David Byrne: The role of science in regulation, The Toxicology Forum at the European Commission, Brussels, 27 May 2002

Brussels, May 2002

Ladies and Gentlemen,

It is a great pleasure for me to address the 2002 Toxicology Forum.

Toxicology is one of the scientific disciplines that plays a vital role in many of the areas within my sphere of regulatory responsibility, for health and consumer protection.

Indeed, none of the committees of our current scientific advisory system could successfully function without touching, at one time or another, on issues of a toxicological nature.

One of our nine scientific committees the Scientific Committee on Toxicity, Ecotoxicity and the Environment as its name implies, is entirely devoted to dealing with toxicological topics.

The European Union regulates a vast array of substances, products and processes. The endpoint of regulatory actions is often based on the evaluation of toxicological data submitted by industry or obtained from various other sources.

This is particularly true in the case of food and feed additives, residues of pesticides and veterinary medicinal products as well as chemical contaminants in food, and the active ingredients of cosmetic products to mention just a few.

The pre-eminent role of science in all these regulatory fields is undisputed. Science has been the basis for national and international regulations for many years, all over the world. With the increase of international trade, particularly during the current era of globalisation, the need has arisen for a universally acceptable measure to achieve both a high level of safety and fair trading practices in international commerce.

Science, with its cornerstone of objectivity, has been identified as such a measure, and has been increasingly implemented in international trade agreements.

Within the European Union, the Treaty establishing the European Communities, recently amended by the Treaty of Amsterdam, requests in Article 95 that the Commission "will take as a base a high level of protection, taking account in particular of any new development based on scientific facts".

Before further pursuing the matter of the role of science in regulatory decision-making, we should stop for a moment and ask: "What is science?"

According to Merriam-Webster's Collegiate Dictionary, science is defined as "the state of knowing knowledge as distinguished from ignorance or misunderstanding".

Knowledge is hardly ever complete and is never static. It is, rather, a dynamic concept, constantly in the process of development and refinement. Consequently, regulation based on science must invariably be considered as a transitory stage reflecting current knowledge at a given point in time.

To base current regulation on the science that prevailed a century ago, would be unthinkable. It can confidently be predicted that the judgement of future generations about our present knowledge of which we are so proud will likewise be less than complimentary.

The history of science is full of contradictions, often of fierce competition, of diametrically opposed views and ideas. Challenges to the knowledge of the day was, and still is, the most powerful propelling force for scientific progress.

It is therefore often extremely difficult to determine what, in a given field at a specific time, contemporary science actually is.

Do the consolidated views of the majority or the unorthodox new ideas of the minority, often of one single maverick, constitute science or "sound science"? Many great discoveries and scientific breakthroughs were hatched as bitterly contested ideas, initially rejected by the mainstream scientific establishment or even condemned as heresies by others.

On the other hand, probably many more interesting, plausible and ostensibly convincing ideas turned out later to be illusions, hoaxes or the products of outright fraud.

Therefore, particularly if public health is at stake, it can easily become an awesome responsibility for decision-makers to opt for the opinion of either the majority or the minority.

The BSE crisis is a tragic case in point. The late acceptance by the majority of well-founded early predictive warnings by the minority regarding the transmissibility of the disease from bovines to humans, led to the belated implementation of appropriate regulatory measures.

Despite these uncertainties, there is no reasonable alternative to science. It must, therefore, firmly remain an indispensable and fundamental ingredient, underpinning all regulatory decisions.

It should, however, be recognised that, in order to be effective, regulatory decisions aimed at protecting the health of consumers often have to be made "on the spot", without delay, before more data can be generated or otherwise obtained, and before any ongoing scientific disputes can be settled.

But as important as science might be, its role in regulation should, however, not be overrated. Rather, it must be unambiguously stated and clearly understood by all stakeholders what, in general and in a specific case, science can offer and what it cannot.

The life span of the scientific validity of any regulatory decision will always be a function of progress in the relevant discipline and, thus, can occasionally be extremely short.

The scientific basis for a particular regulation that is universally deemed rock solid one day can, like sand, be washed away by the next.

In the preparation of legislative measures and in daily regulatory practice, the European Commission has always relied on scientific advice emanating from different sources.

One of the most important of these sources was, and remains, the system of our own scientific committees. In recent years, with increasing complexity and sophistication of both science and legislation, it became apparent that the mechanisms of the past could not satisfy the needs of the present and of the future.

Therefore, in the aftermath of the BSE-crisis, the European Commission took a number of decisive steps to eschew the deficiencies of the past and to introduce measures to enhance the integrity and the effectiveness of its scientific advisory mechanisms.

Foremost among these measures was the concentration of all scientific committees, previously scattered throughout the European Commission, into a single entity, the Directorate General for Health and Consumer Protection, under my jurisdiction.

Subsequently, a more competitive and open method of selection of committee members, as well as major changes in operating procedures, were introduced.

The members of the scientific committees, representing numerous disciplines, are appointed on the basis of their professional excellence and independence.

Currently, there are eight scientific committees dealing with issues of food safety; animal nutrition; animal health and welfare; plant protection; the safety of cosmetics and non-food products; and chemicals as well as medicinal products and medical devices.

A multi-disciplinary ninth group, the Scientific Steering Committee, exercises an overriding co-ordinating function in addition to dealing with specific issues, mostly overlapping the area of mission of two or more subject-specific scientific committees (such as with BSE-related topics).

During the past five years, these committees have generated and adopted several hundred scientific opinions in response to a plethora of questions, mainly posed by the European Commission.

Immediately following their adoption, these opinions become via the Internet available to the public, as are the lists of the members of the scientific committees, their agendas and the minutes of their meetings including minority opinions.

Thus, in addition to the attributes of excellence and independence, transparency is equally an essential trait characterising the operation of our scientific committees.

Yet, the success of the past few years does not seduce us to complacency. Quite the opposite. As many of you might be aware, we are currently engaged in a major overhaul, indeed in the process of taking a quantum leap, in refining our regulatory philosophy and practice regarding food safety, including its toxicological aspects.

Ever since I entered this office in September 1999, food safety has been my top priority. In January 2000, we published the White Paper on Food Safety. With this seminal document, the European Commission set the stage for the most radical and far-reaching changes ever embarked on in the area of food safety.

Following the publication of the White Paper, the Commission submitted to the European Parliament and Council an appropriate legislative proposal.

Testimony to the timeliness of our proposal was that these European institutions and the Member States, embracing the ideas of the White Paper, acted rapidly and decisively resulting in a record-time adoption of the Regulation setting up the European Food Safety Authority (EFSA) and a new framework for European Union food law.

With the establishment of EFSA the role of science in the European regulatory system will receive a tremendous boost. Despite the widely recognised achievements of the current regime of scientific advice, the steadily increasing workload reached the upper limits of its performance capacity.

The presently available infrastructure can no longer adequately support and serve the members of the scientific committees enabling them to deal efficiently with the number of pending cases, and could not be expected to meet the challenges of the future.

In addition, while recognising the necessity of a fruitful interaction between risk assessors and risk managers, the process of objectively establishing, analysing and scientifically interpreting the facts, requires a high degree of independence.

To achieve this independence, was one of the principal motivational factors behind our determination to create EFSA. We have recently described elsewhere in great detail the mandate, the tasks, the structure and the mode of operation of this institution.

Suffice it to say here, that EFSA will be, in essence, an independent, distinct legal entity in charge of science in relation to safety along the entire length of the food chain.

Its core task will be to provide independent scientific advice on all matters with direct or indirect impact on food safety. It will also give scientific advice on non-food and feed GMOs, and on nutrition in relation to European Union legislation. In fact, EFSA will be responsible for risk assessment and, within its mandate, for risk communication.

Risk management in its widest possible sense will remain, on the other hand, within the domain of the Commission, the Parliament and the Council. No matter how clear the scientific answer might be, it can only serve as the basis and guidance.

The final decision, taking into account all relevant aspects, must be the function of accountable political structures. Consequently, the Regulation states explicitly:

"It is recognised that scientific risk assessment alone cannot, in some cases, provide all the information on which a risk management decision should be based, and that other factors relevant to the matter under consideration should legitimately be taken into account including societal, economic, traditional, ethical and environmental factors and the feasibility of controls."

Reading through your programme, I was impressed by the multitude of interesting topics, many of them with direct or indirect relevance to my area of responsibility.

I noticed that for tomorrow afternoon, a contribution entitled "Acrylamide An Unexpected Food Ingredient" is on the agenda. If anything, acrylamide is for me the prototype of man-made, synthetic chemicals. In its polymerised form we encounter this substance in numerous plastic products we use in our daily lives.

But how can acrylamide get into food? At first, I thought it might be the consequence of some form of contamination. But, I have learned from my associates that this does not seem to be the case. Although, very little is known as yet about the mechanism of its formation in food, it would appear that acrylamide is being generated, particularly in starchy food, during the process of baking. Our Scientific Committee on Food is addressing this issue, analysing the results of Swedish scientists.

At present, it would not be prudent to jump prematurely to any conclusion. On the basis of what we know today, it appears that an accidental finding drew attention to a substance, which ever since humans have baked their food, through countless generations, have been exposed to through their diet including their daily bread.

In other words, we have here a hitherto unrecognised, age-old phenomenon uncovered by new analytical methodology.

The fact that acrylamide has been classified by the International Agency for Research on Cancer as "probably carcinogenic to humans", gives this observation particular significance.

While eagerly awaiting the results of the scientific evaluation, we are naturally considering possible risk management options. There is one secret that I can share with you here today: We are not going to ban bread!

Ladies and Gentlemen, as I find myself amongst so many internationally recognised toxicologists, allow me, before closing, to make a personal observation.

I am often utterly puzzled by the distorted public perception of risk. The risks I have in mind are very often of a toxicological nature. Notwithstanding our track record in championing the cause of the protection of the life and health of the European consumers, I often wonder about where we failed in the past, and what could we do better in the future, to introduce more objectivity and balance into the debate on risk, particularly on risk perception.

I find it hard to understand, for example, how, in our enlightened society, irrefutable evidence of high risks attributable to the panoply of carcinogenic and otherwise deleterious chemicals in tobacco smoke can be ignored, whilst never-demonstrated, hypothetical effects of infinitesimally low amounts of relatively harmless substances are often wildly exaggerated.

I hope this is a field that will become fertile ground for multidisciplinary collaboratory efforts between scientists, regulators and communication experts.

To this end, I have asked my officials to organise a conference on risk perception that will address these issues, probably in the first half of next year.

In my position as Commissioner, I continue to find regulatory work a fascinating and intellectually stimulating challenge that is fraught with great responsibility.

Regulation always entails limitation, both for individual citizens as well as for public and private institutions. Limitations should invariably be imposed for the benefit of the community at large and limitations should be limited to the unavoidably necessary extent.

We are, rightly, accountable for our actions or inaction in public service. Should we procrastinate in face of real danger, we would recklessly violate our foremost task to protect public health.

Should we, on the other hand, be too glib about thwarting the development or prohibiting the marketing of ultimately safe and useful products, we would inexcusably disregard our duties towards society, by needlessly damaging the livelihood of others and undermining the very basis of our prosperity. In our endeavour to strike the right balance, science is our reliable guide.

In closing, I would like to reiterate that the great significance of science in regulatory decisions is now universally recognised. The quality of scientific advice is therefore of paramount importance to any process of decision-making.

With the aim of enhancing the level and integrity of the scientific constituent of regulation, our institutions have undergone, or are currently undergoing, appropriate organisational and operational changes.

Whenever the need arises in future, other changes will follow. We recognise, however, that science is only one factor, albeit a decisive one, of decision-making. We have therefore embraced new scientific concepts and methods in risk analysis including the precautionary principle, which has given, during the past decade, new impetus to rapid development in several areas of the safety evaluation of substances, products and processes.

I can assure you that we are going to continue on the same path in future.

We are delighted to have taken the opportunity of hosting the 2002 Annual Meeting of the Toxicology Forum. Judging by the programme for this event, you can look forward to three exciting, intellectually stimulating and rewarding days.

I wish you every success in your endeavours, and a very pleasant stay in Brussels.

Thank you.

DN: SPEECH/02/230 Date: /05/2002