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Regulating Uncertainty: The European Food Safety Authority and GMOs

By Charles Ebikeme

In September of 2012, a paper published in Food and Chemical Toxicology, garnered widespread media attention. The paper documented how rats fed a particular line of herbicide-resistant maize showed higher tumour and mortality rates over the two year study period. The study by Gilles-Éric Séralini advocated the banning of genetically modified organisms (GMOs). In the end it has been criticized by various regulatory authorities and scientists, retracted before being republished in June of this year.

The study is an example of how the public, policy makers and the media take an active interest in many issues related to the aims, outcomes and implications of science.  A special session on Science in Society at FEBS EMBO brought together many different angles on safety and security in the biological sciences, and reflections on the responsibilities of all those involved.

One organisation that sits at this intersection is the European Food Safety Authority. Elisabeth Waigmann spoke to the late Sunday FEBS EMBO crowd on the role of the EFSA and risk assessment of genetically modified organisms. Indeed, the EFSA’s review of Séralini’s paper outlined its limitations.

Elisabeth Waigmann gave more insight into how the EFSA undertakes its risks assessments, performing them with regard to human and animal health as well as the impact on the environment. In the case of GMOs, it operates under the technological definition.

For science that is rapidly moving — technological advances not only to methods but also to the ways in which we use science to change to the plants and animals we eat, EFSA must provide guidance.

In 2012, the European Commission requested the EFSA Panel on GMO deliver a scientific opinion related to risk assessment of plants developed using the zinc finger nuclease 3 technique (ZFN-3) which allows the integration of genes in a predefined insertion site in the genome of the recipient species.

Repair_outcomes_of_a_genomic_double-strand_break_for_ZFN_cleavage
“Repair outcomes of a genomic double-strand break for ZFN cleavage” by Dana Carroll – Carroll, D. Genome engineering with zinc-finger nucleases. Genetics Society of America, 2011, 188(4), pp 773-782. Licensed under Creative Commons Attribution-Share Alike 3.0 via Wikimedia Commons

The opinion given is always a measured one. “How far do you go in the risk assessment and how to appropriately convey risk?” is the key question she asks. Interestingly, the EFSA’s opinion is never the definitive answer. She suggests that the assessment of risk is much more of a societal question that a purely scientific one. It is up to society at large to fully evaluate the risk.

What this alludes to is a tension between prevention and precaution, the central issue behind Patrick Rüdelsheim’s presentation. A talk on biosafety highlighted some of the problems and issues in dealing with known hazards (prevention) versus the uncertainty of the unknown (precaution).

Biosafety is an evolving field. Biosafety is becoming increasingly more evidence based. But is often hampered and held back by the fact that it is sometimes formulated in legal terms.

Normative imprecise policy language makes biosafety difficult to quantify and measure. Patrick Rüdelsheim ended with a call for more scientists to get involved and to express their interest. After all, if science is to be a part of society then so should the scientists that do it.

Views expressed in this blog post are those of the author and not necessarily shared by PLOS.

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Charles Ebikeme is a science journalist with a PhD in parisitology who serves as a Science Officer with the International Social Science Council of UNESCO and writes frequently on global health, health policy, neglected tropical diseases and infectious diseases for The Huffington Post, The Guardian, Scientific American, and Think Africa Press. He is based in Paris. You can find him on Twitter @CEbikeme.

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