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The ELD: Applicability to Nanotechnology Risk and the Liability Implications of Environmental Damage

  • Karena HESTER, Martin MULLINS, Robert FORD and Finbarr MURPHY

Abstract

This paper examines the potential impact of the European Union’s Environmental Liability Directive (ELD) 1 on the nanotechnology (NT) sector. In terms of risk governance the ELD represents a new paradigm, affording the environment an enhanced status both in legal and indeed ontological terms. However, the nature of the NT industry itself is such as to create complexity in the implementation of the ELD. Whilst the field of nano-toxicology is making advances, debate still prevails around issues pertaining to exposure, (eco)-toxicity, metrics, potential impact and legal causation. Levels of uncertainty remain high and hence measuring environmental impact is problematic. The paper addresses the potential environmental liability exposures of NT manufacturers and producers pursuant to the provisions of the ELD and by extension highlights the importance of the insurability of the liability risk all of which bears significance for the sustainability of the industry. It also examines the legal and regulatory challenges of the application of the ELD in the context of the NT industry, highlighting the challenges which this pervasive technology presents for regulatory policy. A cursory discussion of the legal theoretical underpinning of the directive helps to explain the rationale of the directive.

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Corresponding author

*Corresponding author: Karena Hester, Kemmy Business School, University of Limerick; email: karena.hester@ul.ie

References

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1 Council Directive 2004/35/EC of 21 April 2004 on environmental liability with regard to the prevention and remedying of environmental damage [2004] OJ L143/56.

2 EM McAlea et al., “Engineered nanomaterials: risk perception, regulation and insurance” (2016) 19(4) Journal of Risk Research 444; Karena Hester “Nanotort Liability at Common Law”, in F Murphy et al. (eds), Managing Risk in Nanotechnology: Topics in Governance, Assurance and Transfer (Springer 2016) 117.

3 M Mohan et al., “Integrating Legal Liabilities in Nanomanufacturing Risk Management” (2012) 46 Environmental Science & Technology 7955.

4 ELD, Art. 14.

5 M Mullins et al., “The insurability of nanomaterial production risk” (2013) 8 Nature Nanotechnology 222.

6 Lloyd’s Emerging Risks Team Report, “Nanotechnology, Recent Developments, Risks and Opportunities” (2007).

7 Allianz report in co-operation with the OECD International Futures Programme, “Small sizes that matter: Opportunities and risks of nanotechnologies” (2005).

8 Swiss Reinsurance Company, “Nanotechnology: Small matter, many unknowns” (2004).

9 The ELD is described as a framework directive due to its intention to accompany and support existing Member State legislation and also due to the existence of numerous amendments which are implemented in each individual Member State at their own discretion.

10 Previous “environmental” legislation dealt with compensating third party property and person arising from an environmental incident caused by an operator.

11 An operator is considered to be those who have a financial interest in, and control over the operation of an occupational activity. An occupational activity is that which is carried out in the course of an economic activity, irrespective of whether it is a public or private enterprise or whether it is of a profit or non-profit nature

12 ELD, Preamble paras. 1, 7, 8, Art. 2; Annex 1 criteria for determination of “significant damage”; Annex II para. 1; Annex II paras. 1.3.1, 1.3.3; Annex II, para. 2.

13 ELD, Preamble, para. 8.

14 The preventative principle is a public international law principle. It is also an EU environmental policy that is related to the precautionary principle and is intended to prevent harmful effects of known risks. The precautionary principle, by comparison, is designed to prevent unknown and probable risks (Gert Van Calster, “European Union” in R Seerden et al., Public International Law in the European Union and the United States – A Comparative Analysis (Vol 5 Comparative Environmental Law & Public Policy Series (2002)) 480, cited in Lucas Bergkamp and Barbara J Goldsmith (eds) The EU Environmental Liability Directive A Commentary (Oxford University Press 2013) 28.

15 The PPP is an EU environmental policy principle that is intended to internalise the cost of preventative measures to prevent environmental damage and, if it does occur, to restore the environment by remediation. The PPP and preventative principles are related: the PPP becomes relevant once the application of the preventative principle has been exhausted, damage having occurred. The operator is then liable to pay for the environmental damage it causes: Bergkamp and Goldsmith, supra note 14, 26.

16 Christopher H Schroeder “Corrective Justice and Liability for Increasing Risks” (1989) 37 UCLA Law Review 439; Gary T Schwartz, “Mixed Theories of Tort Law: Affirming Both Deterrence and Corrective Justice” (1996–1997) 75 Texas Law Review 1801.

17 Richard L Abel, “A Critique of Torts” (1990) 37 UCLA Law Review 785.

18 GP Fletcher, “Fairness and utility in tort theory” (1972) Harvard Law Review 537.

19 Gregory C Keating, “Distributive and Corrective Justice in the Tort Law of Accidents” (2000) 74 Southern California Law Review 193.

20 Schwartz, supra note 16.

21 KW Simons, “Jules Coleman and Corrective Justice in Tort Law: A Critique and Reformulation” (1992) 15 Harvard Journal of Law and Public Policy 849.

22 Tom Regan, “The Nature and Possibility of an Environmental Ethic” (1981) 3(1) Environmental Ethics 19.

23 Primary remediation: ELD, Annex II para. 1(a).

24 Complementary remediation: ELD, Annex II para. 1(b).

25 Compensatory remediation: ELD, Annex II para. 1(c).

26 Project on Emerging Nanotechnologies (2013). The Consumer Products Inventory is available at: <http://www.nanotechproject.org/cpi> (accessed 6 January 2017).

27 Health and fitness category comprises 742 products or 42% of all consumer products. Of that personal care products comprise 39%.

28 Nanoscience and Nanotechnologies: Opportunities and Uncertainties (The Royal Society and Royal Academy of Engineering 2004), available at: <https://royalsociety.org/~/media/Royal_Society_Content/policy/publications/2004/9693.pdf> (accessed 6 January 2017).

29 Danial Hristozov and Ineke Malsch, “Hazards and Risks of Engineered Nanoparticles for the Environment and Human Health” (2009) 1 Sustainability 1161.

30 Supra note 6.

31 Jun-Gang Li et al., “Comparative study of pathological lesions induced by multiwalled carbon nanotubes in lungs of mice by intratracheal instillation and inhalation” (2007) 22(4) Environmental Toxicology 415; Julie Muller et al., “Clastogenic and aneugenic effects of multi-wall carbon nanotubes in epithelial cells” (2008) 29(2) Carcinogenesis 427.

32 Kai Savolainen et al., “Nanotechnologies, engineered nanomaterials and occupational safety – A Review” (2010) 48(8) Safety Science 957.

33 For a review of exposure research see Kai Savolainen et al., “Risk assessment of engineered nanomaterials and nanotechnologies – A Review” (2010) 269(2-3) Toxicology 92.

34 Edilberto Bermudez et al., “Pulmonary response to subchronic inhalation of ultrafine titanium dioxide particles” (2004) 77(2) Toxicological Science 347.

35 Anna A Shvedova et al., “Unusual inflammatory and fibrogenic pulmonary responses to single-walled carbon nanotubes in mice” (2005) 289(5) American Journal of Physiology – Lung Cellular and Molecular Physiology L698; Anna A Shvedova et al., “Critical issues in the evaluation of possible adverse pulmonary effects resulting from airborne nanoparticles” in Nancy A Monteiro-Riviere and C Lang Tran (eds) Nanotoxicology – Characterisation, Dosing and Health Effects (New York: Informa Healthcare, CRC Press, Taylor & Francis Group 2007).

36 Valeria Matranga and Ilaria Corsi, “Toxic Effects of Engineered Nanoparticles in the Marine Environment: Model Organisms and Molecular Approaches” (2012) 76 Journal of Marine Environmental Research 32.

37 White Paper on Environmental Liability, Com (2000) 66 Final, 9 February 2000.

38 To which a natural bridge exists between it and nanotechnology (Yang Dayong et al., “DNA materials: bridging nanotechnology and biotechnology” (2014) 47(6) Accounts of Chemical Research 1902).

39 Supra note 37.

40 On the distinction between directives and regulations, see <http://europa.eu/eu-law/decision-making/legal-acts/index_en.htm>.

41 Gerd Winter et al., “Weighing up the EC Environmental Liability Directive” (2008) 20(2) Journal of Environmental Law 163.

42 ELD, Art. 2(2).

43 Formerly regulated under Directive 67/548/EEC and now regulated under Regulation EC No 1272/2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006.

44 Formerly regulated under Directive 199/45/EC and now regulated under Regulation EC No 1272/2008.

45 Biocidal products are regulated under Regulation EU528/2012 and the regulation explicitly defines NM and makes regulatory provisions in relation to them.

46 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC [2006] OJ L 396.

47 “Significant” is not expressly defined in the directive. The criteria to assess the significance of the effects of environmental damage referred to in Art. 2(1)(a) are set out in Annex I. Broadly speaking, it refers to damage which has adverse effects on reaching or maintaining the favourable conservation status of habitats or species. “Damage with a proven effect on human health must be classified as significant damage”.

48 Council Directive 2009/147 EC of 30 November 2009 on the conservation of wild birds [2010] OJ L20/7.

49 Council Directive 92/43 EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora [1992] OJ L206/7.

51 Supra note 26.

52 “Smaller silver nanoparticles more likely to be absorbed by aquatic life”, Nanowerk News, 8 October 2015.

53 Brigitta Szala et al., “Potential Toxic effects of Iron Oxide NP in in vivo and in vitro experiments” (2012) 32(6) Journal of Applied Toxicology 446.

54 Per Laleng, “Causal Responsibility for uncertainty and risk in toxic torts” (2010) 18 Tort Law Review 102.

55 ELD, Art. 3(a).

56 Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (Text with EEA relevance) (OJ L 167, 27.6.2012).

57 Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342).

58 Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee – Regulatory Aspects of Nanomaterials, COM (2008) 366 final; Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee – Second Regulatory Review on Nanomaterials, COM (2012) 572 (final).

59 K Tiede et al., “Application of hydrodynamic chromatography-ICP-MS to investigate the fate of silver nanoparticles in activated sludge” (2010) 25(7) Journal of Analytical Atomic Spectrometry 1149; R Kaegi et al., “Behaviour of Metallic Silver Nanoparticles in a Pilot Wastewater Treatment Plant” (2011) 45 Environmental Science & Technology 3902; MM Shafer et al., “Removal, partitioning, and fate of silver and other metals in wastewater treatment plants and effluent-receiving streams” (1998) 17 Environmental Toxicology and Chemistry 630; L Hou et al., “Removal of silver nanoparticles in simulated wastewater treatment processes and its impact on COD and NH4 reduction” (2012) 87 Chemosphere 248; Y Yang et al., “Potential nanosilver impact on anaerobic digestion at moderate silver concentrations” (2012) 46 Water Research 1176; Y Wang et al., “Fate and biological effects of silver, titanium dioxide, and C60 (fullerene) nanomaterials during simulated wastewater treatment processes” (2012) 201 Journal of Hazardous Matter 16.

60 B Wiechmann et al., Klärschlammentsorgung in der Bundesrepublik Deutschland (Bonn: Umweltbundesamt 2012).

61 K Schlich et al., “Hazard assessment of a silver nanoparticle in soil applied via sewage sludge” (2013) 25 Environmental Sciences Europe 17.

62 Mark Geistfeld, “Scientific Uncertainty and Causation in Tort Law” (2011) 54 Vanderbilt Law Review 1011.

63 Eberhard Feess et al., “Environmental Liability under Uncertain Causation” (2009) 28 European Journal of Law and Economics 133.

64 Case C-378/08 Raffinerie Mediterranee (ERG) SpA v Polimeri Europa SpA and Syndial SpA v Ministero dello Sviluppo economico [2010] ECR I-01919.

65 Stevens & Bolton LLP (2013), The Study on Analysis of integrating the ELD into 11 national legal frameworks, Final Report prepared for the European Commission – DG Environment; Feess, supra note 63.

66 Joint and several liability is a designation of liability by which members of a group are either individually or mutually responsible to a party in whose favour a judgment has been awarded. Joint and several liability is a form of liability that is used in civil cases where two or more people are found liable for damages. The winning plaintiff in such a case may collect the entire judgment from any one of the parties, or from any and all of the parties in various amounts until the judgment is paid in full. In other words, if any of the defendants do not have enough money or assets to pay an equal share of the award, the other defendants must make up the difference. Defendants in a civil suit can be held jointly and severally liable only if their concurrent acts brought about the harm to the plaintiff. The acts of the defendants do not have to be simultaneous: they must simply contribute to the same event. For example, if a number of operators contribute to the cause of environmental damage to water or land then all of them can be held jointly and severally responsible.

67 Nina Liao, “Combining Instrumental and Contextual Approaches: Nanotechnology and Sustainable Development” (2009) Journal of Law, Medicine and Ethics 780.

68 Ibid.

69 BR Bürgi and T Pradeep “Societal implications of nanoscience and nanotechnology in developing countries” (2006) 90(5) Current Science 645.

70 Ibid.

71 Ibid.

72 “Costs” means cost of assessing environmental damage or a threat of environmental damage, assessment of alternative actions, administrative legal and enforcement costs, data collection costs, monitoring and supervision costs.

73 ELD, Art. 8(4)(a).

74 “Emission” is defined as “the release in the environment, as a result of human activities, of substances, preparations , organisms or micro-organisms”.

75 ELD, Art. 8(4)(b), also known as the development risk defence.

77 Nanosilver and titanium dioxide are used together in cosmetics and electronics; titanium dioxide and zinc oxide are used in cosmetics, sunscreens and paint; calcium and magnesium in supplements; nanoceramics and nanosilver used in water filtration and cosmetics.

79 Supra note 15, 294.

80 Jamie Grodsky, “Geonomics and Toxic Torts: Dismantling the Risk-Injury Divide” (2007) 59 Stanford Law Review 1671.

81 Toxicogenomics is the study of the relationship between the structure and activity of the genome and the adverse effects of chemical substances. It combines the emerging technology of geonomics and bioinformatics to identify and characterize the mechanisms of action of known and suspected toxins.

82 Toxicogenetics is a high-speed, high-volume technology which can scan a human genome for chemically-induced changes.

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