Dear all,

Thank you for your participation and feedback. This discussion is now closed. Hans will post a moderator’s summary in a few days.

The next round of discussion will take place next month on the development of a package that aligns the Guidance with the training manual. 

Best regards,
Manoela

POSTED ON BEHALF OF HANS BERGMANS

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Dear Participants of the Open-ended Online Forum,

Thank you very much for the time and effort made to provide substantive contributions to this discussion. In spite of a slow start, the discussion picked up towards the end with a good number of interventions and concrete suggestions made to ensure that the concept note and questionnaire are of the highest standards to move forward with the testing.

With regards to the concept note, there was some initial concern amongst participants regarding the source of information that can be used for the “actual case of risk assessment” in the testing of the Guidance. The Secretariat revised the concept note and clarified that the technical and scientific data of actual cases of risk assessment that can be used in the testing may originate from various sources, including application dossiers, summaries of notifications, as well as previous and ongoing risk assessment processes. Several participants further noted that the testing procedure should focus on the scientific and technical aspects of the dossiers rather than the regulatory context of the dossier.  Given that dossiers may originate from various national regulatory frameworks, they may vary both in scope and details; as such, testers can consider using dossiers from more than one country to enable access to a broader range of scientific data. It was also noted that in order to have a more effective comparison of responses, it would be useful if testers submitted feedback using the same dossiers. 

Additionally, the Secretariat made a request to participants to make available one or more dossiers with the extensive data sets for the release of LMO(s) into the environment for the purposes of the testing of the Guidance by Parties, other Governments and relevant organisations who may not have access to such data. In response, many participants indicated their willingness to make available dossiers that may be used during the testing. I hope that more participants will come forward and make available full dossiers to the Secretariat before the 15 May deadline.

Several clarifications were sought by participants regarding the requirement for linking a BCH Risk Assessment Record to the questionnaire. The Secretariat clarified that, in line with Article 20 of the Protocol, the link is to ensure transparency in guaranteeing the use of “actual cases of risk assessment” in the testing as requested by the COP-MOP.  In the case of risk assessment dossiers that are still under consideration by the relevant competent national authorities, it is noted that their respective risk assessment summaries can be submitted to the BCH at any point during the extended period of the testing process.

Finally the submission of a single testing questionnaire from each Party, other Government or relevant organisations, by their respective BCH National Focal Points or through their head offices, is to ensure that the submission best reflects the consolidated view of each Party, other Government or organization.

With regards to the content of the questionnaire, several suggestions in the form of additional questions and approaches were made by participants towards improving the questionnaire. The Secretariat has compiled these suggestions and will take them into account, as appropriate, when revising the questionnaire. To elicit a higher number of responses, several participants also requested that the questionnaire be clear and simple, using common expressions that are succinct and easily comprehensible to non-native English speakers.

The comments and proposed questions can be categorized into the following 3 main areas:

• Better construction of the questions and answer options to ensure objectivity and neutrality of responses. Some concrete suggestions were made in this regard towards the wording of the questions and their responses. The use of a numerical answer scale was also suggested.

• Ways to translate the level of satisfaction with the Guidance, as regards its practicality, usefulness and utility, into concrete improvements. Suggestions were made for additional text fields to be included to enable testers elaborate further on the reasoning behind their answers.

• Questions on the specific nature of the case(s) of risk assessment such as the LMO tested and type of release (e.g. field trial or commercial release). It is however noted that this information is normally part of the BCH Risk Assessment Records and may be imported directly into the questionnaire of the testing.

Finally it was suggested that the main considerations and details of the best approach to the testing of the Guidance on Risk Assessment of LMOs be outlined in a set of instructions. These instructions could be provided in the form of a hyperlink at the beginning of the questionnaire.

It was a pleasure to be a moderator of this forum once again and I look forward to future discussions.

Best regards,
Hans Bergmans