Research note. Consulting the public on EFSA’s risk assessment policy

Research note by Sarah Hartley

Since the food safety crises that plagued Europe in the 1990s, the number of experts in science governance has been growing alongside an increasing interest in public[1] involvement. This research note is based on two papers (The Challenges of Consulting the Public on Science Policy, Review of Policy Research and Policy Masquerading as Science, Journal of European Public Policy). They explore recent efforts to consult the public in risk assessment, a domain of science governance that relies heavily on experts. These two papers draw on an empirical case study of the European Food Safety Authority’s (EFSA’s) public consultations held on two Guidance documents (“Guidance”) that established the risk assessment framework for genetically modified (GM) animals in the EU: 1] ‘Guidance on the risk assessment of food and feed from genetically modified animals and on animal health and welfare aspects (2011), and; 2] ‘Guidance on the environmental risk assessment of genetically modified animals (2013).

These papers contribute to the literature on risk decision-making, exploring the use of expert knowledge and public involvement in the traditionally expert domain of risk assessment. In particular, they examine the tensions involved when expert domains are opened up to public involvement, the impact of public consultations on risk assessment policy, and the degree to which experts influence policy decisions. The first paper identifies four key tensions when expert domains are opened up to publics, namely: balancing the goals of scientific excellence and openness; protecting science from interests; addressing value judgments; limited opportunities to debate ethical and social issues. These tensions are explored through the case study. The second paper delves deep into the public consultation held in development of one of the Guidance. The literature on the role of experts in decision-making processes suggests that experts may have a great deal of influence on policy, raising questions about how much influence publics have compared to experts. The results of the study demonstrate the inability of publics to influence the Guidance through the public consultation. Despite international legal obligations to develop risk assessment policy, the European Commission and EFSA failed to recognise the Guidance as policy. This failure places unjustified restrictions on publics in the consultation process and the value judgements inherent in risk assessment policy are cloaked from public scrutiny.

EFSA is an independent regulatory agency providing scientific advice to the European Commission (‘Commission’) Directorate General for Health and Consumer Protection (DG SANCO) on food-related risk. EFSA has responsibility for risk assessment (the traditionally science-based stages of risk analysis) and risk communication and the Commission has responsibility for risk management (where the broader aspects of risk can be considered). While EFSA relies heavily on advice from scientific experts, it also has a statutory obligation to provide public consultations. However, EFSA’s public consultations are science-based: the social and ethical issues fall outside EFSA’s remit.

EFSA’s Guidance are risk assessment policies that establish the risk assessment framework for applicants (industry) and risk assessors (EFSA and EFSA’s experts). They explain the principles behind risk assessment and specify the information and data which industry must provide. Risk assessment policies are distinguished from risk assessment in risk analysis by the use of the term ‘policy’ to acknowledge the political or values-based decisions involved with determining the overarching risk assessment framework. Risk assessment policies involve value judgements in determining the scope of risk assessment and how much of which types of evidence might be necessary and/or sufficient for particular types of products or processes to be permitted, restricted or forbidden. While risk assessment policies should be informed by science, scientific input alone is not sufficient. The Codex Alimentarius Commission (‘Codex’) requires the Commission, as risk manager, to develop explicit risk assessment policies in advance of risk assessment and in consultation with the public.

The first paper identifies four key tensions between EFSA’s scientific remit and its public consultations. First, EFSA needs to balance the goals of scientific excellence and openness carefully so that opening up to non-expert publics does not undermine scientific excellence by bringing values or interests into risk assessment. Importantly, there are two assumptions that underlie this tension: 1] A clear distinction between science and values is possible (see the third tension, below); 2] An opportunity exists to address non-scientific issues which fall outside of EFSA’s remit (see the fourth tension, below). In the case of GM animals, EFSA managed this tension by prioritising scientific excellence over openness and by prioritising expert knowledge over public knowledge. In this way, public input has limited influence on the Guidance.

Second, EFSA needs to protect science from interests. EFSA relies heavily on its ‘Declaration of Interest’ policy to protect the independence of science. However, EFSA’s ability to protect science from interests has been called into question by researchers, publics and the European Court of Auditors. Ultimately it may not be possible in practice to separate science from interests and therefore new approaches may be called for such as innovative forms of ‘opening-up’ that allow interests to be transparent and openly debated.

Third, EFSA needs to address value judgments in science-based risk assessment. EFSA does not officially recognise that the science used in risk assessment involves values-based decisions despite a body of evidence to the contrary. Further, it does not recognise that Guidance are risk assessment policies. EFSA’s public consultations present an important opportunity to identify and discuss value judgements that are made in the context of risk assessment policy. By denying both the existence of values in the Guidance and the opportunity to discuss them, EFSA’s values are insulated from scrutiny and debate.

Fourth, the Commission needs to provide the opportunity for publics to debate the social and ethical issues raised to GM animals. The current governance framework for GM animals consists of EFSA’s Guidance and is based solely on science. This exclusion of the social and ethical issues has led to public frustrations with EFSA’s consultation process. Publics want to debate a broader set of issues than EFSA allows, yet with no other forum to debate GM animals, publics voice the concerns through EFSA’s consultation.

The second paper examines EFSA’s public consultation on its draft Guidance on the environmental risk assessment of GM animals, held in June 2012. EFSA received 720 comments from 35 participants. Evaluation of the comments reveals that participants challenged the consultation’s boundaries and were unable to have their say, primarily due to the timing and response time of the consultation, lack of opportunity for dialogue and exclusion of social and ethical issues, particularly as EFSA’s remit does not allow it to consider non-scientific issues in development of Guidance. The consultation was ineffective at capturing the full range of affected publics, resulted in an official complaint about the independence of experts and, more importantly, had minimal impact, particularly due to the timing of the consultation at the end of a long, expert-driven process. EFSA’s consultation was a form of tokenism, allowing publics a limited voice, but did not influence the Guidance.

The Commission and EFSA failed to recognise the Guidance as risk assessment policy. This failure raises the authority of experts and constrains the influence of publics. The concern here is not that the political is shaping the scientific, but that the scientific is shaping the political and in doing so masking political choices being made by scientific experts. Essentially, policy is masquerading as science. In technocratic models of decision-making scientists inform policy-makers and although their advice may be the sole basis of policy, it is the policy-makers who decide and therefore make policy. However, in this case study, the framing of the Guidance as a scientific rather than a policy document resulted in the Commission and EFSA relinquishing authority to EFSA’s scientific experts – a group of experts with no democratic accountability. Experts not only informed policy, they made policy because policy-makers failed to acknowledge the limitations of science for risk decision-making. By framing the Guidance as a scientific document, value-choices were hidden from the public and allowed experts to make policy. Participant frustration with this ‘cloaking’ of values was clear in the consultation and the issue has been raised frequently in the academic literature.

There are a number of policy implications from this study. Although risk assessment is the responsibility of EFSA, development of risk assessment policy is the responsibility of the Commission, according to Codex rules to which the European Union (EU) is a signatory. If the Commission takes responsibility for risk assessment policy development in the future, it may need to involve publics upstream in the policy process to allow them to examine and contribute to the inherent value-judgments. There is little recognition from Codex about the challenges of identifying risk assessment policy or information available to risk management agencies tasked with their development. Research is needed to reveal ‘best practice’ cases, where risk assessment policy has been conducted by risk managers rather than risk assessors, to identify the process through which these policies were identified and the mechanisms employed for public involvement.

Second, as the risk manager, the Commission may need to create a mechanism at the EU level for debating the risk management issues related to controversial technologies such as GM animals alongside EFSA’s consultation. The case of animal cloning offers an example of what is possible. However, in the case at hand, public participants took advantage of EFSA’s consultations to submit comments that addressed social and ethical issues, yet these issues did not get considered by EFSA, EFSA’s experts or the Commission. Leaving these comments unaddressed risks the legitimacy of EU governance more broadly.

Third, EFSA’s public consultations present a valuable and innovative opportunity to flush out and debate value judgements inherent in risk assessment in a way that can strengthen food safety governance. As others have argued, it is precisely these implicit value judgements that present the strongest argument for EFSA’s public consultations. By denying both the existence of values in risk assessment and the opportunity to discuss them, EFSA’s values are insulated from criticism and debate. The institutional denial of values in risk assessment suggests that EFSA may see public consultations as best serving its risk communication function rather than its risk assessment function appear to be contrary to the good governance agenda that EFSA is striving to achieve.

[1] The public/publics is used here to describe organisations and individuals who do not have direct responsibility for developing the policy on which they are being consulted. Publics may include government departments/ agencies, university/research organisations, industry, public interest groups and individuals.


Sarah Hartley is a Research Fellow, Faculty of Social Sciences, at the University of Nottingham.

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