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

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Opening of the discussion [#7560]
Dear AHTEG members,

It is a pleasure for to start another cycle of the AHTEG activities and open this discussion to evaluate proposed new places in the Guidance to link background/reference materials. 2016 will be a very busy year, as we will have to present the result of the work of the AHTEG & Online Forum at the COPMOP in December and hopefully provide the basis for major progress in the COPMOP decision on risk assessment and risk management. This round of online discussion this week is the first step in the course of many more steps to follow. I am confident that with all your efforts and expertise we will manage together to fulfill our tasks and I am looking forward to our continuing collaboration.

As you are aware, the external background materials are an important component of the Guidance on Risk Assessment of LMOs. During the testing of the Guidance, quite a number of comments asked for the background materials to be linked more specifically to the places, in the Guidance, where particular topics are mentioned. As a result, the Secretariat made proposals to re-structure the location of the background materials. In practice, the Secretariat made proposals to add background materials to each of the new text boxes that were and will be introduced into the Guidance, as well as to individual elements for consideration.

During the coming week, you are kindly invited to review the proposals for new places in the Guidance where background materials could be linked, as contained in the document prepared by the Secretariat to assist in this discussion and available at the discussion page (http://bch.cbd.int/onlineconferences/ahteg_ra.shtml). For ease of reference, the proposals for “new places” where the background materials would be linked have been highlighted in blue, whereas the “old places” where background materials are currently linked have been highlighted in green.

As noted by Manoela in her email of 11 January, the Secretariat’s proposals may result in editorial challenges related to formatting but, at this point, I would like to invite you to focus on what would be the best way to link the background materials to the Guidance by providing feedback on whether or not you support the Secretariat’s proposals and whether you have additional suggestions on how to improve the way in which background materials are linked to the Guidance.

I am looking forward to your feedback and to a lively debate on an important subject in the course of this week.

Best wishes
Helmut
(AHTEG Chair)
posted on 2016-01-17 23:16 UTC by Mr. Helmut Gaugitsch, Austria
This is a reply to 7560 RE: Opening of the discussion [#7561]
Dear Secretariat, dear Helmut, dear AHTEG colleagues,

Happy new year for all of you!

Reviewing the Secretariat proposals for new places in the Guidance where background documents/reference materials could be linked,  I see that except for the boxes: "Protection goals, assessment endpoints and measurement endpoints", "Information requirements in the case of field trials or experimental releases" and "Problem formulation"; the changes basically delete the webpage of references  (http://bch.cbd.int/onlineconferences/ra_guidance_references.shtml) cited at the end of each part or subtitle and it is proposed to pass references to an intermediate places related with each item in "Elements for consideration:".

In regard to assigning a specific reference to each item in "Elements for consideration:", I think that this time-consuming editorial task probably implies to re-read each reference assigned to those Parts of the Guidance and probably not all the items will have a specific reference. Therefore, I suggest leaving it as it is now and, in the future, the new references proposed to the Secretariat to be included in the background documents could be send with an indication of an specific place to be linked to. 

For the boxes mentioned below, I would like to suggest these following references, among others:
"Protection goals, assessment endpoints and measurement endpoints"
• Garcia-Alonso, M., & Raybould, A. (2014). Protection goals in environmental risk assessment: a practical approach. Transgenic research, 23(6), 945-956.
• Wolt et al. (2010). Problem formulation in the environmental risk assessment for genetically modified plants., Transgenic Research Volume 19, Issue 3, pp 425-436 (http://link.springer.com/article/10.1007/s11248-009-9321-9/fulltext.html)

"Information requirements in the case of field trials or experimental releases": 
• Garcia-Alonso et al. Transportability of confined field trial data for environmental risk assessment of genetically engineered plants: a conceptual framework. (2014) Transgenic Research, Volume 23, Issue 6, pp 1025-1041
• ROBERTS, Andrew, et al. Environmental risk assessment of GE plants under low-exposure conditions. Transgenic research, 2014, vol. 23, no 6, p. 971-983.

"Problem formulation":
• Wolt et al. (2010). Problem formulation in the environmental risk assessment for genetically modified plants., Transgenic Research Volume 19, Issue 3, pp 425-436 (http://link.springer.com/article/10.1007/s11248-009-9321-9/fulltext.html)

Thanks for the opportunity to comment in this round of discussion.
Best regards,
Patricia Gadaleta
posted on 2016-01-21 19:34 UTC by Dr. Patricia Gadaleta, Argentina
This is a reply to 7561 RE: Opening of the discussion [#7563]
Dear colleagues,

I would like to thank Patricia for "breaking the ice" and posting a reflection from her side on the current topic of our AHTEG online discussion, that is how to re-structure the links to the background materials in the Guidance. That is very much appreciated!

I would like to invite other colleagues to provide your feedback as well in the remaining few days. Let me remind you that this dicussion will close soon, on 25 Janaury at 1:00 am GMT, which in fact means for most of us that the latest time to post comments is already on Sunday, 24 January.

Please let me also remind you that any suggestions for new background materials linked to the Guidance are separate from this discussion and should be provided via the Management Centre of the BCH and thereby trigger the regular review process by the AHTEG. The Secretariat will be pleased to assist if needed.

I am looking forward to the subsequent discussion and wish you a very nice weekend.

Best wishes

Helmut
posted on 2016-01-22 13:00 UTC by Mr. Helmut Gaugitsch, Austria
This is a reply to 7560 RE: Opening of the discussion [#7564]
Dear Colleagues,

Thank you to the Secretariat for the good proposals in the placement of reference background documents which is a task given to AHTEG by state parties.

I agree with the proposal to have these documents referenced at the Elements for consideration. However, I suggest that this referencing be done at the end of all Elements for Consideration as opposed to 'after each element for consideration'. It is possible that more than 1 element have the same background document and it would look too overcrowded if referencing is done on each. The reference document can be numbered in the text and the link or actual reference provided at the end of topic.

I also propose new areas of reference as follows; Lines 1893, 1926, 1929, 1979, 2011/2018

Rgds

Josphat
posted on 2016-01-22 14:34 UTC by Josphat Muchiri, Kenya
This is a reply to 7561 RE: Opening of the discussion [#7565]
Dear Helmut, dear all,

A little late but still,  a happy new year to everyone.

I have had the chance to review the documents with the blue and green highlights  where  the reference material could be included. In my humble opinion,  I don´t see that it would make much difference to inexperienced regulators learning about risk assessment from the guidance, where the extra reference material is found, as long as it is clearly highlighted.

The issue that  I see that would have a lot of impact,  is the type and quality of information that  we, as specialists,  decide to include in the document to guide the new regulators/developers  in doing a sound and objective environmental  risk assessment of the technology.

With this in mind I strongly support the articles presented by Dr. Patricia Gadaleta, especially the paper by Wolt, Keese, et al. on Problem Formulation.

Here are the r articles that Patricia suggested that I also found very useful:

"Protection goals, assessment endpoints and measurement endpoints"
• Garcia-Alonso, M., & Raybould, A. (2014). Protection goals in environmental risk assessment: a practical approach. Transgenic research, 23(6), 945-956.
• Wolt et al. (2010). Problem formulation in the environmental risk assessment for genetically modified plants., Transgenic Research Volume 19, Issue 3, pp 425-436 (http://link.springer.com/article/10.1007/s11248-009-9321-9/fulltext.html)

"Information requirements in the case of field trials or experimental releases": 
• Garcia-Alonso et al. Transportability of confined field trial data for environmental risk assessment of genetically engineered plants: a conceptual framework. (2014) Transgenic Research, Volume 23, Issue 6, pp 1025-1041
• ROBERTS, Andrew, et al. Environmental risk assessment of GE plants under low-exposure conditions. Transgenic research, 2014, vol. 23, no 6, p. 971-983.


Best regards to all,

Maria Mercedes
posted on 2016-01-22 21:08 UTC by Dr. Maria Mercedes Roca, CIBIOGEM, Mexico
This is a reply to 7560 RE: Opening of the discussion [#7566]
Dear Helmut, Secretariat and my colleagues

A happy and productive new year to all!

I apologise in advance if I have misunderstood our assignment in any way as a result of being unable to attend the meeting in Brasilia.

Am I correct to assume that the mechanism for linking particular background documents involves submitters indicating where they think the document is relevant and then, following acceptance of the document by the Chair, an automatic update occurs in the Guidance to include this reference? And as such, we are being asked to comment on where these updates occur and to the scale of detail?

As those before me have posted, I too think that the precise location of the citations is of less importance than consistency of placement. I agree with Josphat that because a reference may apply to more than one Element, it would be simpler and clearer to list relevant documents at the end. However, where a reference does only apply to some Elements, it may not be clear to which ones, as I think Patricia is saying.

Perhaps a way to proceed is to simply ask submitters to indicate which Elements within the topic area they believe are most relevant, and for the generated list to indicate those choices. But I suspect that would place a great deal of responsibility on either the submitter or the Chair. However, it would also serve to alert us to the need for additional background documents if there are Elements for which we have not identified a background document.

I see value in having a great resource of background documents available to the readership of the Guidance. Provided that the material meets the “Criteria for the quality of scientific information”, its inclusion should not be a significant distraction from the regular AHTEG work.

While some are suggesting additional reference for the Guidance and this is welcome, am I correct in assuming that the process of nominating additional material or new linkages is on going and that there is no particular urgency for such nominations now? Or are we being asked specifically to do this now?

I look forward to reading what others think. I also want to take this opportunity to thank the Secretariat for generating the calendar of events which should be of great value in planning the year.

With best wishes
Jack
posted on 2016-01-23 21:50 UTC by Mr. Jack Heinemann, University of Canterbury
This is a reply to 7560 RE: Opening of the discussion [#7567]
Dear Helmut, Dear all

I think that the background documents/reference materials should be placed at the end of each section and each box. In the case where the material is only relevant to only one specific point and not any others points in a given section. it could be linked to that point only. and I believe this needs to be clarified somewhere in our document that that reference materials at the end of the section are relevant to several points in that section while those added in other places in the text are only relevant to that specific place.

We can ease the process by asking the one filling the online form to indicate if it is better linked to a step or to a given line/ place and to indicate that place.

On the proposal of adding some new references I agree with Jack and would suggest that we just do that online to go through the established process for doing that.

On another issue, I think we had the discussion that we need to put some more history in the document. Para starting line 126.. it talks about the AHTEG but actually there have been more than one AHTEG working on that document and it does not reflect the amount of work that has been done and the number of testing and discussions conducted.


O.A.El-Kawy
(edited on 2016-01-24 09:34 UTC by Ossama AbdelKawy)
posted on 2016-01-24 07:31 UTC by Mr. Ossama AbdelKawy, Mauritania
This is a reply to 7567 RE: Opening of the discussion [#7568]
Dear colleagues,

thanks to those who have provided input over the last couple of days, I am glad that the discussion has started off to some extent.

As the question has been raised I just wanted to clarify what I have tried to explain in my previous posting: Any suggestions for new background materials linked to the Guidance are NOT part of this discussion and should be provided online via the regular way: that is via the Management Centre of the BCH. Such a notification by any BCH user then triggers the regular review process by the AHTEG, resulting in a decision by the Chair. The Secretariat will be pleased to assist if needed.

It is correct that such future notifications should indicate the place(s) in the Guidance where the Background material fits. In this way, the result of our discussions this week will have implications on this notification process in the future.

I kindly invite you to use the remaining hours to provide further input on the topic of this discussion, that is comments to the reflections of the Secretariat where links to the Background document could be placed in the Guidance.

Thank you and best wishes
Helmut
posted on 2016-01-24 12:10 UTC by Mr. Helmut Gaugitsch, Austria
This is a reply to 7568 RE: Opening of the discussion [#7569]
Dear All,

Happy New Year!

As the Chair has suggested, for this round of discussion I will not refer to the quality of background documents. In my view the new location of the cites for the reference documents, proposed by the Secretariat, looks very much relevant and easy to follow in the context of the sections and boxes. I am of the opinion to accept the new locations of the cites.

The content of background documents we may discuss in one of the next round of on-line session.

Regards,
Angela
posted on 2016-01-24 17:54 UTC by Angela Lozan
This is a reply to 7569 RE: Opening of the discussion [#7570]
Hello everyone.

I agree that the placement of the references at the end of the sections and the boxes is appropriate. 

However, it might still be necessary to list the references by number in a 'reference' section, as Josphat suggested, and then indicate the numbers of the reference at the end of the section or box.

In this way it will also be possible to indicate by number when a reference is relevant to a specific point within the section or the box, and when one reference should be included in multiple sections or boxes.

Also, as Jack suggested, those submitting references can indicate where (which section or box) a reference should be included, and if a document is relevant to a specific point. 

If this is possible, it might be the best way to ensure the references are used by the reader as intended by the submitter.

Hope this is helpful.
Thanks for the opportunity to comment.
Karen
posted on 2016-01-24 18:40 UTC by Ms. Karen Hokanson, University of Minnesota
This is a reply to 7570 RE: Opening of the discussion [#7571]
Dear colleagues,

Let me start by wishing you all the best for the year 2016. We have an interesting and intensive year ahead of us before the COP-MOP in December. I am very happy to work with you all!

Thanks again to the Secretariat and Helmut for clear guidance on our present task.

And thank you Josphat, Ossama, Karen and others for good and clear suggestions on how to proceed with this task. There was a clear message from the testing that the reference materials should be linked more specifically to the places in the Guidance, where particular topics are mentioned.

I am very content with the suggestions made by the Secretariat. I see no problems in referring to the background/reference materials within the boxes. But I see the problem pointed out by e.g. Josphat when we now think of adding reference material after each specific element. However, we should do this to the extent possible.

One possibility would thus be to have specific references when they exist (put a reference after just the element to which it is valid for) and have those references at the end of the list of elements in the case where a particular reference is valid for several elements. With these references that are valid for several elements, we could point out the elements that they are valid for.

I leave the practicalities (whether we number the references or give them other identifications) to the Secretariat/for later.

I hope this is helpful and talk to you soon again.

Marja RL
posted on 2016-01-24 20:18 UTC by Marja Ruohonen-Lehto