PRRI comments on the EFSA discussion paper “Transformation to an Open EFSA”

PRRI comments on the EFSA discussion paper “Transformation to an Open EFSA” – 15 October 2014



The European Food Safety Authority (EFSA) has launched in July 2014 an open consultation on the discussion paper “Transformation to an Open EFSA”.  The discussion paper was released with the aim of collecting comments and suggestions from interested parties before drafting a policy document on Openness and Transparency at the EFSA.

The comments of the Public Research and Regulation Initiative (PRRI) on the discussion paper are presented below, using the online format provided by EFSA, which follows the headings of the discussion paper. Given that the format did not have a section ‘general comments’, PRRI included its general comments under the heading ‘Executive Summary’.





General observation: as an organisation of public sector scientists, PRRI underlines the importance of transparency and openness in science in general and – as for example Directive 2001/18 shows – in risk assessment in particular.

Yet, as the EFSA discussion paper correctly recognises, transparency and openness are not goals per se, but are a means to an end, i.e. in this case to strengthen the role of EFSA.  Transparency and openness should be result driven, and not be seen as a matter of simply ‘more is better’.

In response to the questions for which EFSA sought specific input under the Executive Summary:

Are you satisfied that EFSA has identified the societal and normative expectations it has to comply with or would you suggest additional ones that the paper does not capture?

The paper identifies several of the main societal and normative expectations.

PRRI proposes the following additional drivers:

  1. a) the expectations of the regulated community, of which public research is a part, that regulatory frameworks be implemented as they were designed, which for example for the regulatory framework for GMOs means: in a scientifically sound, predictable and proportional manner.
  1. b) expectations from actors outside the EU that the EU will contribute to the international debate and international harmonisation. In the field of GMOs, EFSA has largely been absent in the discussions under the Cartagena Protocol on Biosafety. EFSA could play a more active role in clarifying its opinions and guidance outside the EU, and in particular in developing countries.


  1. c) the need for scientific innovation, in particular vis a vis the challenges of sustainable food production and food security.


How can EFSA increase its openness to meaningful contributions from individuals and organisations beyond its Panels and Committee? Should a two-way interaction between EFSA’s Panels and interested parties be facilitated? What limits should be set to such interaction?

While EFSA offers various opportunities for stakeholder groups to share views and experiences, in the field of GMOs EFSA diverts from what is good practice in the Member States and in other parts of EFSA, and that is the need to engage in direct dialogue with individual applicants prior to submission and during the processing of a submission.


How can EFSA ensure that commercially sensitive information and data are protected while providing access to key information, data and documents necessary to make its assessments reproducible? Should EFSA embrace the principle of reusability?


The current rules for protection of commercially sensitive information can work well. The question of reusability of data is too general – there are cases whereby reusability can be beneficial, provided it is done in accordance with rules for ownership of safety data. Further work is needed to strengthen the mutual acceptability of data. Many data accumulated in other parts of the world could be used directly by EFSA, and would not require repetition of expensive testing, which is particularly inhibitive for the public research sector
How can EFSA foster even further an environment of creative debate amongst its experts while striking the appropriate balance between availability and quality of information?


A prerequisite for a creative debate amongst experts is the possibility to allow them to express views and hypotheses in closed sessions, while of course ensuring that the final opinions (and any final dissenting opinions) are properly motivated and transparent.

Would you identify any other strategic drivers, contextual elements or policy options for the Authority to consider when implementing its vision of becoming an Open EFSA?


One of the key drivers should be to constantly keep an eye on the legal role EFSA. EFSA is an agency of the European Union established to provide scientific advice and scientific and technical support on all direct or indirect risks related to the food chain. EFSA should not turn into a quasi political body


The introduction states that “Openness is meant as an enabler for citizens to participate more closely in the decision-making process”.


It should be made clear that EFSA is an advisory body, and not a decision making body. The role of openness for advisory bodies is different than for decision making bodies.


The introduction also states: ”Decentralised agencies of the Union need to be particularly attentive to the need for openness, and of their operations being understandable and accountable to Union citizens and interested parties”.  While it is very true that EFSA’s operations should be understandable to everyone, the phrase “accountable to Union citizens and interested parties” also suggests a political role that EFSA does not have. EFSA is accountable to the EU Institutions and Member States, and its binding principals are the law and sound science.





The text under “Opportunities” refers to the availability of information on the Internet and to concept of “citizen scientist”. This needs further clarification, to avoid misunderstanding. Meaningful medical diagnoses are drawn up by doctors, not by lay people who spent time on the Internet.


The text under “Challenges” correctly recognises that greater involvement and participation could also hide potential risks, such as disproportionate influence of a limited number of actors or loss of control by the Authority over the content of a document.





It is indeed essential that the EU citizens trust the EU food safety system. However, that trust cannot be built of the political decision makers keep ignoring EFSA’s opinions.


3.1 Improving the overall quality of available information and data used for EFSA’s outputs


The text correctly recognises that risk assessment follows a systematic methodology based on evidence. This paradigm should be repeated over and over again in the follow up reports and plans.


The text also justly quotes that Data are “the lifeblood of the knowledge economy”.


However, the claim that “EFSA is likely to gain from receiving further input through its interaction with society” needs further thought, because EFSA’s work may very well get clogged with such interaction.



3.2 Complying with normative and societal expectations


The phrase “comply with societal expectations” raises some questions. While politically elected bodies may have a duty to comply with “societal expectations”, EFSA’s task  is laid down in the EU’s rules and decisions, not in societal expectations.  In this context it should be noted that the Executive Summary lays down the objective of the discussion paper: ” a plan for the transformation of the European Food Safety Authority (EFSA) into an Open Science organisation “.  The phrase “Open Science organisation” is not explained. It would be important that this term be clarified to ensure that the process aims to strengthen transparency and openness within EFSA’s legally binding task and not seek to alter its task.


The text under “ Democratising science” needs further clarification, as it could give the false impression that sound science can be replaced by popular vote. It cannot. The safety of vehicles on the road is assessed by mechanics, not by neighbourhood committee polls.





PRRI supports the notion that “EFSA must investigate whether a complete and unchecked opening up of scientific meetings is likely to diminish the qualitative and quantitative level of the scientific discourse. Science and regulatory science are not definitive disciplines. Total transparency may inhibit actors in these challenging sectors, preventing the correct recourse to “trial and error” processes, hindering creativity, the formulation of dissenting opinions or even of basic questions, and favouring entrenchment in mainstream thinking.”





PRRI supports the step described as EFSA then identified different options at its disposal for meeting the critical success factors, including a legitimacy check to ensure that it complies with application of the institutional and legal frameworks.”