Leading experts and practitioners of regulatory science from across Europe and beyond took part in a workshop organised by EFSA to gather feedback and insights on the Authority’s on-going efforts to harmonise and strengthen the cross-cutting methodologies that underpin its scientific assessments.
The ‘Workshop on Increasing Robustness, Transparency and Openness of Scientific Assessments’ focused on four EFSA initiatives that aim to develop structured approaches for: using evidence, weighing up evidence, assessing uncertainty, and determining the “biological relevance” of effects observed in test species for the target population of the assessment.
The first two initiatives (Promoting Methods for Evidence Use; draft Guidance on Uncertainty) are at more advanced stages of development, therefore, the discussions with the assembled experts focused on the work done so far. The other two (draft Guidance on weight of evidence and on biological relevance) are still taking shape and the participants were asked to help EFSA to further define their objectives, scope and interaction.
The invitees positively received the four initiatives and, generally, EFSA’s efforts to harmonise methodology developments in these areas. There was a consensus that moves in this direction help to ensure impartiality and make assessments more transparent and rigorous.
Among the key conclusions of the workshop there was agreement that:
- Clearly defined and, if possible, harmonised terminology is essential to avoid ambiguity and to be able to apply the methodologies across a diverse range of scientific areas.
- Clarity upfront in defining the ‘question’, or aims of each assessment, is also crucial and requires close involvement of the ‘requester’.
- Flexibility is necessary given the differing types of requests (for example, urgent advice or longer assessments).
- Applying the methodologies systematically will require substantial training (EFSA is already preparing training for its scientific staff and experts).
- Although working practices may initially lengthen, in the long run these more structured approaches will probably become routine parts of the assessment process.
The workshop was the second step in a consultation exercise begun by EFSA in 2014 – as part of the Authority’s efforts for greater transparency and engagement in its work – to gather input on key scientific initiatives during the course of their development. EFSA frequently consults publicly on its most important scientific outputs but this usually takes place at a more advanced stage of development when the bulk of the work is already done. In this case, experts from scientific advisory bodies with roles similar to EFSA’s – including national assessors in EU Member States, other EU agencies, the scientific committees of the European Commission, the Commission’s Joint Research Council, the WHO, the OECD, scientific assessment bodies in the USA, Canada and New Zealand, as well as a clutch of academics – had previously provided feedback on an EFSA Journal editorial that first introduced these methodology developments to the wider scientific community. The workshop built on the contributors’ previous feedback and may be followed up by similar forms of cooperation.
Dr Tobin Robinson, head of the Scientific Committee and Emerging Risks Unit at EFSA, which organised the workshop, said: “We are extremely satisfied with how engaged the discussions were and with the constructive contributions from our guests. It was extremely useful for us and will help us to further develop our ideas and proposals in these areas.” Exchanges like these, according to Dr Robinson, help to ensure “that we take on board ideas and critical thinking taking place beyond EFSA’s own scientific set up”.
The results of the workshop will feed into the on-going development of these four initiatives. EFSA will publish a report on the workshop in the coming weeks.
Participant List(160.62 KB)