Risk versus hazard: How to regulate in the 21st century

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.

[1]  Peter Montague,et al.  Reducing the harms associated with risk assessments , 2004 .

[2]  A. Arcuri.  Book Review: The Application of the Precautionary Principle in Practice , 2011, European Journal of Risk Regulation.

[3]  Howard Kunreuther,et al.  Risk, Media and Stigma: Understanding Public Challenges to Modern Science and Technology , 2001 .

[4]  C. Hughes,et al.  An Extensive New Literature Concerning Low-Dose Effects of Bisphenol A Shows the Need for a New Risk Assessment , 2005, Environmental health perspectives.

[5]  B Fischhoff,et al.  Risk perception and communication unplugged: twenty years of process. , 1995, Risk analysis : an official publication of the Society for Risk Analysis.

[6]  Joshua T. Cohen,et al.  Weight of the Evidence Evaluation of Low-Dose Reproductive and Developmental Effects of Bisphenol A , 2004 .

[7]  K. Crofton,et al.  In utero and lactational exposure to bisphenol A, in contrast to ethinyl estradiol, does not alter sexually dimorphic behavior, puberty, fertility, and anatomy of female LE rats. , 2010, Toxicological sciences : an official journal of the Society of Toxicology.

[8]  Lester B. Lave,et al.  At risk: The framework for regulating toxic substances , 1989 .

[9]  K. Crofton,et al.  Rebuttal of "Flawed Experimental Design Reveals the Need for Guidelines Requiring Appropriate Positive Controls in Endocrine Disruption Research" by (Vom Saal 2010). , 2010, Toxicological sciences : an official journal of the Society of Toxicology.

[10]  Paul Slovic,et al.  The Social Amplification of Risk: Contents , 2003 .

[11]  P. Slovic.  Perception of risk. , 1987, Science.

[12]  Dianne Dumanoski,et al.  Our Stolen Future , 1996 .

[13]  Jerry Busby,et al.  Is Risk‐Based Regulation Feasible? The Case of Polybrominated Diphenyl Ethers (PBDEs) , 2011, Risk analysis : an official publication of the Society for Risk Analysis.

[14]  Inger Schörling.  The Greens perspective on EU chemicals regulation and the White Paper. , 2003, Risk analysis : an official publication of the Society for Risk Analysis.

[15]  E. Fisher.  The Rise of the Risk Commonwealth and the Challenge for Administrative Law , 2003 .

[16]  G. Majone.  Dilemmas of European Integration: The Ambiguities and Pitfalls of Integration by Stealth , 2009 .

[17]  Jerry Busby,et al.  Risk Migration and Scientific Advance: The Case of Flame‐Retardant Compounds , 2006, Risk analysis : an official publication of the Society for Risk Analysis.

[18]  Wendy E. Wagner,et al.  The Science Charade in Toxic Risk Regulation , 1995 .

[19]  Frank B. Cross,et al.  Paradoxical Perils of thePrecautionary Principle , 1996 .

[20]  David Michaels,et al.  Doubt is their product : how industry's assault on science threatens your health , 2008 .

[21]  Lisa Heinzerling,et al.  Priceless: On Knowing the Price of Everything and the Value of Nothing , 2004 .

[22]  Annika Nilsson.  Att byta ut skadliga kemikalier : substitutionsprincipen - en miljörättslig analys , 1997 .

[23]  G. Marchant,et al.  Arbitrary and Capricious: The Precautionary Principle in the European Union Courts , 2004 .

[24]  M. Hamburg,et al.  Advancing Regulatory Science , 2011, Science.

[25]  Ortwin Renn,et al.  Food safety governance : integrating science, precaution and public involvement , 2009 .

[26]  G. Bounds,et al.  Risk and regulatory policy : improving the governance of risk , 2010 .

[27]  K A Thayer,et al.  Relative binding affinity-serum modified access (RBA-SMA) assay predicts the relative in vivo bioactivity of the xenoestrogens bisphenol A and octylphenol. , 1997, Environmental health perspectives.

[28]  Mark Schapiro.  Exposed: The Toxic Chemistry of Everyday Products and What's at Stake for American Power , 2007 .

[29]  Sierra Rayne,et al.  Exponential increases of the brominated flame retardants, polybrominated diphenyl ethers, in the Canadian Arctic from 1981 to 2000. , 2002, Environmental science & technology.

[30]  M. Karlsson.  The Precautionary Principle, Swedish Chemicals Policy and Sustainable Development , 2006 .

[31]  T. McGarity,et al.  Bending Science: How Special Interests Corrupt Public Health Research , 2008 .

[32]  B. Fischhoff,et al.  How safe is safe enough? A psychometric study of attitudes towards technological risks and benefits , 1978 .

[33]  Laura N. Vandenberg,et al.  Flawed experimental design reveals the need for guidelines requiring appropriate positive controls in endocrine disruption research. , 2010, Toxicological sciences : an official journal of the Society of Toxicology.

[34]  D. Sarigiannis,et al.  Bisphenol A and baby bottles: challenges and perspectives , 2010 .

[35]  E. Jakobsson,et al.  Brominated flame retardants: a novel class of developmental neurotoxicants in our environment? , 2001, Environmental health perspectives.

[36]  Dick Taverne.  The March of Unreason: Science, Democracy, and the New Fundamentalism , 2005 .

[37]  D. Paustenbach.  Human and Ecological Risk Assessment: Theory and Practice , 2003 .

[38]  J. Graham,et al.  Risk vs. Risk: Tradeoffs in Protecting Health and the Environment , 2009 .

[39]  Ortwin Renn,et al.  The Social Amplification of Risk: A Conceptual Framework , 1988 .

[40]  S. R. Jammalamadaka,et al.  Against the Gods: The Remarkable Story of Risk , 1999 .

[41]  N. Oreskes,et al.  Merchants of Doubt: How a Handful of Scientists Obscured the Truth on Issues from Tobacco Smoke to Global Warming , 2010 .

[42]  J. McCormick.  Environmental Policy in the European Union , 1996 .

[43]  R. Löfstedt.  The Swing of the Regulatory Pendulum in Europe: From Precautionary Principle to (Regulatory) Impact Analysis , 2003 .

[44]  Duncan Liefferink,et al.  Strategies of the 'green' member states in EU environmental policy-making , 1998 .

[45]  Sarah A. Vogel.  The politics of plastics: the making and unmaking of bisphenol a "safety". , 2009, American journal of public health.

[46]  Ragnar E. Löfstedt,et al.  Risk management in post-trust societies , 2005 .

[47]  D. Feldman,et al.  Bisphenol-A: an estrogenic substance is released from polycarbonate flasks during autoclaving. , 1993, Endocrinology.

[48]  Peter M. Wiedemann,et al.  Evaluation of communication on the difference between "risk" and "hazard , 2010 .

[49]  J. Hayward,et al.  State and Society in Contemporary Europe , 1979 .

[50]  K. P. Phillips,et al.  Risk Communication of Endocrine-Disrupting Chemicals: Improving Knowledge Translation and Transfer , 2008, Journal of toxicology and environmental health. Part B, Critical reviews.

[51]  Marko Tainio,et al.  Comparative Risk Analysis of Dioxins in Fish and Fine Particles from Heavy‐Duty Vehicles , 2008, Risk analysis : an official publication of the Society for Risk Analysis.

[52]  John D. Graham,et al.  Europe's precautionary principle: promise and pitfalls , 2002 .

[53]  W. Viscusi,et al.  Rational Risk Policy , 1998 .

[54]  Grant Jordan.  Shell, Greenpeace and the Brent Spar , 2001 .

[55]  Julie E Goodman,et al.  An Updated Weight of the Evidence Evaluation of Reproductive and Developmental Effects of Low Doses of Bisphenol A , 2006, Critical reviews in toxicology.

[56]  J. Busby,et al.  Interrupting the social amplification of risk process: a case study in collective emissions reduction , 2009 .

[57]  H. Fineberg,et al.  Improving Public Understanding: Guidelines for Communicating Emerging Science on Nutrition, Food Safety, and Health , 1998 .

[58]  Kristina Nordlander,et al.  Hazard v. Risk in EU Chemicals Regulation , 2010, European Journal of Risk Regulation.

[59]  Ragnar E Löfstedt,et al.  Swedish Chemical Regulation: An Overview and Analysis , 2003, Risk analysis : an official publication of the Society for Risk Analysis.

[60]  R. Löfstedt.  Risk communication guidelines for Europe: a modest proposition , 2010 .

[61]  Ellen Vos,et al.  Wrestling with uncertain risks: EU regulation of GMOs and the uncertainty paradox , 2008 .

[62]  E. Vos.  Antibiotics, the Precautionary Principle and the Court of First Instance , 2004 .

[63]  J. DeSesso,et al.  The Potential of Selected Brominated Flame Retardants to Affect Neurological Development , 2010, Journal of toxicology and environmental health. Part B, Critical reviews.

[64]  Ragnar E. Löfstedt,et al.  Are renewables an alternative to nuclear power? An analysis of the Austria/Slovakia discussions , 2008 .