Viewpoint: With European risk management at a crossroads, can reason prevail?

As Daniel Patrick Moynihan, American politician and diplomat famously put it, “You are entitled to your opinion. But you are not entitled to your own facts.”

But it seems to me that opinions, unsupported by facts, seem to have held sway in a series of recent decisions by Europe’s regulators and judges.

Compelling evidence provided by scientific studies, with clear protocols that enable results to be verified, has been set aside in favour of “informed opinion”.

The fundamental insight of Paracelsus, the concept that the dose makes the poison, is ignored when precaution replaces risk evaluation as Europe makes major decisions about managing risks to human health or the natural world.

In July this year, judges at the European Court of Justice ruled that the new and highly controllable Crispr techniques of gene editing must be treated as if they were the equivalent of older and far less controllable genetic engineering methods used to create first-generation genetically modified organisms, such as pesticide resistant corn and cotton.

The ruling will prevent the use of Crispr in targeted development of new crop plants with desirable traits.

It is not clear what scientific evidence drove the decision, or how this was weighed against the potential loss for innovation in Europe. In the US and in China, modern gene editing tools have been deemed safe for this type of use and for use in products for human use.

The decision of the European Court was presumably justified on precautionary grounds.

Other decisions demonstrate a similar approach. Availability of crop protection products in the EU is being cut back because an EU law from 2009 imposes hazard-based cut-off criteria that fail to consider at what level human exposure is likely to occur.

Exposure and risk, the fruits of toxicological knowledge developed over centuries through the application of reason, are not considered. Continued widespread use of phthalates, pesticides, and bisphenol-A remains under review because of national restrictions unjustified by high quality science. Despite countless high quality studies demonstrating its safety, glyphosate remains under threat, following the International Agency for Research on Cancer’s deeply flawed hazard-based assessment.

Noble heritage

Many observers may take the view that these decisions are simply an expression of the spirit of the European people. This is a reasonable argument - precaution has a noble heritage as a doctrine to guide governments when they must make risk management decisions in the absence of data - regulation of drugs, design of aircraft and bridges, assumptions about the dose-response relationships in humans derived from animal studies, all are guided by precaution.

The problems emerge when precautionary steps replace considered risk evaluations and the consequences of decisions are not fully considered. Plasticisers are condemned without considering how linings for tins and bottles, and the flexible catheter, intravenous lines and transfusion sets which make modern medicine possible, have all depended on the science of making compounds with variable properties.

Hazard-based cut-off criteria for crop protection products not only remove products from the market but also create barriers to trade by dramatically cutting tolerances for residues on imported goods. A recent study suggests that agricultural imports into the EU with a total value of nearly €70 billion might be adversely affected.

Similar problems could emerge if the EU attempts to place barriers on imported crops developed using new gene editing techniques.

It is troubling that Europe’s willingness to impair domestic economic efficiency and innovation is at least partly dependent on the assumption that when it comes to managing risks, feelings, opinions, and conjecture are of equal value with reason and knowledge.

There is a danger of converting the legitimate use of precaution as a risk management tool into an anti-rationalist culture of governance, where opinion and conjecture replace science and reason.

Changing direction will not be easy. Europe’s leaders should affirm a commitment to the values of the Enlightenment. None of the effective technologies sustaining advanced civilisations would be possible without validated scientific knowledge, and in the absence of this quality of information we are stuck with conjecture.

Future laws for the management of technologies should be dependent on risk rather than on hazard. Regulators can adopt robust guidelines, based on the scientific method and well-established methodologies, for protecting the integrity of scientific evidence used to support rule-making.

Risk evaluation not hazard identification is the way to protect health and to permit continued scientific development. Decisions based on hazard alone achieve neither.

Sir Colin Berry is Professor Emeritus of Pathology at Queen Mary, London.