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AHTEG on Risk Assessment and Risk Management: 2014-2016 Intersessional Period

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Opening of the discusssion on "Taking stock of the progress and challenges encountered by the AHTEG Sub-group" [#7411]
Dear AHTEG members,

Following the email sent by the Secretariat on 7 July, it is a pleasure for me to open another round of discussion of the AHTEG on “Taking stock of the progress and challenges encountered by the AHTEG Sub-group”.

Let me please start by thanking the five members of the AHTEG Sub-group (Abisai, Angela, Francisca, Marja and Wei) for the hard work over the past few months to consider the many comments that were provided through the testing of the Guidance.

I would also like to thank the Secretariat for preparing a summary of the work of the Sub-group and two background documents to facilitate this discussion.

As noted in the summary prepared by the Secretariat, the first background document contains proposals by the Sub-group of possible ways forward to address the more general issues identified in the testing of the Guidance. The second background document for our discussion contains a large table where the specific suggestions for substantive changes, which were provided through the testing of the Guidance, were prioritized and justified by members of the Sub-group.

The objective of the current discussion is to give the AHTEG an opportunity to take stock and provide feedback on the progress of work by the Sub-group and recommend adjustments, as appropriate.

In doing so, I would like to invite each and every member of the AHTEG to refer to the background documents and consider the following when preparing your interventions:

- Please provide your general feedback on the progress of the work of the Sub-group of the AHTEG.

- Do you have any comments and suggestions for the next steps to take?

Moreover, although the objective of this discussion is to provide general feedback, you are also welcome to share your views on any of the specific suggestions made by the Sub-group (please refer to the two background documents).

I am looking forward to our online discussion over the coming week which will be an important step towards progress in our overall task to having an improved version of the Guidance on Risk Assessment of LMOs by COPMOP-8. I would like to thank you already now for your work and look forward to your comments.

Best wishes,
Helmut
(edited on 2015-07-13 11:04 UTC by Manoela Miranda)
posted on 2015-07-11 01:36 UTC by Mr. Helmut Gaugitsch, Austria
RE: Opening of the discusssion on "Taking stock of the progress and challenges encountered by the AHTEG Sub-group" [#7412]
Dear AHTEG members,

Following the message by the Chair, this is a reminder that the system does not allow documents to be attached to the automatic email messages that you receive when a message is posted in the online discussion.

To access the background documents while reading this message in an email, please click on the link "See this post in the online forum" at the bottom of the message. Alternatively, you also access the documents from the discussion page (http://bch.cbd.int/onlineconferences/ahteg_ra.shtml).

The background documents include:

- Note by the Secretariat summarizing the work of the AHTEG Sub-group;
- Possible ways forward identified by the AHTEG Sub-group to address challenges identified during the testing of the Guidance;
- Streamlining by the AHTEG Sub-group of the suggestions for changes provided during the testing;   

Please do not hesitate in contacting the Secretariat if you encounter any technical difficulties.

Thank you and we look forward to reading your contributions to this discussion.

Best regards,
Manoela
posted on 2015-07-13 11:04 UTC by Ms. Manoela Miranda, UNEP/SCBD
RE: Opening of the discusssion on "Taking stock of the progress and challenges encountered by the AHTEG Sub-group" [#7413]
Dear AHTEG members,

I would like to gently remind you that our current online discussion on "taking stock of the progress and challenges encountered by the AHTEG sub-Group" will close in a couple of days, coming Saturday, 18 July at 1:00 am GMT. Please observe that this time there is only a one-week time-period for the online discussion.

So far we have not seen any posting after my opening message and the clarification by the Secretariat. I fully understand that there is quite some material to be studied by you before any feedback and that is why I am confident that many of you will respond very soon.

I would just like to re-iterate that at this stage, you are primarily invited to provide a general feedback, if the work of the sub-Group is going in the right direction or if you have any general recommendations for the way forward.

It would of course be very important to have some feedback at this stage from the entire AHTEG as a group. Therefore I am very much looking forward to your postings in the comign days.

Thank you and best wishes

Helmut
AHTEG Chair
posted on 2015-07-15 06:50 UTC by Mr. Helmut Gaugitsch, Austria
RE: Opening of the discusssion on "Taking stock of the progress and challenges encountered by the AHTEG Sub-group" [#7414]
Dear colleagues, Helmut and people of the Secretariat
I can realize reading the documents that there is a huge and good work done. So first of all, I would like to thanks to Angela, Francisca, Marja, Abisai and Wei for their efforts to complete this work in a tiny time, and also, I especially acknowledge the great intellectual work done in analyzing deeply all the comments from the testing. Of course, I would also like to thank the Secretariat for preparing these documents.
Regarding the document ¨Possible Ways Forward to Address Challenges Identified in the Testing of the Guidance on Risk Assessment of Living Modified Organisms¨ my general comment is that I agree with almost all of the statements of the possible way forward of each subcategory presented in on this document. But I would like to stress that this document is an unavoidable confirmation that the Guidance needs to be improved. And it is evident that there is a lot of work to do to complete the tasks of editing, incorporating examples, and developing more widely some concepts like, for example, problem formulation methodology.
My opinion about the Excel document about the level of priority of the comment, once again, is that I can see that there is a lot of analysis work of on it, buy I think that if any of the comments was misunderstood or wrongly classified on its level priority, this should be noted more easily by the person who made the comment in the first place. So, I wonder if these documents would be shared soon in an Open Online Forum. If so, I think that this will be a good first opportunity to verify the outcomes of the testing and reach to an agreement of how to go forward in the improvement of the Guidance.

Best regards,
Patricia
posted on 2015-07-15 18:46 UTC by Dr. Patricia Gadaleta, Argentina
RE: Opening of the discusssion on "Taking stock of the progress and challenges encountered by the AHTEG Sub-group" [#7415]
Dear all,
Many thanks to the Sub-group members (Angela, Francisca, Marja, Abisai and Wei) for the laborious work taking in account the different comments, to the Secretariat for summarizing and Helmut for coordinating this forum. The challenges identified in the document summarize very well issues and specific points. The sub-categories describe the main concerns.
My own concern is that we are probably repeating things that have been said many times, and there are many needs in the biosafety academic community (or related)…..
We have to pay much more attention to one of the sub-categories –which I think might summarize or address several of the other issues—the experience with LMO and conventional practices.
My personal feeling is that we have to capitalize the knowledge that has been acquired by those countries that have been developing their own Biosafety procedures and regulations for many years, applying several RA protocols and are using GMOs, mainly the experience with GM crops. In all the cases biosafety assessment is based in a comparative analysis, the nature of the modification, and the available “know-how” is very useful to help others. This knowledge and “familiarity” will help to ask the relevant questions and formulate the problem in a sensible way. 

Specific topics which I consider priority:
• The importance of the casual link and how difficult is to establish causality between specific impacts and the LMO.
• The need of absolute precision for the definition of protection goals and measurement endpoints, which cannot be described in a guide, they must be defined by each country according to their own circumstances, conditions and needs.
• I agree, it is very important to make clear that the Guidance is just that: a guide, it is not a method on how to perform RA, each country has the responsibility to establish their own methodology

Abrazos,

Elizabeth
posted on 2015-07-16 02:02 UTC by Professor Elizabeth Hodson, Colombia
RE: Opening of the discusssion on "Taking stock of the progress and challenges encountered by the AHTEG Sub-group" [#7416]
Dear colleagues,
I wish to thank the Secretariat for the summary of work and I would like to say many thanks to the Sub-group members (Angela, Francisca, Marja, Abisai and Wei) for their impressive work on the proposals. I join to the previous posts in my way forward – the job is well done. The members of the Sub-group captured the general issues, which is presented in the first background document. As well as they made very good proposals for the one part of these issues in the column «Possible ways forward». They also pointed and tried forwarding on the possible ways for the other part of issues which at the same time on my opinion need to be further discussed during the AHTEG group.
One comment to the «Possible Way Forward in the Sub-category: Experience with LMO & conventional practices». I propose to add to the list of the proposals in the Column «Possible way Forward» and inclusion as the background materials Consensus Documents on Biology of different Crops. These documents are available on the Internet and usually provide valuable information for the Risk Assessment: ex.gr. descriptions with links to the scientific papers regarding the biology of non-LMO crops, agronomic practices, Сentres of origin/diversity, reproductive biology, weeding potential, inter-species and genus crossess, introgression into relatives (sometimes data on LMO potential for introgression are available, including experimental data), interactions with other organisms, etc.
And I am also supporting the proposal in the Sub-category: «Other issues to consider» to add specific references throughout the text of the Guidance in addition to the general background documents for better understanding of the text.
With my best wishes, Galina.
posted on 2015-07-16 10:47 UTC by Dr. Galina Mozgova, Belarus
RE: Opening of the discusssion on "Taking stock of the progress and challenges encountered by the AHTEG Sub-group" [#7417]
Dear Secretariat, Helmet and AHTEG members,

Firstly, I would like to thank the Secretariat and the AHTEG sub-Group for preparing a list of possible ways forward in addressing each of the identified general issues, and for prioritising the specific suggestions for changes provided through the testing of the Guidance (i.e. Low, Medium and High priority).
Considering the AHTEG Sub-group has provided us with the following three documents: 1) Summary of the work of the AHTEG Sub-group; 2) Background document 1; and 3) Background document 2, I have organised my comments below under the applicable document title.

1) Summary of the work of the AHTEG Sub-group:
I would add that risk assessors can also draw on knowledge and experience gained from commercially cultivated / already released LMOs when choosing a comparator and/or when conducting the risk assessment. This is particularly relevant for risk assessment of new LMO maize, cotton, and soybean crop varieties as these LMOs have been grown in the environment for decades.
2a) Background document 1 / Sub-category: Scope:
1. Alternatively, might “Problems arising from spillage during handling and transport” be better discussed in the ‘Conducting the Risk Assessment’ section of the Guidance as some risk assessors may choose to consider when assessing controlled LMO releases.
2. Focused clarification on “the relationship between the outcome of the risk assessment and monitoring (monitor only if uncertainty in RA)” and elaborating “on problem formulation with a view to assist in developing a more focused monitoring plan” might best be provided in the ‘Conducting the Risk Assessment’ section of the Guidance as this may reduce repetitive text.
2b) Background document 1 / Sub-category: Relevancy of points to consider:
If the risk assessor is to choose which demonstrated/reasoned ‘points to consider’ are applicable for their RA (or will serve as references for their RA), then, like comments #405-406 in Background document 2, I suggest the language be rephrased to ‘points that may be considered as appropriate’ – or a phrase to that effect. Further, I suggest taking note of comments made by #198, #322 and #326 in Background document 2 when describing reasons for each point (i.e. why and how mechanism of potential adverse effect).
Further, submitters’ concerns regarding the suggestion to assign 100% likelihood to adverse effects when there is a high level of uncertainty in assessing likelihood (see #179-180 and #224-225, Background document 2) need to be elevated to ‘High’ priority. Franco Teves expressed a similar concern in the Online Forum (https://bch.cbd.int/onlineconferences/onlineconferences/forum_ra/discussion.shtml?threadid=6758), and stated efforts should be focussed on adequately identifying and characterizing the hazard/cause of hazard when there is a high level of uncertainty (post #6932). Colin McGowan also cautioned the Online Forum of the dangers of slipping into a ‘pseudo-quantitative’ analysis when mixing terms such as 100% and likelihood, or when attempting to describe the rankings for likelihood, and the associated ranking for uncertainty (post #7175). In the New Zealand context, the decision-maker shall take into account the need for caution in managing adverse effects where there is scientific and technical uncertainty about those effects. In practice, the decision-maker can request additional information and/or impose controls that will manage uncertainty, and compliance with those specific controls will be monitored (as opposed to general monitoring).
2c) Background document 1 / Sub-category: Language:
Also check for contradictory/inconsistent text within the Guidance. The AHTEG sub-Group has assigned a Medium-High priority to such concerns in Background document 2 (including #61, #194, #262, #179).
2d) Background document 1 / Sub-category: Human health:
While the Protocol includes text “taking also into account risks to human health”, it is advisable to approach related analysis with caution, given that studies conducted on the links between LMOs and human-health related issues have not conclusively established causality.
2e) Background document 1 / Sub-category: Other issues:
In my view, statements about benefit assessment being outside the scope of the Guidance, and the Guidance not meant as a RA methodology, are best placed in the ‘Scope’ sub-category.

Many thanks for this opportunity to comment, Stacy.
posted on 2015-07-16 21:20 UTC by Stacy Scott
RE: Opening of the discusssion on "Taking stock of the progress and challenges encountered by the AHTEG Sub-group" [#7418]
Dear all,
As an additional source of information (and help) in Biosafety general concepts we could suggest the use of the “FAO’s Biosafety Resource Book. Anyone can access the book in the link:
http://www.fao.org/docrep/014/i1905e/i1905e.pdf 
It is not a step by step guide, rather is a compilation of basic concepts needed for RA and related biosafety issues.
Kind regards,
Elizabeth
posted on 2015-07-16 21:49 UTC by Professor Elizabeth Hodson, Colombia
RE: Opening of the discusssion on "Taking stock of the progress and challenges encountered by the AHTEG Sub-group" [#7421]
Please let me thank the members of the subgroup and the Secretariat for their excellent work, and to Helmut for chairing the discussion.

With regards to “provide feedback on the progress of work by the Sub-group and recommend adjustments, as appropriate”, I consider that the Sub-group is doing an excellent job and I see no need for adjustments.

With regards to the offer to “share your views on any of the specific suggestions made by the Sub-group”:

(1) For subcategory Audience, the second of the three options makes the most sense, while the first is not realistic in my view.

(2) With regards to Sub-category: Other issues “[LM mosquito section] Need to discuss the aspects of epidemiology in the risk assessment”.  As an epidemiologist and someone who was the Senior Epidemiologist in my State government investigating outbreaks of disease in the State, many of which were mosquito-borne, I am happy to offer my assistance to the Sub-group for this section if they need it.

With regard to suggestions that other members of the AHTEG have made, I disagree with Stacy Scott’s view [#7417] that a comparator for an LM crop could be another LM crop, on the basis that (1) some LM crop varieties have only been grown for a short time and (2) there are many different LM varieties of some crops, so what criteria would you use to determine which one to pick as a comparator?   

It also appears that Stacy may be arguing that we should not consider human health unless causality has been conclusively established.  Yet humans are part of the environment and as such, human health needs to be a part of the risk assessment process.  Furthermore, speaking as an epidemiologist, the only real way of obtaining conclusive evidence for causality for a particular LMO and a health concern in humans, is via one of two ways: (1) before the LMO is released into the environment by conducting a randomised controlled trial (ie a clinical trial) where the LMO and a comparator crop are fed to human volunteers and any adverse effects are recorded, or (2) waiting until after a risk assessment has been conducted and the LMO has been released into the environment so that people are now exposed to it, and then comparing the health of a group of people who are exposed, to that of another group that are not exposed to the LMO via a case-control or cohort study design. Therefore, if Stacy wants conclusive proof that the LMO is (or is not) causing a health problem at the risk assessment (pre-environmental release) stage, she is essentially calling for clinical trials to be conducted on the LMO before it is released into the environment so that any evidence of any causal link can be assessed as part of the risk assessment process. 

I support Ossama’s call [#7420] for human health to be integrated into the environmental risk assessment.

Best wishes to everyone

Judy Carman
posted on 2015-07-17 14:51 UTC by Dr Judy Carman, Institute of Health and Environmental Research
RE: Opening of the discusssion on "Taking stock of the progress and challenges encountered by the AHTEG Sub-group" [#7419]
POSTED ON BEHALF OF JANNE ØVREBØ BOHNHORST

-----

Dear all,

Thanks to the Sub-group members for identifying the most important comments and for suggesting how to move forward to improve the guidance based on the comments, and of course thanks to the Secretariat and the Chair. 

Here is my short response to the progress made.

My impression is that the Sub-group have made a good selection/extraction and presentation of the comments. This is an important step and I think the Sub-group have managed to identify and suggest reasonable solutions to several of the comments that will be quite possible to include and take into account without too much change of the guidance text. For example the suggestions to clarify what is the intention, audience etc, of the guidance and referring to other sources instead of including a lot of new text in the guidance document.

In addition, I support the suggested discussion within the AHTEG for some of the more challenging issues. 

To me it is a bit unclear how good examples could best be achieved and included in the document.

I am looking forward to the next step and discussions.

Regards from Janne (on vacation at Curacao :) )
posted on 2015-07-17 14:18 UTC by Ms. Manoela Miranda, UNEP/SCBD
RE: Opening of the discusssion on "Taking stock of the progress and challenges encountered by the AHTEG Sub-group" [#7420]
POSTED ON BEHALF OF OSSAMA ABDELKAWY

-----

Dear Helmut, dear all

I would like to echo with others and thank the members of the subworking group and the secretariat for the effort they made to produce the background documents we have now.

I have some points to raise with regards to the way forward.

- I believe that a one week discussion forum asking to check on progress of a process and to have a look on several documents produced is a little bit unpractical for some participants especially those who travel a lot. I would advise that any upcoming  discussion forum should be at least two weeks.

- Bearing in mind the current discussion of the AHTEG and the previous one and recalling the fact that some of the documents produced could have benefit from further explanation. I think we sometimes need more active discussion that cannot be appropriately achieved through a discussion forum. I think a real online conference may be needed.

- Additional note with regards to the issue of human health. A Guidance on integrating human health into the environmental risk assessment is crucial. The previous AHTEGs on risk assessment were reluctant to actively include the issue of human health waiting to see the result of the discussion under socioeconomic considerations in order not do duplicate work. Now that it is clear from those discussions that human health should be brought on board under environmental risk assessment, I believe that it is our responsibility to do that and we should not postpone it further.

Regards,
Ossama
posted on 2015-07-17 14:25 UTC by Ms. Manoela Miranda, UNEP/SCBD