An agenda item for GACS ‘risk assessment policy’ oversight Erik Millstone

1. An agenda item for GACS ‘risk assessment policy’ oversight Erik Millstone SPRU – University of Sussex e.p.millstone@sussex.ac.uk

2. One question for today was framed as: • 'Why should we trust what scientists say about food?' • I shall rephrase that question as: • ‘Under what conditions should citizens trust what FSA expert advisory committees say about food.’ • Science is not monolithic, scientists do not speak with one voice.

3. ‘Trust’ in expert scientific advisory committees has at least 2 dimensions: • 1. ‘technical competence’ and • 2. ‘alignment of social interests’. • Those variables are substantially independent of each other; both are vital. The first does not guarantee the second. • Expert advisors in such contexts cannot be on ‘everyone’s side’ or on ‘no-one’s’ side.

4. This poses the question: • how can we understand the role of scientific advice in food policy-making, or more generally in risk policy-making? • To answer that question I provide several schematic models that have been used both descriptively and prescriptively.

5. Public policy-makers, such as government ministers, often used to claim that policies to regulate food safety risks are always and only based on ‘sound science’. But how realistic was that?

6. Model 1: the technocratic model policy is based (only) on sound science (cf MAFF’s mythical narrative) Policy Making Science (= facts)

7. The technocratic model has been torpedoed by the obvious fact that science evidence is often incomplete, equivocal and uncertain. • From 1986 to February 1996, we did not know whether or not BSE could cause CJD. • The carcinogenic risks from saccharin are quantifiably uncertain (0.22 to 1,144,000, extra cases of cancer in US popl. from ~70mg/cap/day) • The local impacts of climate change, or of cultivating GM crops, are uncertain and contested.

8. Even if per impossibile all scientific uncertainties were eliminated, science still could not decide food safety policy. • Policy judgements are concerned with the acceptability of possible risks in exchange for anticipated benefits, and those are socially variable value judgements – they are policy matters, not scientific issues.

9. Model 2 - USA/OECD/EuroComm Red Book decisionist model (= conventional official orthodoxy) Risk assessment Risk management Risk communication Science Values and practicalities Social science

10. That model is flawed because the source of many of the uncertainties are the non-scientific assumptions that frame risk assessments, which Codex’s calls ‘risk assessment policy’.

11. For example, what should be the scope of the assessment of the risks (and maybe benefits too) of eg GM crops – short-term and direct effects or also longer-term and indirect effects? • For food additives – just toxicological effects or also behavioural and/or nutritional effects? • What kinds of studies should be conducted and which kinds of data should be included and/or discounted? Only peer-reviewed and published or also unpublished studies and/or anecdotal reports?

12. How should data be interpreted? Should rodent studies be treated as a good model for humans? 400 rats for 50 million citizens? • Anticipate false +vs &/or false –vs? • Those are policy questions about science, but not questions that science can answer. • In practice, however, policy-makers often left it to scientists to decide those matters.

13. But the CODEX Alimentarius Commission (in 2003) and all its Member States incl. the UK (in 2007) abandoned the Red Book Model in favour of what science policy analysts called a co-evolutionary model – ie a model in which science and policy-making mutually influence each other. • The key change was marked by the introduction of the concept of ‘risk assessment policy’.

14. Model 3 - the co-evolutionary model: reciprocal links between science and policy Socio-economic and political factors Scientific factors Technical, economic, social and political factors - Policy-making aka Framing assumptions: risk assessment policy Expert Assessment Risk management reciprocal communication

15. Codex refers to Risk Assessment Policy in the following terms: “Determination of risk assessment policy should be included as a specific component of risk management. Risk assessment policy should be established byrisk managersin advance of risk assessment, in consultation with risk assessors and all other interested parties… The mandate given by risk managers to risk assessors should be as clear as possible.”

16. Risk assessment policy has three main elements: substantive procedural and interpretative and they are interdependent.

17. The co-evolutionary model indicates institutional structures and procedures through which policy-making can become both democratically and scientifically legitimate.

18. FSA’s procedural RAP guidance

19. Food Standards Agency, 2002, Report on the Review of Scientific Committees, 15 April 2002, said: • “Chairs of [FSA] advisory committees …[should ensure]…that the proceedings of the committee...are properly documented…so that there is a clear audit trail showing how the committee reached its decisions....committee decisions should include an explanation of where differences of opinions have arisen during discussions and why conclusions have been reached...They should also explain any assumptions and uncertainties that are inherent in their conclusions.”

20. A key agenda item for the GACS therefore is to ensure: • that all FSA expert advisory committees are provided with explicit risk assessment policy guidance by the FSA Board, and • that the committees can be transparently seen to be acting in accordance with that RAP guidance, esp. procedural guidance.