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The Precautionary Principle in EU and US Chemicals Policy: A Comparison of Industrial Chemicals Legislation

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Regulating Chemical Risks

Abstract

In this chapter, the precautionary principle will be considered as the ­starting point for decision-making on chemicals in cases of scientific uncertainty. The principle will serve as the reference point for an analysis and a comparison of chemicals­ policies and, in particular, of legislation for industrial chemicals in the European Union and the United States of America. In the second section, the precautionary principle will be described on a general level and operationalised with respect to chemicals management. The third section will focus on EU precautionary and chemicals policy and, in particular, on the recently adopted REACH regulation. A similar analysis will be made of US policies in the fourth section, with a focus on the Toxic Substances Control Act. In the fifth and concluding section, the results from the analyses will be compared and discussed with the aim to identify measures that could improve the management of chemicals under uncertainty.

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Notes

  1. 1.

    The latter became evident when the pre-registration of chemicals under the EU REACH regulation came to include over 146,000 chemical substances, 20 times the number anticipated by the EU Commission (Dancet 2009).

  2. 2.

    See further in Hansson and Rudén, Chapter 5 this volume.

  3. 3.

    For a detailed discussion of management of complex environmental risks, see Karlsson (2005).

  4. 4.

    See also e.g. Ashford (2007), de Sadeleer (2007b), Tickner (2003b) and Applegate (2000) for interpretations and accounts of the precautionary principle that partly overlap with the operationalisation below.

  5. 5.

    This follows the so-called ‘maximin-rule’ advocated by e.g. Rawls (1971); see also (Hansson 1997).

  6. 6.

    This is long before common use of the German concept ‘Vorsorge Prinzip’, a fact missed in much of the literature on the precautionary principle, which cites von Moltke ( 1988 ), Boehmer-Christiansen ( 1994 ) and others who claim that the German concept is the original one.

  7. 7.

    See e.g. Krämer ( 2006 ) for an overview.

  8. 8.

    Between 1993 and 2008 only 118 substances had gone through most of the risk assessment process, and only 56 substances had been dealt with completely (ECB 2008 ).

  9. 9.

    REACH is divided into a preamble and titles, chapters and articles, which I will cite when appropriate.

  10. 10.

    It is unclear whether the limit refers to the entire article, and thus often rendering registration exceptional, or to its various components.

  11. 11.

    This is the case as long as pre-registration has taken place or is not required (Article 28).

  12. 12.

    See further in Hansson and Rudén, Chapter 5 this volume, for details on data and test requirements.

  13. 13.

    The basis is the new EU regulation on classification (EC 2008), which implements the GHS (Globally Harmonised System of Classification and Labelling of Chemicals), see further in Bengtsson, this volume.

  14. 14.

    See further de Sadeleer (2007c) on further details of authorisation and its relation to the restriction phase.

  15. 15.

    There are no limitations on how early or how late the sunset date can be set. Furthermore, in spite of non-authorisation, a substance might still be permitted in articles after the sunset date (Article 69(2)).

  16. 16.

    Here, though, restrictions may apply.

  17. 17.

    A substance in Annex XIV is not to be subject to new restrictions (Article 58), unless it entails risks from the presence of the substance in other articles (Article 58).

  18. 18.

    Decisions are made in the same manner as for authorisation.

  19. 19.

    The substances previously restricted under EEC 1976 were transferred to Annex XVII on 1 June, 2009.

  20. 20.

    However, in cases of urgent need for protection, this information can also be disclosed.

  21. 21.

    Non-animal laboratory testing is preferable, but – in order to prevent large-scale risks outside laboratories – must be reliable, which requires scientific guidance, independent expert reviews, etc. (see EDF 2007a).

  22. 22.

    See Hansen et al. (2007) on previous proposals on substitution in the REACH regulatory process.

  23. 23.

    Endangered Species Act 16 U.S.C. §§1533–1539; Clean Water Act 33 U.S.C. §§1311–1317; Clean Air Act 42 U.S.C. §§7409–7412.

  24. 24.

    Ethyl Corp v. EPA, 541 F2d 1 (D.C. Cir. 1976); Lead Industries Association v. EPA, 647 F2d 1139 (D.C. Cir. 1979).

  25. 25.

    These include PCBs (Title I, Section 6(e)), asbestos (Title II), radon (Title III) and lead (Title IV).

  26. 26.

    I will use the numbering as TSCA was enacted (e.g. Section 8 corresponds to §2607 in the U.S.C.), and I will cite sections, subsections, paragraphs and subparagraphs, as appropriate.

  27. 27.

    ‘Substantial’ and ‘significant’ are defined by EPA (EDF 2007a).

  28. 28.

    million pounds equals 454 (metric) ton.

  29. 29.

    Ideas for managing industry data are presented by Applegate and Baer (2006), e.g. measures for increased transparency, penalising overuse of confidentiality claims and creating a registry of study results.

  30. 30.

    The EPA originally proposed 23 chemicals.

  31. 31.

    There are several exemptions for e.g. polymers, intermediates, R&D and low volumes, even though many granted exemptions are controlled (GAO 2007).

  32. 32.

    Corrosion Proof Fittings v. EPA, 947 F.2d 1201 (5th Cir. 1991). See also Harremoës et al. (2001).

  33. 33.

    Applegate (2008) focuses on the three decades between the CEQ and TSCA in 1971/1976, and the White Paper and REACH in 2001/2006, respectively, and analyzes the pairs as thesis and anti-thesis. Evidently, REACH is a reaction, but more to previous EU law than to TSCA, even if there were similarities between these.

  34. 34.

    This depends on the situation; not all tests are always needed.

  35. 35.

    The HPVC Program is based on potentially 18 tests. For details, see also Table 4 in EDF (2007a).

  36. 36.

    See further important suggestions in e.g. Hansen et al. (2007).

  37. 37.

     See e.g. GAO (2005), Applegate (2000), Wagner (2000) and GAO (1994).

  38. 38.

    EU and U.S. risk policies have influenced each other quite a lot over time; see Löfstedt and Vogel (2001).

  39. 39.

    See e.g. the Report from the University of Pittsburgh’ Seminar ‘REACH: A New EU Approach to Chemicals Safety: Lessons for the United States’, on June 7–9, 2007, which gathered together several scholars and bureaucrats (see www.ucis.pitt.edu/euce/events/policyconf/07).

  40. 40.

    This contrasts sharply with the critical view of REACH in the previous administration, see H. R. (2004).

  41. 41.

    Bill S. 3040, by Senators Lautenberg, Menendez, Whitehouse, Clinton and Kerry, and Bill H. R. 6100, by Reps. Solis and Waxman.

  42. 42.

    See Heyvaert, this volume, who analyzes REACH as a blueprint for an international risk governance model.

  43. 43.

    See also important proposals in e.g. Denison (2009) and Ditz (2007).

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  1. School of Life Sciences, Södertörn University, SE 141 89, Huddinge, Sweden

    Mikael Karlsson

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  1. , Department of Political Science, Södertörn University, Alfred Nobels allé 7, Flemingsberg, 14189, Sweden

    Johan Eriksson

  2. , Department of Political Science, Södertörn University, Alfred Nobels allé 7, Flemingsberg, 14189, Sweden

    Michael Gilek

  3. , Philosophy Unit, Royal Institute of Technology, Teknikringen 78B, Stockholm, 10044, Sweden

    Christina Rudén

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Karlsson, M. (2010). The Precautionary Principle in EU and US Chemicals Policy: A Comparison of Industrial Chemicals Legislation. In: Eriksson, J., Gilek, M., Rudén, C. (eds) Regulating Chemical Risks. Springer, Dordrecht. https://doi.org/10.1007/978-90-481-9428-5_14

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