Brussels, 17 January 2002
Speech in PDF file
The US, Europe, and Precaution: A Comparative Case Study Analysis of the Management of risk in a Complex World
Grand Hotel-Bruges
11/12 January 2002
Robert J. Coleman
Director General
Health and Consumer Protection Directorate
European Commission
I Introduction
1. I would like to thank the organisers for their kind invitation to address this important conference on precaution or the precautionary principle.
2. This topic is of major importance to the Community and to our trading partners and therefore it is in all our interests to foster a general understanding of the use of precaution in decision making both within the Community and internationally. Recent debate on this subject has often been marked by emphasis on the differences – some real, others borne of misunderstanding.
It is therefore welcome that in the next couple of days an opportunity exists for informal discussion with a view to finding the common ground that exists between us; and, probably even more important, for better defining any significant differences and the reasons for them.
3. My task is to outline the Community’s approach to the use of precaution, its initiatives relating to precaution and how the Commission views the activities on this matter in the international arena.
Risk Analysis Framework
4. As the Directorate General responsible for health and consumer safety, my department is constantly faced with the challenge of balancing the freedom and rights of individuals, industry and organisations with the need to reduce the real and potential adverse effects of products and processes on human, animal or plant health or the environment. Finding the correct balance so that proportionate, non-discriminatory, transparent and coherent actions can be taken requires a structured decision-making process, based on scientific and other objective information within the overall framework of risk analysis.
5. Many risks are complex and multifaceted. A new risk may emerge whose nature and extent may have never been identified before. The challenge is to characterise the risk and then, within the structure of the risk analysis process, identify the correct action needed to protect health or the environment, while aiming to ensure that there is consistency between measures and objectivity in the manner in which decisions are made.
II Science and its limits.3
6. But, at this point, a word or two is perhaps appropriate about science and its limits. The EU bases regulatory policy making first and foremost on available scientific evidence. A clear demonstration of this is to be found in the general food law shortly to be adopted by Council and Parliament. Article 6 of that law, which precedes Article 7 on precaution, specifies that “risk assessment shall be based on the available scientific evidence and undertaken in an independent, objective and transparent manner” It is also the reason for the creation of the European Food Safety Authority as a clearly independent source of the best available expertise.
This is as it should be: science has been the basis for national and international regulation for many years all over the world. With the increase of international trade during the second half of the last century, the need has arisen for a generally acceptable measure to establish both a high level of safety and fair trading practices in international commerce. Science, with its hard earned reputation for objectivity, has been increasingly relied upon in international standards and agreements, amongst others in those regulating trade.
7. On the other hand, science has limits. For example, it takes time to generate the experience, the raw data, which will permit reliable scientific analysis of innovation to be done. The recent publication of the European Environment Agency on late lessons from early warnings is interesting in this regard. In addition there is the nature of the scientific process itself. I do not intend to explore, much less resolve the old, but still unsettled, debate concerning the difficulties of determining what, in a given field at a given time, science or “sound science” actually is.
Suffice it to say that in any scientific exercise there are ample opportunities, indeed it is virtually unavoidable, for the introduction subjective elements of value judgement in the course of planning, conducting and evaluating the process of scientific investigations.
Taking as an example toxicological studies, the basis of numerous regulatory decisions within the scope of our mission, the choice of the test animal species, the strain, the sex, the age of the animals, the route and the duration of the administration of the test substance, the length of the observation period, the choice of the test parameters to be evaluated and many other factors can profoundly influence indeed determine, the outcome of the test.
Hence subjective judgement, while we attempt to cultivate scientific objectivity, will always remain an inevitable fact of life.
8. No matter how rigorous the scientific approach may be, ambiguities and open questions, by the nature of science itself, will often remain. But at the same time, we have to recognise that, as a rule, in order to be effective, a regulatory system has to take decisions aimed at protecting the health of consumer often “here and now”, before scientific controversies can be resolved and the final verdict is in. In other words, we have to recognise what in general and at a specific time science can deliver and what it cannot and therefore when other bases for action can be relied upon.
III The precautionary principle or precaution
9. In many ways, the precautionary principle is a principle of common sense. It is a legitimate tool available to decision makers in those circumstances when we are faced with potentially harmful effects on health or the environment, but there is scientific uncertainty concerning the nature or extent of the risk. When faced with these circumstances decision-makers must consider taking action, whether this is adopting legal measures or other appropriate actions. Those in public office entrusted with the protection of health or the environment have a duty to respond and not wait until their worst fears are realised. Precaution requires them to err on the side of safety when there is scientific uncertainty in order to achieve the necessary level of health or environmental protection.
10. This is because in the Community not only is there a moral duty to act but also because precaution is part of primary and secondary European legislation (e.g. Article 174 of EC Treaty says action in the environmental field “shall be based on the precautionary principle”).
General Food Law and precaution
11. The Regulation on General Food Law to which I have already referred, provides the general principles, definitions and requirements on which all future food law in the Community will be based. Enshrined in the Regulation are the principles of risk analysis and the circumstances and conditions under which the precautionary principle should be invoked. I would like to look at the precautionary principle in the General Food Law in some detail, as I believe that this clearly illustrates our understanding and use of precaution today.
12. First, there is a close link between the articles on the risk analysis process, including science based risk assessment, (Art 6) and the precautionary principle (Art 7). This is to ensure that precaution is used within the overall framework of risk analysis, including science based risk assessment.
13. Second, the precautionary principle article is in two parts; the first establishing the circumstances when precaution is relevant. It specifies that:
14. “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.”
15. It is clear from this important article in the General Food law Regulation that the principle can only be considered when certain pre-requisite conditions are satisfied. These are:
(1) there are potentially dangerous effects deriving from a phenomenon, product or process that have been identified, and;
(2) that scientific evaluation does not allow the risk to be determined with sufficient certainty;
(3) 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.
16. 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 or health identified and the type of scientific information needed to clarify the scientific uncertainty and to conduct a more comprehensive risk assessment.
17. It is also worth recalling that when we are drafting food law measures there are several general Treaty requirements that have to be borne in mind and which must be respected in order to ensure that we obtain the correct balance. Precautionary measures must comply with the basic principles for all other legislation and be: proportional, non-discriminatory in their application; consistent to the extent possible with similar measures already taken; and the least trade restrictive measures that will contain the risk.
18. And finally, 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.
IV Precaution at the international level
19. Given the controversy that the subject of precaution provoked at international level, it seemed to the Commission essential to try to promote broader understanding of the EU’s position on the matter. The Communication on the subject published in February 2000 was an attempt to demystify the EU’s use of precaution and to show incidentally that used, in that way, it corresponds to what many of trading partners also in reality do.
20. One of the most important contributions of the Communication is that it establishes guidelines for the application of the precautionary principle. These guidelines establish the limits necessary to ensure that precaution is applied when appropriate in science based risk analysis on the one hand, therefore avoiding inappropriate abuse as a disguised form of protectionism on the other.
21. The Commission believes that we should be developing similar guidelines at the international level to promote a common understanding of how to assess, appraise, manage, and communicate risk where science is not yet fully able to evaluate it. The Council and the European Parliament supported fully the Commission’s Communication. Indeed the resolution from the European Summit in Nice calls upon the Commission to apply systematically its guidelines on the conditions for use of the precautionary principle, and to incorporate the precautionary principle, wherever necessary, in.7 drawing up its legislative proposals and in all its actions. We have begun to respond to this, for example, in the newly established general food law.
22. The Council also called upon the Commission to promote a general understanding of the precautionary principle at the international level and we have tried to respond to this also. The Commission has pressed for risk analysis principles to be better understood and accepted in WTO, and in particular, in the field of food safety, health and consumer protection.
23. In that context, the Commission is playing an active role in revising the framework of risk analysis principles within the Codex Alimentarius, which, within the framework of the United Nations organisation, is responsible for the development of standards and codes for the international trade of foods.
24. The European Commission has insisted that consideration is given to the precautionary principle in Codex. Discussions are still under way on some of the detail and technical aspects but the Commission will continue to push for a general international acceptance and consensus on risk analysis principles, and in particular, the role of the precautionary principle. We welcome the work that is currently underway in relation to the development of risk analysis guidelines for use within the Codex system and we will continue to push for Codex guidelines on risk analysis, including the use of precaution for use by governments.
25. The Commission has also promoted risk analysis principles in other international discussions, for example: in the context of the SPS and TBT Agreements of the World Trade Organisation, in the work of OECD, in the Transatlantic Dialogues for both businesses and consumers, and in the discussions within the Transatlantic Economic Partnership.
26. We welcome the declaration from the November WTO meeting in Doha, which provides for further consideration of precaution in relation to trade matters by reaffirming the right of governments to set the level of protection that they deem necessary to protect health and the environment. We believe that clarification on the application of the precautionary principle in the WTO framework is an important issue and we will continue to press for work to be taken forward in this context.
V Conclusion
. The European and international debate on the use of precaution has matured markedly over the past year and I detect a growing understanding and acceptance of precaution in health and environmental protection matters. I hope that our discussions at this conference can advance this further.
Source: Health and Consumer Protection DG http://europa.eu.int/comm/dgs/health_consumer/index_en.htm