Public consultation on the draft Guidance of the Scientific Committee on transparency in the scientific aspects of risk assessment carried out by EFSA - Part 2: general principles

EFSA’s Scientific Committee has drawn up a draft opinion on ensuring transparency in scientific aspects of the risk assessment process. This is the second part of the Scientific Committee’s recommendations on transparency, following its guidance document on procedural aspects of risk assessment published in May 2006.

This draft opinion focuses on general principles concerning scientific aspects of EFSA risk assessments, including identifying, documenting and explaining key factors underpinning the scientific process, their relative importance and their possible influence on the assessment outcome. These include:

• The rationale for any decision to include or exclude data and the strengths and limitations of the data set used.
• Key assumptions inherent in the risk assessment, for instance in relation to data extrapolation from test animals to human beings.
• Identification of limitations or uncertainties underlying the risk assessment, arising for example from limited exposure data.
• Variability factors for instance between different population groups or species that may affect the risk assessment.
• Different outcomes compared with other scientific assessments, including implications of potentially contradictory data and diverging views with other expert bodies.

This forms part of an overall framework of good risk assessment practices supported by the Scientific Committee’s recommendations. These include EFSA’s quality assurance process, based on the Scientific Committee's recommendations for an internal and external review, to continually review and strengthen the quality of EFSA’s scientific work.

EFSA has also prepared a draft technical report summarising the guidance documents, guidelines and working documents developed or in use by EFSA and its Scientific Panels. This is to be read together with the draft opinion – it is not subject to the consultation. EFSA will review and update this document regularly.

In line with EFSA’s policy on openness and transparency and in order for EFSA to receive comments from the scientific community and stakeholders, EFSA has launched a public consultation on the draft opinion. Interested parties are invited to submit written comments using the online form by 15 February 2009, 17:00 CET. Please note that comments submitted by e-mail or by post cannot be taken into account. It should be noted that a submission will not be considered if it:

• Is submitted after the deadline set out in the call
• Is presented in any form other than what is provided for in the instructions and template
• Is not related to the contents of the document
• Is related to individual cases
• Contains complaints against institutions, personal accusations, irrelevant or offensive statements or material
• Is related to aspects outside the scope of EFSA’s activities

Comments complying with the criteria will be evaluated by EFSA’s Scientific Committee and taken into consideration where these will enhance the scientific quality or understanding of the document. EFSA will publish the relevant comments received, as well as a short report on the outcome of the consultation.