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,