received growth hormones, a ban that was instituted pursuant to concerns that eating such beef could be carcinogenic. 5 Discussions reached a fever

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1 Journal of International Economic Law (2000) Oxford University Press EU COMMUNICATION ON THE PRECAUTIONARY PRINCIPLE Natalie McNelis * INTRODUCTION On 2 February 2000, the Commission of the European Communities published a communication on the precautionary principle, 1 a term which describes a cautious approach to managing potential threats to the environment, human, animal, or plant health. Precautionary principle talk is heard when scientific evidence is inconclusive. There is, according to some scientists, a risk perhaps unquantified, perhaps uncertain, but possible nonetheless. The precautionary principle stands for the proposition that when in doubt, authorities should err on the side of caution when, for example, the health of human beings is at stake they can, even should, act without waiting for certainty. While there are merits to that approach, the Communication does not place restrictions on the use of the precautionary principle sufficient to avoid protectionist abuses. BACKGROUND The precautionary principle has garnered much support in Europe in recent times, in the wake of a series of food scandals. To cite a few examples, there was the discovery back in that there was a potential risk that BSE 3 ( mad cow disease ) could jump the species barrier and cause a similar malady in humans who consumed affected beef. Then in January 1998, the WTO Appellate Body held that the EU was not entitled under the WTO SPS Agreement 4 to maintain its prohibition on marketing beef from cattle that had received growth hormones, a ban that was instituted pursuant to concerns that eating such beef could be carcinogenic. 5 Discussions reached a fever * Senior associate, Stibbe Simont Monahan Duhot, Brussels. Correspondence address: Stibbe Simont Monahan Duhot, Henri Wafelaertsstraat 47 51, 1060 Brussels, Belgium. natalie.mcnelis@stibbe.be 1 COM(2000) 1 final, hereafter cited as Communication. 2 In March 1996, the Spongiform Encephalopathy Advisory Committee stated that eating beef from cattle that had BSE was the most likely cause of certain cases of Creutzfeld Jakob Disease, or CJD in humans, see ECJ, Case C-180/96, UK v. Commission, [1998] ECR 2211, para 9. 3 Bovine spongiform encephalopathy. 4 The Agreement on the Application of Sanitary and Phytosanitary Measures. 5 Appellate Body Report European Communities Measures Affecting Meat and Meat Products (Hormones), WT/DS26/AB/R, adopted 13 February 1998.

2 546 Natalie McNelis pitch when the dioxin crisis denuded supermarket shelves across Belgium in late spring There, it was discovered that the meat and eggs of chickens that had consumed tainted feed contained levels of the noxious chemical dioxin capable of harming people who ate it. Currently, the precautionary principle is figuring prominently in the debate about the proper EU approach to issues such as the repercussions of Genetically Modified Organisms ( GMOs ) on human, animal, and plant health. 6 THE COMMUNICATION That context, and other elements such as the comments of the Appellate Body on the precautionary principle in its report in the Hormones case, 7 complaints by WTO Members (notably the US) that the precautionary principle is not adequately defined, and calls from the EU institutions for more clarity, 8 spurred the EU to solidify its thoughts on the precautionary principle in this Communication. The Commission says that its Communication aims first of all to inform the public and other Community institutions of the manner in which the Commission has applied the precautionary principle in the past and intends to apply it in the future. The Commission notes that its goal is to establish a common understanding of the factors leading to recourse to the precautionary principle and to establish guidelines for its use based on reasoned and coherent principles. The Commission takes pains to emphasize that this Communication is not the final word on the subject, but rather a contribution to the debate. Triggering factors and types of measures To begin with, the Commission describes the precautionary principle itself, highlighting the factors that trigger recourse to it and the kind of measures that result from its application. According to the Commission, the precautionary principle only comes into play when a potential risk has been identified, it has 6 For example, reference to the precautionary principle has been added in the proposed Directive to replace Directive 90/220/EEC on the deliberate release into the environment of GMOs (see Common Position of the Council of 9 December 1999, with a view to adopting Directive 2000/... / EC of the European Parliament and of the Council of... on the deliberate release into the environment of GMOs (see Common Position of the Council of 9 December 1999, with a view to adopting Directive 2000/... /EC of the European Parliament and of the Council of... on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/ 220/EEC, OJ 2000 C 64/1, at whereas 8, Article 1 and Article 4(1)). 7 Cited above, at paras For instance, in a Resolution of 28 June 1999 on Community consumer policy , the Council calls on the Commission: to be in the future even more determined to be guided by the precautionary principle in preparing proposals for legislation and in its other consumer-related activities and develop as a priority clear and effective guidelines for the application of this principle. The Commission says in the Communication that its paper is part of the Commission s response, Communication, para. 1.

3 EU Communication on the Precautionary Principle 547 been scientifically studied, and the results of scientific inquiries are mixed or inconclusive. In such a situation, decision-makers may have to respond, sometimes under varying degrees of pressure from public opinion. According to the Commission, the appropriate response is the result of an eminently political decision, a function of the risk level that is acceptable to the society on which the risk is imposed. 9 The trigger for precautionary action is that the desired level of protection for the environment or health could be jeopardized. The Commission specifies that the absence of scientific proof of factors such as the cause effect relationship or a quantitative evaluation of the probability of adverse effects should not be used to justify inaction, and also notes that the minority view of scientists should be taken into account. 10 With regard to the type of measures flowing from the precautionary principle approach, the Commission notes that they can vary enormously, from the less radical (a decision to fund research or inform the public) to the more extreme (instituting a ban of the products concerned). The Commission stresses its wish to rely on procedures as transparent as possible and to involve all interested parties at the earliest possible stage. Guidelines for the use of the precautionary principle Next, the Commission provides some guidelines for the use of the precautionary principle, as it acknowledges that inappropriate application of this principle could lead to unacceptable trade restrictions. It calls for decision-makers to take a structured approach, involving as complete and objective a scientific evaluation as possible. In the Commission s view, in selecting the best course of action, authorities must weigh the risk to the environment or health against the freedom and rights of individuals, industry, and organizations. The Commission clarifies that, to achieve the proper balance, measures based on the precautionary principle should be, inter alia: proportionate, non-discriminatory, consistent, should involve an examination of the benefits and costs of action or lack of action, and they should follow up on scientific developments. First, according to the Commission, proportionality means that measures have to be commensurate with the level of protection desired. They must do no more and no less than what is necessary to make it possible to achieve that level of protection. Regarding the level of protection, the Commission states that authorities must not strive for zero risk, which can rarely be achieved, and it comments that in some cases, a measure such as a total ban might be inappropriate, while in others, it might be the only response to a potential risk. Second, the Communication states that measures must be nondiscriminatory. This means that like situations must be treated as like, and 9 Communication, para Communication, para 6.2.

4 548 Natalie McNelis different situations should not be treated in the same way. Furthermore, measures should not arbitrarily make distinctions on the basis of geographical origin or the nature of the production process. Third, and similarly, an authority should maintain a consistent approach across the board. In other words, in adopting measures, regard should be had to measures already adopted in similar circumstances. For example, where scientific uncertainty exists and an authority intends to take measures based on the precautionary principle, it should try to ensure that those measures are comparable in nature and scope with measures already taken in equivalent areas in which all the scientific data are available. Fourth, the Commission calls for a cost-benefit analysis of action versus inaction, taking into account both the long and the short term. Relevant to this cost-benefit analysis, the Commission says, are not only economic factors; in fact, the Commission states that non-economic interests should be given pride of place. Fifth, the Communication states that measures cannot simply be put into place in an era of scientific uncertainty, and then left in place permanently. Where measures are adopted in a climate of scientific uncertainty, authorities must continue to monitor the issue and to conduct further research to elicit the additional information required for a more objective assessment of the risk. As and when the understanding of a particular risk evolves, measures should be modified, or if appropriate, abolished. Finally, the Commission points out that one way of applying the precautionary principle is to prohibit placing certain products (such as drugs, pesticides, and food additives) on the market until they are proven safe. This reverses the burden of proof, so that certain types of products are hazardous until proven safe, rather than safe until proven hazardous. According to the Commission, this would place the onus of financing necessary research on the persons or businesses with an economic interest in the production and/or marketing of the product in question. Then, if the authority concerned is convinced that the studies show that the product is safe, it can approve its placing in the market. If it is not convinced, it can maintain the prohibition. In other words, the Commission speaks of two layers of the precautionary principle here: one is in presuming the product hazardous until proven safe, and the second is in the evaluation of the relevant scientific evidence. The Commission calls it inappropriate for prior approval to be applied systematically. Rather, it says that the possibility of reversing the burden of proof should be examined on a case-by-case basis. COMMENT AND CONCLUSION A consumer reading this Communication will most likely agree wholeheartedly with the approach it advocates. After all, if authorities are not sure whether a substance or process is dangerous to an interest like health, they

5 EU Communication on the Precautionary Principle 549 had certainly better be cautious. However, there is a larger point at issue here: are authorities accepting the responsibility delegated to them to grapple with these questions? The Commission acknowledges the danger that the precautionary principle could be used to justify unwarranted restrictions on trade, that it could in certain cases serve as a justification for disguised protectionism. 11 This danger indeed seems acute when one considers the responses of governments around the world to the above-mentioned food scandals: their measures banning imports of the product concerned were immediate and downright gleeful. In response, the Commission announces that one of the objectives of this Communication is to avoid unwarranted recourse to the precautionary principle. It calls upon decision-makers to balance the freedom and rights of individuals, industry and organisations with the need to reduce the risk of adverse effects to the environment, human, animal, or plant health. It says that achieving the correct balance requires a structured decision-making process, relying on detailed scientific and other objective information. The Commission notes that actions taken must be proportionate, nondiscriminatory, transparent and coherent. 12 However, looking closely at the Communication, it does not place meaningful constraints on the application of the precautionary principle. 13 For example, with regard to the balancing that the Commission calls for, it is admittedly tipped in favor of adopting preventative measures. To explain, one element of the Commission s structured decision-making process is a cost-benefit analysis. However, in weighing the costs and benefits, there is a thumb on the scale non-economic interests, says the Commission, will weigh heavier than economic interests. 14 There is undoubtedly merit to that stance; human lives should not be counted in terms of dollars and cents. That being said, calling for a cost-benefit analysis is meaningless unless it is subject to some strictures that ensure that any sort of non-economic interest will not trump a more important economic concern. The balancing act especially threatens to be skewed when the cost is domestic and the benefit is foreign. Another element of worrying discretion is in the determination of the level of protection chosen. According to the Commission (and in saying this it has 11 Communication, para Communication, para 1 of Summary and at para 6.3 et seq. 13 In this regard, see also the reaction of the US government to the Commission Communication, expressed at the April meeting of the Codex Alimentarius Commission s General Principles Committee in Paris. Although the US welcomed the EU s efforts, it particularly criticized the Communication s failure to give a clear definition of the precautionary principle. The US in particular expressed the concern that the precautionary principle could lead to a reliance on political considerations rather than scientific ones in determining food safety standards, as reported in Inside US Trade, vol 18, no 14 (7 April 2000). 14 Communication, para

6 550 Natalie McNelis the support of the WTO Appellate Body 15 ), it considers that it is entitled to prescribe the level of protection, notably as regards environmental protection and human, animal and plant health, that it considers appropriate. 16 The choice of a level of protection is left entirely open. The danger is that an authority could adopt a level of protection completely out of proportion to the risk involved. However, the proportionality principle, though cited, is not accepted as a limitation in this regard. To explain, there are potentially two types of proportionality controls at issue here. On the one hand, there is the question of whether the level of protection chosen is proportionate to the kind of risk that is at stake. In other words, would it be appropriate to aim for a very high level of protection when the risk is one in a million? On the other hand, there is the question of whether the measure itself is proportionate to the level of protection sought. There, the question might be, is a total ban proportionate to the goal of reaching that high level of protection? When the Communication addresses proportionality, it is concerned only with the second concept: The measures envisaged must make it possible to achieve the appropriate level of protection... [m]easures based on the precautionary principle must not be disproportionate to the desired level of protection... (emphasis added). 17 The Commission does not consider that the proportionality limitation applies to the question of what level of protection would be appropriate, in other words, how risk-averse authorities can be except to say that authorities should not strive for zero risk and to say that in certain cases a total ban may not be a proportional response to a potential risk. 18 However, it is rather here that more guidelines and structure is needed in order to ensure that the level of protection chosen is proportionate to the risk at issue. An overarching observation is that the Communication seems to place the blame for any overzealous application of the precautionary principle on politics and political pressure. The Communication begins by almost bemoaning the fact that advances in mass communication ensure that the public is more aware of potential risks, and earlier. In such a situation, the Commission says decision-makers may have to respond, sometimes under varying degrees of pressure from public opinion. According to the Commission, the news reports often result in fears, which must be met 15 Appellate Body Report, Hormones, above, note 5, para 172, and WTO Appellate Body Report, Australia Measures Affecting Importation of Salmon, WT/DS18/AB/R, adopted 6 November 1998, para Communication, end of para Communication, para Ibid. Note that in calling zero risk inappropriate, the Commission constrains itself more than the WTO Appellate Body decisions would require. There, the Appellate Body has explicitly said that Members can define their level of protection as zero risk, Appellate Body Report, Australia Salmon, above, note 15, para 125.

7 EU Communication on the Precautionary Principle 551 with preventative measures. 19 The appropriate response, says the Commission, is the result of an eminently political decision, a function of the risk level that is acceptable to the society on which the risk is imposed. 20 This repeated reference to politics raises the concern that the Commission would excuse hiding behind politics and political pressure, rather than calling for authorities to take and stand behind carefully thought-out decisions. As the Commission highlights, applications of the precautionary principle can result in unjustified restrictions of trade, which in turn can quell innovation. Take, for example, the biotechnology field, an industry which is booming and which promises to grow incrementally in the years to come. There are already indications that biotechnical research can lead to discoveries with a positive impact for mankind, for instance in the area of the development of new medicines and new types of food. 21 It would be unfortunate if investment in such research was discouraged by an overly restrictive reaction from authorities. One cannot underestimate the challenges authorities face in their decisionmaking process when such fundamental issues are at stake. The public has entrusted in them the daunting responsibility of guarding their health and well-being, as well as the health and well-being of future generations. That being said, the public has entrusted its government with more than that: it has delegated to them the task of investigating and evaluating risks, and determining the appropriate responses to them in light of all the interests at stake. Elected officials and the authorities they appoint cannot hide behind politics in order to avoid taking difficult decisions. Rather, they should give the public some credit, have the courage of their own convictions, and be prepared to stand behind and explain the stances that they take Communication, para Communication, para An example is the engineering of golden rice, which aims to compensate for vitamin deficiencies in certain diets by the genetic modification of rice in order to incorporate beta-carotene. 22 Ten days after the Communication, the Commission published a White Paper on Food Safety (COM (1999) 719 final). There it unveiled a more proactive approach, advocating the creation of an independent food safety authority. This might allay some of the concerns about the Communication. The EU governments have backed the proposal but have stopped short of giving the authority decision-making powers.