Date: Aug 03, 2000
Decision makers are "bound to makechoices involving variables and to balance the freedom and rights of individuals, industryand organizations with the need to reduce the risk of adverse effects to human health andthe environment."
As highlighted in its Communication on thePrecautionary Principle (COM (2000)1 of 2 February 2000), the European Commission wants "tofind the correct balance so that proportionate, non-discriminatory, transparent andcoherent actions can be taken - under a structured decision-making process withdetailed scientific and other objective information."
The issuance of this long awaitedCommunication had been made necessary by the growing controversy surrounding the cornerstone of the EU's new approach to risk management: the precautionary principle.
The precautionary approach - althoughnot yet accepted unanimously as a legal principle - represents a concept which imposesprecaution as an essential element in the decision making process.
Starting with the 1970s and first consideredand accepted internally (e.g. in Germany and, later, in France) the approach has now been accepted internationally as a legal principle in the environmental field. In the wake of the BSE crisis, the dioxin scare, and the disputes surrounding the placing on the market of GM seeds, and as the public has become gradually more concerned about food safety issues, the concept of precaution has become a key element in related disputes between decision makers and private companies and/or consumer organizations. In today's highly globalised society, these disputes shift in no time to an international debate. This follows primarily the recourse by the European Union to the precautionary principle as a legal defence against the US and Canada in the "hormone in meat" case (complaint WT/DS 26 and WT/DS 48).
Also intended to provide an input to the ongoing debate on this issue, the Communication is aimed at "outlining the Commission's approach to using the precautionary principle, establishing the Commission's guidelines for applying it, building a common understanding of how to assess, appraise, manage and communicate risks that science is not yet able to evaluatefully, and avoiding unwarranted recourse to the precautionary principle, as a disguised form of protectionism."
Even though there is still no definition of the precautionary principle, it is supposed to cover "those specific circumstances where scientific evidence is insufficient, inconclusive or uncertain and there are indications through preliminary objective scientific evaluation that there are reasonable grounds for concern that the potentially dangerous effects on the environment, human, animal or plant health may be inconsistent with the chosen level of protection."Guidelines and recommendations for its application are thereby laid down.
In summary, when confronted with the possibility of a risk, decision makers will perform a risk analysis consisting of risk assessment, risk management and risk communication. During the risk assessment phase,scientific advice will be given. Risk management involves taking a decision considering the scientific conclusion and, when this is an uncertain, other factors; riskcommunication consists of communicating the decision taken to the public.
According to the Commission's Communication, the precautionary principle belongs to the risk management phase. Indeed, it is the decision makers, who, faced with the possibility of occurrence of an unacceptable risk to the society, will adopt the measures to overcome this risk.
This distinction between the three phases of the risk analysis poses several problems: firstly, what constitutes scientific uncertainty and thus when does the possibility of applying the precautionary principle occur (notably the role of minority opinions), secondly, what constitutes an unacceptable risk to the society, and thirdly, what measures can be adopted and how far can the restrictions imposed thereby go?
According to the Commission's Communication, scientific uncertainty occurs when a scientific evaluation of the risk makes it impossible to determine with sufficient certainty the risk in question because of either the insufficiency, the inconclusive or imprecise nature of the scientific data. Secondly, the decision as to what constitutes an unacceptable risk to the society is, again according to the Commission's Communication, an entirely political decision. Finally, in order to prevent the occurrence of a potential risk, any measure can be adopted, from the most drastic one, such as prohibiting the marketing of potentially dangerous products, to less onerous ones, such as imposing conditions on the marketing ofa product.
One of the aims of the Commission's Communication is to clarify the role of private companies and/or consumer organizations in the risk analysis process. Accordingly, it states that the decision making process should be transparent and should involve as early as possible and to the extent reasonablypossible, all interested parties. However, no further details are given in this respect.Certainly, the manufacturers, importers or distributors of the products in question (i.e. products that are not considered harmful but that may ultimately be shown to be harmful) should qualify as interested parties and should be able to intervene in the risk analysis. They should also be able to ensure that the measures based on the precautionary principle comply with the general principles of risk management, and should be able to take action, if necessary.
As the Commission's Communication itselfstates, measures have to be proportionate with respect to the level of protection chosen, and must not aim at zero risk. They should not discriminate between similar situations,and should be consistent with the measures already adopted in similar situations. Themeasures in question should also be taken only after examination of all costs andbenefits, including economic benefits, and should be maintained only as long as thescientific data are inadequate, imprecise or inconclusive and as long as the risk isconsidered too high to be imposed on society.
Compliance with these principles is imposedin order to make sure that abusive measures in the application of the precautionaryprinciple shall not be adopted. However, it is important to point out that the non-bindinglegal nature of the Commission's Communication does not provide the legal basis tochallenge in Court an act adopted on its basis and may, consequently, only lead to furtheruncertainty and controversy as to the application of the precautionary principleinternally and internationally.
At present, internationally, theprecautionary principle is the subject of rather confused negotiations within the CodexAlimentarius Commission, where during the last meeting of the Codex Committee on GeneralPrinciples (CCGP) in Paris on 10-14 April 2000, Malaysia, the Philippines, India andseveral other developing nations successfully contained US-EU compromise paragraph thatwould have enshrined the precautionary principle in a footnote to the CCGP paper on"the role of science and other factors in relation of risk analysis."
The debate must - and no doubt it will - continue. The adoption of a clear legal status for the precautionary principle is now a prerequisite to help the EU meet the dual challenge it is facing: to restore the confidence of its citizens while keeping - or rather restoring - that of its trade partners.
© Article from Keller and Heckman's "EuropeanAdvisory", June 2000 issue.
For further information, please contact Jean Savigny at firstname.lastname@example.org.