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Nanotechnology and Risk Governance in the European Union: the Constitution of Safety in Highly Promoted and Contested Innovation Areas

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Abstract

The European Union (EU) is strategically committed to the development of nanotechnology and its industrial exploitation. However, nanotechnology also has the potential to disrupt human health and the environment. The EU claims to be committed to the safe and responsible development of nanotechnology. In this sense, the EU has become the first governing body in the world to develop nanospecific regulations, largely due to legislative action taken by the European Parliament, which has compensated for the European Commission’s reluctance to develop special regulations for nanomaterials. Nevertheless, divergences aside, political bodies in the EU assume that nanotechnology development is controllable and take for granted that both the massive industrial use of nanomaterials and a high level of environmental and health protection are compatible. However, experiences such as the European controversy over agri-food biotechnology, which somewhat delegitimized the regulatory authority of the EU over technological safety and acceptability, arguably show that controllability assumptions are contestable on the grounds of alternative socio-economic and cultural preferences and values. Recently developed inclusive governance models on safety and innovation, such as “Responsible Research and Innovation” (RRI), widely claim that a diversity of considerations and issues are integrated into R&D processes. Even so, the possibility of more radically alternative constitutions of socio-technical safety seems to be seriously limited by the current ideology of innovation and economic imperatives of the global, knowledge-based, capitalist economy.

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Notes

  1. For instance, estimates show that 160,000 nanorelated jobs already existed globally in 2008, representing a 25% increase from 2000, and that every euro invested in research areas such as nanotechnology results in a tenfold return, largely affecting small- and medium-sized enterprises (SMEs). SMEs are expected to account for most nanorelated jobs. In Germany, for example, 80% of nanotechnology firms are small- or medium-sized ([55], pp. 3–4).

  2. “Responsible innovation” for the EC not only refers to environmental, health and safety (EHS) risks but also to ethical and societal consequences.

  3. For instance, global public and private investment in nanotechnology R&D had risen to more than US$18 billion annually during the last decade ([112], p. 174). The world market for nanomaterials has been evaluated at 11 million tonnes (having a market value of €20 billion), direct employment in the nanotechnology sector stands at 300,000–400,000 jobs across the EU, and products underpinned by nanotechnology are estimated to be worth €2 trillion ([89], p. 93).

  4. The funds allocated in the EU to the assessment of the environmental, health and occupational risks of nanomaterials are low compared to overall investment in nanotechnology R&D. For example, the EU Sixth Framework Programme for R&D (2002–2006), or FP6, devoted 2% (€28 million) of its total expenditure (€1.4 billion) on nanotechnology R&D to risk assessment research ([3], p. 7, [45], p. 3), and FP7 (2007–2013) 2.9% (€102 million) until 2011 ([96], pp. 5, 19).

  5. Namely, in the size range from approximately 1 to 100 nm, according to the definition of the International Organization for Standardization (ISO): https://www.iso.org/obp/ui/#iso:std:iso:19430:ed-1:v1:en:term:3.1. Accessed 21 March 2017.

  6. Due to their shape similarities (long and needle-like), carbon nanotubes have been seen to have asbestos-like impacts on mice [128].

  7. The abovementioned categories of nanomaterials represent classes, and therefore, toxic capacity will be different among single nanomaterials, with relevant variations in their physicochemical properties ([9], p. 335).

  8. The OECD’s Working Party on Manufactured Nanomaterials (WPMN) launched in 2007 a Sponsorship Programme for the Testing of Manufactured Nanomaterials. The goal of this program is to verify the testing methods used on manufactured nanomaterials: http://www.oecd.org/chemicalsafety/nanosafety. Accessed 17 March 2017.

  9. “The Nanodatabase”, developed by the DTU Environment, Danish Ecological Council and Danish Consumer Council. On the database website, the reporting process is described as follows: "Help us improve and expand The Nanodatabase (nano.taenk) by telling us about products that claim to be 'nano' or you think may contain nano materials. Do like this: Search shop shelves and find products, where the word 'Nano' appears on the packaging or on the product itself. (...) After we have received your report, we will contact DTU Environment, who will examine the reported product and in turn authorize its publication in the database". See http://nanodb.dk/en. Accessed 2 March 2017.

  10. In fact, what seems to be at stake is rather more than just developing a new set of rules. Societal regulations are often outpaced by extremely fast, market-oriented mass development and the application of emerging technologies such as nanotechnology, which would arguably demand a new regulatory paradigm—or “predisposition” [144]—based on principles such as flexibility, adaptation and participation [107].

  11. And even where production levels reach the threshold, “the usually low concentration of nanoparticles in the final article is likely to exclude many nanoengineered articles from the REACH legislation, since no registration is required when the concentration of a substance is lower than 0.1% w/w [weight by weight]” ([104], p. 212).

  12. The EC has envisioned amendments to several of the technical provisions in the REACH Annexes ([63, 87], pp. 302–303), expected to be published in May 2017 [38].

  13. This demand needs to be understood in the context of the “functional barrier,” meaning, in the field of intelligent packaging systems, “a barrier within food contact materials or articles preventing the migration of substances from behind the barrier into the food” ([51], p. 4). Behind the functional barrier, substances that are not included in the “Community list” of authorized substances can be used (under certain conditions) ([51], p. 6). Nanoparticles, however, are considered a special technology requiring specific treatment, and they “should not be covered by the functional barrier concept” ([51], p. 4).

  14. The EC is the executive branch of the EU. The European Council confers to the Commission, under certain conditions, or procedures, “powers for the implementation of the rules which the Council lays down” ([24], p. 23).

  15. Ingredients with nanomaterials “shall be followed by the word ‘nano’ in brackets” ([73], p. 73).

  16. Moreover, under this regulation, the EC was required to compile a catalog, by January 2014, of all nanomaterials used in cosmetic products placed on the market, indicating the cosmetic product categories and reasonably foreseeable exposure conditions ([73], p. 71). An annual status report was also to be sent to the EP and European Council on developments in the use of nanomaterials in cosmetic products within the Community, and on issues such as the progress made in developing nanospecific assessment methods and safety assessment guidelines ([73], p. 71).

  17. It should be noted that difficulties relating to the definition of “nanomaterial” transcend the issue of inconsistent formulation. On the one hand, at the moment, there is a lack of one single measurement method to detect and characterize nanomaterials according to defined characteristics, and the task becomes even more complicated when we take into account that the properties of nanomaterials are susceptible to change in their life cycle ([6], p. 411). On the other hand, the limits set by the definition(s) are constitutively (or necessarily) conventional, meaning that materials that do not fall within such limits (i.e., that are not classified as nanomaterials because of their size of percentual presence) may display nanorelated risks in certain contexts of use or in relation to certain properties ([11], p. 122).

  18. Regulatory measures constraining the commercialization and use of GMOs taken in this period, such as the EU moratorium and other safety bans enforced individually by some member states, also seriously affected international trade relations. The importation of GM products to the EU from major producer and exporting countries such as the USA, Canada and Argentina was blocked. In response, the above countries filed a World Trade Organization (WTO) case against the EU, claiming that regulatory measures in Europe were scientifically unjustified and violated compulsory trade agreements. The WTO ruled against the EU, based on legal criteria established by its Appellate Body in other, past disputes, where more precautionary regulations and considerations were approached as illegitimate [156, 157].

  19. In relation to this cautious perspective on the uncertain risks of agri-food biotechnology, Directive 2001/18/EC—unlike previous Directive 90/220/EEC—limited the validity of GMO authorizations to a 10-year period ([70], p. 10). Authorization renewal was granted after a new application detailing the behavior of the GMO during the previous 10-year period had been approved ([70], p. 11).

  20. The public backlash against agri-food biotechnology was not only motivated by safety concerns. Regulatory reforms included rules for the mandatory labeling of products containing GMOs--as already claimed--, mandatory information to the public prior to the commercialization of GMOs, the introduction of ethical advice as an additional criterion for decision-making, and the socio-economic assessment of approved GMOs [70].

  21. For example, Günter Verheugen, former EC Vice President for Enterprise and Industry (2004–2009), stated that “The debate must (…) remain science-based, and we must take a balanced view on matters of concern, such as GMOs, and avoid taking extreme positions” [150].

  22. This is even true of scientific safety assessments. The vulnerability of knowledge to the influence of “subjective,” or ideological, considerations should be approached as characteristic rather than accidental. As the consequences of mistakes in the evaluation of safety hypotheses and models, to a large extent proposed on a relative lack of evidence, are non-epistemological—i.e., they are environmental and sanitary, as well as economic—science-related decisions based on ambiguous and insufficient evidence are said to be necessarily taken under the influence of social criteria ([32], pp. 87–114, [105], pp. 397–403).

  23. The European Food Safety Agency (EFSA) reached the same conclusion [65].

  24. It was estimated that the hazard testing of the nanomaterials available at the time (i.e., 2009), in itself, could take between 3 and 5 decades and would require an investment greater than $1 billion [18].

  25. Synergies between nanomaterials also occur. The agglomeration of nanomaterials may change their properties, which would affect “their behavior in the indoor and outdoor environments as well as their potential exposure and entry into the human body” ([131], p. 7).

  26. The Lisbon Strategy, established in 2000, aimed to make the EU “the most competitive and dynamic knowledge-based economy in the world” by 2010 ([64], p. 12).

  27. NRC experts also make it very clear when stating that “The involvement of decision-makers, technical specialists, and other stakeholders in all phases of the processes leading to decisions should in no way compromise the technical assessment of risk, which is carried out under its own standards and guidelines” ([115], p. 11).

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Acknowledgements

This work is based mainly upon research supported by the Basque Government’s Department of Education, Universities and Research under a Postdoctoral Fellowship for the Improvement of Research Personnel in a Foreign Country (grant BFI08.183). It has also been supported by the Basque Government’s Department of Education, Language Policy and Culture (grant IT644-13), the Spanish Ministry of Economy and Competitiveness and the European Regional Development Fund (grant FFI2015-69792-R), and the University of the Basque Country UPV/EHU (grant EHUA15/13). The author also wishes to thank Heather A. Okvat for her assistance in revising the initial, original version of the article, and to two anonymous reviewers for their constructive and thorough comments on the present version. Any shortcomings in the work remain the responsibility of the author.

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    Hannot Rodríguez

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Rodríguez, H. Nanotechnology and Risk Governance in the European Union: the Constitution of Safety in Highly Promoted and Contested Innovation Areas. Nanoethics 12, 5–26 (2018). https://doi.org/10.1007/s11569-017-0296-3

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