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Interim Summary and revised draft documents [#5294]
Dear AHTEG members, dear colleagues,

Thank you for your contributions of concrete and useful suggestions on the draft concept note and questionnaire in the AHTEG Forum. These suggestions will undoubtedly assist the Secretariat in improving the tools to focus and structure the testing of the Guidance.

I have carefully considered each comment and suggestion provided and made, with the assistance of the Secretariat, an attempt to reflect emerging thoughts directly in the text of the draft concept note and questionnaire. You may find these marked as track changes in the documents attached to this message (please go to the AHTEG Forum in the BCH to view the attachments as the system does not allow them to be sent via email).

I must note that accommodating diverging views has always been a challenging endeavor. I have however made an attempt to be very inclusive but as you will note, there were a few issues which could not be reflected in the revised documents. I will try to briefly explain the rationale behind these issues and hope those who have made the suggestions will understand the limitations and accept my suggestions on a way forward.


In the concept note:

On the issue of the number of submissions per country or organization, it is important to recall the limitation put on us by the COP-MOP in paragraphs 2-4 of its decision BS-VI/12, in particular paragraph 3, which states:

“3. Also encourages Parties, other Governments and relevant organizations, through their risk assessors and other experts who are actively involved in risk assessment, to test the Guidance in actual cases of risk assessment and share their experiences through the Biosafety Clearing-House and the open-ended online forum;”

Accordingly, rather than inviting the risk assessors and other experts, the COP-MOP encouraged the Parties, other Governments and relevant organizations to test the Guidance and share their experiences. In this context even if multiple cases of risk assessment are used in the testing or if multiple actors within a country or organization undertake the testing, the three entities identified by the COP-MOP that can submit the result of the testing are Parties, other Governments and relevant organizations. Furthermore, the mode of compiling the different views within these three entities in responding to a single questionnaire is at the discretion of the Party, the Government or the organization submitting the results. In reporting back to the COP-MOP at its seventh meeting, the Secretariat will present an analysis of the submission from each of the Parties, other Governments and relevant organizations.

Concerning the use of the word “utility”, the decision requests the Executive Secretary to “[g]ather and analyse, in a transparent manner, feedback provided as a result of testing on the practicality, usefulness and utility of the Guidance, (i) with respect to consistency with the Cartagena Protocol on Biosafety; and (ii) taking into account past and present experiences with living modified organisms”.

Since specific parameters for the testing were provided in decision BS-VI/12, my suggestion in this case is that we be faithful to the request by the COP-MOP and retain the word “utility” in the concept note and questionnaire.

With regard to risk assessments generated by non-regulatory or independent processes, the BCH already allows the submission of such information under the category “Reference Record” (http://bch.cbd.int/managementcentre/register/#reference). This type of risk assessment includes any risk assessment created through means other than a country’s regulatory processes, e.g. a risk assessment conducted by a business, academic or non-governmental organization. Allowing risk assessments generated through non-regulatory or independent processes will enable relevant organizations to participate in the testing of the Guidance as mandated by the COP-MOP.

As a final point on the concept note, an intervention noted a possible inconsistency between items (b) and (k). My understanding is that these points enable Parties, other Governments and relevant organizations to engage their risk assessors and other experts in testing the Guidance either individually or in group activities (e.g. workshops). I do not see the inconsistency between these two points but if that is the general feeling, I kindly invite concrete text proposals to clarify these points.


In the questionnaire:

With respect to clarifying the type of documentation used in testing the Guidance (e.g. application dossiers, summary of notifications, etc) I note that this information will be available from the answers to question 4 requesting the respondent to either provide references to Risk Assessment Records in the BCH, or hyperlinks to the original source of the documentation. These links will enable a verification of the type of information used in testing the Guidance. 

Furthermore there were suggestions to add additional questions regarding “clarity” and “relevance” of the Guidance. I kindly urge the Group to focus the questionnaire while keeping in mind the COP-MOP request to “[g]ather and analyse…” (see above). By adding questions that are beyond the scope of the COP-MOP’s request and repeating them for each section of the Guidance we would risk producing a questionnaire that is too complex and, more importantly, which would not necessarily provide answers to the COP-MOP’s request. I therefore note that since questions 8, 10, 12, 14 and 15 contain fields that allow the entry of comments in the form of text, each Party, other Government and relevant organisation can provide further details regarding their experience in testing the Guidance.


In response to the very practical procedural suggestions made, I have added a box with "Chair`s Notes" at the beginning of our discussion site in order to highlight the topics and timelines of our discussion for your ease of reference. I fully understand the time constraints between our normal duties and the AHTEG deliberations. To fulfil our mandate as set out by the COP-MOP in a timely manner I have to set specific time lines for the various subtopics, I kindly ask for your understanding to allow me to structure the debate as needed to fit the available time in a clear and transparent manner. Since most of the topics are interlinked it has been possible to provide comments on related issues in a flexible manner.

In the remaining time allocated to this discussion, i.e. from now till Sunday, 26 May at 1:00 a.m. GMT, I would like to invite the Group to focus on the revised documents attached to this message. I would also like to invite the Group to provide short and concise text that could better explain the terms “practicality”, “usefulness”, “utility”, “consistency” and “taking into account past and present experiences with LMOs” in such a way that assists the respondents.

With the view to facilitating a further revision, I would appreciate if you could provide any comment or suggestion for improvement in the form of concrete text proposals.

I look forward to the continuation of our discussion. Thank you and best wishes,

Helmut
posted on 2013-05-21 20:55 UTC by Mr. Helmut Gaugitsch, Austria
This is a reply to 5294 RE: Interim Summary and revised draft documents [#5295]
Dear Mr. Chair and other colleagues,

In the concept note: As request by protocol, the risk assessment should be conducted in a scientifically sounded manner and due to that the experience is not always scientific sound, I would propose to add 'of scientific sound' to 'present and past experience' in the Testing process point (a), it would read as '(a) The objective of the testing is ....., and taking into account past and present experiences of scientific sound with living modified organisms;'.

Regarding of my past reasonable concern that the testers' interest may bias the testing process, thus it could be necessary to have a statement of interest conflict in the questionnaire. I warned this because I recall my past experience during MOP6. I am not sure if the statement works and I thus pleas for the input of intelligence of our colleagues in this aspect. We should take appropriate tool and measure to ensure an unbiased testing.

Thank you!

Wei Wei
Institute of Botany, Chinese Academy of Sciences
posted on 2013-05-22 00:58 UTC by Mr. Wei Wei, China
This is a reply to 5294 RE: Interim Summary and revised draft documents [#5299]
POSTED ON BEHALF OF PATRICIA GADALETA
----------------------------------------------------------

Many thanks to Mr. Chair and the Secretariat for the thorough analysis, the interpretation and the consideration of each comment and suggestion done in this forum, as well as the clarifications made for changes proposed.

I strongly support the new versions of the Concept note and the Questionnaire but I am also open to hearing new comments and suggestions of the colleague members to discuss especially about the ¨use of terms¨ in both documents.

Kind regards,

Patricia Gadaleta
Biotechnology Directorate
Ministry of Agriculture, Livestock and Fisheries
Argentina
posted on 2013-05-22 18:50 UTC by Dina Abdelhakim, SCBD
This is a reply to 5294 RE: Interim Summary and revised draft documents [#5301]
Dear Helmut, dear secretariat

Many thanks for a challenging task wonderfully done as always. I am satisfied with the new revised versions of the Concept note and the Questionnaire as they stand now.

Warm regards,
O.A.ElKawy
posted on 2013-05-23 09:28 UTC by Mr. Ossama Abdelkawy, Syrian Arab Republic
This is a reply to 5294 RE: Interim Summary and revised draft documents [#5306]
Dear Chair and the Secretariat,

thank you for providing us with the new text of the Concept and Questionnaire.

I find the modifications reasonable and useful, the concordance between the two documents appropriate.

Kind regards,

Angela
posted on 2013-05-23 18:45 UTC by Angela Lozan
This is a reply to 5306 RE: Interim Summary and revised draft documents [#5318]
Dear AHTEG Members,

Thank you for your comments and active participation in this discussion.

At its last meeting, the COP-MOP decided that the Guidance will be tested nationally and regionally for further improvement in actual cases of risk assessment and in the context of the Cartagena Protocol on Biosafety. The COP-MOP requested the Executive Secretary to develop appropriate tools to structure and focus the testing of the Guidance, and to gather and analyse, in a transparent manner, feedback provided as a result of testing on the practicality, usefulness and utility of the Guidance, (i) with respect to consistency with the Cartagena Protocol on Biosafety; and (ii) taking into account past and present experiences with living modified organisms.

I would like take this opportunity to recall our mandate with regard to the testing of the Guidance as per the terms of reference annexed to decision BS-VI/12 (paragraph 1(a)):


“Provide input, inter alia, to assist the Executive Secretary in his task to structure and focus the process of testing the guidance and in the analysis of the results gathered from the testing;”


In view of our challenging time constraints, due finding the space between our own national duties and the tight AHTEG schedule, I urge all Members once again to focus on the task at hand and limit your interventions to the mandate entrusted upon us by the COP-MOP, by using effectively our remaining time between now and the closing of the discussion on 26 May at 1:00 a.m. GMT.

Thank you for your continued support to this important process.

Best regards,
Helmut
posted on 2013-05-24 18:44 UTC by Mr. Helmut Gaugitsch, Austria
This is a reply to 5318 RE: Interim Summary and revised draft documents [#5332]
Thanks a lot to the Participants and the Secretariat for important changes made in the Concept Note and in the Questionnaire. They have become clearer and I support it. To the terms in the Questionnaire I think they are ambiguous wording and it would be better if they are strongly associated with text going after them, e.g. “Practicality”- how easy it is to use Section in a real situation of risk assessment. As not a native English speaker I still have troubles with the terms «Usefulness» and «Utility».
posted on 2013-05-25 07:25 UTC by Dr. Galina Mozgova, Belarus
This is a reply to 5318 RE: Interim Summary and revised draft documents [#5333]
Dear All
I once again apologize for not participating very actively but I am on my annual holidays with poor internet access.
I have read the changed concept note and the questionaire and want to express my thanks to the secereteriat and the chair. I fully support what has been worked out.
best regards
Beatrix
posted on 2013-05-25 11:12 UTC by Beatrix Tappeser, Federal Agency for Nature Conservation
This is a reply to 5294 RE: Interim Summary and revised draft documents [#5336]
Dear Helmut, colleagues and Secretariat:
I unfortunately was not able to be very active due to being out of the office and overload of work.  It is just now that I could sit down, read the messages and the revised versions of the Concept Note and Questionnaire.
My first comment is that they are much more comprehensive and clearer in their current versions (29May2013). This has been achieved through “collective” work which has been fruitful.
I only have two issues in my mind that I would like to put up front:
I.- The Questionnaire could  have a section that could be filled in relation to:
• Who participated in the testing ,
• What previous experience in relation to risk assessment do those who have participated have,
• Under what modalities (individual/workshop/etc) was the testing performed.
This type of information could give extra transparency to the testing process.

II.- In relation to identifying the sources used with regards to the technical and scientific data of actual cases of risk assessment used in the testing :
• In the concept note in “testing process” in little “I” it falls short in relation to little “f” (the latter talks about Risk Assessment BCH records  or other sources with a clear “hyperlink” while the former talks about  Risk Assessment BCH records  only…reference to other sources should be added)
• The same is true in the Questionnaire in relation to question 4.

I thank again for the nice work.

Un abrazo,
Francisca
posted on 2013-05-25 13:55 UTC by Ms. Francisca Acevedo, Mexico
This is a reply to 5294 RE: Interim Summary and revised draft documents [#5345]
Dear all,

I would like a slight modification in the questionnaire in section #4.

Type of information to be used in the testing would be made clearer if the instruction sentence read  "Please enter the record numbers of BCH Risk Assessment Records and/or hyperlinks containing the <insertion begins here>technical and scientific data of<insertion ends here> actual cases of risk assessment used in the testing.

regards,

Nobuyuki Fujita
posted on 2013-05-26 00:42 UTC by Mr. Nobuyuki Fujita, Japan