Testing of the Roadmap for Risk Assessment

Dear all,
I have created this thread in the Discussion Group for Testing of the Roadmap as a place to submit the questionnaires with your answers.
Best regards,
Manoela

POSTED ON BEHALF OF ALEXANDER EGYIR-YAWSON

Please see attached file.

Attached are my responses to the questionnaire.

Hector Quemada

Dear all,
I am attaching my answers to the questionnaire to test the roadmap.
Adriana

(Edited by Manoela Miranda to attach the questionnaire)

Brief response.

Please see my comments under another thread regarding the scope of risks considered.

Mark Benedict

Questionnaire attached

Dear colleagues,

Thank you for the opportunity to comment on this document.

Best regards,
Cheryl Corbett

Questionnaire atteched.

Thank you.

Please find attached comments on the draft roadmap as framed by the questionnaire.

First of all, thank you very much for the opportunity to comment on this initiative. It is very commendable that AHTEG are trying to provide some guidance on how to conduct risk assessments for LMOs.

In my view, this document is a very good attempt and brave effort to provide risk assessors with guidance on how to conduct these risk assessments. However, in my opinion, like in other risk assessment guidances that try to cover all aspects of LMO risk assessment, there is a long list of things to do for risk assessors, with many abstract concepts and not enough clarity on what exactly the risk assessor needs to do/assess. Key concepts like what constitutes and adverse effect or what are the potection goals are an essential part of the risk assessment and unless they are defined and clear to the assessor, the risk assessment may not cover all the areas of regulatory concern.  This could result in some serious challenges in situations were there is not need to be, like small releases of LMO's previously released and with available assessments. I would propose that some of the more abstract concepts are clarified further and the requests simplified to make sure that the risk assessments that are produced are really fit for purpose and not a blocking tool for the development of LMO's. One key piece of advice to a novice risk assessor could be: Has the product been previously assessed under Annex III? and if so is the risk assessment suitable for your region?, identifying what may need further exploration can then drive the key questions simplifying the process.

I attach my comments to the questionaire.
Thanks again
Monica
My response to the questionaire is attached.

Questionnaire attached

I have already made some of the comments in the first thread. Anyhow please find attached my questionnaire

Dear all,

Please find attached files of questionnaires on the testing of the Roadmaps.

Best regards,
Yasuhiro YOGO

Dear Manoela

I have compiled the results of 7 people who tested the Roadmap at OGTR for Q1-8.

Q1 Slightly disagree 1; Neutral 3; Slightly agree 1; Strongly agree 2
Q2 Strongly disagree 5; Slightly disagree 1; Neutral 1
Q3 Slightly disagree 6; Neutral 1
Q4 Strongly disagree 2; Slightly disagree 1; Slightly agree 4
Q5 Slightly agree 3; Strongly agree 4
Q6 Slightly disagree 3; Slightly agree 4
Q7 Strongly disagree 1; Slightly disagree 1; Slightly agree 2; Strongly agree 3
Q8 Slightly agree 4; Strongly agree 3

Best regards
Paul

POSTED ON BEHALF OF YOUNG CHEOL PARK
(this message was received by email shortly after closing of this discussion group)

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Please see attached questionnaire