I would favour of clearly focusing on the two objectives described in points (iii) and (v) and consolidating the language used throughout this guidance. These objectives are addressed by case-specific monitoring and general surveillance. Point (iv) should also be addressed by case-specific montoring.

Case-specific and general surveillance
The distinction between CSM and GS is very unclear throughout the guidance – or at least, it is clear in the section on ‘types of monitoring’ but the definitions are contradicted repeatedly later in the document. If the subgroup cannot distinguish between these (in the context of LMO minitoring), there is little point in referring to CSM and GS.

However, they address two clearly definable objectives that are very important to reflect i.e. (i) addressing assumptions on the occurrence and impact of potential adverse effects identified in the RA and (ii) identifying unanticipated effects. This is a useful distinction because different approaches are required to address each of them (these could be better explained in the guidance). That is not to say that tools such as existing monitoring schemes, farmer questionnaires etc. need to be restricted to GS. It is possible that a combination of these tools may be appropriate in addressing an objective.

Responsibilities
There are a number of statements about responsibilities in the guidance. The descriptions of who should be doing what is not always consistent. The guidance often assigns responsibility to the CA unnecessarily e.g. it may be important that reports are made publicly available, but there is no reason why the consent holder could not be required to do this. Assigning responsibility unnecessarily to the CA imposes an unreasonable burden.


Implementation
There are a number of recommendations in the guidance that are very difficult (at best) to implement in Europe let alone in developing countries. e.g. using existing surveillance networks. The guidance recommends that it may be necessary to reconfigure/adapt these networks or introduce new ones. This does not seem proportionate purely to address the potential for unanticipated effects. It is more reasonable to suggest that existing networks might be used rather than should be. There is no reason why GS has to be carried out in this way.


When to monitor?
I am not clear from the guidance whether the suggestion is that monitoring is always required. If its is, then I presume this would be GS as CSM is case specific.  When would GS apply e.g. would it apply when environmental exposure is minimal as is the case with small-scale field trials? This point relates to proportionality and the importance of generating

Dear Colleagues,


I would like to take the opportunity, since spelling/grammar issue has been raised, to address this point. A good case has been made for General Surveillance, indeed.

First, the task for spelling/grammar editing was mine – so I take full responsibility here. My apologies go particularly to members of the SWG, and those who put time and effort in this document. Hopefully this has not led broadly to significant adverse effects on you, dear Reader, to comprehend the draft.

Second, I can assure you that monitoring measures were indeed implemented, and a spell/grammar check was performed along with manual checking of the document.  On experimentation, I see now that my spell check software is not functioning as it should, and there are many errors that the system does not detect. All the reason not to over-rely on one detection system! Will check on this to avoid such false-negatives in future drafts.

And that I am well practiced in English, it might come as a surprise (relief?) to the non-native speakers here that yes, we native English speakers actually sometimes make errors too!

Now that this issue is addressed, I hope we can return to the important case in front of us - further progress on the existing draft.

Many thanks for the guiding questions kindly provided by Manoela and the Secretariat to help stimulate the discussion.


Best,

David

I greatly appreciate the opportunity to comment this draft. We have discuss it with the team in charge of carry on the monitoring of GMO released to the environment in Mexico and I am here giving our comments for the first two points asked by the Secretariat to be focus for this discussion.  The suggestions about background documents will be done in my next participation.

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

There are issues that are irrelevant to this topic that have been included in this draft, for example all the related with general surveillance, this is not part of the monitoring as established in the Anex III.

2) Suggestions for improvements to the current text and/or structure;
The first paragraph of the introduction mentions that this document was developed as a decision of the AHTEG. Then it is clear and important to keep in mind, that this is going further of the decision of the COP MOP. First of all, we suggest that if there is a decision of the COP MOP on the development on this kind of guidance of particular subjects, the Secretariat should conforms AHTEGs for each particular subject (This include mosquitoes, trees, etc).  It is acknowledged the effort on the development of the draft. In the document is reflected the valuable effort of one person that have some idea, but not of a group of experts on the kind of monitoring referred on the Anex III of the Protocol.

The redaction of the draft is very redundant and not clear, for example just in the first paragraph mention …the development of a guidance… in order to provide a guidance…. Or in the scope is mention …short- or long-term, immediate or delayed. Maybe it is because English is not our first language, but the redaction sound redundant.

There are interpretations of the Protocol that are out of reality, for example on the second paragraph.  The monitoring can not be a safeguarding “the conservation and sustainable use of biological diversity, taking into account human health” after a consent for environmental LMO release is made. 
If there is a consent for environmental release it is because there have been a RA and the authorities have a level of confidence that the risk (impossible to be cero) is manageable and maybe, that the decision can help to the conservation and sustainable use of biological diversity, taking into account human health. Our interpretation of the Anex III, Protocol and CBD about monitoring of GMOs is that it plays an important role for test hypothesis about the level of risk. The ANEX III is clear: the monitoring must be done WHEN there is uncertainty on some level of risk identified by the risk assessment, and then what should be monitored are variables or indicators related with the risk hypothesis identified during the RA, HOW? Sampling data of these variables on the particular receiving environment.

By RA you identified if the release and use of a particular GM may have adverse effect or may help to the conservation and sustainable use of important components of biological diversity, as mandated by the CBD: by identifying processes that may have adverse effects, and monitor for these effects via sampling. Monitoring, as is interpreted by the text of the CBD must be done only in cases where there is uncertainty on the levels of a particular risk hipothesys identified during the RA.

Our interpretation of the Road map is quite different of the one presented on this document (Paragraph 4), the “Roadmap for Risk Assessment” provides guidance on the risk assessment, and specific considerations in how to conduct it. With respect to monitoring, data generated the steps 2 to 5 in the pre-release assessment can be useful in the test of hypotheses formulated during the step 1 of possible adverse effects, if there is uncertainty on the levels of risk established during the step 4, or about the level of mitigation with the measures established during the step 5, this uncertainty may be addressed post-release through monitoring on the receiving environment.

It is suggested to eliminat paragraph 5 from this draft and from the road map, it is confusing and goes further than the Protocol. It sames that monitoring is the miracle medicine for everything.

It is suggested that this guidance stay focus on monitoring that may be used for addressing or evaluating uncertainties associated with the level of risks, considering that the determination of when monitoring is appropriate and what should be monitored in the receiving environment is made within the process of RA case by case.

I hope the comments are useful and in the future, if there is a decision of the COP MOP on the development on this kind of guidance it can be considered by the group of experts in charge.

Concernig the proposed draft on "Post-Release Monitoring and Long-Term Effects of LMOs Released into the Environment", I would like to make following comments;

There are three cases of transboundary movement of LMO, as follows;
a)intentional introduction into environment, such as cultivation of crops using LMO-seeds in the territory of the Parties
b)direct use as food or feed, or for processing
c)contained use.
It would be thought that this Guidance will be applied to the case of a).  However, as it is not clearly stated that in the current document, readers might misunderstand that the Guidance will be applied to all cases of a), b), c), mentioned above.  Especially, in the case of b), it would not be required such intensive monitoring explained in the Guidance, because the environmental release of LMO in this case is restricted in small amount of spills of commodities during transportation.
In order not to create above mentioned misunderstanding, it would be suggested, for example, to state clearly that the Guidance is targeted for the case of a) in the beginning of the document, or to describe the principle of monitoring in each case of a) and b) respectively.

The Document shows two types of monitoring of CSM and GS.  Because of the following reasons, I could not avoid pointing out that GS may not be included in the document;
a)CSM seems to be enough to correspond to the Cartagena Protocol.
b)It seems difficult to explain scientifically the necessity of the GS.
c)As it would be difficult for applicants to make plan of GS, the Guidance might impose excessive burden to the Parties of importing LMO.

Isao Tojo

Dear participants and moderators,
I greatly appreciate the opportunity to comment this draft. Thanks to all the people who worked on the draft document and its revision till now.

I would like to mention (trying not to repeat what was said till now) after reading the draft documents:

- logical inconsistencies and operational impracticality – I agree that there are some, and I hope the comments already posted (namely Dr Benedict and Ball) have pointed the most important ones.
      • The clear presentation of the objectives of the document is of most importance – for the revision/comments participants of the Open-ended forum present and, after revision, for the reader/user. As it is unclear in the present document, mentioning corrections is difficult. Maybe the ones presented by Dr Ball could be a good guidance for starting the revision.

- improvements – many suggestions were posed, and I would like to say that I strongly agree with Dr Otero-Arnaiz and her team (I am not going to copy or repeat them here).


Our main concern in all the revisions of different drafts that had circulated have always been to be “close to reality” as possible. Our position is that monitoring could not be used as a safeguard after consent for environmental release of a LMO – if it is not safe, why approve a release? If a LMO is consider safe then why to ask any monitoring? So, a guidance document could be useful to help management and/or when there is an “uncertainty” for a specific risk (it means – variables/indicators are clearly identified in the process and this indicator could be measured on particular environment conditions); so, case-by-case analysis.
I would like to call attention to the point mentioned by Dr Yoshikura, who said in his message “the biological diversity will continue to change, even without involvement of LMO release.” So, in a document like this draft one, it will be of importance to mention the need of a clear end-point, and that the indicator to follow during monitoring phase has to be measurable and, mainly, need to reflect a real risk.

Regarding background documents to suggest, it will be sent opportunely.

I hope those considerations (and support to some comments already mentioned by other participants) could be useful for the revision.

Thank you for the opportunity to comment on the draft of the document “Post-release Monitoring and Long-term Effects of LMOs Released into the Environment”.  Below are comments in response to the specific questions posed by the Secretariat:

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

I agree with the comments—in particular those from Dr. Otero-Arnaiz of Mexico—regarding the relevance of General Surveillance in the context of the Protocol.   As she and the introduction to this current draft point out, monitoring in Annex III is called for in specific situations: “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.(emphasis mine)”  I think it is clear that the intent of the monitoring mentioned in Annex III(8f), is to address specific issues of concern.  Thus I support the deletion of General Surveillance as a subject relevant to the guidance under the Protocol.

2.  Suggestions for improvements to the current text and/or structure;

General comment:  The concepts in the draft are largely undocumented and lack sufficient grounding in the scientific literature on environmental monitoring.  Thus, it is unclear whether the concepts expounded in this draft have scientific support.  It would be helpful to have produced a draft that was appropriately referenced, in order to establish the scientific basis for it.

A specific issue:  Lines 121-131 refers to monitoring of small scale field trials and large scale releases as though they are identical activities, but just at different scales.  This is in fact not the case.  As those who have either conducted or regulated confined field trials will know, monitoring in those cases is done primarily to assure compliance with measures that were designed to minimize the impact of the LMO on the environment.  Therefore monitoring of small scale trials, especially a General Surveillance approach, would not provide the type of information relevant to risk assessment that carefully designed experiments, based on proper problem formulation, would provide.

3.  Suggestions for background documents to be included

A recent review (Lindenmayer & Likens 2010) can be especially useful when considering of different types of environmental monitoring.  While the authors do not use the term, I think it is quite clear where General Surveillance falls in their classification, and what they would say about that approach.  I am attaching a pdf copy of the paper.

Dear participants,

First of all I would like to thank the subgroup for this comprehensive and very detailed document on post release monitoring. It covers a wide range of topics which have to be considered when conducting monitoring. Furthermore I fully support the comments of O.A. El-Kawy on the importance of monitoring in general and with regard to LMOs in particular.

Specific comments:

I agree with Hector Quemade that it is  important to distinguish between the monitoring of contained field releases before and monitoring after approval for placing on the market has been given. Field trials are usually of small scale and use a specific plot design. Furthermore comprehensive containment measures are applied. Therefore the monitoring approach differs in many aspects from the approach of post market monitoring. Nevertheless, the data and knowledge gained in these small field observations are very important for the ERA and the objectives of the post market monitoring. I’m in favour of the suggested step by step approach of the approval process, but the use of the monitoring experience and results before approval has been given might be limited.

I support the approach of the document, that post release monitoring should cover direct, indirect, immediate, delayed, long term, cumulative as well as unanticipated effects on the environment. To address these different effects needs appropriate strategies. As it is mentioned in the document the ability of an environmental risk assessment to assess potential effects, to identify uncertainties and to predict risk levels is limited (limitations in time and scale, selection of species, complex interactions can’t be covered etc.). From a scientific point of view the post release monitoring should be linked to ERA but needs also additional strategies to address effects which are not or couldn’t be covered by ERA. Therefore in my view the general surveillance is a must of post release monitoring.  But I agree that it is a challenge to develop an appropriate strategy. The document provides important proposals how to deal with this challenge.

I agree with Luise Ball, that existing programs might be used for the monitoring of GMOs. It is one possibility among others. But if it is envisaged that the involvement of existing programs will be a main pillar of general surveillance (as it is discussed in the EU currently) some requirements have to be considered. In my understanding the document gives some guidance what has to be considered, what are criteria for the suitability of programs etc.

I'm of the opinion that if the application of a risk management measure is a requirement of the consent given (e.g. a specific pesticide application regime to protect flora and fauna) the observation of the efficacy of this risk management measure should be an integral part of the monitoring.

I am attaching my comments to the draft document on Post Released Monitoring.

Regards

Elizabeth Bravo

POSTED ON BEHALF OF HIROSHI YOSHIKURA

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I appreciate Dr Stephanie James for a comment to my previous posting. While writing the previous comment, I expected somebody will address this issue.
1. In response, I should say that the debate will depend on how we interpret “organisms which have conventional counterpart(s) with long history of safe use”, and how we define the word “use”.

2. Back to mosquitoes (though my experience on this organism is limited to filaria vectors more than 50 years ago when it was still endemic in Japan), the accumulated knowledge on mosquitoes, particularly the knowledge obtained through the control of malaria, filaria, yellow fever, etc. is enormous (at least to me). We may have data what may happen to other organisms (including humans and animals) in the environment after elimination of mosquitoes and after its resurgence after stopping the elimination activity. In this sense, mosquitoes (at least certain species of them) are already familiar.

3. The word “use” can be used in various ways. For example, in a biosecurity provision, the word “use” is used to include “destruction” of pathogens. In this sense, the mosquitoes have long history of use as it has been the target of the mosquito “eradication” (eradication is a kind of “destruction”, and, as a consequence, a kind of “use”).

4. In my view, mosquitoes already have a history of extensive investigation relating to their biological and ecological behaviors. So, I added to the end a sentence “For organisms with no familiarity, LMOs should be developed only after extensive investigation relating to their biological and ecological behaviors”.

5. In the future debate, defining the words in usable way is very important. I really appreciate Dr. James for raising this issue.

Best regards,
Hiroshi

Dear Colleagues,
First of all, I’d like to once again thank you all for the work done so far, the constructive comments and the possibility to contribute to the development of these draft guidances.
There are several reasons that make a well-designed post market environmental monitoring (PMEM) of LMOs a highly important topic. However, to develop the concept, to put it into practice a successful, feasible and useful PMEM to access useful and good quality data proportionate to needs.  Moreover to effectively and wisely use acquired data to environmental and regulatory decision taking to fulfill the goal of achieving sustainable development, or conservation and sustainable use of biological diversity (as written in different parts of the Protocol). It involves many considerations, there is no doubt that writing a good guidance is a big challenge. We should not ignore or forget to consider already available experience. When writing guidances, either on monitoring or any other, it is essential to consider experience such as those with trees as mentioned by Prof. S. Strauss, mosquitoes as mentioned by Dr. Hiroshi, and in the case of crops from the different phases of development to already over 15 years in the market and more than 148 million hectares planted.
I share similar concerns with several postings already done, such as Mark Benedict, Louise Ball, Hector Quemada, and others that have already mentioned about the disproportion, unworkableness and the several points to correct in the draft guidance.
In my opinion, one of the most important points to correct mainly because it should actually be the basis of the development of whole guidance is the fact that monitoring under the protocol is suggested in some cases of uncertainty on specific subjects which may be identified. As one can read in the text of annex III:
“The process of risk assessment may on the one hand give rise to a need for further information about specific subjects, which may be identified and requested during the assessment process, while on the other hand information on other subjects may not be relevant in some instances. To fulfill its objective, risk assessment entails, as appropriate, the following steps: …  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”. 
There are several excellent reasons to consider monitoring as in the protocol, and that have being forgotten in several parts through the draft guidance. If we keep monitoring as in the protocol, and I believe we must among other reasons because it is not up to us to change it, several mistakes throughout the draft guidance will be evident.
My best regards, Lúcia

POSTED ON BEHALF OF PHIL BEREANO

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I appreciate the opportunity to participate with colleagues in this dialogue on monitoring.  A number of issues have been raised and I would like to comment on them.

1) In general, I support the views expressed by Drs Abdel-Kawy and Zughart.  Elizabeth Bravo’s comments on considering the distributional aspects of any impacts from the use of LMOs cannot be emphasized too strongly.  Just as the benefits are not equally shared by all, neither are the risks. Risks to vulnerable communities need to be especially monitored.  For example, as in many public health policies,  children may be especially sensitive and thus are closely monitored.

2) As the literature makes clear,  risk assessment is always iterative, not static.  One of the key consequences of monitoring is to give feedback to the RA which then may need to be modified based on these  observations. This is, overall, an aspect of risk management which we cannot ignore. See my next point.

3) All environmental risk assessments involve uncertainty. Since there may be thousands of species in a receiving environment  (and thousands of biological processes going on) and since we have knowledge about  only a tiny proportion of these, it is not possible to assume a stance of perfect knowledge in a RA. Our stance, rather, needs to be of inquiring humility. The Precautionary Principle, twice included in the Protocol, recognizes the necessity of this sort of posture. Monitoring is thus essential to carry out precaution.  Thus, I differ with the suggestion of Dr. Benedict—the risk analysis and the monitoring need to be expansive; if the argument is that this would be costly, my response is that such expenses should be internalized into the actual cost of the LMO rather than borne by government taxpayers or innocent victims.

4) As a result, I must differ with my friend Yoshikura-san when he says that monitoring should be proportional to risk.  On a logical level, this may be so, but in actual experience, we often don’t really have a firm grasp of what the risk actually is, and so applying his approach is really not practical.  That is why there is discussion of “unanticipated” consequences (and hence risks). Many of the proffered assessments are performed by the industry proponents (in the US, government agencies almost never do independent assessments of LMOs); these are usually highly flawed—they don’t use real world conditions, may assess isolated compounds (like the Bt chemical instead of the plant incorporating the Bt gene), the samples are too small, etc.  These deviations from reality make monitoring all the more necessary.  If there is a “conventional counterpart” (a concept I question, since the whole point of an LMO is that it differs from conventional organisms), the proponents imply that the risks are lowered; Yoshikura-san’s points 3 and 4 seem to be  contradictory as to whether monitoring then should be more necessary or less.

5) Dr.  Deise Maria Fontana Capalbo,  says “Our position is that monitoring could not be used as a safeguard after consent for environmental release of a LMO – if it is not safe, why approve a release? If a LMO is consider safe then why to ask any monitoring? So, a guidance document could be useful to help management and/or when there is an ‘uncertainty’ for a specific risk”.  Dr. Adriana Otero-Arnaiz expresses a similar view.  However, “safe” is a value judgment that the assessed risk is acceptable; “safe” is not an objective term—otherwise everybody would or would not smoke cigarettes or wear seat belts without the necessity of legal compulsion, whereas individuals have different conclusions as to whether these are safe activities.  An RA under the Protocol does not determine “safety;” it attempts to determine “risk.” Thus, I strongly disagree with these two statements.

As my discussion of uncertainty, above, indicates, any assessment of the risks of an LMO in a receiving environment is—at best—an approximation.  With deference to the sensibilities of our Japanese colleagues, the risks of radiation exposure at Fukishima apparently did not anticipate the simultaneous striking of an earthquake and a tsunami.
I agree with Dr. Quist that appreciating the importance that unanticipated effects may have makes monitoring all the more necessary.

6) Risk Analysis comprises more than direct effects (so-called “first order”).  Effects of effects (second and higher order) may be of far greater importance to human health or biodiversity.  While it is imperative that such effects be included in the assessment, each step does tend to introduce greater uncertainty and hence greater need for monitoring. This would include socio-economic consequences, relevant under Art. 26.

I appreciate again this opportunity to participate.

Philip L. Bereano
Professor Emeritus
University of Washington

POSTED ON BEHALF OF LUCETTE FLANDROY

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Dear participants,

I first want to thank for the efforts made till now by the coordinator of this subgroup of the AHTEG and by the participants to the forum.

I regret to have very few time to dedicate to this discussion in this period. I confess that I even did not take the time to read really accurately the 2 draft guidances on GM trees and monitoring, but I followed as much as possible the messages of the participants.

As such, I notice especially the divergences of views on the usefulness of a General Monitoring process.  

I think that at least part of the divergence is maybe coming from a lack of commun understanding of what is meant by "identified" risks.

1) There are kinds of precise, simple, short-term potential negative effects that can be experimentally tested during the risk analysis phase. In case the "worst conditions" tested in the risk analysis indeed reveals that those negative impacts could occur, the probability of these "identified" potential dangers ( the identified risk ) can then be evaluated in function of the foreseen use, receiving environment etc…
Concerning this kind of risks, it is true that monitoring should not have to replace the risk assessment phase, where all the risks that can be identified should be, as well as possible, with the adequate methods and statistics, without forgetting anyway to signal accurately the final uncertainties that should then be followed in the monitoring phase ( concerning the uncertainties: one may for ex. not extrapolate with total certainty from laboratory tests what could result from wide and complex environmental interactions; results of effects tested on one focal species could not be at 100 % extrapolated to effects on the whole systematic group or ecosystem function that this focal species represent ) .  

2) But, as concisely well explained by Dr. Wiebke Züghart ( and with examples and details in part of the comments of Elisabeth Bravo ) , and as discussed also ( among other by me ) in the preceding forum on Revision of the roadmap ( in particular when tackling the Uncertainty chapter ), there are risks that:
- can be imagined, speculated ( I noticed that some participants do not like that word, whereas speculation is one of the important characteristics that distinguishes human beings from animals, at the basis of creativity, also in scientific research, and that can be useful to predict important hazards ) and thus predicted ( I know there is also no commun understanding of that word ), are plausible through general scientific knowledge, through experience, through analogy with similar situations, through empirical knowledge, …..
- …...but that cannot be tested at short term and of which the probability could not be defined precisely or at all, for reasons of time, scale, and/or complexity of interactions, or by lack of adequate methods.
That kind of risks can be considered as "identified" if they can be precisely expressed, even if not testable, and they deserve to be looked at in the monitoring phase and to be avoided as much as possible through risk management measures ( at least if the consequences are considered important, in case the hazard occured, in the context of the stipulated protection goals ) , even if their probability cannot be estimated at all.
Of course, it is not really possible, in that case, to develop a monitoring system that is proportionate to the risk ( if the probability is not estimable ) but well to the hazard itself.
And I think it will also not be easy or possible to always define, for that kind of hazard, simple and unique, "monolithic", indicators/parameters to be measured. Maybe that kind of risk has to be monitored through what is described as " Question-driven monitoring" ( rather than "mandated monitoring" ) in the review of D.B. Lindenmayer and G.E. Likens, posted by Hector Quemada ( whom I thank for that ) and that I quickly went through.   

3) In addition to these 2 different kinds of "identified" risks, there could indeed exist risks that are totally unforeseenable, for the same reasons of time, scale, complexity of interactions, and  scientific ignorance.
Indeed, it is a challenge, and can be expensive, to define precise monitoring procedures and parameters to look for undefined risks ! 
However, all around the world already exist and are developped alarm/warning systems for health or environmental critical situations, are developed medical records of some diseases, ……. Generally, this kind of alarm systems, managed by experts, are also open to information/warnings sent by the general public. This is a kind of system, already existing for other purposes, that could be used simultaneously to alert on eventual pertinent preoccupying observations made relatively to GMOs, without having to develop new specific monitoring systems. 

Annex III, describing the risk assessment process, indeed considers to establish risk management strategies and/or monitoring especially in the case of identified risks with a probability somehow defined.
Art. 10, concerning the Decision Procedure, allows to take a decision concerning the import of a LMO, and a.o. to authorize the import, with or without conditions, in order to avoid or reduce as much as possible potential adverse effects of that LMO, even in the absence of scientific certitude concerning the extent of these potential adverse  effects, due to insufficient relevant scientific information and knowledge.  It seems to me this leaves room for monitoring of "identified" potential hazards for which the probability has not been defined ( my category 2) hereabove ) and for unforeseen negative effects ( my category 3) hereabove ) as a condition for the import of LMOs. 

It goes without saying that a close link and coherence must exist between the chapter on Uncertainties in the Risk Assessment guidance and this guidance on Monitoring.

With best regards to all the participants, members of the AHTEG, and secretariat.

Lucette Flandroy

Dear colleagues,

I am very grateful to David for making a new draft and to all others that have contributed to this text, and I am very grateful for the opportunity to make comments.

That being said, I'm afraid that I still have a lot of problems with this text.
The major one is that in the approach that is chosen it appears to be expected that adverse effects will be found in monitoring. It is even like that monitoring has failed its objective if no effects could be found. But in reality, it cannot be put strongly enough that the null-hypothesis of monitoring is that the LMO in question will be safe and will have no adverse effects.
A second major problem is that there is no feeling of cost effectiveness in the text: monitoring efforts should be in proportion to the severity of the risks, even taking into account Phil Bereano's observations. This is a fully justified approach that we take everywhere in our lives where we are balancing risks and benefits. 

I think that the observations of Louise Ball, and others that made similar comments, should be taken very seriously, that it:
- will be very difficult for competent authorities with little experience to follow this guidance without a significant revision;
and that the document
- does not help competent authorities to adopt a systematic, proportionate, evidenced based approach to LMO monitoring;
- overstates what monitoring can achieve and understates the challenges.
I also agree with the many others that have made similar comments.

Like others, I am also bothered b y the internal inconsistencies in the text. I am afraid that I have only been able to start to point some of them out in my comments.

It has been pointed out by several people that GS does not belong in this document, for various reasons, the most compelling being that is out of the scope of Annex III. I would agree in principle with this point of view. GS is however part of various regulations, also our own in the EU, and for that reason I would not be against having GS in the document. But, the explanation of GS as different from CSM should be better highlighted. GS is still represented as an approach that is, or may be, hypothesis driven, while it is not. GS is means to look for unexpected and therefore unknown effects; once such an  effect has been found, if any will be found at all, it can be further approached by CSM.

While I would not discard all the arguments of Ossama, the text that he proposes to be added to the introduction is a very specific interpretation of monitoring obligations of Parties of the CBD, based on a number of articles of the CBD. Interpretation of these articles and their consequences for obligations of Parties needs a broader discussion within the CBD, and cannot be part of a discussion under the CPB.
Also, the interpretation that monitoring under the CBD is equivalent to GS as we deal with it in this guidance document, is faulty.
The text is an example of what Louise Ball points out: it overstates what monitoring can achieve and understates the challenges.In summary: I'm afraid that the text that he proposes is not acceptable to us.

Best wishes,

Hans Bergmans

Thank you for this opportunity to comment on the draft guidance document on post-release monitoring.

The AHTEG has taken on a difficult topic in this guidance, as it is being widely debated in the biosafety regulatory community, with varying opinions and not much experience.

I share the concerns expressed by many others who have commented so far about the guidance document as it is written.  In particular, I am concerned that the whole tenor of the document implies that monitoring should be required or is a necessity, which I do not believe is in line with the objectives and provisions of the protocol. This misconception will cause considerable unnecessary hardship for developing country regulators and publicly developed products of biotech.

The actual text in Annex III of the protocol says:
“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.”  (This text only appears as a footnote in the guidance document.)

This actual text clearly indicates to me that monitoring is optional and if used, should be to address uncertainty related to specific issues, not uncertainty in general.  This is the final step in the methodology, following the identification of adverse effects, estimation of the risk of those adverse effects, and a recommendation as to whether or not the risk is acceptable or manageable.  If the result of the risk assessment is a recommendation that the risk is acceptable, then it should not be necessary to monitor. 

A risk assessment under the protocol does not attempt to determine ‘safety’ or ‘risk’ (neither can be determined with 100% certainty).  It attempts to determine whether the level of risk is acceptable or manageable, and this ‘should be considered in the context of the risks posed by the non-modified recipients or parental organisms in the likely receiving environment’ (Annex III  General Principle #5). 

For this reason, I agree with those who have already commented that monitoring in the form of General Surveillance is not helpful in this guidance document.  There may be a role for Case-Specific Monitoring, where uncertainty related to specific issues has been identified during the risk assessment.  However, if it can be determined that the level of risk is acceptable or manageable based on the risk assessment, no formal monitoring should be required.  The need for monitoring where specific issues have been identified should be viewed as the exception, not the rule.  This guidance document should be approached from this perspective.  Monitoring in the way that nonmodified recipients or parental organisms are monitored should clearly be listed as an option.

I also agree with other commenters that the document throughout confuses monitoring ‘post-release’ with the option of requesting further information ‘pre-release’, even though the text in Annex III (quoted above) clearly distinguishes these (either/or).  Data collection for risk assessment before a decision is not the same as data collection during monitoring after a decision. The portions of the guidance document that discuss as monitoring the collection of data before a risk assessment should be deleted.  It does not belong here.

This is further complicated by the statement in the Objective and Scope which says “It should be explicitly noted that “post-release monitoring” for the purposes of this document relates to approved releases of LMOs into the environment that were part of a risk analysis and decision-making process, including experimental or field trail releases made within a Party’s national biosafety framework.’  As has been noted many times before in the discussion of the roadmap (and by others already in the current discussion), risk assessment and monitoring for the purposes of a field trial are based mainly on the confinement measures which limit exposure during the trial.  This guidance document on post-release monitoring is not relevant for the monitoring of field trials.

The sections with the headings ‘The capacity of the party of import to carry out monitoring activities should be taken into account when designing a plan, to identify any additional resources needed for capacity building’  and ‘The party of import may also require the exporter to carry out the implementation and coordination of monitoring activities, and bear the cost of doing so’ seem strangely out of place in this guidance document compared to the other guidance that the AHTEG is developing.  These should be deleted. 

A published perspective by Sanvido et al. (2011) discusses clearly the challenges of post-release environmental monitoring, and argues for more efficient and rigorous pre-release risk assessment rather than mandatory post-release monitoring.  This should be a useful reference for the guidance document.  I am attaching a pdf copy here.

Thank you again for this opportunity to comment.

Sincerely,
Karen Hokanson

Dear participants,

I appreciate the opportunity to comment on this draft of the document “Post-release monitoring and long-term effects of LMOs released into the environment.” I’d ask you to please consider the following points.

It is indicated in the document (lines 147-152) that long-term effects are not adequately addressed by risk assessment. Although it is not specifically stated, such statements can be seen to imply that all risk assessments will be flawed. The corollary to this is that monitoring must be applied following all risk assessments in order to address long-term effects. While I appreciate that some may hold such a perspective, in Canada we consider the potential for long-term effects in our risk assessment and only if there is significant uncertainty would monitoring conditions be applied. Similar text that seems to suggest that all risk assessments are inherently flawed, this time more broadly inclusive of the limitations of the risk assessment, is again found on lines 246-250. Such statements are in danger of drawing general conclusions for all risk assessments before conducting the risk assessment itself. I would therefore recommend that such leading statements be removed from this draft and that care should be taken that it is not implied that monitoring will be required in all cases.

As several others have already pointed out, I think it is key that this document focus on monitoring as a tool for addressing uncertainty in the risk assessment. In several places, there is a lot of emphasis placed on the adverse effects identified in the risk assessment as the focus for monitoring (for instance, lines 245-246, 386-387, 457). Many potential adverse effects identified in a risk assessment may in fact be discounted because it is recognized that there is no likelihood that they will be realized. It is only when there is uncertainty in the conclusions regarding the potential for an adverse effect to exist and the likelihood that that adverse effect will occur, and it is recognized that the uncertainty could sufficiently impact the outcome of the risk assessment, that monitoring should be considered.

Based on these two arguments, I also support the suggestion of other participants that a differentiation between types of monitoring not be made in this document. General surveillance “surveys for unanticipated adverse effects not identified in the risk assessment.” This again suggests that risk assessments are not sufficiently robust to identify all adverse effects and makes a general conclusion about all risk assessments that would lead to the necessity to apply monitoring in all cases. By using uncertainty as the trigger, if a risk assessment indicates that there is uncertainty in the risk assessment around the potential for unanticipated adverse effects to be unaccounted for, monitoring could then be applied. This puts the onus on the risk assessor to come to this conclusion, when it is appropriate. In addition, by taking this approach, there will always be some guidance as to what to monitor for, based on the nature of the uncertainty. A provision for general surveillance makes the depth and breadth of monitoring that is necessary very unclear and potentially limitless. Clear guidance could not always be given to indicate when to use CSM vs. GS (e.g., lines 287-288, 431-432) and there was redundancy when describing what to monitor (compare lines 397-399 and 421-423), both of which further suggest that monitoring not be subdivided in this way.

Best Regards
Jaimie Schnell

Dear Colleagues,

I appreciate the efforts of contributors in drafting this document and thank you for the opportunity to give the following suggestions.

The monitoring guidance is predicated on following the "Precautionary Principle" which is not cited in the Protocol—instead the precautionary approach is referenced. Lack of definitive information should not prevent a risk assessment finding and decision under the protocol.  Misapplication of the Precautionary Principle also creates concerns in regards to monitoring.  The guidance does specifically mention both case specific monitoring which is tied to an adverse endpoint which has been identified as appropriate but also supports general surveillance which is indefinable and not science-based.  Indeed the guidance mentions that this general surveillance does not need to be hypothesis based.
Hypothesis testing is an essential aspect of any collection of data based on the scientific method so it is difficult to see how this could be included in guidance for scientific risk assessment of transgenic organisms.

In addition, a level for burden of proof should be placed on showing a cause-and-effect between the LMO and perturbations observed during general surveillance. Otherwise, any change could be attributed to the LMO when the negative effect might be due to any of many causes. This might be added as another point to consider at line 470.

I look forward to reviewing and providing comments on the next version of this document.

Dear All,

I have serious and similar concerns about the PMEM document and the GM Tree document, so I therefore post this message in both on line discussions.

My concerns are very much along the lines of the concerns expressed by Louise Ball, Janet Gough, Adriana Otero-Arnai, Hector Quemada, Lucia de Souza, Hans Bergmans, Steven Strauss, Les Pearson, Karen Hokanson, Kazuo Watanabe, Jaimie Schnell and David Heron, and I will therefore not burden this posting by repeating those concerns.

In summary, I believe that both these documents (still) suffer from the same shortcomings as I posted on the first draft of the PMEM document, namely that these documents offer little practical guidance to people with limited experience, because they:
1) are difficult to understand due to inconsistencies and repetitive or incomprehensible language,
2) do not reflect the state of the art of knowledge and experience.

In addition, these documents - and in particular the PMEM document - convey a flavour that we have to start from scratch and that there must be adverse effects resulting from the introduction of GMOs.

In short, I fully support those who have suggested that these documents need a fundamental revision, and I propose that such revision should involve people with substantial experience in the respective fields.

This brings us to a key problem of the whole process, and that is that by adding new guidance documents to the list of documents to be developed, while at the same time we haven’t finalized the road map and other earlier guidance documents, we are spreading our resources very thin, and we run the risk of inconsistencies between the roadmap and the specific guidance documents.

I therefore, in support of the suggestion by Janet Gough, repeat my proposal that for now we suspend further work on the documents on PMEM and GM Trees and first properly finalise the road map and other guidance documents.

Regards

Piet

Dear Online Forum Members,

I have been following the discussion here with interest, and appreciate the many thoughtful and constructive ideas and suggestions for improvement of the monitoring document. Evidenced from the diversity of view expressed here, I might have actually been worried if we had actually achieved broad consensus at this early stage of the document! It will be a strength of future developments of the document to have such diverse views considered so early on.

A few brief comments to some of the posts, in no particular order:

In relation to the use of GS in the guidance, there were a number of comments by Adriana Otero-Arnaiz, Hector Quemada, Jaimie Schnell and others who felt that the monitoring guidance should only attend to the specific provision in Annex III, particularly paragraph 8 (f) as it relates to case specific monitoring (CSM), and that GS as a concept goes beyond what is specificed in the Protocol.

It is important to keep in mind the purpose of our guidance in general is not only to elaborate on Annex III, but to utilize more contemporary concepts of risk assessment and risk management that have been developed since the Protocol itself.  We do this in many cases in the Roadmap, with the consideration of “the choice of comparators” for example, and is a necessary feature of any elaborated guidance to expand on contemporary, well establised ideas.

Others felt that General Surveillance (GS) is internationally recognized as a complementary approach to CSM, as pointed out by Hans Bergmans, to take into account for effects that may not have been anticipated or evaluated in the RA in the first place, and survey for unforseen effects, as noted by Wibeke Zughart, Phil Berano, Ossama Abdel-kawy and others. In this sense GS represents an important concept for the guidance. That is, the RA will inevitably have some level of uncertainty that is indeterminant or arising from total ignorance, and that may be accounted for through a General Surveillance Plan.

Further, David Heron and others in their comments suggest that if a hypothesis has not been formulated (particularly for GS), it cannot be a “science-based” activity, and thus has not place in this monitoring guidance. That is, the scientific method is predicated on the use of hypothesis formulation in empirical observation. Perhaps there is some general confusion on what science practice and the scientific method entails. By my understanding, a “science-based” activity would be any empirical activity (conducted via structured experimentation or merely by observation, including hypothesis free observations)  for gathering information and knowledge to better understand a phenomenon. From the evidence and information obtained, testable models and hypotheses (subject to falsification with further empirical study/new knowledge) may be constructed to derive causal relationships. That is, the application of the scientific method, particularly when the phenomenon is unanticipated or not understood in the first place, does not start from a testable hypothesis, but from observation and knowledge creation that leads to testable theories later on. In the case before us, GS can develop information that eventually leads to empirical testing to establish possible correlation.

I also appreciated the very interesting commentary raised by Mark Benedict and further by Hiroshi Yoshkura regarding the  inherent nature of complex systems, that change does not reach some point of “stasis” but may continue through time. This undescores a very essential feature of monitoring, that changes are captured, and a causal relation established with exposure to the LMO or its products that may have an adverse effect of the indicator or parameter being monitored. Identifying and establishing baselines, discussed in the guidance, is a central facet for deriving a causal link that may exist from changes that are occuring through time. The inherent limitation of observation (montioring) period decides the “window” of change that may be detected. This point should be better elaborated in the guidance.


The discussion regarding what should be recommended in the guidance, the burdens in may create for competant authorities brought up by Isao Tojo is worthy of mention. In relation the the general experience of LMO monitoring to date, which is limited, a clear message has been that in order to be (cost) effective and practical, there are a number of considerations that must be taken into account to ensure that any proposed monitoring is worthwhile in the first place. That is, if not undertaken correctly (use of standardized methods, baselines, relevant indicators, etc), the practical value of monitoring will be low, resources wasted, and objectives unmet. This is why detailed elaboration of technical requirements must be specificed in the document to orient the user to the monitoring needs to ensure it is cost effective and useful. By understanding the nature of the undertaking necessary for useful outcomes from monitoring that meets the objectives of the Protocol, CAs will be in a better position to make informed choices on the implementation of a monitoring plan. The guidance should be realistic of what can be achieved, and what it takes to fulfill the objectives of monitoring set out prior to the activity being implemented.

Lúcia de Souza, Hans Bergmans and others mention the concept of “proportionality” with regard to the requirments for monitoring, and what should be presented in the guidance. While the concept can be agreed upon in general, Lucette Flandroy and Phil Berano underscore the difficulty of this in practice.  Where the proportionality of risk vs. monitoring need (or even risk management need) could be estimated at all, it could no be predicted a priori, but taken as a decision of the competent authority depending on the scale and nature of the release (intended use, type of LMO and nature of the modification, context of the receiving environment etc) in relation to identified monitoring needs. Therefore, how the guidance can be of service is to describe the basic needs of a well-designed monitoring plan that can be utilized under a broad scope of scenarios, that a CA may choose undertake, base on their own judgement of proportionality, not ours (if possible to determine at all). This point could be better clarified in the guidance.

While the notion of an evidence-based approach, raised by Louise Ball, certainly sounds scientific enough, the use of this term in relation to our guidance must be treated with caution (if I correctly understand what was meant here, apologies if I misunderstood). The monitoring approach cannot be categorically “evidence-based” or “not evidence-based”, but utilizes evidence of varying quality across a gradient. Determining the quality of evidence is a diffiicult undertaking for which there standard protocols for meta-analysis, etc are lacking to be useful as an approach to monitoring. However, if it was meant “evidence-based” in relation to designing future monitoring practice based on the “evidence” of past experience, it seems quite clear that current experience in monitoring, particularly with GS approaches is lacking, or has been too poorly implemented, to be a useful guide to the future of monitoring. But we should learn from it, clearly.

I very much appreciate sobering views that came from Louise Ball and echoed by  Hans Bergmans  on what is acheivable with monitoring. As mentioned, it is imperative to provide the user with a clear view on the practical challenges to meeting the desired outcome and objectives that may be obtained from monitoring – as this may be an important factor for decision-making and the consideration of risk management strategies. While the challenges were considered strongly enough in the text to warrant its own section, it may be better served to highlight these challenges where appropriate in the text.

Lastly, it should come as no surprise that this topic of who might bear the financial costs associated with monitoring (brought up further by Karen Hokanson) came up early in our discussions among the subworking group members. It was thought that it would be out of place if we did NOT address the topic, in some form. As with other areas of the guidance, there are diverging opinions on this topic and I am sure will be discussed in the future.

Once again, it has been very fruitful to hear these exchanges of viewpoints, along with the concrete suggestions from the members here; it will undoubtably lead to a more useful monitoring guidance document for our target audience.

Kind regards,

David

Dear All,

I am impressed with the level of interest this document has garnered among followers of the online forum.  I too wish to add my support to the suggestion that we need to start anew with this guidance.  The topic is undoubtedly a challenging one, but the valuable reviews posted by many experience scientists like Hans, Mark Benedict, Yoshikura-san, Louise Ball, and many others will be a good starting point to restart this process. 

Thanks to all,
Tom Nickson

There has certainly been a lot of useful and enlightening discussion on this document.  I would like to support the observations of Hans and others with regard to ensuring that monitoring activities are commensurate with potential risks. This will be a crucial consideration if countries are to successfully deploy products developed at home and abroad with the resources at hand, especially if the cost burden is shifted to developers.

If one the goals of this document is to provide guidance to developing economies that are looking for expert advice in the development of regulatory systems, then the guidance falls short if it does not stress the importance of hypothesis driven monitoring with testable links to causality.  This point can be developed with specific examples which can provide context and help illustrate the practical considerations.

There has been extensive discussion on case specific monitoring vs. general surveillance and I would support the points made by Mark Benedict and others that hypothesis free monitoring will lead to conclusion free results.  There have been excellent discussions in other fora about the perturbations in an ecosystem that are necessary to achieve an observable outcome and I don't think our goal is to encourage countries to embark on large scale natural history projects.

I would also agree that what can be achieved by monitoring is overstated here and that the challenges are understated, but more importantly the value of what can be determined with a risk assessment is minimized.

Finally, as has been stated by others, it is misleading to quote text from the Roadmap when this document is still under revision.

Dear All,

I agree with the points described by some participants, like Mark Benedict, Phil McDonald, Piet van der Meer and others, and those comments related to the necessity to keep the guidance attached to the concept of monitoring established in the Protocol. New concepts of RA and RM, even if they are “more contemporary” concepts developed after the Protocol, can’t be added to an international document without the agreement of the Parties and the monitoring guidance extrapolates concepts and obligations established in the Protocol.  

There is not a lot of experience of post-release monitoring, mainly with GS, in different countries, that can be used as a practical experience for the general surveillance and case specific monitoring proposed in the guidance, and maybe it will be more interesting to start with a more concise monitoring guidance and add complexity according to the experience that will be obtained. 

Some of the suggestions and comments reflecting this view are presented in the attached document, but a complete review of the guidance is necessary to have an applicable document.

Best regards.

Luciana P. Ambrozevicius
Ministry of Agriculture - Brasil

RECEIVED SHORTLY AFTER THE CLOSING OF THE DISCUSSION AND POSTED ON BEHALF OF GEORGINA CATACORA

----

Dear all,

As part of the main target audience of the guidance on Post-Release Monitoring and Long-Term Effects of LMOs (re: “countries who lack elaborated guidance and/or experience with monitoring”), we would like to mention that we highly appreciate this first draft, particularly the sections on Monitoring Plan, Reporting and Use of Monitoring Results, and Annex 3 (Reference Guide). The whole document and particularly the sections mentioned, contain useful information that in our view are consistent with the objective and scope of the Protocol.

We also appreciate the synthesis and analysis of comments made by David Quist. We strongly suggest improving the first draft of the guidance in light of these comments.

Some additional comments / suggestions from our side:

-       Monitoring is crucial to make operative the precautionary approach and evaluate the effectiveness of RA procedures. As mentioned by others, post-release and long-term effects monitoring will allow to assess unanticipated effects and most importantly prevent / minimize adverse effects on the conservation and sustainable use of biological diversity, taking also into account human health resulting from transfer, handling and use of LMO. In our view, this does not mean minimizing the value of the findings of RA. On the contrary, it implies a more responsible risk management. In addition, experience shows us that a significant amount of adverse effects taking place in the receiving environment of LMOs were not considered during the RA procedure. In our view, this is a compelling reason strengthening the monitoring procedures under the CPB.

-       We strongly support the inclusion of GS in the Monitoring Plan. We acknowledge the challenges that GS implies; however, it is also important to recognize its utility on observation and knowledge creation on potential adverse effects. Both have practical and direct relationship with the CPB. As stated by Ossama El-Kawi, under the Nagoya – Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety, re: “damage by definition should be measurable or otherwise OBSERVABLE taking into account, wherever available (…)”. In addition, GS is an unavoidable the exercise that countries facing illegal introductions require to go through in order to identify effects that require response measures. In this sense, GS in monitoring activities will also contribute to Parties to increase their capacities on managing illegal introductions.

-       We suggest that the guidance does not restrict itself to a specific audience. We believe that the principles and approaches included in it should provide a common ground on monitoring to all Parties to the CPB.

-       Finally, the guidance will be highly enriched if specific examples can be included for practical illustration purposes.

Many thanks to all who developed this first guidance draft and looking forward to its second version.

Georgina Catacora-Vargas,
on behalf of the Vice-Ministry of Environment
Plurinational State of Bolivia