THE PRECAUTIONARY PRINCIPLE IN INTERNATIONAL ENVIRONMENTAL LAW

1. THE PRECAUTIONARY PRINCIPLE IN INTERNATIONAL ENVIRONMENTAL LAW • SUMMARY: • The idea of precaution • Precaution as a legal principle • Environmental law and the precautionary principle • A case study: Nanotechnologies and the precautionary principle • Conclusions

2. 1. THE IDEA OF PRECAUTION 1.1. Risk, uncertainty of science and precaution 1.2. "The Skeptical Environmentalist": even the "environmental emergency" is uncertain 1.3. "Better Safe than Sorry": an idea only apparently obvious 1.4. "Precaution" in the language and perception of public opinion

3. 1.1 Risk, uncertainty of science and precaution “Risk” definition “Risk society” (Beck): distributing disadvantages Jonas’ “ethics of responsibility” (Weber, Anders, Arendt) The problem of the burden of proof (Cazala) The precautionary principle: intelligent interpretation (Veronesi; Italian Bioethics Committee) vs. demolition (Marchant and Mossman)

4. 1.2 "The Skeptical Environmentalist": even the "environmental emergency" is uncertain Lomborg’s book - main points: • We are now better off • The priority issue • Anthropocentric ecology • The “Disaster Strategy” rightly criticized Lomborg’s book - main criticism: It does not underline the positive role of national and international environmental legislation: this is why we are better off (Stiglitz)

5. 1.3 "Better Safe than Sorry": an idea only apparently obvious Obvious when you assess a situation a posteriori Much more difficult in advanced assessment: • The idea of being able to control the risk • Inadequate information (Manzoni’s Don Ferrante) • Risk-Taking and social or personal targets • The technologically unknown (Stella) and the so called “normal accidents” (Perrow) The precautionary principle as a tool for reducing (not erasing) risks: • Proportionality • Cost-benefit analysis • Procedures (i.e. traceability)

6. 1.4 "Precaution" in the language and perception of public opinion Prevention (“prudence”) vs. precaution (“caution”) Linguistic analysis shows a static and passive idea of the precautionary principle Environmental risks’ misrepresentation: evidence of objective errors in the perception of the public – Science and the public – Statistics and the public (Best) – “intuitive toxicology” (Sunstein) and the public – desire for an external enemy (Boncinelli) and the public “Breaking the vicious circle” (Breyer): • Teaching the scientific method • Supporting independent and authoritative technical State agencies

7. 2. PRECAUTION AS A LEGAL PRINCIPLE 2.1. International Law: fifteen years after Rio de Janeiro 2.2. Community Law: one of the pillars of European environmental policy  2.3. Italian law: from the law on electrosmog to the reform of environmental legislation approved by Delegated Legislative Decree No. 152/2006 2.4. “Strict" or "active" version of the precautìonary principle? The position of the European Commission 2.5. “Tunnel Vision", "Risk Tradeoff' and the dose-risk ratio (linear relationship, threshold, hormetic effect) 2.6. Precaution and proportion 2.7. Precaution and cost-benefit analysis 2.8. Precaution and procedures: the example of traceabilty

8. 2.1 International Law: fifteen years after Rio de Janeiro - 1969 Swedish Environmental Protection Act: the beginning - 1992 United Nations Conference on Environment and Development: the solemn recognition together with the first … precautions in handling the principle: • “serious and irreversible damage” • “lack of full scientific certainty” • “cost-effective measures” (still “the law” declared by the International Tribunal for the Law of Sea – i.e. 2001 Mox Plant Case – and by the International Court of Justice – Southern Bluefin Tuna Cases) - 2000 Cartagena Protocol on Biosafety and 2001 Stockholm Convention on POP: the recent developments Conclusion: a general principle of international environmental law (Trouwborst)

9. 2.2 Community Law: one of the pillars of European environmental policy  1992 Maastricht Treaty: the beginning The three main principles of the European environmental policies: polluter-pays, prevention and precaution Prevention and precaution: very similar (Trouwborst) and very diverse (De Sadeleer) The (failed) developments in the European Constitution The Commission Communication of February 2000

10. 2.3 Italian law: from the law on electrosmog to the reform of environmental legislation approved by Delegated Legislative Decree No. 152/2006 Art. 10 of the Constitution The precautionary principle cited in some specific environmental laws (e.g.: Law n. 36 of 2001 on electromagnetism) Many general administrative laws make reference to the European principles Ministerial Decree 31.01.2005 on Guidelines for BAT and BATNEEC Delegating Law n. 308/2004 and art. 301 of the Environmental Code n. 152/2006: “Implementation of the precautionary principle” in accordance to the Commission Communication of February 2000 (proportionality; cost-benefit analysis; non-discrimination; subject to review)

11. 2.4 “Strict" or "active" version of the precautionary principle? The position of the European Commission “Strong” version of the principle (strict? rigid?): wide coverage in the media “Weak” version of the principle (active?) - Commission Communication COM(2000), whereby the precautionary measures must be • “proportional to the chosen level of protection; • Non-discriminatory in their application; • Consistent with similar measures already taken; • Based on an examination of potential benefits and costs of action and lack of action (including … an economic cost-benefit analysis); • Subject to review in the light of new scientific data; • Capable of assigning responsibility for producing the scientific evidence necessary for a more comprehensive risk assessment”. A political responsibility: what is an acceptable level of risk? (need to distinguish political reasoning from scientific evaluations – reasonableness)

12. 2.5 “Tunnel Vision", "Risk Tradeoff' and the dose-risk ratio (linear relationship, threshold, hormetic effect) Possible inefficiencies in regulations aimed at progressively reducing a specific risk: a) Tunnel Vision: single environmental target with no wider picture b) Risk Tradeoff: decrease of risk 1) causes an increase of risk 2) c) Dose-risk ratio: • Linear relationship (default) • Threshold relationship (minimum level beneath which the risk is not significant) • U-shaped or Hormetic relationship: substances toxic at high level, but beneficial below a certain threshold) In both non linear cases, cutting the exposure below the threshold is not effective In the hormetic case, going below the threshold is mandatory

13. 2.6 Precaution and proportion Subsidiarity and proportionality as two sides of the same coin: • The former = when the Union should act • The latter = what action should be taken Proportionality as a general principle of Community Law (ECJ, Case C-139/04 of 12 January 2006) International Law (Israeli HCJ 2056/04 of 30 June 2004 on the “wall” case) and Italian Law (Consiglio di Stato, n. 7993 of 4 December 2003 and n. 4648 of 9 September 2005) Proportionality as a condition for any legal limitations to economic freedom

14. 2.7 Precaution and cost-benefit analysis Cost-benefit analysis as a quantitative and qualitative tool (Sunstein)… … and as a new kind of answer to unjustified fears: more information, rather than more regulation Cost-benefit analysis and the environment - three advantages: • Better information of the public • Risk Tradeoffs are taken into account • The role of science is promoted ECJ (Case C-236/01 of 9 September 2003): only by Cost-Benefit analysis is it possible to show that certain precautions are necessary Cost-Benefit analysis and EIA (Consiglio di Stato, n. 129 of 18 January 2006)

15. 2.8 Precaution and procedures: the example of traceabilty The precautionary principle as a procedural path (Comitato Nazionale di Bioetica), as it allows: • The involvement in the scientific evaluation of the greatest number of parties; • The most effective response to cognitive uncertainty. Traceability as an example of precautionary procedure: • Food traceability • Waste and nanomaterials traceability • Persons traceability

16. 3.ENVIRONMENTAL LAW AND THE PRECAUTIONARY PRINCIPLE 3.1 The precautionary principle and legislation on the cleaning up of contaminated sites 3.1.1 Extreme application of the principle: the water is drinkable, but contaminated 3.1.2 lnadequate application of the principle: contamination hidden by law 3.2 Precautionary principle, air pollution and electrosmog 3.2.1 Harm from electrosmog: "it does not exist, but we believe it does“ 3.2.2. Harm from passive smoking, radon, traffic and land devastation: it exists, but we do not take all the necessary precautions 3.2.3. Boiling hot summers: the difficult case of global warming between the precautionary principle and the "No-Regrets" strategy 3.3 Eccentricities of insufficient precaution: mercury in the mouth 3.4 Possible harm from too much precaution: is DDT more harmful than malaria? 3.5 Uncertainties of precaution: the case of the use of sewage sludge in agriculture 3.6 Community Courts and the Italian Constitutional Court confronted with the precautionary principle

17. 3.1 The precautionary principle and the Italian legislation on the cleaning up of contaminated sites The history of the Italian legislation on contaminated sites remediation: • 1997 and 1999: target values directly indicated by the law • 2004 and 2006: target values to be identified through risk analysis Inconsistencies on both sides with the precautionary principle

18. 3.1.1 Extreme application of the principle: the water is drinkable, but contaminated Errors on the safe side in the “acceptable contamination limits” originally fixed (Ministerial Decree 471/1999): Values that – though being remediation targets (and not screening limits) – are irrationally rigid: e.g. 1: PCB values for soil: 0,001 mg/kg for residential soil and 5 mg/kg for industrial soil (whereas almost everywhere in Europe the values are higher) e.g. 2: Chlorinated aliphatic compounds values for groundwater: 1,5 nanograms/litre for Trichloroethylene (whereas water is potable up to 10 nanograms litre, according to Legislative Decree n. 31/2001!) Only partial improvement under Legislative Decree n. 152/2006 (risk analysis; change in PCBs values)

19. 3.1.2 lnadequate application of the principle: contamination hidden by law Errors on the unsafe side: both the previous and the present law fail to oblige the owner of an industrial site to verify whether or not it has been subject to contamination in the past (if I do not officially know, I can avoid to take action) And the previous “Register of sites in need of remediation” (Legislative Decree n. 22/1997) has become a “Register of sites undergoing a remediation process” (Legislative Decree n. 152/2006) This is worsened by the provision whereby in contaminated sites where activities are being carried out (even just for the “maintenance and protection of the property for the future resumption of activities”!), all that is required is to set up a simple “operational security measure”, thus putting off any actual remediation until the (far-off and by no means certain) “cessation of activities” This is in breach of the precautionary principle, which involves a “duty to investigate” Another unsafe error: “excessive costs”, “total turnover” and “company performance”

20. 3.2 Precautionary principle, air pollution and electrosmog Air and electromagnetic pollution and the precautionary principle: errors both on the safe and on the unsafe side

21. 3.2.1 Harm from electrosmog: "it does not exist, but we believe it does“ “Electrical, magnetic and electromagnetic” fields can be: • “low frequency” (powerful electric plants for energy transport or for power traction) • “high frequency” (radio and television broadcasting systems, radio base stations for mobile phones and radar systems) Should we be afraid of these “fields”? Environmentalists and scientists seem to agree on one point only: Italian legislation (Law n. 36/2001) is in this field among the strictest in the world The slight possible risk (scientific literature) and the cost-benefit analysis output This again is in breach of the precautionary principle (“It is not true, but I believe it”), let aside what some Municipalities do

22. 3.2.2 Harm from passive smoking, radon, traffic and land devastation: it exists, but we do not take all the necessary precautions (I: smoking) “There is sufficient evidence that involuntary smoking (exposure to second-hand or 'environmental' tobacco smoke) causes lung cancer in humans” (IARC). The precautions adopted by Italian legislation look belated and inadequate. They are belated because it was not until Law No. 3 of 16 January 2003 that reasonably effective measures were adopted for the first time (putting them into practice has, however, been subject to several delays) to curb passive smoking in most public places. They are also inadequate, because they will not prevent exposure to passive smoking – even once they have been fully implemented – in large sectors of workers who are obliged to work in places where clients are allowed to smoke

23. 3.2.2 Harm from passive smoking, radon, traffic and land devastation: it exists, but we do not take all the necessary precautions (II: radon) IARC has officially recognised that a high concentration of radon in closed environments is directly responsible for some types of tumours, with a substantial aggravated risk in smokers. The EC – in Recommendation No. 143/1990 – has encouraged Member States to confront the radon issue, which has recently been exacerbated partly because of the steady cutback of ventilation in buildings due to energy saving plans . The precautions laid down in Italian legislation are totally inadequate (no general regulations; only some by-laws by the Regions) A comparison between what we are actually doing (serving no established purpose) to combat so-called electrosmog and what we are not doing (incautiously) to prevent the risk of exposure to radon is dramatically and patently obvious

24. 3.2.2 Harm from passive smoking, radon, traffic and land devastation: it exists, but we do not take all the necessary precautions (IIIa: vehicles) IARC has officially recognised that vehicles’ emissions (diesel more than gasoline) are directly responsible for some forms of tumors EEA – in a very recent report on urban pollution caused by traffic – has peremptorily stated that “evidence of the adverse health effects … is continuously emerging” US Supreme Court (Massachusetts v. EPA, 2 April 2007, 127 S. Ct. 1438 (2007)) has stated – against EPA’s opinion – that EPA has, under the Clean Air Act, the Authority to discipline vehicles’ emissions, in order to reduce their contribution to global warming Italian legislation basically only provides for emergency action where the maximum air quality values have been repeatedly exceeded, together with a time frame for altering the properties of fuels that does not always respect the deadlines set by Europe . These measures are clearly inadequate, implying an error on the unsafe side from the point of view of the precautionary principle

25. 3.2.2 Harm from passive smoking, radon, traffic and land devastation: it exists, but we do not take all the necessary precautions (III: vehicles) Precautionary measures against traffic emissions have been in principle approved by our Constitutional Court (Decision n. 66/2005) and could provide: - clear and adequately sanctioned obligations for local bodies to take action when faced with risk situations; - rational assessment of the effectiveness of the measures selected and adopted; - modern fiscal policies incorporating incentives for the use of public transport and less polluting vehicles; - financial penalties for private traffic (such as the “congestion charge” recently brought into various cities, London included, with excellent results); - full application (and, where possible, anticipation) of European legislation on fuel quality. MTBE (“methyl tertiary butyl ether”) and Risk Tradeoff

26. 3.2.2 Harm from passive smoking, radon, traffic and land devastation: it exists, but we do not take all the necessary precautions (IV: land) The plundering of a major quota of the Italian natural environment which has been going on systematically for decades is there for all to see: with obvious and serious damage not just to the environment, but also to the tourist industry The precautionary profile which is mainly taken into consideration lies in the need to protect what “free space” is left, within a duty of responsibility towards future generations . In this sector, legislation – rather than putting the brakes on in the name of the precautionary principle – has instead stimulated behaviour that is harmful to the environment, through repeated and steadily increasing provisions for building and landscape amnesties, not to mention the progressive mitigation of the severity of the procedures and constraints attached to the construction industry

27. 3.2.3 Boiling hot summers: the difficult case of global warming between the precautionary principle and the "No-Regrets" strategy (I) It is very likely that two phenomena – increase in temperature (even when it is not derived from human activities) and increased greenhouse gas concentration – may influence each other, in a vicious circle. Different scientific opinions with regard to: - projections about the possible future expansion of the phenomenon; - evaluation of the consequences of this expansion; - identification of some efficient remedies. IPPC (Intergovernmental Panel on Climate Change) : - significant warming already occurred, due to human activities; - further warming as a relevant risk; • With no immediate actions, it might be impossible to stop very dangerous (and, perhaps, sudden) changes in climate

28. 3.2.3 Boiling hot summers: the difficult case of global warming between the precautionary principle and the "No-Regrets" strategy (II) The “optimistic opinion” (e.g.: Robert Erlich - George Mason University): a) almost certainly in recent decades, a certain amount of “global warming”; b) probably due to humans; c) probably, in 2100, further warming will be of about 3 degrees, but the mathematical models available today do not enable us to exclude the risk of a greater increase; d) if the further increase in temperature is low, it is more likely that, overall, it will (although with important differences from zone to zone) be positive for human beings. If, instead, the increase is high, within the upper half of the projections of the IPPC, it should not be particularly negative for the greater part of developed countries, but it will cause problems and very serious harm to many developing countries and the populations living in them . There is also in this case the possible risk of irreversibile large-scale non-linear impacts. Now let us try to evaluate: • whether, from a legal point of view, there are reasons for invoking – when faced with the problem of global warming – the precautionary principle; • (and, if the answer is affirmative), which precautionary measures are compatible with the proper application of the principle, in the terms set out in this book. With regard to the first question, we have already seen how, according to the Commission Communication of 2 February 2000, the application of the precautionary principle always requires that there is a risk (uncertain, but) identified, in other words, a “preliminary objective scientific evaluation”, which indicates that “there are reasonable grounds for concern ….”. So, in the case of global warming, the risk is (discussed within the scientific community as probabilities and dimensions, but) clearly identified and potentially serious. There is, therefore, a precise legal basis for calling on the application of the precautionary principle . And failure to consider the problem of greenhouse gases from the point of view of the precautionary principle could also give rise to legal liability and claims for compensation for damages . Very much more complex is the answer to the second question, concerning the identification of appropriate precautionary measures, in the light of the precautionary principle, rightly taken into consideration in its “active” version. From this point of view, we have the duty to identify precautionary measures which are: - proportionate to the risk; - able to sustain an economic cost-benefit analysis (which also duly takes the problem of “Risk Tradeoff” into account); - targeting as much the reduction of greenhouse gases as – where possible and economically more efficient – the development of adaptation and resilience strategies . It is well-known that the international community (or, more precisely, part of it, not only due to the opposition of the U.S.A., but also thanks to the lack of the direct involvement, to date, of large countries like China and India) has planned a series of actions within the ambit of the Kyoto Protocol . And the European Union is in the front line in implementing these, mainly through a system of trading emission quotas (European Parliament and Council Directive 2003/87/EC of 13 October 2003 on greenhouse gas emission allowance trading) . The objective of these actions is, obviously, to contain greenhouse gases emissions. And, moreover, as far as the precautionary principle is concerned, the two fundamental aspects are: - the identification of the dangerous level of further warming (in order to avoid it, significant investments are “proportionate” ); - the identification of the instruments for reaching the objectives of the reduction of greenhouse gases. Regarding the first aspect, the recent initiative of the Government of the United Kingdom appears to be exceptionally important. It has, in fact, started a very high-level scientific programme aimed at determining what level of atmospheric warming is effectively “dangerous”: in the belief that – if the programme is successful – containment initiatives aiming at averting this level being exceeded shall seem to everyone to be “proportionate” and may, therefore, also gain the support of countries (like U.S.A., China and India) which, up until now, have not been involved in the Kyoto Protocol . Regarding the second aspect, the more meticulous scholars are beginning to explicitly favour the so-called “no-regrets” strategy, which leans towards the adoption of measures which are, nevertheless, expedient, independently of their efficacy in reducing greenhouse gases. From this viewpoint: a) in Western countries, a sector of action that is as important as it is disregarded is road traffic , for the following reasons: • it is responsible for a high and growing percentage of greenhouse gas emissions ; • even leaving this aside, the emissions from motor vehicles create serious environmental and health problems, due to the carcinogenic effect of some of the compounds (found especially in the emissions of vehicles run on diesel) and for the fact that petrol contains potentially toxic additives for humans (for example, benzene) or additives harmful to the natural environment (for example MBTE), and for the contribution of all motor vehicle emissions to the spread of so-called “fine dust” . b) more generally, attention should also be paid to measures for containing methane (inspection of pipelines, energy recovery of biogas from dumps, action on some agricultural practices and on intensive farming), often such that they produce positive changes more quickly than those required for reducing carbon dioxide emissions ; c) for carbon dioxide, it is necessary to understand that – in the mid and long term – the radical solution to the problem does not pass through the development of more techniques for containing emissions in traditional plants, but, instead, by identifying new energy strategies, which permit the dependency of our economy on fossil fuels to be gradually lessened. In a direction compatible with this strategy, we can include the efforts made to: - involve the countries which are not currently bound by the Kyoto mechanisms (and, in particular, the U.S.A. and China, which are responsible for a large part of CO2 emissions at global level) in alternative (and, in some respects, not as strict) strategies to Kyoto, but also directed towards the reduction of greenhouse gas emissions ; - identify better instruments (in particular, an increase in economic freedom) aiming at transferring to developing countries the technologies needed for reaching a significant reduction in greenhouse gases . The operational suggestions briefly mentioned above – and, especially, the “no-regrets” strategy – appear to be perfectly in line with the application of the “active” version of the precautionary principle, which we have already referred to many times. A final clarification – not, however, of little importance – is necessary. As already mentioned earlier in this paragraph, and as the more meticulous scholars have not failed to underline , “aggressive action to combat climate change would be more beneficial to poor countries than to wealthy ones”: contrary to that which occurs in other sectors , where the distributional effect of the precautionary principle works in a completely opposite way. Also, for this reason, the struggle to combat global warming is one of those fields in which the intelligent and courageous application of the precautionary principle is to be highly recommended

29. 3.2.3 Boiling hot summers: the difficult case of global warming between the precautionary principle and the "No-Regrets" strategy (III) Two questions: • a) reasons for invoking the precautionary principle? • b) (if the answer is affirmative), which precautionary measures? a) Commission Communication of 2 February 2000: risk (uncertain, but) identified. In the case of global warming, the risk is (discussed, but) clearly identified and potentially serious. b) Precautionary measures should be proportionate to the risk and based on an economic cost-benefit analysis (which also duly takes the problem of “Risk Tradeoff” into account) The “no-regrets” strategy - US Supreme Court (Massachusetts v. EPA, 2 April 2007, 127 S. Ct. 1438 (2007)) and traffic emissions Aggressive action to combat climate change would be more beneficial to poor countries, thus correctly addressing the distributional issue

30. 3.3 Eccentricities of insufficient precaution: mercury in the mouth Dental amalgam, mercury hazardous wastes (Code CER180110*) and the precautionary principle Italy: Ministerial Decree of 10 October 2001 of the Ministry of Health: - the substitution of dental amalgams with other materials is not justified because these do not show a higher level of safety; - but prohibits putting in place or removing the amalgam for pregnant or breast-feeding women, for children under six years of age and for persons with serious kidney diseases ? The cost issue Europe: “Consultation Document” of 15 March 2004 by the European Commission on the “Development of an EU Mercury Strategy”, - Very high estimated use of mercury in dental amalgam in Europe; - “there are no controls on the use of such dental amalgams at EU level”

31. 3.4 Possible harm from too much precaution: is DDT more harmful than malaria? (I) “I’m not saying it’s safe for humans. I’m not saying it’s unsafe for humans. All I’m saying is that it makes hermaphrodites of frog” (Tyrone B. Hayes ). “Silent Spring” (Carson) DDT (Dichlorodiphenyltrichloroethane): anti-parasitic; eradicating malaria; implicated in the decline of some species, in particular, birds; labelled with the R 40 risk phrase ("May cause irreversible effects"); according to IARC in the 2B category ("possibly carcinogenic to humans”, with the following overall assessments about the carcinogenic risk: “inadequate evidence in humans”, but “sufficient evidence in experimental animals”).

32. 3.4 Possible harm from too much precaution: is DDT more harmful than malaria? (II) Consequently: - in countries where malaria has practically disappeared, the global banning of DDT is justified; - instead, in countries where malaria is still a serious threat, prolonged appropriate use of DDT should still be encouraged for a specific period (very gradual application of the precautionary principle necessary also for distributional reasons). The Stockholm Convention on Persistent Organic Pollutants (POPs Convention) approved on 22 May 2001 provides a general ban on twelve substances considered to be toxic (“the dirty dozen”), including DDT, but permits some exemptions which – with special reference to DDT – concern those countries where malaria is still a threat (“active” version of the precautionary principle).

33. 3.5 Uncertainties of precaution: the case of the use of sewage sludge in agriculture (I) The use of sludge coming from sewage treatment plants in agriculture is specifically regulated, in Italy, by Delegated Legislative Decree No. 99 of 27 January 1992, with two aims: - avoiding harmful effects to soil, vegetation, animals and humans; - encouraging the proper use of sludge in agriculture. A series of threshold values linked to the existence of heavy metals in the sewage sludge Moreover, the Italian legislation contains a further duty which is not expressly provided for in the European Directive, namely, that laid down in Art. 3 (1), to avoid the use, in agriculture, of sludge containing “toxic and harmful and/or persistent and/or bio-accumulable substances” – even those that are different from heavy metals – “in concentrations damaging to the soil, crops, animals, humans and the environment in general”.

34. 3.5 Uncertainties of precaution: the case of the use of sewage sludge in agriculture (II) The Italian provision – wider than the Community legislation – moves within the perspective of sustainable development, and the application of the European precautionary principle. However, a very general indication: the fundamental technical document to interpret it is the European Commission's “Working Document on Sludge, 3rd Draft”, of 27 April 2000, which provides various standards for sludge, no longer limited to heavy metals (in particular, for organic components, there are no limits for “total hydrocarbons”, while there is a value (6 mg/Kg), as well as a method for analysis (ISO 13877) for PAHs and for other compounds including polychlorinated biphenyls, dioxin and furan, halogenated compounds, phthalates.

35. 3.6 Community Courts and the Italian Constitutional Court confronted with the precautionary principle (I) The European Court of Justice and the European Court of First Instance have dealt repeatedly with the precautionary principle. A recent study (Marchant and Mossmann) of the jurisprudence of the European Courts identifies four different trends within the Community jurisprudence: a strict approach, an active approach, an intermediate approach (defined by the Author as the “third way”) and even an intrinsically conflicting approach. But in such study the jurisprudence of the European Courts is looked at in a plainly partial and incomplete manner; furthermore, the differences in jurisprudence are exaggerated, probably in an attempt to discredit the seriousness of the precautionary principle. After all, therefore, the contribution of European jurisprudence mainly moves – although with some uncertainties and lack of conformity in its accent – in the direction of an interpretation of the precautionary principle which is reasonable, active and substantially in conformity with the Commission Communication of February 2000 . So much so that – also for this reason – it seems reasonable to argue that, today, the precautionary principle is a legally binding rule of international customary law . The Italian Constitutional Court, on its part: - has for some time expressly held – from a clearly precautionary viewpoint – that scientific uncertainty is not enough to exclude the adoption of pre-established measures for protecting health ; - has confirmed the prevailing values of protection of the environment and health in a series of decisions dedicated to the so-called “balancing” of various constitutional interests ; - has enhanced the importance of science and the role of national and international technical-scientific bodies: a) explaining that on the matter of protecting health “the elaboration of trends based on the verification of the state of scientific knowledge and experimental evidence” (elaborations being up to the “technical-scientific bodies”) prevail over “the pure policy discretionality of the legislator” ; b) making it even clearer – very recently – that imposing restrictions on the exercise of the freedom of economic initiatives “on the basis of the prevention and precautionary principles in the interest of the environment and of human health” may legally take place solely on the basis of “trends based on the verification of the state of scientific knowledge and experimental evidence acquired through institutions and bodies which are usually national or international, that is, those which have been delegated to do so, given the fundamental role which, for these purposes, these scientific bodies play” ; - has, nevertheless, confirmed that in “normal situations”, compliance with technical regulations is (not only necessary, but also) enough to guarantee that the objective of “sustainable development” is followed ; - has finally and in summary form defined the precautionary principle as a “guideline criterion which shall inspire the elaboration, definition and implementation of the environmental policies of the European Community on the basis of scientific data … about the effects that may be produced by a given activity”

36. 3.6 Community Courts and the Italian Constitutional Court confronted with the precautionary principle (II) The Italian Constitutional Court: - scientific uncertainty is not enough to exclude the adoption of pre-established measures for protecting health; - the importance of science and the role of national and international technical-scientific bodies: on the matter of protecting health “the elaboration of trends based on the verification of the state of scientific knowledge and experimental evidence” (elaborations being up to the “technical-scientific bodies”) prevails over “the pure policy discretionality of the legislator” • the precautionary principle as a “guideline criterion which shall inspire the elaboration, definition and implementation of the environmental policies of the European Community on the basis of scientific data … about the effects that may be produced by a given activity”.

37. 4. A CASE STUDY: NANOTECHNOLOGIES AND THE PRECAUTIONARY PRINCIPLE 4.1 What are nanotechnologies? 4.2 The extraordinary opportunities for appIication 4.3 Foreseeable risks 4.4 Guidelines for the development of nanotechnologies within the framework of the precautionary principle

38. 4.1 What are nanotechnologies? Nanoscience – and the resulting nanotechnologies – are intended to construct new, extremely useful materials and machinery by “playing” with atoms (a human hair = one hundred thousand nanometres). Richard Feynman: 1959 conference “There’s Plenty of Room at the Bottom” Miniaturisation of electrical components (the so-called “top-down” approach) and the tendency to put together complicated structures using atoms and molecules as a starting point (the so-called “bottom-up” approach, based, among other things, on “molecular manufacturing”).

39. 4.2 The extraordinary opportunities for appIication Applications intended to significantly improve our ability to control and cure diseases, “clean up” the environment and – more generally – produce “intelligent” materials and (nano)machines: “Nanomedicine” , “nanoelectronics”, “nanoecology”, “nanocosmetics”. Military applications. Anti-terrorism applications. Hypothetical applications include the following: - inserting sensory networks inside the human body for dramatically improving our mental, physical or sensory capacities; - making copies of a person’s memory and thought processes; - more generally, “molecular nanotechnology”, consisting of the ability to programme matter with molecular precision.

40. 4.3 Foreseeable risks (I) Part of the potential risk depends on the way in which nanotechnology will respond to the researchers’ most radical aspirations (based on the “bottom-up” approach which have incited fears of self-replicating nanorobots, or so-called “grey-goo”) . The most recent research seems to emphasize the risks (military, political and environmental) actually inherent in conventional nanotechnologies (those that take the “top-down” approach, based on the application of conventional technologies to the nanodimension) . A significant environmental and health risk profile actually derives from the very small size of the materials in question. This, therefore, raises the question of the possible effects of exposure to nanoparticles on health, particularly with regard to the workforce employed in laboratories and plants where nanoparticles are being produced. Recently, the European Commission stated that their immediate concerns are with “free” nanoparticles, rather than the “fixed” kind, and that these also extend specifically to “nano-waste” involuntarily produced and released by conventional technologies (for example, the waste from aircraft combustion). Finally, there are ethical and social concerns, which can only be briefly discussed in the context of this study, the extent (and possible validity) of which largely depends on whether (a subject of much debate within the scientific community ) the most adventurous nanotechnological applications will actually see the light of day. These concerns include, for example: - the suspicion – certainly well-founded, should the current lack of serious and “proactive” international regulations persist – that nanotechnological applications further increase the north/south divide, creating a new barrier: the “nano-divide” ; - the protection of privacy and intellectual property ; - the possible misuses of military nanotechnologies (a subject on which several different viewpoints exist ), particularly in the event of these falling into the hands of dictators or unscrupulous States, or even terrorists ; - the likelihood that self-replicating robots, capable of producing a potentially infinite number of copies of themselves, might even attempt to take over world dominion (so-called “grey goo

41. 4.3 Foreseeable risks (II) Recently, the European Commission stated that their immediate concerns are with “free” nanoparticles, rather than the “fixed” kind, and that these also extend specifically to “nano-waste” involuntarily produced and released by conventional technologies (for example, the waste from aircraft combustion). Finally, there are some ethical and social concerns: • a new barrier: the “nano-divide”; • protection of privacy and intellectual property ; • possible misuses of military nanotechnologies; • likelihood that self-replicating robots, capable of producing a potentially infinite number of copies of themselves, might even attempt to take over world dominion (so-called “grey goo)

42. 4.4 Guidelines for the development of nanotechnologies within the framework of the precautionary principle (I) The risks associated with nanotechnologies are unquantifiable in terms of magnitude but clearly recognized within the scientific community. This, therefore, constitutes a necessary and sufficient reason for the application of the precautionary principle. For this purpose, the precautionary principle should be considered in its “active” version. A generalized ban would actually prove to be very tricky, since it would deprive us of the advantages offered by nanotechnologies. The Foresight Institute has issued some guidelines: - to set the boundaries for a proactive research approach to ensure that molecular nanotechnology is developed responsibly; - to prevent compulsory regulations based on insufficient information; - to disseminate various specific criteria by which researchers must abide, with immediate effect, which are also based on the principles of responsibility, self-regulation and traceability.

43. 4.4 Guidelines for the development of nanotechnologies within the framework of the precautionary principle (II) European Commission Communication of 12 May 2004: need to identify and respond to anxieties about safety, health and environment associated with nanotechnologies Five possible alternatives for the regulation of research into nanotechnology: - no regulation; - moratorium on research and/or marketing; - voluntary measures; - complete and thorough legislation specific to nanotechnologies; - maximum utilisation of the existing legislative structure (regulations on hazardous substances, labelling etc.), and – where necessary – its amendment for adapting it to the nanotechnological phenomenon (so-called “incremental process”, which the Commission regards as the most preferable choice): e.g. REACH

44. 5. CONCLUSION 5.1 The lawyer of the new millennium as a user of science and expert in “peer review“ 5.2 "Small is no longer beautiful": new responsibilities from the precautionary principle for national and European technical-scientific Agencies 5.3 Neither "arbitrary" nor "capricious", the precautionary principle elevates equilibrium to a constitutional duty mandatory for public authorities

45. 5.1 The lawyer of the new millennium as a user of science and expert in “peer review“ Lawyer as a user of science, with a similar role to that of a conductor: although he cannot play every single instrument himself, he is in tune with the entire programme as well as the part to be played by each member of the orchestra. The jurisprudence of the American Supreme Court (Daubert): “a jury ordinarily should be the arbiter of the weight of expert testimony, but the trial court judges must be ‘gatekeepers’ who exclude scientific expertise not based on valid research”. Lawyer as an expert of “peer review” (see decisions of the European Court of Justice and of our Constitutional Court). Peer review criteria.

46. 5.2 "Small is no longer beautiful": new responsibilities from the precautionary principle for national and European technical-scientific Agencies (I) The European and national technical-scientific Agencies are those best placed to formulate guidelines for the precautionary principle (European Council Resolution of 4 December 2004). The implementation of the precautionary principle should not involve an aprioristic anti-technological attitude, but should be based on scientific knowledge that is in the process of being acquired, with the resulting need to shift major strategic decisions regarding environmental safety into the realms of higher government. At national level, in Italy, the text of Art. 117 of the Constitution (resulting from Constitutional Law No. 3/2001) is extremely significant.

47. 5.2 "Small is no longer beautiful": new responsibilities from the precautionary principle for national and European technical-scientific Agencies (II) In Italy, the Constitutional Court, in decision n. 116/2006, stated that: ● imposing limits on the exercise of free enterprise “on the basis of the principles of prevention and precaution in the interests of the environment and of human health” can legally take place only on the basis of “policies founded on the verification of the state of scientific knowledge and experimental evidence acquired normally through national or supranational institutions and organisms, that have been delegated this task, given the fundamental role which, for these purposes, these technical-scientific bodies play” ; ● “the drawing up of such policies only be entrusted to State law, which is called to identify the point of equilibrium between opposing needs, which can be imposed in terms that cannot be derogated from by Regional legislation.

48. 5.3 Neither "arbitrary" nor "capricious", the precautionary principle elevates equilibrium to a constitutional duty mandatory for public authorities (I) “The hard question is not whether something is bad or good, … it is finding the point of optimality amidst risks on all sides. The regime we now have is too often radical in its stark dichotomies; the future may be radical in its moderation” (Jonathan B. Wiener ). Critics of the precautionary principle sometimes focus their objections on an imaginary enemy, confusing the principle in question with the quite distinct problem of identifying – and recognising the characteristics of – the precautionary measures that can (or should) be adopted in each individual case. The precautionary principle is now officially recognised by legal orders at international, European and national level. Its proper meaning (in the “active” version supported by all the key legal documents) does not impose passivity and inaction, quite the reverse.

49. 5.3 Neither "arbitrary" nor "capricious", the precautionary principle elevates equilibrium to a constitutional duty mandatory for public authorities (II) The various potential risks should naturally be assessed at the same time, in order to evaluate problems such as the “gallery effect” and “Risk Tradeoff”, and the various possible relationships between the amount of exposure and the risk should also be kept in mind. The possible “distributional” effects of the precautionary measures. A real (constitutionally guaranteed) burden of equilibrium, to be recognized at national or supranational level, from which public powers cannot legally derogate. A similar point of equilibrium – which now appears to be missing in our environmental legislation - is crucial if the precautionary principle is to be really useful in reconciling science and society: as pointed out in a recent WHO (World Health Organization) report, a correct application of this principle is able to demonstrate that “there is no contradiction between pursuing scientific progress and taking precautionary action”. The staunch defenders of this principle are essentially those who – in applying it “with equilibrium” (in other words, by exercising great caution…) – are contributing to making it more powerful, authoritative and acceptable.