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Chemicals management The precautionary principle and EU chemicals policy Mary Taylor, Safer Chemicals Campaign, Friends of the Earth Europe, Friends of the Earth, 26-28 Underwood Street, London N1 7JQ, United Kingdom (maryt@foe.co.uk) In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation. Principle 15 of The Rio Declaration on Environment and Development (1992) The EC Treaty has incorporated the precautionary principle since 1992 (Treaty of Maastricht), although without defining it in any detail. Its incorporation into the Treaty is highly significant and should set the stage for environmental protection measures to be undertaken quickly, before “absolute proof” of harm is evident. In 1999 the Council of Ministers adopted a Resolution urging even more determination to be guided by the principle, further emphasizing acceptance of its place in EU policy and law. As noted by the European Commission, “applying the precautionary principle is a key tenet of [Community] policy”. 1 It is recognized that the precautionary principle applies in both environmental and health spheres. 2 The precautionary principle in the Treaty Community policy on the environment shall aim at a high level of protection taking into account the diversity of the situations in the various regions of the Community. It shall be based on the precautionary principle and on the principles that preventive action should be taken, that environmental damage should as a priority be rectified at source and that the polluter should pay. Maastricht Treaty (now the Amsterdam Treaty, Art 174(2)), 1992 However, putting the precautionary principle into practice is conceptually and politically challenging. In 2000 a Communication from the European Commission attempted to set out an approach and guidelines for using and applying the principle. 3 This was partly in response to accusations of “arbitrary” decision-making, since use of the precautionary principle is regarded by some non-EU countries – the US in particular – as restricting trade. There is also potential for conflict even between EU countries if there is no common acceptance of how to interpret the principle. A key argument for the Commission was that World Trade Organisation rules incorporate the precautionary principle, 4 recognizing the “independent right” of countries “to determine the level of environmental or health protection they consider appropriate.” The Commission’s paper has turned out to be controversial. The Commission has proposed that risk assessment and management is central to the concept and that invoking the principle has to start with a scientific evaluation, albeit one which should be explicit about any uncertainties. Intrinsic hazardous properties alone should not trigger the principle, according to the Commission. Given the problems with risk assessment (which needs both hazard and exposure information) in chemicals regulation, environmentalists viewed this as a weak start. The Commission also noted that precautionary action should be based on cost-benefit analysis, with the proviso that non-economic factors could be taken into account. But it is feared that this may turn to the advantage of economic short-term interests that can quantify their costs more easily. Sweden has argued that it should be about cost-effectiveness and not costbenefit analysis, 5 which accords more with environmentalists’ views. Principle 15, in our view, should be interpreted as finding the cost-effective way to take action once the decision to act has been taken, and not about using cost-benefit analysis to decide whether to act or not. Precaution and the chemicals policy debate Debate about the precautionary principle is very pertinent to current discussions on the regulation of chemicals. In many ways, much current chemicals policy in the EU is the antithesis of the precautionary principle and concerns about the current lack of regulation. Our ignorance about most chemicals in use, and worries about a number of synthetic chemicals being found in human tissue, have led the European Commission to produce legislative proposals. The historic and unregulated production of chemicals means that we have all grown up in a society that produces and uses thousands of chemicals in an almost infinite variety of ways. Our world is made up of chemicals – so much so that the European chemical industry employs 1.7 million people and produced over EUR 500 billion worth of chemicals in 2002. The industry is making much use of impact assessments to try to show the harm to industry that new regulations will bring. Yet the vast majority of chemicals (aside from certain groups such as medicinal products, pesticides and newly registered chemicals) have never had basic safety assessments undertaken. Their use has been taken for granted and, in general, manufacturers have not been required to provide safety data for the 100,000 chemicals that were known to exist and catalogued back in 1981. We are exposed to probably hundreds of synthetic chemicals every day. Hazardous chemicals can be found in all sorts of household goods – clothes, cosmetics, PCs, even toys. Chemicals do not sit still forever in these products. We are exposed directly in some uses (such as shampooing hair), or and environmental monitoring. If all toxicity studies are negative, use of the substance may be considered (Figure 7). For substances with low persistence and potential for bioaccumulation (non-PB) we propose a tiered testing system in which production volume and results from previous tests determine further test requirements and risk management decisions. This system includes five parallel pathways for tiered testing (Hansson and Rudén 2004): 1. general acute toxicity; 2. general sub-acute to chronic toxicity; 3. reproductive toxicity; 4. mutagenicity; 5. ecotoxicity. Here we will briefly outline the principles of this system, using the tests for general (acute) toxicity as an example (Figure 8). Data on sensitizing properties and acute toxicity are essential in risk assessment. For a company that is considering using a chemical substance, this is the most elementary information that it needs to obtain from the supplier. Without this information, it is impossible to determine what measures are needed to ensure safe handling at the company’s own workplace and what safety-related information should be passed on to costumers. Therefore, in our proposed system in vivo testing for skin and eye irritation and for skin sensitization are mandatory for non-PB substances with a production volume of 1 tonne per year, and the same applies to test data that enable an estimation of acute systemic toxicity. Substances with a production volume of less than 1 tonne per year should either be submitted to these tests or be classified and labelled as insufficiently investigated. We are well-aware of the shortcomings of the current test methods for acute mammalian toxicity. We emphasize the need to replace these tests with new ones. Development and validation of methods that reduce the need for animal testing should be highly prioritized. The usefulness of any new test method should be evaluated in the light of the surprisingly low accuracy of the harmonized classifications of acute systemic toxicity based on data obtained with current test methods (Rudén and Hansson 2003). For substances that are acutely toxic we propose additional testing of general toxicity, primarily in the form of a 28-day toxicity study. This should also be required for all substances with a produc- 16 ◆ UNEP Industry and Environment April – September 2004
Chemicals management they may migrate out of articles during use, accidental damage and disposal. We can be exposed to persistent chemicals not just during their initial use, but through the food chain, through dust, and even in the womb. Many long-lived synthetic chemicals are now found in our bodies and the environment. They contaminate the oceans and polar regions and their wildlife. Environmentalists are particularly concerned about persistent and bioaccumulative chemicals. A number have hormone-like properties and may interfere with the endocrine system in subtle ways, possibly causing birth defects, decreases in sperm count and increases in certain types of cancer, for example. Yet when concerns are raised about specific chemicals, the battle for regulation is often long and fierce, with manufacturers forcing a very high burden of proof before decisive action to restrict or ban the chemical can be taken. In the meantime, production may continue for many years. Even when proof of harm is accepted, the chemicals are still circulating the world and much harm will continue. Environmentalists think such chemicals should be banned because of their intrinsic properties, without having to wait years for evidence to accumulate. The current problem can be illustrated by the prolonged struggle over a group of possible endocrine-disrupters called phthalates, which are added to some plastics and which have been used in some toys. The European Commission has managed to instate a number of temporary bans on their use in toys that are intended to be put into the mouths of children under three. But in the view of environmentalists this is a rather weak measure and still leaves the possibility of widespread exposure through other routes. Phthalates have been found in human tissue and may be present in glues and many PVC products. It is hoped that the new legislation, once finally agreed, will really push manufacturers to substitute persistent and bioaccumulative chemicals with safer chemicals if at all possible – unless there is an essential societal use of the chemical that outweighs the concerns. By definition in the new legislation, chemicals that are carcinogenic, mutagenic, reproductive toxins, very persistent and very bioaccumulative, or that have endocrine-disrupting properties, are regarded as of “very high concern”. In general, such chemicals will be candidates for the authorization process of REACH, a system that would ban all uses unless specifically authorized. 6 However – and here we get to the flaw – the current draft introduces a concept of “adequate control”. This would authorize continued use of substances of very high concern in certain circumstances even if a safer substitute were available. To our mind, it is impossible to truly control very persistent, very bioaccumulative chemicals. And since they may have subtle effects at very, very low concentrations which current toxicity testing regimes are finding difficult to assess, we should really be very uncomfortable at their continued use. These intrinsic properties should make them unacceptable for use except in extreme circumstances. So the draft legislation falls far short of implementing a precautionary principle at the moment. It also introduces the notion that many endocrine-disrupting substances have to be shown to have “serious and irreversible effects to humans or the environment”, surely another contradiction to the precautionary principle. While the legislation is still under discussion, the question of whether the precautionary principle will be fully reflected in the final legislation remains open. We hope our EU politicians will be brave enough to take action that will declare some chemicals guilty without years of experiments and observation of harm, and that will have impacts for generations to come. The precautionary principle should embrace a number of components: ◆ transparency and public participation; ◆ respect of societal (non-scientific) values; ◆ reversal of the burden of proof; ◆ consideration of a wide range of alternatives (including the possibility of not undertaking a proposed development); ◆ early preventive action in response to reasonable suspicion of harm; ◆ recognition that lack of evidence is not the same as evidence of no harm; ◆ recognition of the limits of scientific knowledge and understanding; ◆ research to address the gaps in knowledge, but without delaying other possible actions. 7 Notes 1. Communication from the Commission on the Precautionary Principle. COM (2000) 1 final. Brussels, 2.2.2000. 2. For example, the Declaration of the Third Ministerial Conference on Environment and Health (London, 1999) re-affirmed commitment to the principle, noting the need “to rigorously apply the precautionary principle in assessing risks and to adopt a more preventive, pro-active approach to hazards.” The principle is also explicit in the Stockholm Convention on Persistent Organic Pollutants. 3. Communication from the Commission on the Precautionary Principle, op. cit. 4. The Communication specifically referred to the Agreement on Sanitary and Phytosanitary Measures and the Agreement on Technical Barriers to Trade. 5. Swedish Committee on New Guidelines on Chemicals Policy, Non-hazardous products? Proposals for implementation of new guidelines on chemicals policy. SOU 2000:53, June 2000. 6. See the accompanying article, “A science-based strategy for chemicals control” by Sven Ove Hansson and Christina Rudén. 7. For example, Kriebel, et al., Environmental Health Perspectives 109:871- 75, 2001; European Environmental Bureau, Position Paper on the Precautionary Principle, “The precautionary principle in environmental science,” 1999. tion volume of more than 10 tonnes per year (in accordance with REACH). Question-marking In the current classification and labelling system, additional data about the properties of a substance can lead to a stricter classification – but almost never to a less strict one (Hansson and Rudén 2003). A strict classification tends to diminish a substance’s marketability. Companies responsible for producing and marketing chemical substances often have something to lose from subjecting their products to testing. They almost never have anything to gain in economic terms. Thus, the classification and labelling system has an incentives structure that discourages rather than encourages toxicity testing. This counterproductive incentives structure will remain in the proposed REACH system. Let us consider a hypothetical example. One company produces and markets dye-stuff A, whereas another company produces and sells the closely related dye-stuff B. Both are produced in volumes below 10 tonnes per year; in each case only the required data for such substances are available. Each substance is in fact a developmental toxicant, but the initially available data sets give no indication of this. The company producing substance A then voluntarily undertakes an extensive state-of-the-art testing programme for its product. As a result, it has to classify and label the substance as toxic and warn its customers against the substance’s toxic properties. The other company performs no tests on substance B. Therefore, substance B will not have to be classified or labelled as toxic. A will be more difficult to sell than B. This outcome is, of course, in sharp contrast to the stated aims of national and international chemicals policies. We have good reasons to prefer a toxic product that is classified and labelled as toxic to an equally toxic product that is neither classified nor labelled. One way to improve the regulatory system in this respect is to introduce an additional dimension into the classification and labelling system, namely the dimension of toxicological ignorance, coupled to a new classification category, insufficiently investigated (Hansson and Rudén 2003). Substances classified in this category should be assigned a warning label, including a symbol such as a question mark that enables users to exercise UNEP Industry and Environment April – September 2004 ◆ 17
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