David BYRNE: Risk and Governance - World Congress on Risk Society for Risk Analysis (SRA) Brussels, 23 June 2003

Brussels, 23 June 2003

Ladies and Gentlemen,

First may I express my thanks to the Society for Risk Analysis for the invitation to appear before you here today.

Risk, and more particularly the management and communication of risk, is a subject of great interest to me. I warmly welcome the SRA's initiative in bringing together such an impressive array of experts from right across the globe.

This is an area where greater international understanding and co-operation is not only desirable but essential to harness greater consensus as regards the practical application of risk analysis.

My address today is entitled "Risk and Governance." It is fitting that I have been asked to share this topic with Dr John Graham a European perspective followed an American one.

Differing attitudes, lifestyles and habits across different cultures, and also differing relationships between governments and their people, give rise to significant variance in the way that risks are perceived.

As European Commissioner for Health and Consumer Protection I cover a wide range of responsibilities from food safety through consumer protection to public health. The use of risk analysis has become ever more central to policy making within the European Union.

I do not intend today to focus on risk theory. You after all are the experts in this field. Instead I will focus on some of the political and societal aspects of risk analysis.

I will focus on three specific areas to illustrate differing aspects of risk in relation to governance and our approach to regulation:

• First SARS, Severe Acute Respiratory Syndrome and the general threat of communicable diseases and emerging risks.

• Second food safety how we use a science-based approach to ensure protection of citizens and how we address the vital aspect of risk communication.

• And third biotechnology and in particular the contentious issue of GMOs a subject never far away from the headlines and one where international tensions run high.

SARS

I decided to start with SARS as this serves as a stark reminder of the vulnerability of global society to new or recurring biological threats to public health.

The SARS epidemic can and must serve as a wake-up call to the entire world.

If this sounds in any way alarmist let me recall the situation that occurred in the early part of the last century. In 1918, at the end of the First World War, a seemingly normal strain of influenza suddenly turned so deadly and struck with such speed and devastating effect that many thought the world was coming to an end.

The Spanish Flu pandemic of that year accounted for the deaths of between 30 and 40 million people striking young healthy adults more than the very young, very old or infirm.

Today of course the science of virology and the development of medications are far more advanced than they were nearly 100 years ago. The threat of influenza is certainly nothing new but perhaps one that is not often given the priority and profile it deserves.

Add to that the significant increase in international travel and the possibility of another serious global public health event comes sharply into focus.

SARS is an example that society and governments should raise awareness of emerging risks .

And effective risk communication has played a crucial role in getting the public to become actively aware of the risk and to take the necessary action such as seeking urgent medical advice if they feel they may be affected.

The SARS epidemic has underlined the need for increased vigilance and ever closer networking on a world-wide basis to identify and communicate health risks and to co-ordinate swift, appropriate and effective responses to potential threats.

I am pleased to say that the European Commission will shortly propose the establishment of a European Centre for Disease Control aimed squarely at addressing these very concerns.

I have been planning this initiative for some time and recent events have simply highlighted its relevance and importance.

The Centre will co-ordinate expertise on communicable diseases and provides for a structured and systematic approach for the control of such diseases. It will also strengthen co-operation with international partners such as the WHO.

The Centre will provide policy makers and citizens with authoritative scientific advice on health threats and will recommend appropriate control measures, thus enabling an effective and timely EU-wide response to emerging threats.

Before concluding on this point, I should note that the heightened threat of bioterrorism that exists today has naturally raised public concern about both communicable and non-communicable diseases.

Naturally occurring threats tend to enter public consciousness mainly when an actual threat emerges such as in the case of SARS.

The challenge in terms of governance is to ensure a high level of preparedness to deal with future health threats whatever their source, and the capacity to ensure that this preparedness can be rapidly translated into effective action.

Food safety

I would now like to turn to another area of particular public interest that of food safety and examine how we in the European Union have developed a modern risk based approach with the clear aim of ensuring the very highest standards of safety for our citizens.

First I should briefly recall that the European Commission embarked, in January 2000, on an ambitious and far-reaching programme of actions designed to introduce a new food safety system fit for the demands of the 21 st century.

This action was, in part, prompted by a succession of high profile food scares which had had the cumulative effect of provoking a drop in consumer confidence in the food supply in Europe.

This new approach included a thorough overhaul of the vast body of food safety legislation that had been built up over previous decades.

Another key aspect was to re-examine our general approach to risk and in particular how we address the specific inter-related elements of risk assessment, risk management and risk communication.

Up until the late 1980s decisions on matters of food safety were taken within the European Union on the basis of a wide range of contributory sources. The introduction of European Scientific Committees sought to introduce a more defined and structured approach to the decision-making process.

However, this system was still very much "in house" and, while built on excellence and independence, lacked public transparency. One of our key achievements has been the creation of the European Food Safety Authority , which is now up and running and on course to take on the full range of its functions during the course of this year.

From the outset we made it clear that the role of the Authority must be defined in the context of the process of risk analysis which comprises risk assessment, risk management and risk communication.

EFSA is truly independent. The Authority has particular responsibility for risk assessment and risk communication. But unlike, for example, the FDA in the United States, the EFSA does not have a regulatory function.

The aspect of risk management remains the responsibility of the European institutions the Commission, the Parliament and the Council as appropriate. This division of responsibilities is crucial, as it is these political institutions that are accountable to the European population.

The activities of the Authority are based on the principles of the highest levels of independence, of scientific excellence and of transparency. It will co-ordinate the efforts of the network of national food safety authorities in the Member States. It will endeavour to reconcile the views of experts where these diverge. And will publish its advice so that citizens will have access to the information which underpins regulatory decisions.

Equally visible will be the actions the European legislator takes in response to EFSA's advice. If such actions depart from the advice given by EFSA this will be clear for all to see.

Interest in risk analysis has undergone a massive upsurge over recent years. Much of this has stemmed from the rapid development of science in recent decades resulting in a virtually exponential increase in knowledge and information.

This does not, however, lead inevitably to an easier life in terms of regulation. Indeed some advances can lead us to re-examine our regulatory approach.

For example, earlier regulation of potentially toxic substances sought to eliminate entirely their presence in food. A zero tolerance approach in other words, as famously encapsulated by the Delaney clause in the United States. With the further development of highly sensitive analytical methods in some cases what may have been zero yesterday can today be easily and accurately measured.

So rather than embark on an unnecessary attempt to redefine what we mean by "zero" in such circumstances, we have to reflect further on how the regulatory system should address the occasional presence of minuscule amounts in the light of their possible effect on human health.

Risk assessment can guide us in making such crucial decisions and indeed has become an increasing important tool in the development of sound regulation.

Precautionary principle

Sometimes decisions need to be taken urgently without waiting for the full scientific risk assessment. It is circumstances such as these where the precautionary principle comes into play. This is worth exploring briefly as it remains a source of considerable controversy and also of mistrust and misunderstanding.

In essence the precautionary principle is the application of simple common sense. It is a legitimate regulatory tool to be used in particular circumstances such as where a risk is identified but the scientific consensus is uncertain as to either its nature or its extent.

Those of us in public office entrusted with public safety have a moral duty to respond and not wait for our worst fears to be realised.

But and this is of great importance we make it clear that the principle can only be invoked when certain preconditions are met:

• Potentially dangerous effects have been identified;

• Scientific evaluation does not allow the risk to be determined with sufficient certainty; and

• There has to be an objective evaluation of the available data.

In other words the principle cannot be used on a political whim as a pretext for unjustified measures. Furthermore, any subsequent measures must be proportionate and not exceed those required to achieve the desired level of health protection with due account being taken of technical and economic implications.

Finally, any such measures must be provisional, to allow time to obtain a full risk assessment upon which definitive measures can be based.

Much of the mistrust and misunderstanding surrounding the precautionary principle stems from its unjustified citation to support arbitrary or blatantly political decisions.

Let me state categorically that this is not our approach and we strongly reject any such abuse.

The European Commission has long held the view that guidelines on precaution should be developed at international level to promote a common understanding on how to assess, appraise, manage and communicate risk where science is not yet fully able to evaluate it.

We strongly support the development of guidelines for the application of risk analysis policies by governments, including the use of the precaution, by international organisations such as Codex Alimentarius.

GMOs

Ladies and Gentlemen, I am sure you would agree that no speech from me on the subject of risk and governance would be complete without some mention of GMOs.

This issue centres on the intriguing topic of risk perception a subject to which we are planning to devote a major international conference in December of this year.

I think it is fair to say that the societal aspects of risk are the most difficult to predict. Perhaps this is not altogether surprising if we, as individuals, consider our own attitudes towards the risks we encounter in our daily lives.

On the face of it, these are often inconsistent. We might run across a busy road for example, drive too fast if we are late or even just impatient, or our dietary habits may expose us to the risk of disease. Some of us choose leisure activities with a high level of personal risk. Yet conversely we might not feel inclined to accept activities and concepts where the estimation of risk is deemed to be very small.

This is precisely what, on a broader scale, can be seen in the attitudes of European citizens towards green biotechnology in general, and GMOs in particular.

The results of the latest Eurobarometer survey on "Europeans and biotechnology" provide food for thought. Overall, in a sample of over 16 000 citizens across the Member States, 44% of those who expressed an opinion were optimistic about biotechnology, 17% pessimistic with the balance of 39% neither optimistic nor pessimistic. The "don't knows" amounted to 25% of those asked.

However, beneath these headline figures, a clear difference emerged between medical applications, for which support was relatively high, and agricultural and food applications, which were not widely supported.

Public perception of risk can be difficult to predict and even more difficult to explain. Frequently it may seem to fly in the face of logic and rationality. Why is it that biotechnology is broadly trusted in the medical domain but regarded with such a large measure of suspicion in other areas? Perhaps part of the answer lies in the lack of a perceived benefit in agricultural and food applications.

The issue of GMOs is amongst the most striking and indeed high profile examples of exaggerated risk perception within European society.

Politically it has proved very difficult to gain a consensus on this issue. In November last year, we finally managed to reach agreement with the European Member States on draft legislation dealing with food and animal feed containing or derived from GMOs.

This was no mean achievement. We needed to ensure that our proposed authorisation system is in line with the latest scientific and international developments.

If we are to see an increase in the currently low level of consumer confidence in GMOs, it is nothing short of essential to get the basic framework absolutely right.

I must at this point make it absolutely clear that I deeply deplore scaremongering about GMOs. Every GMO authorised in the EU has been evaluated for its safety by independent scientists. There are no known adverse effects on human health from GMOs.

However, it is plain for all to see that public unease about GMOs, despite scientific reassurance, still remains and our citizens have made it abundantly clear that they want food produced from GMOs to be properly labelled.

So this is precisely the route we have proposed as a practical response which offers citizens the choice that they so clearly demand.

Against this background and given the significant progress we have made on this difficult issue, I believe it to be unnecessary that this subject has become the focus for a challenge within the WTO.

And regardless of the outcome of this challenge in the WTO, the effect of such a public dispute is, I am afraid, only likely to harden European consumer attitudes towards GMOs, not soften them.

Conclusion

To conclude, I very much hope that we can learn lessons from current events and move forward to greater understanding of risk in the future.

I started with a section on SARS an area where it is clear that international co-operation is absolutely essential. Equally important is the need to foster greater understanding and to exchange ideas in other areas connected to the management of risk.

This conference is an admirable initiative and a useful opportunity for experts from all across the globe to explore how we can learn from each other towards the ever more effective use of risk analysis in future.

Thank you.

DN: SPEECH/03/317 Date: 23/06/2003