September 15, 2014, by Sarah Hartley

Risk assessment policy as regulatory science

This blog is a joint posting by Sarah Hartley and Warren Pearce

Following the University of Nottingham’s Circling the Square conference an interesting debate emerged around some of the fundamentals of science: objectivity, the confounding of science with regulatory science and what counts as science. Much of this took place under a post by our colleague, nano-physicist Philip Moriarty, who presented an idealised view of ‘research science’ and began to develop an argument that ‘regulatory science’, the science that is most often used in policy-making, is not really science at all due to the values at play. We agree with Philip’s concerns about regulatory science.

We use the illustrative case of European risk assessment policy to demonstrate that despite clear guidelines concerning what counts as policy from the Codex Alimentarius Commission, the international body for food standards, policy-makers and scientists still claim that development of risk assessment policy is a ‘scientific’, not a ‘policy’ process. This failure to recognise risk assessment policy as a policy, cloaks the value choices made by scientists who are not democratically accountable, and shuts out the public and stakeholders from contributing to the policy discussion.

Risk assessment ‘policy’

Attempts have been made at the international level to stop calling regulatory science ‘science’ and to start calling it policy. For example, Codex members adopted the Working Principles for Risk Analysis for Food Safety for Application by Government 2007 which committed risk managers (the policy-makers) to establish risk assessment policy in advance of risk assessments and with the input of a broad range of voices. Risk assessment policy addresses the implicit values and judgments in risk assessment.

Codex defines risk assessment policy as “documented guidelines on the choice of options and associated judgments for their application at appropriate decision points in the risk assessment” (p.114). Basically, this means that risk assessment policy sets out the framework through which future applications must pass before products can be considered safe enough to be released into the environment or onto the market. This policy tells the applicant and the assessors what will be considered in the risk assessment process and how.

Millstone et al summarise the kinds of issues addressed in risk assessment policy as:

• Which kinds of impacts are deemed to be within the scope of the assessment and which were outside it?

• What counts as evidence and how much is needed?

• How should the available evidence be interpreted?

• How should uncertainties be addressed? And

• How should precaution be applied?

However, differences in the way that risk managers ask these questions can result in different risk assessment policies across countries. Millstone et al argue that these differences in risk assessment policy can explain the trade conflicts that arose over beef hormones, recombinant Bovine Somatotropin and GM maize. They state that: “Risk assessment policy judgements have routinely played a key role in risk policy-making processes, but they have often remained implicit, unacknowledged and unexamined.” This highlights that risk is not a concept amenable to the kind of global objectivity associated with research science.

The cloak of objectivity

In the EU, the European Food Safety Authority (EFSA) plays a significant role in establishing risk assessment policy through the development of what it calls ‘Guidance’. Guidance documents are presented as ‘Scientific Opinions’ made by independent scientific experts who sit on permanent Panels with the support of EFSA staff. EFSA has a policy on public consultation and frequently holds public consultations in the development of Guidance. However, participants are not allowed to raise any ‘policy’ issues – they can only make scientific comments on a draft scientific document. Any policy-related comments that are made through the consultation process are not considered. For example, in the guidelines for the public consultation held in 2012 on the Guidance on the Environmental Risk Assessment of Genetically Modified Animals, EFSA states that “a submission will not be considered if it is related to policy which is out of the scope of EFSA’s activity”.

It’s true that EFSA, as a scientific body with responsibility for risk assessment and risk communication does not have the ability to consider policy issues. It is the European Commission who is the risk manager (policy-maker) and, according to Codex rules, it is the Commission as risk manager who should have responsibility for risk assessment policy-making.

When the European Commission and EFSA frame the Guidance as a scientific document, value-choices are not open to public scrutiny and debate. Frustration with this “cloaking” of values has been raised frequently in the academic literature and appears in submissions to EFSA’s public consultations – for example; see submissions in response to the draft Guidance on the risk assessment of food and feed from genetically modified animals and on animal health and welfare aspects.

Democratisation of science

When people talk of the ‘democratisation of science’, a phrase which raises alarm bells for many scientists, this is often what is being referred to: the democratisation of *regulatory* science, rather than research science.

The problem that we face is the claim by scientists and policy-makers that the scientific opinions developed through regulatory science are objective and free of values. This claim closes down the possibility for debate about values. What’s needed is a de-cloaking. We need scientists and scientific bodies like EFSA and the European Commission to acknowledge that objectivity is hiding implicit values in regulatory science, to open up these value choices to deliberation by a broader range of voices to debate the full range of issues. After all, the EU has already committed to developing risk assessment policy, but it’s failing to recognise what counts as risk assessment policy.

Posted in biotechnologyGM FoodGMOsinnovationPoliticspublic engagement with sciencepublic participationpublic policyregulatory scienceriskScience and Governmentscience and politicsScience Policytechnology