Speeches Commissioner Byrne

Speech by David Byrne, European Commissioner for Health and Consumer Protection : Risk analysis - Risk communication: "The decision maker's dilemma" - Joint WHO/FAO/OIE Conference on BSE and its Risks, Paris, 13 June 2001

Ladies, and Gentleman

I am very pleased to join you today in Paris for this important conference.

I especially welcome the tripartite nature of the conference. There is a very distinguished panel of speakers, all well known to the scientific and public health community. It is entirely appropriate that the three major international organisations in the respective fields of human health, food and agriculture and animal health should meet to discuss BSE and its risks.

The lessons to be learned from BSE must inform policy in all these important areas. While the links between your respective areas of competence are not always immediately clear, they exist. It is a cliché, but a valid cliché, that our systems of agricultural and food production and veterinary health have a major influence on public health.

Directly, through threats to food safety arising from food-borne diseases and zoonoses. And, less immediately evident, but of even greater consequence, through nutrition. But, this conference is on BSE and I will focus my address on this disease.

We are all aware of the huge damage done by BSE. It is perhaps useful to reflect on the full extent of that damage:

- More than 180.000 cases of BSE discovered;

- The more than five million cattle destroyed in the UK under the over thirty month scheme to stop potentially infected animals entering the food chain;

- The costs of the various protective measures introduced throughout the EU, including the wide scale testing of cattle for BSE and the ban on meat and bone meal in animal feedingstuffs.

- The huge economic consequences of the successive crisis which have led to sharp falls in beef consumption in the EU and expenditure running to billions of EURO on market support measures;

- The damage to the image of the European agricultural industry and the confidence in the safety of its products;

- The damage to the credibility of public authorities and the scientific community due to the perceived mistakes in the handling of the crisis which has had a profound impact on a range of other issues.

But, most of all, we must reflect on the human cost. A recent landmark was passed with the confirmation of the 100 ^th case of variant CJD in the EU. We do not yet know the full extent of the disease. Estimates, from credible sources, range up to 170.000 potential human victims. Hopefully, these upper estimates will prove to be excessive but only time will tell.

The European Commission has been a key player in the unfolding crisis and is uniquely positioned to draw conclusions on the lessons to be learned. And it has been a very painful process for the Commission. I have not and will not hide the fact that mistakes were made in the handling of the crisis. That is a matter of record set out in the report of the European Parliament in the matter.

However, I am convinced that the Commission has taken very radical measures to address these mistakes. I can point to the following examples:

- The major changes to the European Treaties to strengthen EU powers in the area of public health;

- The radical re-organisation of the Commission to bring a range of key services together under a single roof and under the direction of a single Commissioner;

- The extensive legislative agenda on key public health and food safety issues, including the proposal to create an independent European Food Safety Authority.

All of these developments have their origin in the BSE crisis. It gave the political impetus for a radical overhaul of how the Commission approaches key public health issues. To put it very bluntly, the Commission realised that any mishandling of public health led to very important risks. The public, the electorate, are less forgiving of mistakes or negligence in relation to their health than virtually any other issue.

This is especially the case in relation to BSE. Let me remind you of the comprehensive nature of the measures in place in the EU to protect consumers from any risks of transmission of the disease:

- The removal of the full range of specified risk materials from cattle, sheep and goats;

- The strict controls on the processing of animal by-products and the ban on the feeding of processed animal proteins - meat and bone meal - to all farm animals;

- The testing of all bovines, at slaughter, aged over 30 months destined for the food chain - over 1.75 million such tests were carried out in the first three months of this year alone;

- The comprehensive measures on research, surveillance and eradication of BSE;

- The large number of inspections carried out by the Commission's Food and Veterinary Office on Member State compliance with the protective legislation in force.

I am convinced that the full application of these measures ensures the protection of consumers from the risks of BSE.

These measures are now all brought together in a single legal text which will enter into force on 1 July 2001. This text also includes the Community's new risk classification measures which incorporates the OIE's code on BSE. It will provide a comprehensive framework to address the key issues in relation to BSE - monitoring and surveillance, eradication, risk classification, risk materials, laboratory analysis etc.

Let me also remind those in attendance here today from outside the EU, that these measures apply also to exports. Thus, for example, when the decision was taken to ban meat and bone meal, this ban was extended to exports. And I took the precaution of writing to the ambassadors of your countries to the EU to advise them of the ban and of the need to take the necessary measures in relation to any such products imported from the EU.

It has been difficult to convey to consumers how the various measures that have been put in place contribute to reducing the risk from BSE. Too often, national or commercial interests in Member States have intervened and so consumers were presented with conflicting messages on the safety of beef.

One lesson I draw from all of this is the need for clear communication that consumers will understand and trust. It is my hope that the European Food Authority will quickly fill this role and gain the trust and confidence of consumers on all issues regarding food safety.

I would now like to turn to the decision making process involved in the Commission's handling of BSE. In so doing, I begin with an open acknowledgement that is one of the most politically sensitive dossiers on the Commission and EU agendas for the past several years. It has provoked some very sharp and difficult political confrontations. And it has led to the resignation of several key political figures in the Member States.

I live with the knowledge that this is a dossier where any mistake carries a very high cost. This is perhaps the "decision maker's dilemma" referred to in the title to my address. A situation, to quote my Oxford mini-dictionary, "in which a choice must be made between unwelcome alternatives".

Clearly, all the key decisions in relation to BSE have confronted the Commission with difficult choices, especially given the continued scientific uncertainties. In this context, my approach has been guided by four key criteria:

- An evaluation of the existence of a risk, real or potential, to public health and consumer protection;

- The scientific evidence or the evidence of failings in control measures giving rise to such a risk;

- The options available to tackle that threat in the quickest and most effective manner possible in a proportionate and non-discriminatory manner and, lastly;

- The measures necessary to communicate the decision taken to the Member States and the public in an open, transparent manner.

I am satisfied that the first of these criteria has always taken precedence: the interests of public health and consumer protection. Any other policy would be both irresponsible and dangerous. The changes agreed in the Community's decision making process in recent years, resulting from the BSE crisis, provide a number of important safeguards to ensure that the public interest is well protected in the decision making process.

- All key pieces of legislation are now decided by co-decision between the Member States and the European Parliament. This ensures very open and transparent debate on all the relevant issues - the consumers greatest ally;

- There is a system for independent scientific risk assessment, again carried out in an open and transparent manner. This system has been especially diligent in respect of BSE which has taken up a huge share of the time and resources of our scientific committees, and finally;

- There are the institutional changes which I mentioned earlier, namely the creation of a focus within the Commission - the Directorate General for Health and Consumer Protection - which is not distracted by other considerations, economic or political.

There are, of course, alternative approaches. I could opt always for the most radical approach and propose the most hardline and draconian measure possible.

If this approach succeeded, I would be vindicated. If it failed, I could always point the finger of blame at the opponents of the proposals concerned. Effectively, I could leave it to them to take the hard and dangerous decisions on where the public interest lies between the competing policy options.

I have rejected this approach. It would be irresponsible. It would be demagogic. And ultimately it would be a real threat to public health protection as the credibility and real motives behind Commission decisions would be undermined. It would only be a matter of time before such measures were exposed as an attempt to secure short-term public approval or as a shield against potential criticism.

This is my position also on the repeated demands on the Commission to invoke the "precautionary principle" on public health issues. I am a strong defender of the precautionary principle and have worked hard in its defence in a range of international organisations.

But if it is to become a code or shorthand for blocking or banning everything which is objectionable, its credibility will very quickly be lost. It is a principle which must be applied within an open and transparent framework which ensures that it is not used to promote any trade or political agenda.

In this respect, the Commission has taken the time and effort to spell out exactly, in a major policy document, how it understands and interprets this principle. I would encourage our trade partners to engage the Commission in the follow-up to this initiative so that we all have a clear understanding of the issues involved.

A suspicion that consistently lingers in relation to food safety decisions taken by the Commission is protectionism. This is perhaps accounted for by the fact that some of the more bitter trade disputes revolve around food or food related issues - hormones, bananas, for example. The perceived vulnerability of the EU Member States to competition in agricultural goods is also often cited as a motivating factor.

This is, to put it very mildly, absolute nonsense. I have not and will not allow trade considerations to dictate my approach towards public health and food safety issues. Nor have I encountered anything other than full support from my Commission colleagues in this respect, including my colleagues in the Agriculture and Trade portfolios.

Let me return to BSE as an example. The Commission has imposed a range of controls on imported meat and meat products. Indeed, if the proposals I presented to the Commission yesterday are approved by the Member States, these controls will be strengthened to include, for example, imported gelatine and tallow.

However, these decisions are soundly based on the independent advice of the Commission's Scientific Steering Committee. Effectively, this Committee has adopted opinions on the risk status, with respect to BSE, of third countries that export such products to the EU.

This process was carried out in an entirely open and transparent manner and on the basis of data supplied by the third countries concerned. It has allowed the Commission to identify the potential risk attached to imports. And to propose the appropriate safeguards to ensure that our consumers enjoy a comparable level of protection in relation to such imports as applies to EU products. But, to repeat, it has not been used for protectionist purposes.

For example, key competitors of the EU in the agricultural area, like Australia, New Zealand, Brazil and Argentina have been placed in category I ("highly unlikely to present a BSE risk") of the risk assessment exercise. This is the highest and safest category, unfortunately not enjoyed by any Member State of the EU. And very significantly, these countries are exempted from the most rigorous controls such as the removal of SRMs.

In fact, an estimated 85% of the EU's imports of meat and meat products come from third countries which fall within category I of our geographical risk assessment. This, surely, is the answer to claims that this evaluation process is motivated by protectionism. Indeed, I understand that the Commission's risk categorisation increasingly serves as the international standard in this area, even in trade not involving the Member States of the EU.

In this respect, I would actively encourage the OIE to accelerate its work on risk classification of BSE and commit the Commission to providing you with full co-operation in this respect.

And, more importantly, I would call on third countries to implement control and surveillance measures to provide a full and transparent picture of their epidemiological status with regard to BSE. The experience and knowledge available from the EU's experience of BSE and the rapid detection tests now available ensure that this can be effectively implemented. It will be a sound and cost effective investment if it ensures that the past mistakes and errors of Europe are not to be repeated in your countries.

The work agenda on BSE is not, however, complete. Let me gave you some idea of its continuing impact on my work agenda.

Yesterday, in the weekly meeting of the Commission, I secured my colleagues agreement to a range of new initiatives in relation to BSE. For example, the testing of "at risk" cattle for BSE from 24 rather than 30 months. The introduction for the first time of the testing of sheep and goats for TSEs. Tighter controls on specified risk materials. The continuation of the existing ban on meat and bone meal which was scheduled to expire at the end of this month.

Later that day, I discussed with the European Parliament the Commission's proposals for a new regulation on the treatment and processing of animal by-products. There are 16 million tonnes of such products produced in the EU each year. Poor processing standards were a key factor in the BSE crisis. This proposal is fundamental to preventing any repeat or similar failing. Good progress was made and there is now an excellent prospect that this legislation will be in place before the end of this year.

Later that same day, I had a similar discussion with the Parliament with the Commission's proposal for a European Food Authority. This initiative also has its origins in the BSE crisis. And to an audience with a heavy representation from the scientific community, the Commission's objectives are clear. We want an independent, transparent, assessment on potential risks.

There is now a good prospect, following the Parliament's opinion on the proposal, of a political agreement between the Member States by the end of this month. The deadline set by the Heads of Government for the Authority to be up-and-running by 1 January 2002 remains on target.

Thus, to repeat a little, within the last 24 hours the Commission has made real progress on several key initiatives related directly and indirectly to BSE.

I am close to concluding. It will not have escaped your notice that the focus of my address has been on the BSE and the decision making process in the EU. This should not hide or obscure the very important work going on elsewhere in the Commission on BSE related issues.

On research, my Commission colleague Philippe Busquin yesterday published a comprehensive paper outlining the Commission's activities in this field. There is a clear recognition, which I am sure you all share, of a need for much more research into TSEs and in particular the human form, variant CJD. I see as particular priorities research into:

- more sensitive tests for the early detection of TSEs;

- research into minimum infective dose, the extent of the species barrier and the period of incubation; and

- research on inactivation methods.

I believe the Commission has done its work to promote and support projects in these areas. Member States and third countries should, however, play their part in fulfilling their responsibilities in the research field.

On epidemiological surveillance, CJD and its variant are already included in the Community network for surveillance, prevention and control of communicable diseases. We are supporting, within my Directorate General, a number of key projects in the surveillance field. These aim, in particular, to bring neurologists and neuro-pathologists into closer co-operation, throughout the EU, in order to detect at an early stage any emerging trends in relation to CJD. This work must be carried out in close collaboration with the WHO if it is to achieve its full potential.

On the issue of risk assessment, I have already spoken at length about the European Food Authority. Professor Pascal, the Chairman of the Commission's Scientific Steering Committee, also addressed you yesterday on the issue of risk assessment. I would like only to encourage the scientific community to seize the opportunity offered by the Commission to have a more forceful role in relation to food safety.

The valid allegation has been made in the past that policy makers blurred the lines between risk assessment and risk management. But, is it not equally valid that scientists were too complacent in their role? There is a need for scientists to be more assertive in presenting the case for science in furthering society's aims and aspirations.

Finally, arising from crisis such as BSE and foot and mouth disease, there is a real and genuine debate underway in Europe on the extent to which our systems of agricultural production are a factor in these crisis. There is also an acceptance that quantity has been given priority over quality. Reforms are already underway which will lead to systems of production which take greater account of environmental, rural development and animal welfare considerations.

I hope that the participants here today, in particular those from outside Europe, will leave Paris with a greater appreciation of BSE and its risks. More particularly, I hope you will leave with the conviction that the European Commission is playing its part in protecting the public from these risks.

Thank you for your attention.

Speeches Commissioner Byrne
FOOD SAFETY | PUBLIC HEALTH | CONSUMER PROTECTION | DIRECTORATE GENERAL "HEALTH & CONSUMER PROTECTION"