THE EUROPEAN UNION VIEW OF THE PRECAUTIONARY PRINCIPLE IN FOOD SAFETY

EU VIEW OF PRECAUTIONARY PRINCIPLE IN FOOD SAFETY

Tony Van der haegen
Minister-Counselor
Agriculture, Fisheries, Food Safety and Consumer Affairs
European Commission Delegation

American Branch of the International Law Association

New York, October 23-25, 2003

1. Introduction

I would like to thank the organizers for their kind invitation to address you on the precaution approach, or as we in Europecall it, the precautionary principle.

This topic is of major importance to the EU and to our trading partners and therefore it is in the interests of all to foster a general understanding of the use of precaution in Food Safety decision making both within the European Community and internationally.

My task here today is to outline the European Union’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.

In many ways, the precautionary principle I am talking about, that is the PP applied to human and animal health, 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, 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 have a duty to respond and not wait until their worst fears are realized. Precaution requires them to err on the side of safety when there is scientific uncertainty in order to achieve the necessary level of health protection. In the European Union, precaution is now 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” and Regulation on General Food Law).

As regards more specifically human and animal health, the European Commission adopted its Communication on the Precautionary Principle in the year 2000. The Council of Ministers and the European Parliament supported fully the Commission’s Communication.

2. Why a Communication?

Originally, the former commissioner in charge of food safety, Ms. Emma Bonino, wanted a harmonized approach of the member states towards the BSE crisis (Bovine Spongiform Encephalopathy), which at that time (end of the '90s) was full of contradictory scientific information. That is the reason she asked for a Communication on the Precautionary Principle: for purely EU reasons.

2.1 The Communication

The aim of the Communication was and is to inform all interested parties of the manner in which the Commission applies or intends to apply the precautionary principle when faced with taking decisions relating to the containment of risk.

2.2 Objectives of the Communication

Outline the Commission’s approach to using the Precautionary Principle;
Establish guidelines for applying it based on reasoned and coherent principles;
Build a common EU understanding of how to assess, appraise, manage and communicate risks that science is not yet able to evaluate fully; and
Avoid unwarranted recourse to the precautionary principle, as a disguised form of protectionism.

2.3 Risk Analysis

The precautionary principle should be considered within a structured approach to the analysis of risk which comprises three elements:

Risk assessment, risk management, risk communication.

The precautionary principle is above all a risk management tool.

2.4 Use of the Precautionary Principle

Recourse to the precautionary principle presupposes that potentially dangerous effects deriving from a phenomenon, product or process have been identified and that scientific evaluation does not allow the risk to be determined with sufficient certainty.

The implementation of an approach based on the precautionary principle should start with a scientific evaluation, as complete as possible, and where possible, identifying at each stage the degree of scientific uncertainty, e.g., hormones in beef (oestradiol 17 beta, progesterone, testosterone, etc.).

2.5 Uncertainty

Decision-makers need to be aware of the degree of uncertainty attached to the results of the evaluation of the available scientific information. Judging what is an “acceptable” level of risk for society is an eminently political responsibility. Indeed, if something goes wrong those in charge of the risk management are accountable.

The first cases of BSE occurred in the UK in 1985, followed by rapidly increasing numbers of BSE-infected cattle across the UK. At that time, most scientists were convinced that mad cow disease could not jump the species barrier, especially not towards humans.

In spite of that, in July 1989 the US took the decision to ban all exports from the UK to the US of live cattle, beef meat and meat and bone meal, even though there wasn’t a single case of BSE in the US—a fantastic example of precautionary measure!

And what did the European Community do? In order to protect the meat industry—nothing at all! Britain continued to export bone and meat meal (the contamination agent) and infected thousands and thousands of cattle all over Europe. But when, in March 1996, the UK government published a report revealing the appearance of a new variant form of Creutzfeld-Jacob disease afflicting young people and raising the possibility that this disease may have come from BSE that spread to humans after eating beef, the European Commission banned, a week later, all exports of beef, live cattle and beef products from the UK. Had the EU taken the same precautionary measures in 1989 as the US did, we would probably not have had so many deaths and certainly not a public opinion which is so wary of food that a large majority refuses GM [genetically modified] food today.

3. Regulation on General Food Law

The principles I just mentioned are enshrined in the Regulation on General Food Law proposed by the EU Commission and adopted by the Council and the EU Parliament in 2002.

The Regulation on General Food Law provides the general principles, definitions and requirements on which all future food law in the EU will be based. 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.

3.1 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.

Second, the precautionary principle article is in two parts: the first establishing the circumstances when precaution is relevant. It specifies that:

“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.”

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.

3.2 he 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 EU, regard being had to technical and economic feasibility and other factors regarded as legitimate in the matter under consideration.” Those measures, or absence of 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.

4. Precaution at the International Level

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.

The Commission has also promoted risk analysis principles in other international discussions, for example: in the context of Codex, the SPS (Sanitary and Phytosanitary) and TBT (Technical Barriers to Trade) Agreements of the World Trade Organization and the WHO.

Article 5(7) SPS - Guidelines. SPS was annexed in 1994 to the WTO agreement. What does it say? Article 5(7) stipulates that: “in cases where relevant scientific evidence is insufficient, a Member may provisionally adopt sanitary or phytosanitary measures on the basis of available pertinent information, including that from the relevant international organizations as well as from sanitary or phytosanitary measures applied by other Members. In such circumstances, Members shall seek to obtain the additional information necessary for a more objective assessment of risk and review the sanitary or phytosanitary measure accordingly within a reasonable period of time.” (See the General Food Law.)

5. Conclusions

We are not married to the expression “Precautionary Principle.” Recent debate on this subject has often been marked by emphasis on the differences between the EU and the US—some real, others borne of misunderstanding.

A couple of weeks ago I had the opportunity to see a draft of the US paper on Precaution. A few months ago, Health Canada published their version. In all honesty, if you compare the three versions, the US, the Canadian and the Communication of the Commission of 2000, all three are very similar and are based exactly on the same principles. Obviously, the precautionary approach or principle is a sensible concept. It needs to be applied wisely and on a case-by-case basis. And given that the dynamics of science are not predictable, it is important to consider the dangers of excessive precaution.

[Quote: J.G.: Take the response of Brussels to “mad cow’s disease.” Once the British government and industry had taken all reasonable steps to address this problem, Brussels instructed member states of the EU to lift their bans on beef imports from the UK. All member states complied except France, who argued that French beef might still be safer than British beef and that France has the right to invoke the precautionary principle. Brussels took France to the European Court of Justice, where the Court ruled against France, indicating that speculative appeals to the precautionary principle must have some grounding in science.

Much more recently, the EC has rejected an unauthorized use of the precautionary principle by the provincial government of Upper Austria. In March of this year, Austria notified Brussels of its proposed ban of genetically modified seeds that the EC had approved for cultivation under the EC Directive 90/220. Upper Austria appealed to the precautionary principle but Brussels overruled them. “Recourse to the precautionary principle presupposes that potentially dangerous effects…have been identified, and that scientific evaluation does not allow the risk to be determined with sufficient certainty.” The EC noted that Upper Austria had not made this case and there was certainly nothing unique about the safety of GM seeds in Upper Austria. Unquote]

Italy and others (France, Germany, Luxemburg, Greece and UK) banned GMOs on their territory, even if they had been approved at the EU level. The Commission took the scientific evidence provided by these member states as justification for the bans and submitted it to the European Scientific Committee for opinion. In all the cases, the Scientific Committee deemed that there was no new evidence which would justify overturning the original authorization decision.

But to suggest, as the National Foreign Trade Council does, that the EU uses the PP to create obstacles to trade continuously is, excuse my French, utter rubbish. The NFTC is clearly biased against everything the EU does, and what it does is promote its own self-interest. The authors of NFTC papers on the subject like to imagine European officials working whole days and sometimes nights on Machiavellian schemes to make life difficult for US industry. But that is totally cock-eyed. As the second largest exporter in the world, the EU has more to lose than any other trading partner if the PP were abused.

The NFTC and the dozen or so US-based industry associations that form the core of the new coalition behave like a kind of Don Quixote fighting windmills that do not exist. But my comparison is perhaps not quite sound—at least Don Quixote’s heart was in the right place.

Hormones

Gauging US reaction to the new Hormones Directive 2003/74, published in the Official Journal on 14 October, based on Scientific Opinions of Scientific Committee on Veterinary Measures relating to Public Health of 1999, 2000 and 2002, which concluded that:

· risk to the consumer has been identified with different levels of conclusive evidence for the six growth hormones [endocrine, developmental, immunotoxic, genotoxic and carcinogenic effects could be envisaged (prepubertal children among most vulnerable)];

· oestradiol 17 beta has to be considered a complete carcinogen;

· for the other five, risk has been identified, but no acceptable daily intake can be established. The new Directive keeps a permanent ban on oestradiol 17 beta and places a provisional ban on the other five, pending further scientific information. Three therapeutic uses of oestradiol will still be allowed under tight conditions—these are to be phased out in the future.

The EU is now in compliance with its WTO obligations and will request that US and Canada lift the trade sanctions. There is a high possibility that the US will want the DSB to examine the WTO compatibility of the new Directive.

If NFTC had personal responsibility for millions of people’s lives, they might sing a different tune. The PP is a legitimate tool available to risk managers who have a tremendous responsibility—when, on the basis of scientific indications, a situation exists that is potentially harmful to human health. They might go to court or to jail if they do not take the appropriate measures in time.

To suggest that the EU now uses the PP to undermine rather than safeguard is unmitigated rubbish.

The truth is that the US industry is not getting used to the fact that the 15-nation EU (and soon 25-nation EU) increasingly assets regulatory powers in the marketplace and, in so doing, threatens the US role as the world’s standard setter for manufacturing and safety.

To conclude, let us look at a paper called “Comparing Precaution in the US and Europe” by Jonathan B. Wiener of Duke University and Michael D. Rogers of the Group of Policy Advisers in the EC, which has been published in the Journal of Risk Research. I think it is an interesting and trustworthy document. What does it say?

The “conventional wisdom” is that the EU endorses the PP and seeks proactively to regulate risks, while the US opposes the PP, bases risk regulation on scientific risk assessment and waits for evidence of harm before regulating. This is a fallacy. The reality is much more complex. Neither actor can claim to be more precautionary than the other.

There is a complex pattern of relative precaution across the Atlantic.

The central conclusion of this paper is that there is no single explanation for the variation in precautionary action between the EU and the US. Sometimes one actor is more precautionary than the other and sometimes it is the other way round.

There is a significant difference between rhetoric and reality.

Considering one risk case in isolation, such as GMOs, can be misleading. Europe appears to be more precautionary than the US about such risks as GMOs, hormones in beef, toxic substances, phthalates, climate change, etc. The US appears to be more precautionary than Europe about such risks as new drug approval, mad cow disease in beef, nuclear energy, diesel, lead in gasoline, the phase-out of CFCs, etc. But, compared to most of the rest of the world, the US and the EU are probably both at the highly precautionary end of the spectrum of risk management actions.

I thank you for your attention.