Hostname: page-component-78c5997874-mlc7c Total loading time: 0 Render date: 2024-11-10T12:44:47.454Z Has data issue: false hasContentIssue false
  • English
  • Français

Risk versus Hazard – How to Regulate in the 21st Century

Published online by Cambridge University Press:  20 January 2017

Ragnar E. Lofstedt
Get access Rights & Permissions [Opens in a new window]

Extract

In Europe, debate as to whether one should regulate chemicals based on intrinsic hazard or assessment of risk, or possibly a combination of both, has been gaining momentum. This article first provides a brief history of this risk versus hazard debate. Secondly, it examines how European regulators are currently handling the regulation of two chemical compounds, namely Bisphenol A and Deca BDE (a brominated flame retardant), based on forty-five expert interviews with regulators, policy makers and industry representatives in eight Member States, as well as with European Commission officials. The paper shows that there is no clear consensus as to when risk or hazard considerations should be the basis for regulatory decision-making, with wide discrepancies between Member States (e.g. the UK is overall more risk based than Sweden) and between regulatory agencies within Member States. The penultimate section puts forward a series of recommendations to help regulators and policy makers develop more consistent and science based regulations for Europe.

Type
Symposium on Risk versus Hazard
Information
European Journal of Risk Regulation , Volume 2 , Issue 2 , June 2011 , pp. 149 - 168
Copyright
Copyright © Cambridge University Press 2011

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

1 McCormick, J., Environmental Policy in the European Union (Basingstoke, UK: Palgrave 2001)CrossRefGoogle Scholar; Alemanno, A., Trade in Food – Regulatory and Judicial Approaches in the EU and the WTO (London: Cameron May 2007)Google Scholar.

2 Nordlander, K., Simon, C., and Pearson, H., “Hazard vs Risk in EU Chemical Regulation”, 1 European Journal of Risk Regulation (2010), pp. 239–250 CrossRefGoogle Scholar.

3 UK Royal Society, Risk: Analysis, Perception, Management (London: Royal Society 1992)Google Scholar.

4 This paper focuses specifically on approaches to regulation of industrial chemicals rather than providing a broad brush approach examining European regulation.

5 For an in-depth historic account of how regulations are developed in Europe please look at Majone, G. (ed.), Regulating Europe (London: Routledge 1996)CrossRefGoogle Scholar.

6 International Chemical Secretariat, “Risk vs hazard”, available on the Internet at <http://www.chemsec.org/chemsec/the-toxic-issue/risk-vs-hazard> (last accessed on 31 March 2011).

7 European Council, “Council Regulation (EEC) no 793/93 of 13th March 1993 on the evaluation and control of the risks of existing substances”.

8 Fisher, E., “Risk, Regulatory Concepts and the Law”, in OECD (eds), Risk and Regulatory Policy: Improving the Governance of Risk (Paris: OECD 2010)Google Scholar.

9 Health Council of the Netherlands, Not All Risks are Equal, Publication No. 1995 06E, Committee on Risk Measures and Risk Assessment (The Hague: Health Council of the Netherlands 1995).

10 UK Royal Society, Risk Assessment (London: The Royal Society 1983)Google ScholarPubMed.

11 FAO/WHO, Application of Risk Analysis to Food Standard Issues. Report of the Joint FAO/WHO Expert Consultation (Rome and Geneva: FAO/WHO 1995)Google Scholar.

12 Swedish Cabinet Bill, Svenska Miljomal: Miljopolitik for ett hallbart Sverige [1997/1998 145] (Stockholm: Riksdagen 1997)Google Scholar.

13 European Commission, White Paper: Strategy for a future chemicals policy (Brussels: COM 2001 88 Final)Google ScholarPubMed.

14 Lofstedt, R., “Swedish Chemical Regulation: An Overview and Analysis”, 23 Risk Analysis (2003), pp. 411–421 CrossRefGoogle ScholarPubMed.

15 Schorling, I., “The Green's Perspective on EU Chemicals Regulation and the White Paper”, 23 Risk Analysis (2003), pp. 405–409 CrossRefGoogle Scholar.

16 European Council, “Council Regulation (EEC) no 793/93 of 13th March 1993 on the evaluation and control of the risks of existing substances”, supra note 7.

17 European Commission, “Communication from the Commission on the Precautionary Principle” (Brussels: COM 2000 1 Final).

18 Fisher, E., “The Rise of the Risk Commonwealth and the Challenge for Administrative Law”, 30 Public Law (2003), pp. 455–478 Google Scholar.

19 Majone, G., Dilemmas of European Integration: The Ambiguities and Pitfalls of Integration by Stealth (Oxford: Oxford University Press 2005)CrossRefGoogle Scholar.

20 European Commission, “Communication from the Commission on the Precautionary Principle”, supra note 17.

21 European Commission, “First Report on the Harmonisation of Risk Assessment Procedures” (Brussels: DG SANCO), p. 6.

22 For a useful discussion see Lofstedt, R., “The Swing of the Regulatory Pendulum in Europe: From Precautionary Principle to (Regulatory) Impact Analysis”, 28 Journal of Risk and Uncertainty (2004), pp. 237–260 CrossRefGoogle Scholar.

23 European Council, “Regulation (EC) No 2002/178 of the European Parliament and the Council of 28th January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in the matters of food safety” (Brussels: European Council 2002).

24 Vos, E. and Wendler, F., “Food Safety Regulation at the EU Level”, in Vos, E. and Wendler, F. (eds), Food Safety Regulation in Europe (Antwerpen: Intersentia)Google Scholar.

25 van Asselt, M. and Vos, E., “Wrestling with Uncertain Risks: EU Regulation of GMOs and the Uncertainty Paradox”, 11 Journal of Risk Research (2008), pp. 281–300 CrossRefGoogle Scholar.

26 Dreyer, M. and Renn, O., Food Safety Governance: Integrating Science, Precaution and Public Involvement (Berlin: Springer 2009)Google Scholar.

27 See, for example, Vos, E., “Antibiotics, the Precautionary Principle, and the Court of First Instance”, 11 Maastricht Journal (2004), pp. 3–7 Google Scholar.

28 The Pfizer and Alpharma judgments dealt with animal health issues while the Gowan judgment was triggered by the authorization process of a plant protection product.

29 UK HM Treasury, Reducing Administrative Burdens: Effective Inspections and Enforcements ((The Hampton Review) London: HM Treasury 2005)Google Scholar.

30 UK House of Lords, Select Committee on Economic Affairs, Government Policy on the Management of Risk, Volume 1 report (London: The Stationary Office 2006), p. 25 Google Scholar.

31 UK House of Commons, Science and Technology Committee, Scientific Advice, Risk and Evidence Based Policy Making, Volume 1 (London: The Stationary Office 2006), p. 83.Google Scholar

32 This quote can be found in Dressel, M., Bochen, S., Schneider, M., Viehover, W., Wastian, M. and Wendler, F., “Food Safety Regulation in Germany”, in Vos, E. and Wendler, F. (eds), Food Safety Regulation in Europe (Antwerpen: Intersentia 2006), p. 318 Google Scholar.

33 Schorling, I., “This Book: The Only Planet”, in Schorling, I. and Lind, G., The Only Planet Guide to the Secrets of Chemicals Policy in the EU: REACH What happened and Why? (Brussels: European Parliament, The Green/European Free Alliance 2004), p. 3 Google Scholar.

34 In addition one could argue that assessing risks from substances that are directly ingested (via food or as a medicine) is less complex than evaluating exposure to substances via the environment.

35 Wurzel, R., Environmental Policy Making in Britain, Germany and the European Union (Manchester: Manchester University Press 2002)Google Scholar.

36 These interviews were not recorded but summarized after the meeting in question. The information gleaned from them was primarily used to assist the author to gain a wider understanding of the regulatory environment in the country or agency in question. When a regulatory or policy maker was quoted in the text below, this was done so anonymously. Prior to scientific peer review the draft article was sent to the regulators and policy makers who were interviewed to ensure factual correctness.

37 Bernstein, P., Against the Gods: The Remarkable Story of Risk (New York: John Wiley and Sons 1996)Google Scholar.

38 For an in-depth discussion please see Paustenbach, D. (ed.), Human and Ecological Risk Assessment: Theory and Practice (New York: John Wiley and Sons 2002)Google Scholar.

39 US National Research Council, Science and Decisions: Advancing Risk Assessment (Washington DC: National Academy Press 2009)Google ScholarPubMed.

40 Karlsson, M., “The Precautionary Principle, Swedish Chemicals Policy and Sustainable Development”, 9 Journal of Risk Research (2006), pp. 337–360 CrossRefGoogle Scholar.

41 Christoforu, T., “The Precautionary Principle, Risk Assessment, and the Comparative Role of Science in the European Community and the US Legal Systems”, in Vig, N. and Faure, M. (eds), Green Giants: Environmental Policies in the United States and the European Union (Cambridge, MA: MIT Press 2004)Google Scholar.

42 Swedish Committee on New Guidelines on Chemicals Policy, Non Hazardous Products: Proposals for Implementation of New Guidelines on Chemicals Policy [SOU 2000:53] (Stockholm: Fritzes 2000).

43 96/211/EC, “Commission Decision of 26th February 1996 concerning prohibition of pentachlorophenol (PCP) notified by Denmark”, Official Journal LO 68,19/03/1996, 0032-0040.

44 Lofstedt, “Swedish Chemical Regulation: An Overview and Analysis”, supra note 14.

45 Tyshenko, M., Pillips, K., Mehta, M., Poirer, R., and Leiss, W., “Risk Communication of Endocrine-Disrupting Chemicals: Improving Knowledge, Translation and Transfer”, 11 Journal of Toxicology and Environmental Health Part B (2008), pp. 345–350 CrossRefGoogle Scholar.

46 Ulbig, E., Hertel, R. and Bol, G. (eds), Evaluation of Communication on the Differences between “Risk” and “Hazard” (Berlin: Federal Institute for Risk Assessment 2010)Google Scholar.

47 G. Majone, “Dilemmas of European Integration: The Ambiguities and Pitfalls of Integration by Stealth”, supra note 19.

48 D. Paustenbach, “Human and Ecological Risk Assessment: Theory and Practice”, supra note 38.

49 Graham, J. and Wiener, J., Risk vs Risk: Tradeoffs in Protecting Health and the Environment (Cambridge, MA: Harvard University Press 1995)Google Scholar.

50 Applegate, J., “A Beginning Not an End in Itself: The Role of Risk Assessment in Environmental Decision Making”, 63 University of Cincinnati Law Review (1995), pp. 1643–1678 Google Scholar.

51 Montague, P., “Reducing the Harms Associated with Risk Assessments”, 24 Environmental Impact Assessment Review (2004), pp. 733–748 CrossRefGoogle Scholar.

52 Viscusi, W.K., Rational Risk Policy (New York: Oxford University Press 1998)CrossRefGoogle Scholar.

53 Ackerman, B. and Heinzerling, L., Priceless: On Knowing the Price of Everything and the Value of Nothing (New York: The New Press 2004)Google Scholar.

54 Michaels, D., Doubt is Their Product: How Industry's Assault on Science Threatens your Health (New York: Oxford University Press 2008)Google Scholar.

55 McGarity, T. and Wagner, W., Bending Science: How Special Interests Corrupt Public Health Research (Cambridge, MA: Harvard University Press 2008)Google Scholar.

56 Wagner, W., “The Science Charade in Toxic Risk Regulation”, 95 Columbia Law Review, pp. 1613–1720 CrossRefGoogle Scholar.

57 For a good policy overview on BPA see Alemanno, A., “The Fabulous Destiny of Bisphenol A (BPA)”, 1 European Journal of Risk Regulation (2010), pp. 397–400 CrossRefGoogle Scholar.

58 Vogel, S.A., “The Politics of Plastics: The Making and Unmaking of Bisphenol A ‘Safety’”, 99 American Journal of Public Health, S3, pp. 559–566 CrossRefGoogle Scholar.

59 Aschenberger, K., Castello, P., Hoekstra, E., Karakitsios, S., Munn, S., Pakalin, S., and Sarigiannis, D., Bisphenol A and Baby Bottles: Challenges and Perspectives (Ispra: European Commission, Joint Research Centre 2010)Google Scholar.

60 For a good review see K. Aschenberger et al., Bisphenol A and Baby Bottles: Challenges and Perspectives, supra note 59.

61 Krishnan, A., Strathis, P., Permuth, S., Tikes, L., and Feldman, D., “Bisphenol A: An Estrogenic Substance is Released from Polycarbonate Flasks during Autoclaving”, 132 Endocrinology (1993), pp. 2279–2286 CrossRefGoogle ScholarPubMed.

62 Colborn, T., Dumanoski, D. and Myers, J., Our Stolen Future (New York: Penguin Books 1996)Google Scholar.

63 Nagel, S., vom Saal, F., Thayer, K., Boechler, M. and Welshons, W., “Relative Binding Affinity: Serum Modified Access (RBA-SMA) Assay Predicts the Relative in Vivo Bioactivity of the Xenoestrogens Bisphenol A and Octylphenol”, 105 Environmental Health Perspectives (1997), pp. 70–76 CrossRefGoogle Scholar.

64 See, for example, Gray, L. jr., Ryan, B., Hotchkiss, A. and Crofton, K., “Rebuttal of ‘flawed experimental design reveals the need for guidelines requiring appropriate positive controls in endocrine disruption research’ by vom Saal”, 115 Toxicological Sciences (2010), pp. 614–620 CrossRefGoogle Scholar.

65 Vogel, “The Politics of Plastics: The Making and Unmaking of Bisphenol A ‘Safety’”, supra note 58.

66 vom Saal, F. and Huges, C., “An Extensive New Literature Concerning Low-Dose Effects of Bisphenol A shows the Need for a New Risk Assessment”, 113 Environmental Health Perspectives (2005), pp. 926–933 CrossRefGoogle ScholarPubMed.

67 EFSA examined the research findings surrounding Bisphenol A on three separate occasions, most recently in 2010, eg., EFSA, “Scientific opinion of Bisphenol A; Evaluation of a study investigating its neurodevelopmental toxicity, review of recent scientific literature on its toxicity and advice on the Danish risk assessment of Bisphenol A”, 1829 EFSA Journal (2010), pp.1–110.

68 Butterworth, T., Science Suppressed: How America Became Obsessed with BPA (Washington DC: George Mason University’s Center for Health and Risk Communication STATS 2009 Google Scholar).

69 EFSA, “Scientific opinion of the panel on food additives, flavourings, processing aids and materials in contact with food (AFC) related to toxicokinetics of Bisphenol A. Question EFSA –Q-2008- 382”, 759 EFSA Journal (2008), pp. 1–10.

70 Goodman, J., McConnell, E., Sipes, I. et al., “An Updated Weight of the Evidence Evaluation of Reproductive and Developmental Effects of Low Doses of Bisphenol A”, 26 Critical Review of Toxicology 2006, pp. 387–457 CrossRefGoogle Scholar.

71 Gray, G., Cohen, J., Cunha, G. et al., “Weight of the Evidence Evaluation of Low-Dose Reproductive and Developmental Effects of Bisphenol A”, 10 Human Ecological Risk Assessment (2004), pp. 875–921 CrossRefGoogle Scholar.

72 Vom Saal and Hughes, “An Extensive New Literature Concerning Low-Dose Effects of Bisphenol A shows the Need for a New Risk Assessment”, supra note 66.

73 vom Saal, F., Akingbemi, B., Belcher, S. et al., “Chapel Hill Bisphenol A Expert Panel Consensus Statement: Integration of Mechanisms, Effects in Animals and Potential to Impact Human Health at Current Levels of Exposure”, 24 Reproductive Toxicology, p. 134 Google Scholar.

74 Health Canada, “Government of Canada protects families with bisphenol A regulations”, Press release from Health Canada on 17 October.

75 See, for example, Vogel, “The Politics of Plastics: The Making and Unmaking of Bisphenol A ‘safety’”, supra note 58.

76 A. Carterbow, “Joint action of NGOs and scientists to call for a reduction of BPA exposure, especially for children and pregnant women” (Brussels: Women in Europe for a Common Future 2010).

77 vom Saal, F., Akingbemi, B., Belcher, S. et al., “Flawed Experimental Design Reveals the Need for Guidelines Requiring Appropriate Positive Controls in Endocrine Disruption Research”, 115 Toxicological Sciences (2010), pp. 612–613 CrossRefGoogle ScholarPubMed.

78 Ryan, B., Hotchkiss, A., Crifton, K. and Gray, L. jr., “In Utero and Lactational Exposure to Bisphenol A, in Contrast to Ethinyl Estradiol, does not alter Sexually Dimporphic Behaviour, Fertility, and Anatomy of female LE Rats”, 115 Toxicological Sciences (2010), pp. 133–148 CrossRefGoogle Scholar.

79 Vom Saal et al., “Flawed Experimental Design Reveals the Need for Guidelines Requiring Appropriate Positive Controls in Endocrine Disruption Research”, supra note 77.

80 Gray et al., “Rebuttal of ‘Flawed Experimental Design Reveals the Need for Guidelines Requiring Appropriate Positive Design Controls in Endocrine Disruption Research’ by vom Saal”, supra note 63.

81 Quote from Andreas Carlgren comes from a press release issued by the Swedish Ministry for the Environment, “Government preparing a national ban on bisphenol A in baby bottles”, 29 July 2010.

82 EFSA, “Scientific opinion on bisphenol A”, supra note 67.

83 Quote from Per Rosander comes from a press release issued by the International Chemical Secretariat, “EFSA fails to lower EU limit on BPA and protect the health of EU's citizens”, 8 October 2010.

84 Quote from Commissioner Dalli is taken from a press release issued by the European Commission, “Bisphenol A: Commission welcomes ban in baby bottles by Member States”, 26th November 2010.

85 Please see press release from the Dansk Folkeparti, “DF sikrer forbud mod Bisphenol A I sutteflasker”, 26th March, 2010.

86 For an illuminating discussion on the pros and cons of GLP, please see R. Alcock, B. MacGillivray and J. Busby, “Understanding the Mismatch Between Demands of Risk Assessment and Practice of Scientists – The Case of Deca-BDE”, Environment International, doi: 10.1016/j.envint.2010.06.002.

87 Fisk, P., Girling, A., and Wildey, R., Prioritisation of Flame Retardants for Environmental Risk Assessment (Wallingford, UK: UK Environment Agency 2004)Google Scholar.

88 UK Royal Society for Chemistry, Environmental Health and Safety Committee Note on: Why do we worry about brominated flame retardants? (London: Royal Society for Chemistry 2008)Google Scholar.

89 Fisk et al., “Prioritisation of Flame Retardants for Environmental Risk Assessment”, supra note 87.

90 Alcock et al., “Understanding the Mismatch Between Demands of Risk Assessment and Practice of Scientists – The Case of Deca-BDE”, supra note 86.

91 See, for example, Ikonomou, M., Rayne, S., and Addison, R., “Exponential Increases of Brominated Flame Retardants and Polybrominated Diphenyl Ethers in the Canadian Arctic from 1981 to 2000”, 36 Environmental Science and Technology (2002), pp. 1886–1892 CrossRefGoogle ScholarPubMed.

92 International Chemicals Secretariat, Electronics Without Brominated Flame Retardants and PVC – A Market Review (Gothenburg: International Chemicals Secretariat 2010)Google Scholar.

93 Swedish Chemicals Agency, Phase-out of PBDEs and PBBs: Report on a Governmental Commission (Sundbyberg: Swedish Chemicals Agency 1999)Google Scholar.

94 Danish Environment Agency, Brominated Flame Retardants: Substance Flow Analysis and Assessment of Alternatives (Copenhagen: Danish Environment Agency 1999)Google Scholar.

95 German Environment Ministry, Substituting Environmentally Relevant Flame Retardants: Assessment and Fundamentals (Bonn: German Environment Ministry 2000)Google Scholar.

96 Alcock, R. and Busby, J., “Risk Mitigation and Scientific Advice: The Case of Flame Retardant Compounds”, 26 Risk Analysis (2006), pp. 369–382 CrossRefGoogle Scholar.

97 See, for example, US National Academy of Sciences, Toxicological Risks of Selected Flame-Retardant Chemicals (Washington, DC: National Academy Press 2000)Google ScholarPubMed.

98 European Commission, “European Commission Risk Assessment Report Bis (pentabromophenyl) ether” (Luxembourg: Office of the Official Publications of the European Communities 2002).

99 European Commission, “Commission Decision 2005/717/ECexemption of DecaBDE from the prohibition of use” (Brussels: European Commission).

100 MacGillivray, B., Alcock, R., and Bussby, J., “Is Risk-Based Regulation Feasible? The Case of Polybrominated Diphenyl Ethers (PBDEs)”, 31 Risk Analysis (2011), pp. 266–281 CrossRefGoogle Scholar.

101 Case C-14/06 and C-295/06, Parliament v. Commission [2008] ECR p. I-1649.

102 University of Surrey, The Effectiveness of the Furniture and Furnishings (Fire)(Safety) Regulations 1988 (London: Department of Trade and Industry 2000)Google Scholar.

103 Greenstreet Berman, A Statistical Report to Investigate the Effectiveness of the Furniture and Furnishings (Fire) (Safety) Regulations 1988 (London: Department of Business, Innovation and Skills 2009)Google Scholar.

104 Fisk et al., “Prioritisation of Flame Retardants for Environmental Risk Assessment”, supra note 87.

105 Eriksson, P., Jakobsson, E., and Frederiksson, A., “Brominated Flame Retardants: A Novel Class of Developmental Neurotoxicants in our Environment?, 109 Environmental Health Perspectives (2001), pp. 903–908 CrossRefGoogle ScholarPubMed.

106 Busby, J., Alcock, R., and MacGillivray, B., “Interrupting the Social Amplification of Risk Process: A Case Study in Collective Emissions Reduction”, 10 Environmental Science and Policy (2009), pp. 297–308 CrossRefGoogle Scholar.

107 Flynn, J., Slovic, P. and Kunreuther, H. (eds), Risk, Media and Stigma: Understanding Public Challenges to Modern Science and Technology (London: Earthscan 2001)Google Scholar.

108 Gregory, R., Flynn, J. and Slovic, P., “Technological Stigma”, 83 American Scientist (1995), pp. 220–223 Google Scholar.

109 Williamns, A. and DeSesso, J., “The Potential of Selected Brominated Flame Retardants to Affect Neurological Development”, 13 Journal of Toxicology and Environmental Health Part B (2010), pp. 411–448 CrossRefGoogle Scholar.

110 Slovic, P., “Perception of Risk”, 236 Science (1987), pp. 280–285 CrossRefGoogle ScholarPubMed.

111 Not all EU institutions are supportive of precautionary decisions against brominated flame retardants. In a recent decision by the European Parliament and the EU Council of Ministers regarding the Restriction of Hazardous Substances in electrical and electronic equipment (RoHS Directive) the Green MEP rapporteur, Jill Evans, proposed a total ban of all brominated flame retardants which was refused as was her compromise position to list all brominated and chlorinated flame retardants in an annex as priority substances for review. Such an approach would have employed a precautionary hazard approach by targeting these substances as leading candidates for future restriction (Chemical Watch 2010).

112 EC 2375/2001 of 29th November 2001 amending Commission Regulation 466/2001 setting the maximum levels for dioxin and furans (Brussels: European Commission).

113 Leino, O., Tainio, M., and Tuomisto, J., “Comparative Risk Analysis of Dioxins in Fish and Fine Particles from Heavy-Duty Vehicles”, 28 Risk Analysis (2008), pp. 127–140 CrossRefGoogle ScholarPubMed.

114 Anderson, I. and Aune, M., Redovisning av uppdrag rorande gransvarden for langlivade miljoforengar I fisk fran Ostersjoomradet (Uppsala: Swedish Food Administration 2010)Google Scholar.

115 Schapiro, M., Exposed: The Toxic Chemistry of Everyday Products and What's at Stake for American Power (White River Junction, VT: Chelsea Green Publishing 2007)Google Scholar.

116 Naturskyddsforeningen, Rapport: Miljoloften for Europa (Stockholm: Swedish Society for Nature Conservation 2009)Google Scholar.

117 Danish Environmental Ministry, Kemikalie-Handlingsplan 2010– 2013. Sikkerhed i Danmark-samarbejde internationalt (Copenhagen: Danish Environmental Ministry 2010)Google Scholar.

118 Liefferink, D. and Andersen, M., “Strategies of the ‘green’ Member States in EU Environmental Policy Making”, 5 Journal of European Policy (1998), pp. 254–270 CrossRefGoogle Scholar.

119 Vos, “Antibiotics, the Precautionary Principle and the Court of First Instance”, supra note 27.

120 Zander, J., The Application of the Precautionary Principle in Practice (Cambridge: Cambridge University Press 2010)CrossRefGoogle Scholar.

121 Lofstedt, R., Risk Management in Post Trust Societies (Basingstoke: Palgrave/MacMillan 2005)CrossRefGoogle Scholar

122 It is interesting to note that EFSA was specifically set up to provide credible scientific advice, yet government and EU agencies feel comfortable over ruling EFSA's scientific opinions as was the case of Bisphenol A.

123 Vom Saal and Hughes, “An Extensive New Literature Concerning Low-Dose Effects of Bisphenol A Shows the Need for a New Risk Assessment”, supra note 66.

124 See, for example, Oreskes, N. and Conway, E., Merchants of Doubt: How a Handful of Scientists Obscured the Truth on Issues from Tobacco Smoke to Global Warming (New York: Bloomsbury 2010)Google Scholar.

125 R. Lofstedt, F. Bouder, J. Wardman and S. Chakraborty, “The Changing Nature of Communication and Regulation in Europe”, Forthcoming Journal of Risk Research.

126 Hayward, J. and Berki, R., State and Society in Contemporary Europe (Oxford: Robertson 1979)Google Scholar.

127 Schorling, “The Green's Perspective on EU Chemicals Regulation and the White Paper”, supra note 15.

128 McCormick, “Environmental Policy in the European Union”, supra note 1.

129 Lofstedt, “Swedish Chemical Regulation: An Overview and Analysis”, supra note 14.

130 Lofstedt, R., “Are Renewables an Alternative to Nuclear Power? An Analysis of the Austria/Slovakia Discussions”, 36 Energy Policy (2008), pp. 2226–2233 CrossRefGoogle Scholar.

131 Zander,“The Application of the Precautionary Principle in Practice”, supra note 120.

132 The 2 parliamentary questions from A. Corazza-Bildt (MEP-EPP) were “Ban on bisphenol A (BPA) in infant feeding bottles” – Parliamentary question 27th May 2010 and “Fermented Baltic herring” – Parliamentary question 3rd September 2010.

133 Geiser, K. and Tickner, J., New Directions in European Chemicals Policies: Drivers, Scope and Status (Lowell MA: Lowell Center for Sustainable Production 2003)Google Scholar.

134 Zander, “The Application of the Precautionary Principle in Practice”, supra note 120.

135 Lave, L., The Strategy of Social Regulation: Decision Frameworks for Policy (Washington DC: Brookings 1981)Google Scholar.

136 Graham and Wiener, “Risk vs Risk: Tradeoffs in Protecting Health and the Environment”, supra note 49, p. 19.

137 See, for example, Cross, F., “Paradoxical Perils of the Precautionary Principle”, 53 Washington and Lee Law Review (1996), pp. 851–921 Google Scholar.

138 Busby et al., “Interrupting the Social Amplification of Risk Process: A Case Study in Collective Emissions Reduction”, supra note 106.

139 Alcock and Busby, “Risk Mitigation and Scientific Advance: The Case of Flame Retardant Compounds”, supra note 96.

140 Ryan et al., “In Utero and Lactational Exposure to Bisphenol A, in Contrast to Ethinyl Estradiol, Does Not Altersexually Dimporphic Behaviour, Fertility and Anatomy of Female LE Rats”, supra note 79.

141 Viscusi, “Rational Risk Policy”, supra note 52.

142 Lave, L. and Males, E., “At Risk: The Framework for Regulating Substances”, 23 Environmental Science and Technology (1989), pp. 386–391 CrossRefGoogle Scholar.

143 For an excellent historical discussion on the substitution principle please see Nilsson, A., Att byta ut skadliga kemikalier: Substitutionprincipen- en miljorattslig analys (Stockholm:Nerenius and Santerus forlag 1997)Google Scholar.

144 Eurobarometer, “Special Eurobarometer 354: Food-Related Risks” (Brussels: TNS Opinion and Social 2010).

145 Eurobarometer, “Special Eurobarometer 354: Food-Related Risks”, supra note 144.

146 European Council, “Regulation (EC) No 2002/178 of the European Parliament and of the Council of 28th January 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”, supra note 23.

147 International Chemical Secretariat, Electronics Without Brominated Flame Retardants and PVC – A Market Review, supra note 92, p. 2.

148 The quote from Frederick vom Saal can be found in R. Sharpe, “Let Common Sense Guide you in the Saga of Bisphenol A”, Independent, 13 April 2010, p. 39.

149 International Chemical Secretariat, “Electronics Without Brominated Flame Retardants and PVC – A Market Review”, supra note 92.

150 One could also argue that another form of stigmatisation is related to the so called REACH “Candidate List of potential substances for substitution” which is nothing more than a “blacklisting” as chemicals put onto that list are almost impossible to take off.

151 Slovic, “Perception of Risk”, supra note 110.

152 See, for example, Fischhoff, B., Slovic, P., Lichtenstein, S., Read, S. and Combs, B., “How Safe is Safe Enough? A Psychometric Study Towards Technological Risk and Benefits”, 9 Policy Studies (1978), pp. 127–152 Google Scholar.

153 Kasperson, R., Renn, O. and Slovic, P. et al., “The Social Amplification of Risk: A Conceptual Framework”, 8 Risk Analysis (1988), pp. 177–187 CrossRefGoogle Scholar.

154 Pidgeon, N., Kasperson, R., and Slovic, P. (eds), The Social Amplification of Risk (Cambridge: Cambridge University Press 2003)CrossRefGoogle Scholar.

155 Alcock and Busby, “Risk Mitigation and Scientific Advance: The Case of Flame Retardant Compounds”, supra note 96.

156 European Commission, Maximising the Contribution of Science to European Health and Safety (Brussels: DG SANCO 2005)Google Scholar.

157 US Office of Management and Budget-Office of Information and Regulatory Affairs, Final Information Quality Bulletin for Peer Review (Washington, DC: OMB-OIRA 2004).

158 Taverne, D., The March of Unreason: Science, Democracy and the New Fundamentalism (Oxford: Oxford University Press 2005)Google Scholar.

159 Kasperson et al., “The Social Amplification of Risk: A Conceptual Framework”, supra note 153.

160 Horton, R., MMR Science and Fiction: Exploring the Vaccine Crisis (London: Granta 2004)Google Scholar.

161 Davies, N., Flat Earth News (London: Chatto and Windus 2008)Google Scholar.

162 Harrabin, R., Coote, A. and Allen, J., Health in the News: Risk Reporting and Media Influence (London: King's Fund 2003)Google Scholar.

163 Fineburg, H. and Rowe, S., “Improving Public Understanding: Guidelines for Communicating Emerging Science on Nutrition, Food Safety, and Health”, 90 Journal of the National Cancer Institute (1998), pp. 194–199 Google Scholar.

164 For an in-depth discussion on media communication guidelines please see: Lofstedt, R., “Risk communication guidelines for Europe: A modest proposition”, 13 Journal of Risk Research (2010), pp.87–109 CrossRefGoogle Scholar.

165 For a discussion see: Lofstedt et al, “The changing nature of communication and regulation in Europe”, supra note 125.

166 Jordan, G., Shell, Greenpeace and the Brent Spar (Basingstoke: Palgrave/MacMillan 2001)CrossRefGoogle Scholar.

167 UK House of Lords, Select Committee on Science and Technology: Science and Society (London: House of Lords 2000)Google Scholar.

168 Fischhoff, B., “Risk perception and communication unplugged: Twenty years of research”, 15 Risk Analysis (1995), pp. 137–145 CrossRefGoogle Scholar.

169 EFSA, Draft Risk Communication guidelines (Parma: EFSA 2010)Google Scholar.

170 European Commission, “Communication from the Commission on the Precautionary Principle”, supra note 17, p. 3.

171 See, for example, Graham, J. and Hsia, S., “Europe's Precautionary Principle: Promise and Pitfalls”, 5 Journal of Risk Research (2002), pp. 371–390 CrossRefGoogle Scholar.

172 Marchant, G. and Mossman, K., Arbitrary and Capricious: The Precautionary Principle in the European Courts (Washington, DC: AEI 2004)Google Scholar.

173 European Commission, “Communication from the Commission on the Precautionary Principle”, supra note 17.

174 An alternative approach would be to clarify the scope and applicability of the precautionary principle by way of legislation. Indeed, there is an increasing body of case law defining the procedural and factual boundaries of having recourse to that principle. Marchant and Mossman's book, “Arbitrary and Capricious”, supra note 172, is one such attempt in examining how the European Courts have interpreted the principle.

175 Hamburg, M., “Advancing Regulatory Science”, 331 Science (25 February 2011), p. 987 CrossRefGoogle ScholarPubMed.