Dear AHTEG Members,

Further to Helmut's message, please use this thread to provide comments on the draft concept note. This commenting period ends on Thursday, 16 May at 6:00 a.m. GMT.

Thank you and best regards,
Manoela

POSTED ON BEHALF OF PATRICIA GADALETA
-----------------------------------------------------------

Dear AHTEG members, Chair and the Secretariat.

As new member of the AHTEG, it is a great honor and a pleasure to be participating in this forum.

In reviewing the Concept Note I would like to to make some suggestions for your consideration.

The point (a) in the section ¨Testing process¨ says ¨The objective of the testing is to evaluate the practicality, usefulness and utility of the Guidance on Risk Assessment of Living Modified Organisms with respect to consistency with the Cartagena Protocol on Biosafety…¨
I would like to suggest deleting the word utility if it was removed from the questionnaire and include consistency with the Cartagena Protocol on Biosafety as third goal. So the sentence could be more simple ¨The objective of the testing is to evaluate the practicality, usefulness and consistency of the Guidance on Risk Assessment of Living Modified Organisms¨

The point  (c) in the same section says ¨The testing may be conducted by individuals or as a group initiative (e.g. workshops)¨
This option is not reflected in the questionnaire.  I suggest including a question in each section about if the test was done by individuals or by a group of initiative and a text entry section to indicate the type of event or workshop and where the testing of the Guidance was conducted.

I follow thinking about the others points and I look forward to seeing how this discussion evolves with enthusiasm

Kind regards,

Patricia Gadaleta
Biotechnology Directorate
Ministry of Agriculture, Livestock and Fisheries
Argentina

Dear colleagues,

I am very pleased that our discussion has started off. Thank you very much to Patricia and Nobuyuki that you have shared your first thoughts with us. I would like to invite other colleagues to come in with your thoughts and reactions as well.

Before we will move to the draft questionnaire in a few hours we still have some time to focus on the concept note first. Of course there will still be an opportunity to comment on the concept note after Tuesday next week as well.

In response to Nobuyuki`s question on the instructions I would like to share the following observations with you: The issues of the concept note and the questionnaire are interlinked. The instructions in the heading of the questionnaire still need to be developed. In my understanding they should be very similar to the text in the concept note but with a little more detail. Therefore I think that it is important to get a common view among the AHTEG members on the big picture before the more detailed instructions can be developed. I agree with Nobuyuki that we should have a transparent process for that purpose as well and I will make a suggestion in due course.

I look forward to more comments on the concept note. Thank you and best wishes

Helmut

Dear Helmut and Secretariat:
Thank you for inviting to participate of this process.
Congratulations Helmut!
I have re read the concept note and would like to include the following opinion:

1.- Full dossiers are  the best option for testing the roadmap, I understand not all who could/might participate can have a hold of these, so those that for some reason cannot should use what is available to them. In either case, what is extremely important is that the sources used for testing are clearly identified when answering the questionnaire.
2.- I still disagree with the fact that a link in the BCH to the sources used be a "must", this might not always be an option (mainly because of timing in the regulatory processess).....a "must" should be making reference and a link (when possible) of all the sources used.
3.- I also disagree with the fact that only one questionnaire be submitted by Party/Non Party/Other Organization...........this in practical terms will imply a bottleneck to the exercise in itself and the reporting of the outcomes. I really think leaving it more open will be much for fruitfull and faithfull to what different actors in the Party/Non Party/Other Organization setting might do through the testing process, find out and report. Leaving it more open will also imply that your N is bigger and therefore more robust.

Kind regards.......y un abrazo desde México.
Francisca

Dear Helmut, dear AHTEG colleagues,

As a new member of AHTEG I would like to say that I am very much honored that I have been given the opportunity to work with such distinguished experts in the field. I would also like to thank Secretariat for my nomination.

Regarding the Concept note, I think in the point e)

“The technical and scientific data of actual cases of risk assessment used in the testing may originate from various sources, including application dossiers, summaries of notifications, as well as previous and ongoing risk assessment processes;”

should be added; “which should be evaluated by using systematic review process.” Or at least “critical review process.”

This review approach is developing methodology in the field of GMO evaluation and in my view could alleviate possible problems in communicating results of risk assessment to the general public.

Best wishes,

Hrvoje

Dear Helmut, members of the Executive Secretariat and AHTEG colleagues,

I appreciate this opportunity to work with you on this important topic.

Concerning our first item, the Concept Note, I have some suggestions that I have made in track change mode in the uploaded file. In making these suggestions, the need for the note to help structure and focus the testing was top-of-mind.  As such, some text was deleted because it wasn't directly relevant to testing.  In addition, some text from BS-VI/12 was added because it was relevant to the mandate and is helpful to potential testers.  Some other changes are suggested to reorder sentences for greater clarity.  Finally, I deleted the reference in paragraph "g" to "or through an independent or non-regulatory process".  First, I cannot recall that this was generally accepted in our online.  (If it was even mentioned, I cannot recall.)  Importantly, this opens testing well beyond what one would see as an actual case of risk assessment.  There are many critiques of risk assessment decisions that might get improperly used in this testing if this language is retained. 

Finally, I think that somehow we need to reinforce the fact that the technical and scientific information that testers will use in the testing is not the subject of the evaluation.  Information used by a tester must be selected on the basis that it is compliant with the Protocol and will be useful as a benchmark for testing the guidance in its completeness. 

Thanks to all.

Tom

I first wish to say that I am honoured to have been invited into the AHTEC and that I am delighted to accept and be part of these very interesting and important discussions.  I further wish to thank Helmut for moderating the discussion.

I wish to discuss the post by Patricia Gadaleta [#5222].  She writes: “The point (a) in the section ¨Testing process¨ says ¨The objective of the testing is to evaluate the practicality, usefulness and utility of the Guidance on Risk Assessment of Living Modified Organisms with respect to consistency with the Cartagena Protocol on Biosafety…¨
I would like to suggest deleting the word utility if it was removed from the questionnaire and include consistency with the Cartagena Protocol on Biosafety as third goal. So the sentence could be more simple ¨The objective of the testing is to evaluate the practicality, usefulness and consistency of the Guidance on Risk Assessment of Living Modified Organisms¨”

I agree with her that if the word “utility” is removed from the questionnaire, it should also be removed from the concept note. 

I am however, concerned at this suggested change to the concept note: “The objective of the testing is to evaluate the practicality, usefulness and consistency of the Guidance on Risk Assessment of Living Modified Organisms”. The draft concept note given to us a few days ago talks about consistency between the Guidance and the Cartagena Protocol.  The suggested changes imply that one is instead now looking at the internal consistency of the Guidance.  I would therefore suggest that the sentence read: “The objective of the testing is to evaluate the practicality and usefulness of the Guidance on Risk Assessment of Living Modified Organisms and how consistent the Guidance is to the Cartagena Protocol on Biosafety, in particular Article 15 and Annex III, and taking into account past and present experiences with living modified organisms”.

Kind regards to all

Judy Carman

In reply to Hrvoje [#5230] from Croatia

Could I please ask Hrvoje [#5230] for more information as to what he means by: “"which should be evaluated by using systematic review process." Or at least "critical review process."”?  The reason I ask is that these terms can have vastly different meanings to people who work in different fields.  In epidemiology, for example, a systematic review generally means a statistical meta-analysis of randomised controlled trials (eg clinical trials where people have been randomised into generally two groups – one group gets a treatment while the other is the control).  While I'm not suggesting that you mean that sort of review, this example does show how such words could be so widely and variously interpreted.

Unfortunately, at this late stage, there is not enough time to discuss each of the many changes that Thomas Nickson has suggested to the concept note [#5231].  I just wish to express my concern at how his suggested changes appear to change the meaning and focus of the concept note and how much more restrictive and prescriptive the concept note now appears.

Thanks, Tom for the hard work. Regarding of the inserted sentences in reporting part, I still have problem to understand the difference between 'usefulness' and 'utility'. I fail to find two different words in Chinese for them. I looked into the dictionary and found 'utility' explained by 'uesefulness':'The quality or condition of being useful; usefulness'.

I am not a native English speaker and really confused by the change of 'a single point of contact with the Secretariat', will each organization have a single point of contact, or many organizations have only one single contact point?

In reporting stage, it is very important keep science in it. The report /and results should be reviewed by scientists. I did not agaist to use 'experts', but the word should be clearly defined. Experts should be persons with scientific training and has reputation in his area  and preferentially with good publications in peer-review journals.

In addition, I do not really think that experience is not science. Experience is something got from works but it is subjective and not necessarily scientific sound. If the secretariat is going to add the condition 'taking into account past, and present experiences with living modified organisms', I propose to read as 'taking into account past, and present scientific evidences with living modified organisms' or something similar.

Best wishes

Wei

Dear Helmut, Secretariat and members of the AHTEG and Forum

I am also very pleased to be working within this group and I am looking forward to this phase of developing concrete text for the Concept Note and Questionnaire.

My thanks to the Chair and the Secretariat for the work they have done to develop a useful and clear Concept Note.

My first comment is to agree with Judy [#5232] that the text from point (a) under the testing process should be consistent with the questionnaire. I would prefer that it remained consistent with decision BS-VI/12 and not be rephrased as: “The objective of the testing is to evaluate the practicality, usefulness and consistency of the Guidance on Risk Assessment of Living Modified Organisms;”

Regarding Tom’s suggested changes [#5231], I do not see how the sentence beginning “In addition, BS-VI/12…BS-VI/12” is relevant to the task of testing and could be deleted.

The additional inserted sentence “To comply with paragraph…that:” is in my view unnecessary, since the following sentences are fully consistent with the decision language and are complaint with that and all other paragraphs. With that suggested sentence removed, it is also unnecessary to insert a new phrase between “Actual cases of risk assessment:” and subpoint (e).

The text: “Furthermore, the Parties mandated…testing” is true to events and wording and should remain unchanged.

I prefer the Secretariat’s language for subpoint (e) because it makes clear that the risk assessment would be based on technical and scientific data, rather than “may involve technical and scientific information”.

Much of the suggested inserted text between (g) and (h) is redundant. I don’t think it improves readability for the document.

Best regards
Jack

Dear Helmut, the Secretariat and AHTEG members,
Thank you Helmut for chairing this AHTEG online forum , it is great to work with you again as (re-elected) AHTEG members.

Here is my brief view:
The document seems fine to me but I do have concern that share by Jack, Judy and others in the "objective of the testing". Although in the decision of BS-VI/12, the Parties to the Cartagena Protocol on Biosafety has requested the Executive Secretary to:
(b) Gather and analyse, in a transparent manner, feedback provided as a result of testing on the practicality, usefulness and utility of the Guidance…
But the language of this request should not be used in the “Testing process” of the concept note namely para. (a), page 1.

But Part 1: The Roadmap for Risk assessment of LMOs of the questionnaires (items 7-12) only concerns “Practicality” and usefulness, hence I do not see the need of having utility in the Concept Note and the phrase “utility” should be deleted. I agree with Judy on her proposed text namely:
“The objective of the testing is to evaluate the practicality, usefulness and consistency of the Guidance on Risk Assessment of Living Modified Organisms¨”
This will make the concept note consistent with the questionnaires.

Thank you.

Kok Gan Chan, PhD
High Impact Research Coordinator
Senior Lecturer
ISB (Genetics & Molecular Biology)
Faculty of Science, University of Malaya
Malaysia

Thank you Helmut for your clarification on the "instructions". I fully understand your views on this issue.

I would like to add some comments on the concept note.

point (a): I support the modification first suggested by Patricia Gadaleta and then amended by Judy Carman in that the consistency between the guidance and the Protocol would better be explicitly listed as one of the objectives of the testing rather than a point to be considered. Whether to delete the word "utility" will depend on the forthcoming discussion on the questionnaire.

point (k): I share the same concern with Francisca Acevedo, but I understand this sentence somewhat differently. In my understanding, the second "may" phrase in this sentence, that is "(Each Party …..) may only complete and submit one questionnaire reporting their results.", does not preclude the possibility that each Party, other Government or relevant organization completes and submits multiple questionnaires each reporting their individual testing result. We may need some clarification on this point.

Nobuyuki Fujita

Dear Helmut.

First my aplogy. Given the time differences and pressure of work I have not been able to contribute as quickly as I would like to this process. Unfortunately I missed the time limit in your email of 14 May and suggest that a 48 hour limitation on a discussion spread over a 24hours of time zones is a bit tight. However, if time limits are to be imposed could we please have a running/ updated agenda (as a word document) with these deadlines kept at http://bch.cbd.int/onlineconferences/ahteg_ra.shtml as I am sure that this would be very useful to all of us that have conflicting demands on our time.

Below are my comments on the concept document which I was too late to contribute to the thread but never-the-less I hope are of interest:

Having read through the postings I would like to express a point of view. Having read many decision documents related to the protocol it is apparent that they are written quickly, due to time constraints, and as a result often contain word usage and phraseology that is not strictly English. This should not be read as a criticism, because I would not be able to contribute to a document in another language, but an observation. However my point is that we need to be very careful in our interpretation of the documents due to this ambiguity.

To start with I was reasonably happy with the concept document as it was presented. Having read Tom’s additions I feel it is now a more fulsome document that is more tightly tied to the original decision so am supportive of these changes. Although I do disagree about the removal of (a) as this was hard won and we need to keep reminding ourselves that we are testing non-prescriptive guidance.

I am also concerned with the drift in meaning that can occur when words are removed as is proposed for ‘utility’. The suggestion that utility be removed to bring the concept document into alignment with the questionnaire is a spurious and as it is the wording of the decision it should remain, and be added to the questionnaire.

If the dropping of words, i.e. utility, is to occur then this is an interpretational issue that as a group need to agree to and the basis of that interpretation needs to be included in the concept document for clarity and for transparency of process. This may mean we need a ‘use of terms’ such as article 3 or at minimum footnotes.

Regards
Geoff Ridley, Environmental Protection Authority, New Zealand

Coming back to Judy’s [#5233] comments, the methodology of systematic review is quite well established and there are many fine explanations of this review process publicly available, since I am not an expert, I will not go into details of explaining what systematic review is. Metadata analysis does not have to be used in systematic review. What I meant in the context of risk assessment is that thorough review of different dossiers, published papers, news articles, etc.  has to be made prior to drawing any conclusions. Narative reviews are also fine, but are prone to bias. I am aware that what I have proposed to be included, the wording “systematic review”, is probably ahead of time, but I am not comfortable with the fact that the word “review” is nowhere to be found in the Concept note. I also agree with Wei [#5235] that, at this stage, more involvement of scientists is needed.

Concerning the Questionnaire, did a trained psychometrician had a look at the questions asked therein? I think that is absolutely necessary if any kind of survey is being conducted on attitudes and satisfaction.
Best wishes, Hrvoje

I realise I am trying to hold back the tide but I am concerned that what should be a focused piece of work on testing the guidance and roadmap is turning into doing risk assessment with dossiers. It is still my belief that what is required is to take an example, real or imaginary, and step your way through the guidance to see if it tell you what you need to know and what you need to do to conduct a robust assessment. I do not accept that you need to do a risk assessment. I am also concerned that we seem to be deep diving into complex methodologies as this will somehow solve the problem. I would like to suggest that we have yet to define what the problem actually is. It also seems to me that the guidance material and roadmap were developed for a notional rather than a defined problem. As a result we have documents that are impressive but no one is sure what they are for. In an attempt to discover what they are for we have introduced “testing” and the test will tell us the answer. Now we are stuck developing a test that will give the answer to the question we don’t know! I am in full agreement with Hrvoje that a professional looks at the questionnaire to ensure that the questions are well designed to elicit a meaningful answer.

Regards
Geoff Ridley, Environmental Protection Authority, New Zealand

Dear colleagues,

It is a privilege to have been invited to this group and have the opportunity to learn from you, as I have training and capacity building responsibilities in regulation and risk assessment for my region - Central America and some Andean countries. This of course has to be done in Spanish.

I have been following the discussion closely, but have restrained from commenting, as I did not want to hold the tide either with my questions and comments. But Geoff has crystalized my thoughts and I couldn’t agree with him more. He wrote:  “… as a result we have documents that are impressive but no one is sure what they are for. In an attempt to discover what they are for we have introduced “testing” and the test will tell us the answer”.

We may get lost in details of English semantics about using this word or the other, and all this may be lost in translations to Chinese, French or Spanish later on.  As Geoff points put, I still don’t know what real questions we are asking. Participating in the socio-economic forum a few months ago, further confused me. 

Asking the right questions of possible, sepcifc and measurable harm is at the heart of a good risk assessment process and is possibly more important than the methodology. Many methodologies already exist  (EPA, USDA,  FDA, EFSA, WHO, Cartagena Protocol Secretariat, etc, etc)  and the one we are trying to develop is just one more.  I am still not convinced how the guidance in its current form would help regulators in my region, especially if it is still in English. I don’t think our regulators would be able to go through the exercise in English, even if they found the time and motivation to do so.

We already have good, clear guidelines using actual risk assessment dossiers that we developed in the region, for the region, in Spanish and Portuguese that are working well for us.  This material is free and publicly available and is being translated into English (a huge and expensive task). Time and resources are very limited for most regulators in our poor countries, so we need to prioritize how we spend our time and resources addressing real questions of harm.

Very genuinely, I accepted to join this group to learn. I am learning, but I am still at the rather confused stage, as I get lost in the complexities of this particular methodology of conducting an ERA and the complexity of the text.  I will stay tuned and hope I will understand things better later.

Best reagrds to all,

Maria