Getting EU risk assessment for protecting environment and health to achieve its legal objectives. Escaping reductionist fallacies

A series of three webinars organised by the European Network of Scientists for Social and Environmental Responsibility (ENSSER)

Thursdays 17 and 24 September and 1 October 2020

16:00 – 17:30 Central European Summer Time

 

European regulatory systems are often portrayed as some of the best in the world in terms of stringency and precaution for protecting public and environmental health. The laissez-faire deregulatory approach of the USA is often portrayed as standing at the opposite end from the EU on a spectrum of regulatory rigour. We recently published a paper[1] critiquing how European legislation on the regulation of agricultural GMOs (genetically modified organisms) is framed and how the European Food Safety Authority (EFSA) – with the blessings, indeed influence of the EU Commission – assesses the risks of agricultural GMOs. In this paper, we highlighted how EFSA’s risk assessors assume a simplistic reductionist model of the ways in which harm might arise. In the end, strikingly, the practical outcome of their risk assessment and the required documentation for GM foods is similar to that of the US deregulatory system. How is that possible?

Moreover, this reductionistic approach to assessing risks and the corresponding reductionistic interpretation of European law, is not limited to GMOs but forms the foundation of many different regulatory regimes, such as those for pesticides, food ingredients, food additives, the environmental release of chemicals and even pharmaceutical products. Reductionism is treated as if it is authoritative because it can provide apparently precise answers by using standardized protocols. However, this precision is achieved at the cost of failing realistically and fully to assess the risks that arise, beyond the walls of the laboratories, in the complexities of actual practices in the real world. Assessing individual compounds in isolation may facilitate international regulatory harmonization, which can help to overcome non-tariff barriers to trade, but it fails to ensure the protection of public and/or environmental health.

With this set of webinars, we wish to deepen and extend the analysis in our recent paper on reductionism in EFSA’s assessments of the risks of GMOs, to show how similar approaches have been applied to other fields of regulatory appraisal, and how, time and again, they also fail to protect us from harm. We will conclude by explaining what can and should be done to overcome these failings, and thereby also help to make EFSA’s science meet its EU legislated objectives.

To do so, we will hold a set of webinars that will highlight EFSA’s inadequately narrowly framed assessments of the risks from GMOs, pesticides and food additives, and provide an explanation of: why EFSA has chosen to take what are unnecessarily reductionist scientific approaches; what a more comprehensive and acceptable framing might look like (including what complementary policy measures from EFSA’s policy client the EC, might be required; how this could be implemented; and what consequences could be anticipated).

The series of webinars is held for an audience with an interest in regulation, risk assessment and the science/policy interface from all sectors. The speakers have contributed in various forms to all these aspects over the course of their careers. No foreknowledge is expected of participants.

The webinars are held in English on zoom. They will be moderated by Diederick Sprangers, scientific coordinator of ENSSER.

Participants are invited to either enter into discussion with the speakers or submit written questions during the webinar. The webinars will be live streamed and recorded and the recordings will be put online on ENSSER’s website and on ENSSER’s youtube channel. Participants entering the oral discussion will be requested to state their name and affiliation. By registering for a webinar, participants give their permission to publish and livestream their recorded oral remarks and their video image online.

Written questions will only be answered when the questioner adds his/her name to the question (which will happen automatically if they provide their name upon entering the zoom webinar). However, the name will not be read aloud when the question is dealt with, to avoid having to gain permission from the questioner for publishing the name and the question.

In addition to zoom, the webinars will also be broadcast by livestream on youtube. Written questions may also be entered in the livestream (on the same condition that the name of the questioner is added), but oral participation in the discussion can only take place via zoom.

 

Programme:

 

Thursday 17 September 2020, 16:00 – 17:30

Science in policy-making to protect public and environmental health

Speakers:

Prof. Erik Millstone, Science Policy Research Unit, University of Sussex, UK

Prof (em.) Brian Wynne, Lancaster University, UK

Dr. Angeliki Lysimachou, Pesticide Action Network Europe

 

The webinar will begin with a chronological and critical review of the main ways in which the role of science in public policy-making has been understood. A crucial problem with many of those interpretations has been that too often they have assumed that scientists can routinely provide robust and definitive grounds for settling policy questions. Another has been the assumption that scientists all ‘speak with one voice’, when in practice the facts are often uncertain, knowledge is incomplete and there is rarely a consensus within the scientific community on key policy-related issues.

The discussion will be illustrated with examples of how the European Food Safety Authority (EFSA) interprets its mandate to provide the European Commission, the Parliament and the Member States with scientific advice on food safety and environmental protection. That discussion should provide an introduction to, and a framework for analysing several case studies, namely: agricultural GMOs, agricultural pesticides and food additives.

The main structural features of the legislative and regulatory regimes covering those domains will be outlined, highlighting the roles that EFSA and the Commission are expected to play; it will focus on the supposed division of labour between science and policy-making.

The remainder of this webinar will focus on the activities and practices of EFSA and the European Commission and Member States in relation to pesticides and food additives. Those case studies show that EFSA’s panels have been framing their risk assessments with very narrow sets of assumptions about how adverse consequences could occur. Consequently we will show that EFSA’s assessments are typically incomplete and incompatible with the EU legislative and policy goals, such as providing high levels of protection and taking a precautionary approach.

 

Thursday 24 September 2020, 16:00 – 17:30

GMO regulations and their interpretation: how current risk assessments of GMOs are bound to fail

Speaker:

Dr. Angelika Hilbeck, ETH Zurich, Switzerland

 

Firstly, we compare the contrasting regulatory approaches of the US and the EU and explain their different underlaying scientific premises. While the legislative texts of the EU set appropriate objectives, their concrete implementation has fallen far short of the legislative goals. EFSA’s prevailing approach to GM crop and food risk assessment starts from what it terms a ‘comparative safety assessment’ (called ‘substantial equivalence’ in other regulatory regimes) which is based on rudimentary data sets of molecular, chemical and phenotypic data from GM plants and any non-GM varieties. Those data are inadequate (and designed) for predicting adverse biological, toxicological and ecological effects. However, when GM products are deemed to have passed a ‘comparative safety assessment’ prior to the risk assessment step, EFSA has interpreted that as grounds for conducting only very narrowly circumscribed risk assessments (if at all), which do not require meaningful data from studies of ecological or eco-toxicological impacts. This allows in the end that, despite the contrasting regulatory premises and goals, under both regulatory regimes of the US and the EU, similar dossiers seeking approval or deregulated status (as it is called in the US) can be filed – much to the convenience of the industry but not in the public interest. How this may play out if the current push for taking newly genetically engineered organisms (using so-called ‘gene editing’ tools) out of regulations succeeds and what the consequences of the ‘no transgene – no risk’ mantra will spell for human and environmental health will also be presented and discussed.

 

Thursday 1 October 2020, 16:00 – 17:30

Towards better EU science which also helps meet democratic legislative objectives for protecting environmental and public health

Speaker:

Prof (em) Brian Wynne, Lancaster University, UK

 

We have focused previous sessions and topics on the undue scientific reductionism which undermines risk assessment (RA) in regulatory decision-making in the EU, and in particular misses possible harms from the many kinds of products supposed to be regulated so as to ensure high EU standards of public health and environmental protection.

Many of these reductionist scientific choices by EFSA and related regulatory scientists are from within the science. What is never recognised by those institutional authorities, claiming to uphold the best scientific standards, is that these are choices, with other scientific options available. They are not, as often claimed or assumed, ‘the only (good science) option’. Policy bodies like the European Commission (EC) which both funds EFSA’s work and uses its “independent science”, already influence that science with normative policy choices, such as burden of proof, framing questions (and thus also, questions excluded). Reductionism in scientific options may provide precision. Precision can be desirable, and sometimes necessary as priority scientific goal; but it is not the only goal. Realism and scope are two other important science goals, which often conflict with precision, and need to be negotiated in different situations in which science is used. Science for environmental and public health goals, such as EFSA science, should prioritise realism, and as comprehensive as feasible, because EU legislation stipulates that cumulative, indirect, long-term, and interactive multifactorial harms should be included within the scope of EFSA’s risk assessments. Existing EFSA science shows itself to have failed to address those legislative requirements.

In this final session led by Brian Wynne, we will review not only the scientific alternative options for avoiding the harms from the prevailing culture of reductionism which has damaged EFSA’s science and undermined public trust in the EU’s processes, decisions and institutions. We will amplify this part of the overall picture with an account of what further changes will be required to improve EFSA’s risk assessments and its culture, and thereby enhance it contributions to the EU legislative aims, and especially the EU’s explicit policy commitment to implementing the Precautionary Principle (PP). We will also show the falsehood of the EC’s claim that the PP is only relevant to post-RA risk management, but not to RAs. Despite claims to the contrary, science is not intrinsically precautionary; science-based risk assessments can be more or less precautionary, depending on their framings. Risk assessments have prior policy choices inherent in their framings, and those are known as ‘risk assessment policies’ (or RAPs). The EU (and all its member states) have signed up to making their risk assessment policies explicit in the UN FAO/WHO Codex Alimentarius Commission’s 2007 policy declaration, but those commitments are not being honoured. Legitimate and publicly trusted EFSA science would also require these currently covert EC policy choices to be made explicit, and taken by properly accountable processes by risk managers rather than risk assessors. Proper implementation of those commitments would help EFSA’s science to become more open, comprehensive, precautionary and trustworthy.

[1]    Angelika Hilbeck, Hartmut Meyer, Brian Wynne and Erik Millstone: “GMO regulations and their interpretation: how EFSA’s guidance on risk assessments of GMOs is bound to fail”, Environ Sci Eur (2020) 32:54, https://doi.org/10.1186/s12302-020-00325-6