NANOMATERIALS: THE ENVIRONMENTAL RISK IS THERE SOME ROOM LEFT FOR ETHICS AND LAW?

1. NANOMATERIALS: THE ENVIRONMENTAL RISKIS THERE SOME ROOM LEFT FOR ETHICS AND LAW? Judge Christian BYK, Secretary General, International Association of Law, Ethics and Science

2. INTRODUCTION: • Nanotechnology offers new scientific and industrial perspectives (in communication, energy… ) • However, the experience of nuclear energy and genetic engineering delivers us a message: • The necessity to set up an appropriate societal reflection on risk acceptability and on our capacity of controlling such risk.

3. I A SOCIETAL APPROACH OF THE RISK • The fear of the implications of nanotechnology on health and environment is not simply a technical issue about toxicity . It is a global concern about how meaningful are risks for our life project and for society. • Technical standards cannot solve this societal issue. Ethics and law must integrate in the debate social, cultural and anthropological components • The objective is to bring society and science to common trust which is the true meaning of bioethics: building a bridge to the future

4. A) Should we fear the impact of nanomaterials ? • The progress based approach to science collapsed when the Second World War makes us aware of the misuses of science and medicine (Nazi doctors, Nuclear bomb). • More recently, this awareness extended to biochemicals and genetic engineering. • From Minamata (Japan) to Seveso (Italia) , Bhopal (India) Chernobyl (Ukraine) and AZF, (France) , we experienced a series of industrial accidents which resulted in a complete reversal of social acceptability. • This is the reason why before evaluating risks we have to deal with the question: in which kind of society we would like to live?

5. What benefice are we expecting from new industrial risks? • For what kind of society? The request for a safer environment in western countries may face an argument for a right to access economical development and consumption society for the emerging economies. • What kind of humans ? Will the incorporation of nanomaterial in clothes, food and drugs make our biology and our body relying on artefacts? Could it affect our anthropology?

6. What kind of risks? How to evaluate the risks? Identifying the risks • Is there a significant risk for the population to be exposed to nanoproducts and what would be the effects of this exposure on human health? • Can nanomaterials be released in the environment? In which form and quantity? What may be the effects of this release?

7. Why should we worry about nanomaterials? • Nanoparticles can cross the biological barriers . As Nanoparticles can also penetrate the nucleus of a cell, carbonic nanotubes have been classified for their capacity to induce genetic mutations as potentially carcinogenic. • Concerning transformation and degradation mechanisms, we know very little about the way they behave in air, soil, water or living organisms . • A question rises: is there any risk created by a potential bioaccumulation?

8. Risks and governance • Policy makers are aware of the importance of controlling the risks. • In France (and other countries) scientific institutions have reported on the risks. • It is also a matter of international concern with initiatives of the European Commission, OECD, the United Nations organizations as well as the informal International Dialogue Conferences on nanotechnologies . • Some think thanks view the global approach as illusory: hundreds of nanoproducts have already been developed and the contributions of so many institutions is creating inconsistency in policy making. • Is the expression governance a politically correct term used to elude the real ethical and political issues ?

9. B) How may ethics and law take part in balancing risks and benefits? • In 2003 the Canadian think thank ETC warned us that the most powerful nanotechnologies are emerging in a space which has no rule or policy to govern them . • In 2008 a former chair of the French National Bioethics Committee reminded us that the ethical reflection should not be the good conscience that may help science in getting rid of social fears. • Consequently it is our view that the ethical reflection is there to point out all the risks with the idea that public discussion is the only way to build trust between nanotechnologies and society.

10. A Reflection that must point out all the risks • Policy makers are now aware that the promotion of nanotechnologies largely depends on a reliable system for preventing risks which implies to define nanotechnology, to identify nanoproducts and risks and to set up appropriate regulation mechanisms. • This step has clearly to take into account that both “the new opportunities expected from nanotechnologies and the new health and environmental risks go hand in hand.” • Contrary to the asbestos contamination scandal, we should not wait to incorporate into our regulations the knowledge that we may obtain about toxicity of nanoparticles .

11. An objective: building trust between new technoscience and society • The effort for reaching a better knowledge of the biotoxicity of nanomaterials is not enough. The ethical reflection is there also to discuss taboo issues not to create unjustified fears but to ease social understanding and, in some way, acceptability of new techniques. • We should not ignore the impact of nanotechnologies on food and agriculture because combining nanotechnologies, biotechnologies and industrial property may lead to some radical changes in food production and distribution. • The need for transparency is therefore essential to build a new trust between science and society.

12. II THE PRECAUTIONARY PRINCIPLE : A DYNAMIC RULE TO MANAGE THE RISKS • The precautionary principle is a moral and politicalprinciple which states that if an action or policy might cause severe or irreversible harm to the public or to the environment, in the absence of a scientific consensus that harm would not ensue, the burden of proof falls on those who would advocate taking the action. • The principle implies that there is a responsibility to intervene and protect the public from exposure to harm where scientific investigation discovers a plausible risk in the course of having screened for other suspected causes.

13. A) The key elements of the precautionary principle • A need by to anticipate harm: it is the responsibility of an activity proponent to establish that the proposed activity will not result in significant harm. • The establishment of an obligation for action to prevent or minimise such harm even when the absence of scientific certainty makes it difficult to predict the likelihood of harm occurring, or the level of harm should it occur. • Those key elements are considered as appropriate in the field of nanotechnology . Nevertheless, the awareness that the precautionary principle should be applied does not bring a clear view of how policy makers would like to do it.

14. Considering uncertain risks:At the national and European level • The French Agency for the Safety of Environment and Work noted that new nanoproducts arrive on the market without any application of preventive measures and recommended specific actions. • The European Commission developed since 2004 a “safe, integrated and responsible” strategy for nanotechnologies. The Scientific Committee on Emerging and Newly identified Risks adopted an opinion which concluded that the existing methods used in toxicology and ecotoxicology are not fully appropriate to detect and evaluate the effects of nanoparticules. The 7th EC Framework program on Research and technology (PCRD) allows financial support and in 2008, the European Commission released a Recommendation on a code of conduct for responsible nanosciences research.

15. Considering uncertain risks:At the international level • Many international organisations (WHO, FAO, UNIDO, WIPO,OECD…) approached the issue. • This resulted in a fragmented technical view and the initiative of an International Dialogue on nanotechnologies with the participation of the European Union , the United States and the United Nations. • It is our view that globalisation should not paralyse the application of the precautionary principle. So, as a first step, we should rely on national and European regulations which already implies to make political choices.

16. B What kind of policy?Points of agreement Developing our knowledge of risks • There is a consensus that the most pressing near-term issues are toxicity and exposure to humans and environment . • The European Union proposed 12 recommendations to develop a new nomenclature and new measuring instruments , to collect data and perform analysis , to develop standardized –risk assessment methods, guidelines and standards for production, strive for the elimination or minimization of the release into the environment and create institutions to monitor the development of nanotechnology. • In the USA, the Environmental Protection Agency (EPA), the Food and Drug Administration (FDA) and the National Institute of Occupational safety and Health inquired into the need to change the existing process to evaluate nanotechnology.

17. Supporting transparency and debate • Nanotechnology are the first step where scientists are no longer capable of autonomously directing scientific research due to the pressures from civil society and State actors . • Public authorities mandated ethics committees to report and organised dialogue with citizens’ groups as the “Grenelle de l’environnement” in France .The European Commission also set up a yearly “Safety for Success Dialogue”. • Transparency is crucial to prevent misunderstandings and to facilitate the social acceptability of a balanced regulation. However, the public concern is not only with transparency about risks. It is something more complex involving sociocultural and even anthropological insights. • There is little consideration regarding the ethics of economy. Managing the risk issue through a system of traceability could lead to a strict social control on individuals. It also creates some fear that the individual could be radically transformed .

18. Regulating • The transparency and safety arguments naturally support the idea that nanoproducts should be submitted to regulations in order to control their existence and safety . • A pragmatic attitude considers that the existing domestic and European regulations applying to the safety of new products and to the protection of workers and consumers may serve as references for such regulation and that nanotechnology are not facing a legal vacuum. • But some divergences appeared concerning how far existing regulations may be used as a concrete model for nanotechnology. Furthermore, some radicals called for a moratorium and even a ban on nanotechnology.

19. Should we impose a moratorium on nanotechnology? • Friends of the Earth called for moratorium . Their report "nanotoxicity and health issue" said that over 720 products are being released for public consumption without adequate safety testing. • Other NGOs criticised nanotechnology as a new feature in their fight against the technoscientific development and claimed that nanotechnology will increase social contol.They also fear it would lead in a loose of control over artificial items that would be able to self replicate. • However, most of those in charge with expressing ethical opinions considered that currently there are no nanotechnological objects capable of self-replication and that this so called ethical question constitutes a distraction because “it forces the discussion to revolve around the risks of possible future research rather than real system for research oversight and regulation which exists today”.

20. Should we adopt specific regulation? • Pragmatic reasons (to prevent overlapping regulations and stigmatisation of nanotechnology) incite governments to favour a less specific approach that would consist to adapt the existing regulations to the specificity of nanoproducts. Moreover, the experience of specific regulations in the nuclear energy and genetic engineering fields is evidence that they do not want to adopt the same approach . • For the European Commission, “the existing EU legislation ( framework directive 89/391/CEE on the protection of the safety and health of workers, directives 91/414/EC on plant protection products and 98/8/EC on biocides , directive 2008/1/EC on Integrated Pollution Prevention and Control , Seveso II directive 96/82/EC , framework directive on water 2000/60/EC and the Reach Chemicals regulation adopted EC/1907/2006) covers in broad extend the risks raised by nanomaterials “. The Commission refers, in particular,

21. Should we adopt specific regulation?EU REACH REGULATION • Although they are no provisions in REACH referring to nanomaterials, this regulation includes nanomaterials through its broad definition of the term “substance” . • Consequently, new substances at the nanoscale have to be registered before manufacturing or importing if they concern quantities of 1 tonne per year (dangerous substances are not submitted to tonnage triggers) • Regarding classification and labelling, “nanomaterials having specific properties may require a different classification and labelling compared to the bulk material”. • Several stakeholders raised the concern that 1 tonne threshold may exclude registration of many substance at nanoscale . With respect to substance identification. It is also discussed at which point nanomaterials with different kind of surface modifications should be seen as belonging to the same substance or whether they should be considered as separate substance.

22. Should we adopt specific regulation?NATIONAL REGULATION • National initiatives are possible in Europe as far as they respect the principle of free circulation of goods. • In France the present article 37 of the so-called Grenelle 1 draft law introduced a compulsory registration for manufactured or imported nanomaterials. • Similar initiatives but on a voluntary basis have also been taken in the USA and in the U-K.

23. CONCLUSION: • We are now conscious about the risks our health and environment are facing as a consequence of human technoscientific development • The ongoing globalization is good incentive to adopt an integrative policy which takes into account not only the scientific and economic view but also the ethical, legal and social approach. • “The visible extent of the world surpasses us visibly; but, since we surpass small things, we believe ourselves capable of possessing them, and yet it requires no less capacity to reach nothingness as it takes to reach everything” Blaise Pascal