Skip to main content
SpringerLink
Log in

Risk Regulation, EU Law and Emerging Technologies: Smother or Smooth?

  • Original paper
  • Published:
NanoEthics Aims and scope Submit manuscript

Abstract

Risk analysis as a regulatory driver has now become firmly entrenched in public health and environmental protection. Risk analysis at any level essentially has to accommodate two gut feelings of the constituency: whether society should be risk-prone or risk averse, and whether government and its institutions can be trusted to make the necessary decisions with a high or a low degree of discretion. The precautionary principle (or rejection thereof) arguably is the ultimate reflection of the promotion of risk to a societal value. There is no doubt that especially amongst the representatives of the Member States (as opposed to the officials at the European Commission), public (pre)caution with respect to the long-term environmental and public health implications of gene technology influenced the reluctance to allow marketing of GM foods and feeds until a strict regulatory regime had been rolled out. Industry would argue that the delay in regulation, as well as the eventual regime was of such a nature as to stifle the technology. This contribution reviews a number of features of standard EU risk analysis decisions, so as to assess its current propensity towards smothering rather than smoothing the introduction of new technology. The current development of a regulatory framework for nanotechnology serves as a case study.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

Notes

  1. George Bush speech to Republican National Convention, 3 August 2000.

  2. See the World Trade Organisation’s Agreement on Sanitary and Phytosanitary Standards–SPS, and the amply analysed decisions of the Panel and the Appellate Body in the EU Hormones case: WT/DS26/AB/R (16 January 1998).

  3. Arguably precisely because of their close links to society’s risk aversion or fondness, risk management patterns are not static and may certainly change over time. Literature has mapped risk management patterns in the USA during the 1960s and 1970s, when the USA led the world in environmental and public health proactiveness, often even in a way which cannot be called but precautionary. See e.g. [15], p. 4 ff.

  4. Ibidem.

  5. Similarly, Chernobyl heavily influenced the not altogether rosy picture painted in [1].

  6. Industrial Union Department, AFL-CIO v. American Petroleum Inst., 448 U.S. 607 (1980; Benzene).

  7. “In promulgating standards dealing with toxic materials (...), shall set the standard which most adequately assures, to the extent feasible, on the basis of the best available evidence, that no employee will suffer material impairment of health or functional capacity even if such employee has regular exposure to the hazard dealt with by such standard for the period of his working life.”

  8. Benzene, note 6 above, at 687.

  9. Congressional directives to the NRC, as quoted in Risk assessment in the Federal Government: Managing the process, Washington, National Academy Press, National Academy of Sciences, 1983, p. 2.

  10. Ibidem, p. 151.

  11. Ibidem.

  12. Ibidem.

  13. Consequently this would in the author’s view not exclude consideration of e.g. environmental issues (stricto sensu, e.g. biodiversity). Hence while the USA may perhaps view ‘scientific risk’ as narrowly focused, risk assessment as understood by the Red Book can include a lot more than strictly defined laboratory risk (compare with [7]). Consequently rather than a conceptual change, US risk analysis may only require a change in practical approach, for it to respond to more ‘modern’ approaches to risk.

  14. Congressional directives to the NRC, note 9 above, pp. 152–153.

  15. While not mentioned by name in the EU Commission’s early 2000 White Paper on food safety [COM (1999), p. 719], the mistakes made in the run-up to the BSE and Dioxin crises heavily inspired the integrated food chain safety approach of the White Paper and of the legislation that resulted from it: Regulation 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety: OJ [2002] L31/1.

  16. Article 3(10) of Regulation 178/2002 (note 15 above): ‘risk analysis’ means ‘a process consisting of three interconnected components: risk assessment, risk management and risk communication’. Article 3(11): ‘Risk assessment’ means ‘a scientifically based process consisting of four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation’. Article 3(12): ‘Risk management’ means the process, distinct from risk assessment, of weighing policy alternatives in consultation with interested parties, considering risk assessment and other legitimate factors, and, if need be, selecting appropriate prevention and control options’.

  17. Note 15 above, p.14 ff.

  18. The latter element refers to the Meroni doctrine of the European Court of Justice, joined cases 9 and 10/56, Meroni e Co, Industrie Metallurgiche, SpA v High Authority. In contrast to the United States, the European Court of Justice (ECJ) has held, in a long line of case-law, that agencies cannot in principle be entrusted with powers that go beyond those for which they do not require discretionary assessment.

  19. European Commission, European Governance—A White Paper, COM (2001), p. 428.

  20. White Paper on Governance, note 19 above, p. 19.

  21. Communication from the Commission on the collection and use of expertise by the Commission: principles and guidelines (improving the knowledge base for better politics), COM (2002), p. 713.

  22. COM (2001), p. 714.

  23. Note 21 above, p. 16.

  24. Rio Declaration on Environment and Development, UN doc A/CONF.151/26 (Vol.1), available via http://www.un.org/documents/ga/conf151/aconf15126–1annex1.htm.

  25. US v Canada, 3 RIAA (1941) 1907.

  26. See for a particularly lucid overview [3].

  27. COM (2000), p. 1.

  28. This is a technical term in the Agreement, obliging the WTO Members to ‘undertake and complete’ procedures leading to sanitary and Phytosanitary measures without undue delay.

  29. Reports of WTO Panel in “European Communities—Measures affecting the approval and marketing of biotech products”, DS291, DS292 and DS293.

  30. Electricity, X-rays, sonar and the like being popular choices: see e.g. Starr, S., Science, risk and the price of precaution, quoted in [12], p. 25 (footnote 58).

  31. Scientific Committee on Emerging and Newly Identified Health Risks—SCENIHR, modified opinion (after public consultation) on the appropriateness of existing methodologies to assess the potential risks associated with engineered and adventitious products of nanotechnologies, SCENIHR/002/05.

  32. With a healthy dose of discussion among NGOs themselves, including with respect to the pros and cons of extensive pro-active involvement in particular of NGO Environmental Defense: see the Environmental Defense/DuPont nano partnership: http://www.environmentaldefense.org/documents/5989_Nano%20Risk%20Framework-final%20draft-26feb07-pdf.pdf.

  33. Friends of the Earth Europe (2006), REACH and nanotechnology—briefing, 5 October, Brussels: FoE Europe, p.1, and proposed Amendments 87, 115, 158, 160, 217, 228, 325 and 333, accepted by the Environment Committee (European Parliament (2006), Recommendation for Second Reading, 13 October, Amendments 24, 56, 79, 87, 161 and 165) but not by the Parliament in plenary.

References

  1. Beck U (1986) Risikogesellschaft. Auf dem Weg in eine andere Moderne. Suhrkamp, Frankfurt

    Google Scholar 

  2. Bowman D, van Calster G (2007) Reflecting on REACH: Global implications of the European union’s chemicals regulation. Nanotechnology Law and Business 4(3):375–384

    Google Scholar 

  3. Fisher E (2002) Precaution, precaution everywhere: developing a ‘common understanding’ of the precautionary principle in the European community. Maastrich J Eur Comp Law 9:7–28

    Google Scholar 

  4. Fisher E (2006) Risk and environmental law: a beginner’s guide. In: Environmental law for sustainability. Hart, Oxford, pp 97–125

    Google Scholar 

  5. Lee M (2005) EU environmental law—challenges, change and decision-making. Hart, Oxford

    Google Scholar 

  6. Linet M, Bailey P (1981) Benzene, leukemia, and the supreme court. J Public Health Policy 2(2):116–135

    Article  Google Scholar 

  7. Marden E (2003) Risk and regulation: US regulatory policy on genetically modified food and agriculture. Boston Coll Law Rev 44:733–787

    Google Scholar 

  8. O’Rourke R (2005) European food law. Sweet & Maxwell, London

    Google Scholar 

  9. Stern P, Fineberg H (eds) (1996) Understanding risk: informing decisions in a democratic society. National Academy Press, Washington

  10. Oud M (2007) A European perspective. In: HodgeGA, BowmanDM, LudlowK (eds) New global frontiers in regulation: the age of nanotechnology. Edward Elgar, Cheltenham

    Google Scholar 

  11. Sunstein C (1996) Health–health tradeoffs. The University of Chicago Law Review, Chicago, p 1533

    Google Scholar 

  12. Sunstein C (2005) Laws of rear. Cambridge University Press, Cambridge

    Google Scholar 

  13. Van Calster G (2006) Governance structures for nanotechnology regulation in the EU. Environmental Law Report, pp 10953–10957

  14. Van der Meulen B, Van der Velde (2004) Food safety law in the European Union. Wageningen Academic, Wageningen

    Google Scholar 

  15. Vogel D (2003) The politics of risk regulation in Europe and the United States. Yearbook of European Environmental Law 3:1–43

    Google Scholar 

  16. Von Schomberg R (2007) From the ethics of technology towards an ethics of knowledge policy and knowledge assessment, working document, January 2007, Publication series of the Governance and Ethics Unit at DG Research, European Commission

Download references

Acknowledgement

Many thanks to an anonymous reviewer for comments on an earlier draft.

Author information

Authors and Affiliations

  1. Collegium Falconis, Tiensestraat 41, 3000, Leuven, Belgium

    Geert van Calster

Authors
  1. Geert van Calster
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Geert van Calster.

Rights and permissions

Reprints and permissions

About this article

Cite this article

van Calster, G. Risk Regulation, EU Law and Emerging Technologies: Smother or Smooth?. Nanoethics 2, 61–71 (2008). https://doi.org/10.1007/s11569-008-0029-8

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11569-008-0029-8

Keywords

Search

Navigation