Public health is the bottom line

This article is written is response to an opinion article by Paul Leonard

The scientific opinions on risk published by the European Food Safety Authority (EFSA) determine the commercial fate of hundreds of products in very large economic sectors. As such, they are absolutely strategic to the companies affected by its decisions. 

I cannot confirm or deny Paul Leonard’s observations about the experience and expertise of the experts involved in the EFSA’s opinion on neonicotinoid pesticides; but I find it striking that it took a decade of accumulating evidence for the EU to issue its very limited ban. Still, Bayer and Syngenta complain about the EU using ‘bad science’ and are suing it at the European Court of Justice. Meanwhile, they lobby the EU’s member states to obtain derogations to the ban.

The EFSA, by law, must be independent, but ‘independence’ in itself does not mean much. Since EFSA’s main task is regulating industry products, and industry’s chief interest is to have its products authorised, independence from companies falling under its remit should be the EFSA’s primary concern. While having links to industry does not compromise intellectual honesty, having such links while sitting on an EFSA panel is a situation of conflicting interests, and there the literature is clear: financial conflicts of interest tend to bias the objectivity of studies and reviews.¹ Leonard argues that no science is independent and this is true (we are all biased), but there are certain biases that public health-driven risk assessments just cannot afford to have. 

The global risk assessment regime is not fit for purpose

Conflicts of interest need not prevent the EFSA accessing essential expertise – it can still use ‘hearing experts’: specialists who contribute their knowledge to the risk assessment process, but do not take part in drafting the panel’s opinion. Unfortunately, the EFSA does not use this possibility much. Worse, last time we checked (April 2012),² almost 59% of scientists on its own panels actually had links to the companies it regulates. Moreover, by letting individual experts bear the responsibility of their declarations of interest and by hardly checking these documents’ content, the EFSA de facto lets individuals bear the burden of its independence and take the blame whenever there is a conflict of interests scandal.

Our understanding is that the EFSA’s limited resources leads it to sacrifice its independence to operational constraints – members of its panels are not even paid. Its independence from industry is also limited by the EU’s research policy, Horizon 2020, whose objectives were largely influenced by big business lobby groups. As a consequence, academics are now forced to establish partnerships with industry to access EU research funds, and that funding is focused on development. In nanotechnology, for example, about 95% of the EU research budget will go to product development and only 5% to risk assessment. None of this, however, can excuse the EFSA’s lack of independence.

A food safety agency’s credibility is not only about the independence of its experts. Leonard’s call for ‘robust criteria for scientific evidence … for policy and decision making’ echoes a long-neglected but finally growing debate on the quality and reliability of the global risk assessment regime. While absolute certainty is never possible, guarantees must be given that it delivers the highest possible degree of objectivity and comprehensiveness, and precaution when knowledge is missing. Yet the existing regime is not yet fit for purpose, and not only because technology develops much faster than the understanding of its effects. 

There is growing criticism from scientists outside the community of regulatory toxicologists, as well as from civil society organisations, about the rigidity and narrowness of the test protocols, indicators, statistical tools and, critically, criteria for using toxicity data in regulation.³ One example is the so-called Klimisch score for rating scientific studies, published in 1997 by a BASF scientist and favouring studies that follow rigid and expensive experimental guidelines: good laboratory practice (GLP). The problem is that GLP was not developed as a measure of scientific reliability but, ironically, to combat industry fraud. GLP is useful for its original goal, but misusing it as a validity metric actually excludes legitimate peer-reviewed science because compliance is so expensive that few scientists financially independent from industry can apply it. This also keeps out SMEs, stifling innovation and creating oligopolies – economic players large enough to have strong political influence, which in turn further secures their market positions.

Perhaps the most serious flaw in the current risk assessment regime is that regulatory toxicology is a discipline largely developed, funded and performed by industry. While it is proper that the cost of a products’ assessment is borne by those who profit from it, having them actually perform the assessment subverts the social mission. Industry’s toxicity studies try to avoid false positives (showing harm where there isn’t) rather than false negatives (not showing harm where there is); they demonstrate products’ safe uses rather than fully test their possible toxicity. Public risk assessment should work the other way around.

Also, because industry considers its data to be market sensitive (especially for new products), it limits and even forbids data being published. This prevents the public from seeing critical information and the scientific community from testing the results. 

One could hope that the overall risk assessment regime evolves towards the normal practices of science (reproducibility and data transparency) and benefits from increased independence, freedom and resources, but such ideal scenarios are a long way off. Meanwhile, in a context of information asymmetry, significant isolation from the academic scientific community, insufficient resources and industry pressures, the EFSA’s independence policy is pretty much the only tool it has to defend the reliability of its work. 

Martin Pigeon is a researcher and campaigner at Corporate Europe Observatory

This article is written is response to an opinion article by Paul Leonard