Convergence or Divergence in the Regulation of Food Safety and Traceability in the EU and USA? Speech by Commissioner David Byrne at the Food Safety Conference in Washington

March 22, 2004

Washington DC, 19 March 2004


The profile of risk and risk-related issues has risen markedly in the last 15 years. There has been a growing recognition of the importance of proper risk management and increasing interest in how this can be best used in relation to governance.

Of the various components of risk analysis assessment, management and communication where the perception of risk fits in is perhaps the most difficult aspect to understand and evaluate. The way that individuals, groups and societies react when faced with risk situations can often be difficult to predict and indeed may appear irrational.

With a view to furthering our understanding of risk perception, the European Commission hosted a major conference in Brussels in December of last year which attracted a wide range of participants from different backgrounds to try to get to the heart of the matter.

I am delighted to have the opportunity today to widen the discussion in a trans-Atlantic forum. I am sure that there is much than we can learn from each other. One of the particular issues highlighted by our Brussels conference was the differing attitudes to specific risks which may arise in different societies and cultures. The contrast in public attitudes to GM foods and BSE are two good examples of divergent perception between Europe and the United States.

I will touch on both of these issues in the course of this address in the context of explaining the European Union's broad approach to issues of risk, in particular in the field of food safety.

Risk Perception

But first a few words in general about risk perception. We do not habitually seek out the safest route as we go about our daily lives. Some risks we regard as inevitable, part and parcel of everyday life. Some risks we actively choose for the value they add to life. There is a risk attached to almost everything we do. Even inactivity carries risk. Zero risk does not exist.

Allow me to mention briefly a few specific factors.

Risks taken by individuals that are under their personal control appear to be more readily acceptable than those which are outside their control.

Linked to this is the question of who decides on the risk. Individuals seem more comfortable with risks they decide to take on their own rather than risks which are decided on their behalf by Governments, for example.

Citizens tend to be more concerned about accidents for which, despite being relatively rare, the chances of survival are slim (such as plane crashes), while more common and random events (such as car accidents) for which the chances of survival are higher are of apparently less concern.

And benefit. What's in it for me? Why should I be asked to take a risk, however small, if I cannot see any tangible benefit from doing so? This strikes an obvious chord with the GM debate in relation to food, a subject which continues to attract significant attention, at least in so far as perceptions in the EU are concerned.

GM foods

Despite repeated scientific assurance about the safety of consuming genetically modified food products, European public attitudes towards GM foods have, to date, shown few if any signs of a thaw. The science-based message simply fails to get across, or if it does, it is ignored.

European citizens have, by and large, made up their minds. Further attempts at public persuasion might even prove to be counter-productive if citizens feel they are being leant on or otherwise coerced into changing their views.

Against this background the European policy response was essentially twofold. First we ensured that a rigorous risk assessment and approval procedure was put in place. Second, we introduced a requirement for the clear labelling of GM products. This will enable European consumers to exercise choice over whether or not they choose to buy GM products.

I know that many on this side of the Atlantic take issue with this approach, but I maintain that it is entirely appropriate and indeed the only tenable way forward in the circumstances, given the weight of public resistance to GM. I acknowledge that friends in the US find the European public's attitude to GM difficult to understand. However, our consumers demanded clear labelling and traceability as essential prerequisites.

Perhaps attitudes will ameliorate over time and with clear choice available. Indeed the availability of GM foods with real benefits could help. But despite the protestations of the biotech industry there appears to be no immediate evidence of any short to medium term benefits.

Trust and transparency

The public's reaction to GM is only one example of how Europe's consumers seek verifiable and trustworthy information about food. It raises the whole question of public trust in relation to governments and public institutions.

The structures of European democracies have shown a marked shift in recent years with the rise of the stakeholder society. At a time when interest and involvement in politics at citizen level appears to be receding, strenuous efforts have been and continue to be made to engage citizens in the processes and decisions which ultimately affect them. To make them feel they are part of the political process and not just the recipients of the decisions of others.

Clearly there is a need to develop trust. The food safety agencies, which have been established in many European countries, serve as good examples. These agencies create a credible and visible distance between different government structures with the broad aim of increasing transparency which, in turn, bolsters public acceptance and confidence.

European Food Safety Authority

It was also necessary to reinforce trust in the pan European system of food safety. In this regard, I established the European Food Safety Authority. This provides independent scientific risk assessment in respect of food safety questions, and communicates risk information to the public.

Because of the legal structure in the EU, and in line with CODEX guidelines, risk management responsibilities have not been delegated to EFSA. These remain with the Commission, the Council of Ministers and the European Parliament as appropriate.

You will hear more later today about EFSA from its Executive Director Geoffrey Podger.

Role of the media

The communication of risk to the public is of crucial importance. Of course, the media plays a major role in how the public perceives risk.

The problem for public authorities becomes one of how to transmit clear and accurate risk messages against the backdrop of certain sections of the media apparently intent on maximising hysteria.


One lesson we can learn from past experience is that conflicting messages are a major cause of destabilising consumer confidence in times of difficulty. Take the BSE crisis for example, which emerged in Europe from the mid-1990s. Indeed, BSE is an issue that has recently come to the fore in the United States.

One of the aftershock effects of the UK government's announcement of a possible link between BSE and new variant CJD in 1996 was a fragmentation of messages from public authorities and the media right across Europe which led to chaos, confusion and a meltdown in public confidence, which went far beyond the question of beef from just one country.

The beef market collapsed. People felt they had been misled.

When stringent measures were introduced to close off the possibility of potentially infected meat entering the food chain public confidence in beef gradually began to return.

Four years after the UK announcement, a similar crisis re-emerged in Germany. When BSE was finally discovered, as scientifically predicted, once again public confidence plummeted.

And in France a second BSE crisis arose in late 2000 when French citizens realised the extent of BSE. History was re-writing itself in terms of the "communications gap".

The clear lesson is that a transparent and consistent approach to risk communication is vital in gaining and maintaining public confidence and trust.

It is interesting to compare the US public reaction to BSE with the European examples I have described. The benign reaction of the US beef market and the apparent lack of widespread public concern following the discovery of the US BSE case just before Christmas shows a stark contrast in public reactions to BSE in Europe.

Why should this be the case?

Are US consumers in general prepared to tolerate the risk of BSE? Contrast this with the ultra-precautionary approach of some of the main trading partners of the US. Here we have further evidence of global divergences in risk perception and consequent risk management measures.

Reform of the EU food safety system

In Europe the reaction to the succession of BSE-related crises, together with a number of other high profile food scares, had a profound affect on overall confidence in the European food industry's ability to deliver safe food.

Despite the fact that such incidents only affected certain sectors, the entire industry suffered. A few rotten apples had effectively contaminated the whole barrel.

Regaining public trust in the European food supply therefore became a major challenge for me when I took up my position as European Commissioner with responsibility for food safety in September 1999. I embarked on a thorough root-and-branch reform of our systems to ensure that risks to the public were minimised.

But, as I have said, zero risk is an impossible dream. We needed to ensure, visibly, that where potential or actual problems are discovered, these could be quickly and effectively eliminated.


We do not have time this morning to go into all of the details as to how we set about restoring confidence. The creation of EFSA was, as I have indicated, a crucial element.

But with the food chain we needed to ensure that if something went wrong it could be quickly identified and put right. Mandatory recall (a key feature of our General Food Law) would not work without mandatory traceability which we also introduced for the first time right across Europe.

On the US side there was still the tendency to stick with voluntary recall and trace-back approaches. But in the intervening couple of years the US food industry was struck by the "Starlink" GM contamination of foodstuffs which, in the absence of mandatory trace-back mechanisms, caused significant damage in terms of confidence and costs.

Now you have had your first finding of BSE. This has fuelled demands for trace-back of related cattle. Moreover, it has brought to the fore the whole notion of mandatory animal identification which has been an essential feature of the European approach to animal health and public health for so many years.

A key element in improving the safety of the food chain has been the strengthening of our traceability measures. Too often when food crises occurred it proved extremely difficult and expensive to trace and withdraw the offending products. "Starlink" is the classic example.

So we have put a system of traceability in place that I term a "one up one down approach" requiring each operator to know the step before him in the food chain and the step after. This system of tracing goods in the food chain is not new. Many firms already had a similar system in place.

The difference in the EU from next year is that all producers will, by law, have to have such a system in place. To enable the EU of 25 Member States to have a fully integrated common market in food such a legislative system is essential.

We have witnessed animal feed contamination where huge amounts of stocks had to be destroyed, and trade disrupted, because adequate traceability provisions were not in place.

These types of occurrences provoke enormous concerns among consumers. Ensuring the confidence of EU consumers necessitates such systems to facilitate withdrawal of goods that can be traded through the 25 Member States.

In the United States, it is interesting to note a degree of increasing convergence with Europe, albeit coming from a different political direction that of the threat of bioterrorism (an area incidentally where the public perception of risk is probably higher in the US than it is in Europe).

US systems for the registration of exporters and the prior notification of imports are motivated by a desire to protect American citizens from the threat of deliberately contaminated food and food products. There is a marked similarity to European systems in this regard.

It seems to me that in traceability (no more so than in many other areas) there is greater convergence than one might otherwise think.

The precautionary principle and risk

Let me now turn to the question of precaution, as it is sometimes called here in the US, or the precautionary principle as it is called in the EU.

I have made it known on many occasions since the beginning of my mandate that I am no fan of the indiscriminate use of precaution. Precaution in this sense can be a thinly disguised trade protection measure, not to mention a badge of political cowardice.

To govern its use in the food arena, we now have legislation in the European Union Article 7 of our General Food Law (1) .

It is clear from this important Article that the principle can only be considered when certain pre-requisite conditions are satisfied.

These are:

  • There are potentially harmful effects deriving from a phenomenon, product or process that have been identified;

  • That scientific evaluation does not allow the risk to be determined with sufficient certainty;

  • There has to be an objective evaluation of available scientific data and other information before any decision is made to invoke the precautionary principle.
It is not a joker or wild card that can be played at any moment as a pretext for unjustified measures.

The second part of the Article provides the scope and limitations for the use of the precautionary principle. It provides that precautionary measures "shall be proportionate and no more restrictive of trade than is required to achieve the high level of health protection chosen in the Community, regard being had to technical and economic feasibility and other factors regarded as legitimate in the matter under consideration".

Those measures are to be reviewed within a reasonable period of time, depending on the nature of the risk to life and health identified and the type of scientific information needed to clarify the scientific uncertainty and to conduct a more comprehensive risk assessment.

I would like to stress that precautionary measures are by their nature provisional. Work must be put in place to identify new scientific data through research, data collection or other activities with clear responsibility for gathering this information being allocated so that the measure can be reviewed at the earliest opportunity.

The European Court (2) has endorsed the philosophy behind the principle and its application, and has clarified the steps that need to be followed. A public authority cannot take a purely hypothetical approach to risk and may not simply base decisions on "zero risk". Existing relevant scientific data must always be evaluated before the precautionary principle is invoked.


It is clear to me that both Europe and the US have very safe food chains. I made that clear to Secretary Veneman in my discussions with her yesterday.

Sometimes we have our differences about how things should be done.

Therefore it is crucially important to have greater common understandings of how our populations perceive risk. Diverging perceptions may ultimately influence how our respective regulatory regimes respond to given risks. Different responses to the same risk. Perhaps irrational, but understandable.

We are living through what we call "globalisation", significantly driven by multi-national corporations and trade liberalisation. It is vital, therefore, for all of us to reach better appreciations of why we might agree on assessments of particular situations, whereas our risk management approaches might be different.

Equally, we should be conscious of divergences in risk assessments and their potential consequences.

It has become increasingly clear that risk perception plays an important role in the mechanics of risk management, and that approaches to risk management require further development for more effective policy making and, ultimately, better governance.

One of the messages that rang out loud and clear from our conference last December in Brussels was the stark contrast in the way scientists look at risk compared with citizens either individually or collectively in society.

The scientific approach is rational and methodical. It deals with probabilities and population averages a logical and theoretical approach, free from emotional distortion. This is of course very useful. However what it misses is the "human factor" and the wide variety of influences which shape human behaviour.

One delegate put it most succinctly people behave according to perceptions, not facts.

In conclusion, may I thank the European Policy Centre, the Atlantic Council and the Grocery Manufacturers of America for helping organise this event. My gratitude is also due to the European Commission Delegation here in Washington.

I look forward to whatever perceptions or facts we can glean from this conference.
(1) Regulation (EC) No 178.2002, Article 7: a) In specific circumstances where, following an assessment of available information, the possibility of harmful effects on health is identified but scientific uncertainty persists, provisional risk management measures necessary to ensure the high level of health protection chosen in the Community may be adopted, pending further scientific information for a more comprehensive risk assessment. b) Measures adopted on the basis of paragraph 1 shall be proportionate and no more restrictive of trade than is required to achieve the high level of health protection chosen in the Community, regard being had to technical and economic feasibility and other factors regarded as legitimate in the matter under consideration. The measures shall be reviewed within a reasonable period of time, depending on the nature of the risk to life or health identified and the type of scientific information needed to clarify the scientific uncertainty and to conduct a more comprehensive risk assessment.
(2) Case T-13/99, judgment of 11 September 2002 of the Court of First Instance (Pfizer Animal Health SA against Council of the European Union)

DN: SPEECH/04/142 Date: 19/03/2004

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